BSI-March 2016 - 13th Anniversary Edition - Recreating Silicon Valley - Raj Gunashekar

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

Volume 14 Issue 3 March 2016 www.biospectrumindia.com

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India at the moment is at this cusp.

RECREATING THE

SILICON VALLEYIN INDIA

What’s

trending in

Indian Biotech

13TH ANNIVERSARY SPECIAL

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


An Publication

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l pag

es in

clud

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India at the moment is at this cusp.

RECREATING THE

SILICON VALLEYIN INDIA

What’s

trending in

Indian Biotech

13TH ANNIVERSARY SPECIAL

COVERDESIGN BY: SHIHAB K A

REGULARS

7 BIOEDIT

8 BIOMAIL

50 BIONEWS

64 BIOSUPPLIERS

66 BIOCOMMENT

COVERSTORY 10

BioContents

RECREATING THE

SILICON VALLEY IN INDIAINDIA AT THE MOMENT IS AT THIS CUSP. THERE IS SOMETHING

HAPPENING IN THE INDIAN START-UP ECOSYSTEM IN THE LAST

10 YEARS

Affigenix Biosolutions ExoCan

CABIS Labs Leucine Rich Bio

GeNext Genomics Seagull BioSolutions

Mir Life Sciences Cleanergis Biosciences

Barefeet Analytics Synthera Biomedical

Denovo Biolabs Orthocrafts Innovation

Geniron Biolabs Shodhaka Life Sciences

Newndra Innovations Consure Medical

Bugworks I nbiosys

Eumentis Informatics RASA

Abiruchi Probiotics Swasti Agro and Bioproducts

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30

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BIOEVENT

The theme of this year’s biggest biotech event was ‘What’s trending in BioTech in India’, where biotechnology leaders forecast the trends in biotech

The Lifesciences industry in Israel is 50 percent dominated by pharma behemoth Teva Pharmaceuticals, followed by Taro Pharmaceuticals, which is now part of India’s largest generics empire, Sun Pharmaceuticals

WHAT’S TRENDING IN BIOTECH IN INDIA

46

Puneet Suri Senior Director, Software Engineering, Thermo Fisher Scientific

PARADIGM SHIFT IN GENETIC DATA ANALYSIS AND CONNECTIVITY

CLOUD COMPUTING SOLUTIONS TO DRIVE PARADIGM SHIFT IN LIFE SCIENCES

58

62

BIOSUPPLIERS

Biotechnology Industry Research Assistance Council (BIRAC)(A Govt. of India Enterprise)

For Supporting Affordable Biopharmaceutical Development

(Identifying novel tools/technologies and Process optimization)

Invites proposals

Small Business Innovation Research Initiative (SBIRI) &

Biotechnology Industry Partnership Programme (BIPP)

Small Business Innovation Research Initiative (SBIRI) Biotechnology Industry Partnership Programme (BIPP)

Who can applyA single or consortia of Indian company (ies) registered under “The Indian Companies Act 2013” with minimum 51% Indian ownership, and DSIR recognized in-house R&D unit, are eligible to apply either alone, or in collaboration with a partner from another Company/Institute/University.(Companies in the process of obtaining DSIR recognition may also apply; however, their funding would be subject to getting DSIR recognition)

Supports discovery, proof-of-concept and early stage innovations in companies for development of biotechnological products and processes with high societal relevance

An Advanced Technology Scheme for high risk,transformational technology/ process development from proof-of-concept to validation leading to high value products for commercialization

How to apply Proposals for both the Schemes are required to be submitted online only. For scheme details and submission of proposal, please log on to BIRAC website (www.birac.nic.in)

For queries, please contact: Head Investment, BIRAC. Email: [email protected]

Last date for Submission of Proposals : 31st March, 2016

**

Identification and validation of novel bioprocesses for biopharmaceuticals at lab scale (5.0 L)Innovative R&D solutions for upstream and downstream process optimization

Pilot scale validation of novel processesDemonstration of novel engineering processes for existing technologies

**

BioContents

BANGALORE INDIA BIO 2016


When BioSpectrum was launched 13 years ago in March 2003, it took baby steps just like the biotech industry which it aimed to cover in detail. The industry was small with few dozen companies trying to make their mark and signs of an industry taking shape was very much there. BioSpectrum reflected the sentiments of the industry with

the cover story that campaigned for a National Biotech Policy to shape the con-tours of the emerging sector.

There has been no looking back both for BioSpectrum and the industry since then, despite a few hiccups here and there which is part of the game in any sector. I am writing this 13th Anniversary Editorial in a happy frame of mind. Why?

After all, the previous issue had detailed how the biotech industry has been stuck in the $4 billion mark for the last two years due to single digit growth and the how the revised National Biotech Strategy is trying to push the industry towards an ambitious $100 billion revenue by 2025.

Here is why: This 13th Anniversary Special Issue has chronicled something remarkable that is happening within the industry, unnoticed by many. I am referring to the presence of dozens of exciting start-ups in the life science sector in different parts of the country, shepherded by key government agencies like BIRAC and many incubators supported by the government.

This issue has listed the names of 88 start-ups which have started operations in the past 4 to 5 years and few were incubated just a few months ago. BioSpectrum team has tried to reach out to almost all of them over the past few weeks and in this issue, we have given snapshots of a random sample of 22 of them. The new age entrepreneurs in biotech present a fascinating picture about the flowering of entrepreneurship in the past few years. There is the highly experienced Dr Aru-mugam Muruganandam, who has set up Affigenix BioSolutions, in his early 50s after successful stints in top foreign and Indian biotech companies.

Then meet this young entrepreneur, Pawan Samdani, 25, who set up data analytics company spe-cializing in life sciences, Eumentis Informatics, right after college, motivated by the vaccine maker Serum Institute’s amazing work with vaccines. Another interesting start-up is the Nagpur-based Genext Genomics started by Supriya Kashikar and Dr Ashwin Kashikar to develop diagnostic and therapeutic proteins. The inspiration to them came from Ankur Seeds chairman, Ravi Kashikar.

The 88 start-ups span a wide range of activities within the life sciences sector. Drug development, vaccine platform development, drug design using informatics tools, veterinary biologics, data analytics, diagnostic devices, tissue engineering and cancer diagnosis. Almost all these companies have found mentors from within the industry and are making full use of some of the funds pro-vided by BIRAC and incubator support from institutions like NCL Innovation Center, IBAB, IKP Knowledge Park and many university departments.

It is time more biotech industry veterans start noticing them and bring them into the fold of ABLE and other associations to accelerate them to the next stage of successful scaling up. And help them also emerge as global leaders in the coming decades and inch towards the $100 billion mark quickly. BS

Narayanan Suresh Group Editor

[email protected]

B iotech start-ups bring cheer to industry

BioEdit


Vol 14; Issue 2; February 2016

A $100 bn biotech industry DBT’s ‘$100 billion dollar biotech industry by 2025’ is an ambitious project and not impossible. It requires care-ful planning, active participation of all stakeholders viz. industry, government, research institutions etc. We also have to work on creating an innovative ecosystem. The policies at present are sedated. We need fresh and rele-vant policies so as to foster innovative R&D and keep up with the latest developments in the sector. Central govern-ment’s start up policy is good in this direction. It has given confidence to the startup community and biotech startups will benefit too, further contributing to the sector.

Mansi Kharbanda, Ahmedabad

Industry eventsIt’s a good thing that many industry events are coming up. These events are a platform for networking and offer good opportunity for start up to market themselves and of course serves as good discussion forums etc. However,

as pointed out these are not on par with international events like BIO and much more needs to be done to take these events to that level.

Sriram Narayan, Hyderabad

Women maniaThis is with reference to the gender disparity story in the last issue of BioSpectrum. While I agree that STEM field was dominated by men things are changing and we are seeing more active participation by women in the sector. Especially in the biotech sector we have seen many suc-cessful women entrepreneurs, Dr Kiran Mazumdar-Shaw is a fine and inspiring example.

Sanam Saluja, Mangalore

Vol 14; Issue 3; March 2016

Publisher: Jagdish Patankar

EditorialChief Editor: Narayanan SureshEditor: Srinivas Rao ChandanExecutive Editor: Srinivas RasoorAssistant Editor: Rahul Koul (Delhi)Senior Correspondent: Raj Gunashekar

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DesignDesign: Shihab KA

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Our Offices - Editorial and Business

In the February issue on page 51, the picture under Dr Geeta Singh, Director, Labland Biodiesel was wrong. The error is deeply regretted.

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CoverStory

RECREATING THE

SILICON VALLEY IN INDIA

The Silicon Valley was never planned

as it is today in all its awe and

grandeur. It just happened over

decades! Yes, it did. Decades of

hard work, persistence, high-end

technology and research, and an

overall conducive ecosystem laying

the red carpet for all the biggies and

start-ups who showed up there with

their great American Dreams.

CoverStory


Raj Gunashekar

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CoverStory

India at the moment is at this cusp. There is something happening in the Indian start-up ecosystem in the last 10 years, especially

after the emergence of block-buster start-ups like Syngene, Flipkart and Snapdeal. Prime Minister Modi’s ‘Startup India’ and ‘Make in India’ campaigns have stirred up the entrepre-neurial spirits within India’s young blood.

While statistics show that 90 percentage of all start-ups fail, the more risky industries like Biotechnology and Pharma-ceuticals are seeing innumer-able start-ups in the country in an unprecedented manner. High-risk, longer gestation pe-riods, impatient investors, and a not-so-conducive start-up environment are among a few murmurs that often slip out of entrepreneurs’ lips.

Venturing into BioIT, Bio-Pharma, Medical Devices & Diagnostics are seen to be a well-treaded trend at this time. More and more students and entrepreneurs are realizing the advantage and the potential of billion-dollar-ideas going glob-al and ending up with an IPO or M&A. Incubators and accelera-

MORE START-UPSActorious Innovations and Research

Aindra Systems

Applied Bioscience India

Applytics Innovative Solutions

ArrayGen

Aten Biotherapeutics

Axio Biosolutions

Azooka Life Sciences

Bencos Research Solutions

Biomoneta Research

Bumpdocs

Cardiac Design Labs

Cellzyme Biotech India

Chargen Life Sciences

Cloudex Healthcare

Coeo Labs

Embryyo

FIBSOL Life Technologies

Florentis Pharmaceuticals

Genelon Institute Of Life Science

GeneXplore Diagnostics And Research Center

iBioanalysis

iClinica

inDNA Research Labs

Indoor Biotechnologies

Indoriv Clinical

Innovator Lab Consultants India

InvivioD Solutions

Ixora Biosciences

Jeevtronics

Jenome Technologies

Jubeln Life Sciences

Lab4Life

Laerdal Global Health

Magellan Life Sciences

Medicloc

Module Innovations

Monitra Healthcare

Mosiab Technologies

MSi Biotech

Nanosniff Technologies

Nayam Innovations

Nextec Lifesciences

NobleExhange Solutions

Novo Catalyz

Oleome Biosolutions

Omix Labs

Onan Biotech

OncoStem Diagnostics

OneBreath

Osteo 3D

Pandorum Technologies

Pentavalent

Plasmatech

Pradin Technologies

Privils

Prodintel Technologies

Purius Nanosystems

Regain Biotech

Remidio Innovative Solutions

Revelations Biotech

The entrepreneurs share their birthing new ideas, innovative works, funding woes and challenges faced


CoverStory

Sascan Meditech

Sattva MedTech

SG Artheart

Skanda Life Sciences

SkinCurate Research

SKL Medtech

Sohum Innovation Lab

Solutions

SSK Biosciences

Stellargene Consultancy

Stellixir

StringBio

Systems Biology

Terrablue XT

TheraIndx Lifesciences

Total Potential Cells

uber Diagnostics

Unilumen Photonics

Unilumen Photonics

Utopia Biosolutions and Services

Vegrandis Therapeutics

Virtis Bio Labs

Vital Bioscientific Solutions

VR Bioremediation Services

Western Range Biopharmaceuticals

Wobble Base Bioresearch

Zephase Therapeutics

tors in colleges and universi-ties are catching-them-young.

BioSpectrum’s Raj Gunashek-ar reached out to a handful of start-ups to check the mood in the industry. The entre-preneurs share their ‘Eureka’ moments, birthing new ideas, their innovative works, fund-ing woes, recommendations to the Government, along with the great obstacles and chal-lenges faced while running their enterprise, and how they overcame them with thunder-ing victories.

We have presented the start-ups profiles in an alphabetical order, culminating with a list of start-ups to watch out for in the next couple of years. BS

MORE START-UPS

Statement of ownership and other particulars about the newspaper BioSpectrum to be published in the first issue every year after last day of February.

1. Place of Publication : New Delhi2. Periodicity of Publication : Monthly3. Printer’s Name : Jagdish B. Patankar Whether Citizen of India : Yes Address : 603, 6th Floor, Rohit House, 3 Tolstoy Marg, New Delhi – 110 0014. Publisher’s Name : Jagdish B. Patankar Whether Citizen of India : Yes Address : 603, 6th Floor, Rohit House, 3 Tolstoy Marg, New Delhi – 110 0015. Editor’s Name : N Suresh Whether Citizen of India : Yes Address : 603, 6th Floor, Rohit House, 3 Tolstoy Marg, New Delhi – 110 0016. Name & addresses of individuals who own the newspaper, and partners or shareholders holding more than one percent of the total paid-up

capital.

Form IV ( See Rule 8)

Sd/-Publisher

Name : Mr Vijay Padmakar ThombreAddress : 1, Sagar Apartment, 6 Mahaganesh Society Paud Road, Kothrud, Pune – 411038

Name : Mr Jagdish Balkrishna Patankar Address : B-55, Mahavir Park Society, Pune - Satara Road, Pune – 411037

Name : Mr Ajey Madhav JhankarAddress : 485 Narayan Peth, Near Lokhande Talim, Pune – 411030

Name : Mr Ravindra Vidyadhar BoratkarAddress : 402, Siddhivinayak Apartment, Khare Town, Dharam Peth, Nagpur

An initiative of the Department of IT, BT, and S&T of the Government of Karnataka ANNOUNCES ADMISSION FOR

Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronic City Phase I, Bengaluru 560100 Tel: (080) 285 289 00, (080) 285 289 01, (080) 285 289 02; Fax: (080) 285 289 04

www.ibab.ac.in

IBAB is a unique initiative in the country. It has received a 'Centre of Excellence for Research and Training in Bioinformatics' designation from the Department of Electronics and Information Technology of the Government of India.

Located on a sprawling 20-acre campus at the Biotech Park in Electronic City of Bengaluru, IBAB has adopted a strategy of ‘Education, Research, and Entrepreneurship in Biotechnology and Bioinformatics’. Besides its flagship MSc in ‘Bioinformatics & Applied Biotechnology’, IBAB also offers doctoral and post-doctoral programmes. IBAB has also successfully incubated twenty biotech start-up companies.

Strengths of the programme Unique, inclusive programme in biotechnology and

bioinformatics; an integration of biology with informational sciences

Advanced topics in cell and molecular biology, biochemistry, and microbiology

Exposure to omics, data analysis, macromolecular modeling, cheminformatics, fermentation, and downstream processing (essential skills for biology and biomedical research)

Enhanced theoretical and practical training in biotechnology (including immunology and genetic engi-neering)

Enhanced theoretical and practical training in bioinformatics (statistics, mathematics and major computer languages including C, C++, PERL, JAVA, and R)

Excellent in-house faculty for effective mentoring (faculty- student ratio of 1:6)

Specialised topics rendered by external experts from academia and industry

Synchronised courses and topics taught from the basics to facilitate assimilation by all students

Living and learning in an exciting environment with students and faculty from inter-disciplinary backgrounds

Opportunities for research in plant, animal, and microbial sciences (including structural and computational biology)

Why IBAB? More than 95% placement record across all previous

courses/batches (many alumni successfully completed PhD in India or abroad; student-wise placement records available on our website)

Opportunities to work at start-up companies incubated by IBAB

State-of-the-art facilities for biotechnology and bioinformatics training (please visit our campus or watch videos on our website)

Faculty involved in advanced research programmes (publication list available on our website)

Important Dates

MSc in ‘Bioinformatics & Applied Biotechnology’ (degree awarded by the University of Mysore)

Eligibility: Bachelors degree in any branch of science/technology/medicine (BSc, BTech, BPharm, MBBS, BDS, BAMS, etc.)

Gateway to Industry and Academia

95% placement record

Last date to submit application: 09 May 2016 Online Test (from anywhere): 10 - 11 May 2016 01 - 03 June 2016 Interview (in Bengaluru only): 16 May - 14 June 2016

Announcement of results: 15 June 2016 Last date for joining: 17 July 2016


CoverStory

AFFIGENIX BIOSOLUTIONS

During his college years in the early 80s, hailing from an agrarian family, Dr Arumugam Muruganandam (52) had an intense desire to start an agriculture-based venture in

India. However, he felt the situation, back then, was not ripe enough to undertake an entrepreneurial risk.

In 1995, he worked for the National Research Council of Canada, and then moved on to be the associate

director & principal scientist for US-based Dyax Corp in 2001.

While in North America for 20 years, he intended to start a drug discovery venture along with his colleagues. But things didn’t work out as planned.

He returned to India in 2008 and worked for Bangalore-based Biocon as the chief scientific manager for the next 4 years. Post which, his good old entrepreneurial dreams began to take shape.

After his stint with Biocon, the year 2012 marked the beginning for Af-figenix Biosolutions, his Bangalore-based biotech start-up, offering in-novative biosolutions to the Life Sciences industry, where he serves as its MD & CSO.

He says that his inspiration directly trickled down from both his father and father-in-law.

Innovative biosolutionsAffigenix’s parent organization is the CREW (Chennai Radha Engineering Works) group of company, where its chairman Mr Sambandam Venkate-

san, is known to be the investor and also the chairman of Affigenix.

Dr Arumugam voices, “As soon as I decided to start the company I in-formed my family first and secured the initial funding from my father-in-law…. The company name was chosen by my children and the logo was designed by a friend. Before reg-istering the company we legally se-cured the website address and logo. Although I did not have formal busi-ness plan, I vetted my ideas to my friends and family and then started to look for an incubator facility.”

In August 2014, the company re-ceived the DBT-BIRAC-BIG 3 seed funding worth Rs 45.2 lakh in in-stallments through its BIG partner -- Centre for Cellular and Molecular Platforms (C-CAMP).

Affigenix’s R&D facility in Banga-lore is equipped to do cutting-edge research in areas such as antibody engineering, drug delivery, and im-muno & molecular diagnosis.

For the short term, Affigenix also provides custom biosolutions to bio-pharma companies mainly involved in manufacturing of biologics such as clearance assay development (host cell protein, host cell DNA, and enzymes used in manufacturing process).

It has also developed some viable low-volume, high-value immuno-as-say products for biosimilar product development, suitable for pharmaco-kinetic, immunogenicity and poten-cy/NAb assay, biomarker discovery and personalized medicine.

“The long-term plan is to discover and develop safe, pure and potent biologics to target complex diseases,” he adds. The company hopes to reach Rs 40 crore mark in this fiscal. BS

Dr Arumugam Muruganandam MD & CSO, Affigenix Biosolutions

A roller-coaster ride for the first 999 days


CoverStory

BAREFEET ANALYTICS

Disruptive next-gen solutionsfor food analysis industry

In 2008, shortly after Dr Venkat Panchagnula (40) joined NCL (National Chemical Laboratory, Pune), there was a scare of melamine contamination in Chinese milk products.

Melamine is a white, crystalline, organic base chemical rich in nitrogen, widely used in the

manufacture of adhesives, plastics and whiteboards.

This chemical has the capacity to in-crease the milk’s nitrogen content, leading to an increased protein levels in the milk, which has been exces-sively adulterated with water.

During this time, Dr Venkat’s group were developing bioanalysis methods for processing large number of sam-ples within a short duration.

These methods were immediately put to use, and an analysis method to rapidly and reliably detect melamine in milk was published.

Over the next few years, the team de-veloped an entire analytical tool kit for pesticide and food contaminant analysis was developed. The primary aim was to cater to the unique analy-sis needs of Indian farmers and ex-porters, which means handling high-volume perishables.

Ultimately, in 2014, NCL alumni from Dr Venkat’s group and a couple of other scientists from NCL set-up Barefeet Analytics to commercialize these methods.

The start-up intends to leverage the teams’ diverse and sound under-standing of both scientific and busi-ness aspects to provide potentially disruptive solutions for food analysis.

The team and the business ideas were nurtured at NCL Venture Cen-ter in Pune.

Barefeet’s current team members in-clude Dr Ajeet Singh (32), Mr Vishal Mahale (25), and Dr Magesh Nan-dagopal (37).

Dr Venkat Panchagnula currently serves as the director of the venture.

“We decided to apply for BIRAC’s Biotechnology Ignition Grant (BIG)

to further develop our proof-of-con-cept for field trials. Approvals for the start-up through the CSIR’s Scien-tist Entrepreneurship Program were obtained. We put a dedicated team together and rented out lab space at NCL Venture Center to begin opera-tions,” says Dr Venkat.

The food analysis market in India presents a huge opportunity for the company. Currently, the export mar-kets, for example, in the US or EU, are highly regulated, while the Indian markets are catching up to meet the food safety standards.

“At every stage of the supply chain, a reliable partner is needed to en-sure that products are meeting the required standards, and regulatory specifications among others. This need is being felt more and more now. And we are looking to serve this need,” Dr Venkat remarks.

There are numerous challenges in the economics and logistics of food analysis with significant rejection rates and losses in the export market.

The company has received its seed funding through BIRAC’s BIG grant worth Rs 47 lakh. The start-up now caters to quality control & food test-ing laboratories. BS

Dr Venkat PanchagnulaDirector, Barefeet Analytics

91-22-41515151 / 41515111

[email protected]

[email protected]

Nilsan Nishotech Systems Pvt Ltd

Plot No. -199E,MIDCThane Belapur Road,

Khairane, Navi Mumbai 400 705


CoverStory

BUGWORKS

Soldiers against drug resistance terror

Here is how a two-year-old start-up is gearing up to fight the invisible emerging threat of antibiotic-resistance Armageddon.

Established in 2014, Bugworks is a drug discovery start-up in-volved in finding novel biophar-

maceutical assets in treating anti-biotic-resistant bacterial infections, using its proprietary systems biology platform.

The start-up is a spin-off of Cell-works, a ten-year-old company fo-cused on designing therapeutics us-ing simulations to screen studies and predicting clinical outcomes, thereby increasing success rates and reduc-ing R&D development costs.

The genesis of Bugworks began at Cellworks while the team started working on infection portfolio. In 2013, the Cellworks team wanted to focus its attention on a large unmet medical need with high mortality rates.

Their quest pointed them towards hospital-acquired infections.

These infections are picked up by people in hospitals through gram-negative bacterial contaminations, which are hard to kill and have great-er drug resistance attribute.

“Decades have passed by and drug resistant superbugs are becoming su-perior and smarter with higher mor-tality rates, with no available treat-ment to combat them effectively. Not

many companies are working in this area, and we thought this would be the perfect stop for us to start,” re-veals Dr Anand Anandkumar, CEO, Bugworks, who also serves as the ex-ternal director and chairman of the board of directors of the Cellworks’ India operations.

He says that patients are being bom-barded with antibiotics for a certain period thereby bolstering the resis-tance rates causing a big void in find-ing new mechanisms fighting them. “Emerging countries are at the worst. India is a worst offender in the world. Antibiotic abuse happens in agricul-ture, poultry and medical stores be-cause of their low-cost availability,” he adds.

Along with him, the company was co-

founded by Dr V Bala Subramanian, serving as the president and Dr San-tanu Datta as the chief scientific offi-cer (CSO) of Bugworks, both of them hailing from a rich, two-decade-plus research experience at AstraZeneca India.

Dr Anand continues, “The need is so bad because of the drug resistance in bacteria due to antibiotic abuse and lack of new drugs. The bugs have be-come used to existing drugs. There are not many drug discovery com-panies ready to invest in fighting the antibiotic-resistance.”

“The last mechanism introduced for gram-negative bacteria was way back in the sixties. We have not had new antibiotic class for a long time,” says Dr Bala Subramanian. BS

Bugworks Founders (L-R) Dr Santanu Datta, Dr V Bala Subramanian & Dr Anand Anandkumar


CoverStory

CABIS LABS

Once the pinch starts….A start-up which began with a tiny investment of Rs 30,000, now

stands at worth more than Rs 2 crore.

Started in 2011, Bangalore-based Cabis Labs (Chemical And Bio-logical Industrial Services) is

a research-based, technology and product development start-up for the pharmaceutical industry.

It is also a contract research venture primarily focused on drug discovery, development and manufacturing of pharmaceutical and pharma inter-mediates including specialty chemi-cals, APIs, and research chemicals.

Dr Rajesh Kavali, MD and co-found-er of Cabis, was a former scientist with Syngene International. He has also been a scientist with Sigma Al-drich and Zydus Cadila.

‘‘Bureaucracy,’’ says Dr Rajesh, ‘‘is a major hurdle while establishing start-ups. Even for a small licensing chore you need to bribe a few people. In the US, if you want to establish an enterprise, there are organizations that are very supportive and they do not charge a penny. Such set-up is not available here in India. Even the Government doesn’t support new ideas, and it doesn’t understand the concept of entrepreneurship. Taxa-tion eats away a lot of money in a start-up.”

He adds that approaching banks for funding is difficult even with great projects in hand.

“Biotech start-ups take a minimum

of 4 to 5 years to see returns. Profits come post that period. Most inves-tors crave for immediate returns and are impatient,” he points.

Cabis bagged its first project only 2 years after its inception.

“Our greatest asset is intellectual property. During the first year, it was all about groundwork, getting the projects, meeting and networking with people,” reveals Dr Rajesh.

Its first project was with Sigma Al-drich, whose support he very much cherishes. “We have also approached US companies. They can fund us, and we can exclusively work for them with mutual agreements including IPs,” he shares.

He says that in today’s high-tech world, it is crucial for start-ups to

have their own web presence.

“Without a good branding, profes-sionally crafted website, or even an email ID for that matter, one can go nowhere in the business world,” Dr Rajesh notes.

He mentions that Mr Somasunda-ram, MD of Supraveni Chemicals, an enterprise worth Rs 20 crore, was a great motivation to him.

“Once the pinch starts, success auto-matically multiplies. When success multiplies, there are many who want to throw stones. But we have taken it up as a challenge,” he opines.

He states that he has learnt to be ex-tremely patient in the biotech field.

“Success will not happen in a year or two. It is important to maintain funds and a steady cashflow. It is crucial to minimize your desires and not needs. It is better to set shorter goals which will boost self-confidence. There is a lot of sacrificing that an entrepreneur has to make.

He or she has to be ready to even sweep and clean the floor at times. But one has to learn to enjoy be-ing an entrepreneur. Everybody in a start-up needs to work for its growth because everybody is an owner in it. Each individuals’ idea should be re-spected,” he explains. BS

Dr Rajesh KavaliMD & Co-founder, Cabis Labs


CoverStory

DENOVO BIOLABS

Immunological tools forunmet demands

According to Mr Manjunath, one of the founders of the start-up Denovo Biolabs, the seeds of entrepreneurship were sown during his academic days at the Institute of Bioinformatics

and Applied Biotechnology (IBAB).

Erected in 2013, Denovo Biolabs is located in India’s Silicon Val-ley – Bangalore, incubated at

IBAB campus.

The start-up is involved in product development through R&D and in-novation for laboratory diagnostics and medical research.

“We develop quality immunological tools to serve the unmet demands of the industry,” voices Mr Manjunath.

The other founders who joined in his endeavor are Mr Rishikesh Kumar, and Mr Dinesh Kumar Saini.

Mr Manjunath and Mr Dinesh for-merly worked as senior scientists with Abexome Biosciences. Mr Ri-shikesh was employed with Molecu-lar Connections and Quintiles Tech-nologies.

Entrepreneurial triggersAs students at IBAB, Mr Manjunath and Mr Dinesh were constantly ex-posed to various entrepreneurial ac-tivities, lectures and networking op-portunities.

Explains Mr Manjunath, “Once we knew the profile of our company, the first step was to solve the financial requirements, which were resolved

with our personal funds and inves-tors. For our infrastructural require-ments, IBAB’s director Prof Yathin-dra and Dr Gayatri Sabrewal played a pivotal role.

Once the infrastructure were in place, the necessary registrations, approv-als and other documentations which were required were put in place. The laboratory set-up was a big step ahead which helped the R&D activi-ties, and as a result yielded in quality products for the company.”

Denovo is in the process of develop-ing biopharmaceutical technologies to deal with global healthcare needs in terms of accessibility and afford-ability of drugs.

It also develops ELISA (enzyme-linked immunosorbent assay) tools for quantitative estimation of bio-pharmaceutical drug level, such as humanized monoclonal antibodies (mABs) and recombinant proteins.

“We provide end-to-end, cost-effec-tive pharmacovigilance solutions to pharmaceutical, biotechnology and medical device companies. We also provide wide range of customized services to academic institutions. We are working towards affordable cancer diagnostics which will help in early detection of cancer and the bet-terment of societal health,” reveals Mr Manjunath.

Initially, the founders faced the hu-mongous task of convincing inves-tors for funding.

“Getting a suitable infrastructure to initiate the R&D activities was a challenge. Then came the R&D and product development challenges ac-companied by providing high quality products, product placement in the market and being ahead of competi-tors,” adds Mr Manjunath, who en-joys travel and exploring mysterious places.

Denova has set a revenue target of Rs 10-15 crore by 2018. BS

Mr Manjunath Devaramani Co-founder, Denovo Biolabs

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EUMENTIS INFORMATICS

Forging ahead with perseveranceHailing from a Marwari family, Mr Pawan Samdani was always around business-driven

people, and was immersed right into the business culture starting from his early childhood.

While in school, he always dreamt of being an entrepre-neur someday. During his

first year in college, he sensed that internet-based businesses would be the future. He started learning web development and created websites.

In the third-year of his college, he started developing SaaS products as ‘Cloud’ seemed to be the buzz at that time.

But it was an internship at the world’s largest vaccine maker, Serum Insti-tute, where it dawned on him that his enterprise would be biotechnology-oriented as he was greatly motivated by Serum’s work.

“I decided not to sit for placements and started my company right away,” recalls Mr Pawan, the 25-year-old founder of Eumentis Informatics, a biotech analytics and consulting start-up incorporated in 2014.

Eumentis is a data analytics start-up providing analytics service and develop data-driven products in the field of Biotechnology, Life Sciences and Agriculture.

Mr Pawan is from IIT-Delhi, holding both his Bachelor’s and Master’s de-gree in Biochemical Engineering and Biotechnology.

So far he has self-funded the compa-ny with an investment of Rs 3 lakh,

and has received support from Ven-ture Center, Pune.

After his degree, he was carrying out his research work at IIT-Delhi, and at International Centre for Genetic Engineering and Biotechnology (IC-GEB), New Delhi.

Both he and his batchmate, Mr Krishna Choudhary, discussed about starting their own data analytics company in Life Sciences.

Simultaneously, the duo were also applying for their respective PhD programs.

Mr Pawan targeted Swiss Federal Institute of Technology (Eidgenös-sische Technische Hochschule Zürich, ETHZ), European Molecu-lar Biology Laboratory (EMBL), and Sanger Institute. But was rejected in

all the three places.

However, Mr Krishna was offered a place for his PhD at the University of California, Davis, USA. He went to pursue the program. Mr Pawan de-cided to stick to his decision in start-ing a bioinformatics company.

Currently, the company provides all types of bioinformatics services in genomics, proteomics, transcrip-tomics and systems biology.

It also specializes in Next-Genera-tion Sequencing (NGS) and its ana-lytics, and consult researchers and companies on utilizing NGS in their research.

Eumentis is developing a diagnostic test for Tuberculosis (TB) which can determine drug resistance to most of the antibiotics using NGS. Later on, it intends to develop tools surround-ing clinical applications of NGS.

It is looking out for partnerships with biomedical device manufactur-ing companies to develop the device for its TB diagnostic tool.

The company is also working on big data technologies like Apache Spark to carry out large-scale and real-time analytics in healthcare (healthcare IoT data, EMR data, and hospital data). According to him Next Gener-ation Sequencing is the future. BS

Mr Pawan SamdaniDirector, Eumentis Informatics


CoverStory

GENEXT GENOMICS

'Only passion and will powerwill enable success'

Ever since its inception, the start-up journey has been a rough ride for Ms Supriya Kashikar (32) and Dr Ashwin Kashikar (37), the founders of Nagpur-based Biotechnology R&D start-

up, GeNext Genomics (GNG). However, their unwavering self-belief, hard work and patience have started paying off.

GNG was founded in 2011, with a focus in the areas of diagnos-tic and therapeutic proteins

development, cellular and molecular assay development and con-tract re-search services.

The company has expertise in pro-tein and antibody engineering, ex-pression and production.

“We have developed a platform whereby we can de-liver antibody quickly without the need of immuni-za-tion,” says Ms Supriya, a Biologist.

Its research focus is in developing antibody for re-search, diagnostics and therapeutics.

With this goal, GNG has developed a therapeutic candidate molecule for MTB (Mycobacte-rium Tuberculo-sis), and TNF (Tumor Necrosis Fac-tor) alpha.

She adds that the main focus is to re-duce the cost of antibody resources, and maintaining its specificity and consistency.

Comments Ms Supriya, “Our idea of starting a new company was to deliv-er cost-effective scientific re-sources to the Indian scientific fraternity.

Our constant effort is to use our intel-lect to identify the bottleneck areas in Life Sciences, and develop technolo-gies right here in our own country and help the society.”

“Our platform will deliver the small-est antibody with high specificity in a lesser timeframe,” she points.

The start-up has a strong team of 9 scientists with ex-tensive experi-ence in proteins, molecular biology and immunology, headed by a very experienced Structural Biologist, Dr Vinod Agarkar.

She says that Mr Ravi Kashikar, the chairman of Ankur Seeds, influenced her to step into the entrepreneurial journey.

Analyzing a niche area, the team found that there is huge need for TB research for new drug development.

“We worked along with Prof Hari-nath in MGIMS (Ma-hatma Gandhi

Institute of Medical Sciences), who has given his whole life researching TB, and identified a novel target. Our company is developing a lead mole-cule against the target, and conse-quently a new bio-logical entity as a therapeutic,” Ms Supriya states.

So far the journey has been tough for the founders.

“We had to collaborate with several labs in and outside the country to facilitate our research. The Govern-ment should bring in more incuba-tors to other towns to foster more innovation. Right from inception, we have faced very tough system in the Indian Government’s policies for companies that are research-based,” opines Ms Supriya.

“For high-quality research,” she continues, “we need quality capital assets, and analytical instruments which incurs huge cost and requires to be imported from abroad. There are so many rules for custom clear-ance and the cost incurred is huge. The Government does give accredi-tation/DSIR when there are sales returns. This gives benefits for the R&D, but for start-ups with no initial ROIs, they have to face tough times.” BS


CoverStory

GENIRON BIOLABS

The Veterinary entrepreneursEstablished in 2013, Geniron Biolabs is an animal healthcare start-up with an ambitious

mission of making India Rabies-free by 2025.

Geniron’s founders and veteri-narians Dr Goutham (28) and Dr Prashanth (28) quit their

cushy dream jobs to begin their new chapter as entrepreneurs.

Dr Goutham, who hails from sub-urban Hassan, worked as a veteri-nary officer with the Government of Karnataka, while Dr Prashanth from Anekal was employed with the iconic Bangalore-based Biocon.

The duo pursued their Bachelor’s studies together in Veterinary Sci-ence in Bidar. It was then that both of them dreamt of starting their own venture.

At the same time, Dr Goutham and Dr Prashanth began to pursue their Master’s degree in the same space, specializing in Veterinary Microbi-ology and Animal Biotechnology re-spectively.

Armed with extensive knowledge in Veterinary and having seen issues surrounding animal healthcare in India, both of them started Geniron, with the aim of serving the animal industry through vaccines and diag-nostics, along with contract research services in animal studies to serve the pharma and biopharmaceutical industry.

However, it took 5 years to start the company with a clear, concrete idea and definite vision.

Adds Dr Goutham, “There was al-ways an itch in us to start a venture. In our third year during undergradu-ate studies, we both decided to start our own company, but we had a lot of different ideas to start-up in the animal husbandry and healthcare sector.”

Awards into investmentsHowever, the path became very clear after the duo won the BEST-ABLE award in 2012.

“It made a great impact, and we chose to be in the animal healthcare sector and started Geniron,” says Dr Prashanth.

The prize money was carefully in-vested in the development of the company. Investments worth Rs 20 lakh from family and friends were also pooled in.

The company’s establishment -- from registration to the setting-up of the infrastructure facility -- was shared equally between the two.

“From then on it has been a roller coaster ride,” says Dr Goutham.

“Later, for our R&D, we were award-ed with BIG funding from DBT, which gave us a boost for developing products and procurement of equip-ment,” recalls Dr Prashanth.

Till now the company has invested nearly Rs 40 lakh, majorly for equip-ment and infrastructure.

Since the company is in its R&D phase, the next two years will be con-centrated towards product develop-ment and market launch. BS

Dr Goutham GCEO & Executive Director, Geniron Biolabs

Dr Prashanth TDirector, Geniron Biolabs

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CoverStory

ABIRUCHI PROBIOTICS

Battling cholesterol withnovel probiotics

Here is how a Pune-based young start-up is innovating to prevent heart diseases in the country.

Cholesterol is one of the lead-ing factors behind all the heart diseases across the globe. Ac-

cording to a report by World Health Organization (WHO), cardiovascular diseases (CVDs) are the number one cause of death globally, and more people die annually from CVDs than from any other cause. Over three quarters of CVD deaths take place in low- and middle-income countries.

Globally, India seems to be leading in two of the major ailments – diabetes and heart diseases.

Aware of this trend, 25-year-old Mr Hrishikesh Mungi is working hard in his lab at NCL (National Chemical Laboratory), Pune, on solving one of India’s major health threats.

In 2012, after graduating with an Engineering degree in Biotechnol-ogy from KLE Engineering College, Belgaum, Mr Mungi was selected to work on a project on the extraction of bile salts hydrolase enzyme at NCL. “We soon realized the commercial potential of our research,” says Mr Mungi.

His guide, Dr Archana V Pundle, a chief scientist at NCL was the first to point out the research’s commercial viability.

Mr Mungi continues, “We then ap-

plied for a patent with the help of NCL. We put together a business plan including market survey and fu-ture goals for building a commercial enterprise.”

The research work was selected by BIRAC (Biotechnology Industry Re-search Assistance Council) for fund-ing the project further through its BIG (Biotechnology Ignition Grant) scheme.

In June 2014, Abhiruchi Probiotics was incorporated by Mr Mungi, with Dr Pundle serving as a scientific advi-sor and non-executive director of the start-up.

Abhiruchi is a technologically-driven start-up, involved in developing nov-el probiotic products having health

benefits.

It is currently focusing on develop-ing, manufacturing and commercial-izing of a cholesterol-lowering pro-biotic formulation without any side effects on the body.

Investments worth Rs 50 lakh has been invested in the company so far.

The company has now acquired pro-visional patent for lowering choles-terol by the application of probiotics.

“At the moment we are validating the technology, and it’d take another 5 years for the products to reach the market,” adds Mr Mungi, who enjoys playing cricket.

Mr Mungi’s father and grandfather were also entrepreneurs who inspired him to actively pursue entrepreneur-ship since his early childhood.

He bagged the ‘Young Entrepreneur Award’ at Eureka 2014, a business model competition conducted by IIT-Bombay.

While developing the technology at NCL, Mr Mungi worked hard for a monthly pay as little as Rs 8,000. At times he had to wait patiently for months together to receive his salary. BS

Mr Hrishikesh MungiFounder, Abiruchi Probiotics


CoverStory

MIR LIFE SCIENCES

Understanding multiple personalities of cancer

At 60, founder Dr Shaji George is equally as excited and passionate about running his start-up as any other entrepreneurs in their 20s and 30s.

Incorporated in 2010, Mir Life-science is a Bangalore-based bio-tech start-up incubated at IBAB

(Institute of Bioinformatics and Ap-plied Biotechnology), involved in re-searching the multiple personalities of cancer cells, and developing diag-nostic products for customizing or personalizing treatments that works best in individuals.

Personalized cancer treatmentMir operates in the field of applying principles of personalized medicine to cancer.

More specifically, it is developing novel diagnostic tests for predicting which chemotherapy drug(s) is likely to work in a particular patient prior to its administration, rather than the present trial-and-error method.

Cancer diagnosed in early stages of-ten require only surgery because the chances of it spreading is very mini-mal. But almost always such patients tend to receive unnecessary chemo or radiation therapy.

The tests are also designed to pre-dict which patient needs only surgery and those which can be managed just with chemotherapy or radiation in addition to surgery.

Mir achieves this by analyzing the

molecular landscape of a tumor by profiling the activity of various genes involved in cancer.

This molecular landscape -- called gene expression signature -- allows predicting which drug is likely to work in a particular patient, or if the cancer has spread or not, allowing physicians to make important deci-sions for effective and more precise treatment, rather than trial-and-er-ror methods.

The start-up is part of Cochin-based Mir Group, a multi-faceted business group, whose financial and manage-ment assistance helped establishing Mir.

Dr George is an experienced biomed-ical scientist both in the academic and industry realm.

He was the former R&D vice-pres-ident at US-based Innovir Labora-tories in New York. Prior to that, he

served as the junior faculty at the Rockefeller University, USA.

He was also the co-founder and pres-ident of Bionova Pharmaceuticals, a New York City-based biotech start-up, focused on developing novel di-agnostics for prostate cancer.

Dr George now serves as the chief scientific officer (CSO) and director of Mir Lifescience.

Lack of bio-banksDr George’s entrepreneurial sparks began at Innovir, where he spent al-most 10 years transforming it from a start-up to a mid-sized biotech orga-nization.

Those years built within him the con-fidence to start a biotech venture all the way from scratch.

“Basic research is expensive and highly unpredictable leading to near-impossibility of securing financial backing for biotech ventures. So we followed the standard biotech model in practice in the US –- in-licensing of technologies at the proof-of-con-cept stage and taking it into the com-mercialization phase. Once the tech-nology was secured, we were able to attract the interest of Mir Group in both funding and taking care of the business side of the company,” says Dr George. BS


CoverStory

NEWNDRA INNOVATIONS

Newndra’s revolutionizing ‘JaipurBelt’

Hailing from Jaipur, Rajasthan, Mr Ganesh R Jangir (26) was the first engineer from his rural village, who had an unquenchable passion to help farmers and people from his own village.

During his school vacations, he had to work at his village farm. He felt excruciating back pain

shooting through his body just after a few minutes of working. He realized that this was the tale of every farmer in the country.

He says that doctors’ advice of get-ting good rest after a hard labor was next to impossible for farmers and workers. That kick-started within him to think in different ways and try hundreds of attempts to innovate a device that could solve the issue. The end result? The birth of the ‘Jaipur-Belt’ (Belt System for Body Support).

“I sent my idea to National Innova-tions Foundation and got the needed support for prototype development and patent filing. Later I sent the de-tails of the functional prototype to Indian Institute of Science in Banga-lore for Kishore Vaigyanik Protsahan Yojana (KVPY) Fellowship. I got through them. That gave me enough confidence of commercializing the device. I knew what had to be done but didn’t know how and where,” re-calls Mr Ganesh, co-founder, Newn-dra Innovations, which was started in 2014.

With headquarters in Jaipur, Newn-dra is a disruptive and frugal inno-vation-based company involved in commercializing products that has

the potential for the betterment of health and lives of people, who are involved in manual labor work.

The company has developed its unique and award-winning flagship ‘JaipurBelt’ for spinal and waist-related issues. It received a grant support worth `10 lakh from the De-partment of Scientific and Industrial Research (DSIR), Government of In-dia.

Mr Ganesh, the inventor of the belt, says that the company’s product will impact billions across the globe, es-pecially for people engaged in agri-cultural and manual labor.

He explains, “Back and waist pain is highly debilitating and affects all in-dividuals regardless of age, ethnicity

or economic status. It is a very com-mon problem for a wide range of pro-fessions including laborers, farmers, housewives, and the elderly.”

It is estimated that more than 90% of the farmers, laborers, and MSME workers’ activities involve frequently bending up and down, and common-ly suffer from back and spinal disor-ders. The problem is equally severe in developing and as well as devel-oped countries.

Mr Ganesh points that laborers and farmers drink alcohol to relieve their physical pain, which has a conse-quential effect on their health, social and economic status.

In other cases, they are forced to in-gest painkillers or have to wear con-strictive elastic belts wrapped around their waists. These belts usually re-strict the body movements than pro-viding the actual support.

He says that painkillers suppress the pain but cannot be a solution. Sur-geries of the spine are complex with severe side effects and prolonged recovery periods. The JaipurBelt, as supporting means, is useful for many applications including manual lift-ing, frequent bending up and down, or other situations where high levels of stress are applied to the spine and waist. BS

Dr Ganesh JangirCEO, Newndra Innovations

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EXOCAN

Unleashing the power of ExosomesStarted in early 2015, ExoCan is an Indian start-up aimed at building interconnected

technology platforms for analyzing and using Exosomes in cancer diagnosis.

While pursuing his PhD at Na-tional Centre for Cell Scienc-es (NCCS), Dr Aman Sharma

(32) worked on brain tumors and his attention drew towards cancer pa-tients who were in great physical, emotional and economical agony.

He then visited a cancer hospital in Western Rajasthan and found that the lab was not researching enough on patients with cancer.

That visit sparked a fiery flame with-in Dr Sharma, who then decided to pursue translational research, and ended up receiving the Biotechnol-ogy Ignition Grant (BIG) worth Rs 49 lakh from BIRAC (Biotechnology Industry Research Assistance Coun-cil) in 2015 to set up his own start-up venture – ExoCan.

ExoCan is involved in developing unique Oncotechnology platforms for applications in cancer diagnosis, imaging and chemotherapy. It aims to develop technologies at lower costs with greater accessibility and clinically manage cancers for better survival outcomes.

As a plan of action, Dr Sharma se-cured seed funding and developed the proof-of-concept with active as-sociation with R&D institutions in India and abroad, and has so far signed MoUs with two national level research institutions.

Contradictorily, ExoCan faced mini-mal initial challenges while setting up. “BIRAC’s seed funding helped us to face the initial stages, and we were incubated at Pune’s Venture Centre. However, the investors we interacted with showed minimal understanding of the healthcare R&D, and it looked like they were never going to take sig-nificant risks for disruptive technolo-gies which we are trying to develop,” voices Dr Sharma.

The company has also applied for 3-4 other government grants which is in the pipeline. It has also been short-listed for two other grants for the next set of rounds.

ExoCan, in the next 18 months, aims to come up with its R&D product which will enter clinics after the nec-

essary regulatory approvals.

In the next 4-5 years, Dr Sharma tells that, the company would be a pioneer in developing disruptive Oncotech-nologies.

Once it has developed 3-4 products, it intends to expand to Europe and the US.

It is now targeting a revenue of Rs 5-10 crore in the next 2-3 years.

He also predicts that there is going to be a dire need for innovations in the oncology sector in next 10 years.

“It might be possible that cancers would no longer be killing lives as they currently do. Moreover, the on-cology industry would be driven, not by big pharmas, but by small or me-dium level and value-based entities,” opines Dr Sharma, who is a fan of geek Nikola Tesla.

He also says that sectors like Agri-biotech and Nanomedicine as prom-ising areas where new start-ups can venture into. He sees Pune as the next biggest hub for the country’s biotech start-ups, and advices that joining an incubator is far better while erecting a start-up.

Being in Life Sciences, Dr Sharma points there is a total lack of under-standing by capitalists about R&D happenings in start-ups. BS

Dr Aman SharmaFounder & CSO, ExoCan Healthcare


CoverStory

SYNTHERA BIOMEDICAL

Thinking longevity over valuationDr Nilay Lakhkar (30) returned to India in December 2014 after completing his eight-month post-doctoral stint at Helmholtz Institute of Biomaterials in Germany. He began travelling

across India exploring opportunities where he could put his skills to good use.

During one such trip, he met Dr Chandra Sharma in Trivan-drum, a foremost researcher in

biomaterials and tissue engineering.

“During our discussion, he men-tioned the possibility of starting a company focused on technologies that I had worked on in my MSc and PhD research, and pointed me to-wards Venture Center, Pune, a start-up incubator located at National Chemical Laboratories (NCL),” re-veals Dr Nilay Lakhkar, founder & CEO, SynThera Biomedical.

Dr Lakhkar holds a Bachelor’s de-gree in Chemical Engineering from University of Mumbai. He received his Master’s and PhD in Biomateri-als and Tissue Engineering from the University College London (UCL), UK, in 2008 and 2014 respectively.

Later, Dr Lakhkar met the director of Venture Center, Dr Premnath, and was quite impressed with his passion for supporting budding entrepre-neurs and the ecosystem he had built on the Venture Center campus.

The duo then began working togeth-er, and over the course of the next few months, Dr Lakhkar met vari-ous people in his field of expertise, including potential customers, inves-tors and partners in R&D, finance, marketing and distribution, which

gave him a good preliminary idea of both the opportunities and the chal-lenges for establishing a well-run medical devices company in India.

“Needless to say, the opportunities far outweighed the challenges, which is how I ended up establishing Syn-Thera in June 2015 at Venture Cen-ter, Pune,” adds Dr Lakhkar recalling his entrepreneurial beginnings.

SynThera Biomedical aims to posi-tion itself as India’s foremost expert in R&D, manufacture and commer-cialization of bone augmentation products, specifically, bone graft sub-stitute material that can be used in a variety of surgical procedures in the dental and orthopedic spaces.

These materials are primarily meant

to serve as replacements for bone tis-sue that may be lost due to injury, disease or congenital deformity.

In the UK, Dr Lakhkar carried out his research at UCL Eastman Dental In-stitute, one of world’s top centers for dental research, which is part of the UCL Faculty of Medical Sciences, a leading University hub for biomedi-cal research.

Over a combined duration of over 4 years, he won the University Medal for topping his MSc course, and authored and co-authored 15 peer-reviewed publications. He has pre-sented his research at leading con-ferences in China, India, the UK and Germany, including the World Bio-materials Congress in 2012.

After deciding to start his entrepre-neurial journey, Dr Lakhkar’s first major tasks were to define a product line, and understand how he could structure a business model around the product line. “This required a lot of brainstorming with relevant experts in R&D, manufacturing, commercialization and finance,” he points.

Parallely, he began the process of incorporating SynThera Biomedi-cal, and firming up a share subscrip-tion agreement with Venture Center. BS

Dr Nilay LakhkarFounder & CEO, SynThera Biomedical


CoverStory

INBIOSYS

PMS for Biotech, Pharma cosDr Ravi Kshirsagar’s first start-up -- Bio-excellence -- ended up failing terribly back in 2003. However, it was then his entrepreneurial spirit was doubly fortified preparing him for his

next big venture – Inbiosys Consulting, established in 2013.

Back then, Bio-excellence func-tioned as a not-for-profit orga-nization for skills development

in Biotechnology.

Dr Ravi says that post his first failure, he continued grooming himself, and was fortunate enough to have a valu-able mentor like Mr Sandeep Saxena, the founder and CEO of Acton Bio-tech.

His second new venture, Inbiosys, provides project management ser-vices (PMS) to pharmaceutical and biotechnology companies engaged in the development, manufacturing and marketing of chemical drugs, biosim-ilars, vaccines, recombinant proteins and in-vitro diagnostic reagents.

Inbiosys serves its clients through three services including establishing project portfolio management pro-cesses, managing third-party out-sourced projects to CROs and CMOs, and project management training.

“Smaller and virtual companies do not have well-defined project man-agement teams to work their way up. We help pharmaceutical and biotech companies to set up project management practices. Also, small and mid-sized companies in inno-vation clusters outsource their proj-ects management needs to India and Asia. We help plan, manage and ex-ecute their projects. We also provide

project management training to Life Sciences professionals,” explains Dr Ravi.

He further adds that today the proj-ect management in the biotech and pharma industry is not up to the mark.

“I don’t see a well-established man-agement function independently working in these two industries. They have adopted the matrix structure having functional departments,” he points.

Dr Ravi previously worked with Bio-con’s subsidiary, Syngene Interna-tional, a contract research and man-ufacturing organization. He holds a PhD from Amravati University. He comes with 11 years of vast and rich

experience in the industry.

It was challenging for him to prepare himself to transition from being an employee to a full-time entrepreneur.

“It took 2 to 3 years to ensure I had enough cash to manage the company. Selling our services is a big challenge. Our start-up is a new idea and con-vincing people in the industry is an-other task. Getting the right talent to work with us and drive along with the vision and mission of Inbiosys was daunting,” he reveals.

In 2008, he enrolled with IIM-Kolk-ata and completed his Executive Pro-gram in Business Management. His years of experience and huge web of industry network came in handy while incorporating Inbiosys.

“I had a big network in the industry. We had clients and customers even before we started. Networking is a big key. So we had our customer base ready even before starting Inbiosys. We got some of our clients through social media as well,” states the sci-entist-turned-entrepreneur.

Dr Ravi didn’t stop there. In Novem-ber 2014, he founded and launched an exclusive recruitment online plat-form DNAJOBZ, designed specifical-ly for the Life Sciences professionals and companies seeking employment and talents. BS

Mr Ravi KshirsagarFounder, Inbiosys Consulting


CoverStory

LEUCINE RICH BIO

Shaping the Indian Clinical Genomics landscape

August 2015 marked the first anniversary for Leucine Rich Bio, a young, Bangalore-based, bioinformatics-driven start-up, specializing in next generation sequencing (NGS) data

analysis & interpretation.

“I have read a lot of blogs, articles and books on entrepreneurship but nothing prepares you for

the journey. It is seductive. It is ad-dictive. It is painful. It grinds you. It shocks you, and it saps you of all your energy. Yet, you go to bed wanting to be back at the first light of the day,” wrote Mr Kumar Sankaran recently, the founder and CEO of Leucine Rich Bio, in his company’s blog, recount-ing his entrepreneurial journey in the last one year.

The start-up focuses on human ge-nome data interpretation, especially for clinical and research use, and developing cutting-edge novel solu-tions for drug discovery.

Mr Prabhath Manjappa joined Mr Sankaran as the co-founder and COO during its inception.

Says Mr Sankaran, “Both of us have years of experience in systems biolo-gy. We have been discussing genom-ics and the latest new trends hap-pening in NGS for a long time. We analyzed the markets, and spoke to a variety of experts in the field, figuring out what was exactly needed.”

Dr Debojyoti Dhar, who holds a PhD from the Indian Institute of Science (IISc), is another member in the dy-

namic team, who serves as the com-pany’s director, and oversees the business development and innova-tional aspects.

The company has developed two dif-ferent technologies - AGIS and LRB-HGVD.

AGIS, stands for Advanced Genome Interpretation Suite, is a flagship clinical data analysis platform for analyzing and interpreting clinically relevant sequence information from human genomes.

It uses powerful algorithms to report precise disease causing mutations, says Leucine.

“This platform is for hospitals and se-

quencing centers around the world,” adds Mr Sankaran.

The Human Genome Variation Da-tabase, also known as LRB-HGVD, is Leucine’s in-house database, curated and maintained by it.

The database is said to provide func-tional information, mutation impact on disease, drug response, and vari-ant impact on protein structure and functions.

He feels that the company’s mam-moth challenge now is the nascent Clinical Genomics market in India. “Overcoming our fears and investing our own money was our first biggest challenge,” recalls Mr Sankaran.. BS

Leucine Rich Bio's Team


CoverStory

ORTHOCRAFTS INNOVATION

Crafting bioabsorbable implants for India

In 2006, Dr Ashish Lele, a chief scientist at National Chemical Laboratory (NCL), was first introduced to screws made of a polymer called Polylactic Acid or PLA, used for repairing of

torn Anterior Cruciate Ligament.

PLA is a biodegradable biomaterial made from corn, sugarcane or sugar beets, widely manufactured

in the United States. The biomaterial instantly attracted Dr Lele’s attention due to its unique properties includ-ing being able to be absorbable inside the body and retaining the mechanical properties to a certain time period.

He then introduced this product to Dr V Premnath, another chief scien-tist at NCL, who has his PhD from Massachusetts Institute of Technol-ogy. Dr Lele holds his PhD from the University of Delaware, USA.

The product was promising and was sufficiently challenging to stir the enthusiasm between the two, and be-fore long, they teamed up together to develop biocompatible maxillofacial volume filling implants.

Four years later, in 2010, Mr Piyush Joshi, a polymer engineer from the University of Pune, joined them. His expertise helped them to identify the benchmark properties of the product to-be developed, and its economics.

They soon realized the importance to make bioabsorbable polymers with varied properties. All the efforts by the team were directed towards synthesis of appropriate molecular

weight PLA material. The three of them participated in Venture Cen-ter’s (Pune) ‘Lab2Mkt’ program which focuses on commercializing early-stage technologies.

The idea bagged its initial funding of Rs 7 lakh from proof-of-concept (PoC) initiative. Thus the team was able to raise a small amount to set up initial experiments to synthesize the bioabsorbable polymers, and carry out further market research.

With sustained market research, the trio understood that this single product will soon envisage the whole product portfolio using bioabsorb-able polymers and their composites.

By 2012, they went on to study and identify other products which use

similar polymers.

“There were no Indian manufactur-ers who made biomedical grade PLA, and this was a real setback for the In-dian medical device manufacturers. Surgeons had to rely on foreign play-ers. We saw this as an opportunity and decided to use the expertise to develop the bioabsorbable material and products for India. This was the moment when the idea was taking firm roots to be considered as a plat-form to create a new venture,” says Mr Piyush Joshi, COO and executive director, Orthocrafts Innovations.

Over the next two years, the whole team was building the chemistry know-hows of medical grade PLA, and was waiting for the appropriate funding opportunities. BS

Mr Piyush JoshiCOO & Executive Director,

Orthocrafts Innovations

Dr Ashish LeleDirector,


Dr V PremnathAdvisor,



CoverStory

RASA

In-silico approach to drug discovery“When good days don’t last long, why worry about bad days?” asks Mr Sameer Chaudhary

(32), founder of RASA Life Science Informatics.

He and his wife Ms Sapana Me-hendale together founded RASA in 2010, a Bioinformat-

ics and Chemoinformatics start-up offering solutions and services in Life Sciences.

The last four years has been very hec-tic for Mr Sameer and his team. In fact, when they bagged their major project with Wipro, he and his wife, back then, had to work even until the day prior to their wedding.

“It was quite exciting,” recalls Mr Sameer, a professional Bioinformati-cian.

Mr Sameer has a decade of experi-ence in datamining, scientific work-flow development, product devel-opment and off-shore services and management. Ms Sapana is a pro in software development and Chemoin-formatics.

He says that his father-in-law and businessman Mr Ashok Mehen-dale was the real inspiration behind starting his company. Alongside, Ms Sapna also had a long-time dream of owning a company in the BioIT space.

So far the founders have invested Rs 8.5 lakh in the company through soft loans from friends and family.

Both the founders bid good-bye to their burgeoning careers with hand-some pay packets to build RASA

from scratch.

“We started our company with a dream to provide BioIT services as well as work more closely on in-silico approach to drug discovery.

But soon we realized that most of the life sciences students and profession-als lack required skills and always wondered about their careers. So we brought the idea of skill-based train-ing to enhance their profiles,” adds Mr Sameer.

“At times we were broke financially and morally. But we helped each other building upon our courage and positive hopes.”

RASA has few products in the pipe-line for launch. RASA plans to open

few more branches in other Indian cities

including Ahmedabad, Kolkata and Chennai.

In the future, it wishes to partner with companies in the US and Eu-rope.

“We believe, very soon, we will be able to grab the attention in the Mid-dle-East, Bangladesh, Sri Lanka and a few African countries,” reveals Mr Sameer, who loves reading and sing-ing.

Mr Sameer feels that a demographic study for a particular business is ab-solutely essential for a start-up.

In the last 4 years, RASA has done business worth Rs 30-40 lakh per year. It has a target of achieving Rs 1 crore in the next couple of years.

Even in the era of internet and social networking, Mr Sameer says that the best visibility for a start-up is through word-of-mouth.

He suggests that India needs more governing bodies like the BIRAC for encouraging start-ups.

Mr Sameer opines that personal-ized medicine with genomics- and proteomics-based clinical diagnos-tics, stem cells, BioIT, NGS are the current happening areas in Life Sci-ences. BS

Mr Sameer ChaudharyCSO & Co-founder, RASA Life Science

Informatics


CoverStory

SEAGULL BIOSOLUTIONS

Eradicating Measles from the worldA Pune-based start-up has developed the world’s first VLP

(virus-like particles) vaccine for Measles.

Gone are the days when start-ups were associated only with young-blooded fresh gradu-

ates from prestigious universities abroad and iconic Indian institutes.

Today, age is proving to be an ignor-able factor for pursuing passionate entrepreneurial adventures.

Fifty-two-year-old Dr Vishwas Joshi founded Pune-based start-up Seagull BioSolutions (SBPL) along with Dr Shailendra Maheshwari in 2011.

The company is incubated at Venture Center, an Entrepreneurship Devel-opment Center, hosted by National Chemical Laboratory (NCL), Pune.

Seagull is involved in developing and commercializing new technologies for advanced healthcare applications and medicines addressing unmet medical needs in the country and are affordable to the common man.

Seagull has developed 2 technology platforms for producing protein and viral therapies and vaccines: eSAME and Active Virosome Technology.

The former is useful for express-ing recombinant proteins and RNA products in different animal cells. The latter helpful in producing new viral vaccines and gene therapy agents.

Both these technologies are propri-etary to Seagull, and allow develop-

ment of biosimilar versions of exist-ing therapies and vaccines, and also produce innovative therapies and vaccines belonging to emerging ther-apeutic classes.

“Thus, they can be called as ‘futur-istic technologies’ ”, says Dr Joshi.Seagull has already tied-up with a US-based biotech company for us-ing the eSAME technology to deliver anti-sense RNA molecules into the cancer cells.

If successful, this will be a more preferred method, since unlike the currently used systems, the eSAME system will not involve integration of the DNA into host cell genomic DNA.

Using both these platforms, the start-up has developed 3 novel prod-ucts: SBPL-0100, SBPL-0200, and SBPL-0500.

SBPL-0100 is an innovative onco-lytic virotherapy which also induces anti-cancer immunity.

This therapy will be effective against breast, lung and prostate cancers and represents a fast follower of US-based drug maker Amgen’s T-Vec, which has opened a new class of non-toxic anti-cancer immunotherapies.

SBPL-0200 is another innovative vaccine agent for Dengue prevention.

“This is our first product produced using the Active Virosome Plat-form. The efficacy of the product was shown by in-house testing, and also confirmed by testing at the Center for Vaccine Development at Mahidol University (MU) in Thailand,” re-veals Dr Joshi.

The third product, SBPL-0500 -- ac-cording to him -- is the world’s first VLP vaccine for Measles. This vac-cine is expected to be useful for im-munizing infants aged between 4 to 9 months, who cannot be vaccinated with currently used vaccine, and still remain susceptible to measles infec-tion and mortality.

“If successful, this will help us get closer to the dream of eradicating Measles from the world altogeth-er,” voices Dr Joshi optimistically. The Dengue vaccine and the cancer therapeutic agent will be developed further up to Phase II clinical stud-ies. BS

Dr Vishwas D JoshiFounder, Seagull BioSolutions


CoverStory

SHODHAKA LIFE SCIENCES

The exclusive scientistand entrepreneur

Almost ten years ago, Dr Kshitish Acharya K (48) began pondering about venturing into the big world of business.

While brainstorming ideas for his venture, he saw the need for high quality data analysis

services - by scientists and for scien-tists.

He recognized it as an opportunity for revenue generation and 'real value addition' to the scientific com-munity. Convinced about the thrust, he started Shodhaka Life Sciences in 2009.

He also believed that a long-term goal of achieving better diagnostics will be possible with novel approach for better biomarker identification.

Today, he also serves as a core faculty member and scientist at IBAB (Insti-tute of Bioinformatics and Applied Biotechnology), in Bangalore, where Shodhaka is incubated at the insti-tute’s business incubator.

He pursued his post-doctoral re-search at Indian Institute of Science (IISc) and the University of Virginia, USA.

Explains Dr Kshitish, “Initially, af-ter my post-doctoral stint at the US, I wanted to be a part of the rapidly growing Indian organizations and contribute to the growth further.”

Shodhaka is now focusing on provid-ing the much required, high-quality

data analysis services and training for scientists, working in different ar-eas in the Life Sciences.

“We have been particularly focusing on data from mass scale techniques such as NGS (Next-Generation Se-quencing) and microarrays. But we have also been active in biocuration and biostatistical analysis of smaller scale data in special domains such as health sciences, and as well as cus-tom-designing biological databases and software.

“We are the only team, perhaps in the world, that dedicates a huge amount of time and effort in compil-ing and studying the bioinformatics resources carefully. Our public portal ‘startbioinfo.com' will make a huge difference in Life Sciences and to re-

searchers in the field for bioinformat-ics analysis,” he elucidates.

Dr Kshitish managed to self-fund his company. At times, he also sought the help from some of his friends and fellow scientists.

This scientist-cum-entrepreneur says that he had no clue about run-ning a business when he started.

“I knew nothing about business and have been handling two responsibili-ties -- as a faculty and an entrepre-neur. In addition, poor networking and marketing caused a little set-back. But I am glad that the loyalty and personal spread of appreciation by our clients has been helping us so far,” he adds.

Dr Kshitish voices that the company now is at crossroads.

“We could partner with like-minded scientists and expand in phases, or bring in bigger investments. Bigger investments will help us to prioritize on diagnostics and prognostics over the next 5 years. Otherwise, we would continue offering services in the ar-eas of data analysis, biocuration, development of databases and soft-ware. If we get bigger investments, we would like to be the world's lead-ing data analysis service providers,” he reveals. BS

Dr Kshitish AcharyaFounder & Director, Shodhaka Life Sciences


CoverStory

SWASTI AGRO AND BIOPRODUCTS

Entrepreneurship starts with your own dream’

Though there was no entrepreneurial background in the family, the concept of entrepreneurship was already imbibed in Dr Abhay Shendye’s DNA.

While in school Dr Abhay en-joyed rearing fish and pho-tography as his prime hob-

bies, which enabled him to set up a small business, giving him the lever-age of having enviable amounts of money in his pocket at his disposal for trying out newer ideas.

He was always influenced by his grandmother, who single-handedly managed the family-owned agricul-ture venture in a unique and sustain-able manner.

Dr Abhay holds a PhD in Microbiolo-gy (Molecular Biology) from National Chemical Laboratory (NCL), Pune, and has been working as an entrepre-neur for the last 20 years.

During that time, Dr Abhay zeroed in on jumping into entrepreneur-ship and seriously started reading journals on R&D policy and manage-ment. Simultaneously, he was also working on an agriculture project called ‘Bharat Yatra Kendra', where he closely experienced the problems faced by common farmers.

"This was the time when ideas about ‘agri-entrepreneurship' started bub-bling in me and there was some scope for testing them," says Dr Abhay Shendye, founder & director, Swasti Agro & Bioproducts.

Swasti is a four-year-old agricultural start-up, incubated at Venture Cen-ter, Pune.

The start-up focuses on sustainable farming involving specialty biomol-ecules and microbes that are difficult to cultivate.

Unique combinations of these two components are used to solve key problems in agriculture such as soil fertility, crop productivity, and dis-ease management.

In fact, Swasti is Dr Abhay's third venture in the space of technology development, and manufacturing of inputs for sustainable agriculture.

Prior to this, he established his first proprietary venture AgroBioTech, a

commercial R&D company, in 1995.

He also was involved in setting up his second dreamy manufacturing venture and a partnership firm, ABT Bioproducts.

When he started AgroBioTech, it already had its own research lab to start the initial work.

"Thanks to about a lakh of rupees earned in photography and invested to build a small research facility at home. But as a venture it was not structured with respect to business plan, financial model, or a team. There was no mission and vision statement written down. No targets and goals set. Keen interest in build-ing sustainable agriculture tech-niques for farmers was the key driv-ing force," points Dr Abhay.

Back then, it was a challenging time for Dr Abhay. But the confidence within him kept telling that some-thing can be done for sustainable farming, and some day it is all going to convert the knowledge into huge material wealth.

During those times, Dr Abhay looked upon Dr Alejandro Zaffaroni, the most successful serial entrepreneur in the biotech space in those days. In 2011, it was another fresh start for Dr Abhay. BS

Dr Abhay ShendyeExecutive Director, Swasti Agro & Bioproducts


CoverStory

CLEANERGIS BIOSCIENCES

Society at large benefits from successful enterprises

For two decades, Dr Sangeeta P Naik (49) worked as a professional biotechnologist. She always cherished the desire to achieve something novel that has the power to impact entire

mankind.

“I came up with the idea of start-ing up my company catering to the industrial needs using my

expertise in the industrial biotech-nology. With years of expertise, I believed I can achieve something sig-nificant in this area,” states Dr San-geeta, founder & director, Cleanergis Biosciences.

She is a trained biotechnologist with a PhD from Indian Institute of Sci-ence (IISc). Her doctoral thesis fo-cused on viral vaccines.

Post which, she pursued her post-doctoral research at the University of France, Paris, in Oncology.

Dr Sangeeta then worked for Cadila Pharmaceuticals and Aurigene Dis-covery. The turning point came when she got a break at the Danish enzyme firm – Novozymes. She managed Novozymes’ R&D activities in Ban-galore. At Novozymes, her interest grew manifold in the industrial ap-plications of enzymes.

“My interest became stronger to ex-plore the possibilities of solving core problems faced by industries. The challenges were to develop efficient, innovative and clean methods to solve those problems,” Dr Sangeeta adds.

The year was 2012. The idea of form-ing a company had already conceived in her mind. By February 2013, she established Cleanergis Biosciences in Bangalore and got it registered.

With customized solutions, flexible scale, and proprietary technologies, Cleanergis Biosciences works in part-nership to ensure efficient and high-quality protein production, process development and scale-up produc-tion of biologics for research and commercial purposes.

The company is currently focused on technologies that would help in pro-ducing food preservatives, and food grade enzymes. “For this, we have already established collaborations

with Indian and foreign companies,” reveals Dr Sangeeta.

No exceptionsSo far, Cleanergis has been funded by the founder, along with the good sup-port of family and friends.

She says that availability of funds is a major challenge faced by any start-up in the country.

“Cleanergis is no exception to this,” says Dr Sangeeta. “Organizing funds was a primary concern. Hence it was difficult to set-up the necessary labo-ratory infrastructure initially. As any other biotechnology company, we also faced challenges with availability of necessary equipment. Also, getting information in the form of patents, reports, and scientific protocols was a challenge, either due to funds or reli-ability. Getting the right contacts for demonstrating the technologies and establishing right partnerships were also challenges that we had to face.”

“Attempts have been made to get government grants, and partial grants have been granted for one of our projects. The company now is on an aggressive look out for addi-tional funds through venture capital sources and business collaborators,” voices Dr Sangeeta. BS

Dr Sangeeta NaikDirector, Cleanergis Biosciences


CoverStory

CONSURE MEDICAL

IPO-ready by 2019Though his first start-up failed in 2004, Mr Nishith Chasmawala’s relentless entrepreneurial pursuit today is helping millions of patients worldwide through his new start-up, Consure Medical, which develops novel critical care products. Its first product is a novel device to

manage fecal incontinence.

Consure Medical was started in 2012. Both the founders were veterans of the medical device

industry and have launched novel class II and III devices in the US, EU and Japan.

The start-up is developing and com-mercializing a novel portfolio of criti-cal care devices that work across a continuum of care settings.

Its first product – Qora SMK - pro-vides a novel means to manage fe-cal incontinence in non-ambulatory patients. Worldwide more than 100 million patients are incontinent each year, and rely on either an absorbent pad (adult diaper) or a fecal drainage device.

The use of pads manifests dermatitis, maceration, increases the length of stay, and has direct impact on health-care costs. Though drainage devices contain fecal exudate in a bag, and hence avoid complications of pads, they have a very narrow indication of use and manifests complications like necrosis and sphincter dysfunction.

With the Qora technology, Consure reimagined management of fecal incontinence by developing a novel drainage catheter that can be used with varying stool consistencies or rectal tone on patients across a con-tinuum of care facilities.

More importantly, this technology can be used by a minimally trained person at costs that are compara-ble or lower than the cost of using a diaper. The patented Qora SMK has been cleared by the USFDA (US Food & Drug Administration), mak-ing Consure one of the few medical device companies in India that has its core patents granted in key geog-raphies and regulatory clearances in place.

Similar to the latent need of inconti-nence, Consure today has 4 products in its development pipeline, and is targeting commercial launch of these additional products by the fourth-quarter in 2016.

Before starting Consure, Mr Nishith was in charge of the core-technology

development team at Kyphon (USA), which was acquired by Medtronic in 2007 for $4.2 billion. He had a great passion to wanting to directly impact the healthcare ecosystem in India, and was exploring ways to come back to India.

Mr Amit, prior to joining him, was a founder of a design and development start-up. He was looking out for a more refined focus to create a lasting impact.

Purely from a design perspective, he saw an inherent conflict of interest in a consulting model because, at the cost of amazing product design, cli-ents always gravitated towards a ‘fit’ within their existing portfolio and business model.

He wanted to start a medical device company that was not encumbered by legacy products and addressed la-tent clinical needs by imbibing bril-liant design methodology and user experience.

Mr Nishith holds a BS in Plastics En-gineering from UMASS Lowell (Uni-versity of Massachusetts), USA; Mr Amit holds a BS in Mechanical En-gineering from Indraprastha Univer-sity, and a MS in Design from Indian Institute of Technology (IIT) Delhi.The start-up hopes to be IPO-ready by 2019. BS

Mr Nishith ChasmawalaCo-founder & CEO, Consure Medical

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BioEvent

The theme of this year’s biggest biotech event was 'What's trending in BioTech in India’, where biotechnology leaders forecast the trends in biotech


What's trending inBiotech in India

The 16th edition of India's biggest biotech show Bangalore India Bio was held from February 9-11, 2016 at Lalit Ashok, Ban-galore. The event was inaugurated by Dr Harsh Vardhan, Union Minister for Sci-ence and Technology and Earth Sciences,

Government of India. The theme for this year’s most awaited event in the biotech industry was 'What's trend-ing in BioTech in India.'

The annual event was graced by many national and in-ternational personalities from government, industry, re-

BioEvent


BioEvent

search and academia viz. Dr Harsh Vardhan, Minister for Science and Technology and Earth Sciences, Government of India; Ms Matia Chouwdhury, Minister of Agricul-ture, Peoples Republic of Bangladesh; Dr C Randal Mills, president and CEO, California Institute for Regenerative Medicine (CIRM), Mr Dominic McAllister, British Depu-ty High Commissioner, Bengaluru; Dr Kiran Mazumdar Shaw, chairperson, Karnataka Vision Group on Biotech-nology, CMD, Biocon Limited, Dr Carlos Barreiro, head of industrial process area, INBIOTEC, Spain, Ms Heajin Jung, president, Smart Avenue, Seoul, Korea, Dr P M Murali, president ABLE, Dr Ajit Sapre, group president, Research and Technology, Reliance Industries, Dr Paresh Varma, president, Bioseed South East Asia and Research Director – BRI, Dr CD Mayee, chairman AFC, Mumbai, etc.

Prof. K VijayRaghavan, secretary, Department of Biotech-nology, Ministry of Science and Technology, Government of India, delivered the keynote lecture. In his speech he said that the government sees incredible value from in-vesting in science and technology and people in India. The Indian vaccine industry has saved lives all over the world and Karnataka has the potential to lead biotechnol-ogy research with Bangalore taking a lead in knowledge based entrepreneurship.

Also present from Government of Karnataka were Mr Krishna Byre Gowda, Minister for Agriculture, Govern-ment of Karnataka, Mr Roshan Baig, Minister for In-frastructure Development, Information and Haj, Gov-ernment of Karnataka, Ms Latha Krishna Rao, IAS, Additional Chief Secretary and Development Commis-sioner, Government of Karnataka, Ms V Manjula, IAS, Principal Secretary, Department of IT, BT, S&T, Govern-ment of Karnataka.

Karnataka has the potential to lead biotechnology research with Bangalore taking a lead

The conference, spanned across three days, had over 25 sessions with over 116 speakers and was attended by 1,000 delegates. The event had international representa-tion from over 10 countries with major delegation from UK, Spain, Korea, and presence from leading countries like USA, Canada, Australia, France, Germany, Poland, Belgium, European Union, Taiwan, Malaysia, SAARC and other South Eastern countries.

The event also witnessed participation from various states like Uttar Pradesh, Madhya Pradesh, Gujarat and Andhra Pradesh.

The various conference topics included making tomor-row's medicine, oncology and precision medicine, rare diseases and orphan drugs, agri biotechnology, IoT healthcare, proteomics and bioinformatics, biotech fin-ishing schools-HR workshop, bio accelerate and bio in-vest for startups and innovators and many more.

The exhibition had over 80 exhibitors from leading cor-porate, R&D institutes, start-ups, states of India, aca-demia as well as small and medium companies showcas-ing their technologies, products and services. Focused pavilions saw participation from consortium of various industry verticals like biopharma, process engineering, laboratory technology, contract services, IT, medical


BioEvent

technology, agri biotech and biofuels business services and industrial biotech etc.

The conference saw a bevy of start-ups who presented their ideas and products, as part of the Bio Invest and Bio Ac-celerate Program. The BEST-India (Biotechnology En-trepreneurship Student Teams) start-ups incubated at IIT-Kharagpur, Defence and Food Research Laboratory, Mysore, Institute of Chemical Technology, Mumbai, etc. presented their breakthrough ideas.

Ninety two poster presenters showcased their research ideas in poster session - Walkway of Discovery. Bangalore India Bio 2016 facilitated over 300 B2B meetings through the B2B partnering tool - InterlinX out of which over 60 percent meetings were between Indian and International Companies.

The Bio Excellence Awards were presented at a glittering ceremony. The process of selection of these awards was conducted by Association of Biotechnology-led Enterprises (ABLE).

The awards in different categories were given to Biocon (Bio Pharma and Healthcare), Ajeet Seeds (BioAgri), Ecron Acu-nova (BioServices), Novozymes South Asia (BioIndustrial) and Mitra Biotech (BioInformatics and Systems Biology).

Emerging Company of the Year Awards were given to: Pan-dorum Technologies (Bio Pharma and Healthcare), Cri-yagen Agri and Biotech (BioAgri), Affigenix Biosolutions (BioServices), Cellzyme Biotech (BioIndustrial) and Med-Genome (BioInformatics and Systems Biology).

The event was organized by the Department of Information Technology, Biotechnology and Science and Technology, Gov-ernment of Karnataka, Vision Group on Biotechnology and Event Partner MM Activ Sci-Tech Communications. BS

Ayesha Siddiqui

Photos: Ajay Ghatage

The conference saw start-ups who presented their ideas and products as part of Bio Invest


BioEvent

The exhibition had over 80 exhibitors from leading corporate, R&D institutes, start-ups, states of India, academia as well as small and medium companies showcasing their technologies, products and services

Photos: Ajay Ghatage


EVENT GALLERY


BioNews

Dermozone develops ‘dalethyne’ for wound healingDermozone announced that it has developed ‘dalethyne’, a revolution-ary chemical molecule compound, proven as an antimicrobial agent against most of the bacteria, fungi and yeasts. Dermozone’s best kept secret, ‘dalethyne’ will be the key in-gredient in the company’s MedCare range of wound healing herbal prod-ucts soon to be launched in India.

Dalethyne will be a life saver for thou-sands of patients especially those suf-fering from chronic skin ailments like acne, fungal infections, dry skin, in-sect bites, athlete’s foot, eczema, blis-ters, carbuncles and more important-ly diabetic wounds, ulcers and burns.

Dermozone’s ‘MedCare’ brand com-prises of four products - WoundCare (wound and burn), VaginyCare (fem-inine usage), BabyCare (allergies, rashes etc) and MedCare soap. Der-mozone also has another brand - ‘Bo-dyCare’ that caters to the cosmetics and beauty care market with a range of 17 products.

Mr KS Dharshan, chairman and CEO of Dermozone, said, “dalethyne is a unique compound created when olive oil is subjected to changes through a process called Ozonation for which I hold the IP right. This unique prod-uct is what ‘dalethyne’ carries, with an increased efficacy stimulating the function of enzymes’’.

BioNews

Sandoz buys Pfizer’s biosimilar infliximabSandoz, a Novartis company and a global leader in biosimilars, has acquired from Pfizer the rights for the development and commercialization of PF-06438179 (biosimilar infliximab) in the 28 countries that form the European Economic Area (EEA). Infliximab is a tumor necrosis factor alpha (TNF-α) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis (RA) and psoriasis.

“Infliximab is one of the most important biologic therapy options for people living with severe autoimmune diseases such as rheumatoid arthritis” said Mr Richard Francis, division head and CEO Sandoz. “We intend to complete the development and registration of PF-06438179 and make it available to patients across Europe as part of our robust portfolio of immunology treat-ments.”

Under the terms of the deal, Sandoz plans to complete the clinical study program and submit the biosimilar infliximab to the European Medicines Agency (EMA) for regulatory approval and registration with the European Commission. Included in the program is a global phase III trial - REFLEC-TIONS (B537-02) investigating the safety and efficacy of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheuma-toid arthritis who have had an inadequate response to methotrexate. Sandoz acquired the rights to infliximab, following Pfizer’s commitments to the Euro-pean Commission in connection with the acquisition of Hospira, to divest the program. Sandoz plans to make 10 regulatory filings over a three year period (2015-2017) having already announced five, which include biosimilar etan-ercept filed with both the EMA and the US Food and Drug Administration.

Zydus receives FDA approvalfor Doxycycline Capsules

Zydus Cadila has received approval from the United States Food and Drug Administration (US FDA) to market Doxycycline Capsules USP, 50 mg, 75 mg, and 100 mg. The drug falls in the anti-bacterials segment.

With this first approval, the group will now commence supplies to the

US market from its formulation manufacturing facility located at the SEZ in Ahmedabad. The group now has 102 approvals and has so far filed over 280 ANDAs since the commencement of the filing process in FY 2003-04.


BioNews

First vaccinations against dengue commenced in the Philippines

Sanofi Pasteur, the vaccines divi-sion of Sanofi, announced that vaccinations with Dengvaxia have commenced in the Philippines fol-lowing official receipt of the first shipment of the vaccine earlier this month.

Dengvaxia, a tetravalent dengue vaccine, was approved in the Phil-ippines on December 22, 2015 for the prevention of dis-ease caused by all four Dengue types in individuals from 9-45 years of age living in endemic areas. The vaccine is administered in three doses given over a one-year period.

Asia bears 70 percent of dengue fever burden globally with an estimated 67 million people being sickened by the disease annually. In the Philippines alone, over 1,10,000 people on average get Dengue every year. Asian endemic

countries spend an estimated $6.5 billion annually in both direct medical and indirect costs due to Dengue.

“This is truly a great moment in the history of vaccinology,” states Dr Guillaume Leroy, vice-presi-dent of Dengue Vaccine, Sanofi Pasteur. He added, “Dengvaxia’s

availability for administration by healthcare providers in the Philippines, to be followed closely by the initiation of a public sector immunization program in the country is a landmark event for global Dengue prevention and a great achievement for the people of the Philippines.”

Dengue is a growing public health threat in tropical and subtropical countries in Asia and Latin America. Mainly an urban disease found in over 120 countries.


BioNews

Biocon gets its first generic formulation approval in EU

Biocon, Asia’s premier biophar-maceuticals company, announced that it has received European ap-provals for its Rosuvastatin Cal-cium 5 mg, 10 mg, 20 mg and 40 mg tablets, a generic equivalent of Crestor tablets, indicated for hyperlipidemia or mixed dyslip-idemia. This first generic formu-lations approval in the regulated markets marks an important mile-stone in Biocon’s small molecules strategy of forward integration from APIs to finished dosages.

The approval for Rosuvastatin Cal-cium, through decentralized proce-

dure will open the doors for Biocon to over 15 European countries and will enable the company to address $1.2 billion opportunity, starting FY17. Biocon was the first generic company to receive a Certificate of Suitability (CEP) for Rosuvastatin Calcium API from the European Directorate for

the Quality of Medicines (EDQM). CEP certification indicates that an API is suitable for use in medicinal products in the EU.

Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said, “This is indeed a proud mo-ment for Biocon’s Small Molecules business. This approval paves

the way for Biocon to launch Rosu-vastatin Calcium tablets in several European countries. We plan to col-laborate with regional partners in the near term to provide access to this affordable generic and thus help patients.”

FTC puts conditions on Lupin-Gavis dealGeneric drug manufacturers Lupin and Gavis Pharma-ceuticals will sell the rights and assets for two generic drugs, one used to treat bacterial infections and the other to treat ulcerative colitis, in order to settle FTC charges that Lupin’s proposed $850 million acquisition of Gavis would likely be anticompetitive. The proposed consent order preserves competition by requiring the companies to divest these products to the New Jersey-based generic pharmaceutical company G&W Laboratories.

Without a divestiture, the merger would have combined two of only four companies that currently market ge-neric doxycycline monohydrate capsules in two dosage strengths, used to treat bacterial infections, likely result-ing in higher prices.

The merger also would have eliminated one of only a few companies likely to enter the market for generic mesala-mine extended release capsules, used to treat ulcerative colitis, in the near future, thereby delaying beneficial competition and the prospect of price decreases. Lupin is required to transfer to G&W Laboratories all of Gavis’s rights and assets related to generic doxycycline monohy-drate capsules.

Sanofi Pasteur support to human vaccines projectSanofi Pasteur, the vaccines division of Sanofi, has signed an agreement with the Human Vaccines Project to par-tially fund the non-profit, public-private partnership con-vening leading academic researchers and industrial part-ners to solve the primary problems impeding vaccine/immunotherapy development by ‘decoding’ the human immune system. The project is a global consortium.

Sanofi Pasteur is supporting the project by providing re-search funding to oversee, coordinate and conduct the scientific and administrative activities of the Human Vac-cines Project Research Program this year.

The funds will be used by the project to launch and ex-ecute pilot studies, build partnerships with and across the stakeholder community, and set up the infrastructure and operational support for the Human Vaccines Project Research Program.

The project, which has been endorsed as potentially transformative by 35 of the world’s leading vaccine scien-tists, seeks to raise $1 billion over a decade. The project incubated at the International AIDS Vaccine Initiative and is supported by research centers, industrial partners.


BioNews

APAC breast cancer market willrise substantially by 2021

The Asia-Pacific (APAC) breast cancer market is set to experience consider-able expansion from $1.9 billion in 2014 to $3.4 billion by 2021, at a ro-bust Compound Annual Growth Rate (CAGR) of 8.5%, according to business intelligence provider GBI Research.

The company’s latest report states that such growth, which will occur across the APAC regions of India, China, Australia, and Japan, will be driven by aging populations, chang-ing lifestyle habits, improved sur-vival rates, and a number of new ap-provals for drugs that are expected to supplement current market leaders.

Ms Deekshita Allavarapu, Analyst for GBI Research, explains: “It is an-

ticipated that popular drugs, such as Afinitor and Herceptin, will be used in conjunction with several prom-ising breast cancer pipeline treat-ments. These include abemaciclib, buparlisib, LEE 011, olaparib, and Neuvax, all of which are forecast to be approved by 2021 and have shown significant clinical benefit in trials.

“Such therapies are on the rise due to their increased use in conjunc-tion with chemotherapy. In addition, the strong efficacy profile of targeted therapies has resulted in favorable reimbursement and increased up-take in Japan and Australia. This is despite the drugs’ premium pricing, which reflects the cost associated with their development and the sig-

nificant therapeutic benefit offered.”

However, the analyst notes that in India and China, even after premium targeted treatments become avail-able, only patients in the richer ter-ritories will be given these drugs, as patients in the poorer districts will not be able to afford them due to a lack of social insurance and inad-equately publicly subsidized services.

GBI Research also states that apply-ing for reimbursement for oncology drugs in Australia is becoming more difficult due to a time-consuming and complex regulatory and reim-bursement process prior to access, which causes a substantial delay in patient access.


BioNews

Merck, Sun Pharma dissolve partnershipMerck & Co and Sun Pharmaceutical have agreed to terminate a joint venture set up in 2011 to develop and market branded gener-ic drugs in emerging markets outside India.

“The company has wind down/terminated the collaboration established in 2011 be-tween affiliates of Merck Sharp and Dohme and Sun Pharmaceutical Industries to de-velop and commercialize novel formula-tions and combinations of medicines for emerging markets,” said Sun Pharma, in a filing to BSE.

In 2011, Merck & Co and Sun Pharma-ceutical announced the creation of a joint venture to develop, manufacture and com-mercialize new formulations of innovative, branded generics in the emerging markets.

Dr Reddy’s to buyback of equity sharesThe Board of Directors of the company in their meeting held on February 17, 2016 has approved a proposal to buyback equity shares of the Dr Reddy’s Laboratories. It is subject to approval by the shareholders, for an aggregate amount not exceeding Rs 15,694 million (hereinafter referred to as the ‘Maximum Buyback Size’) and (being 14.9 percent of the total paid-up equity capital and free re-serves of the company as on March 31, 2015 (being the date of the last audited accounts of the company), at a price not exceeding Rs 3,500 per equity share (hereinafter referred to ‘Maximum Buyback Price’ and such Buyback the ‘Buyback’) from all shareholders of the company (including persons who become sharehold-ers by cancelling American Depository Shares and receiv-ing underlying equity shares, and excluding the promot-ers and promoter group of the company).

Under the open market route in accordance and conso-nance with the provisions contained in the Securities and Exchange Board of India (Buy Back of Securities) Reg-ulations, 1998 (‘Buyback Regulations’) (including any

statutory modification(s) or re-enactment of the Act or Buy-back Regulations, for the time being in force) and the Companies Act, 2013 and rules made thereunder.

In accordance with the provi-sions of Regulation 15(b) of the Buy-Back Regulations, the Buy-back shall not be made from the promoters and promoter group of the company. The Maximum Buy-back Size, excludes transaction

costs viz. brokerage, applicable taxes such as securities transaction tax, service tax, stamp duty etc (‘Transaction Costs’).

imum Buyback price represents 18.6 percent premium, compared to the average of the weekly high and low of the closing share price of the company during the last two weeks (i.e. up to February 16, 2016).

The Buyback is proposed on account of the company’s strong cash flow position and is expected to be EPS ac-cretive contributing to an overall enhancement of value for shareholders going forward.

Cipla completes acquisition of generic businesses in USThe acquisition was made by Ci-pla (EU) through a wholly owned special purpose vehicle which would merge into InvaGen Phar-maceuticals after the acquisition. The combined revenue for the two companies for the year end-ed 2015 is over $230 million.

This acquisition is the second landmark acquisition in Cipla’s 80 year history - the first was Ci-pla Medpro, South Africa.

The acquisition will give scale to Cipla’s US business - currently 8% of total revenue as well as providing a launch pad to intro-duce Cipla’s pipeline of products

in respiratory and injectables, among others, in the coming years.

Combined with the pipeline of InvaGen products, the overall portfolio will be wide-ranging and will cover chronic therapies like CVS, CNS, respiratory, on-cology and diabetes among oth-ers.

The acquisition of InvaGen phar-maceuticals also provides Cipla with about 40 approved ANDAs, 32 marketed products, and 30 pipeline products which are ex-pected to be approved over the next four years.


BioNews

GEAC halts GM mustard cultivationGenetic Engineering Ap-praisal Committee (GEAC), the regulatory body for ge-netically-modified food un-der the Environment Minis-try, had deferred a decision on allowing commercial cul-tivation of genetically modi-fied (GM) mustard and has asked the developer of the hybrid mustard to provide some more information on bio-safety related data.

On February 5, 2016 GEAC conducted a meeting. “In today’s meeting, we sought more information from those who devel-oped GM mustard (Centre for Genetic Manipulation of Crop Plants, Delhi University) and had applied for permission for commercial cultivation. We will not rush through and will take a decision only after due deliberations,” said Mr Prakash Javadekar, Environment Minister, after the meeting.

Reportedly, GEAC suggested eight additional bio-informatics tests for inclusion in the seed’s biosafety dossier and asked the Centre for Genetic Manipulation of Crop Plants (CGMCP) to prepare a Risk Assessment and Risk Management (RARM) document. It set a timeline of two weeks for submission of the revised biosafety dossier but separately recommended a long winding procedure for further review and consultation on the biosafety data. According to the regulator, the revised dossier received from the applicant would be considered by the Sub-Committee and a Biosafety RARM report would be prepared for consideration of the GEAC.

Aurobindo Pharma’s Isosulfan injectionAurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Isosulfan Blue Injection, 1 percent (50 mg/5 mL) sin-gle-dose vials. The product is expected to be launched in Q4 FY15-16.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Lym-phazurinTM Injection, 1 percent, of Covidien. Isosulfan Blue Injection under Cardio Vascular therapeutic group, is used in a lymphography procedure. The approved product has an es-timated market size of $57 million for the twelve months end-ing December 2015 according to IMS.


BioNews

Bharat Biotech announces breakthrough for Zika vaccine

Vaccines and Bio-Therapeutic manu-facturer, Bharat Biotech, announced breakthrough in developing world’s first, 2 promising candidates ZIKA-VAC vaccines for Zika infection.

“We have two ZikaVac vaccine can-didates in development; one is a re-combinant vaccine and another an inactivated vaccine that has reached the stage of pre-clinical testing in animals,” Dr Krishna Ella, CMD, Bharat Biotech, announced. Bharat Biotech began work on the Zika Vi-rus a year ago.

WHO just announced a disease linked to the Zika virus in Latin America poses a global public health emer-gency requiring a united response. Zika is now present in 23 countries. Brazil, the hardest-hit country, has reported around 3,530 cases of the devastating birth defect called mi-crocephaly in 2015 that are strongly suspected to be related to Zika.

The Zika virus is spread by mosqui-toes of the Aedes genus, which can breed in a pool of water as small as a bottle cap and usually bite during the day. The mosquito-transmitted infection is related to Dengue, Yellow Fever and West Nile virus.

“We believe we have an early mover advantage in developing the ZIKAVAC and we are probably the first in the world to file for global patent for Zika Vaccine candidates.’’

in development. One of them

is an inactivated vaccine that has reached the stage of pre-clinical test-ing in animals.

Currently our efforts are towards scale up and characterization of the vaccine product. Our interest in Zika virus, an obscure virus when we start-ed the project a year ago was that the clinical features at an early stage of infection are indistinguishable from that of Dengue and Chikungunya.

Right now consistency in process development has been achieved at 40 L pilot scale. Furthermore, a re-combinant vaccine using the surface antigens of the virus is being concur-rently developed,” said the firm in a statement. “Considering that women of childbearing age and pregnant women are the prime target group for Zika virus vaccine, we consider safety as the overriding factor in de-velopment of a new vaccine for this virus.

‘‘The vaccine methods developed early on, before the devastating con-sequences of the epidemics in Brazil came to light provided us a push to accelerate vaccine development,” said Dr Sumathy, director, R&D Bharat Biotech.

Another FDA approval inDr Reddy’s kittyDr Reddy’s has announced that its US subsidiary, Promius Pharma, has received approval for Sernivo (be-tamethasone dipropionate) Spray, 0.05 percent from the US Food and Drug Administration (US FDA). Ser-nivo Spray, a prescription topical ste-roid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the coming quarter.

Commenting on the approval, Mr G V Prasad, co-chairman and CEO, Dr Reddy’s Laboratories said, “The FDA approval of Sernivo Spray is a significant milestone for Promius, as it validates our committed efforts and resources to developing differ-entiated dermatology products from concept to commercial launch. We are delighted to receive a first round FDA approval of Sernivo Spray as we look to expand our portfolio of medi-cal dermatology products available in the US market.”

Promius has conducted two success-ful multi-center, randomized, dou-ble-blind, vehicle-controlled clinical trials in subjects aged 18 years and older with moderate plaque psoriasis to evaluate the safety and efficacy of Sernivo Spray.


BioNews

Mylan to acquire Meda for $9.9 bnMylan NV has announced a public offer to the shareholders of Meda, a Sweden based specialty pharma company, to transfer all of their shares in Meda to Mylan for a con-sideration consisting of a combina-tion of cash and Mylan shares. The total offer consideration consists of a combination of cash and Mylan or-dinary shares (‘Mylan Shares’) with a value at announcement of SEK 165 per Meda share. The total value of the offer for all Meda shares, including Meda net debt, is approximately SEK 83.6 billion or $9.9 billion.

The offer has been unanimously ap-proved by Mylan’s board of directors and unanimously recommended by Meda’s board of directors.

Invictus Oncology raises funds from Ratan TataChairman Emeritus of Tata Sons, Ratan N Tata has invested in Delhi-based Invictus Oncology, an inno-vation-driven oncology company developing next generation cancer therapeutics that are more effective and less toxic. The investment in the company comes as part of the first close of Invictus’s Series A financing round, joining existing investors Na-vam Capital and Aarin Capital.

Invictus Oncology employs a supra-molecular technology platform to design anti-cancer drugs that home into the tumor and modulate the tumor immune response. Its lead molecule, IO 125, has already been validated in multiple cancer models,

and is poised to enter IND-enabling studies to obtain US Food and Drug Administration (US FDA) approval for initiating clinical studies.

Recent acquisitions and partnership deals in this area have taken place at multi-billion dollar valuations. “I have admired Ratan Tata’s insights and astute assessment of technology for decades now, so I am thrilled he has invested in Invictus, which is not just developing ground-breaking in-nwovations for cancer treatment, but is also among the very first startups based out of India to tread the path of novel discovery and biotech innova-tion,” said Invictus Co-Founder, Dr Raghunath A Mashelkar.


BioSuppliers

Paradigm Shift in Genetic Data Analysis and Connectivity

Puneet Suri

How Genetic analysis can be leveraged in the future

BioSuppliers

Senior Director, Software Engineering,

Thermo Fisher Scientific

Imagine a child with a bad cough that takes a sudden turn for the worse.You watch with helpless foreboding as he/she is whisked off to the emer-gency room in the infectious diseases unit of your local hospital. There are questions streaming down your mind, what is causing this? Is it viral or bacterial? Can the doctors help? Is your child safe? What tests are the doctors doing? An epidemic may or may not be at your door. Is there an-

other child in Atlanta or Ecuador with the same bug? Organizations like the CDC and WHO need to know as soon as possible to avoid a public health emergency.They are monitoring in real time across the world and are continually innovating on policies for a timely and effective response. Genetic Analysis tools providers like Thermo Fisher Scientific make the enabling technologies and instruments to detect and identify of pathogens and other disease conditions, generating the raw data that defines the disease.

Even a few years ago, while our instruments generated the data, the organization of the data was local to the researcher. The analysis solutions were desktop-based.This severely limited the computation, storage, and collation needs that are vital to discovery. Researchers resorted to using huge Excel spreadsheets and painfully mapped the associations to find meaningful insights. It took days to weeks of pre-cious time to analyze information. Particularly in the infectious disease scenario, with the rapidly evolving strains, this was a great roadblock to responding in time to the emergency. People begun to realize that an incredible amount of data needs to be stitched together quickly and in a time sensitive manner to tease out an un-derstanding of the scientific truths of interest. This typically translates to millions of records in databases requiring sophisticated algorithmic processing, cross-ap-plication analysis, interactive visualizations, and infrastructure for collaboration.

The writing was on the wall: A biotechnologist needs unlimited storage, compute, memory and scalability to do science at the pace and scale commensurate with the genetic analysis data deluge happening today.

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BioSuppliers

The writing was on the cloud!We made the decision to move all our analysis to the cloud.We aimed to give every scientist across the world unlimited storage, compute,memory and scalability; essentially providing them a supercomputer on their desk.We envisioned an ecosystem with genetic analysis results from large numberof subjects complete with meta-data about the experiments needed to make context relevant conclusions.Partners across the globe can contribute and leverage from that information source.And it will be possible to monitor the evolving fingerprint and footprint of disease in real time,empowering health organizations to react to disease trajectories in un-precedented ways.We wanted the reality where when your child visits that hospital wing with a bad cough, his blood analysis results can already be correlated to other places it has been reported,and the best pos-sible information is accessible to his doctors maximiz-ing his chances for survival.This vision is no longer far-fetched but a reality in the making.

In the mere span of 18 months we have more than 10 apps on the Thermo Fisher Cloud,presenting solutions to analyze the data from CE (Capillary Electrophoresis) and qPCR (quantitative Polymerase Chain Reaction) in-

struments for gene expression,genotyping and Sanger sequencing.The challenge before us was providing a scalable, cost-effective solution that could handle 1000’s of samples, each interrogated at 1000’s of gene loci, translating to millions of records of raw signals. In terms of the architectural requirements,this translated to solution along four dimension of complexity:

Storage – Ability to store millions of records

Compute – Real time analysis of huge data sets

Performance – Needed a response time of 2-3 sec-onds while manipulating complex visualizations

Scalability – Platform to scale for thousands of us-ers and millions of studies.

Our offering is built on top of the AWS (Amazon Web Service) platform, the largest cloud-computing plat-form in the world.The solution we have on top of AWS’s service framework required several iterations of architecting and engineering to deliver on the final goal of a seamless experience,from running the sam-ples on our instruments to analysis,tocollate other available data with results of that analysis, to gener-ating scientific insights.

WHAT WE SAW FOR THE FUTURE?

Our solution architectureThe architecture diagram shows the services from Amazon that were de-

ployed in meeting the needs pre-scribed by our use case scenarios.

The diagram ties the elements of our use case to technological solutions we

How did we do it?


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chose to deploy. Thermo Fisher Cloud is a now a PAAS (Platform as a Ser-vice) that enables customers to man-age, store, analyse and share data ef-fortlessly as we usher in a new era of data analysis power for our customers.

The cloud solutions are revolution-izing the way we do science.Graph below shows performance improve-ments, and time saving we have already achieved across our qPCR and CE applications. What was of-ten weeks’ worth of work is a coffee away with 10X improvements to the performance. The cloud is enabling studies across data volumes that were not possible to analyze together before. And these results can be reli-ably and securely shared, cross-ana-lyzed, collated, and cross-correlated with ease, paving the way for validat-ing findings of interest and turning them to breakthrough insights.

Track evolution of diseaseNot only is this revolutionizing the

way we do science, it is allowing us to diversify R&D dollars into newer and more radical initiatives as we drive down our operating costs for develop-ment and sustaining. Deploying soft-ware updates, sharing, reconciling the differences between versions is easily maintainable. License administration becomes convenient. And the built-in visibility into our software usage pat-terns, failure modes is allowing us to learn about our customers’ conscious and unconscious needs, positioning us to innovate on the next generation of product offerings with maximum chances of success.

Of course,we have only just begun.A talk was given by the software team at the recent AWS re: Invent Confer-ence, the premier cloud conference in the world with over 13,000 attend-ees. Visit to learn how cloud comput-ing is enhancing our customer work-flows by optimizing applications with orders of magnitude improvement in performance and scalability. BS


BioSuppliers

Cloud computing solutions to drive paradigm shift in life sciencesThe Lifesciences industry in Israel is 50 percent dominated by pharma behemoth Teva Pharmaceuticals, followed by Taro Pharmaceuticals, which is now part of India’s largest generics empire, Sun Pharmaceuticals

T hermo Fisher Scientific officially unveiled its Software Engineering Centre of Excellence in Bangalore on January 20, 2016. The cen-tre will provide expertise in cloud computing technologies and specific platforms includ-ing advanced Java, Spring, .NET, Python

and statistical programming frameworks.

Currently the facility employs more than 250 professionals including software engineers from prestigious institutions and scientists with doctoral degrees. This team is building next-generation software, acting as an extension to Thermo Fisher’s global software R&D teams. The Software Centre of Excellence is Thermo Fisher’s first such facility globally.

According to the company’s press release, cloud computing has the potential to significantly change lab workflows and facilitate access to powerful data analysis techniques.

Mr Mark Field, VP & CTO, Thermo Fisher, who was in India on the occasion, told BioSpectrum that “the plan of erecting the centre has been realized after three years. Cloud com-puting and Internet of Things (IoT) are causing incredible disruptions across the world. The former has already made


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a stand in India. I have been in the software industry for 20 years, and India stands at the very forefront in mak-ing software and delivering the capabilities to the world. Software is a global phenomenon.”

Mr Amit Chopra, MD, VP/GM, Thermo Fisher Scientific India, added that “Indian scientists are adopting cloud computing technology, and the adoption rate is going to pick up rapidly. This technology enables scientists to leap forward in pioneering developments and be at the forefront.” As a result of using cloud technology, when something such as powerful genetic analysis software is released, it can immediately be deployed in the cloud, en-abling scientific communities around the world to quickly and easily access the new capabilities.

Mr Field added that “We have hundreds of users of this technology in India, from prestigious institutes to com-mercial organizations, and they are willing to experiment and play around a little bit before engaging in it fully. Cloud-based computing solutions have already been de-ployed in the US and Europe on a massive scale. This trend will soon catch up in India, and we are already see-

ing it coming.”

Cloud computing in the life science space is expected to make labs more productive and collaborative. “In the next five years, the cloud will become an innovation platform, much like the Internet. In the future, many incredible in-novations and impossible things are going to come out of the using the cloud,” opined Mr Field.

Through the cloud, thousands of labs and scientists are expected to get connected and act collaboratively, bring-ing in amazing capabilities and creating major paradigm shift in the life science space. “The cloud,” Chopra noted, “will change how scientists conduct research. We are pro-viding them the platform to leverage and drive faster re-search solutions.”

According to Mr Field, “It’s way too early to predict the market size for cloud technologies. As scientific instru-ments become more and more sophisticated, the amount of data these instruments produce will far exceed the analyti-cal capabilities or many labs around the world. And scien-tists alone will not be able to manage all this data.” BS


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India’s medical devices market will hit $17.6 bn by 2020The medical devices space in India will see impressive expansion, rising from $10.4 billion in 2014 to reach $17.6 billion by 2020, representing a robust Compound Annual Growth Rate (CAGR) of 9.4 percent, accord-ing to research and consulting firm GlobalData.

The company’s report states that al-though this market will not see the same level of growth as the phar-maceutical sector, it will still un-dergo significant changes, driven by mounting patient awareness of ad-vancements in medical technology, and an aging population.

Mr Adam Dion, GlobalData’s senior industry analyst, says that India’s medical device market is one of the fastest-growing, thanks to the coun-try’s strong economic growth, im-proving living standards and large population.

Mr Dion comments, “Purchasing pow-er within the country has been rising gradually over the last two decades due to high and consistent economic growth and increasing job opportuni-ties. The influx of people has resulted in more densely-populated cities and, by extension, an increased demand for medical facilities and devices.”

“In addition to benefiting from in-creased purchasing power within the region itself, the Indian medical devices arena is also profiting from a booming medical tourism market, which is driven by the comparatively low cost of treatments,” he added.

In terms of current opportunities within the medical devices arena, ophthalmic devices take up the larg-est proportion of market share.

In 2014, sales for these devices were valued at approximately $3 billion, having grown at a CAGR of 7.3 per-cent from $1.98 billion in 2008.

Bausch + Lomb enters partnership with Bosch IndiaBausch + Lomb entered into a partnership with Bosch. This cooperation brings together leading providers of eye care solutions and technology in India and SAARC re-gion, to market technological advanced diagnostic devices in the ophthalmic segment. Bausch + Lomb will market Bosch’s innovative digital Fundus camera - a compact retina camera, with special software that can detect con-ditions such as cataract at an early stage.

Post signing the partnership, Mr Sanjay Bhutani, MD, India and SAARC, Bausch + Lomb, said, “Our partner-ship with Bosch is in line with our strategic expansion plans. With this collaboration, Bausch + Lomb will fur-ther strengthen its portfolio in the ophthalmic diagnostic devices market. Being a leader in the eye care industry, this alliance will enable us to leverage our distribution strength to supplement growing market of eye care solu-tions.”

“To collaborate with ‘Bausch + Lomb’ is a motivating pros-pect as the company is renowned for its contribution to the eye care field”, said Mr Vijay Ratnaparkhe, MD, Bosch Engineering and Business Solutions. “At Bosch, we look to leverage this partnership as it would help us reach out to a larger population and thereby prevent the incidence of avoidable blindness and vision impairment in the coun-try. Our constant endeavor is to leverage our technology expertise to develop innovative solutions that address the healthcare needs and challenges across countries.”

NICE recommends Medtronic’s insulin pump systemsThe United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued positive guidance for the use of Medtronic insulin pump systems integrated with glucose sensors, for managing Type 1 diabetes and the avoidance of potentially life threatening hypoglycemic episodes.

The guidance reviewed two insulin pump therapy systems and recommends the MiniMed Paradigm Veo system for managing glucose levels in people with Type 1 diabetes who experience ‘disabling hypoglycemia’ - defined as repeated and unpredictable occurrence of low-blood sugar attacks that result in persistent anxiety about recurrence, and is as-sociated with a significant adverse impact on quality of life.

Since the assessment of the MiniMed Paradigm Veo system in the Diagnos-tics Assessment Programme (DAP), NICE has recognised that in 2015, Medtronic launched a successor system, MiniMed 640G.The MiniMed Paradigm Veo and MiniMed 640G sys-tems, are the only systems said to offer low glucose suspend mode.

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ndustry Principles on Valueof Biopharmaceuticals

I

Srinivas Rao ChandanThe author is Editor of

BioSpectrum [email protected]

BioSpectrum’s team of re-porters during the first two weeks of February 2016 spent a lot of time meeting the who’s who of the biotech industry. The senior execu-

tives from the industry had gathered in Bangalore to discuss various issues con-cerning the industry and the way ahead for it in its march towards the $100 billion mark. Start-ups, new age agricultural com-panies, biofuels players, the experts in the informatics and next generation sequenc-ing, the traditional pharma, BioPharma, CROs and CRAMs companies all met un-der one roof during the Bangalore India Bio 2016. The interesting aspects of build-ing and fostering the start-up ecosystem have been well advocated. BioSpectrum has featured the stories of two-dozen start-ups to understand what they are doing and how they are forging ahead as part of our anniversary cover story.

We have always said that the industry, academia, funding community, regulators, and consumers should come in unison for the industry to takeoff. I would like to draw your attention to an interesting develop-ment at Biotechnology Innovation Organi-zation (BIO). It released a new Principles on the Value of Biopharmaceuticals. These voluntary Principles represent the first-ever systemic, industry-endorsed set of commitments by research-based biophar-maceutical companies to support compre-hensive and sustainable solutions to im-prove patient access to and affordability of innovative medicines that are transform-ing how we treat and cure patients with once-devastating diseases.

BIO President and CEO Jim Greenwood, said, “America’s innovative biopharma-ceutical companies exist to advance the health and well-being of patients by tack-ling head-on the unrelenting scientific

challenges inherent in the discovery, de-velopment and delivery of new, high-value cures and treatments. These Principles represent a commitment by our industry to do our part to improve the ability of pa-tients to access those medicines on a sus-tainable and affordable basis, while also continuing to take the big risks and make the enormous investments required to ful-fill the promise of the next generation of cures.”

Among other principles, BIO members are committed to open dialogue with patients, healthcare providers, and payers on the value of their biopharmaceutical innova-tions and to take these stakeholders’ views into account in the development and deliv-ery of such cures and treatments. In addi-tion, BIO and its members will work with such stakeholders, as well as policymakers, to explore a broad range of novel delivery approaches to maximize the value of these innovations for patients and the overall healthcare system, including by seeking to remove legal barriers that currently limit the ability to engage in value-based con-tracting and communications.

“As evidenced by these Principles, the re-search-based biopharmaceutical industry welcomed the vigorous public debate about the cost and value of our medical innova-tions,” Greenwood said. “BIO members already are doing their part to find sus-tainable patient-centered solutions, and as an industry we are committed to doing even more. To effectively accomplish these goals, it is essential that other stakehold-ers in the healthcare system do their part, as well. To that end, we call upon payers, healthcare providers and policymakers to join with us in designing and implement-ing comprehensive solutions that will en-sure patients continue to benefit from the tremendous medical advances biotechnol-ogy has made possible.” BS

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