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ASEAN is growing, and growing with
it is the region’s pharma sector.
With growth in developed markets
flattening, pharma industry
is betting on lucrative ASEAN
markets for profits. Think of Asia’s
emerging markets and the instant
names that appear are India and China.
Undoubtedly, these are huge markets
for the industry. But apart from these
main markets, ASEAN’s emerging markets,
with an annual growth rate of 11 per cent and
huge untapped potential, provide a massive
opportunity for big pharma to expand and grow in
this region.

Discover the best professional documents and content resources in AnyFlip Document Base.
Published by MMA Media, 2018-06-28 05:39:49

BioSpectrum Asia July 2018

ASEAN is growing, and growing with
it is the region’s pharma sector.
With growth in developed markets
flattening, pharma industry
is betting on lucrative ASEAN
markets for profits. Think of Asia’s
emerging markets and the instant
names that appear are India and China.
Undoubtedly, these are huge markets
for the industry. But apart from these
main markets, ASEAN’s emerging markets,
with an annual growth rate of 11 per cent and
huge untapped potential, provide a massive
opportunity for big pharma to expand and grow in
this region.

Keywords: ASEAN ,Malaysia,Thailand,China,singapore,japan,maldives,taiwan,europe,asia

MCI (P) 027/05/2018




Chief Editor Gathering medical health records of the patients in digital form seems to be the
new interest area of the pharmaceutical companies. Given the fact that the
[email protected] immense possibilities Electronic Health Records (EHR) can offer, no wonder
the pharma companies would like to lap it up at any cost. The takeover of Flatiron
health by the Swiss pharma giant Roche for $ 2 billion a couple of months back is
one such example. US based Flatiron is a health tech & services company which is the
market leader in oncology specific EHR software. It works with 250 US community
cancer clinics and six academic research centres gathering huge data on cancer.

On the same line, CVS has proposed a buyout of insurer Aetna for $ 64 billion.
Apple has introduced health app in its iPhone that will allow users to store and share
their medical records and 12 hospitals & clinics have till now partnered with Apple
for this. In view of this development Amazon has responded by partnering with J P
Morgan & Berkshire Hathaway to form a joint venture to reduce healthcare costs.
Cigna has planned to buy pharmacy benefits manager Express Scripts for $ 50 billion.

Realising the emerging trend and growing interest of pharma companies in the
data, the tech companies are investing in healthcare industry. Many startups are
utilizing these opportunities. US based startup OneRecord allows people to see their
health records at one place. It is working with New York State to standardise health
record data.

Industry watchers expect many more such deals to take place between tech
companies in health sector and drug manufacturers.

Increasing digitisation of health records has brought about an easy transmission
from the conventional paper format. The online availability of the data has also
opened up immense possibilities for its usage.

The last few years have seen a significant growth in gathering and maintaining the
health records in electronics format. Number of hospitals in US that enable patients
to electronically view, download and transmit their health information increased
significantly from 10% in 2013 to 69% in 2015. By the previous year nearly 90%
office-based physicians used EHRs. A recent Stanford Medicine survey found that
more than 6 in 10 primary care doctors say EHRs have led to improved patient care.
As a result the global EHR market is expected to reach $ 24 billion by 2020 at 41%

The EHR data is important from different angles. It can be used for many
purposes especially for checking the effectiveness of the drug beyond clinical trials.
Drug companies had been conducting clinical trials to test a drug for the safety of
patients, to test the efficacy of the drug and for regulatory complaince. But those
were restricted to only randomised samples. By doing the data analysis of the patient
EHRs it is possible to examine how the drug is working in routine & regular clinical
practice and on the population beyond the selected sample. When pharma sector is
turning towards personalised medicine such a data assumes even more importance.

However, there have been apprehensions expressed over having such a huge
information about the people’s health with corporates due to its possible misuse
by them for commercial purpose. There are two main and real challenges. One
is protecting the data & honouring patients’ privacy and selecting to focus on the
required data that is important. It will be a challenge before the pharma companies,
tech companies and data gatherers. Even the Stanford survey mentions that 4 of the
10 respondent doctors say the EHRs bring more challenges than benefit. Answers
will have to be found out to overcome these challenges. Innovative solutions will have
to be looked into, possibilities of using blockchains as suggested by some people will
have to be explored. All these steps are needed since this development cannot be
stopped now.



The Robotic Way Cancer care
It is very fascinating to know that The write-up on cancer care in Vietnam

- healthcare robots are being used in a was quite interesting. There is an urgent

wide range of applications. The robotic need for the ASEAN to combat this

surgery definitely holds a major share in rising health crisis. Please publish more

this market. Hoping to read more on this such articles for further information.
- Leena Raj, Malaysia
in the coming editions.
- Angie Lui, China

Budget boost AI trend

The medical research sector in Australia Artificial Intelligence (AI) systems can
surely has a reason to feel happy with dramatically improve the quality of
the 2018 budget. Looking forward healthcare services and allow health
to more follow-up articles on this facilities to cut costs. Please write
announcement. more about the use of AI in the field of
- John Creek, Singapore
- Dr Shekhar Singh, New Delhi

Vol 13; Issue 07; July 2018 MM Activ Singapore Pte. Ltd. India
Alok Srivastava
Publisher & Managing Editor: Singapore Business Head- Ad Sales &
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Editorial: Saradha Mani #9, UNI Building, 3rd Floor, Thimmaiah
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MCI (P) 027/05/2018
Printed and published by Ravindra Boratkar Copyright: MM ACTIV Sci-Tech
on behalf of MM ACTIV Singapore Pte Ltd. Communications Pvt. Ltd.

Printed at Times Printers Private Limited
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Reprinted in India for private Circulation



COVERStory 18


ASEAN is growing, and growing with
it is the region’s pharma sector.
With growth in developed markets
flattening, pharma industry
is betting on lucrative ASEAN
markets for profits. Think of Asia’s
emerging markets and the instant
names that appear are India and China.
Undoubtedly, these are huge markets
for the industry. But apart from these
main markets, ASEAN’s emerging markets,
with an annual growth rate of 11 per cent and
huge untapped potential, provide a massive
opportunity for big pharma to expand and grow in
this region.

25 Q&A 27 Q&A

Industry as a ICMR has
partner brings to do more work in
best success non-communicable diseases

Dr Renu Swarup, Prof Balram Bhargava,
Secretary, Department of Biotechnology, Secretary, Department of Health Research, (Ministry of Health &
Family Welfare), Government of India and Director General, Indian
Ministry of Science and Technology,
Government of India Council of Medical Research (ICMR)


“India will now play a Singapore &
bigger role in AstraZeneca’s War on
global operations” Diabetes

Veena Rajan,
GMD Site Lead, Bengaluru, India



Chinese pharma moving SHARE
towards innovation

37 Q&A

‘We treat our product
as a part of medicine’

Grace Xu,
Sales Manager, Zhengli Pharmaceutical Packaging, China


“Vietnam has roadmap to upgrade
and modernise healthcare system”

Jozica Habijanic,
Country Manager at Roche Diagnostics Philippines


“Quality by design is growing
importance in pharma industry”

Alagu Subramanium,
Managing Director, India - West Pharmaceutical Services, Inc.


BioEdit.............................................. 04 Connect with us
BioMail............................................. 05
Regulatory News........................... 08
Company News............................. 10 BioSpectrumMag
Finance News................................. 12
Start-Up News................................ 13
World News.................................... 15 BioSpectrumMagazine
WHO News...................................... 17
Science News................................. 42
Academics News........................... 44 /BS-LinkedIn
Supplier News................................ 45
People News................................... 47
Bio Event.......................................... 49


partners with Medix
Japan approves
stem cell based AIA Singapore and Medix have access to optimal treatment,
trials for heart have entered into an exclusive and are supported through their
treatment partnership to provide Personal treatment journey till recovery.
Medical Case Management This will alleviate the stress and
A special health ministry Services (PMCM) to customers. pressure that customers and their
panel gave Osaka University This adds to AIA Singapore’s families face when dealing with
the approval to carry out comprehensive healthcare serious medical problems, and
a study involving the use proposition, which
of induced pluripotent is focused on ensure that customers
stem (iPS) cells to treat providing quality receive the best quality
heart failure. This would healthcare and the care.
be the second instance of best customer
using iPS-derived cells experience, AIA Max Essential
for disease treatment in enabling A and A Saver
Japan, after groundbreaking customers to policyholders will
trials involving retinal receive the best be able to use
cells launched in 2014. possible treatment Medix to receive
The trial treatment will be and personalised personal support
administered to three patients ongoing support throughout their along every step in the
suffering from ischemic medical journey when they face management of their
cardiomyopathy, a serious serious medical conditions. serious medical conditions. This
condition that occurs when includes medical assessment,
narrowed coronary arteries The service, which is the first re-evaluation, referral for testing,
limit the supply of blood of its kind in Singapore, will ongoing multi-disciplinary
to the heart. The plan is to help AIA Singapore’s customers consultations and long term
start the trials by the end facing serious medical conditions medical guidance by Medix’ 300
of next March and spend a by making sure they obtain the in-house doctors and a global
year examining the effects right diagnosis as fast as possible, network of over 3,000 leading
and potential safety issues. independent specialists.
The researchers will grow
cardio muscle cells created Dubai to adopt inventive
from iPS cells stocked at the
Centre for iPS Cell Research healthcare innovations
and Application at Kyoto
University, where Nobel Dubai Health Authority (DHA) has signed a
laureate Shinya Yamanaka Memorandum of Understanding (MoU) with four
serves as director. The created cutting-edge international companies to adopt
cells, in the form of their inventive healthcare innovations, in a bid to
0.1 millimeter-thick utilize the latest medical technologies in artificial
sheets, will be layered intelligence (AI) to provide quality health services
onto the surface of to the people of Dubai. The four companies include
the patient’s heart.
As the sheets Babylon health app, Neuro Head band to
secrete protein, detect stroke for high-risk patients, Health
the nutrition pods from Bodyo and Flow cell sensors by
is expected to Admetsys. DHA is keen to be at the forefront
help grow blood
vessels and of the transformation, which aims to establish
improve heart an integrated global platform for the future of
the strategic sectors and to create economic
value based on embracing and adopting
future businesses and technological



Vietnam proposes Nepal knocks
adverse event
reporting system out trachoma

The Ministry of Health in Vietnam has as public
proposed a system to identify, report and
categorise adverse events to prevent untoward health problem
incidents at medical facilities. According to
the draft circular proposed by the ministry, The World Health Organization (WHO) has validated
the system will identify the types of incidents Nepal for having eliminated trachoma as a public
to determine their level of seriousness. The health problem – a milestone, as the country becomes
ministry has encouraged medical facilities the first in WHO’s South-East Asia Region to defeat
to set up the incident reporting system to the world’s leading infectious cause of blindness.
identify causes and propose solutions to A letter acknowledging validation was presented
medical incidents. The system would be recently to Nepal’s Minister of State for Health and
secured and would not be operated for Population Padma Kumari Aryal by the WHO South-
punishment purposes, and reporting adverse East Asia Regional Director Dr Poonam Khetrapal
medical events is the responsibility of the Singh and the WHO Director-General Dr Tedros
entire medical staff. Medical workers who Adhanom Ghebreyesus in Geneva.
identify adverse events would handle such In 2002, the Government of Nepal stepped up efforts
incidents to ensure the safety of patients. to eliminate the disease with the establishment of a
Each medical facility has been asked to set national trachoma programme. From 2002 to 2005,
up a patient safety department under the following the implementation of sustained control
quality management council to investigate and activities, the prevalence of active (inflammatory)
analyse an incident within 24 hours and report trachoma fell by 40 per cent.
it to the health ministry’s national patient Azithromycin was donated by the pharmaceutical
safety board or local health department. company Pfizer through the International Trachoma
Initiative and was delivered in Nepal by Nepal Netra
Jyoti Sangh (NNJS) with support from the United
States Agency for International Development-funded
ENVISION project, implemented by RTI International.

KWSH to expand
eldercare facilities

The Ministry of Health has Meanwhile, the new nursing
awarded Singapore’s largest home, which will have 438
single-site nursing home beds, will be located at Potong
operator Kwong Wai Shiu Pasir.
Hospital operating rights for
another new nursing home When the new facilities are
and two new community completed, KWSH will become
care centres at three different one of the largest nursing
locations. By 2021, Kwong home operators with a total
Wai Shiu hospital will be bed capacity of over 1,180.
expanding its services to six
different locations. To meet rising demand, the
number of nursing home beds
The new care centres in Singapore increased from
will be located at Jalan 9,400 in 2011 to more than
Besar Community Club and 12,000 in 2017. The Health
Circuit Road in MacPherson. Ministry aims to have 17,000
beds in Singapore by 2020.



Jeil Pharma unveils WuXi Biologics to
new research centre
build new CDMO plant
Jeil Pharmaceutical has recently opened a new
technology research centre in Yongin, Gyeonggi WuXi Biologics, a leading global open-access
Province. The new research centre is part of the biologics technology platform company, offering
company’s plans to strengthen investment in the end-to-end solutions for biologics discovery,
R&D sector and enhance the development of new development and manufacturing, is planning
drugs and generics. The new centre, dedicated to build an integrated biologics development,
to formulation research, has reorganized the clinical and commercial manufacturing centre in
existing pharmaceutical and analytical laboratory the city of Shijiazhuang, capital of Hebei province
at Baekam Central Research Laboratory. The in northern China. The new facility of $240
company completed the transfer of workforce and million is an addition to WuXi Biologics’ existing
equipment last month. CDMO facilities in Shanghai and a $392 million
biologics CDMO facility in Ireland, announced last
The company expects that the new R&D facility month. The new state-of-the-art biologics centre
will accelerate the development of new drugs and will include process development labs, clinical
generic treatments against diabetic, hyperlipidemia, manufacturing facility (MFG9) with 5,000 L
hypertension, benign prostatic hyperplasia and bioreactor capacity and commercial manufacturing
smoking cessation by using advanced technology facility (MFG8) with 48,000 L bioreactor capacity
such as fluidized bed granulator and pellet coating. which will be built to meet cGMP standards of the
United States, the European Union, and China.
Besides serving global clients, the new integrated
centre will also support Marketing Authorization
Holder (MAH) system in China and address urgent
needs of Chinese partners. Initial phase of the
center will be operational in 2020.

Asymchem cofounds Innovative Drug Fund

Asymchem Laboratories has The IDF serves as a fully biotech companies via multiple
cofounded the Innovative Drug integrated support platform for collaboration models (in-licensing
Fund (IDF) together with SDIC the introduction of new drugs or joint venture), and leverages the
Fund Management Company Ltd., from overseas to help drive CMC, R&D, and manufacturing
the Tianjin Haihe Industry Fund China’s pharmaceutical industry. services of Asymchem. Coupled
Management Co., Ltd., and the The IDF partners with western with the additional preclinical
Tianjin Economic Development and clinical services support
Area Administrative Commission, of a partner network, together
in a significant joint effort to with support from the national
support the development of and local governments, new
innovative drugs into China in companies around biopharma
accordance with the Chinese assets are formed with the goal of
Government’s Healthy China advancing the speed with which to
2030 Planning Outline. launch new drugs into China.



Luye Pharma Shuwen Biotech partners with Bliss
Biopharma for cancer diagnostics
China based Shuwen Biotech Co. Ltd.,
AstraZeneca’s an emerging leader in innovative
diagnostic products and services has
core CNS signed a partnership agreement with
Bliss Biopharmaceutical Co., Ltd., a
products biopharmaceutical company engaged
in the discovery, development and
Luye Pharma Group recently commercialization of biotherapeutics
announced their acquisition for unmet medical needs. Under the agreement, Shuwen will develop
of AstraZeneca’s core companion diagnostics for Bliss’ oncology drug candidates. Shuwen also
CNS products - Seroquel commits to provide testing services in its CAP-certified central labs for
and Seroquel XR. As with BlissBio’ clinical trials. The terms of the collaboration are undisclosed.
previous acquisitions such This collaboration will fuel continued innovation by BlissBio and further
as Lipusu, Xuezhikang, demonstrate how Shuwen can deliver value through its strong companion
Beixi and Rivastigmine diagnostics development team and its CAP-accredited lab facilities.
Transdermal Patch, the
decision to acquire Seroquel Shanghai Pharma, Bracco
and Seroquel XR was made Imaging sign new agreement
by Luye Pharma based on a
comprehensive evaluation of Bracco Imaging S.p.A., a global development of innovative
the target. Factors considered leader in diagnostic imaging, Shanghai Pharmaceuticals
include: whether the target and Shanghai Pharmaceuticals therapeutic drugs in the oncologic
is a signature product with a Holding Co. Ltd., a leading field. Microbubbles have already
high sales volume and high pharmaceutical group in China - changed medical imaging in
margins, whether it has good focused on providing innovative Contrast Enhanced Ultrasound
competitive positioning, how drugs in the field of oncology, (CEUS) - a high-sensitivity,
much it can contribute to infectious and cardiovascular non-invasive, real-time, cost-
existing core product portfolio diseases - have signed a effective and radiation-free
and whether it can help collaboration agreement on new modality that improves the
improve the group’s operating R&D activities in China. visualization and assessment
capabilities or optimize of cardiac cavities, large vessels
strategic resource integration. The collaboration is focused and tissue vascularity - and are
Seroquel (quetiapine on the exploitation of the now also considered as a high
fumarate, immediate potentialities of the Bracco potential platform for treatment
release, IR) and Seroquel microbubbles technology monitoring in oncology.
XR (extended release platform, to support the
formulation) are atypical
anti-psychotic medicines with
antidepressant properties.
In accordance with the
acquisition agreement, Luye
Pharma will acquire the assets
of Seroquel and Seroquel XR
in 51 countries and regions
including China, the United
Kingdom, Brazil, Australia,
Saudi Arabia, Mexico, South
Korea, Thailand, Argentina,
Malaysia and other countries
and regions in Asia, Latin
America, Africa, Oceania and
Eastern Europe.



JHL Biotech raises
$106M in pre-IPO funding

JHL Biotech, a Taiwan developer completed a voluntary de-listing Refuge
of cheaper alternatives to patent- of its Taiwan shares, a transaction
protected biological drugs, has that allowed shareholders to retain Biotechnologies
raised $106 million from a ownership of their holdings. JHL
convertible bond issue, ahead is among at least two other non- secures $25M
of its planned Hong Kong initial mainland companies that have
public offering (IPO) aiming to been preparing or mulling to tap funding
raise some $250 million. JHL the Hong Kong stock exchange’s
will allocate its new capital to equity-raising channel that was Refuge Biotechnologies, Inc., a
support clinical trials and further recently broadened to allow pre- cell therapy company based in
development of its biosimilar revenue biotechnology firms to California bay area leveraging
portfolio. Earlier this year, JHL list for the first time. gene engineering technologies
to develop intelligent cell
Salubris announces investment therapeutics programmed to
deal with MedAlliance make decisions inside of patients,
recently announced the closing of
Splendris International Limited, an affiliate of Shenzhen Salubris a $25 million Series B investment
Pharmaceuticals Co Ltd., a multi-national leader in the development round. The round was led by 3SBio
and commercialization of cardiovascular products in China and and Sequoia China and followed
beyond, recently announced a strategic investment and in-licensing by new investors Danhua Capital
agreement with Swiss cardiovascular pioneer M.A. MedAlliance S.A. (DHVC), Sangel Capital and
Ocean Pine Healthcare Fund and
Under the terms of the agreement, Salubris will make a $20 million existing investors 3E Bioventures,
equity investment in MedAlliance and will commit an additional $10 WuXi Healthcare Ventures and
million in developmental milestones in exchange for exclusive rights ShangBay Capital. Zhenping Zhu
to develop and commercialize MedAlliance’s lead investigational of 3SBio and Trency Gu of Sequoia
product Selution, a potential best-in-class sirolimus micro-reservoir China, will join the Refuge board
drug-coated balloon (DCB), for peripheral and cardiovascular of directors. The fund will be used
applications in the Chinese market. MedAlliance will also be eligible to continue developing cell therapy
for royalty payments on sales. programmes based on Refuge’s
receptor-dCas platform. Under
MedAlliance’s DCB technology is a next-generation approach the investment term, 3SBio and
for patients with peripheral artery disease (PAD), coronary artery Sequoia China will have exclusive
disease (CAD) and arteriovenous fistulas (AVF). With unique rights to negotiate with Refuge on
micro-reservoirs, the technology efficiently delivers sirolimus to the the right to the development and
target lesion, where it provides controlled and sustained release. commercialization of cell therapies
MedAlliance’s technology will further enable surgeons’ desire to move using Refuge’s platform in China.
away from metal scaffolds and durable polymers that remain within Refuge and 3SBio will also
the patient in PAD by providing a safer and more effective alternative collaborate on therapeutic protein
to paclitaxel-coated balloons. research using Refuge’s platform.
Concurrent with the financing,
Zhenping Zhu, M.D., Ph.D., of
3SBio and Trency Gu, Ph.D., of
Sequoia China, have joined the
Refuge board of directors.



CStone Pharma completes $260M Series B Funding

CStone Pharmaceuticals (CStone) participated in this round, for immuno-oncology. CStone has
has completed a $260 million built a portfolio of more than ten
Series B funding round. The including Oriza Seed Venture assets, including four in various
investment was led by GIC Private clinical stages.
Limited, Singapore’s sovereign Capital, Boyu Capital and WuXi
wealth fund, with participation The funds raised in this
from new investors including Healthcare Ventures (currently round will be primarily used
Sequoia China, Yunfeng Capital, for clinical development of
6 Dimensions Capital, CITIC PE, a 6 Dimensions Capital fund). CS1001 and other clinical stage
Taikang Insurance Group, ARCH assets, expanding the company’s
Venture Partners, Hillhouse Together with the $150 million pipeline through internal R&D
Capital, King Star Capital, 3W and external partnerships. Funds
Partners, AVICT and Terra raised in Series A financing in will also be channeled towards
Magnum Capital Partners. attracting top industry talents to
2016, this most recent round of deliver breakthrough therapeutic
Existing investors also solutions to cancer patients.
funding brings the total capital

raised to $410 million. Founded

in 2016 and headquartered

in Suzhou, China, CStone is a

biopharmaceutical company

focused on the development of

drugs and combination therapies

China invests $85M Health start-up
in Ansun Biopharma
UCARE.AI secures $8.2M
Ansun BioPharma, Inc., a San Diego based
biotechnology company focused on the development UCARE.AI, a Singapore-based healthcare startup that
of novel broad spectrum anti-viral biologic uses artificial intelligence (AI) to optimise healthcare
therapeutics to combat severe viral respiratory resources and reduce healthcare costs across
tract infections, has announced the completion of the industry, has raised $8.2 million in funding.
an $85 million Series A financing round. Investors in the Series A round included venture
capital firm Walden International, insurance group
The round was led by Sinopharm Healthcare Great Eastern, Singapore businessman Peter Lim,
Fund and Lilly Asia Ventures. Additional new and WPGrowth Ventures, the startup initiative of law
investors participating in this round included Lyfe firm WongPartnership. According to the startup, the
Capital, Yuanming Capital, Matrix Partners China, new money will be used for talent acquisition and
3e Bioventures Capital, Oceanpine Capital, VI market expansion into South-east Asia. Founded
Ventures, and Joincap Investment. in 2016, the startup uses proprietary deep learning
and neural network algorithms built on existing
Ansun plans to use the proceeds from the Series healthcare data to help prioritise healthcare resources
A to fund a Phase 3 clinical trial of its experimental to reduce preventable hospitalisation. This is said to
anti-viral medication, DAS181. The FDA has potentially lead to significant annual savings in the
granted both Fast Track status and Breakthrough industry. UCARE.AI also boasts a highly accurate
therapy designation to DAS181, and Ansun is predictive capability by correctly identifying the risk
currently in the planning stage of a Phase 3 trial to of rehospitalisation for a segment of Singaporean.
treat hospitalized, immunocompromised subjects
infected with parainfluenza virus.



Brii Bio raises $260M Grail receives
to bring drugs to China
$300M for
Brii Bio, a startup committed to serving patients’ needs and improving
public health in China, recently announced its launch with significant early cancer
partnerships and financing. The China-US startup has raised $260
million in initial capital to bring diagnostics
innovative drugs to China. The
funding was led by ARCH Venture Grail, a Hong Kong-US
Partners, 6 Dimensions Capital, oncology diagnostics
Boyu Capital, Yunfeng Capital, company, recently
Sequoia Capital and Blue Pool announced a $300 million
Capital. C financing. Ally Bridge
Group led the round along
Brii, which plans to combine with Hillhouse Capital
partnerships, R&D and digital/big Group and 6 Dimensions
data, will use WuXi AppTec and Capital. Blue Pool Capital,
WuXi biologics for development of its projects, rather than building its China Merchant Securities
own facilities. A partnership with Vir, a leading U.S.-based biotech focused International, CRF
on infectious diseases, grants Brii Bio options on exclusive greater China Investment, HuangPu
rights for up to four assets in Vir’s portfolio. This therapeutic pipeline River Capital, ICBC
holds the potential to prevent, treat and cure a wide range of infectious International, Sequoia
diseases. The startup has also entered into a first-of-its-kind digital and Capital China, and
data insight partnership with AliHealth, the healthcare arm of Alibaba WuXi NextCODE also
Group to collaborate and explore disruptive approaches to optimize contributed. The latest
clinical and commercial development efforts by capturing value evidence financing will support
and improving patients’ experience with new therapies. development and validation
of its early cancer detection
HiFiBiO raises $37.5M products. The firm plans
from Chinese investors to launch its first product
in Hong Kong this year
HiFiBiO Therapeutics, a Boston company developing therapeutic for the early detection of
immune modulators, closed a $37.5 million Series B financing led by two nasopharyngeal cancer.
China investors, Sequoia Capital and Lyfe Capital. The financing round Grail was launched in early
was also supported by existing Series A investors, VI Ventures and Nest. 2016 by Illumina with $100
Bio Ventures, as well as new investors, Legend Star Capital and Proxima million in funding from
Ventures. The company said the funding would transform HiFiBiO that firm as well as Arch
into a more mature biopharmaceutical company, with a stronger Venture Partners, Bezos
global presence and rich pipeline of novel antibodies for cancer and Expeditions, Bill Gates,
autoimmune disorders. HiFiBiO Therapeutics made its first step towards and Sutter Hill Ventures.
becoming an innovative therapeutics company by appointing a new It raised a further $900
management team of experienced industry veterans. HiFiBiO currently million in a Series B round
has more than 50 full-time employees operating out of three facilities in in early 2017 and used
the USA, France and China. some of that money to buy
back part of Illumina’s
stake in the firm. In 2017,
Grail merged with Cirina,
a Hong Kong cancer
diagnostics company,
which was co-founded
by Dennis Lo, an early
scientific leader in the field
of molecular diagnostics.



AstraZeneca to use Emulate’s Organs-on-Chips technology

Emulate and AstraZeneca’s Innovative Medicines and Early
Development (IMED) Biotech Unit have formed a strategic agreement
to embed Emulate’s Organs-on-Chips technology within the laboratories
of the IMED Drug Safety organisation.

The companies hope the technology will improve prediction of human
safety in trials and the efficacy of drug candidates. They will also use it to
conduct studies aimed at gaining new insights into disease mechanisms.

As part of the agreement, Emulate will co-locate scientists within
AstraZeneca’s laboratories. The new partners aim to accelerate the
development of organ-chip technology and testing within the context of
a pharmaceutical organisation.

AstraZeneca began collaborating on Emulate’s Organs-on-Chips
technology in 2013. The technology consists of the organ-chips,
instrumentation, and software apps. In the future, the system is expected
to reduce the use of animal testing in research as well as cost and time of
discovery and development.

Novo Nordisk US researchers
increases commitment
to cell therapies develop tool to improve

BioLamina and collaborators have partnered with diagnostic accuracy
Novo Nordisk, a Danish multinational pharmaceutical
company, allowing Novo Nordisk to develop novel A research team at the University at Buffalo
stem cell based therapies based on Biolaminins, human (UB) in the US has developed a new protein
recombinant laminin cell culture matrices, developed analysis tool called IonStar which can
and produced by BioLamina. enhance the speed and accuracy of disease
diagnosis and the analysis of drug effects.
Novo Nordisk is increasing its commitment to cell
therapies, including areas outside of diabetes. The three The tool is designed to quantify and
cell therapy projects they have licensed are all based compare the abundance of proteins in
on BioLamina technology. These projects aim to treat patients with those of healthy people. This
Parkinson’s disease, heart failure and loss of vision, all measurement is considered important to
severe chronic conditions. detect a disease or pharmaceutical reaction
and for making new drugs, as it has the
Malin Parmar’s research group at Lund University potential to reveal new biomarkers.
and Karl Tryggvason’s research group at Duke-NUS in
Singapore have developed potential cell therapies based Existing protein analysis approaches
on BioLamina’s unique Biolaminin matrices. Both groups are said to be time-consuming or lack
have signed research and potential licensing agreements accuracy, leading to the false identification
with Novo Nordisk with the aim to develop these of biomarkers.
projects further together with Novo Nordisk, enabling a
translation of cell therapy pre-clinical studies, to clinical The new tool is said to address
trials and eventually towards patient treatments. these issues and reduce missing data
by improving on sample preparation
techniques and alignment, while integrating
designs for mass spectrometry analysis.

The tool has been used to analyse
protein variation in diabetes, cancer,
cardiovascular disease, neuro and retinal
degeneration. The researchers now plan to
work on increasing the number of samples
that IonStar can analyse.



€19.6M Dutch grant to fund Jubilee medical
public health in Ethiopia
app to roll out in
The government of the Netherlands has extended €19.6
million in grants to Ethiopia to finance its public health Uganda, Tanzania
infrastructure development. The grant will be used
primarily for the construction of a Cardiac Care Centre Jubilee Insurance is set to roll out a
to be accommodated at the Black Lion Hospital in the medical mobile app, JubiCare in Uganda
capital Addis Ababa. Ethiopia’s State Minister of Finance and Tanzania by September. The app,
and Economic Cooperation, Admasu Nebebe and Dutch launched in February, will allow clients to
Ambassador Van access policy data in real-time as well as
Loosdrecht signed the locate the underwriter’s medical providers.
grant agreement. The app has various features including
health facility finder and navigator,
The main objective e-health records, pre-authorisation
of the project is requests, medical card management
to expand access services and e-wellness feeds. Plans are
to quality public underway for Uganda and Tanzania
health infrastructure clients to access the app. Lately, the
by establishing a insurer has made substantial investments
sustainable and in the development of the transmission
equitable cardiac centre. The construction of the cardiac of claims electronically, wider use of
care centre is part of the Netherlands government’s biometric identification cards and digital
aspiration to improve Ethiopia’s health infrastructure. Both mobile apps and artificial intelligence.
countries have agreed to jointly finance the construction The insurer has been reviewing systems
of the centre and the Dutch government will fund its and operations, implementing enhanced
construction. The Dutch government will also cover information technology controls to curb
technical and consultancy services in addition to the fraud and re-engaging with its key service
financing support. The centre is expected to be the first in providers to find new and innovative ways
its kind in Ethiopia and will have some 94 beds and three to manage medical fees.
operating fields.

GE Healthcare collaborates with Kenya Cardiac Society

General Electric (GE) and the Kenya Cardiac Society
(KCS) have entered into a two-year collaboration to
offer echocardiography training to physicians and
technicians in public and private hospitals in the country.
The training will enable the physicians and technicians
to better offer primary baseline assessment for patients
with identified cardiac illnesses. The trainings,
which will be held in six-month cohorts, will enrich
participants with technical skills on cardiac imaging
with focus to anatomy, physiology and hemodynamics
as well as sonographic measurement and probe
manipulation skills. The training will include several
practical sessions led by professional sonographers and
physician cardiologists. GE Healthcare has a long history
in supporting education and training to drive improved
health outcomes. In 2016, GE inaugurated a healthcare
training and skills institute in Kenya designed to train
health professionals. Over 1900 professionals have
benefited from the institute since its launch.



WHO plans collaboration WHO, WB to
for developing Nipah vaccine strengthen
global health
To tackle the Nipah Virus and to develop a roadmap to do the same, security
the Center for Infectious Disease Research and Policy (CIDRAP) at the
University of Minnesota, with support from the Wellcome Trust, will WHO and World Bank
collaborate with the World Health Organization (WHO). This will facilitate Group have recently
the collaborative development of a draft ‘Nipah R&D Roadmap’. Nipah launched a new mechanism
Virus is one of the pathogens in the WHO R&D Blueprint list of epidemic to strengthen global health
threats that need urgent research and development action. According security through stringent
to WHO, the roadmap prioritises the development of countermeasures independent monitoring
(diagnostics, therapeutics and vaccines) that need to be taken by Nipah- and regular reporting of
affected countries. It is the result of extensive consultations with the Nipah preparedness to tackle
R&D roadmap taskforce, national and international experts and other outbreaks, pandemics,
key stakeholders. The first Blueprint list of priority diseases was released and other emergencies
in December 2015, and the list was reviewed last in February 2018. The with health consequences.
disease’s potential to cause a public health emergency and the absence of WHO Director-General
efficacious drugs and/or vaccines helps the experts determine if there is an Dr Tedros Adhanom
urgent need for accelerated research and development for these diseases.
Ghebreyesus and World
WHO publishes first Bank Group President
essential diagnostics list Dr Jim Yong Kim co-led
the creation of the Global
The World Health Organization essential diagnostics. Of the total Preparedness Monitoring
(WHO) has unveiled the first tests, 58 are listed for detection Board. The Board will
Essential Diagnostics List, a and diagnosis of several common be co-chaired by Dr Gro
catalogue of 113 in-vitro tests to conditions. The remaining 55 are Harlem Brundtland, former
diagnose the most common and for identifying, diagnosing and Prime Minister of Norway
global priority diseases. The move monitoring priority diseases such and former WHO Director-
is intended to address the lack as HIV, malaria, tuberculosis, General, and Elhadj As Sy,
of access to diagnostic services hepatitis B and C, syphilis Secretary General of the
or accurate diagnosis, resulting and human papillomavirus. International Federation
in patients failing to receive the Among these, certain tests are of the Red Cross and Red
correct treatment. Similar to specific for primary healthcare Crescent Societies. It will
the WHO essential medicines facilities and do not require include political leaders,
list, the new list is meant to act trained personnel, while some heads of UN agencies and
as a reference for countries to are particular for larger medical world-class health experts,
update or devise their own list of facilities. serving in their individual,
independent capacities.





ASEAN is growing, and growing with it is
the region’s pharma sector. With growth in
developed markets flattening, pharma industry
is betting on lucrative ASEAN markets for
profits. Think of Asia’s emerging markets and
the instant names that appear are India and
China. Undoubtedly, these are huge markets for
the industry. But apart from these main markets,
ASEAN’s emerging markets, with an annual
growth rate of 11 per cent and huge untapped
potential, provide a massive opportunity for big
pharma to expand and grow in this region.



Some years ago, looming patent cliff and flat
profits in developed markets prompted big
pharma to look at Asia’s emerging markets for
some respite. It was like a marriage made in heaven!
High unmet medical needs, government support,
growing middle class in Asia’s emerging economies
attracted pharma companies who were struggling
with slumping sales, tight regulations and pricing
pressures in mature markets. Fast-forward to today,
with a share of nearly 53 per cent, Asia’s emerging
markets are leading the world’s pharmerging sector
says a Transparency Market Research report.

While the global pharmerging market is expected
to reach $ 2,231.9 billion by 2025, Association of

Southeast Asian Nations, (ASEAN)’s emerging
economies will ride high in this wave, thanks to
increased investments for medical research, fast

urbanization, and growing lifestyle diseases.
Outside of Asia’s main markets like China,

Japan and India which are the region’s
leading centers for pharma innovation and
manufacturing; the members of ASEAN
like Indonesia, Thailand, Malaysia,

the Philippines and Vietnam has seen
significant growth in the last decade as
lucrative markets for big pharma. These
markets are no longer bystanders or

just consumers; they are growing as
competitors capable of developing
their own products with many leading
home grown companies racing to
launch new medicines to grab a
slice of the pie. The ensuing


COVER STORY Pharmerging in
ASEAN region
urbanization, low cost of manufacturing and
R&D associated with government support is Indonesia:
paving the way to make ASEAN’s emerging
markets the global hub for innovation. Southeast Accounting for 27 per cent of the ASEAN
Asia alone is expected to generate $40 billion in markets, Indonesia is one of the largest pharma
pharmaceutical sales by 2020. market among the ASEAN. Indonesia’s pharma sector
is predicted to reach $10.11 billion by 2021, according
Dr Siddharth Dutta, Associate Vice President to business and information Analytics Company,
Healthcare, Markets and Markets Research, GlobalData. The regions key market drivers are the
says, “Currently, Asia looks like a market full introduction of 15 economic policy packages to attract
of opportunities, investment, R&D etc. China foreign investors, the implementation of Universal
will remain the major attraction for next two Health Coverage scheme (Jaminan Kesehatan
years but the new regulations are expected to Nasional, JKN), and the growing urban population.
promote local Chinese manufacturers and there In 2016, Indonesia imported over $800 million in
may be disruptions in the growing market. Soon, pharmaceutical products, according to reports, an
countries such as Malaysia, Thailand, Indonesia increase of $90 million compared to $710 million
in imports in 2014. According to the International
“The emerging markets such as India Pharmaceutical Manufacturers Group (IPMG), an
and Indonesia are shifting towards association of foreign pharmaceutical companies in
“generics” and the companies selling Indonesia, overseas drug companies have invested
“branded” medicines will face the over $1 billion in Indonesia’s pharma market in
pinch sooner or later, unless they recent years. Currently there are 24 multinational
enter these markets with the generic pharmaceutical companies active in Indonesia with
versions. Countries like China, a combined IDR 12.7 billion market share, or, 28 per
Vietnam and India are putting price cent of the total Indonesian market.
capping on local markets to cut
down the cost on healthcare, which Malaysia:
will directly or indirectly impact the
pharma world. Besides these, there Malaysia’s pharmaceutical market is
are health care infrastructure issues, estimated to be worth $3 billion, more than two times
cost-containment policies, shortage that of Singapore, according to market research firm
of expertise (talent retention) in some The Pacific Bridge. Malaysia’s pharmaceutical market
markets and corruption. The intensity is expected to grow at approximately 10 per cent
of these factor varies from market to annually, double the Asia-Pacific average. When it
market. The pharma companies must comes to healthcare, Malaysia has been hailed by the
strategize well and tailor make them UN Development Program as a shining example for
for individual markets. There is no other developing countries.
The Malaysian Government has provided strong
one size fits all policy in APAC. support and commitment to bio-based industries
Companies have to through pro-business policies, infrastructure
decide whether they building and Human Resource Development (HRD).
can be an active Besides providing attractive commercial incentives,
player and/or a the Government has also invested extensively in
winning player.” building infrastructure, logistics and technology to
- Dr Siddharth bring the industry on par with advanced economies.
Dutta, Associate Incentive packages include BioNexus status,
Vice President which offers qualifying companies 10 years’ tax
Healthcare, exemption on statutory income, maintenance of
Markets 100 per cent company ownership and assistance
and Markets in the navigation of local procedures. Malaysia has
Research designated healthcare as one of the country’s 12
National Key Economic Areas (NKEA), placing a
particular emphasis on pharmaceuticals. Currently,


the government is encouraging private investments COVER STORY
as well as more public-private collaborations in the
pharmaceutical sector. RISING ASEAN EMERGING MARKETS I Source: IHS
GDP, in USD billion
With an estimated value of over $5 billion,
Thailand’s pharmaceutical market is the second 1,000.0
largest in Southeast Asia. As the country moves
towards becoming Asia’s healthcare hub through 800.0
its medical tourism sector, the pharmaceutical
industry is riding on its success. A number of 600.0
government initiatives have also boosted the
country’s pharmaceutical industry. The 11th National 400.0
Economic and Social Development Plan (2012-
2016) and the Second National Plan for Older 200.0
Persons (2002-2021) are the major government-
implemented programmes in Thailand. The value 0.0
of Thailand’s pharmaceutical market is expected to 2015 2020 2025 2030
double by 2020. Pharmaceutical sales per-capita
are also predicted to grow from $75 in 2016 to $125  Malaysia  Philippines  Thailand  Vietnam
by 2024, according to reports. The country has also
become a popular destination for drug clinical trials and the Philippines will emerge as preferred
due to its developing healthcare system and medical destinations over China and India.”
infrastructure. Clinical trials in Thailand are cost-
efficient and there is a large patient population. In Home to over half a billion people ASEAN is
addition, the government’s Board of Investment enjoying a golden period, with high-growth and
actively promotes Thailand as a prime destination to resilient economies. The pharmaceutical market
conduct clinical research. in Asia, mainly Southeast Asia, has undergone
a paradigm shift in the past few years. The
Vietnam: major global pharmaceutical companies have
shifted their focus to this region to drive their
Vietnam’s pharmaceutical market is revenue growth. Sharing his insights on some
estimated to record revenue of $5.2 billion in 2017, of the major pharmergieng markets of ASEAN,
a 10 per cent increase from last year. The market Micheal Sieburg, Associate Partner, Solidiance,
is set for double digit growth within the next five said, “In Asia, mainly Indonesia should enjoy
years. The government has initiated efforts to reduce strong pharmaceutical market growth through
dependence on imports and started promoting local the end of the decade. From 2008 to 2015, the
manufacturing. Many MNCs have started capitalizing pharmaceutical market there has doubled and
on this by forming joint ventures and acquiring local another near doubling can be expected in the
facilities or constructing new facilities. Vietnam has period from 2015 to 2020. Vietnam and the
a strong economic growth and the Gross Domestic Philippines should also enjoy decent growth
Product (GDP) in Vietnam was worth $194 billion in in the next few years, as they will also have
2015, which is enabling the government to spend six the strongest economic and income growth.
per cent of GDP ($11.6 billion in 2015) on healthcare. Meanwhile in the Philippines, the industry
This is higher than the spending of top pharmerging could receive a further boost from efforts to curb
nations such as China ($640 billion in 2015) and India counterfeit drug production and distribution.”
($104 billion in 2015) and the highest in the entire
ASEAN region, say experts. Vietnamese government Big pharma investing in
is supporting the local production of generics to ASEAN markets
reduce imports and has planned to meet 80 per cent of
domestic demand by 2020 through local production. Pharmaceutical companies in South East Asia
Government is also promoting investment from enjoy high growth in the region and probably
both domestic and foreign pharma companies and some of the highest worldwide. Four major
proposed plans to invest $241 million in eight projects ASEAN nations – Indonesia, Malaysia, the
within the domestic manufacturing industry. Philippines and Thailand – are expected to join
the ranks of Asia’s group of nations that have
a GDP exceeding $1 trillion by 2030. Pharma
companies have realized this and are investing
to capitalize on this market. Recently, global
drug giant, Sun Pharma said it had invested
about $4.5 million to increase its stake in
Ranbaxy Malaysia to 85.9 per cent from 79.55



GLOBAL MARKET BY REGIONS/GEOGRAPHY (2018 TO 2025) offers lucrative deals from the local governments. One
100 of the recent examples is Biocon which had set up it’s
production plant in Malaysia in 2016, has received a
80 Rs 460 crore ($ 70.3 million) insulin supply pact with
Malaysian government in 2017 and this is expected to
60 de-risk Biocon’s investment in setting up the plant.”

40 What is fueling this growth?

20 The rapid growth of pharma in emerging markets has
been attributed to several factors. One major factor
0 United States China Europe Japan Southeast Asia India is the patent cliff affecting several branded drugs that
have been in the market for decades. Another is the
 2018  2022  2025 shift toward the use of generic drugs in developed
and developing countries, as well as the increasing
per cent. It is Sun’s second boost in the venture in availability of biosimilar drugs. The third factor is
three months. Abbott acquired a 51.69 per cent stake the change in disease patterns in emerging countries.
in Vietnam’s leading pharma firm Domesco. In late Less healthy lifestyles have led to an increase in costly,
2015, Sanofi inaugurated its third plant worth $75 chronic disorders, such as cardiovascular disease and
million in Saigon High-Tech Park in Ho Chi Minh City, diabetes. Finally, the significant differences between
Vietnam. South Korea’s Daewoong Pharmaceutical manufacturing costs and prices between developed
recently inaugurated a new biotech research Centre and emerging markets has made these regions
at Universitas Indonesia (UI), a state university in manufacturing powerhouses for big pharma.
Depok, Indonesia. Currently, Malaysia, Indonesia,
Thailand and the Philippines are the most business Growing healthcare needs have also prompted
friendly markets for MNCs and these markets also Asian governments to make long-term investments
in improving their health infrastructures. Sieburg
“In Asia, mainly Indonesia should enjoy added, “Strong economic growth across the region
strong pharmaceutical market growth (+6-7 per cent in Vietnam and the Philippines and
through the end of the decade. From +4-5.5 per cent in Indonesia, Malaysia, and Thailand)
2008 to 2015, the pharmaceutical market is allowing for increased ability-to-pay out-of-pocket
there has doubled and another near as well as driving the uptake of private insurance
doubling can be expected in the period that can supplement public healthcare systems.
from 2015 to 2020. Vietnam and the Along with rising incomes, consumer behavior will
Philippines should also enjoy decent help boost the pharmaceutical markets. Consumers
growth in the next few years, as they will prioritize product safety and effectiveness, which
also have the strongest economic and over time, should bode well for innovative pharma
income growth. Meanwhile and branded generics. While rising health awareness
in the Philippines, in these countries also drives market growth, longer
the industry could life expectancy and an ageing population along with
receive a further shifting diets and other lifestyle habits are leading
boost from efforts to the increased burden of chronic diseases in the
to curb counterfeit region. This will be a long-term trend that the health
drug production systems and stakeholders in these countries will need
and distribution.” to adapt to provide for patients.”
- Micheal
Sieburg, Sharing his views Patrick van der Loo, the
Associate Emerging Markets Asia Lead for Pfizer Essential
Partner, Health, says, “Emerging Asia is a dynamic region
Solidiance with a total population of more than 2 billion people.
Rising income, growing middle class, urbanization,
the aging population, and rising incidence of
Noncommunicable diseases (NCDs) will continue
the high public demand for better healthcare and
infrastructure. We are also seeing strong political will
as well as push for universal health coverage across
developing Asia for the development of a strong



2014 PHARMA SPENDING (2014-2019 CAGR)

$3.0 billion (11%) $5.7 billion (10%)
• Health care coverage: nascent • Health care coverage: nascent
• Out-of-pocket spending: 51% • Out-of-pocket spending: 43%
• Private insurance: 11% • Private insurance: 12%

$7.5 billion (5%) $9 billion (9%)
• Health care coverage: maturing • Health care coverage: nascent
• Out-of-pocket spending: 21% • Out-of-pocket spending: 37%
• Private insurance: 12% • Private insurance: 25%

$1.7 billion (8%) $1.2 billion (7%)
• Health care coverage: maturing • Health care coverage: mature
• Out-of-pocket spending: 41% • Out-of-pocket spending: 51%
• Private insurance: 12% • Private insurance: 9%

Source: Economist Intelligence Unit database.
Note: The maturity of various health care systems is defined by parameters described in “Health and Health-Care Systems in Southeast Asia: Diversity and Transitions,” Virasakdi Chongsuvivatwong et al., The
Lancet 377, no. 9763 (2011): 429-437. Private insurance is offered as a CAGR; the predictions are for life insurance, whole market, policies and premiums, and gross written premiums from 2015 through 2019.

healthcare system. Strong hospital sector growth and Innovation is not a new concept in Asia, it started
developing private hospitals in emerging markets is from China few years back and now countries such
leading to more patients being diagnosed and seeking as Indonesia, Korea and India have joined. Over
treatment. Also, there is a rapid transition to new the years pharma giants have realized that smaller
digital health model and health data is pervasive, companies require handholding from discovery to
which should help track and optimize resource the final technology transfer. The APAC market has
allocation for healthcare.” been promising high growth for quite some time and
it is imperative that bigger companies should tap
ASEAN, the powerhouse of pharma R&D this opportunity. Few examples are: South Korea’s
Daewoong Pharmaceutical recently inaugurated a
Although traditionally, emerging clusters in Asia have new biotech research centre at Universitas Indonesia
been an industry choice for outsourced manufacturing, (UI), a state university in Depok, Indonesia. The
big pharma is now focusing on strengthening their facility will focus on biologic drugs including
R&D capabilities and infrastructure in ASEAN epidermal growth factor and growth hormones from
markets, thanks to increased local demand and 2018 onwards. This will not only help the Korean
potential economic upsides. Experts opine that company to maintain it’s foothold in the local market
investment in local research and manufacturing to but also support the Indonesian government’s
be the most effective levers for commercial success initiative to reduce imported drugs.”
in these regions, and this has prompted many MNC’s
to form alliance with local drugmakers. Also, easy Diversity of ASEAN
availability of human capital, and low-cost skilled markets pose a challenge
labour within these countries make them strong areas
for outsourcing and development. Studies have shown However, despite their huge untapped potential,
that performing clinical trials in emerging countries ASEAN’s emerging markets display a wide diversity
is less costly and can reduce drug development costs in their stages of development, particularly with
significantly, making it easier to lower prices while regard to their healthcare infrastructure. For this
maintaining gains. reason, there can be no “one-size-fits-all” approach
to emerging markets in Asia. Varying income levels,
Dr Dutta explains, “Reverse Innovation, low cost regulatory hurdles, and changing policies are some
of setting up of R&D centres in Asia and attractive of the major challenges of these markets. Asia’s
promotions by the local government (such as health systems are at varying stages of evolution,
incubation centres and science parks) are driving ranging from Singapore which has one of the most
innovation and growth in the Asian market. Reverse



highly developed and efficient healthcare systems to specific market segments. For example, recent
in the world, to the relatively underdeveloped changes to the regulatory landscape in Vietnam will
and extremely underfunded healthcare systems likely dramatically alter the distribution landscape
of Cambodia, Laos and Myanmar. As a result, and the business models employed by most foreign
the healthcare systems across Asia have country- pharmaceutical companies. While incomes are
specific needs and operate within different financial rising and public health insurance is expanding in
constraints, necessitating different tailor-made these countries, out-of-pocket payments can limit
strategies for pharmaceutical companies wishing to the patient ability-to-pay for pharmaceuticals in
be successful in each market. these countries. In Vietnam, out-of-pocket payments
account for just less than 50 per cent of healthcare
Sieburg maintains, “Regulatory challenges spending while in Indonesia, Malaysia, and the
can come in the form of pricing pressures as the Philippines it is around 40 per cent. However, private
government seeks to contain costs, especially where health insurance penetration is also increasing at ~10
the government is moving towards universal health per cent per year in these countries that will soften
insurance as we see in Indonesia, Thailand, and the burden of out-of-pocket payments over time.”
Vietnam. Broader patient access to the healthcare
system in these countries is a positive step and “The burden of cancer on patients, healthcare
while it opens up new doors of opportunity for the systems and economies is rising throughout the
pharmaceutical sector, that door is wider for lower Asia region, and the actions we take now will have
cost therapies, especially as governments move a profound effect on generations to come. With the
towards reference pricing and generics substitution. exception of a few developed markets, the majority
Other regulatory issues might be more relevant of the healthcare systems in Emerging Markets Asia
are under-developed with limited public funding and
“Emerging Asia is a dynamic region infrastructure, a shortage of qualified Health Care
with a total population of more than 2 Professionals (HCPs), and high out-of-pocket (OOP)
billion people. Rising income, growing burden on patients. We are encouraged by the efforts
middle class, urbanization, the aging of several emerging Asian markets that are working
population, and rising incidence of to improve and strengthen their intellectual property
Noncommunicable diseases (NCDs) (IP) regime; however, we continue to face challenges
will continue the high public demand obtaining and enforcing our IP rights in this region.
for better healthcare and infrastructure. The public sector is the largest healthcare provider
We are also seeing strong political will and payer and health expenditure has been increasing
as well as push for universal health exponentially. But a common challenge remains on
coverage across developing Asia for cost containment coupled with limited or lack of access
the development of a strong healthcare to quality healthcare and medicines for patients.
system. Strong hospital sector growth and Despite many of the developing nations in Emerging
developing private hospitals in emerging Markets Asia graduate to developed economies, the
markets is leading to more patients being public investment in healthcare (drugs in particular) is
diagnosed and seeking treatment. Also, still lagging (4 per cent of GDP vs. OECD’s average of
there is a rapid transition 10 per cent),” maintains Patrick van der Loo.
to new digital health
model and health Nonetheless, it is estimated that in the next decade,
data is pervasive, the global population will increase by one billion
which should help people, and most of this growth will occur in ASEAN
track and optimize emerging markets. These newly-formed middle-class
resource allocation for consumers coupled with high incidences of diseases
healthcare.” will represent the single biggest opportunity for big
- Patrick van der Loo, pharma. Also, growth prospects in pharma sector
the Emerging Markets largely stem from the many underdiagnosed and
Asia Lead for Pfizer untreated diseases in emerging markets. Hence,
Essential Health despite challenges, the aforementioned rapid rise
in incomes, more informed patients and expansion
in healthcare access all add to the opportunity for
pharma expansion in emerging markets of Asia.

Aishwarya Venkatesh
[email protected]



Industry as a partner
brings best success

« What is the progress so far regarding the
National Biopharma Mission?
Dr Renu Swarup, Biopharma mission was launched last year. This was
the first largest mission which the DBT launched
Secretary, Department with approval of the cabinet in which the World
Bank became our 50 per cent funding partner. The
of Biotechnology, uniqueness of this programme is that we intend to
support lot of research programmes in bio-pharma
Ministry of Science related activities. We know that we are the best
vaccine manufacturers in the world. Today India has
and Technology, gained a position in the field of biosimilars, medical
devices and diagnostics. We are supporting all these
Government of India areas. Through this mission we are trying to create an
eco-system wherein indigenous product development
Avery senior and experienced official in the can be supported, and the industry and academia can
Department of Biotechnology (DBT), Dr work together to take it forward. It is not the product
Renu Swarup has been appointed as the that we are supporting, it is the full eco-system that we
Secretary, DBT. Prior to that she was Advisor for DBT
and Managing Director of Biotechnology Industry are creating, where we would pick up the leads, try to
Research Assistance Council (BIRAC). She has been put them through this product development phase and
working with the DBT in different capacities since in that full exercise create that national infrastructure
1989. She was actively engaged in formulation of the which is required. We intend to help researchers and
Biotechnology vision 2001 and National Biotechnology start-ups in their product development for which
Development Strategy 2007 as the member secretary they will have nationally available facilities, and the
of the experts’ committee. She was also a member government becomes their product development
of the Task Force on Women in Science constituted partner. We are implementing all this through BIRAC.
by the Scientific Advisory Committee to the Prime By being a product development partner, we can
Minister. In conversation with BioSpectrum Dr own up the product in next five years and that is our
Swarup elaborated on her vision and plans for DBT. eventual objective. By next one month or so you will
Edited Excerpts- see the first lot of projects being supported. Overall,
we have very high level, high standard, international
What is your vision for DBT’s work and experts’ committees which are part of our current
development further? scientific and technical advisory groups.
DBT is in a very unique position today. We have
established a very sound bio-tech eco-system in terms
of the support we have for the research, education,
the human resource and infrastructure. Now we need
to consolidate and converge by connecting all the
stakeholders especially the state governments, for both
national and international levels. We need to bring
our research to the society. We need to ensure the
proper translation of our products. It is important for
us to position bio-technology as the key element in the
bio-economy. The next 2-3 years are very important
for the research, for the products being rolled out, for
marketing and for reaching out to the society. In order
to meet these requirements, skilled human resources
are extremely important. We need to work on this. We
need the right kind of skills to carry out the required



DBT had previously approved a project on and academia? What is your expectation from
accelerating the application of stem cell
technology in human diseases. How effective the industry?
would this strategy prove out be? Translation is a huge priority for us. DBT has really
DBT has a major programme on stem cells. The done well in the last couple of years by creating sound
research part is going on, not only through one foundation for the translational ecosystem. Connecting
programme but we have a number of programmes the researchers to the industry and to the entrepreneur
and activities. Besides national programmes, we also is done wonderfully through BIRAC and it is a success
have a major Indo-Japan programme through which story which everyone knows. DBT has created two
we will be creating a bio depository. We are using the vibrant bio clusters, one at Bangalore and the other
stem cells for the treatment of retinal disorders. Also, at Faridabad. Now one more is being supported at
the DBT and ICMR have jointly brought out the stem Kalyani. We will soon be looking at industry academia
cells guidelines and regulations which researchers are translational bio clusters as well. Currently, these bio
following. The stem cell technology has already started clusters include the best of the academic institutes,
making an impact and it would be moving really fast. and the best of science that is globally recognised.
Also our incubation centres are co-located with these
How setting up of the DNA databanks at different bio clusters. The entrepreneurs or the start-ups which
levels would help? come in have access to this technical knowledge that
We are looking at different types of databanks. We comes from the institutes and the researchers from the
have a bio depository that has been set up for clinical institute also think of moving to the incubation centre.
trial work, and one for maternal and child health But we need to rope in the industry for such activities.
database. We are also looking at developing one for our The best success comes when the industry becomes a
genomic programmes. Getting the data and putting partner from the beginning as a co-developer. Rota
into bio depository is most crucial and important. virus is a wonderful example of this association. The
Earlier it was difficult, but with big data analysis, deep initial research was done by the academic groups
learning etc. there could be enormous opportunities but when they got into the development stage, the
now. We intend to create depositories for different industry became a partner. Today, the product is part
sets of programmes we are supporting. But more than of our immunisation programme. That is the level of
just creating these depositories we wish to involve partnership that needs to take place.
researchers to try and see how best they can use the
data. It will surely create a huge impact. Another example is the Dengue vaccine
programme, where the ICGEB researchers started
How does DBT plan to ensure the development working with Sun Pharma. Such co-developmental
of a translational ecosystem connecting industry activities need to be promoted and encouraged.

We are currently working on policies around it
because this would require some well laid policies
on working together, sharing of knowledge, and the
commercialisation rights.

How is India’s biotech industry fairing against

nations like Australia, China and Singapore?
India is definitely being recognised today in the bio-
space as a leader in terms of its research capacity,
and in terms of its scientific research strength. On
the other hand, in the biotech industry today we
have some layers which are globally well recognised.
Of course, Singapore has many vibrant clusters
but India is not far behind. We have a wonderful
collaboration with Australia. Many good things are
taking place in India. We have developed a whole
biotech ecosystem in a short period of time and we
are working on taking it ahead. We need to put in the
right time and effort and make India a global player.
We are on the right track.

Milind Kokje
[email protected]



ICMR has to do more work in
non-communicable diseases

« with the Kerala government health ministry and
have been able to contain it. In the 2001 and 2007
Prof Balram Bhargava, epidemics, much of the samples went to the US CDC
for diagnosis. This time not a single sample had to go
Secretary, Department of to US. Complete diagnosis and prevention programme
was carried out in India through our viral research
Health Research, (Ministry laboratories in Manipal & Alappy and also through
National Institute for Virology. That has worked
of Health & Family phenomenally well. To neutralise the Nipah positive
patients, we have been able to procure the M1025.4
Welfare), Government of antibodies from Queensland within five days, getting
all the permissions from drug controller, getting all
India and Director General, our protocols cleared on compassionate ground,
getting all the permissions through various regulatory
Indian Council of Medical agencies, ministries. The drug is available in Kozicode
today. This happened by the efforts of ICMR through
Research (ICMR) the Ministry of Health.

Acardiologist by profession, Dr Balram is one of We are also in close talks with the producers
the foremost leaders in biomedical innovation, of this antibody so that we are able to initiate some
public health, medical education and medical dialogue with private players to manufacture those
research. He is the Founding, Editor-in-Chief of the antibodies here in India itself. The main question is
British Medical Journal Innovations (BMJi). He has that whether a Nipah virus vaccine can be developed.
been awarded the ‘Padma Shri’ the fourth-highest And that is the third thing we are trying to do. Along
civilian award by the President of India and the with Norway and Wellcome Trust, CEPI (Coalition for
UNESCO Equatorial Guinea International Prize for Epidemic Preparedness Innovations) has signed a tri-
research in Life Sciences at Paris. In conversation with partiate agreement with DBT and they will go ahead
BioSpectrum, Prof Bhargava elaborated on his vision with the development of vaccine and we will provide
and plans for the Indian Council of Medical Research all support in terms of providing samples & also
(ICMR) and Health Research. Edited Excerpts- supplying antigens for testing of the vaccine.

What is your vision of ICMR’s work and What measures, ICMR is taking to develop new
development further?
ICMR is more than 100 years old and it has done so vaccines and improve the disease burden in our
well in communicable diseases, in terms of viral and
bacterial infections. Also, recently in Nipah epidemic country?
it has done phenomenally well, coordinating with The strength of ICMR has been more on point of care
Ministry of Health and the state government as well. diagnostics for viral diseases. We are also trying to
What I look at is we also have to do more into non- develop new vaccines. But the new vaccine programme
communicable diseases and also look at the issues will have to work in very close collaboration with the
which are related to national priorities and sustainable Department of Biotechnology (DBT), where they have
development course. Those two have to be in sync. shown some success. ICMR will provide full support
ICMR will work towards that. to DBT and other stake holders, may be private or
government, to develop the vaccines. But the lead
What actions are being taken to combat the should be taken by DBT or by private players and
Nipah virus? then we will be happy to facilitate, whether in terms of
Nipah has been one of the success stories of public clinical trials, testing or even in terms of getting them
health system of India wherein the Ministry of Health, funded through mobilisation also.
the ICMR, the Department of Science and Technology
(DST), National Centre for Disease Control, (NCDC) Milind Kokje
and the teams from All India Institutes of Medical [email protected]
Sciences (AIIMS), Safdarjang, Dr Ram Manohar
Lohia Hospital, have worked phenomenally well



“India will now play a bigger role
in AstraZeneca’s global operations”

« of the global business strategy. It was mostly focused
on our key therapy areas. That is not at all related to
Veena Rajan, this new venture of ours. The shutdown had to do with
the consolidation in the company’s pharmaceutical
GMD Site Lead activities. The new GMD centre is more on the
development side which include the design and
Bengaluru, India conduct of clinical trials, other regulatory sciences and
supporting our 51 mature products.
Global science-led biopharmaceutical company
AstraZeneca recently announced the opening What are the specific recruitment plans for the
of its new Global Medicines Development
(GMD) Centre in Bengaluru, India. This development new centre? How do you plan to shape it up?
comes four years after the biopharmaceutical company By the end of this year, our recruitment number would
had shut its research and development site here. touch 100. We would be exploring more opportunities
BioSpectrum got in touch with Veena Rajan, GMD Site based on the different talent we come across. We
Lead Bengaluru to find out more about India’s role in have ramped up from a size of 24 in 2016 to 100 now
the company’s global operations. Edited Excerpts, in 2018. We are comfortable with the talent that is
available in India. We are constantly looking out for
What key projects are lined up for the new Global more. For the regulatory section, we hire life science
Medicines Development (GMD) Centre? graduates and PhDs in science, for the clinical side
It is more about the functions rather than projects here we take in only physicians, and for the patient safety
at the new centre. This new centre has been developed sector, we take in a mix of physicians and life science
to handle the mature and established products graduates, both Masters and PhDs.
of AstraZeneca. We would be handling around 51
products, catering to more than 50 countries and their How would this new centre in India contribute
markets, and supporting around 70 million patients.
Our global mature brands lie in the categories of towards the company’s global operations?
oncology, respiratory, cardiovascular and metabolic AstraZeneca has a long-standing commitment in
diseases. The key functions which are part of this India for over 40 years. The GMD expansion is part
centre are patient safety, regulatory and clinical. of AstraZeneca’s continued commitment to enhance
At AstraZeneca, there are three science units with scientific innovation in the country. The GMD unit
two being the Biotech units- Innovative Medicines expansion is the first from a five-year $90 million
and Early Development (IMED) and MedImmune, commitment made earlier this year by the parent
and the third unit is the developmental centre or company. The expanded site is one of nine such global
the GMD centre. This GMD centre covers late stage sites that supports designing and conduct of clinical
development, life cycle management and maintenance trials, monitoring of safety and efficacy and other
of our products. The centre is purely for carrying out regulatory management required during a product’s
developmental activities for our mature products. lifecycle. AstraZeneca India has a specific footprint in
the form of marketing companies, global technology
Would this new centre be used for carrying out centre, IT sector, manufacturing unit, and science
any research activities since the company’s R&D unit. We plan to effectively collaborate through these
centre got shut down in Bengaluru few years units with the Indian government as well. Since
ago? AstraZeneca is an Anglo-Swedish company, we do
The R&D centre which got closed earlier dealt with keep collaborating with the Swedish government
more of the pharmaceutical developments. It was part as well. Besides, we cover more than 50 markets
including APAC region, US, Europe, Japan, China and
Australia. With this new centre, India will now play a
bigger role in the AstraZeneca’s global operations.

Dr. Manbeena Chawla
[email protected]



Singapore &

Singapore has one of the highest diabetes-
over 1,500 amputations per year due to complications
related lower extremity amputations rates arising from diabetes, roughly 4 per day.

in the world, with 180 such amputations Realising the gravity of the issue the Singapore
Health Minister Gan Kim declared ‘War on Diabetes’
performed for every 100,000 adult diabetics in April 2016. While debating on his ministry’s budget,
the minister said that his ministry will first work on
in 2015. Diabetes is the second leading upstream prevention by promoting healthy lifestyle
and reducing obesity rates in order to cut down on
cause of morbidity and mortality in Singapore. new diabetes cases. “The government will also move
to strengthen early screening and intervention so as
Realising the gravity of the issue the Singapore to identify the disease early among those at risk or
undiagnosed,” he said and added “the government
Health Minister Gan Kim declared ‘War on will support better disease control so that disease
progression can be slowed and complications reduced.”
Diabetes’ in April 2016. In just over two years
To coordinate the strategies on the War on
the government has taken up a holistic Diabetes, the government had formed Diabetes
Prevention and Care Taskforce. Health Minister Gan
approach with involvement of different Kim is co-chairing the task force with Minister for
Education. The taskforce included representatives
ministries and involving citizens to realise from government agencies, the private sector, patient
advocacy and caregiver groups.
a sustainable healthcare future where all
Singapore’s Prime Minister Lee Hsien Loong,
Singaporeans enjoy Better Health, Better in his National Day Rally 2017 speech, highlighted

Care, Better Life.

Diabetes is a growing problem in Singapore
today. It is the second leading cause of
morbidity and mortality in Singapore. Figures
from the National Health Survey 2010 reveal that 11.3
per cent, or 1 in 9 Singapore residents (Singapore
citizens and Permanent Residents) aged 18 – 69 years
were affected by diabetes. Of these, 1 in 3 diabetics
were unaware that they had diabetes. Among the
diabetics who were aware of their disease, 1 in 3 had
poor control of their condition.

In 2014, around 440,000 Singapore residents aged
18 years and above had diabetes. It was estimated that
the number of diabetics in Singapore could rise to
670,000 by 2030 and nearly 1 million by 2050, based
on an estimate by the Saw Swee Hock School of Public
Health if no measures are taken now.

Poorly controlled diabetes can lead to serious
complications such as heart disease, stroke, kidney
failure, blindness, and lower limb amputations. These
complications, which are often life-long, affect an
individual’s health and quality of life. Furthermore,
these can in turn affect their family members who
need to take care of them and worry about their health.

Based on figures from the National Registry of
Diseases, in 2014, about 1 in 2 heart attack cases had
diabetes; 2 in 3 new kidney failure cases were due to
diabetes; and 2 in 5 stroke cases had diabetes. There are



Citizens’ Jury’s Recommendation and Ministry of Health’s Response

1. Education and Awareness 2.10 Citizen-led “Drink Water” Campaign (Support)
1.1 Public outreach programmes targeted at 2.11 Healthy food preparation and cooking

residents of HDB heartlands (Support) competitions (Support)
1.2 Inclusion of the at-risk solitary, elderly 2.12 Expand, popularise and collaborate with

and illiterate groups through face-to-face existing organisations that offer cooking
interaction (Support) courses (Support)
1.3 Diabetes awareness campaign and curriculum Healthy Living – Incentives
for children (Support) 2.13 Health points/travel rebates as incentives to
1.4 Introduction of the “Go Green Guide” (Explore) encourage physical activity (Explore)
1.5 A platform/repository to consolidate diabetes- 2.14 A rewards/incentives scheme to encourage
related material (Support) better disease management among people
1.6 Raise awareness of this consolidated platform living with diabetes (Explore)
(Support) 3. Enhancing Skills of Healthcare Providers
1.7 Central repository for registered interventions and Caregivers
(Explore) 3.1 Communication-focused Diabetic Care Clinic
2. Healthy Living – that may adopt motivational interviewing as
Supportive Environment an approach to influence positive behaviour
2.1 Re-examine the “Healthy Meals in Schools” (Support)
Programme and encourage wider adoption 3.2 Expand the role of Singapore Association
(Support) for Counselling (SAC) to include clinical
2.2 Popularise “My Healthy Plate” guidelines communication and chronic disease counselling
(Support) (Support)
2.3 A “Healthy Hawker” competition (Explore) 3.3 Expansion of the responsibilities of the
2.4 Rating hawker centres (Unable to support at Association of Diabetes Educators Singapore
present) (ADES) (Explore)
2.5 Limit on fast food and snacks advertisements 4. Peer and Community Support
(Explore) 4.1 Increase peer support by expanding the number
2.6 Restrictions on the use of garnish in food of peer groups (Explore)
advertisements (Explore) 4.2 More effective peer matching through a central
2.7 Limit promotion on or shelf placement of health platform (Explore)
nutritionally poor foods (Explore) 5. Medical Care Costs and Outcomes
2.8 Celebrity/mascot endorsements for healthier 5.1 Raise the Medisave – claimable amount for
foods (Support) CDMP to $750 (Support)
2.9 Use emotionally targeted counter advertising to 5.2 Adoption of a Patient-Outcomes funding model
improve behaviours (Explore) (Explore)

the importance of fighting diabetes and went on to Health, Dr Amy Khor. Dr Khor commended the
encourage citizens to exercise more, go for regular Jury’s commitment and enthusiasm to work with
medical check-ups, eat more healthily, and cut down the Ministry of Health to co-deliver solutions to
consumption of soft drinks. fight the War on Diabetes. She was encouraged that
Singaporeans were ready to step up, take ownership
In addition to forming a task force to deal with this and co-create solutions with the Government to make
issue, the Ministry of Health, in collaboration with the a difference for the community.
Institute of Policy Studies, embarked on the Citizens’
Jury for the War on Diabetes to mobilise citizens to raise In a post-event survey, 90 per cent of the
awareness about diabetes and generate community- participants indicated their keenness to contribute
based recommendations on how to better prevent and more actively to whole-of-society efforts in the War on
manage diabetes as a nation. Over a span of seven weeks Diabetes, and to inspire their community, family and
(November 2017 to January 2018), participants sought friends to do so. Also, 86 per cent of the participants
advice from subject matter experts. They discussed felt that their Citizens’ Jury participation helped
and debated ideas and proposals among themselves, them better understand the challenges of balancing
to come to a consensus on the recommendations that competing needs and finite resources in developing
they, as a Jury, wanted to put forth. solutions for the benefit of all Singaporeans. The
findings demonstrate a larger and longer-lasting
The Citizens’ Jury concluded on January 13, impact of the Citizens’ Jury for the participants that
2018 when the 76 participants submitted their went beyond their recommendations.
recommendations to Senior Minister of State for



Citizens’ Jury has made 28 recommendations who will support them to take on proactive roles in
to Ministry of Health under five broad categories – disease management and lifestyle changes.”
seven (Education and Awareness), fourteen (Healthy
Living – Supportive Environment and Healthy Living As part of the War on Diabetes, Parliamentary
– Incentives), three (Enhancing Skills of Healthcare Secretary for Health, Amrin Amin, at the Ministry of
Providers and Caregivers), two each (Peer and Health Committee of Supply Debate 2018 said “We
Community Support and Medical Care Costs and will continue to support all Singaporeans regardless
Outcomes). Off these the Ministry of Health has of economic and socio-economic backgrounds to eat
agreed to support 15 recommendations and pointed healthily, be screened, and exercise.”
that it will look at exploring 13 other recommendations
in the coming days. Recognising the work and initiatives undertaken
by the Singapore government related to War on
Sharing the initiatives of the government, Dr Lam Diabetes, the World Health Organization (WHO) has
Pin Min, Senior Minister of State for Health, at the appointed Singapore Minister for Health Gan Kim
Ministry of Health Committee of Supply Debate 2018 Yong as a member of the High-level Commission on
held in March said that his ministry is developing a Noncommunicable Diseases (NCDs) on February
Patient Empowerment for Self-care Framework to 17, 2018. Reacting to this Gan Kim Yong said, “I am
empower people with diabetes. The main objective honoured to be appointed to the Commission. Non-
is to initiate and sustain lifestyle changes, with the communicable diseases (NCDs) continue to pose a
support of healthcare professionals, community- major health challenge to Singapore and the world. In
based providers, and other forms of social support. Singapore, NCDs are responsible for more than 80 per
Under this framework, there will be a National cent of the total disease burden. In 2016, Singapore
Curriculum developed with educational materials for declared War on Diabetes and mobilised the nation to
patients, caregivers and the public; and resources tackle one of our most pressing NCD concerns. I look
which healthcare professionals and community-based forward to sharing Singapore’s experience, exchanging
providers can use for patient empowerment. The first views with our global counterparts, and contributing
tranche of materials will be available by mid-2018. to the work of the Commission.”

The Ministry of Health is concurrently enhancing Winning the War on Diabetes requires the whole
its diabetes management programmes. As part of the of society to work together. To do this, Singaporeans
Disease Management Workgroup, set up under the must help each other live free from or live well with
National Diabetes Prevention and Care Taskforce, diabetes. Inherent throughout the recommendations
the government has rolled out initiatives targeted at put forth by the Citizens’ Jury is the underlying spirit
eye and kidney complications. The ministry will now of the community coming together to ensure everyone
addresses diabetic foot complications, as diabetes is cared for. Ministry of Health agrees and appreciates
is the most common cause of non-traumatic lower this, and welcomes and supports the community-
extremity amputations (LEAs). In 2015, about 180 organised efforts by supporting over 60 per cent of its
diabetes-related major LEAs were performed for every recommendations.
100,000 adult Singaporeans with diabetes, compared
to the Organisation for Economic Co-operation and “The Ministry of Health will continue to invest
Development (OECD) with an average of 60. and promote good health. It will work closely with
individuals, families, industry and community
The Ministry of Health will be setting up a workgroup partners. But personal responsibility for healthy living
to review the national organisation of diabetic foot remains a key factor. The goal of the government is
services, make recommendations on national care to realise a sustainable healthcare future where all
guidelines, and review the roles and training needs of Singaporeans enjoy Better Health, Better Care, Better
healthcare professionals involved in diabetic foot care Life,” concludes Amrin Amin.
to decrease the lifetime risk of amputation for diabetic
patients. The ministry has thus provided funding Narayan Kulkarni
to support cluster-led, community-based diabetes [email protected]
prevention and management programmes.

Dr Lam Pin Min further said “Later this year,
the National University Health System (NUHS) will
launch the Patient Activation through Community
Empowerment/ Engagement for Diabetes Management
(PACE-D) programme in the west where patients will
be assigned to dedicated multi-disciplinary care teams



Chinese pharma moving
towards innovation

From favorable policies to capital injections, Chinese companies working
on creating new medicines have plenty on their plate now. China’s
biopharmaceutical sector is on the go. Spurred by healthcare needs,
generous government investment and the return of thousands of
China-born, west-trained scientists, a string of new and innovative
biopharmas have emerged in China.

With 1.3 billion population and a burgeoning this is changing now. A new
middle class, China has witnessed an generation of pharma and
unprecedented increase in healthcare biotech players have sprung
consumption. China is the world’s second largest up who are racing to launch
pharma market, only behind the US and is currently innovative medicines and
one of the most lucrative and promising markets for grab a slice of the market
the global pharmaceutical industry. share. Reports suggest that
the number of applications of
The market of China is currently ruled by foreign local innovative drugs entering
players who enjoy more than 70 per cent of the clinical trials in China
market share. For long, China was symbolized as has grown from
the ‘world’s factory’ known for its cheap and low- 21 in 2011 to
end products. Pharmaceutical products have strict 88 in 2016, a
regulatory requirements and for long ‘Made in compound
China’ was not an acceptable brand. However, as annual
the market has grown, so has talent and technology growth
in the country, thus changing the idea that Chinese rate of
products are inferior. 33 per
Thanks to factors like mounting medical needs,
government support, introduction of policies
favorable to innovation, and capital injections, the
Chinese pharma industry is entering a golden age
of innovation and development. The government,
under the leadership of President Xi Jinping has
made pharma innovation a national priority. Global
consulting firm McKinsey estimates that there are
nearly 800 molecules in development and soon
China might receive US FDA nod for first ever drug
candidate that is “Made in China.”

Discovered by Tu Youyou, Artemisin, a
drug that treats malaria was the first novel
Chinese drug to receive approval in
1970s. Though discovered in China,
Artemisin didn’t get global recognition
until Novartis commercialized and
marketed it in 1990s. Since then,
China has not discovered any drug
candidates for the global market. But,



Sharing his insights, Sanjeev Kumar, both in basic research, in industry research
Industry Manager, Transformational and development. We believe that in the
Health: Life sciences, Frost & next few years, there will be more “first-
Sullivan, said, “By 2020 China is expected in-class” or “best-in-class” drugs, as well
to be in a phase of active innovation. More as unique combination therapies, developed
homegrown biotech firms will come up
with innovative products and lead by Chinese innovative pharmaceutical
the innovation initiatives. The companies”
consolidation of local players is also Headquartered in Hong Kong,
Chi-Med, a leading Chinese
expected, which will allow them biopharma company has developed
to leverage technology and a broad pipeline of novel oral
assets from other companies. drug candidates for oncology
China is expected to have many first in
class molecules by 2020, owing to current and immunological diseases. Chi-Med has nearly
government initiatives to speed up the new eight drug candidates now in active or completing
drug approval process. We might also see clinical trials, and has submitted first China New
some breakthrough drugs coming out of Drug Application on fruquintinib-drug that treats
china. More local companies with R&D focus colorectal cancer. Chi-Med has also initiated first
are expected to go global by expanding into global Phase III registration study on savolitinib-
overseas market.” again a cancer drug and has five other pivotal Phase
China-based Beigene focusses on III studies underway. Chi-Med plans to launch
developing novel candidates that treat fruquintinib in China in 2018. In its annual report,
lymphomas. The company has four lead the company stated that it aims to launch 1-2 novel
indications under development and has drugs each year.
increased its R&D spending to $269.02 million
in 2017 compared to $98.03 million Jiangsu Hengrui Medicine is a frontrunner
in 2016. Beigene hopes to file its in pharma innovation in the country. Hengrui
first New Drug Application Medicine invests 10 per cent of its annual turnovers
(NDA) later this year. The in research and development, and has constituted a
company’s spokesperson thorough innovation system with R&D centers and
said, “Over the past few years, clinical division in New Jersey, Shanghai, Chengdu,
pharmaceutical innovation and Lianyungang. The company specializes in the
in China has picked up. In research and development of new medicines in areas
terms of revenue, China’s of antineoplastics, endocrine system, cardiovascular,
pharmaceutical market is the and the immune system.
second largest worldwide,
after the United States. With Based in Shanghai, Hua Medicine is another
expanding reimbursement leading, clinical stage innovative drug development
coverage, increasing patient company in China focused on novel therapies for
affordability and willingness the treatment of diabetes. In 2017, Hua advanced
to pay, continued growth a first-in-class oral drug for the treatment of Type
is expected to address the 2 Diabetes into NDA enabling stage and started
significant unmet medical two Phase III trials in China for drug naive and
need among China’s patient metformin treated T2D patients.
population. Meanwhile,
reforms at the China Food In line with its peers, China’s Luye Pharma has
and Drug Administration also upped its R&D budget and made significant
(CFDA) show its commitment progress in terms of new molecule development.
and determination to Phase II clinical trials for its new anti-depressant
accelerate the pace of drug-Ansofaxine have achieved positive results in
pharmaceutical innovation in China. Key clinical trials for Rivastigmine Multi-
the country. In short, China Day Transdermal Patches have been initiated in
has already stepped into a Europe. In terms of biological antibodies, it has
new era of drug innovation, lead Recombinant monoclonal antibody injections
in different phases of clinical trials. The company
has also launched a series of R&D projects on the
subject of biological antibodies, in collaboration with
domestic and foreign partners.



Stage set for biotech boom “Made in China 2025” initiative and plans to invest
heavily in creating R&D and innovation hubs in
China’s huge market potential can never be ignored. China,” Sanjeev added.
Analysts expect the pharma industry to grow into
a $1 trillion behemoth by 2020. China faces steady Availability of Talent
healthcare needs—one in three Chinese have diabetes
and more than 700,000 new cases of lung cancer A decade ago, Chinese scientists returned to their
are diagnosed each year. President Xi Jinping has country lured by their homeland’s fast growth and
identified his country’s reliance on foreign drug government support. Many of these ‘West-trained’
imports as a critical concern and “Made in China Chinese alumni of MNCs have established biotech
2025” is arguably Xi’s one of the most decisive
attempts to boost local innovation. As part of its UNDERWHELMING R&D
“Made in China 2025” plan the country aims to boost China punches below its weight in global new drug discovery
domestic innovation in medicine and reinvent its
pharmaceutical industry. Being able to create national  Pre-market R&D in 2015  New molecules 2007-2015
heavyweight companies that can dominate the Chinese
market, compete and beat foreign competitors, ticks 60.0%
all the boxes of the “Made in China” plan.
Sharing her views Sakshi Sikka,
Pharmaceuticals & Healthcare 40.0%
Analyst, BMI Research,
opined, “The development of 30.0% China contributed
a ‘Healthy China’ is central to 20.0% 2.5% of new drugs
the government’s agenda for
improving the healthcare sector 10.0%
and the country’s president, Xi
Jinping, has put healthcare at 0.0% Japan U.K. Germany Switzerland South Korea China
the center of China’s policy- U.S.
making endeavour. Local
pharmaceutical firms in Sources: China Pharmaceutical Enterprise Management Association, China Pharmaceutical
China will benefit from Industry Association, China Chamber of Commerce for Import & Export of Medicines & Health
greater government Products, R&D-based Pharmaceutical Association Committee
support. A number
of government-led

initiatives were rolled out in the country over the
course of 2017, many of which will have important
ramifications for the local pharmaceutical industry
such as far-reaching reforms to the country’s
regulatory system that aims to speed up approvals
of medical technologies in the country. In line with
the ‘Made in China 2025’ plan’s focus on improving
manufacturing innovation and strengthening the
industrial base, Chinese domestic drugmakers
are developing drugs to cater to the needs of the
country’s vast ageing population. The domestic
market also offers huge potential for sales as the
burden of chronic disease in China grows.”

“The “Made in China 2025” campaign has led
to significant increase in Smart Manufacturing,
Industrial IoT and Cloud platforms across the
program’s focus industries, including medical
technology and R&D in Pharma. AI and VR are major
innovation segments that medical products in China
will introduce. China wants to keep ahead of the
technology race, which is a major component of the



startups that aim to address the gaps in healthcare encompass younger talent and foreign scientists, and a
needs of the country. In 2008, China’s central decade later, the Thousand Talents Plan has attracted
government announced the Thousand Talents Plan: more than 7,000 people overall. For Chinese scientists,
a scheme to bring leading Chinese scientists living the scheme has given them a strong financial incentive
abroad back to China. Now in its tenth year, the to return home and establish biotech startups with
initiative has helped many Chinese settled abroad expertise gained abroad.
to return to China. In 2011, the scheme grew to
Supportive policies
DRUG BOOM: driving the wave of innovation
From May to October 2017, China Food and
500 Drug Administration (CFDA) rolled out a series
of supportive policies to encourage innovation in
450 medicines and medical devices. For long, intellectual
property rights in China was a major concern.
400 China has long been criticized by the international
community for its lack of appropriate intellectual
U.S. dollars in billions 350 property rights and protection; thus hampering
pharma innovation. Addressing this issue, China
300 established a three anchor points linking drug
and patent, patent period compensation, and data
250 protection in 2017. With this approach, China has
a systematic protection mechanism to effectively
200 protect the patentee’s legitimate rights and interests,
driving the wave of innovation.
Also, on June 1, 2017, CFDA officially became
100 a member of the International Council for
Harmonization of Technical Requirements for
50 Pharmaceuticals for Human Use (ICH). This was a
landmark event for the Chinese pharma industry,
0 U.S. China Japan Brazil India Russia marking the true integration of its drug regulatory
system into the international community. ICH
QuintileslMS Institute Medicine spending in 2016 is a door that lets China in to the international
community, allowing the country to catch the high-
speed new drug development wave in Europe and the
United States.

Sanjeev pointed out, “Reform measures were
announced in 2017 in the area of clinical trials
that will help the market to expedite the review
and approval process of generic drugs as well as
any innovation in the pharma sector. Reforms
announced ensure that more medical institutions
will receive approval and ministry support to conduct
phase 1 clinical trials. Special regulations will be
announced in 2018 to reduce the time-to-market for
innovative medical devices for consumers.”

Deep pockets

Ongoing policy changes and steady increase in size
of the market has lured investors. According to the
Annual Report on China’s Equity Investment in
2017, there was a total of 9120 investment cases in
China, of which 1008 were related to the biotech and
pharmaceutical industry. In terms of investment
number, biopharma is second only to the internet



and IT sector and in terms of investment volume the government is trying to bring a change in the
biotech ranks fifth in all industries, with a total of system to facilitate a faster innovation, in reality it
$11 billion. Among the investment firms, C-Bridge would be tough to implement as China has a complex
Capital, Tasly, Temasek Holdings, Shenzhen Capitol healthcare system with several roadblocks.”
Group are the most active. Chinese investors who
are looking to diversify their portfolios away from Sakshi added, “The overall transition of Chinese
property and manufacturing are encouraged by the drugmakers towards innovative treatments will
growth prospects of the life sciences, given China’s be a long-term process. Drug discovery presents
unmet medical needs and ageing population. significant risks on the return on investment,
necessitating China-based firms to evolve their
Yet, say experts, even as China is emerging current business models that are primarily focused
as a new center for pharmaceutical research, the on generic drugs. As such, the short-to-medium
industry is still in its early days. There is time before term will see Chinese drugmakers forming
its aspirations of becoming a world-class innovator partnerships with multinational drugmakers instead
become a reality. The Chinese pharmaceutical of playing a leading role in the R&D. In addition,
market is notoriously fragmented, with most Chinese consumers prefer multinational firm’s
companies selling generic drugs. This fragmentation pharmaceutical products due to concerns over the
keeps investment in research and development quality of domestic drugs. China has been a prolific
low, with R&D investment averaging 5 per cent source of counterfeit and defective medicines. For
of sales for Chinese companies, compared with instance, in 2012, Chinese authorities seized 77mn
20 per cent for U.S. companies. Creating a truly domestically produced gel capsules that were created
innovative biopharmaceutical sector requires further from industrial waste and contained excessive levels
development of the entire drug and health care of cadmium. According to the Office of the United
system, in addition to investment, policy reforms, States Trade Representative, in 2016, 90 per cent of all
education and nurturing of scientific talent counterfeit pharmaceuticals seized at the US border
were from China, Hong Kong, India, or Singapore.”
Sanjeev further said, “Smaller R&D Investments
by local small to mid-sized pharma companies Sharing his insights, Beigene spokesperson
focusing on mere dosage modifications of existing pointed out that attracting top talent, especially in
drugs leads to intense competition amongst clinical development is a major challenge. Shortage
local players. China has a highly fragmented of research hospitals in China where clinical trials
pharmaceutical market with more than 4000 pharma for these important investigational medicines can
companies, as a result of lack of economies of scale be conducted. It is important to increase bandwidth
and lower efficiency which makes this market highly and resources for regulatory agencies, potentially to
complex. It might be difficult to innovate unless accelerate review times without sacrificing the quality
we see a lot of consolidation in the market. Sales of of these important processes.
most of the high end products such as monoclonal
antibodies are dominated by bigger MNCs creating Despite challenges, today, pharma industry
monopoly across the Chinese markets. With the in China is at a turning point, with many key
Government taking steps towards price reductions of elements in place for innovation: a university
drugs, a general pressure on the medical insurance system churning out doctorates, cGMP compliant
system is evident with lesser profit opportunities facilities, substantial financial backing from both
for pharma companies. This will negatively impact the private and public sectors, regulations that are
R&D spend. Slow implementation of regulatory becoming globally harmonized and a vibrant group
policies and schemes is another issue. Even though of entrepreneurial Chinese leaders with ambitions
for China and abroad. As China jumps into the
bandwagon of drug discovery, experts opine that
it will challenge the market dominance of US and
European pharmaceutical giants both in the Chinese
soil and across geographies. The Chinese government
has seen its aging and increasingly ill population
as both a risk and an opportunity, and has curated
policies that may soon end foreign monopoly,
raising the Chinese flag high in drug discovery,
commercialization and development.

Aishwarya Venkatesh
[email protected]



‘We treat our product
as a part of medicine’

« production centres at some other places also. We have
workforce of 450 people and 35 per cent of them are
Grace Xu, technicians and engineers.
Sales Manager,
Zhengli Pharmaceutical Who are your competitors? What is your market
Packaging, China share?
Our competitors are advanced pharmaceutical
Packaging is the final step in pharmaceutical packaging enterprises in the world. Our products are
production but a very key one in the entire widely used in anti-tumor, bio-tech, vaccine blood
pharma production value chain. Based in products, contact lenses, cosmetics and other fields,
Ningbo city of China, Ningbo Zhengli Pharmaceutical and also used to match with preparation products like
Packaging Co. Ltd. is one among more than 1,500 freeze-drying, power injection, Hydro-acupuncture.
Chinese pharmaceutical packaging enterprises. The We provide quality products to more than 200
company received ISO9001:2000 in the year 2000, and customers in the country. We have more than 10
successfully registered the US FDA DMF in 2007. It was year of stable cooperation with six major institutes
present at the The Health Industry Summit (tHIS 2018) of Biological products under the Ministry of Health.
held at Shanghai, China from April 11 to 14. Grace Xu, With such a wide customer base we sell about 20
Sales Manager of the company, talked to BioSpectrum billion pieces of different varieties each year. Our
about the pharma packaging market in China and the market share is 80 per cent in biological products and
company’s plans. Edited excerpts; 50 per cent in high-end pharmaceutical field in China.

Can you give details of your company? How do you see the market condition in China for
Our company was established in 1991 and it your products?
specializes in producing glass injection vials made Market condition in China is more and more strict, but
from glass tube. We have invested more than $48 it is good for us as we focus on production quality much.
million to set up a top-grade production centre with We treat our product as a part of medicine and not only
an annual production capacity of 2 billion pieces of a package to keep the medicine in it.
glass containers. The centre includes 45,000 square
meters inspection and packaging workshop. We have Do you export your products?
Yes. We have gone to oversees market also and 15 per
cent of our total production is exported to Europe, USA,
South East Asian countries and Middle East countries.

What are your plans?
As we have the best production facility and a very
good production testing room, we are producing the
best quality goods of pharmaceutical packaging. Since
glass package is more stable, we also want to go for
plastic packaging in near future.

On the export front we wish to focus more on
overseas market to have more share. We want to
increase our exports from 15 per cent to 50 per cent and
expand overseas market to Russia, South America and
Africa, all over the world. We have confidence to grow
and expand our overseas market.

Milind Kokje
[email protected]



“Vietnam has roadmap to upgrade
and modernise healthcare system”

« diseases, fast-ageing populations and the growing
burden on already struggling healthcare resources.
Jozica Habijanic,
We know delayed diagnosis can result in higher
Country Manager at upstream costs of treatment, poorer outcomes for
patients, putting tremendous burden on healthcare
Roche Diagnostics systems. Yet, diagnostics remains greatly undervalued
and under-utilized. It represents just 2 per cent to 3
Philippines per cent of all healthcare spending but influences 60
per cent to 70 per cent of medical decision making. So,
Clinical laboratories are an integral part of the there is a significant need to move healthcare from the
overall care delivery system and 60 per cent of volume-based care that we currently have, to care that
medical decisions are based on results produced is centered around the value it brings – to patients,
by clinical laboratories. A leaner and more efficient doctors and healthcare systems. In this context,
laboratory leaves room for growth by removing excess diagnostics has a critical role to play.
waste and improving processes related to specialized
testing services. A high growth market, the government By giving diagnostics its rightful place across
in Vietnam launched the 2020 vision to modernise the entire healthcare continuum from screening,
health infrastructure in the country. However, diagnosis, prognosis to patient stratification and
Vietnamese laboratories face challenges in establishing treatment monitoring, we can help to improve clinical
laboratory practice and high-quality standards which practice, enhance quality of care and ultimately patient
means that the lab practices, quality standards and outcomes. And, we are gradually seeing this happen.
patient safety can be further improved to bring it at The in vitro diagnostics (IVD) market in Asia Pacific is
par with other countries in Asia Pacific (APAC). To expected to reach $19.64 billion in 2021 growing at a
enhance clinical laboratory practice in Vietnam, Roche CAGR of 6.3 per cent. But it’s not to say there aren’t
Diagnostics together with leading industry associations, challenges. Doctors rely on diagnostic tests to make
government-linked bodies developed an educational the right clinical decisions for their patients. Which is
Lean Six Sigma program designed to improve and why improving quality standards of clinical laboratory
ensure laboratory quality standards through a lab practice is undeniably critical to clinical practice and
quality improvement workshop to specifically address patient treatment.
the needs and challenges of these labs in Vietnam.
In an exclusive interview with BioSpectrum Asia Furthermore, healthcare infrastructure is not
Magazine, Jozica Habijanic, Country Manager at Roche homogenous across emerging markets in Asia Pacific.
Diagnostics Philippines, talked about the impact of the There are some areas, such as larger metros, which are
program, trends in the medical diagnostics industry, relatively more advanced while the distant interiors or
and future plans of the company. Jozica supported rural areas may not have the adequate capabilities. But
the LEAN Clinical Laboratory Practice Programme we are starting to see this change, slowly and steadily.
in Vietnam in her former role as Head of Strategic More governments in the region are working to enhance
Development at Roche Diagnostics Asia Pacific. Edited healthcare delivery. For example, the Vietnamese
excerpts- government has developed a comprehensive roadmap
to 2020, which aims to upgrade and modernise the
In the context of emerging markets in APAC, what healthcare system. As a result, laboratories will play an
are some of the opportunities and challenges even more important role.
that we see in clinical laboratories practices?
The rapidly evolving healthcare landscape calls into Please elaborate on Roche Diagnostics’s LEAN
play new ways of working that can effectively address
existing challenges: the rising burden of chronic programme in Vietnam, and its partnerships

with business associations & government bodies

The LEAN Clinical Laboratory Practice Programme
in Vietnam is a multi-stakeholder and multi-pronged
approach that aims to raise lab quality standards and



create lasting improvements by establishing good major factors. Our partners – the Vietnam Association of
laboratory practices. Chemical Biochemists (VACB), the University Medical
Center (UMC) and the Hanoi Medical University (QCC)
This is a first of its kind public-private partnership – supported this initiative tremendously, right from
that brings together local and regional associations to programme development to execution.
spearhead laboratory excellence in Vietnam. Roche
Diagnostics has partnered the Asian and Pacific What role does Roche see for itself in working
Federation of Clinical Biochemistry (APFCB), the
Vietnam Association of Chemical Biochemists (VACB), with government bodies and associations to
the University Medical Center (UMC), and the Hanoi
Medical University (QCC) for this initiative. shape good clinical laboratories practices? What

The LEAN Clinical Laboratory Practice Programme does Roche aim to achieve?
is split into two core areas, and is based on the We are committed to delivering innovative diagnostic
participants’ skills sets and level of experience: solutions that can improve the lives of people. This
includes supporting capacity and capability building
a.   LEAN Facilitator Workshops: Created efforts. One area that we identified within the context of
specifically for senior laboratory staff, the train-the- Asia Pacific, was the need to enhance laboratory quality
trainer workshop uses real-life scenarios to illustrate standards. Together with like-minded partners, we have
certain methodology and principles of LEAN thinking. embarked on this mission of uplifting the overall quality
This allows participants to better understand the of healthcare delivery. Laboratories play a crucial role
concepts and they can apply it to their daily operational in this regard. Lab test results help physicians make
practice within the laboratory. The train-the-trainer decisions so good laboratory practices are essential to
model ensures the sustainability of the programme as it maintaining high quality standards within the healthcare
develops local talent and builds local capability. It helps system. The outcome is quick and accurate results that
participants build their skills as trainers and gives them allow physicians to make decisions confidently so that
the confidence to conduct a two-day LEAN workshop patients can get the right treatment, faster.
independently. Since the launch, 31 trainers from 13
institutions in Vietnam have completed the train-the- How can doctors, service providers, government
trainer workshop.
bodies, industry associations or other
b.   Education and knowledge building
workshops: Targeted at a wider range of participants, interested stakeholders help to ensure better
from laboratory managers, section heads to junior staff,
participants are given practical cases and examples on clinical laboratory practices and standards are
the different sections within the laboratory. Participants
are encouraged to review the different processes from implemented across APAC?
start to end and identify possible solutions. Currently, The responsibility to deliver quality care lies with all
210 laboratory staffs have been trained under the stakeholders within the healthcare system. The same
programme. holds true in the case of improving laboratory quality
standards. Public-private partnerships create an
c.   Practical application of LEAN environment that encourages the sharing of knowledge
methodology and learnings: As phase two of this and best practices, with everyone working towards
programme, we will work towards the implementation a common goal. With the LEAN Clinical Laboratory
of LEAN methodology within selected labs. The aim Practice Programme, we are tapping the collective
is to apply LEAN in practice within the laboratory experience, expertise and network of a diverse group to
environment, improving workflow and processes with improve operational efficiency, and ultimately, deliver
the aim to improve clinical laboratory practices by good quality healthcare to patients in Vietnam.
optimising turn-around time (TAT) and reducing the
sample rejection rate. Priyanka Bajpai
[email protected]
Are there plans for Roche to expand the LEAN

programme to other markets? Why those markets

At the moment, our focus is on continuing this
programme in Vietnam, and there were several factors
that led to the launch of this pilot programme in Vietnam.
The strong in-country expertise, robust educational
network and keen interest from local stakeholders were



“Quality by design is growing
importance in pharma industry”

« Through a focus on quality and manufacturing
excellence, we’ve been able to meet increasing demand
Alagu Subramanium, for our high-quality packaging components in India
and Asia Pacific while reducing lead times – helping
Managing Director, our customers deliver important medicines to patients
quickly and efficiently.
India - West
Any new products launched from this Sri City
Special Economic Zone (SEZ) in the last four
Services, Inc.
West Pharmaceutical Services, a leading We have very robust production operations in the
manufacturer of packaging components Sri City Special Economic Zone. One of the products
and delivery systems for injectable drugs we manufacture at our SEZ facility is West’s Flip-Off
and healthcare products, opened a plant at the Sri seals. Seals play an essential role in keeping injectable
City Special Economic Zone in Andhra Pradesh, medicines safe. They ensure that drug products in vials
strengthening its manufacturing base in the Asia- are sterile and free of contaminants and particulates
Pacific region (APAC). It has invested $15 million (Rs that could present risks to patients. Selecting the right
90 crore) over two years in the 1.64 lakh sq ft facility and seal is essential for proper drug product vial closure.
aims to roll out 1.6 billion drug-packaging seals a year West offers a wide range of Flip-Off seal products –
by 2018. BioSpecrum spoke to Alagu Subramanium, including multiple sizes, colors and configurations –
Managing Director, India - West Pharmaceutical to meet customers’ varying requirements. Our seals
Services, Inc. about the latest developments of the are produced with the highest-quality aluminum and
facility and challenges before the industry. Edited plastic materials and manufactured using precision
excerpts of the interview, technology proven to deliver consistent machinability,
maintain container closure integrity and support a
In July 2014, West Pharmaceutical Services, Inc. safe, convenient user experience.
dedicated its manufacturing plant in the Sri City
Special Economic Zone (SEZ) in Andhra Pradesh, Each year, we manufacture more than one billion
India. How this plant has helped in fulfilling the Flip-Off seals at our SEZ facility for customers in India
needs of India and Asia pacific market? and the Asia Pacific region. Because of our operational
Our manufacturing facility in the Sri City Special efficiency we’re able to produce and deliver seals to
Economic Zone (SEZ) is a key part of West’s strategy our customers very quickly, significantly reducing lead
of partnering with our customers in India and teams in the supply chain.
throughout the Asia Pacific region to help them provide
medicines to patients efficiently, reliably and safely. You have whole range of products on offer to
The pharmaceutical market in India is experiencing
an impressive period of growth, with many local drug pharma companies. Of these products, which
manufacturers expanding operations and several
global pharmaceutical companies building their products are doing well in India? What are the
presence in the country in recent years. Establishing
manufacturing operations for West in India was a driving factors for this growth?
natural progression of our overall market-led business We continue to see growing demand for our
strategy and it has allowed us to meet growing high-quality packaging components across the
demand for innovative solutions for injectable drug pharmaceutical, biotechnology and generics markets
administration. as drug makers look to meet increasing regulatory
standards for quality. Driven by concerns for
Since the plant’s opening in 2014, we have patient safety, regulatory agencies are asking drug
experienced exciting growth locally and regionally. and packaging manufacturers to build quality into
their products from the start to ensure consistent
quality throughout a drug product’s lifecycle. West’s
NovaPure components are designed using Quality by
Design (QbD) principles to reduce particulate and



ensure consistency of delivery. What are the key challenges before the industry
Biologics and biosimilars are also driving
and company?
significant growth in India. Over the past several One of the biggest challenges we hear from customers
years, the industry has seen a steady rise in new is meeting regulatory standards for quality. Increasing
biologic drugs coming onto the market for the regulatory scrutiny and quality standards are
treatment of many chronic conditions. And India placing added demands on drug manufacturers,
is poised to become a major player in biosimilars suppliers and contract service providers. Quality by
manufacturing as biologics come off patent. These Design is, therefore, growing in importance in the
sophisticated therapies often have very specialized pharmaceutical industry. A QbD approach delivers
containment needs. Biologics can be sensitive to an improved, data-driven output that can lead to
certain materials used in injectable drug packaging a superior product, while allowing stakeholders to
and delivery systems, such as silicone oil or tungsten. better understand risk and how to minimize it. By
Concerns around possible interactions between incorporating QbD principles into the design and
biologics and the materials used in container/closure manufacturing of packaging components and delivery
systems are driving the need for packaging and systems like West’s NovaPure components, we ensure
delivery systems that minimize the adverse impact that the products we provide to drug manufacturers
on injectable drug products. West developed the are of the highest quality.
SmartDose drug delivery technology platform to
safely contain and deliver these innovative therapies. Another significant challenge is ensuring speed to
The SmartDose drug delivery technology platform is market. Generics manufacturers offer low-cost options
a wearable, subcutaneous injector with an integrated for patients and provide needed medications when
drug delivery system that incorporates human factors critical drugs are in short supply. But to lead in today’s
and usability testing to deliver a truly patient-centric generic drug environment, manufacturers need to
approach to self-administration. file drug applications quickly, as well as respond to
unforecasted market demand. The unique needs of
Additionally, our Daikyo Crystal Zenith this market require that manufacturers keep pace with
containment and delivery systems offer high- quality, speed and simplicity in all aspects of generic
performance alternatives to glass and integrated drug manufacturing. The West AccelTRA component
lifecycle solutions for containment and delivery program is designed to deliver quality, speed and
systems designed to help maintain drug safety, simplicity to meet the unique needs of the generic drug
purity and efficacy from development through industry. The components in the AccelTRA component
commercialization. program offer market leading delivery times and a
single next-generation formulation for stoppers that
Another trend driving growth is a move toward help generics manufacturers stay competitive.
more self-administration. In India and around
the world care for many chronic conditions is Narayan Kulkarni
moving out of the doctor’s office and into the [email protected]
home environment. Our self-injection systems are
designed to minimize discomfort, offer accurate and
effective drug delivery and help foster an improved
patient experience. In addition to the SmartDose
drug delivery technology platform, West offers the
SelfDose patient-controlled injector. This award-
winning injector is ergonomically designed for
optimal patient administration.

Finally, another driving factor - an area of focus for
West – is the need for speed and flexibility in the supply
chain. Generic companies want to minimize the speed
to market / filing of drugs without compromising the
quality. The reliability & compatibility of our AccelTRA
component program delivers packaging quality, speed
and simplicity for generics customers, for whom it is
so important to file quickly. The AccelTRA component
program offers market-leading delivery times and a
single next-generation formula for stoppers that help
customers stay competitive.



SGH develops tool to
assess surgery risks

A team of anaesthesiologists routine pre-surgery assessments.
at Singapore General Hospital The score is then used to
(SGH) has developed an online
tool that allows doctors to more predict the patient’s percentage
accuratelygaugetherisksinvolved risk of death within 30 days and
before carrying out surgery. The of having to stay in the intensive
Combined Assessment of Risk care unit for more than 24 hours
Encountered in Surgery (CARES) post-surgery. The accuracy rate
calculator takes into account the of the calculator in predicting
demographics, lifestyle choices post-surgery mortality is around
and healthcare systems unique 93 per cent, up from 87 per cent
to Singapore. It then generates for existing tools. The CARES
a cumulative score based on calculator can measure risk
nine health indicators including for all types of surgery except
age, gender, anaemia and red transplants, burns and cardiac-
cell distribution width. All the related operations. It will be
required data can be derived from made available online in coming

Singapore Korean team develops
algorithm for diseased genes
researchers discover
A new study, affiliated with Ulsan National Institute of Science and
new potential of Technology (UNIST), South Korea has recently presented a novel
statistical algorithm, capable of identifying potential disease genes in
stem cells a more accurate and cost-effective way. This algorithm has also been
considered as a new promising approach for the identification of
A group of researchers from candidate disease genes, as it works effectively with less genomic data
National Cancer Centre and takes only a minute or two to get results. In the study, the research
Singapore, National University team presented the
of Singapore (NUS), Duke- novel method and
NUS Medical School, and the software GSA-SNP2 for
Singapore General Hospital pathway enrichment
has discovered a laboratory- analysis of GWAS
synthesised chemical substance P-value data. According
that can be used to increase the to the research team,
number of stem cells harvested GSA-SNP2 provides
from umbilical cords. Harvesting high power, decent
bone marrow stem cells typically type I error control
involves an invasive procedure, and fast computation
and as a result there are few by incorporating the
donors. As for peripheral blood, random set model and
the cells collected usually have SNP-count adjusted
more immune cells. These cells gene score. The research team expects that their GSA-SNP2 is able to
could in turn attack the patient visualize protein interaction networks within and across the significant
and cause side effects. Umbilical pathways so that the user can prioritize the core subnetworks for
cord, however, is promising as further studies. With this algorithm, the researchers can easily identify
it contains the highest number new drug targets, thereby deepening the understanding of diseases and
of undifferentiated stem cells unlock new therapies to treat it.
but not high enough for rapid
recovery in adult patients.



Chinese scientists create
nanogel for cancer therapy

Scientists at the High Magnetic Field the synthesis of hybrid nanogels due to
Laboratory of the Chinese Academy of their tunable pore space and multiple
Sciences have developed a method to imaging function. However, the complex
synthesize hybrid nanogels that can be preparation process of MOF-based
used in cancer therapy. Researchers hybrid nanogels limit their uptake by the
have been interested in generating biomedical sector. The researchers found
multifunctional hybrid nanogels by that their nanoparticles could convert light
combining nanomaterials in a polymer energy into heat energy, and used this
network. Such nanogels have potential property to destroy tumors. By shining
applications in biomedicine due to their near infrared light on tumors where the
tunable properties that allow them to be nanoparticles had accumulated, they
used for bioimaging, biosensing, stimuli- were able to destroy the cancer cells. In
responsive drug release and cancer addition, the hybrid nanogels could serve
therapy. as a positive magnetic resonance contrast
agent, which means that it could be used
Nanoscale metal–organic frameworks to locate tumors in the body.
(MOFs) demonstrate great potential for

Scientists use New blood test to identify
chronic pain instantly
RFID chips to track
Australian researchers have developed a new blood test, called
biological samples painHS, which instantly identifies the severity of chronic pain
by using colour biomarkers. The research was led by the director
Researchers in the U.S. and Japan of the Australian Research Council Centre of Excellence for
plan to use Radio frequency Nanoscale BioPhotonics at the University of Adelaide.
identification (RFID) chips for keeping
track of organoids, samples of human painHS employs light
tissue that mimic pieces of organs measurement tools to carry out
and are grown from stem cells. The hyperspectral imaging analysis
organoids, the researchers embedded for detecting the molecular
with RFID chips functioned normally structures of pain in
and withstood extreme conditions, blood cells. Expected to
suggesting that they could be a useful be a cost-effective option,
way to organize and identify the large painHS will potentially be
quantities of organoids that are often available for use in 18
needed in experimental situations. months to identify the
severity of chronic
Human organoids are a promising pain in patients
avenue for research into human suffering from
development and disease because fibromyalgia, lower
they replicate the structure, function, back and pelvic pain, migraine and cancer pain.
and phenotype of human organs in
miniature in the lab. Grown from The team believes that the test can specifically help
human induced pluripotent stem with diagnosis in people who cannot communicate the extent
cells, they divide, differentiate, and or source of their pain, such as babies and dementia sufferers.
self-assemble according to the growth They further expect the test to aid in the development of next-
programs of their corresponding generation drugs targeting chronic pain conditions, as well as to
organs. And particularly in medicine, eliminate the use of placebos in clinical trials to determine the
they can illustrate the effects of certain effectiveness of an investigational drug.
drugs on human organs in ways that
more traditional cell cultures cannot.



NHSA to bring Israeli Health Tech to UK

The Northern Health Science Alliance (NHSA), a system made
up of eight research universities, eight teaching hospitals and
four academic science networks across the north of England,
has signed a memorandum of understanding (MoU) with
the UK Israel Tech Hub, with the purpose of bringing Israeli
health and MedTech innovations to northern England.

The agreement will support Israeli healthcare firms
establishing a presence in the UK, specifically in northern
England. The NHSA will provide support to these companies,
identified by the UK Israel Tech Hub, giving them the
opportunity to access UK clinical research in the region
and engage with health research professionals, teams, and
clinical experts for the development of tech that will benefit
the Northern Health Science system.

The MoU was signed by NHSA Head of Corporate
Affairs Suzanne Ali-Hassan with the British ambassador to
Israel David Quarrey at the Mixiii-Biomed 2018 life science
conference in Tel Aviv.

WuXi, Tsinghua announce Sidra Medicine signs
strategic partnership
MoU with DIGS
WuXi Biologics, a leading global open-access biologics
Qatar based Sidra Medicine
technology platform company offering end-to-end solutions has signed a Memorandum of
Understanding (MoU) with the Doha
for biologics discovery, development and manufacturing, and Institute for Graduate Studies (DIGS)
for mutual exchange of knowledge,
Tsinghua University Innovation Center for Immune Therapy expertise, research and studies.
The MoU is the first partnership
(ICIT), have formed a strategic partnership in discovery, to stem from Sidra Medicine’s new
Externship Programme with the
development and manufacturing of biologics. aim of supporting the healthcare
organisation’s medical education and
ICIT focuses on learning and development strategies.
DIGS will nominate students to join
discovery and development the specially designed programme
that will support the students training
of therapies for immune and internship requirements as
part of their curriculum. The MoU
and cancer diseases. will also provide Sidra Medicine
clinicians and researchers to consider
Through this partnership voluntary faculty appointments and
teaching opportunities within the
ICIT will have access fields of psychology and social work
at the Doha Institute. Sidra Medicine
to WuXi Biologics’ currently offers mental health services
for children and young people as
comprehensive, integrated well as perinatal mental health care
services for women.
services include innovative

biologics discovery, cell line

development, cell culture

process development,

purification process

development and formulation development and manufacturing

for ICIT’s monoclonal antibodies, bispecific antibodies,

recombinant proteins, and protein conjugates (i.e., ADCs).

Tsinghua University Innovation Center for Immune

Therapy (ICIT), a joint entity of the Institutes for Immunology

and Institute of Technology Transfer at Tsinghua University,

was established in August, 2016. ICIT aims to accelerate

transformation of basic scientific discoveries into innovative




PerkinElmer Agilent to acquire
assets from YI Scientific
Agilent Technologies Inc. has signed a definitive agreement to acquire
Shanghai the Agilent-related business from Young In Scientific Co. Ltd. YI
Scientific is a leading distributor of analytical and scientific instruments
Spectrum in South Korea and a long-time distributor of Agilent instruments and
services. Founded in 1976, YI Scientific has grown into one of the largest
Instruments distributors of analytical instruments, solutions and services in South
Korea. Once the acquisition is final, former YI Scientific customers of
PerkinElmer, Inc., a global Agilent products and related services in the South Korean market can
leader committed to innovating look forward to an integrated sales and service portfolio directly from
for a healthier world, recently Agilent. More than 100 employees from Young In and its affiliates
announced acquisition of are expected to join Agilent Technologies Korea Limited when the
Shanghai Spectrum Instruments acquisition is final.
Co., Ltd. (SSI). Located at
Shanghai Caohejing Hi-Tech GE Healthcare, A*STAR co-develop
Park in China, SSI is one of innovative medical technologies
the leading manufacturers
of analytical instruments in GE Healthcare and the Agency for joint research and development
China. SSI delivers analytical collaboration that was initiated in
solutions and services to a wide Science, Technology and Research 2014. The new technologies have
range of research, academic, been built into GE Healthcare’s
government, pharmaceutical, (A*STAR), in Singapore have products across a range of
industrial, life sciences and different patient care equipment
chemical analysis laboratories. announced the co-development of and applications, with others in
Its portfolio includes the process of being implemented
photoelectric colorimeters, UV- innovative medical technologies into GE Healthcare’s solutions
Vis spectrophotometers, atomic globally. Some of these
absorption spectrophotometers that will aid healthcare providers innovations are available in
and accessories. SSI has GE Healthcare equipment in
customers in 10 countries, along worldwide to deliver faster and Singapore, the United States,
with a strong supply chain Europe, China and Japan.
and dealer network in China. more accurate diagnoses, improve
PerkinElmer plans to build on As part of the collaboration,
SSI’s R&D and manufacturing treatment strategies, and achieve GE Healthcare and A*STAR are
capabilities in China to deliver developing a pipeline of digital
continuous hardware and greater productivity in workflow. solutions, including a diagnostic
software innovations for its imaging system for Parkinson’s
customers and support China’s Leveraging GE Healthcare’s Disease and advanced capabilities
goal of strengthening local for surgery motion tracking.
manufacturing. This acquisition expertise in medical and
complements PerkinElmer’s
leadership in atomic information technologies,
spectroscopy to better serve
local customer needs within and A*STAR’s capabilities
environmental, industrial and
food markets. in data analytics and high-

performance computing,

both parties have developed

technological advancements in

imaging diagnostics and patient

monitoring. These developments

are the result of a five-year



Shimadzu enhances its SCIEX announces
Mass Spectrometry platform
new BioPharmaView
Shimadzu Corporation has announced the launch of the
quadrupole time-of-flight (Q-TOF) LCMS-9030 system. The Software 3.0
Shimadzu LCMS-9030 is a research grade mass spectrometer
designed to deliver high-resolution, accurate-mass detection SCIEX, a global leader in life science
with incredibly fast data acquisition rates, allowing scientists analytical technologies, recently
to identify and quantify more compounds with greater announced the newly released
confidence. It utilizes the same engineering expertise as BioPharmaView Software 3.0 solution
Shimadzu’s high-performance triple quadrupole (LC-MS/MS) for the complete LC-MS Multiple
platform and integrates that with powerful TOF architecture Attribute Methodology (MAM)
to transform high mass accuracy workflows by achieving high- Workflow that enables simple yet
sensitivity, high-speed, and high-resolution detection. Ultra- in-depth characterization of biologics
fast (UF) acquisition rates and core ion beam technologies through powerful mass spectrometry.
developed for the triple quadrupole platform have created new Moving to LC-MS-based MAM
possibilities in quantitative mass spectrometry by delivering workflows has historically been
exceptional sensitivity, specific quantitation, and enhanced challenging for biopharma labs and
target compound verification. The new LCMS-9030 Q-TOF CROs due to unnecessary complexity in
builds on this proven platform by rethinking time-of-flight data processing and analysis caused by
detection. In the LCMS-9030, core ion beam technologies the lack of a single software platform.
transition toward a unique approach in ion The SCIEX Workflow for MAM
gating using UFaccumulation to create a addresses this need, offering a unique,
precise pulse of ions into the flight tube single software solution for routine
optimized for high sensitivity and high running of a high-resolution LC-MS
resolution using iRefTOF reflectron assay during biologics development.
technology. The iRefTOF generates The growing popularity of protein-
an ideal reflectron field, delivering the based drugs as treatments for various
highest resolution for the flight path illnesses has resulted in the need for
with highly stable mass accuracy. By new analytical methods that are faster
bringing together UF technologies and and more cost-effective. The complex
innovative TOF thinking, the LCMS- nature of biologics means that high-
9030 represents a step-change in Q-TOF resolution, sensitive instruments are
performance and capability by unlocking needed to identify differences between
a new solution for analyzing even the protein structures.
most complex samples.

Bio-Rad launches anti-idiotypic antibodies range

Bio-Rad Laboratories, Inc., a global have recently been approved anti-pembrolizumab and anti-
leader of life science research and for the treatment of multiple nivolumab antibodies inhibit the
clinical diagnostic products, has cancers including non-small binding of the drugs to their target,
recently announced the launch of cell lung cancer, head and neck programmed cell death protein 1
a range of anti-idiotypic antibodies squamous cell carcinoma, and (PD-1), enabling the free drug to be
targeting the immune checkpoint metastatic melanoma. Bio-Rad’s detected.
inhibitor drugs: pembrolizumab
(Keytruda) and nivolumab The anti-pembrolizumab and
(Opdivo). Anti-pembrolizumab anti-nivolumab antibodies are
and anti-nivolumab antibodies are approved for in vitro research
designed for use in bioanalytical purposes and for commercial
assays to monitor the drug levels in applications of in vitro testing
cancer patients. services to support preclinical and
clinical drug development and
Pembrolizumab and nivolumab patient monitoring.



Insmed Incorporated
appoints Leo Lee to its Board

Insmed Incorporated, a global at Merck & Co. from 2008 to
biopharmaceutical company
focused on the unmet needs 2011. From 2003 to 2008, he held
of patients with rare diseases,
recently announced various commercial positions
the appointment of
Leo Lee to its Board at IQVIA (Cegedim Dendrite), a Biostage
of Directors. Lee has
more than 21 years life sciences services ropes in Dr Wei
of experience in
the pharmaceutical company. Zhang on Board
industry in Japan;
most recently at Lee has also Biostage, Inc., a biotechnology
Merck KGaA, a global company developing
pharmaceutical company, where served in various bioengineered organ implants to
he served as President, Japan. treat life-threatening conditions
roles at Accelrys, of the esophagus, bronchus and
Prior to his role at Merk trachea, recently announced
KGaA, Lee served as President, Inc., a software that Dr Wei Zhang, a faculty
Japan of Allergan plc, a global professor of innovation at Peking
pharmaceutical company, from company serving University, has been elected
2011 to 2015. Before that he to its Board of Directors. At
served as Vice President of Sales pharmaceutical and Peking University, Dr Zhang has
led company specific business
biotech companies, strategy programs across the
world for clients such as Novartis,
from 1997 to 2003. Nestle, IBM, Johnson & Johnson,
Roche, and Marsh & McLennan,
Currently, Lee serves on the among others. Dr Zhang was a
permanent faculty member of
Board of Directors of Regeneus management at China Europe
International Business School
Ltd, a global pharmaceutical (CEIBS) from 2008 to 2012
and was the founding director
company based in Australia. of CEIBS Center for Healthcare
Policy and Management. He
Lee received a B.S. in Molecular was also a Distinguished Bing
Fellow of Health Economics
Genetics and Microbiology from at RAND (US) in 2008 and
has been an adjunct faculty at
the University of California, Los Peking University School of
Government. Dr Zhang received
Angeles. his Ph.D. in health policy from
Harvard University as part of an
APCO brings Yi to lead South interfaculty program between
East Asian Healthcare Biz the Graduate School of Arts
and Sciences, Business School,
APCO has announced the appointment of James Yi, a Kennedy School of Government,
communications expert with over 20 years of experience, as its and Medical School; and his
new Managing Director for South East Asia. Prior to joining APCO, M.D. from Peking Union
Yi held leadership posts with GLOBALHealthPR as the executive Medical College (founded by the
director for Asia Pacific, with Burson-Marsteller as the CEO and Rockefeller Foundation in 1918).
Market Leader for Korea, with Ogilvy Public Relations as the
managing director for Vietnam and with MAX Public Relations in

Earlier in his career, Yi held senior roles in Asia with Fleishman-
Hillard, McCann Health and Baldwin Boyle Shand. Yi’s expertise in

health care and health policy adds to a growing
roster of APCO health experts including
Nancy Turett, James Tyrrell, Wayne Pines,
William Pierce and Elizabeth Funderburk.
Yi will lead a team of communications,
public affairs, technology and corporate
branding experts at APCO with deep
ties in Southeast Asia, including Garry
Walsh, Yanichnat Oom Chalermtiarana,
Ambassador Devinda R. Subasinghe,
Rami Sharaf, Mike Chinoy, Yuli Ismartono,
Amanda Douglas and Levie Cequena.



BIO 2018 makes history in Boston
The 2018 BIO International Convention (BIO
2018) wrapped up four days of programming U.S. BIOSCIENCE
under the theme of “Make History” on June 7, INDUSTRY REACHES
in Boston. Hosted by the Biotechnology Innovation $2T ECONOMIC IMPACT
Organization(BIO), BIO 2018 attracted thousands
of U.S. and international attendees, celebrated A study released at the BIO International
innovations that have shaped the past 25 years and Convention shows that the U.S. bioscience
recognized the companies, patient groups, academic industry has reached $2 trillion in annual
centers and investors that continue to advance novel economic impact while maintaining accelerated
solutions to the world’s toughest challenges. venture capital investment and job growth
numbers. Among U.S. technology sectors, the
The Convention drew 18,289 biotechnology bioscience industry has held a leading position
industry leaders – the most attendees in the last as an economic driver and job generator. The
10 years – from 49 states, the District of Columbia, report, Investment, Innovation and Job Creation
Puerto Rico and 67 countries. in a Growing U.S. Bioscience Industry 2018,
finds U.S. bioscience firms directly employ 1.74
“This year’s 2018 BIO Convention demonstrated, million people, a figure that includes more than
more than ever, that partnering and collaboration 273,000 high-paying jobs created since 2001.
will drivecutting-edge advancements and propel the The average annual wage for a U.S. bioscience
industry forward,” said Joanne Duncan, President, worker reached $98,961 in 2016. These earnings
Membership and Business Operations at BIO. “With are more than $45,000 greater, on average, than
46,916 one-on-one meetings held during the last the overall U.S. private sector wage. The report
four days, we know that the knowledge exchange and further shows that since 2014, the bioscience
partnerships forged this week have the potential to industry has grown by 4.4 per cent with four
transform our world for the better.” of its five major subsectors contributing to this
overall job gain.
To encourage students to attend BIO and learn more
about careers in the biotechnology industry, BIO 2018 Robert K. Coughlin, President and CEO of MassBio.
included the first Free Student Day. Eligible participants “From Cambridge to Worcester to Springfield, our
got a one-day Exhibition Access registration and the state is the hub of biotechnology innovation, and
opportunity to meet with representatives from the BIO 2018 allowed us to show what’s possible when
biotechnology community. The breadth and depth of industry, academia, and government work together as
offerings and the networking opportunities afforded partners to advance patient health worldwide.”
to thousands of industry stakeholders and students
continues to make the Convention the premiere event Setting a Guinness World Record for “The Largest
for the biotechnology industry. Business Partnering Event,” BIO 2018 hosted 46,916
partnering meetings, facilitated by BIO’s One-on-One
BIO 2018 drew companies, academic centers, Partnering system— a 13 per cent increase over 2017.
patient groups, researchers and investors working These invaluable connections form the foundation
to advance innovation in key areas such as drug of innovative industry collaborations and scientific
development, brain health, digital health, oncology, breakthroughs.
opioids, renewable fuels and agriculture. Celebrities
also made a presence at BIO, with stories of triumphs BIO 2018 also included over 1,800 exhibitors, more
over illnesses such as cancer and addiction. Robin than a thousand speakers, 180 sessions, 17 plus super
Roberts, a cancer survivor and an award-winning sessions and fireside chats and 19 education tracks.
journalist, and Rob Reiner, an actor, director Special programming, such as the Start-Up Stadium,
and advocate, delivered keynote addresses that also provided a forum for up and coming companies
emphasized the challenges faced by patients, the to receive invaluable advice to accelerate their growth
importance of patient advocacy and the need for and potential.
continued innovation to address unmet needs.
The 2019 BIO International Convention will take
This year’s International Convention was held place in Philadelphia from June 3-6. In 2020, the
with the support of BIO’s state affiliate organization Convention returns to San Diego for the fourth time
MassBio. “MassBio and our members were thrilled to from June 8-11.
welcome the world to Massachusetts this week, so they
can see firsthand why we’re the state of possible,” said



Dr Promila
of Health
2018 in New
Delhi, India.

ASSOCHAM Pharma Conclave 2018

Affordable solutions needed
to intensify innovations in
Indian pharma sector: DGHS
Advanced, affordable and accessible solutions
is the only way forward towards intensifying own health priorities is quite limited.
the innovations in Indian pharma sector, a top There are other factors like changing burden of
Union Health Ministry official said at an ASSOCHAM
event held in New Delhi, India recently. disease owing to emergence of non-communicable
diseases, more chronic diseases, cancerous
“We need to build and develop an enabling conditions, lifestyle diseases and India is now said to
ecosystem that unleashes the country’s be on threshold of diabetes capital of the world.
entrepreneurial energy so that it creates a vast and
vibrant marketplace for small, medium and large “All these require us to find advanced but
enterprises which are symbiotically interconnected affordable and accessible solutions and steer our
to deliver superior and sustainable solutions,” efforts towards intensifying the innovations in
said Dr Promila Gupta, Director General of Health pharma sector,” added Dr Gupta.
Services (DGHS) while inaugurating an ASSOCHAM
Pharma Conclave 2018 on the theme Strengthening She urged the Indian pharmaceutical industry
Indian Pharmaceutical Industry through R&D and to take advantage of opportunities that have come
Innovation on May 9, 2018 in New Delhi. up owing to recent revolutions at molecular level,
genomics, proteomics, metabolomics, bioinformatics
She rued the fact that despite having technical and imaging technology which has led to advanced
capacity together with vast talent pool and potential, research in terms of understanding the underlined
India’s role in new drug discoveries, be it bio- mechanism of several diseases.
pharmaceuticals or bio-similar, even for country’s
“I feel that academic institutions, research
laboratories and pharmaceutical industry involved
in healthcare research, should utilise these



India looking for Pharma innovation

India is a leader in global generic pharmaceuticals manufacturing. It supplies 20 per cent of global
generic drugs and is a preferred location for generic drug production. In FY 2016, India exported
pharmaceutical products worth $ 16.89 billion, with the number expected to reach $40 billion by 2020.
The country’s pharmaceutical industry is expected to expand at a CAGR of 12.89 per cent over 2015-20 to
reach $ 55 billion.

The industry attracted 4.48 per cent of the total foreign direct investment (FDI)’s into India from
April 2000 to December 2016. The cumulative FDI inflows worth $14.53 billion were made during the
same period.

Although India has strong position in the production of generic pharmaceutical medicines but has not
yet realized it’s potential to develop a strong, research based pharmaceutical industry that can produce
innovative medicines. India has an opportunity to build on its strengths in generics and move up the value
chain by enabling innovations and new drug discovery. However, the Indian pharmaceutical industry
does not have a strong track record of innovation. A comparison of India with established pharmaceutical
innovation leaders-the US, UK and Japan with countries that have recently moved up the innovation
ladder-South Korea, China and Singapore – shows that there are multiple gaps in the Indian ecosystem.
India invests just 0.9 per cent of its GDP (Gross Domestic Product) towards overall research and
development compared to an investment of 1.6 per cent in the UK, 1.9 per cent in China, 2.8 per cent in
the US and 3.3 per cent and 4 per cent in Japan and South Korea respectively. Availability of funding and
overall investments are key concerns that should be discussed.

India is not short on intention and has started to recognize the need to develop an enabling
ecosystem that supports investment, technology transfer and growth in innovative areas such as
biosciences. However, India needs to undertake multiple initiatives across infrastructure, financing,
human resources and the legal and regulatory framework to find a place as a preferred destination for
pharmaceutical innovation.

opportunities properly and come up in a big way for said Dr Gupta.
discovery and development of new medical products Highlighting the steps taken by the Union
and services in the country,” further said Dr Gupta.
Government, she said that draft new Drugs and
She also lauded the domestic pharmaceutical Clinical Trial Rules notified in February 2018 contain
industry for playing a crucial role in manufacturing various provisions for encouraging research and
generic drugs which are being exported to about 200 development of drugs - reducing time in disposal
countries as India takes care of about 20 per cent of of application given for conducting clinical trial for
global needs of generic drugs. a new drug or investigational new drug as part of
discovery, research and manufacture in India; waving
The DGHS, however strongly suggested the off local clinical trial requirement if the new drug
industry to shift its approach and put more focus is approved and marketed in any of the countries
on research and development (R&D) of innovative identified by the DCGI (Drug Controller General
medical products and services for sustainable growth of India) and special mechanism incorporated to
considering the significant changes in global pharma expedite development of new drugs and approval
markets in terms of trade practices, competitiveness, processes intended to be used in life threatening
market demands and many other factors. or serious disease conditions or rare diseases and
for drugs intended to be used in diseases of special
She said that although during the last decade relevance to Indian scenario or unmet medical needs
many Indian pharmaceutical companies have started in India or for disaster or for specific defence use.
investing in R&D for innovation of newer molecular
entities, the success in terms of translating the “Realising the importance of clinical trials for
innovation from laboratories to markets in India is innovation of new drugs to cope up with challenges of
limited. disease burden in public health, the CDSCO (Central
Drugs Standard Control Organization) and the
“This requires effective co-ordination and Ministry of Health and Family Welfare have taken
exchange of information and collaboration between various measures to promote the scientific and ethical
academic institutions, universities and industry and clinical trials in the country,” she added.
a very clear understanding of regulatory pathways
which is the need of the hour for these innovations,”

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