BSA June 2016

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

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Innovation - Industry's first method development and
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2 BioSpectrum | June 2016 | www.BioSpectrumAsia.com | An MM Activ Publication
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BioEdit
C
hina’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 Kokje
Editor
Race or partnership?

BioSpecial
Special articles
It 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 special
I 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 tourism
It’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
articles
Sir, 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
Publisher and Managing Editor:
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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
HEALTHCARE
sector
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
fighters
FA PRECISION
MEDICINE
Does India need
Initiative

Racho Jordanov
President and CEO, JHL Biotech
Ernest Lee
VP Sales, Singapore, Malaysia
Brunei, Alcatel-Lucent Enterprise
Jan Mäkelä
GM, 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
BioEdit��04
BioMail��05
BioNews��41
BioPeople��48
BookReview ��49
twitter.com/BioSpectrumMag
facebook.com/BioSpectrum-
Magazine
bit.ly/BS-LinkedIn

BioSpecial
domestic policy
to support global
innovation’
domestic policy
to support global
innovation’
T
aiwan 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’
RD 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
innovation as is
needed or possible

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Learn more at merckgroup.com/life-science

BioTalk
S
everal 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 Jordanov
President 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

AN IN-DEPTH ANALYSIS
BY BMI RESEARCH
C
hina'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 Reform
China'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 Health
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
(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 pressure
In 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 Business
through Silk Road
China'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 environment
in China to
get more complex
Chinese 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 reforms
In 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 effect
There 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 boost
medical industry
China’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 India
be ace partners
in 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 RD 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
I
n 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
T
he 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-time
The 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 patients
Healthcare 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
facebook.com/BioSpectrumMagazine bit.ly/BS-LinkedInhttps://twitter.com/BioSpectrumMag

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 Mäkelä
GM, BioProcess business, GE
Healthcare’s Life Sciences business
Interview
O
n 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
B
elieve 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
fighters
FA

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 works
Depending 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 outcomes
No 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
P
recision 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 scene
The 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 elements
The 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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