BSI_May-2016_Raj Gunashekar

1An MM Activ Publication | www.biospectrumindia.com | May 2016 | BioSpectrum

Volume 14 Issue 5 May 2016 www.biospectrumindia.com

An Publication

`100

Tota

l pag

es in

clud

ing

cove

r 68

EMERGINGNEW WAVE OF

THERANOSTICS

‘MAKE IN INDIA’ IMPACT ON BIOSCIENCES SECTOR ELECTRONIC WEARABLE INJECTOR A REALITY

BIOANALYSIS BIOSUPPLIERS

A COMBINATION OF DIAGNOSIS WITH THERAPY GEARED TO REVOLUTIONIZE

THE WORLD OF HEALTHCARE.

ANNOUNCINGANNOUNCING

DECEMBER 02-05, 2016RESHIMBAGH GROUND, NAGPUR MAHARASHTRA, INDIA

Workshop National Expo Conference

Book Now and Avail Early Bird Offer!Supported By Organized By

To be a Sponsor, Exhibitor, Delegate kindly contact: Agrovision SecretariatNew Delhi : Kusum +91 72760 01696 Ph.: +91-011-4354 2737Nagpur: Vinay +91 97647 96709 Ph.: +91-0712-2544 929 | Pune: Dipak +91 99232 02884 Ph.: +91-20-2729 1769Email : [email protected] | [email protected]

Connect With Us

#agrovisionindia

www.agrovisionindia.in

4 BioSpectrum | May 2016 | www.biospectrumindia.com | An MM Activ Publication

Volume 14 Issue 5 May 2016 www.biospectrumindia.com

An Publication

`100

Tota

l pag

es in

clud

ing

cove

r 68

EMERGINGNEW WAVE OF

THERANOSTICS

‘MAKE IN INDIA’ IMPACT ON BIOSCIENCES SECTOR ELECTRONIC WEARABLE INJECTOR A REALITY

BIOANALYSIS BIOSUPPLIERS

A COMBINATION OF DIAGNOSIS WITH THERAPY GEARED TO REVOLUTIONIZE

THE WORLD OF HEALTHCARE.

COVERDESIGN BY: SHIHAB K A

BioContents

REGULARS

7 BIOEDIT

8 BIOMAIL

13 BIONEWS

52 BIOSUPPLIERS

53 BIOPEOPLE

COVERSTORY 18

BIOSUPPLIERS

ELECTRONIC WEARABLE INJECTOR A REALITY55

BIOTALK

10

Dr Anne Lindblad director, EMMES

WE HAVE NO PLANS TO LEAVE INDIA

40

Ms Elizabeth BaileyDirector, Consortium for Affordable

Medical Technologies (CAMTech)

INDIA WILL BECOME A LEADER IN MEDTECH SPACE

60

Mr Christiaan EngstromPresident, Cell Culture Company

BIOSIMILARS ARE OPENING UP NEW OPPORTUNITIES

BIORESEARCH

BioSpectrum takes a look at the opportunities that wearables offer for the healthcare sector and how this technology can become an indispensable part of the healthcare system.

WIPE HEALTH WOOS WITH WEARABLES46

EMERGING NEW WAVE OF

THERANOSTICSA combination of diagnosis with therapy geared to revolutionize and disrupt the world of healthcare diagnostics


BioContents

BIOANALYSIS

IS INDIAN HEALTHCARE READY FOR BIG DATA ANALYTICS?

25

LUNG CANCER BURDEN OF ASIA57

BIOCOLUMN20TH ANNIVERSARY OF THE GLOBAL COMMERCIALIZATION OF GM CROPS

36

Clive James Founder and Emeritus Chair, ISAAA

BIOPRENEUR

FIB-SOL Team -- (L-R) Mr N K Gokul, Mr Anant Raheja, Dr Kavitha Sairam & Ms G Saranya)

‘BELIEVE AND TAKE THE LEAP OF FAITH’

62

ANATOMIZ3D Team – (L-R) Mr Sohrab Kothari, Mr Sagar Shah, Ms Shruti Kale, Mr Samkit Shah, Mr Ameeth Deshpande, & Ms Firoza Kothari

ANATOMIZING 3D PRINTING65

BioSpectrum tries to find out how the ‘Make in India’ campaign has affected the pharma and medtech sector.

‘MAKE IN INDIA’ IMPACT ON BIOSCIENCES SECTOR

31

https://twitter.com/BioSpectrumMag

facebook.com/BioSpectrumMagazine

bit.ly/BS-LinkedIn

To subscribe online, visit http://bit.ly/1YZEMil

Or call Srinivas Rasoor +91-9845039237

www.biospectrumIndia.com


BioEdit

The Narendra Modi govern-ment has given something for the national biotech sector to smile in

April 2016. A five-year wait to set up the country’s first Inter-disciplinary University for Life Sciences and Biotechnology has borne fruit under Mr Modi’s leadership on April 26, 2016. This historic occasion happened

when the Regional Center for Biotechnology (RCB) Bill 2016, piloted by Minister for S &T, Dr Harsh Vardhan, was approved by the Lok Sabha on that day. RCB, currently functioning from a 200-acre campus as part of the Biotech Science Cluster in Faridabad in the National Capital Region (NCR) has been functioning on the basis of an executive order since June 2010.

Set up in collaboration with the United Na-tions Educational, Scientific and Cultural Organization (UNESCO), RCB will be an in-ternational facility open to citizens of all the countries in India’s neighborhood to develop highly trained human resources in biotech-nology. The Parliamentary approval process will be complete when the upper house (Rajya Sabha) too gives its approval to the legislation.

The legislative approval grants the status of an institution of national importance to RCB, set up at a cost of Rs 100 crore that can grant degrees directly to students. Currently there are hundreds of life science departments in universities and a large network of public and private research centers that are affiliated to various universities. RCB will be the first uni-versity dedicated only to biotechnology. The private Shoolini University of Biotechnology and Management in Himachal Pradesh has its footprint restricted to only the state.

In a relatively short period, students and facul-ties of RCB have made a mark, winning many na-tional laurels. RCB will now be able to showcase

India’s expertise in biotechnology to the world and also take up a lot more inter-disciplinary activities that involve people in areas such as-nanotech, vaccine development, implantable devices, diagnostics and stem cell biology.

The RCB Bill was introduced in the Lok Sabha in 2011 but it was not taken up for discussion and lapsed with the dissolution of the House in 2014. In December 2015, the Modi govern-ment approved a revised RCB Bill and apart Parliamentary approval has come in just four months. This is certainly a demonstration of the government’s commitment to finally fulfil an international obligation given to UNESCO 10 years ago when the UN agency approved setting up this center in India.

Of course, the biotech industry will be more happy when the long pending legislation to set up a single biotech regulatory authority also gets the Parliamentary approval. The Biotechnology Regulatory Authority of India (BRAI) Bill, sent to Parliament for approval in August 2011, has lapsed. The Modi government has not so far re-vealed its stand on sending a revised version of it for Parliamentary approval. Various govern-ment agencies are currently studying a volumi-nous 2,000-page note on its pros and cons.

There is also a talk of junking the bill in its present form and incorporate its provisions in various existing legislation as the single biotech regulatory agency concept has been opposed vehemently by many civil society or-ganizations. Also the wranglings between vari-ous ministries on who will be the administra-tor too has not been resovled.

More twists and turns could be expected in the BRAI bill saga in the near future. BS

Narayanan Suresh Group Editor

[email protected]

I ndia gets firstbiotech university


Vol 14; Issue 4; April 2016

BioSupplier Technologies The coverage of recent innovations and BioSupplier tech-nologies that are helpful in expediting the drug discovery was informative. It was interesting to read about the latest tools and technologies available in the market to help re-searchers on the path of drug discovery.

The articles were very useful and many of them suggest novel solutions. Looking forward to more informative ar-ticles in the future.

Anshul Khandelwal, Mumbai

Wrong numbersThis is with reference to the online news story on Bio-Spectrum India website, ‘POC diagnostics market to rise to $3 bn by 2021.’ I respectfully disagree to the forecast claimed as above, because we are working in POCT indus-try, and know the challenges associated with penetrating the healthcare field, and resistance to pay premium of

instant, reliable, diagnostics report.You may contact me and I would be happy to providemore details.

Tushar Barad via website

Interesting interviews Your interview with 2016 Padma Awardees in sciences in the April issue covered important areas of research status in India. Research in India is quite far behind countries like China, the US and the UK. Research should be en-couraged and we need to have quality researchers. Also, scientists mentioned lack of proper funding.

We need to address that and make science a lucrative ca-reer choice, so as to attract more talent in this field.

Somehow, science has lost its sheen to more rewarding careers like IT.Overall,Ifind the interviews very inspiring and made forvery engaging read.

Shivi Jain, Bhopal

BIOSPECTRUM

LATEST BIOSUPPLIER TECHNOLOGIES

APRIL 2016

Volume 14 Issue 4 April 2016 www.biospectrumindia.com

An Publication

`100

Tota

l pag

es in

clud

ing

cove

r 84

India’s

trillion-dollar

opportunities

in ICT, IoT

LATESTBIOSUPPLIERTECHNOLOGIES



BIOTALKPadma ShriAwardee,Prof. DipankarChatterji

BIOTALKPadma ShriAwardee,Prof. VeenaTandon

BIOTALKPadma BhushanAwardee,Dr Alla VenkataRama Rao

ARTICLES BYTHE INDUSTRY CAPTAINS

Vol 14; Issue 5; May 2016

Publisher: Jagdish Patankar

EditorialChief Editor: Narayanan SureshExecutive Editor: Srinivas RasoorSenior Correspondent: Raj Gunashekar

ProductionAssistant Editor: Ajay GhatageSub-Editor: Ayesha Siddiqui

DesignDesign: Shihab KA

Sales and MarketingAVP - Sales & MarketingGurunath S AngadiSr Manager Sales: Vikas MongaAsst Manager (Digital): Priyamvada BhideSr. Product Executive: Pavana Praveen

Print & CirculationGM, Print Services: T SrirenganAudience Service: Sarita Shridhar (E-mail:[email protected])Press Coordinator: Harak Singh

BangaloreMM Activ Sci-Tech Communications#9, UNI Building, Thimmaiah Road, Millers Tank Bund, Vasanthnagar, Bangalore - 560 052Tel.: +91-80-41131912/13

MumbaiMM Activ Sci-Tech Communications133, Kaliandas Udyog Bhavan, Babasaheb Woralikar Marg, Near Century Bazaar, Mumbai - 400 025Tel. No: +91 22 2438 5007/8/9

PuneAvinash GulguleMM Activ Sci-Tech CommunicationsAshirwad, 36/A/2, S.No. 270, Pallod Farms, Near Bank of Baroda, Baner Road, Pune- 411045Tel. No: +91 20 2729 1769

New DelhiMM Activ Sci-Tech Communications103-104, Rohit House3, Tolstoy Marg, Connaught Place, New Delhi - 110 001Tel. No: +91 11 4354 2737

HyderabadY V L N MurthyMM Activ Sci-Tech CommunicationsFlat 205, Sai Sharmistha Residency, Springfields Colony, Jeedimetla Village, Hyderabad-500055, Telangana State Mob: +91 9246577114

Chennai & Kerala Krishna Kumar VMM Activ Sci-Tech CommunicationsMagattuparampil House, 1st Floor, Lakshmi Nivas, Kannankulangara Kidangu Road, Thrippunithura, Eranakulam, Kerala, Pin:682301Tel: +91 484 2777997Mob: +91 9526 44 3331

INTERNATIONAL

SingaporeManager Admin & Sales Support: Saradha Mani#14-06, High Street Centre, 1 North Bridge Road, Singapore - 179094Tel: +65-63369142Fax:+65-63369145

USAMedia Representative: Ms Leslie Hallanan Avani Media Inc., 80 Liberty Ship Way, Suite 25, Sausalito, CA 94965 USATel.: +1-415-3312150 E-mail: [email protected]

EuropeMedia Representative: Mr. Stuart Smith Global Media Sales Limited PO BOX 1126, Bromley, Kent, BR1 9TX United KingdomTel: +44-(0)20-8464-5577E-mail: [email protected]

Printed and published by Jagdish B. Patankar on behalf of MM Activ Sci-Tech Communications Pvt LtdPrinted at Rakesh Press, A-7 Naraina Industrial area, Phase II, New Delhi - 110 028 and

Published from 103-104, Rohit House, 3 Tolstoy Marg, Connaught Place, New Delhi - 110 001Editor: N SureshWebsite: www.biospectrumindia.com

Our Offices - Editorial and Business

91-22-41515151 / 41515111

[email protected]

[email protected]

Nilsan Nishotech Systems Pvt Ltd

Plot No. -199E,MIDCThane Belapur Road,

Khairane, Navi Mumbai 400 705


BioTalk

Located in Bangalore and Maryland, USA, EMMES Services, a contract research orga-nization, set its foot in India in 2006, with a mission to contribute to India’s public health challenges and the clinical research as a whole.

The company is backed by strongly skilled professionals including statisticians, epidemiologists, biomedical sci-entists, data management and information technology professionals, and support personnel, who are necessary to initiate and complete all aspects of clinical projects.

“In 2006 the clinical research environment was very dif-ferent. Eighty percent of our work in the US are through

BioTalk

Though the clinical research industry in India has been, and is going through tumultuous ordeal, Dr Anne Lindblad, director, EMMES, says that it hasn’t impacted her organization as much as other CROs.

We have no plans to leave India


BioTalk

national institutes of health. Often they carry out global trials, and sometimes in partnerships and collaborations with biotech companies and the industry, or at times on their own. Now, things have changed in India. But having an India office has helped us even in the US. We would like to create relationships with people that will be long-term, and show our value by working along with them,” explained Dr Anne.

“It is an unfortunate occurrence. Things can be much more streamlined. The population here still has public health needs and requires access to medicines. I’m con-fident that as we move forward things will work through, and again we’ll be able to have clinical trials in India more efficiently through the regulatory process,” she added op-timistically.

Pulling out of IndiaThe change in the regulatory process is an essential re-quirement as it has big effects on CROs. As a result of unclear, stringent and impractical regulatory guidelines, many CROs pulled out their operations out of India, and others moved to Eastern Europe and different countries which have simplified clinical research regulations.

“We have no plans to move our operations to other coun-tries. We feel that India is an important place to stay. We think that, besides pharma, there is potential opportu-nitiesin helping physicians at hospitals, addressing pub-lic health issues, learning risk factors for diseases in the country and improvising care. It’s a matter of time. We are not trying to become the biggest CRO in India, but

rather, we want to be the most important, and improve the health scenario in India,” Dr Anne asserted.

Numerous CROs have also knocked on the doors of China because of its simplified regulatory process.

“Middle Eastern Europe is another place where people are researching in this area. India is working on its own regulations and when it is complete, it will be much eas-ier.We understand it is going to take a long time and we are here for long-term. Even in this regulatory situation, we can still contribute to hospitals for pragmatic stud-ies that may help understand risk factors, improve public health, and how it impacts the outcomes of the patients,” she stated.

Clear regulatory pathShe held that a more pragmatic approach is what will propel the future. “It should all come back to a rational approach with proper monitoring ensuring human sub-jects are protected appropriately for the research that they are volunteering to do,” she remarked.

According to her observation, providing a very clear guidance in how to get through the regulatory hurdles to launch a trial seem to change frequently in India.

Despite the looming uncertainties, she confidently voiced, “Soon we are hoping that this will become clear to companies as to what needs to be done, or even chart out the steps needed to be taken by national institutes in the US to partner, so that it is a fair and plain field for

We feel India is an inportant place to stay. Besides pharma there is potential opportunities in helping physicians at hospitals

Dr Anne Lindblad director, EMMES


BioTalk

everybody.”

Most CRO clients’ hope to get assisted in terms of getting through the regulatory hurdles.

“That’s a challenge for any CRO because the rules here keep changing,” Dr Anne noted. “Our strength is that we have a very strong root in biostatistics and analysis.Armed with that, we can help various organizations in In-dia for consulting, analysis, providing publications with data from India, and provide directions for the next steps in healthcare.”

Entrepreneurs & innovatorsThe company’s clients in India are a mix from biotech firmstomid-sized pharma organizations. It has also worked much with government agencies, both in the US and India.

As for EMMES, collaboration, certainly, is one of its im-portant goals. “We are ready to carry out clinical trials or research, which could be alongitudinal study or obser-vational, and not just about getting drugs approved,” Dr Anne said.

EMMES, in the US, has been around for 38 years, and has carried out over a 1,000 clinical trials in 40 different countries in multiple disease areas. It directly works for 12 of the 27 national institutes of health in the US.

Dr Anne has visited Indian incubators and is impressed-by the country’s investments in young budding entrepre-neurs with great ideas. “That’s an area where we can work along with those entrepreneurs in developing their ideas further. One of things that would make India a leader is the support of entrepreneurs and innovators in the bio-sciences,” she emphasized.

Research in US vs IndiaHailing from a rich experience in the US, Dr Anne noted that the funding mechanism in India is different from what it is in the US.

“In the US, there is government funding, and it is very clear as to how to gain access to those fundings. The

amount of fundings available for public agencies in India is very less. The regulatory environment further bolsters the hurdles. So funding and regulatory are very much a big differentiator between the two countries. Thus, launching a trial in India is tougher than in the US,” she stressed.

India has a great diversity of population, not only in terms of genetics, but also in access to care and information, both at patient level and physician level. She observed that a lot is being done in India to create centers of excel-lence to train investigators on evidence-based approach as they gear to tackle health problems in India.

“In the US too, we haven’t solved the same problems completely either. But in India it is at a different scale. I’m very encouraged to see how much the government is taking interest in trying to improve in these areas. And we want to be a part of these developments,” Dr Anne opined.

Growth driversDr Anne highlighted that EMMES, unlike other CROs, is not driven by randomized clinical trials.

“What drives us is carrying out research that has results, and can be published in scientific literature that will change practice. When the regulatory hurdles in India changes, other CROs are going to come back here, but we are going to stay the same and our mission is not going to change. Our drivers will be the investments that India is putting into entrepreneurs and innovators. Regulatory should see to find a proper balance in patients’ safety, and yet not shutting enterprises, which we have witnessed in the last few years,” she said.

“Getting to be known is a major challenge,” she said while speaking about market entry challenges in India. “It has been 9 years in India, and we are getting to know the challenges. The challenge are getting a foot-in-the-door. This will improve and we’ll gain momentum as we work in India.”

Dr Anne expressed her excitement about the opportuni-ties in India and her organization’s role in contributing to its public health. “Our future plans are organic, and to meet as many like-minded institutions and researchers to develop relationships, and enable our staff to do more that will impact the Indian population. That’s our mis-sion and goal,” she ended. BS

Raj Gunashekar & Ayesha Siddiqui

Our future plans are organic, and to meet as many like-minded instutions and researchers to develop ties


BioNews

New threat againstaffordable medicinesin trade negotiationsAccess to affordable medicines could be severely restrict-ed for millions of people around the world under the cur-rent proposals in the Regional Comprehensive Economic Partnership (RCEP) trade agreement,the international humanitarian medical organization Médecins Sans Fron-tières (MSF) warned.

“Proposals in the RCEP negotiations are trying to intro-duce intellectual property measures far tougher on access to medicines than what is required under international trade rules”, said Ms Leena Menghaney, South Asia Head of MSF’s Access Campaign.“If accepted, the agreement would restrict access to affordable generic medicines for peoplein many countries that will be part of the agree-ment-including Indonesia, Thailand, Myanmar, Cambo-dia and Laos - and for the millions of people around the world who rely on lifesaving affordable generic medicines from India.”

“Many of the intellectual property provisions that have been tabled mirror those in the Trans-Pacific Partnership agreement, considered the worst trade deal ever for ac-cess to medicines”, said Brian Davies, East Asia Head for MSF’s Access Campaign.’’Countries that did not join the TPP-particularly India and key members of the Associa-tion of Southeast Asian Nations (ASEAN)-will be pushed to adopt similar standards in the RCEP negotiations.”

Themeasures that would harm access to affordable medi-cines are all the more concerning given India is one of the countries included in the RCEP negotiations. India - of-ten known as the ‘pharmacy of the developing world’ for its wide-scale production of generic medicines-supplies life-saving affordable medicines needed to treat commu-nicable and non-communicable diseases in developing countries.

Two-thirds of all the drugs MSF purchases to treat HIV, TB and malaria are generic medicines from India.

BioNews

Biotech/GM crops planted on 2 billion hectaresfrom 1996 to 2015International Service for the Acquisition of Agri-Biotech Applications (ISAAA) released its annual report detail-ing the adoption of biotech crops,” 20th Anniversary of the Global Commercialization of Biotech Crops (1996-2015) and Biotech Crop Highlights in 2015,” showcasing the global increase in biotech hectarage from 1.7 million hectares in 1996 to 179.7 million hectares in 2015. This 100-fold increase in just 20 years makes biotechnology the fastest adopted crop technology in recent times, re-flecting farmer satisfaction with biotech crops.

Since 1996, 2 billon hectares of arable land - a massive area more than twice the landmass of China or the United States - have been planted with biotech crops. Additional-ly, it is estimated that farmers in up to 28 countries have reaped more than $150 billion in benefits from biotech crops since 1996. This has helped alleviate poverty for up to 16.5 million small farmers and their families annu-ally totaling about 65 million people, who are some of the poorest people in the world.

“More farmers are planting biotech crops in developing countries precisely because biotech crops are a rigorous-ly-tested option for improving crop yields,” said Clive James, founder and emeritus chair of ISAAA, who has authored the ISAAA report for the past two decades. For the fourth consecutive year, developing countries planted more biotech crops (14.5 million hectares) than industri-alized countries.


BioNews

SAGE issues recommendations to WHO for using dengue vaccineThe SAGE advises that countries with high dengue transmission consider introduction of the dengue vaccine as part of an integrated disease preven-tion strategy including vector control to effectively lower their dengue dis-ease burden.

Successful introduction of dengue im-munization alongside other preven-tion efforts should help endemic coun-tries to achieve the WHO objectives to reduce dengue morbidity by 25% and mortality by 50% by 2020.

“We welcome these recommendations for Dengvaxia from SAGE, the advisory group to the WHO, for vaccines and immunization,” said Dr Elias Zerhouni, MD, President of global R&D, Sanofi. “Dengvaxia has been approved in four countries already, including Mexico and Brazil, which have regulatory au-thorities recognized by WHO. These WHO SAGE recommendations further validate the scientific and medical value of Dengvaxia and send a clear message to endemic countries about the strong public health benefit to be gained by

introducing the dengue vaccine in in-tegrated disease management efforts to combat their dengue burden.”

Dengvaxia vaccine’s anticipated im-pact on dengue fever disease burden is expected to stem from the vaccine’s proven ability to prevent 8 out of 10 dengue hospitalizations and up to 93% of severe dengue cases -- including dengue hemorrhagic fever -- in study participants 9 years and older, as dem-onstrated during 25 months of follow-up of phase III efficacy studies.

Healthcare sector to reachover $280 bn by 2025

NATHEALTH, Healthcare Federa-tion of India, an apex body for the healthcare sector partnered with De-loitte to present imperatives and de-velop recommendations for actual-izing ‘Make in India’ for the medical devices industry and released ‘Code of Ethics’ in collaboration with In-dian Medical Association (IMA).

“The healthcare sector is expected to reach $145 billion by 2018 and over $280 billion by 2025. Though India’s healthcare sector has evolved signifi-cantly in the last decade,challenges exist in providing access to quality healthcare in the country,” saidAn-jan Bose, secretary general, NA-THEALTH.

“Lower financing and expenditure on healthcare, inadequate healthcare infrastructure and dual diseases bur-den are key challenges faced by the sector,” addedBose.

Medical technology cost in setting up a tertiary care hospital amounts to 30-40 percent. Cost of medical tech-nology/equipment/devices is 20-25

percent of total healthcare cost for a patient.

“Given the increasing demand for healthcare and the critical role of medical devices in providing afford-able and accessible health, the time is right to align the eco system to view medical devices as a strategic driver. The ‘Make in India’ initiative is the perfect opportunity to create a

step change in Indian healthcare and especially in the medical devices in-dustry,” said MsCharu Sehgal, part-ner and Life Sciences and Healthcare Leader, Deloitte India.

The medical devices market is esti-mated to grow organically at 15 per-cent to $8.6 billion by 2020. Though the current domestic medical devices market represents only 1 percent of the global market, India is among the top 20 in the world and among the top 4 in Asia (after China, Japan, South Korea). The medical devices market has grown at 10 percent in the past decade and is expected to have an organic growth of 15 percent in the medium-term against global industry growth of 4-5 percent,” in-formed Sushobhan Dasgupta, presi-dent, NATHEALTH.

Industry estimates that India’s medi-cal devices market has the potential to become $50 billion industry by 2025 when the contribution of India to the incremental medical devices industry growth would become sub-stantial at 31 percent.


BioNews

Sun Pharma receives FDA approval for BromSiteSunPharma has announced that one of its wholly owned subsidiaries has received approval from USFDA for its New Drug Application (NDA) related to BromSite (brom-fenac ophthalmic solution) 0.075% for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.

BromSite is the first non-steroidal anti-inflammatory drug (NSAID) approved by the USFDA to prevent pain and treat inflammation in the eye for patients undergoing cataract surgery; other NSAIDs in this class are currently indicated for the treatment of inflammation and reduc-tion of pain.

BromSite developed by InSite Vision, is the first brom-fenac ophthalmic solution formulated in DuraSite, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability, and residence time as compared to conventional topical therapies.

Sun Pharma acquired InSite Vision in November 2015 and is likely to commercialize BromSite through its newly

formed, US-based division, Sun Ophthalmics, in the sec-ond half of 2016.

Sun Ophthalmics has crossed a key business milestone through BromSite’s approval. Sun Ophthalmics targets to provide eye care practitioners products that enhance their practice patterns and treatment options and to de-liver those products through its unique, concierge level approach to customer care.

With BromSite’s approval and additional late-stage can-didates in its pipeline, Sun Ophthalmics is strongly posi-tioned to offer a range of beneficial products and estab-lish itself as a respected and trusted partner.

“Over the years, I’ve worked closely with the InSite team and watched them develop multiple high quality products using the DuraSite platform,” commented Dr Richard L Lindstrom, MD, founder and attending surgeon of Min-nesota Eye Consultants and Adjunct Professor Emeritus at the University of Minnesota Department of Ophthal-mology.

Sanofi invests €300 million to expand biologics site in Belgium

The investment in Geel, Belgium, fur-thers Sanofi’s commitment to driving the future of biologics by expanding manufacturing and commercial ca-pabilities in order to ensure quality, capacity, and scale.

Through the investment, Sanofi plans to adapt and expand existing production capabilities to support Sanofi’s pipeline of monoclonal an-tibodies.

Updates to the existing facility will include the development of new lab-oratories focused on quality control and manufacturing sciences.

“This investment not only strength-ens our goal of becoming a leader in biologics but represents our focus on patients’ needs,” said Philippe Lus-

can, Executive Vice President, Global Industrial Affairs and President of Sanofi in France. ‘‘We have a robust development pipeline of biological molecules, including monoclonal antibodies, and this investment fur-thers our work and expertise in key disease areas such as cardiovascular disease, rheumatoid arthritis, and atopic dermatitis. This is an exciting

opportunity for our site in Geel and we are very pleased with the support we received from the Government of Flanders, the Flanders Investment and Trade and the Flanders Entre-preneurship agency.”

Sanofi and its specialty care global business unit, Sanofi Genzyme, have already invested €600 million in the Geel site, which began industrial bio-tech activities in 2001.

The site is currently responsible for the global production of a protein therapy for Pompe disease, a rare, genetic muscular disease that is of-ten fatal.

The protein therapy is produced us-ing cell cultures in large bioreactors, followed by a purification process.


BioNews

Merck Animal Health to acquire rights to Whisper Veterinary Stethoscope SystemMerck Animal Health (known as MSD Animal Health outside the United States and Canada)has announced plans to acquire worldwide rights for the Whisper Veterinary Stethoscope System from Minnesota-based Geissler Com-panies.

The Whisper Veterinary Stethoscope System is a Bovine Respiratory Disease (BRD) detection system which is used to determine the severity of an animal’s lung condition so that the ap-propriate treatment regimen can be started to protect the health of the animal.

Bovine Respiratory Disease is the most com-mon disease affecting cattle in North America.This complex, multi-factorial infection affects the upper and lower respiratory tracts and can often be fatal, causing billions of dollars in eco-nomic losses for farmers. Identifying the cause of the disease and appropriate treatment path-ways is vital to maintain an infected herd.

“We are pleased to add the Whisper Veteri-nary Stethoscope System to our comprehensive portfolio of vaccines and pharmaceutical prod-ucts for the cattle industry,” said Rick DeLuca, President, Merck Animal Health.

‘‘It is important to provide our customers with the most innovative solutions available today that will meet their needs to maintain healthy stock and advance animal well-being.”

Orchid receives FDA nod for Rasagiline generic formulationChennai-based Pharma major, Orchid Pharma, has received final approval from the US FDA for its ANDA (Abbreviated New Drug Application) for Rasagiline Tablets 0.5 mg and 1 mg. This product is a FTF (First-to-file) application with a shared 180-day exclusiv-ity for Orchid.

Orchid expects to launch this product in Q4 of FY 16-17. Rasagiline Mesylate Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.

With a market size of over $300 million and limited generic com-petition, Orchid hopes to garner a decent market share from this product launch.

Pfizer terminates proposed merger with AllerganPfizer has announced that the merger agreement between Pfizer and Allergan has been terminated by mutual agreement of the companies. The decision was driven by the actions announced by the US Department of Treasury on April 4, 2016, which the com-panies concluded qualified as an ‘Adverse Tax Law Change’ under the merger agreement.

“Pfizer approached this transaction from a position of strength and viewed the potential combination as an accelerator of existing strategies,” stated Ian Read, chairman and chief executive officer, Pfizer. “We remain focused on continuing to enhance the value of our innovative and established businesses. Our most recent prod-uct launches, including Prevnar 13 in Adults, Ibrance, Eliquis and Xeljanz, have been well-received in the market, and we believe our late stage pipeline has several attractive commercial opportuni-ties with high potential across several therapeutic areas. We also maintain the financial strength and flexibility to pursue attractive business development and other shareholder friendly capital al-location opportunities.”

“We plan to make a decision about whether to pursue a potential separation of our innovative and established businesses by no lat-er than the end of 2016, consistent with our original timeframe for the decision prior to the announcement of the potential Allergan transaction,” continued Read. ‘‘As always, we remain committed to enhancing shareholder value.”

In connection with the termination of the merger agreement, Pfiz-er has agreed to pay Allergan $150 million for reimbursement of expenses associated with the transaction.


BioNews

Lupin to market Novartis’ inhaler in IndiaPharma major Lupin and Novartis Healthcare (NHPL) have entered into a co-marketing agreement to promote Novartis’s Indacaterol/Glycopyrronium 110mcg/50mcg inhaler, a treatment for chronic ob-structive pulmonary disease (COPD) under the brand name of Loftair.

Lupin would be using its own specialty field force to promote Loftair inhaler. NHPL will continue to market Indacaterol/Glycopyrronium 110mcg/50mcg inhaler under its brand name Sequadra through its own sales force.

Loftair is a fixed dose combination of two bronchodi-lators: Indacaterol maleate, a long-acting beta2-adren-ergic agonist (LABA) and glycopyrroniumbromide, a long-acting anticholinergic (LAMA) for the treatment of COPD. The once daily Indacaterol/Glycopyrronium combination significantly reduced the rate of moderate or severe exacerbations by 31% compared to the current standard of care (SFC twice-daily salmeterol + flutica-sone combination) in patients with moderate-to-severe chronic obstructive pulmonary disease.

This combination has also shown superior efficacy vs SFC (salmeterol/fluticasone) for lung function, breathlessness (assessed using the Transition Dys-pnea Index), health-related quality of life (measured using the St George’s Respiratory Questionnaire) and on-demand (rescue medication) salbutamol use. Inda-caterol/Glycopyrronium combination is approved for use in COPD in 82 countries including US, EU, Japan, Canada, countries within Latin America and Australia. The agreement helps address the growing incidence of COPD, by making better treatment options available to patients in India.

Announcing the agreement, Shakti Chakraborty, group president, India Region Formulations, Lupin said, “We at Lupin are excited about the expansion of our ongo-ing partnership with Novartis Healthcare Private Lim-ited (NHPL) for the Inhalation/COPD segment. We had previously entered into a similar agreement with NHPL to market Onbrez. We are confident that this partner-ship for Loftair will enable us to further consolidate and strengthen our market leadership within the Indian COPD, Anti-Asthma, Inhalation therapy segments.”

Illumina files patent infringement suitagainst Genoma SAIllumina has announced that it, and its wholly owned subsidiary, Verinata Health (together Illumina), filed a patent infringement suit against Genoma SA in the Fed-eral Patent Court in Switzerland. Illumina is seeking all available remedies, including damages and injunctive relief.

The patents asserted are European Patent (CH) 2 183 693 B1, European Patent (CH) 0 994 963 B2, European Patent (CH) 1 981 995 B1, and European Patent (CH) 2 514 842. The patents are directed to using cell-free fetal DNA for non-invasive prenatal testing (NIPT).

The suit accuses Genoma’s Tranquility NIPT testing ser-vice, including its use of next-generation sequencing to analyze cell-free DNA from a sample of maternal blood.Genoma’s testing facility in Switzerland also services samples collected from its other labs, including those located in Spain and Italy.

“We will continue to monitor activities in the NIPT field and file suits where appropriate to protect our substan-tial investments in this technology covered by our intel-lectual property,” said Charles Dadswell, Senior Vice-President and General Counsel for Illumina.

The Tranquility NIPT service uses the IONA Test sold by Premaitha Health. Illumina previously filed separate suits against Premaitha in the United Kingdom for sale of the IONA Test.


CoverStory

CoverStory Raj Gunashekar

Imagine a very tiny capsule injected

just below the skin of your arm.

The capsule has a sensor

capable of continuously

measuring blood glucose

levels and sends the

information to your

phone. Well, let’s spice

it up one level above the

notch. Say, when the blood

glucose level crosses its

threshold, visualize the tiny

little capsule releasing a dose of

insulin in your blood stream. What

this does is offer total freedom from

regular needle pricks to measure blood sugar

levels, and frees patients from the anxiety of

taking the right insulin doses at the right time.

EMERGING NEW WAVE OF

THERANOSTICS

www.kromasil.com

Kromasil ClassicShellExpanding opportunitiesKromasil ClassicShell columns arebased on solid-core particles andintended for the analysis of samplemixtures in various areas ofresearch as well as quality controlin pharmaceutical, environmental,food and beverages and industriallaboratories.

AkzoNobel / KromasilSeparation Products, SE445 80 Bohus, Sweden,tel: +46 31 58 70 00, email:[email protected]

C Abhaykumar & Co.117, Hindustan Kohinoor Indust. CoL B S Marg, Vikhroli (W)Mumbai 400083 (India)tel: +91-22-40764-700/701email: [email protected]

Shreetech Associates156/5120 PrasadNew Tilaknagar, Chembur,Mumbai 400089 (India)tel: +91-22-6522 5762email: [email protected]

Our authorized partners in India:

www.kromasil.com

Kromasil ClassicShellExpanding opportunitiesKromasil ClassicShell columns arebased on solid-core particles andintended for the analysis of samplemixtures in various areas ofresearch as well as quality controlin pharmaceutical, environmental,food and beverages and industriallaboratories.

AkzoNobel / KromasilSeparation Products, SE445 80 Bohus, Sweden,tel: +46 31 58 70 00, email:[email protected]

C Abhaykumar & Co.117, Hindustan Kohinoor Indust. CoL B S Marg, Vikhroli (W)Mumbai 400083 (India)tel: +91-22-40764-700/701email: [email protected]

Shreetech Associates156/5120 PrasadNew Tilaknagar, Chembur,Mumbai 400089 (India)tel: +91-22-6522 5762email: [email protected]

Our authorized partners in India:


CoverStory

SCIENCE FICTION OR REALITY?

Nope, this isn’t something straight out of a Steven Spielberg’s upcoming science fiction movie. This is Ther-anostics. A combination of diagnosis with therapy geared to revolutionize and disrupt the world of healthcare diagnostics.

“The idea of Theranostics is old,” says Dr Biplab Bose, an Associate Profes-sor in the Department of Biosciences and Bioengineering at the Indian Institute of Technology (IIT), Guwa-hati. “However, the term was coined and gained popularity in recent times, thanks to the development of targeted drug-delivery, microfluid-ics, and nanotechnology. Both in In-dia and abroad, extensive work is go-ing on to use targeted nano-delivery systems for Theranostics. A prime focus on this is to create drug loaded nanoparticles that are suitable for both in-vivo imaging and as well as for targeted drug-delivery.”

Theranostics is the development and use of molecules for both diagnostics and therapeutic purposes, thereby providing precision medicine to pa-tients first in a clinical setting for fur-ther understanding their diseases at

molecular level, and then prescribing specific medicines.

“For example,” adds Dr Aman Shar-ma, the Founder of Pune-based start-up ExoCan Healthcare Technology which focuses on Oncodiagnostics and Therapeutics space, “fever in different patients has similar symptoms like rise in the body temperature. Howev-er, it may occur due to different infec-tions. Hence, detecting the infection, whether bacterial or virus, accurately and then providing specific therapy is addressed by Theranostics.”

The classic example is the use of Her-ceptin drug, a monoclonal antibody (mAb), against HER2 receptor, a specific protein expressed in almost 30% of breast cancer patients, to treat grade IV breast cancer patients.

Theranostics approach would be to first identify HER2 over-expression in breast cancer patients by a diag-nostic test, and then prescribe Her-ceptin as a drug to those who have this over-expression.

In other words, Theranostics deliver customized treatment plan for pa-tients, resulting in the availability of right drug, for the right patient, at the right time.

“This combining of therapeutic and diagnostic modalities for personal-ized treatment of patients enhances drug efficacy and ensure patients safety,” comments Dr Arumugam Muruganandam, MD & CSO of Ban-galore-based Affigenix Biosolutions. “At present in India, patient-centered care which focuses on integrating two disciplines such as imaging and therapy for targeted drug-delivery at the site of action is in limited prac-tice except in specialty hospitals for cancer and cardiovascular diseases (CVDs).”

INDIAN THERANOSTICS SCENE

India is yet to get its share of mod-ern Theranostics field. There are a few start-up companies in India that are operating in the Theranostics and personalized medicine in general.

“Theranostics and personalized med-icine are very nascent sectors in In-dia, as compared to the West, where personalised medical approaches have reached the clinic on a much larger scale,” shares Dr Nilay Lakh-kar, Founder & CEO, SynThera Bio-medical, a start-up focusing on man-ufacturing and commercialization of biomaterials-based medical devices.

Unfortunately, Indian pharma companies are slow to pick the thread from laboratories, and have not yet built upon the developments that have happened in academic labs…”

Dr Arumugam Muruganandam MD & CSO, Affigenix Biosolutions

Dr Nilay Lakhkar Founder & CEO, SynThera Biomedical


CoverStory

The West may be early adopters of the evolving field of Theranostics into their routine healthcare as it promotes safer and more efficacious pharmacotherapies to patients which is supported by patients, and encour-aged by insurance companies.

“Whereas in India, we may gradu-ally implement Theranostics across urban areas as it becomes affordable with appropriate testing systems, and expertise becomes available,” re-marks Dr Arumugam.

Currently in the West, a severe dis-ease like cancer is treated through precision medicine. For example, mutational typing of a cancer is first performed and the right therapy or drug is then prescribed based on the mutation.

Considering the Indian population and its disease burden, Theranos-tics will eventually enter the Indian healthcare market in a big way in the next couple of years.

“In the next 5 or 6 years, we would see some form of Theranostics in clinical use, particularly for solid tumours. I

believe oncologists along with radi-ologists will probably be the first to introduce Theranostics in clinics,” Dr Biplab predicts.

However, the key question is whether India will be able to develop any such products indigenously?

There are several lacking factors, points Dr Biplab. “Factors include lack of access to advanced instru-ments. India is lacking in the de-velopment of real-life microfluidic devices. However, Indian scientists have gained reputation in the field of nano-materials, including nano-drug delivery systems. Unfortunately, In-dian pharma companies are slow to pick the thread from laboratories, and have not yet built upon the de-velopments that have happened in our academic labs,” he stresses.

Also, the patients in India are not much clinically educated. “One of the fundamental issue is cost fac-tor, and the absence of active clini-cal trials and proper counselling in government hospitals; and lack of high throughput facilities are among many reasons which retard the de-

velopment of opportunities in Ther-anostics in our country,” highlights Dr Aman.

The key areas of Theranostics have developed rapidly in the last few years including Photo-Immunother-apy (PIT), and nano-particle-based drug-delivery and imaging systems. “We may soon see some successful clinical trials in these two segments,” reveals Dr Biplab.

In a way, personalized medicine, Theranostics and precision medi-cine are all interlinked from the view point of treatment.

Dr Arumugam explains, “It is all about the right drug, at the right time, for the right patients. Ther-anostics mainly refers to treatment strategy that combines therapeutics with diagnostics as one treatment unit. Personalized medicine imply that drugs are being customized for each individual patient. In precision medicine, the dosing regimen is de-signed for patients based on drugs used, condition to be treated, ge-netics, environmental and lifestyle factors.”

Theranostics require active collaboration between academia, clinicians and the industry. In India such collaborations are rare, if not absent…”

Dr Biplab Bose Associate Professor, Department of Biosciences and Bioengineering, Indian Institute of Technology (IIT) Guwahati

Dr Aman Sharma Founder & CSO, ExoCan Healthcare Technology


CoverStory

Theranostics is important for both personalized as well precision medi-cine, feels Dr Biplab.

“I would say, it is important more for precision medicine. Take the ex-ample of a drug-delivery system that combines targeted drug-delivery and imaging of drug-delivery. Such drug-delivery system would allow the phy-sician to deliver the drug to specific location as well as confirm it by imag-ing,” he notes.

INDIA’S OPPORTUNITIES AT HAND

Indian population is genetically very diverse. Scientifically, the West-built Theranostics tools may not work well for Indian population.

Moreover, the mutations or genomic anomalies present in the Western population may not be harbored by the Indian patients due to different genetic makeup.

Dr Aman explains, “Hence, develop-ment of indigenous pool of databases for Theranostics in various diseases is what we should start with. Three vital opportunities lie ahead for Theranos-tics in India. Firstly, disease-specific database (diabetes, heart disease, and cancer can be taken on priority) generation for personalized medicine by genotyping known mutations and validation of existing biomarkers.

“Secondly, setting up minimal infra-structure for Theranostics tests in hospital level settings. Lastly, there must be patient counseling centres in-side hospitals to make patients aware of their disease type. Economically, we are one of the biggest markets for Theranostics as mentioned earlier due to very divergent genetic makeup of the population. The government can encourage public-private partnerships to promote Theranostics research in

collaboration with pharma and bio-technology giants and improve infra-structure for such opportunities.”

For advanced diseases like cancer, the greater diversity in Indian popu-lation creates a window of opportu-nities for Theranostics or precision medicine.

Dr Nilay opines that opportunities do exist for Indian companies to focus on cutting-edge Theranostics prod-ucts and services with demands be-ing driven by a growing, affluent, and knowledgeable patient pool.

“However, the Indian market for per-sonalised medicine is still very much a niche market focused on high-net-worth individuals (HNWIs), and up-per middle-class consumers, since these therapies are highly expensive, and not yet easily scalable,” he justi-fies.

Dr Biplab believes that the first use of Theranostics would probably be in oncology clinics, where physicians would use targeted drug-delivery for solid tumours, and would be able to image or monitor such delivery in real-time.

“Cancer is one of the leading causes of death in India, and its burden is increasing. Unlike many other dis-ease, precision medicine is crucial in cancer. In near future, we may see several players in cancer Theranos-tics to enter the Indian market,” adds Dr Biplab.

India also has vast potential to ex-ploit the Theranostics especially in nano Theranostics for patient care, provided the regulation and funding support system helps in the discovery by academic sector; development by biopharma sector; and adoption by healthcare providers for personalized treatment.

STRICT COMPETITION?Experts believe that the real completion is yet to begin per-haps due to great investments required in any Theranostics pro-grams.

One of the reasons is that it re-quires a huge sample base to start with, and compilation of information to reach statistical end-points.

“Subsequently, that information is then put-up into R&D to de-sign effective therapies for pa-tients. The whole process is far more costly than just develop-ing a common drug which would be used by bulk and unsorted population. Though, the field has far reaching implications for mankind, it is yet to take off to reach to its newer heights,” says Dr Aman.

Dr Arumugam also believes that though Theranostics has good potential it does not have any competition at the moment.

“In India, both doctors and pa-tients may prefer to go with ‘one-size-fits-all’ approach, and continue with trial-and-error method for treating patients. Potential impact on revenue by the ‘slice-and-dice’ approach in selecting patients for personal-ized treatment will prevent wide acceptability by bigger hospital managements and biopharma companies, and may resist to change,” he emphasizes.


CoverStory

“The middle income group popula-tion is growing in India, and medical tourism is on the rise, and my guess is that wealthy patients may be more willing to pay for personalized treat-ments,” Dr Arumugam says.

OVERCOMING OBSTACLES

Therapy and diagnosis go hand-in-hand, and both are expensive for a country like India,

“Patient affordability is going to be a big challenge,” stresses Dr Arumu-gam. “There is also perceived loss of opportunity by drug manufacturers for particular drug to be used by cher-ry-picking patients for treatments as it reduces the market potential of the drug. Educating doctors, patients, in-surers and regulators will be a chal-lenge as Theranostics does not pro-vide guaranteed outcome yet.”

Theranostics is closely related to patients. “Hence we should educate more patients about their disease types and right therapies, and how it can enhance lifesaving chances in case of a deadly disease,” recom-mends Dr Aman.

There is a need for the existence of certain private equity bodies, venture capitalists and government schemes who can invest in high-risk upcom-ing areas like Theranostics.

It also calls for setting up infrastruc-ture to create biobanks, tissue banks, and minimal research setups in hos-pitals and medical colleges for creat-ing our own indigenous databases.

Dr Aman continues, “One of the most important shortcomings is the lack of good research in this area in our country. The government should set up special grants schemes to promote biological research in Theranostics,

and should also make a provision to bring research entities, medical col-leges, and hospitals under one um-brella to make the best use of existing knowledge and resources.”

Just like drug development, work on Theranostics requires clarity on specific clinical requirements, under-standing market dynamics, and the limitations of current technologies.

“Therefore, successful development of a Theranostics requires active col-laboration between academia, clini-cians and the industry. In India such collaborations are rare, if not ab-sent,” Dr Biplab mentions.

THE FUTURE

In longer terms, Theranostics would pave the way for a healthier world around us.

Advancement in nanotechnology, biosensors, bioelectronics, pharma-cogenetics, cancer immunotherapy, biomarker profiling, companion di-agnostics, and the ability to combine therapeutic and diagnostic capabili-ties into one single agent (nanoma-terials) have already started a ripple effect in healthcare.

“The only limiting factor is going to

be the affordability for personalized treatment,” states Dr Arumugam.

In the future, patients who suffer from chronic diseases will have a combination of wearable devices and implantable Theranostics.

Dr Biplab observes, “These will mon-itor our critical health parameters in real-time and intervene at the right time. Considering the speed in de-velopment of micro-fabrication and micro-electronics, I believe, such de-vices will be in our homes within the next 10 years.”

Five years down the line, break-throughs in Theranostics R&D may bring down treatment costs, and in-crease scale-up potential.

“A focus on building strategic part-nerships with global players in the pharma and diagnostics sectors may be the way forward for Indian com-panies in this space,” suggests Dr Nilay.

Through Theranostics, the treat-ment costs might go up initially, but a faster disease recovery would be ensured.

Dr Aman voices, “Theranostics might improve patient survival chances es-pecially in cancer and heart disease patients. In totality, a greater health, emotional, and life security is what the goal of Theranostics is.”

At the moment, India does not have a statistical data on molecular nature of disease(s) among the Indian popu-lation.

Nevertheless, combining the three major diseases including diabetes, heart disease, and cancer, Theranos-tics market should value anywhere between $300-500 billion in the next 5 years. BS


BioAnalysis

BioAnalysis

The buzz word Big Data Analytics no doubt has lot of applications in healthcare starting from basic research to clinical trials. But are lifesciences and healthcare firms realizing the opportunities that big data brings to healthcare? And most importantly, how relevant it is for Indian healthcare system and is our country

ready to exploit analytics in healthcare. BioSpectrum tries to find out.

IS INDIAN HEALTHCARE READY FOR BIG DATA ANALYTICS?


BioAnalysis

Primary objective of big data analyt-ics is to discover new knowledge from multiple dissimilar data sources to create actionable values that has high impact, says Prahalad Achutharao, Founder & CEO, InterpretOmics, In-dia’s first data sciences company that provides state of the art genomics software solutions to pharma, bio-tech, CROs and healthcare organisa-tions.

He added, “For example, which dis-eases are co-morbid? Bangalore is considered the breast cancer capital of India; whereas Vidarbha is consid-ered as the oral cancer capital of In-dia. The answer to the question ‘why’ will require terabytes of data to be processed that will include, genomic data, phenotypic data, clinical data, and of course environmental data.”

By analyzing trends and comparing them to stored knowledge base, we can achieve a significant number of predictions and put in place proac-tive disease management protocols.

“The power to access and analyze enormous data sets can improve our ability to anticipate and treat illnesses better. This data can help throw light on individuals who are at risk for serious health problems. The ability to use big data to identify gaps in the healthcare system can also lower the cost of healthcare across

the board,” says Ravi Ramaswamy, Senior Director of Healthcare at Phil-ips Innovation Campus (PIC).

ARE HEALTHCARE FIRMS LEVERAGING ANALYTICS IN HEALTHCARE?

By and large most of the firms (healthcare and life sciences) are try-ing to understand the potentials of big data, however, the adoption is still at nascent stage in India and has been minute compared to the oppor-tunities and potential of big data.

Healthcare sector, in general, lags behind some other industries in us-ing data and analytics to improve quality lower cost.

“In life sciences, big data analytics is a key way to translate gene sequences into actionable genomic targets. In healthcare services, big data analyt-ics is used less frequently because the uses are less well established and because of the high cost of acquir-ing the necessary data and technical expertise. That said, more and more companies see the need for big data analytics and are making strategic plans to incorporate it,” said Huse.

Apollo Hospitals, for example, is us-ing big data analytics in many areas.

“We are using big data analytics for

By analysing trends and comparing them to stored knowledge base, we can achieve significant number of predictions

Mr Ravi Ramaswamy

Senior Director of Healthcare at Philips Innovation Campus (PIC).

POTENTIAL AND PROMISES OF BIG DATA

The most evident and apparent ap-plication of big data is in the area of precision medicine, but that’s not all. Healthcare is a very big domain and big data has a lot of potential in how we envisage disease.

“Apart from precision medicine, there is optimism that big data ana-lytics will help improve care. For ex-ample, big data technologies have the potential to reduce avoidable read-missions, enable new research proj-ects, and track patient vital statistics in real time,” said Dan Huse, Vice-President, MarketScan Databases and Tools, Truven Health Analytics.

According to Dr Anurag Agrawal, Principal Scientist, CSIR Institute of Genomics & Integrative Biology and Associate Professor, AcSIR and Bay-lor College of Medicine, USA, said, “Big data analytics is relevant not just to the personalized health man-agement an individual patient, as is promised by precision medicine, but towards reinventing healthcare it-self. For example, even the semantic framework of medicine e.g. disease names like diabetes, asthma etc., would be changed if we could see dif-ferent clusters of risks and outcomes within each disease.”


BioAnalysis

infection control and surveillance. This initiative was recently recog-nized as the winner of the 2016 – Microsoft innovation awards. The implementation of the analytical tool brought the process of analysis and clinical DSS (decision support sys-tems) to near real time. The process that used to typically take three weeks is now made real-time at bedside and available for direct clinical decision support within the EMR,” said Ar-vind Sivaramakrishnan, Member, FICCI Sub-committee on Electronic Health Record (EHR).

The value for big data in healthcare today is largely limited to research because using big data requires a very specialized skill set.

The industry is still far from using big data for commercial healthcare applications to its full potential says Rama Chandra Dash, Business Unit Leader, IBM Watson Health, India Software Lab.

He explains, “The reason being: in the present state of healthcare indus-try, all the 4 V’s (4 Vs volume, variety, veracity, velocity) that defines big data are relevant, but the industry is swamped with some very pedestrian problems such as regulatory report-ing and operational dashboards. Most just need the proverbial ‘air and water’ right now, but once basic needs are met and some of the initial advanced applications are in place, new use cases will arrive (e.g. wear-able medical devices and sensors) driving the need for big data style so-lutions.”

RISK AND CHALLENGES

Healthcare is a high risk service where life and death decisions need to be taken and big data has its own set of challenges.

“Companies will need to pay atten-tion to daily operational necessities such as security and privacy require-ments, systems management, data access, government regulations, en-cryption and where necessary, data obfuscation and de-identification. There is a risk that companies will invest a lot of time and money in developing a big data analytic infra-structure and not obtain the expected return on investment,” said Huse.

Data transparency pose another challenge. “Over a period of time, India will build a staggering amount of healthcare data but it would be spread among hospitals, primary care providers, researchers, health insurers, and state and central gov-ernments — just to name a few. Each of these acts as a silo, preventing data transparency across the healthcare system,” said Ravi Ramaswami.

Perhaps the biggest challenge is to tackle the issue of patient privacy as data privacy in healthcare is of prime importance.

“In addition to aggregating a massive amount of data, there’s the challenge of maintaining patient privacy. Fig-uring out how to leverage that infor-mation to deliver better quality care to patients while keeping it secure is a major challenge, and one that all organizations are taking seriously,” said Ramaswami.

Variety of data is another key chal-lenge for big data analytics. “The data can be structured, unstructured or semi-structured. Deriving insights from handwritten notes of doctors and medical practitioners through image recognition has a certain de-gree of error associated with it. The data collected from fitness gadgets, social media research and other sources are unstructured compared to the data collected traditionally

Mr Rama Chandra Dash Business Unit Leader, IBM Watson Health, India Software lab

Mr Dan Huse Vice President, MarketScan Databases and Tools, Truven Health Analytics

Dr Anurag Agrawal Principal Scientist, CSIR Institute of Genomics & Integrative Biology and Associate Professor, AcSIR and Baylor College of Medicine, USA


BioAnalysis

by hospitals. Deriving insights from such a variety of data is a challenge in itself,” said Rohit Verma, CEO, iPre-dictt. iPredictt Data Labs is a big data analytics start-up that provides ma-chine learning software to B2C com-panies to solve their complex data challenges.

Several issues will have to be ad-dressed to capture the full potential of big data. Policies related to pri-vacy, security, intellectual property, and even liability will need to be ad-dressed in a big data world.

“Organizations need not only to put the right talent and technology in place but also structure workflows and incentives to optimize the use of big data. Access to data is critical — companies will increasingly need to integrate information from multiple data sources, often from third par-ties, and the incentives have to be in place to enable this,” said Ramas-wamy.

BIG DATA: HYPE OR HOPE FOR BETTER HEALTH OUTCOMES?

Definitely not hype and it is not a hope any longer – it is a reality says Dr Asoke Talukder, co-founder and Chief Scientific Officer, Interpre-tOmics India.

“Big data analytics is clearly a hope for better health outcomes. The exe-cution of the big data analytics needs to be carefully planned and executed in order to reach the desired out-comes. This clearly means that the right levels of investment of time and effort has to be done. Mere financial investment cannot assure results. The quality of human resources in-vested in this process is crucial and must be at the right levels at every stage of the initiative,” said Sivara-makrishnan.

It is not a hype but everyone jumping onto it without realizing its potential or application is a cause for worry says Dr Debojyoti Dhar, Founding Member & Director (Business Devel-opment and Innovation) at Leucine Rich Bio.

Leucine Rich Bio is a bioinformatics driven company based in Bangalore, India, specializing in Next Genera-tion Sequencing (NGS) Data Analysis & Interpretation.

Big data analytics is not a hype, it en-ables us to predict health outcomes which gives us the opportunity to monitor our health in better ways.

“We need big data analytics in India. In a big country like India with such a large population, big data enables us to analyze and predict the health of patients. There is acute shortage of doctors in the country and big data will enable us to manage our pre-cious resources in a better and effi-cient manner,” said Verma.

PROTECTING PATIENT PRIVACY

Data security/privacy is of para-mount importance for patients/hospitals more so in case of genetic diagnostics. How do firms utilizing big data address that? Are there any regulatory challenges to the usage of patient data, yet?

“Data security/privacy is a major concern in firms when tackling big data. In USA, the HIPAA act and HI-TECH Act is the cornerstone regard-ing healthcare and regarding the data associated with it,” said Verma.

In healthcare, HIPAA compliance is non-negotiable agrees Dash.

He added, “Nothing is more impor-tant than the privacy and security of

Mr Rohit Verma CEO, iPredictt

Dr Asoke Talukder co-founder and Chief Scientific Officer, InterpretOmics India

Mr Prahalad Achutharao Founder & CEO, InterpretOmics India


BioAnalysis

patient data. There aren’t many good, integrated ways to manage security in big data. Although security is com-ing along, it has been an afterthought up to this point. And for good reason, if a hospital only has to grant access to a couple of data scientists, it re-ally doesn’t have too much to worry about. But when opening up access to a large, diverse group of users, secu-rity cannot be an afterthought.”

Security and privacy concerns are among the highest in this industry. Implementation of security controls is based on multiple factors and is put in place after assessment of the risks, vulnerability and impact.

“Aspects that need to be taken care of include identity management, physi-cal security, personnel security, ap-plication security and privacy among others. Various security measures that are put in place include attribute based encryption policy that covers Ciphertext policy ABE, Key Policy ABE and fully homomorphic encryp-tion. There are a lot of regulations that drive the way cloud technologies are deployed in respective countries. For example, in the case of Indone-sia and Singapore, patient data can-not be taken out of that country. This necessitates the Cloud providers to have specific data centers in each of these countries. Europe in general is a lot more stringent when it comes to data privacy, security and porting across regions,” said Ramaswamy.

India does not have the appropriate regulatory framework in place yet.

“In India, it’s Information Technol-ogy (Reasonable Security Practices and Procedures and Sensitive Per-sonal Data or Information) Rules, 2011. But, these rules are generic rules in terms of data privacy which among others include healthcare data. Basically, the IT Act enlists pa-tient data under private data and re-stricts its use,” said Verma.

The lack of specific directives for healthcare data, is a concern for big data firms.

INDIAN HEALTHCARE READY FOR BIG DATA?

Indian healthcare is still in its embry-onic stage when it comes to adopting big data analytics.

The bigger private hospitals in the cities use computers to store data electronically through hospital ad-ministration software and other use-ful software. This enables big data in-tegration due to large amount of data collected.

“But, the average Indian in rural and semi-urban areas still visit small

clinics and hospitals which rely on paperwork. The benefits of big data analytics will reach the masses only if this problem is tackled,” said Verma.

“We have been using big data analyt-ics in both genomic and healthcare data. We have also developed big data solution platforms – iOMICS Research and iOMICS Clinical that are used by globally at the bedside and bench (research),” said Achuth-arao.

Dr Talukder explains, “The iOMICS Research software product takes hundreds of terabytes of data from DNA, mRNA, miRNA, ChIP, etc, combine them to derive an action-able functional insight. And iOMICS Clinical on the other hand helps ge-nomics to phenomics to go one step further to solve the complex ques-tions of pharmacogenomics and healthcare.”

Healthcare across the globe requires big data analytics to improve care and reduce costs. India is no exception. As India continues to adopt more and more healthcare technology, more and more big data analytics will be possible, Huse concluded. BS

Security and privacy concerns are among the highest in this industry.

Ayesha Siddiqui


BioAnalysis

It’s been a little over a year (19 months, to be exact) since the PM launched his pet project, ‘Make in India’ campaign. The topic has been talk of the town and PM’s

numerous offshore visits has also made sure that the topic is abuzz and has never stopped trending on social media. Apart from making headlines, BioSpectrum tries

to find out how the campaign has affected the pharma and medtech sector.

‘MAKE IN INDIA’ IMPACT ON BIOSCIENCES SECTOR


BioAnalysis

In September 2014, Prime Minister Narendra Modi launched ‘Make in India’ program, rolling out the red carpet to investors through a string of measures including easier norms and rules aimed at transforming India into a manufactur-ing hub. BioPharma and Medtech were amongst

the 25 sectors that the government has identified and are covered under the ‘Make in India’ plan. In recent times, the campaign has created a lot of buzz, and has been a topic of discussion at various business meetings. But has any concrete steps been taken to boost this campaign es-pecially in the biopharma and medtech sector? BioSpec-trum tries to find out.

Impact of Make in IndiaThere are some contradictory response to this. Though, some believe that the campaign has failed to meet expec-tations, some say it is a move in the right direction.

Speaking for the Medtech sector, Dr GSK Velu, founder and managing director, Trivitron Group of Companies, said “There are some significant benefits to this move which will bring down the cost of medical equipment and devices by 30 to 50 percent and also the uptime of equip-ment in tier 2/3/4 towns will improve due to easier avail-ability of spare parts. Local production will also lead to additional employment generation, local R&D and local skill development programmes. Moreover, the PM’s vi-sion has already attracted some major MNC players to set up low cost manufacturing units in India to serve emerg-ing market.”

The campaign has a positive impact on the generic phar-maceutical firms, but for the biotech sector nothing sig-nificant, feels N Venkat, co-founder, Vyome Biosciences.

He said, “Nothing much is yet visible in the PM’s ‘Make in India’ campaign for the biosciences/medtech industry and the players. The policies and investment thesis only talks about increase in investment but concrete plans should be brought to the fore. There has been a positive effect, though, for the generic pharmaceutical players.”

Any positive outcomes?“Definitely, with the Indian government supporting ‘Make in India’ all industries including healthcare are further sharpening their focus in India,” said Ms Rekha Ranganathan - Global General Manager, Mobile Surgery & Head, Philips HIC.

She added, “We expect even higher contribution from the region in the months to come. HIC, which aims at enhancing access to affordable healthcare in emerging markets, as well as across the globe, is a key contributor to Philips globally. There has been substantial increase in our healthcare footprint. Over the last few years, the facility has successfully launched five global products, doubled unit growth and filed multiple patents, making it a very important hub globally.”

Currently the government is willing to listen to the views of Indian manufacturers in this segment and implement changes to the tariff structure and regulatory structure in the upcoming budget.

“Indian manufacturers are of the view government should do away with 100% customs duty exemption for all prod-uct categories as this has not benefited the end patients over the past two decades. As per recent reports in the media, a Drug Eluting Stent which is being manufactured for Rs 5,000 is being imported to India for around Rs 40,000 with nil customs duty and in the end patient pays

Dr. GSK Velu

Trivitron

N Venkat

Vyome Biosciences

Rekha Ranganathan

Phillips


BioAnalysis

around Rs 1.5 lakh for the same. Hence there is no ratio-nale for zero customs duty for any finished goods imports and there should be at least 20% customs duty exemp-tion between finished goods imports and raw material/components import for ultimate manufacturing in the country,” Dr Velu said.

“No positive effects have been visible yet for the biotech-nology industry, except for the momentum that Indian pharmaceutical industry already has by being a global supplier of pharma generics. The trickledown effect might be visible some time later,” said N Venkat.

Though, at present, the effect might be negligible, the in-dustry is optimistic that the future holds good promise for the campaign.

Major announcements/initiatives to promote the sectorsIndian medical devices industry is extremely import de-pendent -- almost 70 percent. To boost domestic manu-facturing, the government has announced 100 percent FDI in medical devices.

Speaking for the biotech sector N Venkat says that as yet there hasn’t been any major announcement which com-plements or supports the campaign for the biotechnology industry.

It may be noted that to realize the vision of Modi’s ‘Make in India’, department of chemicals and fertilizers had set up three task force, among which one was on ‘Promotion of domestic production of high end medical devices and pharmaceutical manufacturing equipment’.

The task force has given recommendations to address

concerns and constraints facing the sector and suggested measures that would augment domestic production of medical devices. The task force has recommended mea-sures to enhance policy and institutional support; sug-gested strengthening of infrastructural support; and, rec-ommended fiscal and financial support to the sector. In addition, the task force has also recommended measures for creating an institutional set-up for efficacy and safety testing, promoting skill development aligned to the need of the industry, strengthening the R&D capability of the sector, pricing strategy for the sector and conducive regu-latory environment.

Making India a manufacturing hubSo, how do we make India a manufacturing hub as envi-sioned by our PM. “By giving more significance to Indian companies than giving more importance to foreign com-panies can transform the country into a manufacturing hub,” said Dr Velu.

In order to establish a region as a manufacturing hub two main pre-requisites must be met: talent and supplier base.

“There is a very young, yet specialized population when it comes to R&D and engineering in India. We have a large base of this population and we need to invest in train-ing this talent to become leaders in healthcare R&D and businesses. The supplier base in India is still at the infant stage in healthcare and we should focus on investing in increasing the supply base and ensure that we have global standards. Philips’ focus is to really develop and nurture this local base to further innovate and manufacture out of India,” said Ms Ranganathan.

N Venkat said following measure can be taken to make the campaign a success and make India a biotechnology manufacturing hub viz. creation of an ecosystem for de-velopment and capital availability for biosciences innova-tion and manufacturing units, creation of optimal, effec-tive and speedy regulatory system for approvals, better export incentives for biotechnology industry with respect to technology licensing in addition to products’ exports, to motivate novel biotechnology oriented companies to invest in and increase exports and lucrative incentives for the global biotechnology players to set up their opera-tions in India and collaborate with Indian biotechnology firms for joint product and technology development.

Time to finally turn discussions into decisions. BS

Ayesha Siddiqui

To establish a region as a manufacturing hub 2 pre-requisites must be met: talent and supplier

BIOPHARMA

BIORESEARCH

BIOSUPPLIERS

BIOINDUSTRIAL

BIOSCIENCE CARES

BIOANALYSIS

BIOAGRI

CROS

BIOINFORMATICS

Connect to your

target audiencein the industry

Connect to your

target audiencein the industry

*Amount in INR

BioSpectrum India Magazine

Corporate Management

Sales & Marketing

Scienti�c / Research Management

Others (please specify)

Biotechnology

BioPharma

Medical Technology

Bioinformatics

Finance / Legal

HR Administration

Non - Managerial

AcademiaQA & QC

BioServices

Distributor / Dealer / Supplier

Training / Education Institute

Government

Research

Healthcare

Legal Services / Patent Services

Media / Event Organisers

Venture Capitalist / Investor

Consultation

Others (please specify)

Mail this form along with your Cheque/DD or Credit Card details to:MM Activ Sci-Tech Communications Pvt. Ltd., No. 9, UNI Building, Thimmaiah Road, Millers Tank Bund, Bangalore - 560 052Ph: +91-80-4113 1912 | Fax: +91-80-4113 1914 | To subscribe online visit, bit.ly/BSI-Subscription | www.biospectrumindia.com


BioColumn

20th Anniversary of the global commercialization of GM cropsClive JamesFounder and Emeritus Chair, ISAAA

FACT 1.

2015 marked the 20th year of the successful commercialization of biotech crops. An unprecedented cumulative hectarage of 2 billion hectares of biotech crops, equiva-lent to twice the total land mass of the US (937 million hectares), were successfully cultivated glob-ally in up to 28 countries annually, in the 20-year period 1996 to 2015; farmer benefits for 1996 to 2015 were conservatively estimated at over $150 billion. Up to ~18 million risk-averse farmers benefitted an-nually, of whom, remarkably, 90% were small, resource-poor farmers in developing countries.

FACT 2.

Progress with adoption in the first 20 years. Following a remarkable run of 19 years of consecutive yearly growth from 1996 to 2014, the an-nual global hectarage of biotech

crops peaked at 181.5 million in 2014, compared with 179.7 million hectares in 2015, equivalent to a net marginal year-to-year decrease of 1.0% between 2014 and 2015. Some countries increased their to-tal plantings, whilst others reduced their hectarage principally due to the current low prices of com-modity crops; these hectarage de-creases are likely to revert to higher hectarage levels when crop prices improve. The global hectarage of biotech crops increased 100-fold from 1.7 million hectares in 1996 to 179.7 million hectares in 2015, mak-ing biotech crops the fastest adopt-ed crop technology in recent times.

FACT 3.

For the 4th consecutive year, de-veloping countries planted more biotech crops. In 2015, Latin American, Asian and African farm-ers collectively grew 97.1 million

BioColumn


BioColumn

hectares or 54% of the global 179.7 million biotech hectares (versus 53% in 2014) compared with industrial countries at 82.6 million hectares or 46% (versus 47% in 2014); this trend is likely to continue. Of the 28 coun-tries planting biotech crops in 2015, the majority, 20, were developing and 8 industrial.

FACT 4.

Stacked traits occupied ~33% of the global 179.7 million hectares. Stacked traits are favored by farmers for all 3 major biotech crops. Stacked traits increased from 51.4 million hectares in 2014 to 58.5 million hect-ares in 2015 – an increase of 7.1 mil-lion hectares equivalent to a 14% in-crease. 14 countries planted stacked biotech crops with two or more traits in 2015, of which 11 were developing countries. Vietnam planted a stacked biotech Bt/HT maize as its first bio-tech crop in 2015.

FACT 5.

Selected highlights in developing countries in 2015. Latin America had the largest hectarage, led by Brazil, followed by Argentina. In Asia, Viet-nam planted for the first time, and Bangladesh’s political will advanced planting of Bt eggplant and identi-fied Golden Rice, biotech potato and cotton as future biotech targets.The Philippines has grown biotech maize successfully for 13 years, and is appealing a recent Supreme Court decision on biotech crops, whilst Indonesia is close to approving a home-grown drought-tolerant sug-arcane. China continues to benefit significantly from Bt cotton ($18 bil-lion for 1997 to 2014), and notably ChemChina recently bid $43 billion for Syngenta. In 2015, India became the #1 cotton producer in the world, to which Bt cotton made a significant contribution – benefits for the period 2002 to 2014 are estimated at $18 billion. Africa progressed despite a

devastating drought in South Africa resulting in a decrease in intended plantings of ~700,000 hectares in 2015 – a massive 23% decrease.This underscores yet again the life-threatening importance of drought in Africa, where fortunately, the WEMA biotech drought-tolerant maize is on track for release in 2017. Sudan in-creased Bt cotton hectarage by 30% to 1,20,000 hectares in 2015, whilst various factors precluded a higher hectarage in Burkina Faso. In 2015, importantly, 8 African countries field-tested, pro-poor, priority Afri-can crops, the penultimate step prior to approval.

FACT 6.

Major developments in the US in 2015. Progress on many fronts in-cluding: several ‘firsts’ in approvals and commercializations of ‘new’ GM crops, such as Innatepotatoes and ArcticApples; commercialization of the first non-transgenic genome-ed-ited crop, SU Canola; first time ap-proval of a GM animal food product, GM salmon, for human consump-tion; and increasing R&D use of the powerful genome editing technology, named CRISPR (Clustered Regularly Interspersed Short Palindromic Re-peats); high adoption of first biotech drought tolerant maize (see below). Dow and DuPont merged to form DowDuPont.

FACT 7.

High adoption of the first biotech drought-tolerant maize planted in the US. Biotech Drought Gardmaize, first planted in the US in 2013, in-

creased 15-fold from 50,000 hectares in 2013 to 8,10,000 hectares in 2015 reflecting high farmer acceptance.The same event has been donated to the public-private partnership WEMA (Water Efficient Maize for Africa), aimed at the timely delivery of a biotech drought tolerant maize to selected countries in Africa by 2017.

FACT 8.

Status of biotech crops in the EU. The same five EU countries continued to plant 1,16,870 hectares of Bt maize, down 18% from 2014. Hectares de-creased in all countries due to several factors including, less maize planted, disincentives for farmers with oner-ous reporting.

FACT 9.

Benefits offered by biotech crops. A global meta-analysis of 147 studies for the last 20 years reported that “on average, GM technology adop-tion has reduced chemical pesticide use by 37%, increased crop yields by 22%, and increased farmer profits by 68%” (Qaim et al, 2014). These find-ings corroborate results from other annual global studies (Brookes et al, 2015). From 1996 to 2014, biotech crops contributed to food security, sustainability and the environment/climate change by increasing crop production valued at $150 billion; providing a better environment, by saving 584 million kg a.i. of pesti-cides; in 2014 alone, reducing CO2 emissions by 27 billion kg, equivalent to taking 12 million cars off the road for one year; conserving biodiversity by saving 152 million hectares of land from 1996-2014; and helped allevi-ate poverty for ~16.5 million small farmers and their families totaling ~65 million people, who are some of the poorest people in the world. Bio-tech crops are essential but are not a panacea – adherence to good farm-ing practices such as rotations and resistance management, are a must

China continues to benefit significantly from Bt cotton


BioColumn

biotech crop highlights in 2015

Million hectares biotech crops

countriesplantedin

179.72 billion hectares of biotech crops planted in ~28 countries since 1996

28

Fastest adopted crop technology in recent times

countries growing biotech crops

contribution oF biotech crops to Food security, sustainability & climate change

major biotech crops

MillionfarMers18

canola5%

others1%

soybean51%maize

30%

cotton13%

Source: James,Clive.2015.20thAnniversary(1996-2015)oftheGlobalCommercializationofBiotechCropsandBiotechCropHighlightsin2015.ISAAA BriefNo.51.

#gmcrops2015#isaaareport2015

vietnamfirst commercial planting of stacked biotech maize in

herbicide tolerance is the dominant trait deployed in soybean, maize, canola, cotton, sugar beet & alfalfa

herbicide tolerance

53%

stacked traits33%

insect resistance (14%)(area in million hectares)top 5 countries growing biotech crops:20 developing 8 industrial

44.224.5

11.611

usaBrazilargentinaindiacanada

70.9

more aFFordable Food

increases crop productivity

reduces production costsdecreases co2 emissions

biotech cotton has made significant contribution to the incomes of 16.5 millionpoor farmers & their families in india, china, pakistan, Brazil, argentina, Burkina faso, myanmar, mexico, sudan, paraguay & south africasavings on fossil-Based fuels

reduces greenhouse gases

helps mitigate climate change

better livelihoods From higher yields

contriButes to alleviation of poverty and hunger

land saving technology

conserves Biodiversity

prevents deforestation

lowers pesticide usereduces agriculture’s eco-footprint

helps farmers earn reasonaBle incomes

isaaa.org @isaaa_org isaaavideoswww.isaaa.orgFormoreinformation,visitISAAAwebsite:


BioColumn

for biotech crops as they are for con-ventional crops.

FACT 10.

Future prospects. Three domains merit consideration. Firstly, high rates of adoption (90% to 100%) in current major biotech markets leave little room for expansion; however, there is a significant potential in other ‘new’ countries for selected products, such as biotech maize, which has a poten-tial of at least ~100 million hectares globally, 60 million ha in Asia (35 mil-lion ha in China alone), and 35 million ha in Africa. Secondly, there are more than 85 potential new products in the pipeline now being field-tested, the penultimate step to approval. They include the WEMA-derived biotech drought tolerant maize expected to be released in Africa in 2017, Golden Rice in Asia, and fortified bananas

COMMITTED TO EXCELLENCE

Thermolab Group, Thermolab House,

Plot No. 19, Vasai Municipal Ind. Area,

Umela Road, Vasai (West) - 401 207, Maharashtra, India

(T) +91-250-2323156, 2324866/7 l (F) +91-250-2321656

(E) [email protected] l (W) www.thermolabgroup.com

Thermolab Group of Companies:

Thermolab Scientific Equipments Pvt. Ltd.

Thermolab Testing Services Pvt. Ltd.

Thermolab Sales & Services Pvt. Ltd.

Thermolab Healthcare Pvt. Ltd.

Thermolab Analyticals

offers a timely and powerful unique set of significant comparative advan-tages over conventional and GM crops in four domains: precision, speed, cost and regulation. Unlike the onerous regulation that currently applies to transgenics, genome-edited products logically lend themselves for science-based, fit-for-purpose, proportionate, and non-onerous regulation.

A forward looking strategy has been proposed (Flavell, 2015) featuring the troika of transgenes, genome ed-iting and microbes (the use of plant microbiomes as a new source of addi-tional genes to modify plant traits) to increase crop productivity, in a ‘sus-tainable intensification’ mode, which in turn can viably contribute to the noble and paramount goals of food security and the alleviation of hunger and poverty. BS

and pest resistant cowpea look prom-ising in Africa. Institutionally, public-private partnerships (PPP) have been successful in developing and deliver-ing approved products to farmers.Thirdly, the advent of genome-edited crops may be the most important de-velopment identified by today’s scien-tific community.

A recent and promising application is the powerful technology, named CRISPR. Many well-informed observ-ers are of the view that genome editing

A forward looking strategy has been proposed featuring transgenes, genome editing and microbes


BioTalk

India will become a

leader in Medtech

spaceMs Elizabeth Bailey

Director, Consortium for Affordable Medical Technologies (CAMTech)

Launched in 2013, CAMTech India’s (Con-sortium for Affordable Medical Tech-nologies) mission is to accelerate medical technology innovation and build entre-preneurial capacity to improve health out-comes in low-and middle-income countries

(LMICs). Its program involves clinical summits, hack-athons, innovation awards, entrepreneur bootcamps, ac-celerator programs, co-creation labs and an online plat-form to support global health innovators continuously and across geographic boundaries.

The director of CAMTech, Ms Elizabeth Bailey, spoke ex-clusively to BioSpectrum, voicing her thoughts on India’s healthcare challenges, accelerating and commercializing

innovations, CAMTech’s India plans, collaborations, and addressing India’s obstacles in the medtech space. Ex-cerpts:

Q What are the current pressing healthcare challenges that you see in India?

A Through our work in India, and specifically since the launch of the CAMTech INDIA program, CAM-Tech has identified critical health challenges relat-

ed to reproductive, maternal and child health (RMNCH) in India.

The program aims to accelerate the development and adoption of new technologies to address preventable causes of death among women and children in India.


BioTalk

Specific areas that our events and initiatives have focused on include RMNCH challenges like newborn survival, safe births and family planning.

In addition to RMNCH, our hackathon in last year focused on innovation in the diagnosis, prevention and treatment of diabetes in India – a significant area of unmet needs.

QHow are these challenges, according to you, different in India compared to other LMIC countries?

A Neonatal mortality in India contributes to about a quarter of the world’s total number of infant deaths each year, and 99% of maternal and newborn

deaths occur in the developing world more broadly.

While there are differences in the Indian ecosystem, we have seen some exciting opportunities for innovation in India to help solve clinical problems on a global scale.

Issues of access to quality care, for example, are not unique to India, but in order for innovations to be suc-cessfully adopted here, they need to have local buy-in with an understanding of the local context.

This is why CAMTech focuses on sourcing local innova-tion that involves local stakeholders.

As we have seen in recent years, diabetes has become one of the leading causes of death in India, which in turn has serious implications on the healthcare system in India.

This has motivated CAMTech to organize events that will work with local innovators in India to develop solutions that will help to address the epidemic in this country.

Q How is CAMTech involved in addressing these challenges?

A The process begins by identifying specific clinical challenges from our network of clinical, academic and industry partners.

We work to tackle these challenges through medical tech-nology hackathons and funding programs, which act as a way to crowdsource innovation and bring game-changing

Diabetes has become one of the leading causes of death in India, which in turn has serious implications

technological solutions forward.

The most promising of these solutions are sourced and de-veloped through CAMTech’s ecosystem of incubation re-sources that help build and foster entrepreneurial capacity.

Our program involves clinical summits, hackathons, in-novation awards, entrepreneur bootcamps, accelerator programs, co-creation labs and an online platform to support global health innovators continuously and across geographic boundaries.

Q How do you view India’s medtech landscape?

A We see so much promise in India’s medtech land-scape. The passion and talent alone is unprecedent-ed, and the entrepreneurial culture seems to be

gaining momentum.

What has been most exciting is to see how much innova-tors can accomplish, even with limited resources, com-pared to groups in the West.

It is much more expensive to do business and launch ven-tures in the West, and I think India has a real competitive advantage because of the lower cost of doing business.

I have no doubt that India will become a leader in the medtech space over the next decade, and it will have a huge impact not only on India but on other emerging and developing countries as well.

And we see enormous potential for reverse innovation where new health technologies coming from India can help to reduce costs and improve the quality of care in markets like the US.

Q In India, what are the major challenges that you have experienced in moving an innovation forward?

A The entire CAMTech team and all of our partners in India have been really inspired by the community of health innovators across the country.

There is a growing network of clinicians, engineers and entrepreneurs who are passionate about making a differ-ence and improving health in India.

The biggest challenge however, seems to be the fragmen-tation of the medtech innovation ecosystem.

There are many people and organizations in India doing


BioTalk

meaningful and impactful work, but they are not always able to work cohesively.

One of the primary goals of the CAMTech program has been to bring these disparate groups together to work more collaboratively to accelerate the whole process of innovation.

There has also been a dearth of resources and support for early-stage health innovators, and we are keenly focused on filling that gap with things like increasing mentorship, funding, technical assistance and partnership opportuni-ties for Indian innovators.

Q Briefly explain what are the key elements needed to successfully accelerate healthcare medtech innovations in India.

A First and foremost, we want to start with real and identified clinical challenges.

All too often, technologies are developed in isolation from clinicians, and that is why we have ended up with many technologies that are not used despite being available.

CAMTech works closely with our clinical partners to identify challenges and have those drive the technology innovation process. We also believe that successful tech-nologies incorporate business, medicine and technology right from the start.

Successful innovations are ones that are not only tech-nically-innovative, but also clinically-impactful and com-mercially-viable.

No one group or discipline should be innovating in isola-tion, and cross-disciplinary teams are the ones who are most successful and expedite the entire process.

In terms of what early-stage innovators need in this space, we often hear that there is not a roadmap or clear place to go to get guidance or needed information or resources.

CAMTech and our partners are working to create an eco-system that can support global health innovators through the entire process of technology development, commer-cialization and market adoption and scale.

Q Currently how does the healthcare entrepreneurship scene look like in India?

A As I’ve mentioned, the innovator community in In-dia and their desire to make a difference has in-spired us. We do hear from those in our innovator

network that it’s not necessarily celebrated to become an entrepreneur, and that parental expectations influence many people to take a more traditional professional path.

We see that changing, however, but it has been slower outside of internet start-ups and particularly slow in the medtech space.

The more that industry, government bodies and academia can do to promote and celebrate entrepreneurship, the more health start-ups we’ll see. The passion is definitely there, but they also need a little push to get comfortable with all the risks a start-up presents.

Q Tell us about your key partners and the role they play in helping healthcare innovations.

A CAMTech’s broad range of clinical, academic and industry partners play a large role in the success and impact that our organization has in India and

throughout the world.

Our partners provide ongoing clinical expertise and prob-lem identification, event sponsorship, as well as mentor-ship, monetary awards and incubation support to global health innovators.


BioTalk

Some of our key partners in India include Lattice Inno-vations, who plays an integral role in the planning and implementation of our events; the Public Health Founda-tion of India (PHFI) and Lata Medical Research Foun-dation (LMRF), whose expertise and experience within diverse clinical backgrounds has helped identify high-priority clinical challenges in India; GE Healthcare India, who has served as host for two CAMTech INDIA events, and the Federation of Indian Chambers of Commerce and Industry (FICCI), which provides a unique opportunity for hackathon teams to compete for a monetary reward as well as mentorship after the hackathon.

The National Health System Resource Center (NHSRC) also offers exciting opportunities in health technology as-sessment, piloting, connections with industry partners and facilitating a closer relationship between state gov-ernments and early-stage innovators.

QHow is CAMTech India supported?

A CAMTech INDIAis supported by the United States Agency for International Development (USAID/In-dia), the Omidyar Network and the Bacca Founda-

tion, in addition to several large medical device and tech-nology companies such as Medtronic, GE, Merck for Mothers, AB InBev, the Novartis Foundation and others.

The organization also draws on the expertise of many lo-cal partners.

Q Enlighten us about current happenings at CAMTech.

A In June 2015, CAMTech launched the CAMTech In-novation Platform, which connects global health in-novators worldwide with an extensive network of

experts (across public health/medicine, technology and business), with a goal to accelerate the development and commercialization of affordable global health technolo-gies and work to enable the entire continuum – from challenge identification to market adoption and scale-up.

And diabetes initiative in October 2015 in Hyderabad was sponsored byMarico Innovation Foundation, Terumo and other industry sponsors, with an exciting group of clini-

cal partners including Narayana Health, LV Prasad Eye Institute, the Public Health Foundation of India (PHFI), Madras Diabetes Research Foundation, Apollo Sugar Clinics and Dr Mohan’s Diabetes Specialties Centre.

Q Tell us about what CAMTech has achieved in India.

A Since its launch, CAMTech INDIA has completed milestone events in Kolkata and Bangalore, includ-ing one hackathon at Vellore Institute of Technolo-

gy (VIT), one open healthcare hackathon and two RMNCH-focused ‘Jugaad-a-thons’, (how CAMTech re-fers to its India hackathons).

CAMTech INDIA has also organized several clinical site visits, which serve as immersion opportunities for par-ticipants prior to the Jugaad-a-thon.

The visits enable participants to gain insights into clini-cal environments and care pathways for women and chil-dren, and to better understand physician and hospital workflow.

CAMTech INDIA has also hosted two clinical summits, a series of panel discussions that take place prior to the Jugaad-a-thon and feature a diverse group of stakehold-ers, such as patients, healthcare workers, government officials and public health experts, who are focused on tackling pressing clinical health challenges.

Following both clinical summits, CAMTech has held two technology showcase events, featuring interactive pre-sentations of early-stage and newly-marketed technolo-gies focused on a particular area of care.

Over 500 participants have attended CAMTech INDIA’s events and tackled over 150 clinical challenges.

During that time, they have created over 100 innovations designed to address critical health problems in the coun-try.

Q Give us an idea about innovations and products that were enabled and accelerated by CAMTechin India.

A Several innovations have come out of CAMTech IN-DIA events and initiatives, including:

2014 CAMTech India Jugaad-a-thon First Prize Win-ner BabySteps: a mobile application that aids in early di-agnosis of developmental delays in children

The organization also draws on the expertise of many local partners.


BioTalk

2014 CAMTech India Jugaad-a-thon Second Prize Winner PEL-Dia:a measurement system developed to di-agnose a condition called Cephalo Pelvic Disproportion - CPD occurs when the baby’s head is too large to pass through the mother’s pelvis

2015 CAMTech India Jugaad-a-thon First Place and CAMTech/USAID Grand Prize Winner Trust+:a mobile platform for adolescents and adults that encourages open and effective communication about safe sex and family planning

2015 CAMTech India/USAID First Place Winner Team Slow Forward: an effective video consultation for rural areas with low bandwidth

2015 CAMTech India/USAID Second Place Winner Team Peekaboo: an interactive gaming application that aids in identifying vision impairment for children

2015 GE Healthcare India First Place Award Winner Team O2-Matic: a low-cost method for oxygen produc-tion to address unpredictable availability of medical gas-es in limited resource settings

Q How you collaborate with Indian academic universities and healthcare

organizations?

A CAMTech’s academic, clinical and industry partners in India have provided ongoing expertise, funding and participation in our events and initiatives.

We seek to engage both public and private sector groups from a range of institutions that will help broaden our reach in the healthcare landscape and support the end-goal of accelerating medical technologies to tackle clini-cal challenges and move them toward commercialization and impact.

Clinical organizations are at the heart of our program, because we want medical technology innovation to start with the clinical challenge and involve clinical end-users throughout the whole process.

We also love working with our academic partners, includ-

ing both students and faculty. Our first academic partner in India – VIT – has been outstanding in terms of sup-porting their students to engage in the CAMTech pro-gram to help drive healthcare innovation in India.

They are a stellar example of what university leadership can enable in an academic setting by enabling their stu-dents to pursue their interests in healthcare innovation and empower them to chart their own path.

Q Going forward, what is CAMTech’s plans in India?

A CAMTech is working to expand its platform in In-dia to look at process and business model innova-tion in health, in addition to technology innovation.

We are looking forward to strengthening our relation-ships with government groups and other stakeholders to help engage adiverse community of innovators focused on improving health in India and embracing new ap-proaches to innovation.

We are also looking to expand our connections to the cor-porate sector, with both more multinationals and small start-ups who want to be part of an open innovation plat-form. Good ideas can come from anywhere, so we want to be as broad and inclusive as we can to drive innovation in pursuit of a healthier India. BS

Raj Gunashekar

We want to be as broad and inclusive as we can to drive innovation in pursuit of a healthier India


BioResearch

Wipe health woos with wearables

From tracking your sleep, calorie intake to the number of steps taken wearables are becoming a crucial tool in lifestyle/activity tracking and

preventive healthcare. BioSpectrum takes a look at the opportunities that wearables offer for the healthcare sector and how this technology can

become an indispensable part of the healthcare system.

BioCluster

BioResearch


BioResearch

H ealthcare and fitness are the two seg-ments where wearables are gaining increasing acceptance. Wearables fit-ness bands are becoming more and more desirable. From general-purpose devices like fitness bands that track

steps, calorie intake etc to the more serious diagnostic devices, wearables are slowly getting integrated into the healthcare system.

Wearable technology companies are addressing several different aspects most prominently lifestyle/active moni-toring, smart watches that can connect with phone and provide notifications and medical grade monitoring of one’s health.

“In an emerging economy like ours, remote diagnostics and medicine is a huge need. Wearable technology can help by taking most of the diagnostics out of hospitals and into the patient’s phones,” says Mr Anshuman Singh, founder, RetiSense, a start-up firm developing Stridalyz-er, an injury-preventing running wearable (insole).

With innovation and advancement in wearable technol-ogy, specifically miniaturization of sensor technology, wireless communication technology, and wearable com-putational technology has made possible the develop-ment of small, light, durable, comfortable, safe and low cost wearable medical devices. “The miniaturization of wearable devices has also enabled clinical monitoring beyond the hospital area, in the home or during outdoor activities,” said Ms Shivani Jaiswal, associate manager, IndustryArc, a market research and consulting firm.

At present majority of the companies are offering general purpose devices that offer activity tracking (step counts, general estimate of physical activity etc). “However, we are starting to see more purpose-built products and ser-vices that fit particular scenarios such as specific fitness activities (running, swimming, golf etc.) and health con-ditions (diabetes, neurological disorders, chronic diseas-es),” mentioned Dr Alick Law, director of marketing and business development, Sensoria. Sensoria designs, devel-ops, and produces body-sensing wearable devices.

Its products include an-klet and sen-sor infused socks that provides step count-ing, speed, calories, altitude, and distance tracking data as well as tracks cadence, foot landing techniques, and weight distribu-tion on the foot as users walk and run; and fitness bras and t-shirts with heart rate monitor that provides heart rate data.

Speaking on similar lines, Mr Mohammed Hussain Nas-eem, co-founder and CEO-2mpower Health Manage-ment Services said, “Many wearable technology com-panies have mushroomed in the past one year. Most of them are focusing on low hanging fruits – preventive care through quantification of data. However, many special-ized companies are focusing on more urgent issues. They are developing wearable medical technology products for disease management, efficient medical measures and real time response during emergency situations.”

2mpower is a technology company focused on preventive health management. GetActive is their current product which promotes physical activity.

Fancy gadgets or serious health devices?Most of the times wearables are seen as cool, intelligent fashion accessory but can it evolve beyond that to become an essential part of healthcare? It can asserts Dr Sriniva-san Murali, CEO at SmartCardia, a spin-off from the Em-bedded Systems Lab (ESL), EPFL. SmartCardia's revolu-tionary wearable technology enables new fitness, gaming, wellness and medical applications.

He said, “While current fitness bands are for gadget lov-ers and early adopters, we will see a wave of products in the near future that would monitor more concrete health parameters, such as blood pressure, stress levels and would connect the users with specialists.”

“The question shouldn't be whether they can become a

Wearables are seen as cool, intelligent fashion accessory. Can it evolve beyond to be an essential part of healthcare.


BioResearch

part of the healthcare system, but rather how soon it'll oc-cur. A lot of movement in the industry is already in place to service this exact gap. Mainstream wearable devices through sponsored wellness programs, and pharmaceuti-cal and provider networks will leverage wearables to in-tegrate with the other content and services around key solutions that go beyond prescriptions and pills to drive meaningful behavior change,” said Mr Pratik Saraogi, founder and CEO at Oxstren Wearables, a start-up devel-oping fitness accessories. Its product line include smart workout gloves, smart wristwraps and smart headbands.

There are active research projects exploring the potential of these products to improve patients’ lives. For example, recently Biogen and PatientsLikeMe's study to quantify physical activity of patients with multiple sclerosis (MS) between doctor appointments finds that wearables im-prove walking ability in MS patients.

“MS impairs the ability to walk for many people, yet we only assess walking ability in the limited time a patient is in the doctor's office. Consumer devices can measure number of steps, distance walked, and sleep quality on a continuous basis in a person's home environment. These data could provide potentially important information to supplement office visit exam," said Dr Richard Rudick, vice-president, value-based medicine, Biogen, while re-leasing the study result.

Hopefully we will see more conclusive outcomes in the near future.

At present, the major market is for activity trackers. The real value add to the consumer would come when we have wearables that can track medically accurate information, helping in preventing health risks (such as cardiac issues) and allowing personalized medication and treatment.

Growing popularity of wearablesThe fact that nearly every month there is a new wearable in the market says something about the growing fascina-tion for these wonder gadgets. Many factors are spurring the growth of these health devices. Consumer awareness of healthy and active lifestyles is one of the major fac-tors why everybody wants to wrap their wrist with these health bands.

Dr Murali said, “Activity tracking and having a healthy lifestyle is picking up. There is a strong need for health monitoring devices that could help the users monitor regularly their health conditions, such as sugar level or blood pressure.”

GetActive introduces fitness and sleep tracker band, a simple and accurate wearable device to track your steps, sleep, calories burnt and the distance travelled.

Smartcardia's revolutionary wearable technology enables new fitness, gaming, wellness and medical applications.

DUCERE TECHNOLOGIES' Lechal is the world's first haptic footwear. Offering hands-free navigation and fitness tracking, this smart footwear is uniquely interactive and intuitive.

ReTisence's Stridalyzer line of products not only analyzes the stride and gait but also provide guidance on how they can improve in their activity, or prevent future injuries.

Oxstren is developing fitness accessories. Its Smart Workout Gloves are envisioned with the aim to provide the most efficient single stop performance assistance during workouts. Their product line also include smart wrist wraps and smart headbands.

GOQii, a fitness technology venture, offers a wearable fitness band paired with remote personalized coaching.

Some of the coolest healthcare wearables start-ups


BioResearch

As per Ms Jaiswal, “The growing popularity of wearables are increasing caused by following reasons like health consciousness among people, increase in health consum-er behavior among people, greater health trend to move from hospital care to home care and subsequently to per-sonal care and so on.”

Also, increasing lifestyle diseases that demand continu-ally monitoring of the vital stats also fuel the demand for these wearable. “With heart disease and diabetes remain-ing two of the major causes of death globally, keeping a healthy and active lifestyle has never been more impor-tant. Our UP bands help people better understand their health and well-being by tracking sleep, activity, and nu-trition along with clear tools - through our UP app and Smart Coach system - to help them take action and live better,” said a Jawbone spokesperson.

The fact that most of the wearables, especially wrist bands, also make for a very good looking accessory could also be one of the reasons that people are drawn towards it.

This is a hype cycle, when people are intrigued and exper-imenting this new technology. The benefit it provides to-day to an individual is limited and utility is ‘good to have’. It has no real urgency for adoption, says Mr Naseem.

Consumer tractionAn Accenture survey (Accenture Digital Consumer Tech Survey 2014) found that more than half of consumers (52 percent) are interested in buying wearable technologies such as fitness monitors for tracking physical activity and managing their personal health. The survey of more than 6,000 people in six countries – Australia, Canada, India, South Africa, the United Kingdom, and the United States – showed that many are also interested in buying smart watches (46 percent) and Internet-connected eyeglasses (42 percent).

Among the six countries, consumers in India were most interested in buying fitness monitors (80 percent), smart watches (76 percent) and Internet-enabled eyeglasses (74 percent).

“Wearables are selling as an 18 billion dollar business. We have companies like Garmin, Fitbit and Jawbone do-ing extremely well. A lot of people now are getting health conscious so people are buying devices. For some people it is becoming a social statement, and people want to show off their bands. But we do see the trend changing, said Mr Chirag Jagtiani, founder and CEO at Fitkat. Fit-

kat is an activity tracker that tracks your steps, calories, water intake and also acts as a pill reminder.

The wearables are being successfully used in home healthcare, remote patient monitoring (RPM), fitness and sports among others.

“I think adoption has been steadily increasing. Momen-tum has picked up in countries like US and some parts of Europe. InternetofThing (IoT) is a big opportunity and wearables are an integral part of this revolution. Con-sumers are intrigued, experimenting and assessing the utility. As companies in wearables space, we need to give more tangible reasons for its adoption to consumers,” said Mr Naseem.

Market research reports are very bullish about the wear-ables industry and pegged it to be the next billion dollar industry in years to come.

Trends: Present and future Wrists band undoubtedly at present are synonyms with the wearables but moving on to the future we will see different forms of these wearables and the future of this space will involve more than just a wrist band.

“Technology is fast changing in the wearables market. The next generation devices would be patches that can stick on different parts of the body and obtain clinical pa-rameters, such as ECG. We will also see electronic skin

Increasing lifestyle diseases that demand constant monitoring also fuel the demand for these wearable


BioResearch

tattoos that a user could wear for a week or so using an adhesive, and would hardly notice even the existence of the patch. We will have sweat sensors that could provide many of the data that we usually obtain using blood tests today,” said Dr Murali.

Wearable blood glucose monitors is another possibility that can surge in the coming future. “The blood glucose monitors are becoming extremely important as persons suffering from diabetes are increasing. Therefore, as the diabetes prevalence rate becomes high across the globe with expensive diagnosis, it is contemplated that wear-able blood glucose monitors will be adopted at mass lev-el,” said Ms Jaiswal.

“We can speak for Jawbone and we can clearly say that the UP platform and hardware continue to grow globally - People love the design and feel of UP, which is a huge competitive advantage for us. People care about it making a difference: we are the only platform delivering insights and behavior change helping people not just see their data, but understand it, and use it to change their behavior. And stepping into the future, we will see more multi-sensor de-vices like UP3, that take the sector and these devices to another level. We have over 1,000 granted or pending pat-ents and no other company matches our expertize around multi-sensors,” said Jawbone’s spokesperson

As per Mr Saraogi, primary wearable devices will act as central connectors for all kinds of devices and informa-tion. Today the smartphone is a de facto wearable device — a central hub for accessories and data gathering. In time, smart watches and smart glasses will emerge as key primary devices, acting as a central collection portal for different wearables. Allocations of these hubs may serve to gather and host specific data, as in the medical field,

or serve more broadly as integrating hubs, like the Apple health kit.

He further added, “Secondary wearable devices will be intended to capture specific action or measurement, data that can then be funneled back into a primary wearable device for more comprehensive context, analysis and, ultimately, actionable insight. Examples of secondary wearable devices include shirts, shoes, helmets, fitness bands, badges and more. These secondary devices will be companion devices to primary wearables — and as sec-ondary devices become more prolific and to the point, the quality of data will improve, making the entire wear-able ecosystem more powerful, more impactful and more actionable.”

The future of technology is wearable and there is no doubt about that. However the form factor will undergo a lot of iteration over the years. “I see the biggest scope of such integrating with textile. Clothes are something we will al-ways wear and be passionate about. So when such tech-nologies start being incorporated into textiles then there will be a dramatic rise in acceptability of such products,” said Mr Aanan Khurma, co-founder at Observe Design.

Observe Design is a healthcare innovation start-up fo-cused on reducing healthcare associated infections in hospitals with innovative design and technology solu-tions. Its integrated platform allows healthcare facilities to observe, record and analyse the adherence to infection control protocols in their facilities.

Most apparel brands like Ralph Lauren and Under Ar-mour are realizing this opportunity.

Ralph Lauren has launched (available for $295) PoloTech Shirt, which works with an iPhone or Apple Watch to put real-time workout data in the palm of your hand. Created exclusively for use with the shirt, the PoloTech App offers live biometrics, adaptive workouts and more. The shirt seamlessly melds modern innovation with an iconic look that is unmistakably Polo.

Similarly, Google and Under Armour are also working on connected clothing. This space as we know it going to change dramatically.

Market in 2020 Global wearable medical device market is growing at a CAGR (compounded annual growth rate) of 21.3 percent from 2014-2020 and is estimated to reach to $41,368 million by 2020 says IndustryArc.

The future of technology is wearable and there is no doubt about that. However the form factor will undergo a lot of iteration.


BioResearch

Industry is positive that Indian wearable industry which is in infancy at present will get mature over the next five years. “In India, the market is just opening up, and by 2020 we will have three or four big players in the field of wearable health monitoring,” said Dr Murali.

By 2020, wearables would start getting mainstream adoption. “We will see various devices (smart watches, smart shoes, smart clothing) being adopted by consum- Ayesha Siddiqui

ers, and various services (payments, security, personal identification, healthcare diagnostics, etc) will be offered by all major industries,” said Mr Singh.

Indian market is lagging by seven years in wearable space as compared to US. But the main reason for this is the cur-rent UTILITY of wearables is minimum on solving burn-ing issues. “It’s used more for behavior change, which has high resistance in countries like India. By 2020, as wearables come into the mainstream, adoptions will be at a very high pace, similar to mobility,” said Mr Naseem.

As with most of the trends wearables growth will depend on the economy. A lot of which depends on how indus-tries, GDP, and how our economy shapes in this defining moment. “As of now, the wearable tech market is limited to the higher income strata of the Indian market, as com-pared to a 25 percent adoption rate in the US but the com-bination of the growing awareness, cheaper production, costs, flash sales, only point out that this can turn into the next frenzy with a CAGR higher than eCommerce!” concluded Mr Saraogi. BS


BioSuppliers

FDA approves world’s smallest pacemakerMedtronic announced it has received US Food and Drug Administration (US FDA) approval of the world’s small-est pacemaker, the Medtronic Micra Transcatheter Pac-ing System (TPS). The Micra TPS is the first FDA-ap proved product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart-providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires (leads).

Comparable in size to a large vitamin, the Micra TPS is at-tached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Unlike traditional pacemakers, the Mi-cra TPS does not require leads or a surgical ‘pocket’ under the skin, so potential sources of complications related to such leads and pocket are eliminated - as are any visible signs of the device. The device responds to patients’ activ-ity levels by automatically adjusting therapy.

Micra TPS is said to be the first and only transcatheter pacing system to be approved for both 1.5 and 3 Tesla (T) full-body magnetic resonance imaging (MRI) scans, providing patients with access to the most advanced im-aging diagnostic procedures available. The Micra design incorporates a retrieval feature to enable retrieval when possible; however, the device is designed to be left in the body. The Micra TPS was awarded CE Mark in April 2015 based on early data from the Medtronic Micra TPS Global Clinical Trial.

BioSuppliersSiemens, Thermo partner for Molecular TestingIn a joint effort to provide customers with one of the most advanced solutions for molecular testing, Sie-mens Healthcare and Thermo Fisher Scientific an-nounced a new strategic relationship that includes the integration of Thermo Fisher Scientific’s real-time PCR system into Siemens’ VERSANT kPCR Molecular Solution.

The combined workflow will offer laboratories Sie-mens’ complete molecular testing solution, which helps ensure leading-edge performance from extrac-tion through detection. Siemens displayed the entire system during the European Congress of Clinical Mi-crobiology and Infectious Disease in Amsterdam, The Netherlands, April 9-12.

Thermo Fisher has brought to market easy-to-use, re-al-time PCR instruments. Designed for mid-through-put, these new systems provide ideal solutions for all users who need a high-performance instrument with features for maximum experiment control. Adding Thermo Fisher’s real-time PCR system to the VER-SANT kPCR Molecular Solution brings a new level of innovation to the market by providing more flexibility and customization to the molecular laboratory work-flow.

“Through our molecular diagnostics systems, we offer a total solution for accurate diagnosis and monitoring,” says Fernando Beils, Head of Molecular Diagnostics, Siemens Healthcare. “We are excited to strengthen our dedication to molecular laboratory innovations through our partnership with Thermo Fisher Scientific.”

“This agreement underscores our commitment to work with leading molecular diagnostic organizations that share our vision to develop advanced laboratory solutions,” said Drew Burch, Head of Licensing and Commercial Supply for Thermo Fisher Scientific. “We are excited to collaborate with Siemens in support of its VERSANT kPCR Molecular Solution as we work to expand our partnerships in the diagnostics space.”


App

oint

men

ts

Lambda has a new presidentLambda Therapeutic Research announces the join-ing of Dr Tausif Monif as President - Global Opera-tions.

Lambda is a leading Global CRO in the clinical re-search domain headquartered in Ahmedabad (In-dia), its global footprint encompasses strategically located offices in Mumbai (India), Poland (Europe), London (UK), USA and Canada (North America) of-fering end-to-end clinical research and total drug development solutions to pharmaceutical compa-nies worldwide.

Dr Tausif brings with him a rich experience of more than 24 years in the clinical research industry.His joining Lambda will support the company’s vision of expanding their global footprints.

He has numerous publications and academic accredi-tations to his credit and has successfully faced mul-tiple regulatory audits across the world in his illustri-ous career.

Sanofi appoints Dr Liu as research head

Dr Yong Jun Liuis one of the world’s most prolific researchers in immunology, with over 94,000 cita-tions (Google Scholar) and more than 250 published articles in top journals such as Nature and Science. His research has led to the development of several key drug targets in the areas of allergy, immunology and oncology.

Dr Liu received his doctor of medicine degree in 1984 from Norman Bethune University School of Medicine in China, and earned his doctorate in im-munology in 1989 at the University of Birmingham in the UK. Dr Liu will be responsible for leading all of Sanofi’s research with the goal of delivering innova-tive and high-value medicines for patients.

BioPeople


BioSuppliers

Fujifilm, NM Medical launches 3D mammography machine

Fujifilm India and NM Medical an-nounced tie-up for installation of Fujifilm’s state-of-the-art Amulet Innovality - a highly advanced diag-nostic machine for early detection of breast cancer in women.

The Amulet Innovality provides 50 Micron 3D image quality and ad-vanced tomosynthesis technology that reveals the internal structure of the breast with a precision that en-ables the detection of those lesions that ordinarily get overlooked in a routine mammography.

The installation of the Amulet In-novality at NM Medical Center will give women access to early detec-tion of breast cancer. The Amulet Innovality uses advanced tomosyn-thesis technology to enable the con-version of digital breast images into a 3D reconstruction of the breast, in contrast to the flat images produced by traditional 2D digital mammogra-phy.

Reconstructed tomographic images

reveal the internal structure of the breast, simplifying the detection of lesions that may be overlooked in a routine mammography.

Amulet Innovality enables diagnosti-cians to obtain a clearer view of the breast tissue, facilitating identifica-tion of early stage breast cancer and reducing the need for additional tests and biopsies.

Yasunobu Nishiyama, managing di-rector, Fujifilm India said, ‘‘It is a known fact that late diagnosis results in slimming the chances of survival. It is therefore vital for healthcare pro-viders to step up and provide women the best early detection screening fa-cilities that can help save lives.

‘‘At Fujifilm, we are continuously in-novating, creating new technologies, product and services and the Amulet Innovality is one such product that has made early detection of breast cancer a reality for women all over the world.”

“The installation of the Amulet In-novality at NM Medical is another step for us in line with our commit-ment to raise awareness and pro-mote early detection and treatment of breast cancer in India. We are grateful to our partner, NM Medical for joining hands with us in this en-deavor,” said Chander Shekhar Sibal, executive vice president and head of Medical Division at Fujifilm India.

Toshiba gains FDA approval for new CT systemProviders can now image a wider range of patients with a low cost of ownership as Toshiba America Medi-cal Systems’ Aquilion Lightning was FDA cleared with a more powerful 50-kw generator.

The Aquilion Lightning meets the business and clinical needs of hospi-tals looking for a reliable, premium-component, entry-level CT system that maximizes their equipment in-vestment.

The Aquilion Lightning is a 16-detec-tor row system designed for routine

volumetric scanning. It has a small footprint to allow providers to save on both space and cost, without sac-rificing exceptional technology. The system offers the same PUREViSION CT Detector technology that is used in premium Toshiba CT systems and in-cludes AIDR 3D enhanced to help re-duce dose and improve patient safety.

To simplify complex scans for more consistent imaging, the system comes standard with Adaptive Diagnostic so-lutions, such as Single Energy Metal Artifact Reduction (SEMARTM) and SURE Subtraction.

These technologies help optimize workflow and patient comfort.

“Toshiba CT puts customers first by providing top-tier solutions on every scanner, including our entry-level systems with a low cost of owner-ship,” said Mr Dominic Smith, senior director, CT, PET/CT, and MR Busi-ness Units, Toshiba. “With numerous features found in our high-end Aqui-lion scanners, the Aquilion Lightning ensures our customers don’t need to compromise quality to meet their business goals.”


BioSuppliers

W est’s leadership team, comprising Ms Karen Flynn and Warwick Bedwell, was recently

on a business trip to Hyderabad, India. Ms Flynn is West’s SVP & CCO, and oversees the company’s new global commercial team that includes marketing, sales and con-tract manufacturing services, and as well as technical customer support for West’s full portfolio of offerings.Bedwell serves as VP & MD for West’s Asia-Pacific (APAC) region.

Ms Flynn revealed that the company is developing new product offerings in the area of generics, having features

and generics.

Bedwell added that India is a key market for the company. ‘‘India is important for us not just in the APAC region but globally. We have recog-nized India’s advantage. We are here for the last 10 to 15 years. Our plant in Sri City, Chennai, is close to two years old now, and has been highly successful, catering to India and ex-ports,” he said.

The facility was completed in 2014 with a cost of $15 million to produce seals used in primary packaging of injectable medicines. In terms of vol-umes, West expects to touch 1.9 bil-

Electronic wearable injector a reality

that will interest generics companies.

“We are inculcating some changes in our commercial strategies to become more oriented to various markets we serve. There is a lot of customer simi-larities around the world in terms of quality standards and wanting reliable supplies. However, there are unique-ness with respect to customer needs. We align ourselves to the market, and get better understanding of the unique market needs, and bring new products and new services specific to the seg-ments,” commented Ms Flynn.

West’s key global market segments include biologics, pharmaceuticals


BioSuppliers

lion pieces by 2019-20 at this facility.

As a Chief Commercial Officer, Ms Flynn noted that the visibility of needs in India is not as same as in the Western markets. ‘‘There is increase in the regulatory enforcements by USFDA. The quality standards are rising here in the local markets. More and more customers are looking to West for primary packaging compo-nents that are pre-washed and pre-sterilized,” she expressed.

Patient engagement trendsGlobally, patients today are increas-ingly seen to be wanting to manage their health and well-being them-selves.

“This is enabled through smart devic-es that can help them to understand what their sugar levels are, for exam-ple, along with medication reminders and controlling of medicine intake. This is addressed through our deliv-ery devices which are electronically connected. For this we have part-nered with HealthPrize,” Ms Flynn stated.

This strategic collaboration was an-nounced in September 2015. Health-Prize is a US-based digital health company in patient engagement and medication adherence solutions.

The companies intend to integrate HealthPrize’s Software-as-a-Service (SaaS) medication adherence and patient-engagement platform with West’s injectable drug delivery sys-tems to provide an end-to-end con-nected health solution for pharma-ceutical companies and patients.

West’s press release pointed that the combined offering will provide volun-tary, electronically-connected drug delivery systems that can track when patients take their medications.

At the moment, 22 to 30 companies in India have used Crystal Zenith.

Annually, 2% of West’s global sales revenuegoes into its R&D. ‘‘All our R&D happens in our centers located in the US, Europe and Singapore,” Bedwell told BioSpectrum.

First Gen Wearable InjectorMs Flynn mentioned that West is do-ing a lot of work in the devices space and primary packaging portfolio.

“We are getting ready to commercial-ize an electronic wearable injector this July,” she pointed.

This is said to be the first generation electronic wearable injector, and its 8 different embodiments are currently under development.

The device, according to the compa-ny, has been tested on humans and has undergone clinical trials.

Globally, today about 2,400 drugs are in development at critical stages.West intends to strengthen its under-standing in drug products and pri-mary packaging compatibility.

“We want to concentrate and focus on the injectable pharma space, and it is a growing market. The market is large. We have more opportuni-ties in this space to expand. We look for technological opportunities and geographical expansion,” Ms Flynn shared.

In 2014, West Pharma’s Pharmaceu-tical Packaging Systems business re-coded revenue of $1 billion. Its Phar-maceutical Delivery Systems business saw $402 million in revenue. BS

(Raj Gunashekhar was flown to Hyderabad by West Pharma to meet its leadership team)

HealthPrize’s system is also said to engage and educate patients to in-crease medication adherence and medical literacy, rewarding interac-tion (gaming theory rewarding sys-tem), and stick to prescribed treat-ment plans leading to favorable outcomes.

Trend is also catching up in want-ing consistent quality products with fewer side effects, treating patients at home and outside of clinical set-tings, with wearables becoming more important and delivery systems en-abling patients to live a normal life.

“Efficient use of the medium is a global trend, and producing prod-ucts that are more efficient. Produc-ing these products encounter higher costs especially in APAC. Products today are made to fit for purpose when it comes to emerging domestic markets,” Ms Flynn opined.

Bedwell observed that there is more innovation happening with custom-ers in their applications to reduce costs.

“There are looking for smaller foot-prints in manufacturing and flex-ible manufacturing systems,” he re-marked.

Crystal ZenithIn 2015, West came up with its prod-uct Daikyo Crystal Zenith (CZ) in col-laboration with its Japanese partner Daikyo Seiko.

Crystal Zenith is made of Cyclic Ole-fin Polymer (CoP) containment and delivery system designed as a high-performance alternative to glass.

It is said to be more inert than glass, and solves issues dealing with tradi-tional glass as in breakages, delami-nation, protein aggregation, or cer-tain reactions.


BioAnalysis

Around 40 percent of lung cancer patients in Asia are with EGFR mutations as

compared to 10-15 percent in Caucasian population

Lung cancer burden of Asia

Lung cancer occurs in two types, small cell lung can-cer and the more prevalent non-small scale lung can-

cer. According to oncology special-ists' analysis, 85 percent of the lung cancer patients are diagnosed with non-small scale lung cancer. Profe-sor Li Zhang, Professor of Medical Oncology, Sun Yat Sen University Cancer Centre, Guangzhou, China, highlights that more than 50 percent of the world's lung cancer incidences occur in Asia of which south east Asia is the most burdened region. Tai-wan, South Korea, China, Singapore and Japan has the highest number of non-small scale cell lung cancer (NSCLC) cases in the whole region as almost 20 percent of the cancer deaths are registered from these countries. Moreover, there is an in-creasing risk in southeast Asia as the

predicted growth rate of lung cancer incidence is 22 percent by 2020.

CRACKING DOWN ON EGFR MUTATION

In 2011, American Society of Clinical Oncology (ASCO) issued a provision-al clinical opinion on using epider-mal growth factor receptor (EGFR) testing for treating patients with ad-vanced non-small cell lung cancer. The objective was to help clinicians decide the line of treatment. Cancer.net remarks that some research stud-ies have shown that mutations to the EGFR may predict whether certain types of drugs, called tyrosine kinase inhibitors (TKIs), can help treat lung cancer. TKIs are a type of targeted therapy, a treatment that targets specific genes, proteins, or the tissue environment that help cancer cells

grow and survive and some TKIs block EGFR from working, which can help stop or slow tumor growth.

Profesor Li Zhang highlights that around 40 percent of lung cancer pa-tients in Asia are with EGFR muta-tions as compared to 10-15 percent in Caucasian population and interna-tional guidelines recommends EGFR mutation testing at diagnosis level of advanced stage of NSCLC.

BOEHRINGER INGELHEIM'S LUX LUNG TRIALS

Target Therapy Vs Chemotherapy

Boehringer Ingelheim (BI) has de-veloped Afatinib, a second genera-tion TKI, is a targeted therapy that


BioAnalysis

has shown survival benefit in NSCLC patients with EGFR mutation. The company conducted two randomized clinical study, Lux Lung 3 and Lux Lung 6, to compare targeted therapy with chemotherapy.

Lux Lung 3 was designed to study global patient population and Lux lung 6 for Asian patient population in which patients with adenocarcino-ma of the lungs with EGFR mutation were given afatinib or chemotherapy. According to the company, the pri-mary endpoint was progression free survival and the study demonstrated that for EGFR mutation targeted therapy is better than chemotherapy.

The study result indicated significant benefits for patients with EGFR mu-tation with delay in tumor growth and tumour shrinkage.

AFATINIB VS GEFTINIB

Professor Keunchil Park, Division of Hematology/oncology, director of Innovative Cancer Medicine Institute (ICMI) at Samsung medical Centre, Sungkyukwan University Scool of Medicine, Seoul, Korea remarks that head to head target agents are better for understanding and comparing different medicines for efficacy and safety prospective. For this purpose, Boehringer Ingelheim is conducting

Lux Lung 7 trial, a first global per-spective randomized head to head trial to study the potential difference between afatinib and gefitinib. Ge-fitinib, marketed by Astrazeneca, is the first selective inhibitor of EGFR tyrosine kinase marketed in over 64 countries for NSCLC.

The aim of Lux Lung 7 study is to pro-vide patients and doctors with a bet-ter understanding of their treatment options in EGFR mutated NSCLC. In Lux Lung 7 trial, patients with adeno-carcinoma of the lung cancer at ad-vance stage with common EGFR mu-tation with no prior treatment for the disease were administered afatinib (second generation EGFR directed therapy) and geftinib (first genera-tion EGFR directed therapy) on head to head basis. Phase IIb LUX-Lung 7 trial was conducted from December 2011 to August 2013 in 14 countries including China, Hong Kong, Tai-wan, Korea and Singapore.

The key progression survival indi-cated significant reduction in risk of lung cancer progression by 27 per-cent with afatinib as compared to gefitinib. Afatinib demonstrated su-periority to gefitinib in reducing the risk of disease progression and treat-ment failure in first line treatments of patients with EGFR mutation pos-itive advanced NSCLC.

According to the study, more patients on afatinib versus gefitinib were free of cancer growth 18 and 24 month-safter the start of treatment.

Afatinib is approved in eight Asian countries including Taiwan, Singa-pore, Korea, Malaysia, Philippines, Thailand, Hong Kong and Indonesia.

BI'S NEXT STEP

Dr Gerd Stehle, vice president, thera-peutic area head medicine oncology, Boehringer Ingelheim, highlights that BI has over 13 compounds in clinical development, that include antibiotics and small molecule medicine.

In July 2015, BI entered into a part-nership with Hanmi Pharmaceuticals to develop third generation EGFR targeted therapy in lung cancer. The third generation EGFR TKI is being developed to target only EGFR mu-tant cells and would spare the cells without EGFR mutations.

In December 2015, BI received FDA breakthrough therapy designations in lung cancer for its third generation EGFR TKI, BI 1482694. The company has completed Phase I study in healthy volunteers in Korea and is pursuing the study for phase II trial. BS

Dr Gerd Stehlevice president, therapeutic area head medicine oncology, Boehringer Ingelheim

Prof. Li ZhangProf. of Medical Oncology, Sun Yat Sen University Cancer Centre, Guangzhou, China

Amrita Tejasvi

Subscribe to digital edition in 3 easy steps:1. Select your subscription option- you can subscribe

for 3/6/12 months or buy a single issue2. Register and complete your order3. Read your NuFFooDS Spectrum online!

You can now read NuFFooDS Spectrum - the most trusted source for the latest developments and trends in industry, business, research, technology on the go!

Nutra News in your pocket

is now on

ACT NOW

AND GET ACCESS

TO 6 MONTHS

ARCHIVAL ISSUES

FREE*

Windows Desktop

www.nuffoodsspectrum.in For more information contact [email protected]

Find us on Facebook: facebook.com/NuFFooDS

Follow us on Twitter: twitter.com/NuFFooDS


BioTalk

Cell Culture Company is a US based Contract Manufacturing Organisation that manufactures automated single-use perfusion bioreactor sys-tems and provide custom manufacturing ser-

vices for diagnostic and therapeutic mammalian protein production.Christiaan Engstrom, in an e-mail interview with BioSpectrum Asia, shares his thought on the pros-pects of biologics manufacturing.

What are new opportunities in biologics manufacturing for CMOs?

A Biosimilars are opening up new opportunities for CMOs as hundreds of drugs have already come off

patent and will continue to do so over the next decade or so.This transition has changed the focus of many drug manufacturers back to innovation and has augmented traditional manufacturing facility needs as multi-product facilities trend upwards.

Pharma companies are definitely interested in investing in biologics, especially as the patient population is taking a more active interest in their treatment.The population

is demanding new, more targeted therapies,which means that large molecule drugs will remain on an upward tra-jectory.Additionally, patients and physicians will be able to choose from multiple commercial sources for drug products,which will add a new element of competition.

What are the benefits of single-use technology and is it getting more popular?

A As manufacturers look to increase productivity and decrease facility footprint and cost,single-use tech-

nologiespresent an easy to implement solution.Whenever a facility is producing multiple products, cross-contami-nation becomes a serious risk.Single use nearly elimi-nates this risk through the disposal of all product contact material.Users can also expand the footprint of their fa-cilities more drastically and rapidly,because of the flexi-ble skids, and eliminate clean-in-place or steam-in-place stainless steel piping—not to mention the tonnesofwaste that come with them.

Single-use technologies have already made a huge impact on the way this industry operates over the last decade.

Biosimilars are opening up new opportunities

Mr Christiaan EngstromPresident, Cell Culture Company

Interview


BioTalk

We fully expect that the trend towards multi-product fa-cilities will eventually become a standard,meaning that single-use technologies will continue to be a solution of choice for the industry.

Do you have plans to expand customer base in Asia?

A Definitely, and, in fact, we already work on certain levels in this market.AtCell Culture Company, our

goal is to ensure that customers have a reliable, global partner.Asia is a critical market of focus for us,and one that we look forward to expandinginoverthe next five years.

What are the challenges in supply chain and cross-border shipments?

A Most biologics are living and highly perishable—unless they are lyophilized—sotimely delivery by

couriers is critical to ensure the product is not lost due to improper cold handling. Global distribution of living products further complicates this challenge.The level of cold and supply chain support needs to be exceptional to ensure product viability.

Right now, we see that most countries or unions are en-forcing individual established policies, but this is not enough.Webelieve that the industry will continue driving towards harmonisation of global importation to address this critical challenge that has now become industry-wide with the uptick in large molecule drug production.

As a new entity, what are the immediate plans of Cell Culture Company?

A We see many opportunities for growth, which is why we are launching C3. Our initial focus will be

on enhancing and growing our core businesses:our cus-tom GMP contract production BioServices, single-use perfusion bioreactor portfolio,and National Cell Culture Center offerings.Our goal is to leverage our30+years of experience in delivering custom GMP production servic-

es from preclinical to commercial stages to the diagnostic,therapeutic and animal healthcare industries.We want to be recognised for being a trusted partner that delivers innovative, high quality products and services that control costs and increase speed to market.

What are the factors do you attribute to for the growth of outsourcing industry in biopharma sector?

A As the drug industry shifts back to innovation, with a greater focus on large molecule development,

manufacturing outsourcing has almost become a neces-sity.Drug makers have to focus their resources on devel-oping the lifesavingtherapies that the market is demand-ing. And, as biologics become more popular, batch sizes have drastically decreased since the days of the block-buster drugs.

A traditional, highvolume manufacturing facility no lon-ger retains the same value for many drug manufacturers.And, as technology advances continue to extend the shelf life of biologics, onsite manufacturing becomes even less attractive.There are numerous other advantages to out-sourcing, including decreased risk and cost by removing operators from the equation.

Of course, that makes the importance of selecting the right contract manufacturing partner crucial. This is where C3 sees our greatest opportunity—in being an ex-ceptional, long-term instruments and bioservices partner to our customers.

How should a CMO ensure the interest of the sponsor companies at the available infrastructure and capacity?

A This is an everevolving question as outsourcing be-comes more commonplace.Eventually, it all comes

down to having proper documentation and full manufac-turing transparency—not only between partners,but also to meet and exceed the various regulatory expectations.

Beyond that, there is such a great element of trust in an outsourcing partnership.The most successful CMOs will have clearly defined supply agreements,including agreedupon transfer methods and details of how the sup-plier plans to deliver exceptional supply chain security.At the end of the day, the value of your product does not matter if your customer cannot get it.

There is a great deal of responsibility placed on the CMO to really know their market and act as a guide for the cus-tomer every step of the way. BS

Amrita Tejasvi


Biopreneur

Biopreneur

FIB-SOL

Geared to redefine global farming scene

FIB-SOL – the latest new start-up aims to change the farming scene through innovative technologies in improving efficiency, cost reduction, and delivering agro-inputs including

fertilizers and pesticides.

For entrepreneurs Dr Ka-vitha Sairam (36) and Anant Raheja (28), the entrepre-neurial journey was more incidental than a planned

one. The duo founded FIB-SOL Life Technologies in 2013 at IIT-Madras business incubator while pursuing their PhDs.

“We aim to make farming profitable,” says Dr Kavitha. “The current state of farming in the country has left indi-vidual and corporate farms high and dry, demanding better inputs.”

Dr Kavitha has a PhD in fungal stress biology, which helped her develop stabilizing formulations for FIB-SOL’s agro-inputs.

At the moment, Anant is awaiting his PhD, and has a rich research experi-ence in developing polymeric nano-materials, which forms the basis of platform technology developed at FIB-SOL.

Prior to FIB-SOL, when the biotech department at IIT-M announced their entrepreneurship support scheme, Dr Kavitha was already looking for career opportunities, and Anant had an inconclusive experi-ment in tow.

The biotech department announced a biotech entrepreneurship support

scheme with a financial support of Rs 10 lakh for an innovative idea, which could be later translated into a product.

“We as a team pitched in the idea of applying nanotechnology for devel-

FIB-SOL Team -- (L-R) Mr N K Gokul, Mr Anant Raheja, Dr Kavitha Sairam & Ms G Saranya)


Biopreneur

oping highly effective fertilizers with a reduced bulk of 1000x. The path was inspired by previous success of Sea6 Energy, which also is an IIT-M start-up,” Dr Kavitha recalls.

Plan of actionThe first plan of action for FIB-SOL’s team was to develop its ideas into an innovative product which would be of real value to its customers.

Dr Kavitha reveals, “In our case, un-doubtedly, our clients were the farm-ers. Therefore, we immediately made an effort to understand our custom-ers. We started visiting local farms, and farms of anyone whom we knew.This gave us a lot of insight into the working of agro-business.”

Following which they built an effi-cient team with like-mindedness to

take the idea forward. This was well supported by the constant interest shown by the interns from IIT-M, and as well as from other universi-ties. In due course, FIB-SOL’s inputs fetched in grants which helped the start-up to hire long-term employees.

FIB-SOL is now closely working with corporate plantations, learning more about their needs, and helping in im-proving product design.

“We would like to work more with small and medium scale farmers, and help them to improve their produc-tivity with our technology,” Dr Ka-vitha expresses.

The agriculture sector, says Dr Ka-vitha, across the globe has seen nu-merous innovations, in the form of machinery, chemical inputs and bio-

ENTREPRENEURIAL MISTAKES TO AVOID:

Lack of long-term vision

Lack of understanding investment partners on board

Lack of simplicity in product design

LIFE SCIENCE START-UP MYTHS TO BUST:

Rapid revenue generation impossible

Complicated products

Only deal with drugs and pharmaceuticals

127, Bussa Udyog Bhavan, Tokershi Jivraj Road, Sewri Mumbai - 400 015. INDIA

Tel: 91 22 24166630 / 24173493 Fax: 91 22 66627766 E-mail [email protected] www.rosalina.in

m-VROC is the leading small sample viscometer in biopharmaceutical

applications used routinely by the leading biopharmaceutical companies at

multiple locations globally. m-VROC is the ultimate viscometer for small sample

protein therapeutics as little as 20 microliter and high shear rate viscosity

measurement up to 1,400,000 s .

Accuracy: 2% of readings

Repeatability: 0.5% of the range

Viscosity range: 0.2 ~ 100,000 m-Pas

Shear rate range: 0.5 ~ 1,400,000 s

Sample volume: 20 microliter +

Specification :

Description Accurate, Precise and top-of-the-line viscometer for R&D application

Min sample volume 20 µl

Maximum shear rate, s-1 0.5 ~ 1,400,000

Viscosity range, mPa-s (cP) 0.2 ~ 100,000

Temperature range* 4~70 oC

Portable No

Accuracy 2% of Reading

Repeatability 0.5% of full scale

Temperature sensor Built-in

Software Included

Non-Newtonians ? Yes

Temperature sweep Yes

Shear rate sweep Yes

1

-1

-1

2

ROSALINAAdvanced Radiotherapy

m-VROC Overview :

:

::

:

:

:

:

:::

:

:

:


Biopreneur

logical entities.

“However, these innovations have not percolated the traditional farm-ing sector in developing and under-developed economies. The increasing awareness on organic and traditional farming practices is a very promising scenario, and hopefully the innova-tions would reach the farming com-munity,” she feels.

Finding a foot holdFIB-SOL’s major strength is in its R&D. “We have developed our first line of membrane products for ef-ficient delivery of agro-inputs. In addition, we offer microbial analyti-cal services to the biotech industry functioning in the field of agriculture and waste water treatment,” adds Dr Kavitha.

As seasoned researchers, the found-ers’ initial challenges was in under-standing the ways of an independent start-up.

“We had to shelve a lot of our ideas to focus on a few, rather than get distracted. Further, it was difficult to manage with limited resources,” she comments. In fact, Anant had to take up a consultancy job to manage his finances to prevent burning out of investments.

However, the start-up began to sta-bilize upon receiving more funds in 2015. So far the start-up has been funded through angels and govern-ment grants. It has not applied for VC funds or full investments.

But we’ll look in that direction during scale-up, says Dr Kavitha.

Through various grants and seed funds, FIB-SOL has invested Rs 48 lakh in the company.

“We have been able to bag 3 seed

grants close to Rs 30 lakh in the last year alone,” she reveals.

Product diversificationThe start-up states that instead of trying to explain to VCs about the functioning of a Life Sciences start-up, it looks for investors or share-holders who are experienced in the field, and are able to understand the technology before investing in it.

We look for technology partners rather than just an investor, Dr Ka-vitha notes.

The start-up plans to diversify its product range, and fortify the exist-ing products with more functionality.

Dr Kavitha explains, “We wish to take our technology to countries which rely on agriculture as their ma-jor income source, such as our neigh-boring countries, African nations and South Americas. Of course, the product would be equally useful for Western nations including US and Europe, which have large acreage of farms.”

The company looks forward to start-up impetus from private corpora-tions and their role in supporting new ideas by taking up the role of cli-ents, investors and partners.

Start-up hubShe says that India and the West are very different in their approaches, but similar in their spirit about start-ups. “India sees start-up community as a means to solve its societal issues. On the other hand, start-ups are more individualistic and a means of making windfall gains, in the West. Both the concepts are equally good in their respective geographies, and should not be compared on the same level,” she opines.

To this, she also adds that Indian

metro cities like Mumbai, Chen-nai and Delhi have very well caught up with Bangalore and Hyderabad’s start-up scene.

“Although, these cities lack the luxu-rious spaces enjoyed at Bangalore and Hyderabad, they do have a very experienced community of entre-preneurs, who have converted small start-ups of yesterday into huge cor-porations of today,” she highlights.

Start-up lessonsAsk her what qualities make a success-ful entrepreneur? “The only essential quality needed in any career is an in-dividual’s perseverance followed by a strong character,” Dr Kavitha voices.

Entrepreneurial journey can teach invaluable lessons. Anant, an avid reader, traveler and videogames player, says that he has learnt to be versatile in planning activities, taking into account numerous uncertainties of a start-up day.

“This journey has taught me not to underestimate the talent of a person, irrespective of their technical back-grounds. Anyone can have a good idea, but it requires perseverance and patience to execute it, which in turn requires a team effort,” he stresses.

In her words, Dr Kavitha says the start-up journey has taught her to handle any tough situation in a more relaxed and natural way. “I have learnt to respect every individual’s capabilities, and to look forward for opportunities in every unusual cir-cumstances. Though we all accept that hard work is the key to success, I have started believing strongly that smart work does not need keys, it just finds the open doors,” concludes Dr Kavitha, who is also a classical dancer. BS

Raj Gunashekar


Biopreneur

ANATOMIZ3D

Anatomizing 3D printingFounded in 2016, Anatomiz3D is a 3D printing start-up in the medical space, and India’s only

company to provide patient-specific soft tissues for pre-operative models.

Anatomiz3D’s founding team consists of a dy-namic team in their 20’s including, Sohrab Kothari (28), Sagar Shah (28),

Samkit Shah (28), and co-founder Firoza Kothari (23).

In 2012, the founders together co-founded another start-up – Sahas Softech – which offers a range of rapid prototyping and 3D printing solutions.

Equipped with profound experience in 3D printing, CAD, CAM and allied services, the team ventured into their brand new start-up this year.

Ms Firoza is a biotechnology engi-neer while the rest of them are MBA graduates. “We were on the look out to start something,” says Ms Firoza, “where we can contribute and not just distribute, and with other co-founders already having a broad idea about the operations along with the promise 3D printing holds for the fu-ture, we believed that this is a space where we can not only learn and explore, but if we use our strengths well, we could also contribute to this technology and industry.”

The team first tried to learn the pro-cesses and procedures involved along with its detailed scope in the health-care segment.

“We assessed our current strengths

and abilities to prioritize our target segment. Once we started gaining more in-depth knowledge, we started reviewing our plans and made altera-tions to our goals as we got a better insight from the customers, medical community, researchers and current market operators,” adds Sagar.

World of 3D printingApart from prosthetics, Anatomiz3D has done a lot of focused work in 3D-printed pre-operative surgical and educational models.

Explains Sohrab, “We take the pa-tient’s CT or MRI scan and design a 3D model right out of the patient’s anatomy. These 3D-printed models assist doctors in planning their entire surgery before even entering the op-eration theatre. It helps them under-stand the exact anatomical relation-ships by replicating the structural conditions.”

Anatomiz3D Team_(L-R) Mr Sohrab Kothari, Mr Sagar Shah, Ms Shruti Kale, Mr Samkit Shah, Mr Ameeth Deshpande, & Ms Firoza Kothari

This allows selecting the best sur-gical plan, and medical teams feel more prepared and confident, saves operating time, reduce blood loss and anesthesia time, and aids faster recovery, leading in the reduction of overall operational costs.

The start-up is also exploring sec-tions of 3D-printed custom implants and surgical guides.

“We can design a patient-specific implant based on his or her exact anatomy, and print them directly in titanium 3D printers with custom meshes that can allow bone regrowth -- a procedure that is very difficult to achieve with traditional manu-facturing. Surgical guides make the surgical procedure easier for doctors as cuts and drills are pre-planned,” comments Samkit.

One of its product categories also in-


Biopreneur

cludes custom braces and splints for fracture rehabilitation.

Based on a patient’s scan, the start-up is able to design a custom fit or-thotic, which is not only light weight but also allows air to pass.

“It can be personalized to look how-ever a person needs. So, one can express their individuality while re-covering from their trauma. Who said injuries can’t be fashionable!” exclaims Ms Firoza.

Anaztomiz3D’s team feels that the possibilities with the 3D printing technology are endless.

“There is a hope that we will one day be able to 3D print organs in a lab out of a patient’s cells itself, thereby reducing the need for organ donors, and the possibility of organ rejections after transplantation,” points Sagar.

New industry, new challengesThe 3D bioprinting being a new space in India, the challenges faced by the start-up bore witness to the current market scenario.

The start-up says that it is still an up-hill task to convince medical practi-tioners and patients to try their ser-vices.

“The cost has to be borne by the cus-tomers without having a cover for insurance on such products, and is a pressing issue even today as not ev-eryone can afford it despite it having a high chance of improving decision-making and planning – whether be-fore, during and after a surgery or the required procedures,” observes Samkit.

Since the team was already suc-cessfully running their other start-up which already had the required

equipment for Anatomiz3D’s works, a lot of capital was saved which oth-erwise would have needed large in-vestments in diverse machines.

Ms Firoza states, “A lot of the funds were obtained from Sahas’ inter-nal accruals, and by simultaneously sharing office space and resources, we managed to mitigate investments as and when required.”

The start-up did approach venture capitalists at some point.

“With a couple of inputs from them, we are back to the planning and de-livery mode where we are investing our time in understanding the nu-ances, differentiation and review our set of priorities which we feel requires some alteration. Also, with the amount of momentum we have achieved, we have started receiving offers from interested parties and are trying to find common goals and ob-jectives to be able to optimally pen-etrate the length and breadth,” men-tions Samkit.

Laser focusThe team admits that the start-up is not bound by any revenue targets.

Sohrab validates, “This being an ex-tremely new industry with very few concentrated players, it is of para-mount importance for us to educate about all the scope of the work…. We are looking to engage with people from all verticals who are keen to learn the benefits, and at the same time experiment with any new pos-sible ideas.”

The West having witnessed a couple of cycles from the dot-com to the in-ternet of things (IoT), their ecosys-tem is said to have a certain level of maturity, benchmarking, fine-tuning and exit plans churned out, and have had a number of ups and downs to further its ecosystem.

“…but the eco-system in India, de-spite having a back-up or a bench-mark based on the Western system, is yet to evolve as far as entrepreneur engagement, planning, and delivery are taken into consideration,” shares Sagar.

Ms Firoza emphasizes that starting up in the healthcare industry re-quires utmost attention. BS

MILESTONES First to handle pediatric

cardiology cases in India

Executed partial amputee prosthetic hand case

First in country to provide pre-op models for soft tissue anatomy like cardiovascular, pulmonology & nephrology

ENTREPRENEURIAL MISTAKES TO AVOID

Failing to learn actual scenarios

More strategizing than getting one’s feet dirty

Not laying core foundations (values, philosophy)

Pricing

Valuation

HOW A PROSTHETIC HAND IS 3D-PRINTED

Scanning a patient's hand or POP casted model

Modifying the prosthetic based on patient’s scan using exact measurements.

3D printing the parts Assembling the parts

Raj Gunashekar

ACT NOW

AND GET ACCESS

TO 6 MONTHS

ARCHIVAL ISSUES

FREE*

Subscribe to digital edition in 3 easy steps:1. Log in to digitalmagazines.mmactiv.in2. Select your subscription option-

you can subscribe for 3/6/12 months or buy a single issue

3. Register and complete your order4. Read your BioSpectrum magazine on the go!

For more information contact [email protected]

Subscribe to the Digital EditionYour most trusted bioscience magazine now available in digital format on

Windows Desktop

Find us on Facebook: facebook.com/BioSpectrumMagazine

Follow us on Twitter: twitter.com/BioSpectrumMag

Volume 13 Issue 3 March 2015 www.biospectrumindia.com

An Publication

`100

Tota

l pag

es in

clud

ing

cove

r 68

Hot Biotech

Industry reacts to Budget 2015

11Start-ups…

A year later

Debate still rages on GM crops

BIO

SPECTR

UM

11 HO

T BIO

TECH STA

RTU

PS - A YEA

R LATER

MA

RCH

2015

Our media design services help you achieve desired performance.

BD™ Media Design SolutionsCustomizable Solutions for Your Media and Feed Development Needs

BD offers a full range of media solutions for the biopharmaceutical industry. Our Media Enrichment Services include a supplement screen, media enhancement, and feed strategy development to optimize your current medium. In addition, our experts can design a custom medium and feed formulation with our Media Design Services, which feature a comprehensive media library panel screen, full medium design, and full medium design and feed development.

Designed to meet your performance goals, BD’s Media Design Solutions leverage our experience in developing peptones and supplements to define the unique drivers in your cell line, allowing for consistency in your developmental process. We combine these solutions with our proven methodology and extensive analytical capabilities to provide you with a variety of solutions that meet your timeline and budget needs.

To learn more about BD’s Media Enrichment and Design Services, please call +91 22 33241600 or go to www.bdbiosciences.com/cellculture/advbio.

Our focus is getting you optimal

results fast

BD and BD Logo are trademarks of Becton, Dickinson and Company. © 2015 BDBDbdbiosciences.com/cellculture/advbio

RNI No. DELENG/2004/13061 Published on 1st of every month L(ND)-11/6170/2014-15-16Posting Date: 7&8 of every month. Posted at Lodi Road HPO

BSI_May-2016_Raj Gunashekar

Documents

Transcript of BSI_May-2016_Raj Gunashekar