BSA June 2016

An MM Activ Publication | www.BioSpectrumAsia.com | June 2016 | BioSpectrum 1


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2 BioSpectrum | June 2016 | www.BioSpectrumAsia.com | An MM Activ Publication

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BioEdit

China’s 13th five-year-plan (2016-20) document, that was released recently, puts greater emphasis on

healthcare industry which is esti-mated to be valued at eight trillion yuan by the end of the plan period.This will be an interesting and im-portant period for the healthcare sector as drugs worth of $250 bil-lion are estimated to expire in next five years and their market share

will be taken by generic drugs. And for this peri-od China has emphasized on changing the mod-el from research and development to innovation with focus on making breakthroughs in biolog-ics medicine and to facilitate better protection of intellectual property rights. Its further plan is to step up production for special APIs, improve development of new drugs and speed up the reg-istration process to expand export.

Interestingly, the plan document coincides with the release of Thomson Reuters report describ-ing China as the global leader of pharmaceuti-cal innovation. During 2015, five of the top 10 global organizations for filing pharma patents were located in China and from 2005 to 2015, three of the top 10 organizations for publish-ing papers about drugs and disease were China institutes.

Both the reports need a careful watch and scru-tiny from the Indian side as both the countries had been in a race during the past few years in faster economic development in general and in biotech, pharmacy and healthcare sectors in particular. India has to particularly take the plan document seriously as China has been relatively successful in achieving its broadly outlined goals in previous five year plans. That may continue with this plan document also.

An important development from the India’s side is that it has announced its Intellectual

Property Right (IPR) policy, which is very cru-cial in the pharma sector. The production of cheap generic drugs in India is the only hope for many poor patients and that is possible only due toIndia’s IPR policy. Through this policy, India has shown its independence and thus, no wonder, the policy has come under severe criticism from US and some other countries.Apparently these countries are exerting pres-sure on India to amend the policy to suit their companies.

On this backdrop, India continues to closely studyand scrutinize the Chinese plan docu-ment and its likely impact in view of the race between the two countries. But at the same time both the countries can also explore pos-sibilities of co-operation than racing with each other. Not only bio and pharma industry lead-ers from both the sides, but even independent observers have been expressing similar opin-ion.Both have their own strengths and weak-nesses.Chinese industry feels India has speed-ed up development of talent pool, registration and certification process and its growth in ge-neric business is phenomenal and impressive.

On the other hand a PWC report in 2010had said that China was entering a ‘golden age’ of the biopharmaceutical sector – facilitated by substantial investment, patent protection and strong regulation by the central government.ThomsonReuters report adds over that at-tributing China’s success to pharma industry innovation,scientific research and fostered a healthy mix of partnerships.

Indian industry feels that two-way trade be-tween India and China in formulations and APIs, in which each of the country is dominant respectively, and contract manufacturing is possible. There are some hurdles,but if efforts are made to remove them, there could be a way for partnership, making both the countries stronger.

Milind KokjeEditor

Race or partnership?


BioSpecial

Special articlesIt was good to see expert articles on BioSupplier tech-nologies. It would be great if BioSpectrum team comes out such specialed articles on diagnostics market as well.

Robert Smith

CMO specialI am happy to know that Biosimilars are opening up new opportunities for CMOs. This transition will change focus on many drug manufacturers in the future. This piece of information will help a small time CMO like ours.

Via Website

Medical tourismIt’s great to see Thailand taking advantage of the great

economical opportunity offered by medical tourism. It’s a great way to improve their economy and provide a services to peo-ple who wish to kill two birds with one stone, so to speak.

Wilford James

Career oriented articlesSir, I am a student on Biotech and would like to see articles re-lated to Biotech career. Kindly publish the data for the Asia Pacific region including India. It will help lot of stu-dents like me.

Murali Vasudevan

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Vol 11; Issue 6; June 2016

Vol 11; Issue 4; April-May 2016


BIOSPECIAL BIOSPECIAL28 30

COVERSTORY14

China's plan is to invest in new drugs and bring innovative drugs targeted for diseases such as cancer, heart diseases, mental illness, pain drugs and ageing population.

China’s vision of PHARMA & HEALTHCAREsector

Meet the Robotic Surgeons who conducted nearly 4,000 procedures in 30 hospitals spread across the country during 2015 to help cut flab. Earlier doctors were using laparoscopic techniques to perform gastric bypass surgery. Today, robotic surgery is the more preferred method.

The

fightersFA PRECISION

MEDICINE

Does India need

Initiative


Racho JordanovPresident and CEO, JHL Biotech

Ernest LeeVP Sales, Singapore, Malaysia & Brunei, Alcatel-Lucent Enterprise

Jan MäkeläGM, BioProcess business, GE Healthcare’s Life Sciences business

10

26

BIOTALK

BIOCOLUMN

BIOSPECIAL

24

08

‘Taiwan has robust domestic policy to support global innovation’

REGULARS

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BioSpecial



Taiwan is ahead of Singapore when it comes to assess-ment of how domestic poli-cies support worldwide life

sciences innovation, according to an analysis by Information Technology and Innovation Foundation (ITIF), a global technology policy think tank. Assessing 56 countries, comprising of close to 90 percent of the world’s economy, on the extent to which the scientific research, drug pricing, and intellectual property policies con-tribute to global biopharmaceutical innovation.

The analysis found that the United States, Switzerland, Taiwan, Sin-gapore, and Sweden have enacted policies that, on a per-GDP basis, contribute the most to global life sci-ences innovation, while India, South Africa, Thailand, the Philippines, and Australia have policies that con-tribute the least.

“World Health Day is a time to re-flect not just on what nations can do to generate better health outcomes for their own citizens now, but also for citizens around the world tomor-row,” said co-author Stephen Ezell, ITIF vice president for global inno-vation policy.“Life sciences innova-tion requires years of painstaking and expensive research. To ensure global

health outcomes continue improving, more nations must do their share to support biopharmaceutical innova-tion and not free ride off the hard work and investment of the leaders.”

Building on previous ITIF research that studied the impact of national policies on the global innovation eco-system, the report focuses specifical-ly on biopharmaceutical innovation. Ezell and co-author JJohn Wu exam-ined three policy areas that not only support lifesciences innovation do-mestically but also have positive spill over effects globally: governments’ R&D expenditures on health; the extent of price controls on biophar-maceutical drugs; and intellectual property protections for lifescience innovations.

“Despite tremendous progress over the past half century, the world is still not producing as much life-sciences innovation as is needed or possible,” said Ezell. “Countries that fail to invest adequately in lifescienc-es research, pay less than their fair share for drugs, or put in place weak intellectual property protections for drugs hurt the entire global com-munity by slowing down biopharma-ceutical innovation that could cure or better manage diseases for future generations.”

The report also found that countries with the strongest lifesciences policies also have some of the most competi-tive innovation ecosystems, meaning that doing well domestically can also mean doing well for the world.

“It is on the one hand understand-able that policymakers tend to focus first and foremost on the short-term interests of their own citizens, but too many ignore the fact that this comes at the expense of less innovation of new drugs,” said Robert D Atkinson, ITIF president. “The bottomline is that all nations need to do their part to support robust global biopharma innovation.” BS

AmritA tejAsvi

Despite tremendous progress over the past half century the world is still not producing as much lifesciences

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BioTalk

Several Asian companies have been increasing their focus on biosimilars, terming it a long term prospect. Although currently small and focused on few diseases, the biosimilars’ opportunity is

all set to grow, thanks to the unprecedented patent cliff and rising healthcare costs. Biosimilars are an affordable option for Asia’s growing healthcare needs and this has offered a clear potential for players in emerging Asian countries to set up operations and leverage this lucrative opportunity.

One such interesting company is a start-up in Taiwan – JHL Biotech, which aims to build a biotech industry in China. Founded in 2012, by two former Genentech col-leagues, JHL Biotech has already received the EU ap-proval to perform clinical trials for its biosimilar ritux-imab and is planning to file an (Investigational New Drug) IND for its upcoming orphan drug biosimilar by the end of this year.

JHL is the first Chinese company to file a clinical trial for biosimilar in Europe. The company has two factories, one for clinical manufacturing and development in Hsinchu in Taiwan, and one for commercial manufacturing and pro-cess development in Wuhan. JHL is also the first to use

‘We aim' to make biopharma more affordable’

Led by an experienced team of

Genentech and Amgen veterans, and

funded by top-tier venture capital firms

including Kleiner Perkins Caufield &

Byers (KPCB), Sequoia Capital, Biomark

Capital and CDIB, JHL Biotech aims

to make biopharmaceuticals affordable

and accessible to all patients through

manufacturing innovation.

Racho JordanovPresident and CEO, JHL Biotech

Interview


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BioTalk

GE Healthcare’s KuBio factory design, that can be built and dispatched anywhere in the world in just 18 months.

Racho Jordanov, President and CEO, JHL Biotech, in an interview with BioSpectrum Asia spoke at length on the company.

When and how was JHL Biotech founded?

A JHL was founded in late 2012. Ms Rose Lin, general manager, JHL Biotech, and I realized that there was

need in Asia for the kind of expertise we had acquired throughout our careers at Genentech, and more impor-tantly, we saw an opportunity to make biologics more af-fordable. We put together a slide deck and quickly secured KPCB as a cornerstone investor. After that, we attracted more funding and set in motion our plans to construct a pilot facility in Taiwan and a full scale plant in China.

Tell us about the biosimilars facility in China.

A Our campus is in a government-backed biotech park in Wuhan. It is called ‘JHL-1’, with the ‘1’ indi-

cating that we have ambitious expansion plans. JHL-1 has space for utilities, two commercial scale API plants, a fill-finish site, and an administration building that also contains space for process development and analytical work. We just celebrated the opening of our first API plant and look forward to breaking ground on the second API plant and fill-finish facilities in the near future.

Our newly opened JHL-1 API facility is built to compliance with the highest standards. It is remarkable for a number of reasons. We are the first to utilize a revolutionary GE mod-ular construction technology called KUBio. It is the larg-est single-use mammalian cell culture facility in Asia. Our whole site was finished in about 18 months, and we spent about 1/3 of what is typical for an mAb site of this scale. I am excited to say that we will soon be starting production in Wuhan. Our site is close to being fully operational and I am very proud of the devotion of our team there.

How important are biosimilars for the Asian market?

A Biosimilars are very important to the Asian phar-maceutical market. This is due to population and

average income. Depending on how you define ‘Asia’, nearly 1/4th of the world's population lives in this part of the world. This also means that the incidence of disease is greater than in other regions; moreover, in the next two decades, the number of new cancer cases here is expected to rise 70 percent. So, we have this massive population, but at the same time, many earn significantly less than their counterparts in the West. Innovator drugs are priced very high in many Asian markets, making it com-paratively more difficult for locals to access these thera-

pies. Biosimilars will be priced much lower and will therefore greatly increase options for patients.

What are the challenges you see in commercializing biosimilars?

A There exist three big challenges. In order of impor-tance: Regulatory, Economic, Manufacturing. Reg-

ulatory challenges are first and foremost, as biosimilars are new and approval pathways are still in development. We have a great regulatory team that has strong relation-ships with relevant authorities. Each of our biosimilars will be approved first in the EU and China, then later, in the US. When our treatments are approved, the econom-ics of biosimilars also dictate that, in markets where mul-tiple biosimilars are competing for market share, success will be driven by price, which means that we have to be able to manufacture more efficiently than anyone else. This plays to JHL's strengths and is at the core of why we will be a dominant biosimilars player: we have world class expertise in the manufacture of these molecules. We also have our own manufacturing facilities. This vertical integration allows us to focus on process innovation, which leads to steep reductions in cost of goods.

Your thoughts on regulatory hurdles in biosimilars space.

A The two biggest issues currently under debate are interchangeability and extrapolation. We do not

believe that, in the near term, any regulators will allow interchangeability. This said, after a significant body of efficacy and safety data are available, which could take a decade or longer, we think regulators will start to con-sider interchangeability. Extrapolation is already allowed in some markets for products that have shown safety and efficacy in the indications most ‘difficult’ to treat. Long term, we believe interchangeability and extrapolation will become common due to the fact that regulators, doctors, and payers will gain comfort with biosimilars.

Could you share with us the impact in China from structural reforms?

A Sure. I shall focus on two groups: government and consumers. On the government side, impact comes

from support for the biotech industry and overhauls to the social security and drug administration systems. On the consumer side, the biggest impacts from reform are due to the effect rising wages and higher quality stan-dards will have on demand for great medical products. The Chinese government has made the biotech industry a key focus of its 13th five-year plan and its ‘Made in China 2025’ plan. This was central to our decision to start JHL in Asia and put our landmark facility in China. The Hubei government, by way of the Biolake biotech development zone, provided strong support to us. For example, aside


BioTalk

from our API facility, all buildings at JHL-1 were built for us by the local government.

In addition to government incentives, the Chinese social security and drug administration systems are undergoing great change. In 2009, the government allocated $125 bil-lion to various levels of government to upgrade hospitals, reduce imbalance in medical care between rural and urban areas, and decrease the burden of medical expenses to indi-viduals. Likewise, since we started working in China three years ago, we have begun to see changes in the tendering process and means of getting on the reimbursable drug lists.

On the consumer side, reforms are underway to make the Chinese economy one driven by consumption. We believe that the growth of service industries and a gradual rise in salaries will, over the long term, drive the new middle and upper class to demand higher qualities of care than currently available. Our biosimilars will make world class therapies affordable to this population.

In your opinion which are the countries poised to ride successfully in the biosimilars wave?

A We have seen great development in every Asian country. Korean firms like Samsung and Celltrion

have invested massively in biologics and biosimilars de-velopment. India has a mature generics industry and very talented people, and we are watching the Indian market closely. JHL has held conversations with Vietnamese au-thorities regarding the possibility of operations in Viet-nam. As you might also guess, we are especially bullish on China. China's regulators have made huge steps towards a biosimilars regulatory framework. The Chinese govern-ment heavily supports development of the biotech indus-try, and, finally, China has a deep and fast growing pool of talented biotechnology experts.

What makes biosimilars an attractive investment option?

A Biosimilars have a lower risk profile than innovator compounds, lower capital costs, and great econom-

ic prospects. Risk in biosimilar development is inherently lower than new entities because the compound has al-ready been discovered and proven. In biosimilar develop-ment, regulators place great value on analytical data and PK/PD efficacy. Unlike a traditional drug development process, in which risk increases with each development phase, much of the risk in biosimilar development is front-end loaded. Thus, investors have an idea of whether a therapy and company are worth investing in much ear-lier than is the case with new entities. Likewise, biosimi-lars development takes about 7-8 years, while new enti-ties can take 15-20 years. Additionally, innovator compounds can cost billions to go from concept to prod-

uct. The capital required for us to go from concept to product is an order of magnitude lower.

Finally, biosimilars are also attractive because of the eco-nomics. We can sell at a sizable discount to innovator compounds and still deliver 80-90% margins. To sweeten the deal, barriers to entry are very high because biosimi-lars are regulated drugs and the development of them re-quires great technical expertise. From an investor's point of view, this combination of lower risk, lower capital in-tensity, and high margins is difficult to beat.

What are the key trends in Asia’s biotech space?Without doubt, the key trend is the growth of world class biotech firms in Asia. Along with this, another very impor-tant trend is the growth of companies making therapies specifically targeting Asian indications. JHL is develop-ing biosimilars for the Chinese and global market, and we also do CMO work for select domestic and international partners. We are working on three projects for BeiGene, China's premier drug discovery company. One of our early investors from Sequoia started ZaiLabs, another company focused on developing new molecular entities, with a focus on entities targeting China and Asia-specific ailments. Every day, we hold meetings with well-funded entrepreneurs looking for assistance in the development of their innovative biologics. We are honored to support this new wave of companies and excited to play a role in the growth of China's biopharma industry.

Could you talk about your product portfolio in depth?

A I love discussing our products, but unfortunately, I cannot say too much, as details of our pipeline are

confidential. Here is what I will tell you, though: our cor-porate goal is to file two-to-three biosimilar INDs per year (China, Europe, and US). At the end of 2015, we filed an IND for our rituximab biosimilar with the UKMHRA, and we have already received approval to perform human clinical trials of it in Europe. We are on track to file an-other IND at the end of this year for an orphan drug bio-similar, and we believe the quality of that product will be so great, it will go straight to Phase III trials. Stay tuned!

Can you elaborate your expansion plans?

A Our first concern is ensuring successful startup of our new API plant. Once done, however, we will

soon start construction of our next API plant and our fill-finish facility. We are also discussing possible locations for our next JHL site, JHL-2. We have a strong product pipeline and see great demand for our products, and we will be expanding aggressively in this decade to ensure we can meet the needs of global consumers. BS

AishwAryA VenkAtesh


China’s vision of PHARMA & HEALTHCARE sector

China has entered into its 13th Five-Year plan for 2016 to 2020 and relays a strong message to reinforce its potentials within the healthcare sector. China has emphasized on changing the model from research and devel-opment to innovation with focus on making breakthroughs in bio-logics medicine and to facilitate better protection of intellectual property rights. In 13th five-year plan, China intends to develop and adopt cyber-medicine and optimized distribution of re-sources to improve the quality of basic health services.

The country is planning to adopt aggressive strategies to increase the free supply of HIV treatment medication, reduce the cost for treating other chronic diseases and support traditional Chinese medicine.

China's plan is to invest in new drugs and bring innovative drugs targeted for diseases such as cancer, heart diseases, mental illness, pain drugs and ageing popula-tion.

In 2015, China's pharma in-dustry had clocked revenue of $175.4 billion out of which API marked $71 billion and formu-lations earned $104.9 billion.China's big names in phar-maceutical industry including Sinopharma, Shanghai Pharma, Yangtze Pharma, Fosun Pharma and CPSC have expanded their strengths in the last few years.China is the biggest exporter of APIs to developed countries.Its API export was valued a $9.8 billion in 2015 out of $26.8 billion of chemical export. Its formulation export is estimated

at $2.3 billion.

There has been a greater em-phasis on healthcare industry in 13th five-year plan and by 2020, the sector is estimated to be valued at eight trillion yuan with rapid developments, growing demand and a boost by the capi-tal investors. The plan is to step up production for special APIs, improve development of new drugs and speed up the registra-tion process to expand export." Said Guangcheng Pan, executive chairman, China Pharmaceutical Industry Association (CPAI).

CoverStory


China’s vision of PHARMA & HEALTHCARE sector

AN IN-DEPTH ANALYSIS BY BMI RESEARCH

China's 13th five-year plan (2016-2020) will be a key guiding document shaping opportunities in the phar-

maceutical and healthcare industry.In the 13th five-year plan, specifically for the healthcare sector,several key areas have been identified such as full implementation of the supplemen-tary health insurance programme proposed for jobless rural and urban residents with major diseases; in-tegration of rural and urban health

insurance schemes;encourage the development of private health insurance policies and the

involvement of insurance firms; advancing comprehensive reform of public hospitals,seeking to end a system focused on profits; optimised distribution of healthcare resources; improved basic healthcare services; encourage the development of tradi-tional Chinese medicines; rationalise drug prices and improve reproduc-tive health.

The government's initiatives will pri-marily reinforce existing trends in the pharmaceuticals and healthcare sector. Consequently, pharmaceu-tical firms and healthcare provid-ers can expect the existing pace of change to accelerate over the com-ing years as the government seeks to achieve its objectives.

China has been relatively success-ful in achieving its broadly outlined goals in previous five year plans.For example, China has been able to make significant progress in making basic medical insurance universally available as outlined in its 12th five-year plan.

However, while the government's commitment to improving healthcare remains strong, other areas such as intellectual protection has not seen similarly strong reform. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), China continues to have restrictive-patentability criteria with low levels of regulatory data protection which will impinge upon patient access to innovative pharmaceuticals.

Health Insurance ReformChina's five-year plan will reaffirm a push to mitigate inequalities in the country's healthcare system. Re-

CoverStory

Forming one of 10 sectors identified in the country's 'Made in China 2025' plan, the importance of the pharmaceutical industry will be accentuated by the ongoing economic slowdown in China


flective of this is the government's commitment to fully integrate Chi-na's new rural cooperative medical scheme (NRCMS) with the urban resident basic medical insurance (URBMI). This is a landmark move that will reshape opportunities for both private healthcare providers and pharmaceutical firms alike.Cu-mulatively accounting for 81 per-cent of the total population with re-gards to health insurance coverage, a merger will see the number of re-imbursable products and treatments available for the population shift.For example, under the NRCMS, only 800 pharmaceutical treatments were covered, as compared to 2,300 in the URBMI. For multinational drug makers, a stronger homogenous in-surance landscape for rural residents will be especially propitious as access expands beyond tier one cities and into less developed regions.

Similarly, Chinese authorities will continue to support the growth of the private health insurance sector.

Beyond alleviating the cost burden on the government, which will only grow as chronic diseases become a bigger feature of China's epidemiol-ogy - a strong private health insur-ance sector can provide a greater ar-ray of products that meet the needs of the country's diverse population.In this manner, private health insur-ance will provide additional coverage for patients and will provide access to high-value medical services and products.

Reproductive HealthNotable new opportunities from the plan stem from the new focus on supporting the country's two-child policy. This marks a shift in China's stance and comes as government officials seek to address the rising number of dependents in the country (expected to increase from 368 mil-lion in 2015 to 553 million by 2050).Areas identified in the plan include reproductive health, women's health and child healthcare, beneficial for pharmaceuticals in the fields of pae-diatrics and fertility.

Drug Pricing pressureIn tandem with China's focus to im-prove health coverage, the five-year plan affirms the growing push by authorities to more efficiently allo-cate resources for pharmaceutical spending. While specifics have not been mentioned in the plan, it re-mains a key area of concern for drug makers. The bidding process that gained significant traction in 2015 has placed downward pressure on high-value pharmaceuticals. Most provinces employ a 'two envelopes elective tender'system, where firms submit drug quality information in one envelope and prices in the sec-ond. However, bidding procedures arenot standardised and the selec-tion of a medical product based on price alone can occur. There are also varying priorities among local authorities. In Hunan, for example, domestic news sources reported that

authorities have sought to cut prices by as much as 50 percent.

TCM Businessthrough Silk RoadChina's 'One Belt, One Road' (OBOR) initiative will have the po-tential to shape the growth trajectory in the country's healthcare sector.Given its scope, the OBOR will serve as a platform for Chinese authori-ties to actively promote traditional Chinese medicine across major mar-kets in Europe, Asia and the Middle East. It also allows China to more proactively lead the advancement of disease surveillance particularly among its neighbouring countries. China's ambitious 'One Belt, One Road' initiative will have broad im-plications for numerous sectors in-cluding healthcare. First put forth by President Xi Jinping in 2013, it seeks

Notable new opportunities from the plan stem from the new focus on supporting the country's two-child policy. This marks a shift in China's stance and comes as government officials seek to address the rising number of dependents in the country

CoverStory

J Jayaseelan, Chairman, IDMA

“India and China need to build an environment of partnership that enables the two countries to grow in future. Collaboration is possible only when we have the intention to grow together and not competing but complementing."


to connect Asia and Europe through a re-imagination of the historical Silk Road. Specifically, the OBOR initia-tive consists of two key trade routes:

Silk Road Economic Belt: A land route starting from Xi'an in Shaanxi province that passes through Central Asia, the Middle East, Russia and Western Europe.

Maritime Silk Road: A sea route extending from Fujian in China to Europe, through the South China Sea, the Indian Ocean and the Red Sea before it joins the land route in Venice, Italy.

China will leverage upon the OBOR to facilitate the growth of the tradi-tional Chinese medicine (TCM) in-dustry. Posing a competitive threat to western pharmaceuticals, this inten-tion was reflected in a strategic plan published by the National Health and Family Planning Commission (NHFPC) which argued that TCM use should be expanded across states in the OBOR. To that end, strategy ad-opted by Chinese authorities is two-fold.Led by government agencies, China will first seek to promote the use of TCM across countries and af-firm its healthcare benefits. This will be followed by an effort led by the NHFPC to establish common stan-dards in the use of TCM across coun-tries in the OBOR.

Business environmentin China toget more complexChinese pharmaceutical market will become more complex for multina-tional drugmakers. This is largely a result of the numerous ongoing re-forms affecting the healthcare sec-tor, including changes to the pric-ing regime and regulatory approval process. Sales practices employed by pharmaceutical firms in China will also evolve, driven by a need to better ensure compliance.

China's pricing environment will continue to evolve as authorities seek to balance greater medicines access while reducing healthcare costs. This aspect was emphasised in a new pilot programme announced by National Health and Family Planning Com-mission (NHFPC) in March 2016.

Under this new scheme, five high cost drugs have been selected to undergo significant price cuts in exchange for a wider national insurance coverage.According to Li Bing, Director, NHF-PC, this is part of the government's move to reduce healthcare costs for patients, with these pharmaceuticals being chosen due to their high cost.

Although the authorities have not of-ficially disclosed the selected prod-ucts, five key therapies that are likely to be covered are Gilead Sciences' Viread (tenofovir), Roche's Tarceva (erlotinib), AstraZeneca's Iressa (get-fitinib), Celgene's Revlimid (lenalid-omide) and Betta Pharmaceuticals' Conmana (icotinib)

Regulatory reformsIn addition, regulatory pathways in China will continue to develop. As highlighted by the Center for Drug Evaluation under the Chinese Food and Drug Administration (CFDA), 2015 was marked by deepening re-form to the approval process and this is expected to be continue in 2016, especially as the number of new drug applications submitted yearly re-mains high at 8,211 in 2015. Beyond expediting the process, authorities have begun to place a strong empha-sis on quality. A circular released in March 2016 by authorities noted that pharmaceutical firms selling generic drugs must ensure that the quality and efficacy of their drugs are on par with the originator medicines.

In addition, it is expected from the government to diligently pursue the implementation of regulatory re-forms.Beyond addressing the medi-cal need within China, expediting the process will form an integral part of the country's strategy to position its pharmaceutical sector as an engine of economic growth.

Forming one of 10 sectors identified in the country's 'Made in China 2025' plan, the importance of the pharma-ceutical industry will be accentuated by the ongoing economic slowdown in China.

Shift in marketing practices Changes in China's pharmaceuti-cal sector will not be limited to the pricing and regulatory environ-ment. Sales practices, for example, will continue to evolve as firms look to change incentive structures and ensure regulatory compliance fol-lowing the GlaxoSmithKline bribery trial. More recently, Bristol-Myers Squibb was fined $14 million in Oc-tober 2015 by the Securities and Ex-change Commission over charges that its joint venture in China made cash payments and provided other

"We should learn from India to speed up development of talent pool, registration and certification process. The way India has grown phenomenally in generics business is very impressive"

Guangcheng Pan executive chairman, CPIA

CoverStory


CoverStory

benefits to healthcare providers at state-owned hospitals in exchange for prescription sales.

Subsequently, the firm noted in March 2016 that it has stopped 'cer-tain initiatives'in China, which, ac-cording to local industry sources, involved a clampdown on the use of expenses and speaker fees for doctors.

Multinational pharmaceutical firms will adapt to the evolving regulatory landscape in China. A top priority will be the new drug approval pro-cess, whose implementation will re-ceive strong support given the medi-cal and economic need in China for the medicine industry to develop. Amidst the uncertainty from these changes,there will be opportunities such as the priority review which

confers an expedited approval pro-cess for products that align with the government's focus.

The year 2016 will be a key year for regulatory reform in China as policy makers implement new reforms to expedite the drug approvals process.The Chinese Food and Drug Admin-istration (CFDA) disclosed in Feb-ruary 2016, that it had approved a total of 342 medicinal products for the year of 2015, of which 70 percent were simple chemical compounds, 22 percent traditional medicines and 7 percent biologic products. This is a 27 percent decline from 2014 when the CFDA approved a total of 470 treatments, and it follows growing concerns among multinational drug makers regarding regulatory delays.

Critically for multinational phar-maceutical firms, 2015 saw the ap-proval of several key products.This included Johnson & Johnson's Zytiga (abiraterone) for prostate cancer and Novartis' Galvus (vilda-gliptin). Roche was also able to ob-tain approval for Avastin (bevaci-zumab) as a first-line non-small cell lung cancer treatment,providing access to a highly significant disease area.

Similarly, Novo Nordisk received ap-proval for Levemir (insulin detemir), which will aid the firm's position in the highly competitive diabetes mar-ket in China.

New policies take effectThere will be opportunities for mul-tinational pharmaceutical firms to enhance their operations through the regulatory reforms in China. Central among these initiatives has been the decision by the CFDA to create a pri-ority review programme, which will assess products on their clinical val-ue and use of advanced technology.

The CFDA has also identified seven areas that will be the focus of this

fast-track scheme that includes can-cer, rare diseases, HIV/AIDS, Tu-berculosis, Viral hepatitis, Pediatrics and Geriatrics.

Benefits disclosed so far include shortened regulatory timelines through the development and ap-proval process. In the notice an-nouncing the scheme, the CFDA has also committed to specific time-frames which will create greater transparency and facilitate the op-erations of pharmaceutical firms. (A BMI Research report).

China to boostmedical industryChina’s State Council has issued a guideline on March 11, 2016 to give the medical industry a healthy boost.It said that by 2020, innovation ca-pacity of the medical industry should be greatly increased,supply of ur-gently-needed clinical drugs will be increased, and the scale of the indus-try will expand, with annual growth rate of the main business revenue higher than 10 percent.

The guideline states that in order to achieve these goals, innovation and entrepreneurship should be encouraged,more innovation-driven middle and small-sized enterprises with technologies and high-end tal-ents should be set up, and the re-search ability of new medical prod-ucts should be increased.

It also required efforts to upgrade the medical equipment,mainly develop-ing the key devices such as digital detectors,superconducting mag-nets and X-ray tubes with high heat capacity, and technologies such as 3D printing and data collecting and analysis.

The new rule Good Manufacturing Practices on Medicines will be strict-ly implemented to perfect the prod-uct tracking systems. It also encour-ages using modern bio-technology to

The CFDA has also identified seven areas that will be the focus of this fast-track scheme that includes cancer, rare diseases, HIV/AIDS, Tuberculosis, Viral hepatitis, Pediatrics and Geriatrics


improve the traditional drug produc-tion methods, build environmental-ly-friendly industrial parks and recy-cle the byproduct materials to reduce pollution.

To better integrate this industry, the government will promote pharma-ceutical enterprises to implement cross-sector mergers and acquisi-tions while optimizing the industrial structures.

Development of the pharmaceutical industry also needs the co-ordination of different regions, according to the guideline. It suggested building in-ternational-level research centres in eastern areas with abundant capital and high technologies,and produc-tion and export bases of the tradi-tional Chinese medicine (TCM) in the western and the northeastern ar-eas that have large amounts of TCM resources.

The guideline also states that to bet-ter develop this industry, the country should also perfect the medical ser-vice systems, relieve patients’ burden by controlling irrationally high ex-penses and reduce repetitive and un-necessary medical examinations in different hospitals while encouraging doctors to work in several medical in-stitutions.

In addition, the pharmaceutical in-dustry should also take the advan-tage of the Belt and Road Initiative to go global, promoting big medical enterprises to invest overseas, build research centers, production bases, and sales and services networks. Ef-forts should also be made to develop internationally influential brands.

The government should also step up efforts to improve legislation on supervision of drugs and medi-cal equipment, punish illegal enter-prises, protect intellectual property rights, and crack down on fake and shoddy products. (As published by China’s National Health and Planning Commission).

Can China and Indiabe ace partnersin pharma sector?European countries are the domi-nant consumers of drugs. However, it will slowdown in future giving way to developing countries like India, China, Russia and Brazil that are es-timated to grow at 10-15 percent and would be the major drivers of global pharmaceutical industry. Can India and China grasp these opportunities with strategic plans to drive develop-ment of pharmaceutical industries of both countries?

In next five years, important drugs are on the edge of expiry. By 2015-2020 drugs worth of $250 billion is estimated to expire and the market share will be taken by generic drugs. In next two decades, India and China

will be the pillar of development for pharma industry.

India has a unique advantage of lan-guage to better understand the regu-latory of global companies. India and China can also have broader co-operation in production and clinical trial data.

“We should learn from India to speed up development of talent pool, regis-tration and certification process. The way India has grown phenomenally in generics business is very impres-sive. China should also grasp such opportunities, nurture China local talent and scientific knowledge and strengthen drug production for ex-ports," Guangcheng Pan, executive chairman, China Pharmaceutical In-dustry Association (CPAI) said.

“We should support China compa-nies to produce generics drugs and be prime exporter to US and Europe. We need to improve the quality and efficacy of our drugs to international standard and need to implement has-sle free policies and regulation proce-dures. In 13th five-year plan, China is aiming to achieve growth rate of 13-15 percent in generics business,” he further said.

Me Pan commented that both India and China are developing countries.Pharmamanufacturing incurs huge cost and a collaboration between India and China on manufacturing would save cost to both the countries.

Song Min Xian, former registration director, Sichuan FDA, remarked that although China and India have memorandum of understanding on exchange between regulators, how-ever, there is a lack of communica-tion between regulators of two coun-tries.

China has over 5,700 chemical com-panies and 4,000 chemical products. China imports 1,400 products of

“US, UK, Russia, South Africa and Nigeria are major export destinations for India and we hope that China also become one of the major buyers for India pharma products.It is a good opportunity for China to invest in India and strengthen bilateral trade between the two countries.”

SV Veerramani, president, IDMA

CoverStory


which 940 are formulation products.

Sharing his views on the current state of India-China partnership, JJ-ayaseelan, Chairman, Indian Drug Manufacturers’ Association (IDMA) said, “India and China need to build an environment of partnership that enables the two countries to grow in future. Collaboration is possible only when we have the intention to grow together and not competing but complementing. We recognize China as a great neighbour and civilization and there are many aspects in com-mon where India and China can work together. Although we have signed MoU for many years now but there has been no real benefit for the man-ufacturers or the drug companies. In-dia has a great R&D base, manpower base and there are agencies than can help in building the strengths of two countries together.”

Daara Patel, Secretary-General of IDMA, mentioned that global pharma market is more than 1 trillion. If India and China join hands and collaborate instead of competing, the industry of both the countries will expand phe-nomenally.Both the nations need to consider the strengths and weakness-es, support each other for local con-sumption and global tenders.

“To further improve the pharmaceu-tical industry, India and China can exchange views on the challenges they face regarding regulatory norms and procedures and take steps to make it better. India and China have been very old business partners, however, India has been primarily an importer of APIs from China. There is a trade deficit and this need to be balanced. One of the way could be if China identifies India as a centre for importing formulations,” suggested Pate.

The turnover of India’s pharmaceu-tical market is estimated at $31 bil-lion in 2015 and is expected to touch

$55 billion by 2020. The current do-mestic sale is around $15 billion and export is valued at $16 billion out of which 77 percent is formulations and 23percent is APIs.

Ninety percent of the Indian pharma market is driven by generics drugs which is estimated to grow at a CAGR of 10-15 percent in next five year. In-dia accounts for 10 percent of the global production of pharma prod-ucts out of which formulations are valued at $12 billion of export and APIs at $4 billion.

“US, UK, Russia, South Africa and Nigeria are major export destinations for India and we hope that China also become one of the major buyers for India pharma products.India ac-counts for 10 percent of global phar-maceutical production and manufac-ture more than 400 different APIs.

“Global pharma market is more than 1 trillion. If India and China join hands and collaborate instead of competing, the industry of both the countries will expand phenomenally.Both the nations need to consider the strengths and weaknesses, support each other for local consumption and global tenders.”

It is a good opportunity for China to invest in India and strengthen bi-lateral trade between the two coun-tries,” said SV Veerramani, presi-dent, IDMA.

He further said that China has emerged as India’s largest trading partner, replacing US. China ac-counts for nearly 73 percent of Indi-an imports of API and other organic compounds. “While we are buying, China shall consider buying formu-lations from India. We support their APIs and China shall consider sup-porting India by buying formula-tions.”

Throwing light on hassles that Indian exporters have to face while regis-tering in China, Veerramani, men-tioned that it takes several years for Indian products to get approval in China whereas India grants product registration in less than a year. “We need a better support to understand regulations in China to increase the trade. China should import drug for-mulations from India to offset trade deficit against API imports. China has over 6,000 domestic pharma companies out of which 70 percent are in API production and India has over 10,000 manufacturers compris-ing over 77 percent in formulation.”

Highlighting avenues through the partnership between India and China can be strengthened, he also shared his thought that China can consider doing contract manufacturing of for-mulations in India.

Also, both countries can set up regu-latory offices in each other’s countries for direct inspection of facilities and faster approval. “There is a need of frequent interaction between regula-tory of each country and we can build a harmonized environment.” He concluded that partnership between IDMA and CPAI should grow more for broader market penetration. BS

CoverStory

AmritA tejAsvi

Daara Patel Secretary-General of IDMA


CoverStory

AmritA tejAsvi

In an interview with BioSpec-trum Asia, at The Health In-dustry Summit (tHIS) orga-nized in Shanghai from April 17-20, Guangcheng Pan, exec-

utive chairman, China Pharmaceuti-cal Industry Association (CPIA) talks about the growth plans of Chinese pharmaceutical industry and the challenges it is facing in the current competitive environment.

In 13th five-year plan, China has highlighted innovation as the key to drive healthcare indus-try. What are plans of pharma-ceutical companies to drive in-novation that complements the nation’s strategy? China is currently leading in produc-tion and export of raw material and it is important for China pharmaceu-tical companies to develop new raw materialand drugs. One challenge of Chinese pharmaceutical companies is that the production of raw mate-rial is far ahead the development of drugs.

We need to balance the output and final product. Therefore, in the next five years, we are looking at increas-ing strength in formulation industry. Even the government affirms that China is already a leading manufac-turer of raw material and the next focus should be on developing raw material for new drugs.

What are the new products that China’s pharmaceutical com-panies intend to develop in next five-years?Our industry should focus on devel-oping drugs that are going to be in demand such as slow release formu-lations, advance drug delivery meth-ods, targeted therapy, and others.

China has a large population and we have a strong demand of drug.China needs to produce lot of drugs and import from other countries as well.Multinational companies have estab-lished themselves in China through joint ventures and that has led China to learn a lot about advance technol-ogies that they brought along.

If ideas are to be exchanged, what would China intend to adapt from countries like India and Singapore?China can learn from India on several aspects such as expanding in interna-tional market, registration and regu-latory process. Singapore has very strong base of international compa-nies and we would like to build simi-lar relations with global world. As part of Chinese delegate, I have vis-ited Singapore and was impressed by the infrastructure and management of international companies. Chinese government wants its companies to learn from Singapore. Singapore has Chinese as well as English speaking

population and this is a great advan-tage to collaborate.

What are the main challenges for Chinese pharmaceutical in-dustry?The biggest challenge that China is facing is lack of innovation. We want innovation to be the key driving fac-tor in China but that needs lot of in-vestment and the return cycle is long.Due to the risks involved, investors shy away from investing in pharma industry.

Another biggest challenge for pharma industry is that the quality standard of international pharma product is very high which the local Chinese companies are unable to match with.Even the quality and efficacy of ge-nerics drugs is not the same as of international standard. To compete in the global market, they must raise their standards.

We also have environmental chal-lenge. Since China is a heavy produc-er of raw material, it has also become one of the main contributors to en-vironmental hazards and pollution. Also, the pharmaceutical companies are facing pricing pressure. They don’t get enough support from gov-ernment and the cost of raw material is rising. However, the price of final products is decreasing. BS

‘We want to strengthen formulation industry’

Guangcheng Pan executive chairman, China Pharmaceutical Industry Association (CPIA)


BioColumn

Lives on the line:How a robust network infrastructure enhances healthcare standards

Ernest Lee

VP Sales, Singapore, Malaysia & Brunei, Alcatel-Lucent Enterprise

The Singapore General Hospital recently reported a Hepatitis Cout break, affecting 22 patients. While the possible cause of the out-break is yet to be determined, this recent scare provides a strong indication of what could go wrong in a hospital. Healthcare insti-

tutes are one of the most complex environments, with numerous players working together to co-create the patient experience. Each player, whether doctors, nurses, pharmacists or front line staff must function seamlessly as a singular, well-oiled machine to deliver efficient and quality service – a hallmark of world class healthcare standards.

Unsurprisingly, studies have shown that the failure to communicate is a significant factor of adverse clinical events and outcomes. The incredibly large amount of interactions taking place every day, each with different dimensions of complexity leaves a very small margin for error. Even the slightest miscommunication can result in devastating consequences.

Simplify flow of background information To minimize communication errors, healthcare institutes should consider investing in a customized business communications solution that is secure and always available. This system should be able to establish a secure au-dio, Web or High Definition video conference with anyone from any tele-phone or multiple video endpoint devices, any location, and any browser for spontaneous collaboration.

With a clear, reliable and secure means of communicating and collaborat-ing, medical and admin staff alike will spend less time battling a spotty network connection, or even be saved a physical trip down the corridor to pass information. All this time saved means that staff, be it doctors or nurses will have on average more time to look into the needs of the patient. Lives may even be saved, such as when a pharmacist catches a lapse in a prescription, and is able to contact the doctor in real-time.

Control communications in real-timeThe healthcare sector has evolved to embrace mobility. Medical personnel are now empowered to administer telemedicine, to ‘see’ patients through video calls, or seamlessly share and pull out patient information via a se-cured database.

However, security remains a major cause for concern in the area of health-care with the proliferation of mobile devices and Bring Your Own Device


BioColumn

(BYOD) policies.IDC predicts that by the end of 2015, 50 percent of healthcare organizations would have experi-enced 1 to 4 cyber-attacks in the year, with 1 in 3 ending up successful.

As such, it is important that healthcare institutes invest in solid network security to ensure that patient data is protected, even while keeping it available to those who rely on it. Healthcare providers can look for Local Area Network (LAN) solutions that give them centralized vis-ibility and control over the wireless network, preventing unauthorized access to staff-only networks.

A healthy network makes for healthier patientsHealthcare institutes often underestimate the impor-tance of a reliable and efficient network infrastructure – a critical backbone to healthcare operations. As healthcare institutes make the migration from paper to digital, more needs to be done to ensure that information systems re-main secure, and new clinical information tools are easy to use. A poorly implemented system would mean that healthcare professionals will spend more time trouble-shooting or worse still, fall back to the traditional way of manual reports.

The promise of connected healthcare is not far. Farrer Park Hospital in Singapore for example, has taken steps to embrace a connected network infrastructure that will serve as a platform for quality patient care into the long term. The hospital enables videos of operations to be broadcast in real-time within the hospital network. This helps with telemedicine and training.

The 220 bedded facilities, officially opened in March 2016, have the latest state-of-the-art equipment and technology. Together with a connected network infra-structure, the seamless flow of information enables those who need the information, receives it in real time. This efficiency leads to improved patient outcomes.

Death by medical errors is unfortunately plaguing hos-pitals even into the 21st Century, and are symptomatic of miscommunication. To counter this, healthcare institutes should consider the possibilities of connected healthcare to enhance the way their medical staff communicate on a day-to-day basis, and ultimately create a worldclass pa-tient experience. With the amount of time and resources saved from navigating clumsy backend systems, health-care professionals will be able to invest their time in the people that matter most – patients. BS

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BioTalk

early stages of cell expansion all the way through to the downstream chromatography steps. This includes technologies such as mixers, bioreactors, filtration and chromatography systems which are integrated through a single automation platform (such as WonderWare or DeltaV).

Using standardized equipment and an optimized layout also provides the bio manufacturer with a facility that can be replicated at multiple sites, for easy tech-transfer and scale-up.

KUBio’s key benefit is rapid construction, and corre-sponding reduction in risk. In comparison to the 2-3 years of design and construction which is typical for con-ventional stick-built bio manufacturing facilities, KUBio is ready-to-run in 14 to 18 months, translating to a faster time to market. This timeline includes every phase of the build including design, construction and full fit-out with bioprocessing equipment.

Every stage of the project is supported by GE technical expertise, including facility design, procuring and pro-duction of process equipment, installation, qualification, staff training, technical support and project manage-ment. Financial guidance is also part of the offering.

There is a huge unmet need for affordable biologics in China’

Jan MäkeläGM, BioProcess business, GE Healthcare’s Life Sciences business

Interview

On May 10, 2016, JHL Biotech (JHL), opened the world’s first KUBio biopharmaceutical manufacturing facility in Wuhan, China.

GE Healthcare’s KUBio is a fully functional off-the-shelf bioprocessing facility specifically designed to meet cGMP requirements while optimizing manufac-turing flexibility and productivity. The facility is pre-fab-ricated and delivered with a complete ready-to-use pro-duction line, based on GE Healthcare’s Ready-to-Process single-use technologies.

In an email interaction with BioSpectrum, Jan Mäkelä, General Manager for the BioProcess business at GE Healthcare’s Life Sciences business, talks about this in-novative facility.

Please throw some light on KUBio manufacturing solution. What is KUBio's core technology and what are its benefits?

A GE Healthcare's KUBio is a prefabricated modular facility based on single-use technologies for mono-

clonal antibody production.

The facility is installed with the Flex Factory platform, which comprises of bioprocessing equipment from the


BioTalk

What are some of the most pervasive operating challenges afflicting biopharma manufacturing today?

A There is an increasing demand for biopharmaceuti-cals worldwide. Seven of the top 10 selling medi-

cines by revenue are in a new class of drug called biolog-ics, sales of which, over the past six years, have grown at 10% per annum to $170 billion, primarily because of the expansion of new treatments for cancer and demand for insulin. Biopharmaceutical manufacturers are looking for ways to expand their capacity and enter markets that have previously been difficult to access due to location. KUBio was launched to address these needs. The speed and flexibility of single-use components is now well-rec-ognized across the industry – and GE Healthcare’s know-how in the sector and global footprint makes us ideally-placed to harness this potential and package it for rapid deployment wherever a customer requires.

Share with us list of your clients that have utilized KUBio's? How has been the reception/feedback by these companies?

A This is the world’s first KUBio, so JHL Biotech are the only owners of one these facilities at present.

GE is now building another KUBio (purchaser has not yet been publicly announced) and is discussing project op-portunities in countries such as Brazil, Mexico, South Ko-rea and Saudi Arabia, among other places.

What are the major markets for KUBio’s in Asia and what is the demand in these countries?

A Currently in China, there is a huge unmet need for affordable biologics. China accounts for 20 percent

of worldwide cancer incidence, the second-highest rate in the world. In 2015, around 4.3 million new cancer cases were reported in the country.

Biologics hold significant promise in their ability to treat cancer, and are especially strong for targeted therapy in specific areas. Today, biologics account only for 4 percent of the medicines prescribed in China (vs. 22 percent in the US).

In a drive to encourage biological medicine and medical device innovation in the region, a number of action plans have been issued by the region, pledging significant fund-ing on the development of new therapeutics and placing a focus on biosimilars.

For example China's State Council’s 10-year action plan ‘Made in China 2025’ recognizes biological medicines and medical devices as one of its key industrial focus ar-eas. The market is growing rapidly in China and, reaching

approximately $350 million in 2019, up from $44 million in 2009.

KUBio offers global biopharmaceutical manufacturers the ability to reproduce world class quality, standardized facilities, anywhere in the world. There is interest coming from both the developed and developing countries.

What are the current trends in biopharmaceutical manufacturing industry and how is GE Healthcare positioned to address the changes?

A The industry movement towards developing and producing more targeted (personalized) treatments

for specific patient groups, has led to a need for more flex-ible facilities to allow manufacturers to quickly switch from manufacturing one product to another one. Flex-Factory uses predominantly disposable, single-use tech-nologies, eliminating cleaning validation steps reducing the risk of cross-contamination, and providing significant time and cost savings.

How is Asia positioned as a hub for biologics manufacturing?

A Due to a large and aging population, coupled with the rising cancer rates and low penetration of bio-

logic medicines, there is a huge demand for biologics in China. A highly skilled workforce as well as the introduc-tion of a number of government funding initiatives to drive biopharmaceutical development provide significant opportunity in the region.

Are Asian markets going to influence biopharmaceutical development around the world?

A The Chinese government has invested heavily in specific initiatives to drive the development of new

therapeutics. MNDIP (Major New Drug Innovation Pro-gram) was the first initiative to change China from a man-ufacturing center for drugs to a center of innovation for new drugs. Started in 2009, this initiative has attracted $4.5 billion from 2009-2012.

JHL Biotech, owner of the first KUBio, announced earlier this year that it has received authorization from the Unit-ed Kingdom's Medicines and Healthcare Products Regu-latory Agency (MHRA) to begin clinical trial for JHL1101, arituximab biosimilar to treat rheumatoid arthritis. JHL is the first company from the Greater China region to re-ceive European approval for clinical trial of a monoclonal antibody biosimilar. Whether this is the beginning of a larger trend is too early to say. BS

AyeshA siddiqui


BioSpecial

Believe it or not India is the third fattest nation in the world with over 30 million or 3.8 percent of the adult population here grappling with obe-sity. Globally a third of the world’s population

are overweight or obese with the United States leading the charge.

Today it is a well recognized fact that obesity is not a mere cosmetic problem, but is the mother of all important dis-eases, including type 2 diabetes, high blood pressure, ischemic heart disease, sleep apnea, and even some can-cers. “There are over two dozen medical conditions that are associated with obesity,” says Dr Arun Prasad, Ro-botic Surgeon, Institute of Robotic Surgery at the Delhi-based Indraprastha Apollo Hospitals.

While the ideal situation is to lose weight through physi-cal fitness measures, often the morbidly obese are trapped in a vicious cycle – their legs cannot support their weight inhibiting them from prolonged exercise, which leads to increased weight gain.

Take Chandrika Jayna, (name changed) who had severe joint pain in her knees and unable to walk had been gain-ing increasing weight. This led to a host of complications.

For people like Jayna bariatric surgery is a life-enhancing procedure. There was a time when there was a lot of stig-ma associated with opting for bariatric surgery, but today as well known names go openly under the scalpel to trim their flab, the benefits are becoming acknowledged.

Meet the Robotic Surgeons who conducted nearly 4,000 procedures in 30 hospitals spread across the country during 2015 to help cut flab. Earlier doctors were using laparoscopic techniques to perform gastric bypass surgery. Today, robotic surgery is the more preferred method.

The

fightersFA


BioSpecial

Doctors admit that bariatric procedures should be the last option and only undergone after all other weight loss measures tried, but they also point out that for the su-per obese it is now an imperative. The good news is that with the advent of surgical robots, bariatric procedures are now becoming safer and cutting down healing time.

How it worksDepending on the case, there are different surgical proce-dures that bariatric surgeons use. But the most common one is gastric bypass surgery. Describing it in layman’s terms, Dr Prasad, who has done over 1,000 bariatric sur-geries in the last 12 years, says this surgery makes the stomach smaller and allows food to bypass part of the small intestine. The stomach is made smaller by creating a small pouch at the top using surgical staples or a plastic band. The smaller stomach is connected directly to the middle portion of the small intestine, bypassing the rest of the stomach and the upper portion of the small intes-tine. As a result, the patient will feel full more quickly, thereby cutting down on food intake and thus the calories consumed. Bypassing part of the intestine also results in fewer calories being absorbed. This leads to weight loss.

Earlier doctors were using laparoscopic techniques to perform gastric bypass surgery. Today, robotic surgery is the more preferred method. Robots operate in 360 de-gree mode and can reach deeper getting to difficult-to-ac-cess parts such as the stomach blood vessels easily. Also, with the flexible robotic equipment suturing is far more accurate than with old straight shaped equipment. There is less blood loss and faster recovery besides leaving prac-tically no scars.

“We call ourselves fat fighters,” says Dr Parveen Bhatia, chairman, Institute of Minimal Access Metabolic and Bariatric Surgery, Institute of Robotic Surgery (IRS), Sir Ganga Ram Hospital.

Bhatia rues at the growing obesity in India. “One quarter of what you eat keeps you alive, the other three quarters

of what you eat keeps doctors alive,” he says. He distin-guishes the super obese as those with BMI more than 50. And ‘super super obesity’ is defined as those with BMI of more than 60 kg/m2.

According to Dr Arun Prasad, “In cases where the patient is super obese, weighing over 200 kgs, the robot is useful in lifting the stomach. However much we may gym, a half hour long procedure involving lifting of stomach becomes tiring for the doctor.”

Compared to laparoscopic procedures where it takes 3-4 days of hospital stay and over a month long rest period, those undergoing robotic surgeries can go back home in 2 to 3 days and return to normal activities within three weeks or so.

Risks and outcomesNo surgery comes without risks, though these are mini-mized in the case of robotic procedures. Bariatric surgery does carry some risks as most of the patients undergoing these have co-morbid conditions like diabetes, hyperten-sion and sleep apnea adding to the complexity. Post op-eration, one possible risk is of nutritional deficiency. Iron and Vitamin B12 deficiency can occur leading to anaemia. However, these can be handled during periodic follow-up consultations.

But increasingly benefits are outweighing the risks. Rare-ly is weight regained. Most people continue to lose weight for a good 12 months after the procedure before settling down to an optimum weight. Ravi Narayan has lost 35 kgs in six months after surgery.

India today has just 190 trained robotic surgeons who conducted nearly 4,000 surgeries in 30 hospitals spread across during 2015. Bulk of these procedures related to urology, gynaecology, thoracic, and head and neck and general surgery areas. BS

(Names of patients have been changed to protect their privacy).

In cases where the patient is super obese, weighing over 200 kgs, the robot is useful in lifting the stomach. However much we may gym, a half hour long procedure involving lifting of stomach becomes tiring for the doctor

BioSpectrum Bureau


BioSpecial

PRECISION MEDICINE

During his State of the Union

address in January 2015 at

the White House, American

President Barack Obama

announced the launch of the

most ambitious healthcare

initiative called the Precision

Medicine Initiative (PMI), with

a mission to usher the US into

a new era of medicine where

patients will enjoy individualized

and tailor-made treatment for

various ailments.

Does India need

Initiative


BioSpecial

Obama said, “Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their

treatment as best they can to individuals. You can match a blood transfusion to a blood type — that was an important

discovery. What if matching a cancer cure to our genetic code was just as easy, just as standard? What if figuring

out the right dose of medicine was as simple as taking our temperature?”


BioSpecial

Precision medicine is an emerging approach of medicine which looks at the root cause of an illness, rather than addressing the

symptoms alone. Precision medicine may not be very well known as Per-sonalized Medicine. But they are one and the same. It takes into account individual variability in genes, envi-ronment, and lifestyle for each per-son. The need and its potential in the Indian healthcare scenario is high, considering that the system is under great pressure due to sheer numbers.

Precision Medicine in the country is considered to be at an early adoption stage. A diverse country like India, with over 4,000 population groups, and a significant percentage of con-sanguineous marriages presents a high-risk and prevalence of inherited genetic disorders that require atten-tion for early diagnosis, right treat-ment, and management. India has a heavy burden of inherited diseases driven by the unique genetic charac-teristics in the population. With 1.4 billion people, the absolute number of patients suffering from diseases in which genetics play a role is signifi-cantly large.

It is reported that Indians witness a loss of around $23 billion from their annual income in treating or getting tested for non-communicable diseases.

The global genomics industry is pre-dicted to grow at around 18 percent in the next 10 years, and India is expect-ed to be a major stakeholder. Reve-nue growth in molecular diagnostics in 2013 was reported to be around 15 percent. Clinical diagnostics in one of the fastest growing fields which may cross $2 billion by 2018. Preventive healthcare is growing at the rate of 25 percent, which will boost healthcare revenue and the country’s Precision Medicine scenario.

“Genetic testing is slowly getting ac-ceptance among our clinicians. The challenges are about creating the awareness for wide-spread adoption. It is not at all too early for the coun-try to embrace precision medicine. This is primarily because India is an emerging market for genomics. A ris-ing middle-class, state-of-art health-care facilities and expert physicians are driving the growth of the indus-try in India…. I expect the industry to attain double digit growth,” says Sam Santhosh, Chairman & Global CEO, MedGenome.

Dr Saleem Mohammed, CEO & Founder, Xcode Life Sciences, agrees that India has a strong need for Pre-cision Medicine which will signifi-cantly reduce its healthcare burden.

“It is estimated that only around 40 percent of the medicines we take are effective and appropriate for us. To-day, we practice trial-and-error med-icine which does not consider in de-tail the person-to-person variability, which is a key source of variation for the effectiveness of drugs. You can imagine being dosed and prescribed by taking into account various factors such as age, gender, genetics, medical conditions and usage of other drugs. That is the promise of personalized medicine, and India needs to take leadership in this domain,” he adds.

In India, Precision Medicine is be-ing practiced in several specialties

like oncology, cardiology, psychiatry and diabetology. It is already being embraced in India to a reasonable extent, especially in cancer.

“Each individual is an island, and so now that the molecular complexity of disease has been deciphered, the role of genetics, environment and epigenetics are clearly telling us that that we all need to receive treatment designed for our physiology and body type,” remarks Dr Villoo Morawala-Patell, Founder & CMD, Avesthagen.

Indian healthcare institutions are fast adopting technologies that can make them on par with the best in the world. The need to modernize, and be on par with global standards can be seen amongst large hospitals and private medical institutions.

Explains Dr Kalyanasundaram Sub-ramanian, CSO, Strand Life Sciences, “There are several targeted therapies that work only on patients who have a specific genotype or genomic varia-tion. So, patients are tested before the therapy is prescribed. Cancer is probably the disease in which pre-cision medicine is most advanced. However, there are several other dis-eases - cardiac, ophthalmic, and cer-tain types of diabetes, where knowing the genetic background of the disease can help with disease management. Here the field is not as advanced.”

Like most technologies, India is ex-

Precision Medicine in the country is considered to be at an early adoption stage. A diverse country like India, with over 4,000 population groups, and a significant per-centage of consanguineous marriages presents a high-risk and prevalence of inherited genetic disorders that require attention for early diagnosis, right treatment, and management. India has a heavy burden of inherited diseases driven by the unique genetic characteristics in the population.


BioSpecial

pected to be a follower-market in Precision Medicine. Doctors would like approval from USFDA or the American Medical Association (AMA) for it to become mainstream in their practice.

But the challenge is that the West is going to fund studies in Caucasian population and not the Indian. In fact, most drugs are designed and manufactured for Caucasian popu-lation. Unless India accelerates re-search in this space, validation in the Indian context will always be questionable.

“Precision Medicine is badly needed to move towards personalized medi-cine and personalized diagnostics, which has a huge potential to reduce the burden of national healthcare costs,” points Dr Amit Kumar, CEO & CSO, BioAxis DNA Research Cen-tre. “At several instances, this results in patients selling assets or borrow-ing money to pay incurring medi-cal expenses. Precision medicine is the best available tool and remedy for combating this huge economic burden.”

Cost of these tests are a concern still, given India is largely a self-paid economy. But as technologies improve, the cost of sequencing is seen to reduce. Precision Medicine offers a possible answer by reducing the costs of hospice stay, and reduc-ing the overall financial, physical and psychological costs of the try-and-test approach of medicine.

“The infrastructure needed for pre-cision medicine is taking shape in India. There are certain issues to be addressed for it to gain the needed momentum,” opines Samarth, CEO & Founder, Positive Bioscience.

“The key is also the analysis of ge-nomics data, which as we automate will provide higher efficiency in the

entire data analysis process, thereby making tests more affordable. We do need more baseline genomics data of Indian origin which will help us in re-fining our analysis on clinical cases in the country,” comments Sam.

Targeted therapies like Imatinib have been around for 40 years. This has changed the prognosis of Chronic Myeloid Leukemia (CML) in children.

“People used to think that the role of genetics ended with hereditary disease. Today we know that every response our body makes has a ge-netic fingerprint to it. We can now predict response to different thera-pies, and thus avoid trial-and-error medicine which is both costly, time consuming, and puts an unnecessary drug and hospitalization burden on the patient,” comments Dr Sooraj Ratnakumar, Founder & Scientist, Swagene.

The US and EU markets do have a head start in Personalized Medicine in terms of accessibility to resources and raw material, government fund-ing, and regulations.

“There is also greater awareness among the people there about the benefits of personalized medicine. In India, we have an excellent gene pool of biotech and IT professionals. With government interest, we can easily build India as the hub of personal-ized medicine,” expresses Ms Anu Acharya, CEO, Mapmygenome.

President, CEO & Founder of Geno-typic Technology Raja Mugasiman-galam says that Precision Medicine is too early for India at the moment. “Precision Medicine is an emerging field and sufficient success should be shown by the western world for India to embrace it. It is in its early phase, and there is not sufficient govern-ment support in the form of research grants in this space,” he adds.

Overly hyped?The way Precision Medicine can help transform healthcare, especially treatment and management of dead-ly non-communicable diseases is tre-mendous, and stalwarts opine that it is not an overly hyped concept.

“The field of Precision Medicine is

“Each individual is an island, and so now that the mo-lecular complexity of disease has been deciphered, the role of genetics, environment and epigenetics are clearly telling us that that we all need to receive treatment de-signed for our physiology and body type,”

Dr Villoo Morawala-Patell, Founder & CMD, Avesthagen


BioSpecial

still in a nascent stage in India, and much needs to be done to create awareness. So the concept cannot be called as overly hyped, but rather passionately acclaimed in the medi-cal and scientific fraternity. Any de-velopment in the science and medical space that revolutionizes how medi-cine will be practiced in the future naturally generates a buzz around it. Yes, the concept is quite novel at this point of time but its scope is tremen-dous. While we may lack the band-width to carry out all the exceptional research at this point in time, slowly it will happen. And once it happens, the impact will be more than just overwhelming. However, there are certain roadblocks that we cannot ignore. But limitations and challenge begets innovation and development,” opines Samarth.

“I see Precision Medicine as a new hope rather than a hype,” Dr Amit states. “Some of our clients say that research insights of the genomics da-ta-related to lifestyle, diet, and clini-cal methods have been very useful in making a decision faster based on a patient’s personalized genetic infor-mation.”

More than hype, Precision Medicine is said to be more of plain, pure com-mon sense. For thousands of years, humans have known that there is inter-individual variability when it comes to things ingested, be it medi-cine or food. Why then patients pop an over-the-counter pill? Or even wonder whether it will work on them or not?

In a recent study by Johns Hopkins University (USA), medical error was suspected to be the third leading cause of death in the US. Many of them are related to improper drugs and improper drug dosages.

“It’s sort of like ‘death by medicine’. Can you imagine what the statistics

are in India? asks Dr Saleem. “Today, we don’t question why the outcome was negative for a patient. We as-sume that the medical establishment did the best they can in good faith. With increasing prevalence of clini-cal decision support systems, and in-surance insisting on good practices, you will see things improve. Com-mon sense dictates that precision medicine is the only way medicine should be practiced and not by trial-and-error.”

Dr Binay Panda, Chief Officer & Head, Ganit Labs, also states that the problem in India is that Precision Medicine is hyped by people who un-derstand little about it.

“Look around and you will find folks who talk about Precision Medicine, who understand little about it or have very little practical and scien-tific experience on developing preci-sion medicine tests. We need rigor-ous scientific minds to talk about the utility of Precision Medicine, like in the West, and not those who use the term as a buzz word or a part of mar-keting supplements only,” clarifies Dr Binay.

India’s research sceneThe research scene for Precision Medicine in India is largely in the be-ginning stage. Some studies are being carried out in various translational research centres across the country.

There are several Government labo-ratories such as IGIB (Institute of Genomics & Integrative Biology),

CCMB (Centre for Cellular and Mo-lecular Biology), hospitals such as CMC Vellore, LV Prasad Eye Insti-tute and other organizations, where research is being conducted. “How-ever, it would be fair to say that the research is fragmented and indi-vidual researcher-driven, and not yet translated to patient care in a big way,” points Dr Kalyanasundaram.

Research is also being carried out at Sir Gangaram Hospital (Delhi), Ma-dras Diabetes Research Foundation (MDRF) (Chennai), Indian Council of Medical Research (ICMR), Insti-tute of Bioinformatics (IOB) (Banga-lore), and Government institutions such as National Institute of Biomed-ical Genomics (NIBMG) and Center for Genome Research.

Large government hospitals like Tata Memorial Hospital, National Insti-tute of Mental Health and Neurosci-ences (NIMHANS), and All India In-stitute of Medical Sciences (AIIMS) are also involved in the identification of new disease genes and biomarkers by applying Genomics.

Dr Mallik Sundaram, Co-founder, President & CEO, Mitra Biotech, says, “The western markets have em-braced it quickly because healthcare is more organized there with the pay-ers being the government or insur-ance companies, thereby translating the benefits of decreased healthcare costs while improving treatment suc-cess rates using Precision Medicine. In countries like India with frag-mented healthcare, and the patient

It is estimated that only around 40 percent of the medi-cines we take are effective and appropriate for us. To-day, we practice trial-and-error medicine which does not consider in detail the person-to-person variability, which is a key source of variation for the effectiveness of drugs.

Dr Saleem Mohammed, CEO & Founder, Xcode Life Sciences


BioSpecial

frequently being the payer, while the benefits remain the same, but ac-knowledging and translating them is more piecemeal.”

India, like many other developing countries, is following success stories of the West.

“Success in Precision Medicine de-pends on several factors includ-ing availability of tests on Precision Medicine, system on which medical payment is made — out-of-pocket versus insurance-based versus gov-ernment-sponsored — overall posi-tive atmosphere in the country to-wards embracing new tests, previous success stories, availability of skilled manpower and the presence of the right environment. On all these ac-counts, we in India, have miles to go. However, we have excellence in pockets, which include brilliant peo-ple who are capable of doing all that. The trick is to encourage those few to develop tests for the Indian popula-tion,” Dr Binay explains.

Paradoxical elementsThe use of Precision Medicine is a lit-tle tricky and paradoxical, say experts.

“It has lot of social impact. But some-one has to draw a line to the extent one should use it. One single muta-tion is responsible for more than one medical condition and vice versa; it may also create confusion and mis-leading interpretations. Precision Medicine may be only a corrobora-tive aspect until we have more con-fidence, and accurate outcomes get-ting reported across the globe,” Dr Amit reveals.

Dr Kalyanasundaram says that the challenge is in marrying personaliza-tion of medicine with reduced drug costs to an individual patient.

“Currently, most of the best genome-based medicines are expensive and

out-of-reach for the average Indian. The other worrying aspect is that none of these medicines are avail-able in India. Imagine the plight of a patient who realizes that there are medicines that may work for him but is unable to access it,” he observes.

Also, the discussion of paradoxes of Precision Medicine often revolves around the cost, i.e., spending more and more to identify therapies that applies to fewer and fewer.

Samarth adds, “This paradox can be compared to the cost of any IT initiative in the eighties era using mainframe computers, and specially created buildings for housing them versus, even higher computational processing being available today in a mobile system; or 3D printing to give a more recent example. As there is a change in approach and increase in use of the technologies, there will be a reduction in costs.”

What Is needed?In Precision Medicine, for success-ful commercialization, many things have to come together.

“There has to be a way of leveraging all the information and insights that is generated in other populations from around the world. The Indian government should be setting up large genomic studies in various dis-ease populations. Indian scientific establishments need to view this as a challenge, and work with physicians to understand the diseases that are most likely to have benefits quick-

ly, and work towards problems in those areas. Indian funding agencies should be funding large translation-al projects with a clear clinical aim. There should be clear frameworks that allow industry to access these in-sights to convert them to products,” urges Dr Kalyanasundaram.

Both Sam and Samarth agree that in-creasing the awareness levels of Pre-cision Medicine among the general population, clinicians and doctors is much needed.

“In our country, the depth and width of the healthcare system is very large, often unorganized, and under tre-mendous pressure. To bring in a new approach to the practice of medicine will need full participation and edu-cation of patients, drug developing pharma companies in pharmacoge-nomics, change in the practices and process of hospitals and clinics, good regulatory framework and the sup-port of the government in building the research infrastructure. Further in order to translate the bench re-search to bedside care, it is important for research academics and medical market players join hands,” suggests Samarth.

Collaboration of genetic testing labo-ratories, hospitals, and medical doc-tors may be the starting point, says Dr Amit. “We require huge genetic, clinical and lifestyle data from India, and this can only be reached if gov-ernmental programs backup such kind of association and research. With the fast decreasing cost of DNA

Precision Medicine is badly needed to move towards per-sonalized medicine and personalized diagnostics, which has a huge potential to reduce the burden of national healthcare costs,

Dr Amit Kumar CEO & CSO, BioAxis DNA Research Centre

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BioSpecial

sequencing of a person’s genome, a model shall be framed which should have genetic medicine and precision therapy as one of the most important inclusion. Government may think of including genetic tests under the insurance coverage, starting with critical illnesses. If we have enough country data, it may offer a lot of very important medical insights.”

According to Dr Binay, India needs 4 Ps to make Precision Medicine suc-ceed. “They are people, processes, protocols and pricing. People mean-ing encouraging and aiding brilliant minds to be involved in developing new and innovative tests; processes meaning developing the right clini-cal and scientific processes or SOPs; protocols meaning coming up with the right regulatory…,” he lists.

Dr Saleem believes that the medical community should actively collabo-rate with genetic service providers to validate concepts in the Indian population.

“We operate in a highly cost-sensi-tive environment. A key barrier to adoption is cost of the test…. In the long-term, genetics should become a major part of the medical curricu-lum. Genetics should get its due im-portance given that we live in an era where we are talking about actively editing genes to cure major diseases,” he notes.

Sam recommends public-private partnerships (PPP) between aca-demic institutes and the industry to promote genomic research in the country.

“Partnerships with private enterpris-es that have already taken the leap into genomics research and are pro-viding solutions to address health-care needs in India…. In addition to this, initiatives like setting up of elec-tronic medical records, and popula-

tion level genome sequencing will go a long way in helping commercial success. It will also be useful to chart out a comprehensive plan to identify key disease areas in India with un-derlying genetic reasons that have high unmet medical need and to al-locate government funds to promote education, research and innovation in these areas,” he stresses.

Should India ape the US?India may follow something similar to PMI launched by Obama, but on a pilot scale.

“The government can play a key role by allocating research funding to this area. Precision Medicine is go-ing to have a tremendous impact on our nation’s healthcare and will im-prove health outcomes while mini-mizing the costs. But someone has to make the investment in accelerating the creation of know-how, and the knowledge base that is specific to In-dia. Given the significance of health for a nation’s economic and social de-velopment, I would say that prioritiz-ing of government grant funding to this area will be highly useful. The US again has taken leadership in this so far with the Precision Medicine un-der the Obamacare,” voices Samarth.

In an interview with BioSpectrum, Dr Mandar Kulkarni, CTO, Cancer Genetics India, states, “I think this is a big challenge even in the US, where most diagnostic testing is paid through insurance reimburse-ments, which are driven by FDA-approvals.”

He further expresses, “Currently, the FDA is reviewing the guidelines and ensuring that the testing is not wasteful. On the other hand, a major advantage for such testing in the US is the availability of well-curated da-tabases that define the effect of mu-tations on the disease-state in terms of prognosis, clinical outcome and treatment options. Unless we adopt the tests and begin this exercise, we will not be able to identify epidemio-logical and etiological differences that contribute to cancer in India.”

Though India’s limited studies in this area show that while the Indian genome has many similarities to the Caucasian, there are significant dif-ferences as well. “So it is absolutely essential that a similar and large PMI be launched in India given the genomic diversity here,” justifies Dr Kalyanasundaram.

Sam also agrees that a initiative like PMI will be useful to India’s Health-care. ‘‘If a similar program is initi-ated, it has to be designed keeping in mind the state of the economy, and the public health issues of the Indian population, and the diseases or disor-ders plaguing our society. The Geno-meAsia 100K consortium is one such initiative in the region,” he urges.

Starting anything new is good, but India needs to revive and encourage what it already has, and have a long-term vision for Personalized Medi-cine.

“Science does not bear fruit over-

The western markets have embraced it quickly because healthcare is more organized there with the payers being the government or insurance companies, thereby translat-ing the benefits of decreased healthcare costs while im-proving treatment success rates using Precision Medicine.

Dr Mallik Sundaram President & CEO, Mitra Biotech


BioSpecialBioSpecial

night,” Dr Binay adds. “One needs to be patient and encourage fund-ing the right talent in this direction. First and foremost, we need to en-courage young minds to pursue sci-ence and be more meritocratic in our institutions.”

Dr Amit emphasizes that both ICMR (Indian Council of Medical Research) and CSIR (Council of Scientific and Industrial Research) need to play a very important role in framing the in-sights related to pharmacogenomics, genetic variation-related drug stud-ies, and population-wise human SNP validation, if India wants a mean-ingful outcomes from such a diverse population.

Dr Raja says that India doesn’t have to ape the West.

One might consider a PMI in India as an overly zealous move for a country where malnutrition and poverty collec-tively kills more people than diseases.

“At the right time we can definitely think of taking a step towards PMI for our own country just like America. India is already the diabetes capital of the world and is slowly inching in vying the top spot for heart ailments and cancer too. I think we all have come to appreciate the fact that all these diseases are genetic-driven by a combination of several mutations in different genes. Precision Medicine guided by genomics not only allows us to diagnose and prevent these dis-eases but also treat and manage them effectively,” elaborates Samarth.

Regulatory woesGenomic information is critical since it not only affects an individual but potentially their family as well. There are legal, technical, social, and po-litical hurdles which needs to be ad-dressed.

Dr Kalyanasundaram stresses, “It

needs to be clear who owns this in-formation, what are the limitations under which researchers get access to it, and how can this information be used and misused. These issues are all critical and need to be addressed by the law.”

However, the current regulatory frameworks are inadequate in terms of providing guidelines for Precision Medicine initiatives.

Information is required on how to bring in a population level-approach for genomics research. Also, policy revisions to support the industry from import duties on reagents are a need of the hour.

“Intellectual property rights and pat-ent policies are not very well defined in the area of Precision Medicine and predictive genomics. This could be a challenge to further innovation. Also, reimbursement from insurance com-panies is another key factor that will

determine the growth of this indus-try. In the western world, insurers have started accepting genomic tests in their formulary as it is expected to reduce the cost of down-the-line treatment. In India the option is to bring the test at affordable prices and foster innovation to reduce the cost of genomic diagnosis,” Sam ex-presses.

Precision Medicine is dependent on the DNA study of an individual, and India does not have a DNA usage policy yet.

“We are hoping for the best since this important master molecule has caught the attention of our PM Na-rendra Modi, and he has announced to put all the efforts towards the DNA Bill of India. Again, draft of this Bill also needs to be concreted by includ-ing insights from industry experts, academicians, research organiza-tions, laboratories and judiciaries,” justifies Dr Amit.

Currently, most of the best genome-based medicines are expensive and out-of-reach for the average Indian. The other worrying aspect is that none of these medicines are available in India. Imagine the plight of a patient who realizes that there are medicines that may work for him but is unable to access it,

Dr Kalyanasundaram Subramanian CSO, Strand Life Sciences


BioSpecial

Dr Binay strongly supports in having strong ethical guidelines to practice Precision Medicine.

Degree of impact Just imagine a patient taking a sim-ple blood or saliva test at a labora-tory, and in the next meeting his or her physician is very well prepared with the patient’s genetic horoscope including the information on chemi-cal compounds, or combination of drugs useful or harmful to him, based on the tried-and-tested genetic test report.

“We will be able to minimize side ef-fects with very beautiful and faster accurate therapies that too at af-fordable costs if Precision Medicine boosts up in India….. If used respon-sibly, it can do wonders and contrib-ute towards every individual’s good health,” notes Dr Amit.

Precision Medicine can also trans-form the national economy, espe-cially in a population whose average lifespan is increasing.

Sam explains, “From an individual’s perspective, it has the potential to make genetic diagnosis of diseases more efficient and cost-effective, by reducing genetic testing to a single analysis, which informs individuals throughout their life. Since it uses state-of-the-art genomic technolo-gies, rich medical record data, tissue and blood banks, and clinical knowl-edge that will allow clinicians and payers to tailor treatments to individ-uals, it can greatly reduce costs of in-effective therapies incurred through the current trial-and-error clinical paradigm.”

The impact can be great, where pa-tients get the right medications, have better outcomes and lower side ef-fects, feels Dr Kalyanasundaram. “This would lead to healthier popula-

tions with better overall health eco-nomics. To make this possible, lots of information needs to be collected, analyzed and translated. Medicines that can exploit the genetic differ-ences need to be present. So the task is formidable but the payoffs are po-tentially enormous.”

Precision Medicine will also allow reduced morbidity, specifically in on-cology cases, help in preventing high burden of genetic diseases, and man-aging high-risk cases with increased surveillance.

It will also have a major impact on the economy by reducing productiv-ity losses, and decreasing costs of treating disease, thereby reducing overall costs on Indian healthcare.

“The internet will further accelerate adoption of precision medicine by empowering patients and doctors who are already demanding more to fight India’s unique challenges with diabetes, heart disease and tobacco use,” said Dr Sooraj.

In 2012, Futures Group predicted a new perspective to healthcare by 2050, where gaps between medical practice, healthcare, and personal health will be bridged.

Another prediction is the predomi-nance of preventive healthcare, where individuals take charge of their health by harnessing the power of technology. Genomic tests – single nucleotide polymorphism and whole

genome sequencing – will be the key catalysts to this change.

“We have seen the beginning of this change. Wellness was once a fancy word. Today, it is part of every hos-pital’s business strategy to engage a new generation of customers, who are actively pursuing wellness us-ing social apps for various reasons – right from fitness and diet to finding the best doctor,” opines Ms Anu.

In India, diseases have a profound physical, psychological and social impact. Most of healthcare costs are paid not out of insurance, but out of pockets.

The impact of illness in one person in the family has a domino effect on the family and the community. “The cost of treatment, for diseases like cancer, cardiac diseases, diabetes, asthma, and the impact of the side effects of medication taken has often seen fam-ilies, even amongst middle class and higher middle class, needing to take loans, or family members having to leave jobs,” Samarth states. “Just the simple factor of reducing treatment time and side effects will have a sig-nificant impact on the socio-econom-ic situation of an individual.”

So, diseases that were previously a death sentence will be manageable, or even curable, because we will be able to individualize therapy for each patient. BS

People used to think that the role of genetics ended with hereditary disease. Today we know that every response our body makes has a genetic fingerprint to it, and thus avoid trial-and-error medicine which is both costly, time consuming, and puts an unnecessary drug and hospitaliza-tion burden on the patient,

Dr Sooraj Ratnakumar Founder & Scientist, Swagene

Raj GunashekaR & ayesha siddiqui


BioNews

Chugai set to present Alecensa’s Japanese phase III results at ASCO

Histogenics to develop Purpose’s NeoCart

Japanese pharmaceutical company has announced that the results of the Japanese phase III study (J-ALEX) of Alecensa, in ALK fusion gene positive non-small cell lung cancer (NSCLC) patients, will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO)in Chicago, IL (USA). Results from the J-ALEX study will be presented at the oral abstract sessions.

The J-ALEX study was an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene posi-tive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemo-therapy regimen.

Glenmark Pharmaceuticals USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for its Rufinamide Tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel Tablets, 200 mg and 400 mg of Eisai.

With respect to 180-day generic drug exclusivity, Glenmark is said to be one of the first ANDA applicants to submit a substantially complete ANDA for Rufinamide Tablets USP, 200 mg and 400 mg, with a para-graph IV certification. Therefore, with this approval, Glenmark is eli-gible for 180 days of shared generic drug exclusivity for Rufinamide Tab-lets USP, 200 mg and 400 mg.

According to IMS Health sales data for the 12 month period end-ing March 2016, the Banzel market achieved annual sales of approxi-mately $155.1 million.

The subjects were allocated to either the Alecensa arm or the crizotinib arm of the study in a one to one ratio. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by a blinded independent review board. The secondary endpoints included overall survival, objective response rate and safety, and other endpoints.

In February, 2016, Chugai carried out a prospectively defined interim analysis, and had an independent data monitoring committee examine the results. Since the results showed that Alecensa significantly prolonged the PFS to a higher extent than anticipated, the committee decided to recommend an early discontinuation of the J-ALEX study.

Glenmark bags FDA approval for new generic

Histogenics Corporation, a NASDAQ-listed regenerative medicine com-pany focused on developing and commercializing products in the mus-culoskeletal space, announced that it has acquired the development and commercialization rights to NeoCart for the Japanese market from its long-time development partner Purpose.

Histogenics says that this agreement is the next step in the company’s strong and evolving relationship with Purpose and provides Histogenics the opportunity to capitalize on the recent advancements in regenerative medicine regulatory pathways in Japan.

Under the terms of the agreement, Histogenics assumes sole responsibil-ity for and rights to the development and commercialization of NeoCartin Japan. The Japanese market for cartilage repair is estimated to represent more than 2,00,000 procedures annually and is growing due to favorable demographic trends, as well as reforms to the national healthcare system related to regenerative therapies.

The Japanese Regenerative Medicine Law was passed in 2014 to poten-tially expedite the clinical development and commercialization pathways for innovative regenerative cell-based medicines that have demonstrated safety and probable efficacy. Two new products have received full and con-ditional approval since the law went into effect.

In exchange for the transfer of development and commercialization rights, Histogenics will pay a success-based milestone to Purpose upon condition-al approval of NeoCart in Japan, as well as commercial milestones and a low single digit royalty on Japanese sales of NeoCart, upon full approval, if any, in Japan.


BioNews

Korean industries may churn out 10 new drugs by 2020As per a recent survey report released by Dong-A Ilbo, Korean pharma and biotech companies are expected to develop more than 10 new drugs by 2020.Bringing in millions of dollars, experts opine that, the bio and phar-ma sectors will most likely help revive in the future the nation’s export, which is slumping due to sluggish per-formance of the shipbuilding and steelmaking industries.

Out of the 56 new drug candidates,21 candidates are in phase 1, 24 in phase 2, and eight in phase 3.For three new drugs, preparation for commercial sale started already. According to the pharma industry, the probability for new drug candidates to become new drugs is about 10 percent for those in phase 1 clinical trial, 20 percent for those in phase 2, and 50 percent for those in phase 3.

The report elaborated that clinical trials are underway for 56 new drug candidates. The document also suggest-ed that companies have begun clinical trials in humans, which are conducted after toxicity test and animal test for new drug candidates, suggests that the chance of success for their commercial development is fairly high.

Dong-A Ilbo, further explained in its report that it takes six years on average from the start of clinical trials to completion of new drug development. As such, by 2022 when the entire process of clinical trials for all the new drug candidates will be completed, Korea is expected to see 14 new drugs. When considering progress of phase 2 and 3 clinical trials accordingly, experts in the pharma industry predicted a total of 10 new drugs will make de-but by 2020.

India slashes prices of 54 essential drugsWith a view to make medicines for critical diseases more affordable, India’s National Pharmaceutical Pricing Au-thority (NPPA) has slashed prices of 54 essential medi-cines by up to 55 percent. This list includes drugs that treat ailments like brain and breast cancer hypertension, diabetes, and other heart disorders.

In an interview with a leading daily, NPPA chairman Bhupinder Singh, said, “The move is aims to bring down health expenditure and prices of commonly used drugs for critical diseases by expanding the span of price regula-tion to cover new drugs.” Manufacturers, distributors and retailers have been asked to implement the ceiling prices

FDA approves additional indication of Eisai’s anticancer agent LenvimaJapan’s Eisai has announced that its US subsidiary Eisaihas received ap-proval from the US Food and Drug Administration (FDA) for an addi-tional indication for Eisai’s in-house developed novel anticancer agent Lenvima (lenvatinib mesylate) in combination with everolimus for the treat-ment of patients with advanced renal cell carcinoma fol-lowing one prior anti-angiogenic therapy.

This is the only combination regimen to significantly prolong progression-free survival (PFS) when compared with a standard of care in patients with advanced renal cell carcinoma following prior anti-angiogenic therapy. Lenvima was designated as a Breakthrough Therapy by the FDA and also received a Priority Review, with approv-al obtained approximately six months after application submission. The approval was based on a Phase II clinical study (Study 205)1 that compared the safety and efficacy of Lenvima alone, and in combination with everolimus,in patients with unresectable advanced or metastatic renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy. From the results of the study, the group who received the combination of Lenvi-ma plus everolimus demonstrated a significant extension in PFS,the study’s primary endpoint, as well as a higher objective response rate compared to the everolimus alone group.The most common treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everoli-mus group were diarrhea, decreased appetite and fatigue.

immediately. The new drugs that have been brought under price control include Trastuzumab injection used in the treat-ment of breast cancer, Temozolomide for brain cancer and various medicines for heart disorders as well as hyperten-sion, including Amlodopine, Ramipril and Clopidogrel.

This the second time in the last 15 days that the national regulatory body has reduced prices of drugs on the list. There are 875 drugs on the regulator’s National List of Essential Medicines, 2015, after it was revised in Decem-ber last year. So far, the price of 280 drugs on the list have been capped.


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BioNews

US arm of Takara to acquire WaferGen Bio-systemsWaferGen Bio-systems,a publicly held genomics technology company,and Takara Bio USA Holdings(TBUSH), have en-tered into a merger agreement pursuant to which TBUSH will acquire WaferGen. TBUSH is a wholly owned subsidiary of Takara Bio. Takara BioUSA(TBUSA, formerly known as Clon-tech Laboratories) is a wholly-owned subsidiary of TBUSH and is a guarantor under the merger agreement.

Under the terms of the merger agreement, TBUSH will ac-quire WaferGen for an aggregate cash purchase price that will be based on a multiple of WaferGen’s 2016 calendar revenue and capped at $50.0 million, subject to the potential adjust-ments described below.

The multiple will range between 1.0 times up to 3.5 times Wa-ferGen’s full year 2016 revenue. If revenues exceed$9.0 mil-lion the multiple will be 3.5.The aggregate purchase price as so determined will be used to pay for all outstanding securities of WaferGen, including options and warrants and other secu-rities as well as outstanding shares. The merger is expected to close after completion of WaferGen’s audited financial state-ments in February or March of 2017, subject to the conditions set forth in the merger agreement.

Australia’s InvitroCue

initiates research on malaria

InvitroCue, the Australian company that works on advanced bio-analyt-ics, has announced a key initiative on malaria to identify and evaluate new drug targets to tropical infectious diseases. Following its successful ini-tiative on leishmaniasis, InvitroCue intends to establish an open and col-laborative strategy that involves in-tegrated partnerships and networks between academic infectious dis-

eases institutes and pharmaceutical companies.

InvitroCue has signed a research col-laboration with Novartis Institute for Tropical Diseases to investigate the lifecycle of Plasmodium cynomolgi (monkey malaria) using in vitro he-patocyte culture systems.

In the recent years, drug resistance against the blood stage of malaria has been increasing. Many institu-tions have been targeting the asymp-tomatic liver stage of the malaria parasite. An in-vitro liver model is crucial to these research efforts.Dr Steven Fang, Executive Director of InvitroCue, said, “The launch of our malaria’s initiative is important for our clients and the global market. We will work in tandem with academia and companies to develop novel in-vitro tools for drug discovery.”

To-date, InvitroCue has built up a complete suite of in-vitro models and assays while guiding the phar-maceutical companies and research institutions through their drug dis-covery and development programs. The company also provides contract drug discovery services, including lead optimization in preclinical drug discovery, compound profiling, high-throughput screening, DMPK toxi-cology studies, is firmly grounded in the art of in-vitro assaying and bio-analytics to predict the safety and efficacy of experimental drug targets and compounds.

InvitroCue’s technology, was spun out of Singapore’s Agency for Sci-ence, Technology and Research (A*STAR) has been developed and validated in collaborations with lead-ing pharmaceutical companies and scientific collaborators.

Fosun bids to buy Gland Pharma: ReportsShanghai-based Fosun Pharmaceutical have sub-mitted a non-binding proposal to acquire a 96 percent stake in India’s Gland Pharma, says re-ports. Fosun Industrial, a unit of the Chinese drug maker, made a non-binding proposal to existing shareholders of Gland Pharma, the company said in a statement to the Hong Kong stock exchange. Private equity firm KKR and Coowns a significant minority stake in Gland Pharma.

In the event that the non-binding proposal made by Fosun Industrial is successful, it will enhance and improve the Group’s drug manufacture and research and development capacity and the de-gree of internationalization,” the statement further said. Established in 1978 and based in Hyderabad, Gland Pharma develops and manu-factures generic injectables, primarily for the US market.It also sells its products in India and oth-er semi-regulated markets. Its manufacturing facilities are approved by the US and UK drug regulators.


BioNews

Indonesia’s pharma market to touch $12.6 bn by 2020The pharmaceutical market in Indo-nesia more than doubled from just under $3 billion in 2008 to reach approximately $7 billion in 2015 and is anticipated to increase further to $12.6 billion by 2020, driven primar-ily by the Indonesian government’s economic and healthcare initiatives, according to research and consulting firm GlobalData.

The company’s latest report states that Indonesia’s pharmaceutical sector will be boosted by the estab-lishment of a universal healthcare scheme, known as the Jaminan Kese-hatan Nasional. This was launched in January 2014 with the aim of provid-ing health insurance to 250 million Indonesian citizens by 2019, which

would make it the world’s largest so-cial health insurance.

Adam Dion, GlobalData’s Senior In-dustry Analyst, says new economic policy packages, the high prevalence of infectious diseases, widespread generic drug supply, increasing af-fordability of healthcare products and the large over-the-counter medi-cines market will also help to drive growth in Indonesia’s pharmaceuti-cal sector.

Despite the overall positive trend, there are a number of factors lim-iting the expansion of Indonesia’s healthcare industry, including the imposition of an Import Tax in 2010, a high level of counterfeit medicines, periodic price cuts to branded gener-ics, and limited access to healthcare facilities for the rural population.

Australia’s leading vitamin maker Blackmores recently announced the acquisition of Chinese herbal medi-cine firm, Global Therapeutics. The $23 mn deal opens up Asia’s doors for Blackmores in its new area of tradi-tional and herbal medicines. The com-pany’s chief executive, Ms Christine Holgate, said, “We need to get in there and understand the business and we know we have got a lot of opportuni-ties in the Australian market but we absolutely believe that in the more medium term this deal enables us to have good growth prospects in Asia.”

Global Therapeutics’ two main brands, Fusion and Oriental Botani-calsare sold only in Australia cur-rently. In an interview with a leading

daily, Ms Hol-gate said, “there were vast op-portunities in China and other Asian countries for the business, which would be run as a stand-alone operation at the ‘front end’ but have better access to capital and Blackmores distribu-tion grunt by being part of a larger group. Global Therapeutics deal, will help Blackmores understand the Asian consumers better.”We do a lot of work with the National Institute of Complementary Medicine at the University of Western Sydney and we have been exploring with them the research behind Chinese traditional medicine and Chinese herbal medi-cine,” she added.

Pelican BioThermal opens new Asia HQGlobal packaging solutions provider, Pelican BioThermal, expanded its footprint into Asia, recently inaugu-rating its new Asia headquarters in Singapore.

Global cold chain is currently a$10 billion industry and is expected to grow further. Last year, Pelican BioThermal has opened successful service centers for Asia, the UK and the US East Coast. Asia is an area of pronounced growth for Pelican Bio-

Thermal, so providing critical capa-bilities through its extensive network to deliver and manage assets in all re-gions, precisely meets its customers business needs.

The facility will be Pelican’s head-quarters for Asia operations and also the state-of-the-art service center, providing capabilities to refurbish and repair the Crēdo reusable line of shippers.

The new office will be co-located with Pelican BioThermal’s distributor for Singapore, Enviropac. The location will be the central base for the com-pany’s Asia sales office, Crēdo on De-mand rental fleet depot and be the re-gional distribution hub for their Crēdo reusable and Chronos single use rang-es of temperature controlled shippers.

Apart from this, the company also announced partnership with Zuellig Pharma in Asia, thus further enhanc-ing the extensive range of products and services offered in the region.

Australia’s Blackmores buys Chinese herbal medicine firm


BioNews

Japan’s Takeda Pharmaceutical Com-panyhas announced a partnership with the Bill & Melinda Gates Founda-tion to support global polio eradica-tion in developing countries.

With this funding, Takeda will de-velop, license and supply at least 50 million doses per year of Sabin-strain inactivated poliovirus vaccine (sIPV) to more than 70 de-veloping countries.The vaccine will be manufactured at Takeda’s facility in Hikari, Japan. This effort is aligned with Takeda’s strategy to utilize innovation and partner-ships to address critical unmet needs in global public health, and the Sustainable Development Goals adopted by the United Nations in September 2015.

Under the terms of the agreement, the Gates Foundation will provide a $38 million grant to Takeda to leverage its innovative vaccine manufacturing platform to develop and license a safe and effective Sabin-strain inactivated polio vaccine, and make at least 50 million doses per year available at an affordable price for developing countries receiving Gavi support. Gavi,the Vaccine Alliance, brings together public and private sectors with the shared goal

Taiwan’s ACT Genomics, an integrated cancer molecular information company that transforms precision cancer care, has raised $12.5 million in Series B funding.Hotung Group, and CDIB Capital Manage-ment, led the round with continued partici-pation from existing investors,Eminent II VC, Hua Nan Venture Capital,President In-ternational Development and UMC Capital in this round.

Based in Taipei, Taiwan, ACT Genomics is providing comprehensive genomic profiling assays and molecular information to physicians and biopharmaceutical cus-tomers.With full spectrum of clinical service, ACT Ge-

Taiwan’s ACT Genomics raises $12.5m in Series B funding

Bill & Melinda Gates Foundation supports Takeda with $38 million to eradicate polio

of creating equal access to new and underused vaccines for children liv-ing in the world’s poorest countries. Takeda’s sIPV was originally licensed from the Japan Polio Research Insti-tute, which is now a part of RIKEN.

Chris Elias, President, Global Devel-opment at the Bill & Melinda Gates

Foundation stated, “In 2016, the world is closer than ever to eradicating polio.To eradicate polio we need to ensure every last child is protected from the disease - this part-nership will help to ensure that the world has enough vac-cine to get the job done and maintain a polio free world.”

“Takeda’s polio program demonstrates our commit-ment to tackle the most important public health prob-lems and promote access for the populations in greatest need,joining our programs in dengue, norovirus, and hand, foot and mouth disease,” added DrRajeev Ven-kayya, President of Takeda’s Vaccine Business Unit. “We’re excited about this partnership with the Bill & Me-linda Gates Foundation, and the potential to reach hun-dreds of millions of children around the globe as part of the final push to eradicate polio.”

nomics helps to expand targeted thera-py treatment options, predict response to immune-checkpoint inhibitors, and utilize ctDNA based assay to monitor tumor burden and resistant markers, in their CAP-accredited NGS labora-tory.

ACT Genomics plans to use the pro-ceeds to further boost the capacity to support the rapid growth and expansion in Japan,Taiwan, Singapore, Malaysia,Thailand, and Hong Kong. The new proceeds will also enable ACT Genomics to ramp up its commercial channels to drive further global expansion, following its move into Asia Pacific region earlier this year.


BioSuppliers

Siemens Healthineers: new brand for Siemens' healthcare businessIt is unique and bold and best describes the healthcare organization and its people - the people accompanying, serving and inspiring customers - the people behind out-standing products and solutions.

"We have an exceptional track record of engineering and scientific excellence and are consistently at the forefront of developing innovative clinical solutions that enable providers to offer efficient, high quality patient care. Go-ing forward as Siemens Healthineers, we will leverage this expertise to provide a wider range of customized clin-ical solutions that support our customers business holis-tically. We are confident in our capability to become their inspiring partner on our customers' journey to success", explained Bernd Montag, CEO of the company. "Our new brand is a bold signal for our ambition and expresses our identity as a people company - 45,000 employees world-wide who are passionate about empowering healthcare providers to optimally serve their patients."

As part of its Vision 2020 strategy Siemens AG announced nearly two years ago that its healthcare business would be separately managed as a company within the company.

With a view to improve the lives of people in the ASEAN, Royal Philips recently inaugurated its new state-of-the-art Philips APAC Center in Sin-gapore. The inauguration ceremony was attended by guests of honor, SIswaran, Minister of Trade and In-dustry (Industry), and Jacques Wer-ner, Ambassador of the Kingdom of the Netherlands to Singapore.

The center is located at Toa Payoh and showcases Philips' innovation and design expertise and business-creation capabilities. The center is a world class facility including a Phil-ips Continuous Care Monitoring Room, where healthcare profession-als remotely monitor the health of

home-based patients with advanced cloud-based healthcare equipment and solutions. Apart from this the space also enables prototyping of new solutions that help make a meaningful difference in the future of patient care. Through the simula-tion of these different environments, the company said in its report that, it

will be able to demonstrate and test new workflows that can then be used to build future healthcare models.

In addition, the building is a show-case equipped with the company's own industry-leading LED lighting systems. Beyond sustainable features like energy savings and lowered car-bon footprint, connected lighting with Philips PoE (Power-over-Ether-net) is built into areas where higher interaction levels are expected.

Facilities management efficiency is improved with less mains wiring since the same cable can serve as the phone line, internet cable and power cable simultaneously.

Australia approves Vela Diagnostics’ HCV Genotyping AssaySingapore-based Vela Diagnostics announced that the Australian Therapeutic Goods Administration (TGA) has approved its Next Generation Sequencing (NGS)-based Sentosa SQ HCV Genotyping Assay for diagnostic use. The Sentosa SQ HCV Genotyping Assay is intended for viral genotyping in patients diagnosed with Hepatitis C Virus infection from human plasma or serum sample. The assay is also currently being reviewed for CE-IVD and HSA approval.

The press release said that the Sentosa SQ HCV Genotyp-ing Assay covers clinically relevant regions of NS3, NS5A and NS5B and detects genotypes 1, 2, 3, 4, 5, and 6, and subtypes 1a and 1b. The limit of detection is 1000 IU/mL for genotypes 1 (including 1a, 1b and others), 2, 3 and 4, and 2000 IU/mL for genotypes 5 and 6. The assay has demonstrated 100% clinical sensitivity and 99.39% clini-cal genotyping correctness.

The Sentosa SQ HCV Genotyping Assay is validated on the highly automated Sentosa NGS workflow which enables automated RNA extraction, library construction, template preparation, sequencing, data analysis and generation of both Pathology report and Quality Control report.

Philips inaugurates new APAC healthcenter

http://www.philips.com/


Narayanan Suresh has joined as the Chief Operat-ing Officer (COO) of the As-sociation of Biotechnology-Led Enterprises (ABLE). For more than 13 years, as an Editor of BioSpectrum, he had worked closely with the biotech sector when the magazine under his leadership played a catalytic role in the growth of the industry in both India and in Asia-Pacific. ABLE rec-ognized the efforts of BioSpectrum by presenting it with an ABLE President's Award for Excellence dur-ing the organization's 10th Anniversary Celebrations in March 2013.

A veteran science journalist, Suresh has been in-strumental in establishing BioSpectrum as India's leading biotech magazine. Under his leadership, the magazine has emerged as successful media platform to engage the biotech industry and has enjoyed the position of being India's number one biotech maga-zine for more than a decade. He has also played key role in launching BioSpectrum Asia edition, Top 20 industry survey, CRO survey, connect with student academia network and many more.

As a COO of ABLE his responsibilities include ensur-ing an orderly growth of the industry, increase the engagement levels within and outside the industry, set up a robust information sharing network, in-terface with policy makers, regulators and the wide range of stakeholders and make the organization the hub of activities for the hundreds of Startups in the biotech sector.

Roche Korea apppoints a new GMSwiss pharma giant Roche recently appointed Matt Sause as the new general manager for its Korean branch. Sause was the former chief of Roche Phar-ma Peru. He was also the former director of Roche Diagnostics Ireland and a former member of Roche Diagnostics UK's leadership team. Sause joined Roche Group in 2002 and has accumulated expe-rience in marketing and organization management across the US, Europe, South America and Asian markets, managing Roche's businesses in the mo-lecular diagnostics and pharmaceuticals develop-ment arena.

BioPeople

AppointmentsTakeda appoints James Kehoe as CFOTakeda Pharmaceutical has announced the appointment of James Kehoe as Takeda's new Chief Financial Officer and Corporate Officer, effective on June 15, 2016. Kehoe will be based in Tokyo and will report directly to Chris-tophe Weber, President & CEO of Takeda. Kehoe is an ac-complished finance executive from the Consumer Goods sector. He is a strong business leader, with a track record of improving operational business performance that in-cludes process optimization. He joins Takeda from Kraft Foods Group in the US, where he most recently held the role of CFO.

DaVita announces its new presidentDaVita Kidney Care recently announced the appointment of Rehan Khan as the president of the company's kid-ney care business in Asia Pacific. Apart from leadership roles at AstraZeneca, Accenture and Venture Media Khan recently served as the managing director of Abbott India.

DSM Sinochem announces business directorGlobal leader in sustainable antibiotics and antifungals, DSM Sinochem Pharmaceuticals, has announced the ap-pointment of Anurag Roy as its new Business Unit Di-rector for Asia Pacific, Middle East and Africa. Roy will also be the Global Product Owner, New API. During his 17 years of strategic leadership experience, Roy has held various senior management positions, most recently as vice president, Custom Pharmaceuticals Services, Dr Reddy's Laboratories (DRL).

BeiGene appoints Dr Ji Li as its Executive Vice PresidentBeiGene is a global research-based biotech company fo-cused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 215 scientists, cli-nicians and staff in China, the US, Australia and Taiwan, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. Prior to joining BeiGene, Dr Li served as VP of Business Development and Licensing at Merck Research Laborato-ries, a subsidiary of Merck & Co., where he was respon-sible for business development activities of late-stage in-bound and outbound opportunities. In addition, he led the team in executing external clinical collaborations in the immune-oncology space and Merck's R&D business devel-opment efforts in Japan and China.


BookReview

This well-written biography with its catchy title, gives readers a cogent answer to the question, who is Kiran Mazumdar-Shaw, as well as its corol-lary, what is Biocon all about. Actu-ally, it leans more towards tracking of the business rather than delving too deeply into the personality traits of its founder but then, the best busi-ness biographies do just that.

So, who is Kiran Mazumdar-Shaw? Myth-breaker. Risk-taker. A woman who was not an engineer and who did not come from a business fam-ily, yet started and steadily grew a ground-breaking business. Initial-ly setting out to be a professional brewmaster, Mazumdar-Shaw faced so much hostility and gender bias that she turned to Plan B: to start a biotech start-up instead, where she could leverage her fermentation knowledge to produce enzymes and

AGAINST Considerable OddsMyth Breaker Kiran Mazumdar-Shaw and the Story of Indian Biotech By Seema Singh

Collins Business/Rs 599/324 pages

biopharmaceuticals instead of beer. Mazumdar-Shaw`s father Rasendra Mazumdar was India`s first brew master and that definitely helped shape her initial interests in brew-ing. Her mother helped, too; in the early years, when Mazumdar-Shaw was going to coastal towns secur-ing fish maw supplies, in Delhi, her mother Yamini Mazumdar, would head to the fish market near the Jama Masjid once every ten days and buy a few hundred kilos of the fish maws, then ship the stock to her daughter in Bangalore.

Her mentor and one-time partner in business, Leslie Auchincloss, de-scribes Mazumdar-Shaw thusly, after his first meeting with her: a fantastic, enthusiastic, ass-kicking woman who is aggressive, demanding and would make a great partner for Biocon Ireland.

Pioneer? That`s a given. Pugna-cious? Yes, if the situation calls for it. Ready to ward off challenges that comes in the form of dirty deeds done by corporate rivals, like the filing of PILs. Ready to take on the Chinese goods wall. Once this businesswom-an bought into some idea, concept or project, she moved forward with lightning speed;witness the setting up of the Mazumdar-Shaw Cancer Centre, together with the renowned cardiologist Dr Devi Shetty.And in John Shaw, she has a spouse and staunch supporter who is more than willing to stay in the shadows and let all the limelight fall on Kiran. As a fi-nance person, he had some pithy ad-vice to give his wife: be adventurous in your science but be very conserva-tive in your finance. That advice has held good.

So, what exactly is Biocon? A research


BookReview

company that is running a number of programmes to bring new drugs to change the course of the disease. Bit by steady bit, the concern has grown incrementally, added technical and managerial muscle to its manufac-turing, started to supply an iron com-plex, Serratio, then statins, and then, insulin. Today this mid-sized compa-ny does novel biologics while earning the margins of speciality generics, even as it harbours ambitions of an innovator company.

Not all roses, though; here are some interesting facts: Biocon took ten years to become the largest Indian insulin brand but still has only 6.5 percent share in the overall insulin market, and 10 percent in the rep-resented market.When Biocon went public in 2004, people were sure it would pave the way for other bio-technology companies to follow suit.

Not a single firm did. It has been a hard climb but if ever anyone wasup to the challenge, it was and continues to be,Kiran Mazumdar-Shaw.

The book is a dispassionate collation of Biocon stories, and introduces to the reader the whole team that pulled its considerable weight and helped Mazumdar-Shaw put her company on the biotech map. Author Seema Singh, former bureau chief of Forbes India and a MacArthur grant award-ee, said the book took two years to write and involved over 200 inter-views. It takes the reader through an interconnected maze involving a feisty woman with a definite vision and the perseverance to stay the long course.

Verily the face of the biotech indus-try in India now,Mazumdar-Shaw is in her early sixties and still going

strong, her business acumen as well as her vision for her enterprise as sharp and clear as it was 37 years ago. Mazumdar-Shaw is all set to take Biocon’s biopharma business to the next level, with the focus on the new field of immuno-oncology. Which is a good thing considering the TINA factor here. There is no alternative to Mazumdar-Shaw as yet. As GS Krish-nan of Novozymes says: `If today Ki-ran chooses to say `enough of indus-try leadership` and steps back, there is nobody to talk to the government on behalf of Indian biotech.`

Sheila Kumar

Sheila Kumar is an independent writer and manuscript editor, as well as author of a collection of short stories titled Kith and Kin Chronicles of a Clan.

Photos: Ajay Ghatage


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BSA June 2016

Documents

Transcript of BSA June 2016