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Stem cells gaining importance Stem cell research stands as a high-priority field in the Asia-Pacific (APAC) and investment in these facilities are growing in order to increase competitiveness in the free market so that clinical applications can be continually discovered. Stringent regulations in Western Europe and the USA in stem cell therapy and regenerative medicine have driven the APAC to grow at the highest rate in this industry. Stem cell therapy is a hot topic in the field of medicine and is growing at a fast pace, BioSpectrum takes a look at how this exciting field is faring in the APAC region.

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Published by MMA Media, 2019-08-02 02:23:04

BioSpectrum Asia August 2019

Stem cells gaining importance Stem cell research stands as a high-priority field in the Asia-Pacific (APAC) and investment in these facilities are growing in order to increase competitiveness in the free market so that clinical applications can be continually discovered. Stringent regulations in Western Europe and the USA in stem cell therapy and regenerative medicine have driven the APAC to grow at the highest rate in this industry. Stem cell therapy is a hot topic in the field of medicine and is growing at a fast pace, BioSpectrum takes a look at how this exciting field is faring in the APAC region.

Keywords: pharma ,bipharma ,medtech.

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Chief Editor Digital Therapeutics (DTx) appears to bring a paradigm shift in the healthcare
sector in near future. The process has already begun with the number of DTx tools
[email protected] growing fast, many more in the pipeline and the number of companies developing
DTx tools and services are also increasing. In general, digital health investment had
reached to 179 billion USD by the end of 2016 itself and projected to reach 536 billion
USD by 2025, according to the “Digital Therapeutics Report 2018-2025”.

Experts are wary of the significant challenge the DTx development may pose to
conventional pharma sector unless it adopts a new strategy as it has the potential to
enhance or occasionally even replace traditional medicine. Realising the challenge
pharma companies have started joining hands with companies specialising in digital
therapeutics and/or constructing their own DTx developing arms.

In a first ever e-health partnership, two French companies in digital therapeutics have
joined hands the previous month. WeHealth digital medicine, which is France’s major
pharma Servier group’s ehealth division, and Lucine, a pioneering French innovative
company specialising in digital therapeutics have announced their joint development
partnership and distribution license.

About eight months back, Roche and Mumbai & Bangalore based Wellthy Therapeutics
announced their partnership. Recently, they presented at the annual scientific session of
the American Diabetes Association the results of their first study showcasing improved
diabetes care outcomes among South Asian patients, who followed a clinically validated
digital therapeutic along with other medication and lifestyle changes.

Over the years DTx companies would have a real power as they will have a wealth of
patient data in very large number widely spread across. Their other strength will be that
they would be able to showcase the results of the digital therapies, tools & services they
provide to patients. The latter will be important from the point of view of enhancing or
changing the treatment as per the needs of the individual patients. It is also expected to
be helpful for payment for outcomes system which is likely to dominate the healthcare
in the future.

One important reason being cited for the fast spread and development of DTx is the
very high cost of developing new drugs. Tufts Center for the Study of Drug Development
has put the cost of bringing a medicine from invention to the shelf at a whopping 2.7
billion. Another article in JAMA Internal Medicine puts it at 648 million USD. A third
study estimates it as 2 billion USD. Figures vary but the fact remains that the cost for
introducing a new drug is very high and the returns are low & slow, which is likely to
affect the prospects of new drug development paving way for DTx spread.

With increasing healthcare spending combined with declining R&D returns, DTx
represents a new way of treatment for Pharma companies, according to Global Data
Pharma analyst, Alessio Brunello. He has assessed that value based care and patient
centricity will help drive the DTx. Insurers and payers can use data and analytics to
manage healthcare cost and at the same time ensure appropriate treatment.

However, one of the challenges the expert fear in spreading the digital therapeutics
is the likelihood of non-payment of the treatment cost by health insurance providers.
But that would surely be a temporary challenge since almost every technology cost
comes down with the larger use and with larger use the insurance companies too will be
compelled to consider reimbursement of cost. In fact they will welcome it due to clear
evidence of the outcomes of the treatment.

Conventional pharma will not be able to ignore the change the DTx will bring since
they will lose an access to a large size of data that will prove helpful in their understanding
and work and the evidence of the drug effectiveness.




Congratulations. The rankings have come out really well. I hope you
have a good response to the issue.

-Dr K V Balasubramaniam, India

Congratulations for the BioPharma ranking issue. Wish the magazine
had more categories so that companies and their respective businesses
could be featured in right perspective.

-Muralidharan, India

Thank you so much for the feature on HP Inc in the 3D printing article.
-Amanda S, Singapore

Thank you so much for the interaction with Dr Sugita at Parexel.
-Nichole Sarkis, US

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COVERStory 18


Stem cell research stands as a high-priority field in the Asia-Pacific (APAC) and
investment in these facilities are growing in order to increase competitiveness in the free
market so that clinical applications can be continually discovered. Stringent regulations
in Western Europe and the USA in stem cell therapy and regenerative medicine have
driven the APAC to grow at the highest rate in this industry. Stem cell therapy is a hot
topic in the field of medicine and is growing at a fast pace, BioSpectrum takes a look at
how this exciting field is faring in the APAC region.


Recognise lung cancer “Engaging patients provides unique insights
as Healthcare problem into value and impact of treatment”



“We are evolving our supply
chain to support innovation”

Regis Simard,
President, Pharmaceuticals Supply Chain, GSK, United Kingdom


BIO Asia-Taiwan 2019

We are showing the world that
Taiwan can help: Tsai Ing-Wen




“We have 30 major Connect with us
launches planned this year”
Ai Hua Ong, BioSpectrumMag
Company Group Chairman, Asia Pacific, Janssen Pharmaceutical Companies, Singapore
REGULARS BioSpectrumMagazine

BioEdit..........................................04 World News................................16
BioMail.........................................05 Science News.............................42 /BS-LinkedIn
Regulatory News.......................08 Academics News.......................44
Company News.........................10 Supplier News............................45
Finance News.............................12 People News...............................47
Start-Up News............................13 Bio Event................................49
WHO News..................................15



Nepal Health Ministry Australia to tackle
launches new policy health insurance
The Ministry of Health and Population in Nepal has
launched the Health Policy 2019 aiming to create Health Ministry in Australia has launched a
opportunities so that the general public would be fresh review of private health insurance that
able to enjoy the basic rights to health enshrined by aims to reduce premiums and reverse declining
the constitution. The vision of the new health policy membership, which experts warn risks pushing
is development, expansion and improvement of all out wait times in the public system. The ministry
types of health systems, improvement of the quality is looking for savings and wants stakeholders to
of services provided by health institutions at all come up with suggestions, having already cut
levels, guarantee the easy access and strengthened the cost of prosthetic devices such as hip and
social health security policy by incorporating the knee replacements. Health Ministry intends
utterly marginalized classes as per the federal set- to continue to reduce the pressure on health
up. Deputy Prime Minister and Minister for Health insurance costs, but also to increase the value
and Population, Upendra Yadav launched the Health proposition.
Policy at a programme in Kathmandu. The policy
contains six objectives, 25 policies and 146 strategies.

Korea to pitch $2.9B for new drug development

Government agencies in Korea support for major new drug
related to new drugdevelopment development researches, as the
have outlined the “National current projects are set to end
New Drug Development from 2019 to 2021. Until now,
Research Project,” which will new drug development projects
invest 3.5 trillion won ($2.9 have had problems, marked
billion) over 10 years from by overlapping investment
2021. The Ministries of Science and inefficiency due to the
and ICT, Health and Welfare, separate implementation of
and Trade, Industry and Energy support projects by different
held a public hearing at the government agencies. The new
Korea Press Center to introduce project, however, aims to resolve
the joint project and receive such issues by establishing an
feedback from various walks of inter-agency support system
life. The project is a government- that assists with basic research
funded plan to provide financial to commercialization.



Singapore Thailand transforms
establishes healthcare through
Rare Disease Fund Microsoft, AI

The Ministry of Health (MOH) in Singapore To improve public health and sanitation, Thailand’s
and the SingHealth Fund have jointly Ministry of Public Health has deployed artificial
established the Rare Disease Fund (RDF), intelligence (AI) and cognitive services from Microsoft to
a charity fund that combines community capture, track and share data on public restrooms through
donations and government matching a mobile app. Leveraging machine learning and computer
contribution to support Singapore Citizens visualisation, the app helps government agencies identify
with specific rare diseases who require public health risks and disease hotspots and mitigate the
treatment with high-cost medicines. The RDF risk of epidemics. This initiative illustrates how digital
aims to encourage community donations transformation can contribute to the social good, and
towards supporting Singapore Citizens with extend the capabilities of government, making a positive
rare diseases who are treated in our public impact on the everyday life of its citizens. Smarter
healthcare institutions. This will give support healthcare starts with improved hygiene and public
to patients whose treatment costs remain sanitation. By addressing public health risks early on,
unaffordable even after government subsidies, the public sector can avoid substantial costs later, and
insurance and financial assistance (such as save individuals from burdensome medical expenses.
Medication Assistance Fund, MediFund) have
been provided, due to the high-cost nature
of the treatments. Through the RDF, the
community and the government can come
together to jointly help patients with rare
diseases, as partners in a caring and inclusive
society. For every $1 in public donation, the
government will provide $3 in matching
contributions to the RDF.

India strengthens efforts to eradicate TB

The Ministry of network of AYUSH.

Ayurveda, Yoga Focused activities

& Naturopathy, envisaged under the

Unani, Siddha MoU will cover joint

and Homoeopathy planning to work with

(AYUSH) and AYUSH organisations &

Ministry of Health professional bodies and

& Family Welfare in promote adjuvant use of

India have signed evidence- based AYUSH

a Memorandum interventions for, TB

of Understanding control and management.

(MoU) to forge inter- It is also intended

sectoral convergence to facilitate research

at the level of policy, collaboration and best

planning and practices of AYUSH

programme implementation for accelerated response healthcare and build up capacities for TB-free work

towards “Tuberculosis Free India” initiative. The places and communities. Both Ministries will appoint

intended collaboration between the two Ministries Nodal Officers for development of implementation

aims at development of linkages and integration of TB plan, modalities of operationalization and steering the

care services within the infrastructure and institutional collaboration activities outlined in the MoU.



PeptiDream announces Janssen Korea
PDC collaboration launches QuickFire Challenge
with Novartis in Smart Healthcare

Japan based PeptiDream Inc. has announced a Janssen Korea and Johnson & Johnson Innovation
new Peptide Drug Conjugate (PDC) collaboration LLC have announced the launch of the Seoul
agreement with Swiss firm Novartis. Under the Innovation QuickFire Challenge in Smart Healthcare
agreement, PeptiDream will use its proprietary in collaboration with the Seoul Metropolitan
Peptide Discovery Platform System (PDPS) Government and the Korea Health Industry
technology for the identification of novel Development Institute (KHIDI). The challenge
macrocyclic/constrained peptides for use as PDCs invites
against multiple targets of interest selected by innovators
Novartis. Novartis will have exclusive rights to from around
the program peptides for radionuclide payloads/ the world
conjugates and certain small molecule payloads/ – including
conjugates, for both therapeutic and diagnostic start-ups,
uses. Under the terms of the agreement, PeptiDream entrepreneurs,
will receive an undisclosed upfront payment, academics,
R&D funding payments, and is eligible to receive scientists,
additional pre-clinical, clinical, approval, and and biotech
commercial sales milestones, as well as royalties researchers
on future sales of any commercialized products – to submit
resulting from the collaboration. the best idea, technology, or solution that aims to
address a health need for the world’s population.
QuickFire Challenge seeks to identify and accelerate
game-changing, early-stage health tech innovations
from around the world. Up to two awardees
will receive up to KRW 150,000,000 (approx.
$134,000) in grant funding, one year of residency
at the Seoul Bio Hub, one year of mentorship and
coaching from experts in science, technology and
commercialization at the Johnson & Johnson Family
of Companies, and access to the JLABS global
entrepreneurial community.

Celltrion, Nan Fung Group to market Biosimilars in China

Korea headquartered Celltrion US FDA and EMA approved biosimilar approved in the EU
and Hong Kong based Nan biosimilar products from and US. Remsima has been
Fung Group have announced Celltrion: CT-P13 (Remsima), commercialized in more than 80
the establishment of Vcell CT-P10 (Truxima) and CT-P6 countries worldwide. Truxima,
Healthcare Limited, a Joint (Herzuma). Remsima, referencing
Venture company between both Remicade referencing Rituxan
parties. At the formation of the (Infliximab), (Rituximab), has
Joint Venture, Vcell Healthcare was the been approved in
Limited has simultaneously first the US and EU;
signed a licensing agreement with antibody and Herzuma,
Celltrion Group. Vcell Healthcare referencing
Limited will obtain the exclusive Herceptin
rights in mainland China (Trastuzumab),
to develop, manufacture has been approved
and commercialize three in the US, the EU
and Japan.



GSK opens Avalon GloboCare collaborates with
GE Healthcare for cellular medicines
new pharma
Avalon GloboCare Corp., a leading clinical-stage global developer of
cell-based technologies and therapeutics, has announced that they
facilities in
have established a strategic partnership with GE Healthcare. The
partnership will accelerate
GSK has opened
new state-of-the-art Avalon’s standardization,
manufacturing facilities
in Singapore following automation and bio-production
an S$130m investment.
The new facilities are for clinical-grade Chimeric
located in GSK’s Jurong
site and include two Antigen Receptor (CAR)-T cells
continuous manufacturing
facilities and an expansion and other immune-effector cells
of one of the site’s
production buildings. for cellular immunotherapy, as
The developments will
enable the site, a leading well as exosomes/extracellular
facility within GSK’s
pharmaceutical supply vesicles (EV) based regenerative
chain, to accelerate
the supply of new therapeutics. User training
breakthrough medicines
to patients globally. One will be conducted both at GE
of the new continuous
manufacturing facilities is Healthcare and on-site at
part of Jurong’s R&D Pilot
Plant and will strengthen Avalon’s Nanjing Epicon GMP facility with access to GE Healthcare’s
the site’s capability in drug
manufacture by allowing expert bio-manufacturing resources. In conjunction with Avalon’s
faster production of APIs
(Active Pharmaceutical extensive clinical network in China, this strategic partnership will
Ingredients) for clinical
trials. The first New empower Avalon to improve manufacturing throughput and efficiency,
Chemical Entity (NCE)
to be developed at the alleviate cost burden, and minimize variability in the automated and
new facility will be
Daprodustat, a new oral standardized bio-production process of clinical-grade cellular products.
treatment for anaemia
associated with chronic Glenmark & Torrent to
kidney disease. The new co-market diabetic drug in India
manufacturing process
is expected to reduce Glenmark Pharmaceuticals completing Phase-3 clinical
the production time of and Torrent Pharmaceuticals trials in which Remogliflozin
Daprodustat, enabling have announced that they have demonstrated good efficacy
faster access to this entered into a non-exclusive sub- and safety profile in a head-
medicine for patients licensing agreement to co-market to-head comparison against
globally. sodium glucose co-transporter-2 Dapagliflozin. Subsequently,
(SGLT2) inhibitor, Remogliflozin Glenmark launched
Etabonate (Remogliflozin) Remogliflozin indicated in the
in India. Under the terms of treatment of Type 2 Diabetes
the agreement, Glenmark will Mellitus in adults under the
receive an upfront payment, brand names ‘Remo’ and
license fees and royalties for ‘Remozen’ while Torrent will
the non-exclusive sub-license commercialize Remogliflozin
rights from Torrent. Glenmark under the brand name ‘Zucator’.
will manufacture and supply
Remogliflozin while Torrent
will market the drug under its
own trademark ‘Zucator’ in
India. In April 2019, Glenmark
received approval from the
Drugs Controller General of
India (DCGI) for Remogliflozin
Etabonate after successfully



Boehringer Novena Global Lifecare merges
Ingelheim inks with Xingkeduo for $350M
$870M worth deal
with Yuhan Corp Novena Global Lifecare, one of the world’s largest integrated
medical healthcare and aesthetic companies with over 100
Boehringer Ingelheim and Yuhan clinics in 20 cities mainly in the Asia Pacific region, has
Corporation have announced completed its $350 million merger with Xingkeduo, an express
a collaboration and license haircut business with nearly 100 stores in high foot-traffic prime
agreement for the development
of a first-in-class dual agonist locations in China’s first- and
for the treatment of NASH and second-tier cities and a China-
related liver diseases that combines wide e-commerce platform. The
GLP-1 and FGF21 activity in one merger provides Singapore-
molecule. The collaboration brings owned Novena Global Lifecare
together Yuhan Corporation’s with access to Xingkeduo’s
expertise in FGF21 biology, obesity internet technology and
and NASH with Boehringer physical network of nearly
Ingelheim’s pharmaceutical 100 stores, which will now
expertise and commitment to be complemented by the
bringing innovative medicines Company’s medical aesthetic expertise through its NOVU
to patients with cardiometabolic Aesthetics (NOVU) brand. This merger will also see an
diseases. German firm Boehringer accelerated expansion of NOVU and Xingkeduo brands in China,
Ingelheim has a long history of as plans are underway for the creation of a one-of-a-kind hybrid
excellence in the discovery and store format offering complementary medtech-based aesthetic
development of medicines for and hairdressing solutions driven by Artificial Intelligence (AI),
patients with cardiometabolic as well as generate cross-selling opportunities for both brands.
diseases. It has established a broad
portfolio of marketed products Incyte & Zai Lab enter
for thromboembolic diseases, into a $77.5M collaboration
type 2 diabetes, acute myocardial
infarction, hypertension, and US based biopharmaceutical company Incyte and China
cardio-renal risk reduction. headquartered Zai Lab have announced that the companies
The cardiometabolic diseases have entered into a collaboration and license agreement for
pipeline extends beyond type 2 the development and commercialization of INCMGA0012, an
diabetes and anticoagulation with investigational anti-PD-1 monoclonal antibody, in Greater China.
a focus on innovative drugs for Under the terms of the agreement, Zai Lab will pay Incyte $17.5
the treatment of the devastating million up front, and Incyte is eligible
consequences of diabetes as well to receive up to an additional
as contributing factors like obesity. $60 million in potential
South Korea headquartered Yuhan development, regulatory
Corporation has over many years and commercial
been a commercial partner for milestones, as well as
selected Boehringer Ingelheim tiered royalties from
cardiovascular and metabolic the low to mid-twenties,
products in Korea. Under the terms with Incyte responsible
of the agreement Yuhan Corporation for all royalties and pass-
will receive an upfront and near through payments to its licensing partner,
term payments of $40 million and is MacroGenics, Inc. Zai Lab will receive the rights to develop
eligible to receive up to $830 million and exclusively commercialize INCMGA0012 in hematology
in potential milestone payments plus and oncology in mainland China, Hong Kong, Macau and
tiered royalties on future net sales. Taiwan. Incyte will retain an option to assist in the promotion of
INCMGA0012 in Zai Lab’s licensed territories.



Anthill, HCG select 6 startups for mentorship programme

Anthill Ventures, an investment months and had launched its call- brings in exciting solutions for
and Speed Scaling platform for for-applications during late last healthcare and life sciences has
early growth stage startups, in year. It is designed to help startups been selected out of over 120
partnership with HealthCare focused on emerging technologies applications received from across
Global Enterprises Limited in Healthcare and Life Sciences, the world. The six chosen start-
(HCG), the largest provider accelerate their business growth ups distributed in India, US and
of cancer care in India, have by providing them support and Singapore are Alixir (cancer
shortlisted six start-ups for mentorship. Lumos Health will detection), AyuRythm (pulse
Lumos Health. Lumos Health is help the selected startups to raise diagnosis through Ayurveda);
a Market Access Program focused investments, provide assistance BiMedis (medical equipment
on scaling technology start-ups with mentoring and regulatory trading platform), C-Test Medicals
in Healthcare and Life Sciences, approvals, increase their customer (oral cancer detection), Kronikare
powered by Anthill Ventures base and generate more revenues. (wound care), Raybaby (sleep and
& HCG. The program is for 12 A cohort of six start-ups that breathing monitor for babies).

Leben Care receives US biotech startup
funding from IP Ventures signs $80M deal
with Astellas Pharma
Singapore based Leben Care has raised angel
funding from IP Ventures to fight avoidable Japanese firm Astellas Health will join US based
blindness. The company provides artificial- biotech startup Frequency Therapeutics as it steers
intelligence based diagnostic and screening its first treatment for the most common cause of
solutions, primarily known for automated, fast hearing loss through the clinic. In exchange for
and affordable retinal screening. Leben Care will $80 million upfront and a potential $545 million
use the funds to strengthen its product, sales and in milestone payments, Astellas will receive
marketing teams. Leben Care enables automated exclusive rights to commercialize the treatment
analysis of retina image using AI algorithms that outside of the U.S. Frequency will hold onto the
can be used by technicians, nurses, optometrists right to sell it in the U.S. Frequency’s approach
to conduct basic screening with minimal specialist involves activating dormant cells that can spur the
intervention, delivering real-time reports. The regrowth of the sensory hair cells that translate
company will also cater to areas such as Glaucoma sound waves into electrical signals that are sent to
and age-related macular edema. With over 700 the brain. The treatment is injected into the ear
million people worldwide at the risk of retinal and was safe and linked to hearing improvements
damage, 200 thousand ophthalmologists and only in an early-stage study completed earlier this year.
35 thousand retina experts, there is a significant Five-year-old startup Frequency is one of the
supply gap that LebenCare intends to fill with its more advanced startups developing treatments
scalable technology. for various causes of deafness. Frequency plans
to launch a mid-stage study of its hearing loss
treatment later this year.



One BioMed closes $5M Orum Therapeutics
Series A Funding Round raises $30M to
advance Ab technology
One BioMed, a Singapore-based medical diagnostics
company, has announced that it has closed a $5 million South Korea based Orum Therapeutics
Series A financing round, led by Singapore-based Biopath has announced an oversubscribed $30
Ventures and US-based ARCH Venture Partners, with million Series B financing. New investors,
Enterprise Singapore’s investment arm, SEEDS Capital, IMM Investment, Smilegate Investment,
also participating. The company, a spin-off of A*STAR in KTB Network, and Stassets Investment,
2016, is developing leading-edge platform technologies join existing investors, InterVest and KB
for diagnostics testing. One BioMed will use these funds Investment/Solidus Investment in the
to commercialise its first product, an automated sample financing. The proceeds of the financing
preparation device for purification and isolation of will be used to expand Oromab, Orum’s
nucleic acids from a wide variety of samples, required proprietary cell-specific, cell-penetrating
as a first step in many molecular biological and clinical antibody platform technology that targets
diagnostic technologies. According to One BioMed, its “undruggable” proteins and delivers
sample preparation device is the foundation upon which it a variety of therapeutic payloads. The
will build next generation platforms, through integration startup is applying the Oromab platform to
of molecular diagnostic tools, including its proprietary discover and develop novel therapeutics for
silicon biophotonics sensing technology, for point-of-care cancer and rare diseases, both internally
infectious disease detection. and with partners. The financing will
also further expand Orum’s R&D labs in
Korea and Boston, where the company was
recently accepted into a biotech incubator
in Kendall Square, Cambridge.

AUM Biosciences expands pipeline with new global license agreement

Singapore based startup AUM potential for clinical development critical cancer targets (pan-PIM
Biosciences (AUM) has announced in breast cancer, lung cancer, kinase, pan-PI3K and mTOR
a global license agreement with leukaemia and neuroblastoma. inhibition) via a single molecule.
Inflection Biosciences (Inflection) AUM302 is the first ‘oral kinase Kinase inhibitors are drugs that
for exclusive worldwide rights inhibitor’ to uniquely inhibit three have played an increasingly
to develop, manufacture and prominent role in the treatment
commercialise Inflection’s first-in- of cancer and inhibiting these
class PIM/PI3K/mTOR inhibitors. three targets has been shown to
Known as the IBL-300 series of be more effective than inhibiting
molecules, the agreement will see them alone. The advancement of
AUM develop the lead candidate, AUM302 continues AUM’s focus
IBL-302 (AUM302), which is on developing a robust industry-
currently in the pre-clinical stage leading pipeline of combinatorial
of development with activity therapies. AUM plans to
predicted across a range of cancers. commence Investigational New
It has been evaluated in over 700 Drug (IND) enabling studies for
cancer cell lines and has shown AUM302 by 2020.



WHO recommends WHO unveils
DTG as preferred HIV multi-partner trust
treatment option fund to combat AMR

Based on new evidence assessing benefits and risks, the In a major boost to combat one of the
WHO recommends the use of the HIV drug dolutegravir gravest risks to global health, a funding
(DTG) as the preferred first-line and second-line treatment vehicle allowing partners to devote
for all populations, including pregnant women and those resources to accelerate global action
of childbearing potential. Initial studies had highlighted against Antimicrobial Resistance (AMR)
a possible link between DTG and neural tube defects was unveiled recently by WHO. The
(birth defects of the brain and spinal cord that cause Tripartite – a joint effort by the Food
conditions such as spina bifida) in infants born to women and Agriculture Organization (FAO), the
using the drug at the time of World Organisation for Animal Health
conception. This potential (OIE) and the World Health Organization
safety concern was reported (WHO), launched the AMR Multi-Partner
in May 2018 from a study in Trust Fund, which is being supported
Botswana that found 4 cases by an initial contribution of $5 million
of neural tube defects out from the Government of the Netherlands.
of 426 women who became The AMR Trust Fund has a five-year
pregnant while taking DTG. scope, through 2024, and aims to scale
Based on these preliminary up efforts to support countries to counter
findings, many countries advised pregnant women and the immediate threat of AMR, arguably
women of childbearing potential to take efavirenz (EFV) the most complex threat to global health.
instead. New data from two large clinical trials comparing The immediate funding appeal is for $70
the efficacy and safety of DTG and EFV in Africa have million, to be used to support countries
now expanded the evidence base. The risks of neural tube and the implementation of the Tripartite’s
defects are significantly lower than what the initial studies AMR Workplan 2019-2020, particularly in
may have suggested. DTG is a drug that is more effective, providing technical support to countries
easier to take and has fewer side effects than alternative designing National Action Plans on AMR
drugs that are currently used. and to scale up local action.

WHO launches 5-yr plan to improve quality of health products

Despite global progress, serious sooner, and facilitating cross- expand WHO prequalification –
problems with health product border collaboration; Increase WHO prequalification of priority
quality and safety persist, regulatory preparedness for public health products has contributed
particularly in lower- and middle- health emergencies – equipping to treating millions of people
income countries. As a result, regulators with the knowhow to with quality, cost-effective HIV
the World Health Organistation deal with emergencies, including medicines, as well as to the
(WHO) has launched a five- by fast-tracking product approval vaccination of millions of children
year plan ‘Delivering Quality- processes and improving crisis through Gavi, the Vaccine
assured Medical Products communication. Strengthen and Alliance. It is now expanding to
for All 2019–2023’. The plan include cancer medicines as the
outlines work and activities cancer burden grows in low- and
to reach four main objectives: middle-income countries; and
Strengthen country and regional Increase the impact of WHO’s
regulatory systems – improving Regulatory Support activities – by
the functioning of regulatory aligning work across all levels of
authorities but also speeding up the organization, with particular
product registration timelines so attention given to countries’
that patients can get the product needs.



WHO applauds NIH studies type 2 diabetes in
sub-Saharan African populations
Rwanda’s Ebola
National Institute of Health people, they found many genomic
preparedness (NIH) researchers have reported variants to be significantly
the largest genomic study of associated with T2D. The findings
efforts type 2 diabetes (T2D) in sub- replicate results for many of the
Saharan Africans, with data from variants which other research
WHO Director-General more than 5,000 individuals studies have already implicated in
Dr Tedros Adhanom from Nigeria, Ghana and Kenya. T2D in mostly European ancestry
Ghebreyesus has Researchers confirmed known populations. The work was funded
commended Rwanda on its genomic variants and identified a by the National Human Genome
ongoing Ebola preparedness novel gene ZRANB3, which may Research Institute (NHGRI), the
efforts and confirmed that influence susceptibility to the National Institute of Diabetes and
no cases of Ebola have been disease in sub-Saharan African Digestive and Kidney Diseases
reported from the country to populations. The gene could also and the Office of the Director at
date. Rwanda has a detailed influence the development of T2D the National Institutes of Health.
National Preparedness Plan in other populations and inform
in place and is training health further research. In a study
workers in early detection published in the journal Nature
and response, educating Communications, researchers
communities about analyzed genomic data available
Ebola, vaccinating health on participants through the Africa
workers in high-risk areas, America Diabetes Mellitus study,
equipping health facilities, the single largest diabetes genomic
and conducting simulation association study conducted
exercises to maintain a on the continent. Using the
high level of readiness. information available from 5,231
An Ebola Treatment
Centre has been set up in Kenya launches data
Rwanda and 23 isolation bank on health facilities
units are being prepared
in hospitals in 15 priority Kenya Medical Research Institute (KEMRI) has launched an inventory
districts. Ebola response that captures the geographical distribution of public health facilities in 50
simulation exercises African countries. The inventory contains information on geographical
have been conducted in
Kanombe Military Hospital, location of 98,745 public
Gihundwe District Hospital, health facilities managed
Kamembe International by governments, local
Airport, and Rugerero Ebola authorities and charitable
Treatment Centre to test organizations. According
Rwanda’s preparedness in to KEMRI, the new data
response to a case, which bank on public health
will include Emergency facilities’ distribution in
Operations Centre activation, Africa will boost provision
active surveillance, case of medical services in a
management and laboratory continent grappling with infectious and lifestyle diseases. KEMRI partnered
testing. About 3000 health with international research entities to develop the database capturing
workers in high-risk areas geographical distribution of public health facilities in relation to socio-
have been vaccinated as economic status of populations they serve. The inventory will help African
a preventative measure, governments and multilateral partners improve the capacity of these health
including more than 1100 in facilities funded by the tax payer to deliver quality services.



Gilead Sciences, Galapagos Merck and
enter into deal worth $5B Broad Institute
US based Gilead Sciences and develop and commercialize all CRISPR license
Belgian firm Galapagos have current and future programs in framework
announced that they have all countries outside Europe. In
entered into a 10-year global addition, Gilead and Galapagos Merck, a leading science
research and development have agreed to amend certain and technology company,
collaboration. Through this terms in the agreement and the Broad Institute of
agreement, Gilead will gain governing filgotinib, the MIT and Harvard (Boston,
access to an innovative portfolio candidate being advanced for Massachusetts) have
of compounds, including six rheumatoid arthritis and other announced an agreement to
molecules currently in clinical inflammatory diseases to provide offer non-exclusive licenses to
trials, more than 20 preclinical a broader commercialization CRISPR intellectual property
programs and a proven drug role for Galapagos in Europe. (IP) under their respective
discovery platform. Galapagos control for use in commercial
will receive a $3.95 billion research and product
upfront payment and a $1.1 development. The institutions
billion equity investment from worked together to develop a
Gilead. Galapagos will use framework that (i) continues to
the proceeds to expand and provide non-exclusive access
accelerate its research and to Broad-controlled IP co-
development programs. Gilead owned with its collaborators
will receive an exclusive product (including Harvard University,
license and option rights to the Massachusetts Institute of
Technology, New York Genome
NIH to launch HIV Center, New York University,
vaccine efficacy trial The Rockefeller University, the
in Americas & Europe University of Iowa Research
Foundation, The University
The National Institutes of Health (NIH) and partners have of Tokyo, the Whitehead
announced plans to conduct a Phase 3 HIV vaccine efficacy trial at Institute for Biomedical
multiple clinical research sites in Research and others) and (ii)
North America, South America and provides non-exclusive access
Europe. The trial, called HPX3002/ to IP from Merck, with certain
HVTN 706 or Mosaico, will assess limitations specific to the
whether an investigational vaccine Merck IP for creation of rodent
regimen designed to induce immune models. Merck’s IP for CRISPR
responses against a variety of technology, offered under the
global HIV strains can safely and Sigma-Aldrich portfolio brand,
effectively prevent HIV acquisition will become available royalty-
among men who have sex with free to non-profit academic
men and transgender people. A institutions, non-profit
complementary study in women business communities and
called HPX2008/HVTN 705 or Imbokodo that launched in 2017 in governmental agencies for their
five southern African countries is ongoing. Mosaico is sponsored internal research, consistent
by Janssen Vaccines & Prevention, B.V., part of the Janssen with the Broad Institute’s
Pharmaceutical Companies of Johnson & Johnson, with funding long-standing practice and
support from NIH’s National Institute of Allergy and Infectious requirements.
Diseases (NIAID).




Stem cell research stands as a high-priority field in the Asia-Pacific (APAC) and

investment in these facilities are growing in order to increase competitiveness in

the free market so that clinical applications can be continually discovered. Stringent

regulations in Western Europe and the USA in stem cell therapy and regenerative

medicine have driven the APAC to grow at the highest rate in this industry. Stem

cell therapy is a hot topic in the field of medicine and is growing at a fast pace,

BioSpectrum takes a look at how this exciting field is faring in the APAC region.

The Asia-Pacific stem cell market is anticipated
to rise with the fastest CAGR of 9.89 per cent
over 2019-2027. Chronic diseases like cancers
have seen a considerable rise in the Asia Pacific region.
As a result, the demand for stem cell market is further
expected to rise in this region, according to Global
Market Insights Inc.

Increasing research on developing novel therapies
and personalized medicines will foster stem cell
therapy market growth. For instance, scientists are
extensively researching on methods to regenerate
healthy heart cells from placenta that can be used in
patients after myocardial infarction. This discovery
will help to cure patients suffering from cardiovascular
diseases and reduce mortality rates. Researchers are
further examining different aspects of stem cell therapy
for its applications in neurological disorders. Thus,
increasing R&D activities to promote developments in
stem cell therapy will positively impact the industry

Rising geriatric population will positively influence
the industry growth in coming years. Elderly people
are susceptible to degenerative diseases such as
Parkinson’s and Alzheimer’s disorders. Stem cell
therapies offer several benefits over the conventional
therapeutic methods that raises its preference for
curing degenerative diseases. Recently developed
stem cell therapies generate healthy cells by replacing



the defective cells through minimally invasive orthopedic diseases such as arthritis and osteoporosis
techniques. Therefore, geriatric population rely on due to its ability to differentiate into bones and
stem cell therapies that proves beneficial for the cartilage. Above mentioned factors will surge segment
industry growth. growth.

The global allogenic stem cell therapy segment was The China stem cell market contributed significant
valued around $3 billion in 2018 and is anticipated amounts of revenue share in 2018. A growing elderly
to expand substantially in near future. Allogenic population and fundamental progress in clinical stem
transplant completely replaces host cells with donor cell research are factors which are majorly driving
cells. It also has the potential to eliminate viral this country’s growth. The other countries analyzed
reservoirs and genetic alterations. Therefore, allogenic in this report include India, Japan, South Korea,
stem cell therapies have been extensively utilized Australia and a few others in the Rest of Asia Pacific
in providing treatment to patients suffering from regional segment. Among these, momentous growth
leukemia and several other life threatening diseases. is expected from the Japan stem cell market. Japan
Thus, benefits offered by allogenic stem cell therapy currently plays a significant role in the cancer stem
will surge its demand, thereby propelling segment cell market in the Asia Pacific region and the Japanese
growth. government is heavily investing in the healthcare
industry in order to improve the healthcare facilities
Orthopedic segment is anticipated to witness more in the country.
than 9 per cent growth over the forecast time frame.
Substantial growth is attributed to rising accidents Some of the leading players in APAC market are
and trauma cases across the globe. Stem cell therapy is Pluristem Therapeutics Inc., Vericel Corporation
successfully applicable in treating bone-joint injuries (formerly Aastrom Bioscience), Qiagen N.V.,
that include spinal and fractured bone defects, ligament Fibrocell Science Inc., International Stem Cell Corp.,
tendon, femoral head and osteogenesis imperfecta. Cellular Engineering Technologies, Inc., StemCell
Mesenchymal stem cell therapy is preferred in curing Technologies, Cytori Therapeutics, Cellular Dynamics
International (Holding Company Fujifilm), GE
Healthcare, Biotime Inc. etc.

According to Market Data Forecast report, APAC
stem cell market was worth $3310 million in 2018 and
estimated to reach $ 5330 million by the end of 2023
with a CAGR of 10 per cent, whereas the global stem
cell market size is expected to reach $ 15.63 billion by
2025, at a CAGR of 8.8 per cent during the forecast
period, according to a report by Grand View Research,

Prominent global industry players operational
in the stem cell therapy include Astellas Pharma,
Cellectis, Celyad, ReNeuron Group, Gamida Cell,
Capricor Therapeutics, Cellular Dynamics, Novadip
Biosciences, CESCA Therapeutics, DiscGenics,
OxStem, Mesoblast, and Takeda Pharmaceuticals.
These key players adopt several initiatives such
mergers, acquisitions and new product launches to
sustain market position. Besides these strategies,
companies also undertake promotional strategies
that enhance their sales. For instance, in June
2018, CESCA Therapeutics announced exhibition
at Orthobiologic Institute’s ninth annual PRP and
regenerative medicine symposium. This strategy
was company’s promotional effort in order to gain
attention of customers.

“Stem cell research is growing at a very rapid rate
worldwide. Most of the major research institutions
focus on the treatment of cancer using stem cells but
research into using stem cells in other diseases is also



“WHEN IT COMES TO STEM CELL THERAPY, IT IS NOT growing at a rapid rate. Since the US Food and Drug
ONLY THE TYPE OF CELL (I.E. HUMAN MESENCHYMAL Administration has only approved using the cord
STEM CELL) THAT IS IMPORTANT BUT THE QUALITY blood and bone marrow for therapies, most forms
OF THE CELL THAT IS ADMINISTERED IS ALSO VERY of research involve using these two kinds of stem
CRUCIAL. THIS IS WHY CELL GRADING NEEDS TO BE cells,” says Wijenthiran Kunasekaran, Chief Scientific
EMPHASIZED. IT IS NOT ENOUGH TO EXTRACT STEM Officer, Stem Cell Therapy Asia/ Cytonex Sdn Bhd.
CELLS AND INJECT THEM. YOU NEED TO ASSESS Based in Malaysia, Stem cell therapy Asia is a Stem cell
THE QUALITY OF THE CELLS BASED ON PASSAGE Treatment centre providing stem cells and research-
THE QUALITY OF THE STEM CELLS BEGIN TO DECLINE. Prof Steve Oh, Director and Institute Scientist,
PASSAGE 2 IS THAT OPTIMAL ZONE WHERE THE Stem Cell Group, Bioprocessing Technology Institute,
QUALITY OF CELLS ARE AT THEIR PRIME AND A*STAR, Singapore echoes the similar sentiment, “In
PRACTICAL FOR LARGE-SCALE EXPANSION WITH Asia Pacific (APAC), China is strong in immunotherapy,
MINIMAL EFFECTS FROM IN VITRO CELLULAR AGEING adult stem cell therapy in Korea, induced pluripotent
COMPARED FROM CELLS FROM HIGHER PASSAGE. stem cell therapy in Japan. Research is extremely
THE MITOCHONDRIAL DENSITY AND EXPRESSION vibrant and therapies are in the cusp of late-stage
INITIATED BY THE TRANSPLANTED CELLS. ALL Japan in the APAC is leading the race for stem cell
THESE FACTORS ALSO NEED TO BE LOOKED INTO therapies particularly of induced pluripotent stem
BEFORE INITIATING CLINICAL TRIALS AND ALSO IT cells (iPS). “Japanese scientists are at the forefront of
ALLOWS FOR STARTING MATERIAL FOR THERAPY Induced Pluripotent Stem Cell research. Yamanaka
received the Nobel Prize for his and Takahashi’s
TO BE STANDARDIZED. THERE NEEDS discovery of such cells that can be generated from
TO BE MORE GOVERNMENT-INITIATED fibroblasts by transfecting with four transcription
SYMPOSIA AND CONFERENCES FOR factors. The advantage with iPS is that when made
CELLULAR THERAPIES TO DISCUSS from a person, they only match perfectly that single
THESE MATTERS FOR RESEARCH, person and making iPS for different individuals
INDUSTRY AND REGULATORY will become expensive and unpractical. But many
SCIENCES.” other APAC countries such as Singapore, China
-WIJENTHIRAN and Australia contribute to the field,” says Dr Karl
KUNASEKARAN, Tryggvason, Founder of BioLamina and Professor at
CHIEF Duke-NUS, Singapore.
OFFICER, BioLamina is a Swedish biotechnology company
STEM CELL with a global presence offering an expansive portfolio
THERAPY of chemically defined and animal component-
ASIA/ free laminin proteins for a variety of applications,
CYTONEX including the reliable expansion of pluripotent cell
SDN BHD. and differentiation and maintenance of specialized
MALAYSIA cell types, such as hepatocytes, skeletal muscle cells
and different neural cells.

In March this year, Hitachi Ltd. and the
government-backed Japanese research institute,
Riken announced that they have successfully
automated the production of sheets of a cell found in
the eye from induced pluripotent stem cells -- a world
first. The sheets of retinal pigment epithelial cells are
used in clinical tests for the treatment of age-related
macular degeneration (AMD).

A month after that, HEALIOS K.K. (Healios)
announced that it has enrolled the first patient in its
ONE-BRIDGE study in Japan, evaluating MultiStem
cell therapy treatment of patients who suffer from
acute respiratory distress syndrome (ARDS). The
clinical trial investigates the efficacy and safety of



MultiStem therapy for patients with pneumonia- Trends in stem cell market
induced ARDS.
● Based on application regenerative medicine is
Kyoto University Hospital began a series of estimated to hold a substantial market share
physician-initiated clinical trials for the treatment of in terms of revenue over the forecast period,
Parkinson’s disease using dopaminergic progenitors, owing to rise in emerging pipeline projects
generated from induced pluripotent stem cells,
in August last year. The trials were designed in ● Progress of acquisition technology is expected
partnership with the University’s Center for iPS Cell to gain momentum during the forecast period
Research and Application (CiRA). owing to the rising research projects that
demand the use of harvesting techniques
Earlier this year, Japan approved a world-first
trial using iPS cells to treat spinal cord injuries. ● Amongst the type of therapies used,
According to a reports, ‘A team of researchers from autologous therapy accounted for the largest
Keio University, which filed a request for the test with share of the stem cell market
the health ministry, will inject neural cells produced
from so-called induced pluripotent stem cells into ● Likelihood of getting new infections is less in
four people who are injured while playing sports or in autologous cell-based therapy, consequently
traffic accidents.’ enhancing its adoption

India, on the other hand, is at a very nascent stage ● R&D activities carried out on large scale and
in stem cell therapy. Stem cells derived from umbilical huge funds granted by funding bodies to
cord blood and bone marrow to treat blood cancers advance cellular research in U.S. have made
and different blood disorders (approved by Indian North America the dominant region in the
Council of Medical Research (ICMR) are ethical and global market
● Vast research studies taking place in Singapore
“The clinical use in any other disease or uses of and Japan is anticipated to propel the Asia
any stem cells other than these are still in the research Pacific market in the forthcoming years
phase and considered to be an unethical practice.
Though various stem cell therapies are being touted/ Source: Grand View Research
hyped as a panacea/solution for everything, but at this
point in time, only the blood-forming (hematopoietic) “A*STAR SCIENTISTS ARE INVOLVED IN STEM CELL
stem cells from bone marrow or umbilical cord blood RESEARCH, INNOVATIONS AND THERAPIES. FOR
are used to treat blood cancers and different blood MYSELF, I WORK ON PANCREATIC BETA CELLS AND
disorders. This is known as a hematopoietic stem cell CELL TYPES AFFECTED BY DIABETIC COMPLICATIONS
transplant (HSCT). For other diseases, studies are SUCH AS KIDNEY CELLS AND NEURAL CELLS. MY
being conducted at various research and clinical trial OTHER COLLEAGUES ARE WORKING
levels which will definitely bring a positive outcome to ON TISSUES AND ORGANS
find out if stem cells can be helpful in curing various SUCH AS NEURONAL CELLS,
other vulnerable diseases,” says Satish TN, COO, RETINAL PIGMENTED
StemCyte is said to be the most experienced CELLS AND LIVER CELLS.”
Global Cord Blood Bank, having completed 10 years
of excellence in India. It claims to do the maximum -DR ADRIAN TEO,
number of transplants worldwide, 2200 worldwide & PRINCIPAL INVESTIGATOR,
47 in India. Besides there are other companies that are INSTITUTE OF MOLECULAR AND
in the business of stem cell therapy and regenerative CELL BIOLOGY (IMCB),
medicine. Companies like LifeCell, Advancells, Reel A*STAR,
labs, StemCyte, Reliance Life Sciences, Stempeutics SINGAPORE
are some of the top stem cell companies in India.

In July this year, Stempeutics Research, a group
company of Manipal Education and Medical Group
(MEMG), partnered with Kemwell Biopharma for
global commercialization of its stem cell product
Stempeucel. During the same time, Fujifilm Holdings
has joined hands with German drug maker Bayer to
develop an immune-based cancer treatment using



induced pluripotent stem cells. The Japan-German Number of clinical trials
alliance intends to surmount these hurdles by in stem cell region wise
using a new method in which iPS cells come from
someone other than the patient. In the conventional Region Name Number of Studies
method, cells from patients themselves are used.
According to reports from Grand View Research, the World 5217
companies are undergoing strategic partnership to
enhance their product line. They are keen on seeking Africa 30
investments from overseas organizations along with
adopting partnership strategies with pharmaceutical Central America 34
organizations, which is set to fuel the market growth.
East Asia 678
Investment scenario
Japan 35
“The investment in stem cell therapy by the Asia
Pacific is growing at a rapid pace. Asia-Pacific has Europe 1154
been projected to be the fastest-growing region for the
global stem cell therapy market in 2017, especially due Middle East 231
to the rise in cardiovascular and metabolic diseases
in these areas and also the increasing technological North America 2715
advancements in healthcare. The growth in the stem
cell therapy market will not only provide treatment Canada 189
options but will also contribute significantly to the
countries’ Gross Domestic Product (GDP). Asia can Mexico 32
leverage this investment market through various
means. One such method would be to create a new United States 2596
regional regulatory body to provide an alternative
option to the US FDA, which will set a new standard North Asia 66
to follow and allow Asia to continue to grow and
dominate in this field,” says Kunasekaran. Pacifica 95

He further adds, “This is because in individual South America 88
countries, especially in Southeast Asia, the regulatory
South Asia 80
TRIALS. SINGAPORE PLANS TO Source: (as on July 29, 2019)
HUB FOR CELL THERAPIES.” bodies are not fully developed and even if they are, they
-PROF STEVE OH, are inefficient. Asia can also leverage the investment
DIRECTOR AND INSTITUTE market by having more collaborative research or
SCIENTIST, STEM CELL GROUP, collaborations with various hospitals and other stem
BIOPROCESSING TECHNOLOGY cell companies in Asia to allow new technologies to
INSTITUTE, A*STAR, mushroom and spread in various countries, which
SINGAPORE will then draw investment into those countries and

APAC is in the early stage of stem cell therapy.
However, regenerative medicine field including cell
therapy and gene therapy is the future direction of
APAC countries for global market penetration.

Talking about the investment scenario, Leonard
Ariff Abdul Shatar, Group Managing Director of
Duopharma Biotech Berhad says, “APAC investment
market for stem cell therapy is still in an immature
stage. However, regenerative medicine including stem
cell therapy is a mega trend for the future bio-health
market. Korea is trying to make closer networking with
APAC countries to become a global leader in this field.
Partnership with Duopharma was a good example of
APAC investment and will be a great success model for
collaboration between APAC countries and Korea.”

In Oct 2018, Duopharma Biotech Berhad
(previously known as CCM Duopharma Biotech
Berhad) had entered into a share subscription
agreement (SSA) whereby Duopharma acquired
common shares and redeemable preference
convertible shares in SCM Lifescience Co. Ltd,
Duopharma has acquired approximately 5.8 per cent
stake in SCM for RM 20.24 million (KRW5.5 billion).



The acquisition marks Duopharma’s first foray into as of making drugs. For example: They hESCs should
regenerative medicine, specifically in allogeneic stem be generated with fully human methods (no animal-
cells, in line with the company’s strategy to enter niche derived components); The culture methods should
areas and expand product portfolio to move into high- be fully chemically defined, which is not common
value therapeutics. yet, as no sera or other undefined components are
allowed; The differentiation method should be totally
Singapore has a unique position to leverage reproducible, which is a major problem as undefined
in the new future stem cell therapy market. “In mouse tumour extracts such as Matrigel or feeder
Singapore, $80 million will be invested in cell therapy cells that contain thousands of unknown proteins in
manufacturing R&D programmes, to address how to varying proportions do not yield highly reproducible
scale up manufacturing, deepen understanding of cell results. Thus the effects of such cells vary from one
attributes relating to safety and efficacy, and develop experiment to another,” says Dr Tryggvason.
analytical technologies to assess quality of products,”
says Dr Adrian Teo, Principal Investigator, Institute It is mandatory to follow certain procedure like
of Molecular and Cell Biology (IMCB), A*STAR, different phases of clinical trials and numerous other
Singapore. He has witnessed the growth of stem cell regulatory follow-ups which is time-consuming and
field in Singapore since 2007. He has completed his hence the development is slow.
training in stem cell research in both Cambridge UK
and Boston USA. “Another challenge is the high cost and length
of time needed to perform clinical trials. We are not
IMCB is a premier molecular and cell biology interested in just doing stem cell therapy for people
institute at the National University of Singapore but we want to make sure that the therapy we do is
(NUS), to develop and support the biomedical R&D based on scientific data and also that our products
capabilities in Singapore. “Singapore has a unique can be registered with the proper authorities and
position to leverage in the new future stem cell regulatory bodies. Doing this can oftentimes lead to
therapy market. However, there are many hurdles on very high costs as well as massive amounts of time
the way and the stem cell research community needs spent just on getting products registered, applying
to work together to strengthen the efforts,” feels Dr for GMP status prior to trials, and depending on
Tryggvason. your country, the regulatory body can be inefficient
and oftentimes may not provide all the information
Challenges needed,” says Kunasekaran.

Stem cell therapy is still at a nascent stage. Funding, Though it is important to be cognizant of all the
and regulations are the biggest hindrance in the
development of stem cell therapies. “REGULATORY BODIES HAVE RESERVATIONS ABOUT
“One of the key hurdles is getting investments FOR RIGOROUS, HIGH-COST AND LENGTHY TESTING IN
to support the development of stem cell work and ANIMAL MODELS, WHICH DELAY TRANSLATION INTO
successful therapies. Stem cell therapy is still a CLINICAL TRIALS. BESIDES THE STEM CELL MARKET
relatively young and growing field. The cost of moving IS FACING THE PROBLEMS SUCH AS REGULATORY
stem cell research into the clinic is expected to be BARRICADES TO COLLECTION OF HUMAN SAMPLES
very costly as there are a lot of details that need to be AND THEIR USE IN ANIMAL MODELS, PERCEPTION OF
taken care of to ensure that the cell product is safe, of NON-SCIENTISTS ON SAFETY AND EFFICACY, PUBLIC
consistently high quality and efficacious,” says Dr Teo. PERCEPTION OF SAFETY AND RARITY OF DISEASES
Vipul Jain CEO, Advancells, India, noticing the
same thing says “The current scenario it’s positive -DR CITRA NURFARAH ZAINI MATTAR,
though it requires an infusion of more funds to make ASSISTANT PROFESSOR, DEPARTMENT OF
India a force to reckon with in stem cell research. OBSTETRICS & GYNAECOLOGY, NUS YONG LOO LIN
Private finding, unfortunately, is nonexistent in
India and government funding is not enough. The SCHOOL OF MEDICINE, SINGAPORE
other challenge is to develop an ecosystem of stem
cell scientists, surgeons, investors, and commercial
entities to work together in order for stem cell therapy
to take off successfully.”

“A major challenge is that stem cell-derived
therapeutic cells are considered as drugs by US FDA
and European Medicines Agency (EMA) and therefore
their production must fulfil the same requirements



“IN INDIA, STEM CELL THERAPY IS IN A VERY guidelines during the clinical trial stage, it is equally
NICHE AND NASCENT STAGE. THERE ARE A FEW important to standardize the post-stem cell procedure

STEM CELL PRODUCT AND THEN THERE “It is not enough that we standardize the starting
ARE COMPANIES LIKE US WORKING ON material to be used for stem cell therapy and to
PERSONALIZED MEDICINE PROTOCOLS. standardize the stem cell therapy procedure, but once
BOTH MODELS ARE CURRENTLY the procedure has been carried out, there needs to be
BEING TESTED AND LOOKS LIKE a follow up that includes obtaining extensive medical
THERE IS A MARKET FOR BOTH OF reports and determine how the future steps in the
THEM.” therapy will take place,” says Kunasekaran.
CEO, ADVANCELLS, Fraudulent practice
The stem cell therapy is often in the news for the
“DUKE-NUS RESEARCHERS WORKING IN THE STEM wrong reasons. There is an abundance of dubious and
CELL FIELD HAVE SEVERAL UNIQUE DISCOVERIES unscrupulous stem cell clinics that provide therapy
THAT CAN BECOME IMPORTANT FOR THE FUTURE without substantial evidence. This makes it very
difficult for stem cell therapy to progress and also
HESC FIELD AND GENERATION OF makes legitimate evidence-based stem cell companies.
ALSO COLLABORATE WITH “Yes, there are some players who have already
OTHER LABORATORIES SUCH started to commercialize stem cells by promising the
AS FROM THE KAROLINSKA moon, but the fact is that it is still in a stage where it is
INSTITUTE IN STOCKHOLM called experimental, has no approvals and should be
AND HOPE TO BE ABLE TO performed only under clinical trial settings,” said Jain.
JAPANESE COLLEAGUES.” Stem Cells belonging to any origin/source have
-DR KARL TRYGGVASON, definitely demonstrated themselves as Master cells/
FOUNDER OF Mother cells which can give birth to all the other cells
BIOLAMINA AND types of the body and that’s the reason why they have
PROFESSOR the potential to treat a wide spectrum of diseases.
AT DUKE-NUS, But along with this fact, comes the obligation of not
SINGAPORE disturbing the predefined natural process of life.

“Various minuscule clinics and doctors having
commercial inclination have polluted the mind-set of
a common man through various social media sources
about the false and unproven benefits of stem cells for
non-significant disease conditions. These diminutive
shops/clinics still have their strong existence and
refuse to stop their malpractices such as offering
diabetes cure, cardiac solution and etc,” says Satish.

People/patients should ask for government
policies to be demonstrated to them before opting for
any stem cell-related therapy performed on them. This
small step will benefit themselves from any medical
concerns coming in their future way and also develop
a fear to these doctors who play with the healthcare/

“In Southeast Asia in particular, there are many
people selling products such as plant stem cells (grape
stem cell, double stem cell, etc.) or animal stem cells,
oftentimes in capsules (deer stem cell capsules, etc.).
While plant ‘stem’ cells might probably have some
antioxidant effect, they do not contain actual useable
or viable stem cells and certainly cannot be used as
regenerative medicine. Also, you cannot use animal
cells to be transplanted into humans as there is a risk



of zoonotic disease transmission and, they may trigger “THE POLICY OF HAVING THEIR CHILD CORD BLOOD
immune response unlike MSCs which are immune PRESERVED THROUGH CORD BLOOD BANKING
privileged and there are enough safety studies SYSTEM, IS DEFINITELY A SMALL STEP TOWARDS
conducted globally. You need human stem cells to ENSURING THE BIG FUTURE OF THEIR
treat human conditions. You wouldn’t get a blood CHILD. IT HAS UNDOUBTEDLY SAVED
transfusion from a cow, would you? Likewise, you MANY LIVES TILL DATE AND
should never get a cell transfusion from something THE PROCESS IS NEVER ENDING.
that isn’t human. Stem cells need to be of human STEMCYTE IS A CUSTODIAN TO
origin and they cannot be capsulated. They have to SHOWCASE MANY SUCH CURATIVE
be preserved in liquid nitrogen (cryopreservation) TREATMENT AND SUCCESSFUL
and processed in an aseptic environment. It’s also RESULTS.”
Human nature to follow the hype as opposed to facts.
Therefore, legitimate stem cell companies need to find -SATISH TN,
more creative ways to draw patients away from these COO, STEMCYTE, INDIA
unscrupulous clinics and to create more awareness
of the problems with plant and animal stem cells and “STEM CELL RESEARCH IS HAPPENING IN THREE
also to stay away from unscrupulous clinics,” says PARTS. ADULTS STEM CELL, IPS, AND EMBRYONIC
“Fraudulent research has hit the stem cell IN THE MARKET. THERE ARE MULTIPLE RESEARCH
research field hard and given promises that cannot GROUPS WORKING ON IPS AND SEVERAL PROJECTS
be delivered. That is, of course, harmful to the stem ARE CURRENTLY IN THE CLINICAL
cell therapy research field but such science usually STAGE. ONE OF THE MOST
dies out relatively soon, as happened in Monoclonal CONCERN IS EXACT MOA
Antibodies and Gene Therapy fields. I have no doubts (MECHANISM OF ACTION) TO
that stem cell-based therapies will relatively soon PROVE THERAPEUTIC EFFICACY.
deliver novel therapies to a huge number of people,” SAFETY ISSUES IN ADULTS STEM
The misbelief that stem cells are a cure for
everything and can be used everywhere needs to be -LEONARD ARIFF ABDUL
eliminated. Doctors should believe in participating in SHATAR,
good practices and promote ethical service.

Stem cell research is growing at a very rapid rate BIOTECH BERHAD,
worldwide. Most of the major research institutions MALAYSIA
focus on the treatment of cancer using stem cells but
research into using stem cells in other diseases is also
growing at a rapid rate. Since the US FDA has only
approved using the cord blood and bone marrow for
therapies, most forms of research involve using those
two kinds of stem cells.

“In the US and Europe, stem cell research is very
much focused on cancer. In Asia, stem cell research
is still fairly broad, which allows different countries
to develop niches of their own whether it’s on the
disease itself or on the type and quality of the stem
cells. This makes it highly depends on the country,”
says Kunasekaran.

In South Korea, much of the research is focused
on orthopaedic stem cell research and anti-ageing
primarily using cord blood MSCs. In Japan, the
research is very much focused on iPSC because of the
Nobel Prize winner Shinya Yamanaka.

“In Southeast Asia, there’s a lot of emphasis on



Number of clinical trials “Stem cell scientists in Singapore are largely using
in stem cells in APAC organoid systems to generate organs of the body for
understanding human disease biology, for novel
Region Name Number of Studies drug screening and discovery, and in the long run, be
positioned for cell replacement therapy points feels,”
East Asia 678 says Dr Teo.

China 428 “As you know, the first, second and third stem cell
products were approved in Korea in 2011 and 2012.
Hong Kong 7 Longer-term safety and efficacy data is accumulated.
By using this market experience, more aggressive
Korea, Republic of 168 combination research with AI, exosome, mitochondria
3D bioprinter is ongoing,” says Shatar.
Taiwan 61
“In Malaysia, stem cell therapy is currently in
South Asia 80 a moratorium period where it is neither legal nor
illegal, meaning therapies can be conducted if there
Bangladesh 1 is evidence to suggest it works. On the bright side, it
allows for good ethical companies provide therapies
India 71 towards patients with various illnesses based on
scientific evidence, and also set themselves up for
Pakistan 8 clinical trials. On the down side, however, it also does
allow for many unscrupulous stem cell clinics to also
Southeast Asia 67 conduct therapy,” says Kunasekaran.

Indonesia 4 Bright future

Malaysia 12 The stem cell market is experiencing growth, owing
to the increasing number of clinical trials around the
Philippines 3 world. North America, especially the United States,
dominated the number of trials undergoing in stem
Singapore 26 cell therapies. The United States dominates the
market in both the products and banking services
Thailand 15 segments, holding around 77.4 per cent of the total
North American market. However, Asia-Pacific is
Vietnam 13 growing at the highest growth rate. Stem cells are
majorly used in regenerative medicine, especially
According to the data on, there in the field of dermatology. However, oncology is
are a total of 5217 stem cells clinical trials initiated expected to grow at the highest growth rate, due to
all over the world as on July 29, 2019. North a large number of pipeline products present for the
America takes the biggest piece of the pie and has treatment of tumors or cancers. With the increase
initiated a total of 2715 stem cell trials. Among the in the number of regenerative medicine centers, the
Asian countries, China has the upper hand with stem cell market is also expected to increase in the
428 clinical trials. future.

aesthetics and dermatology, neurodegenerative, Stem cells banking is gaining importance with the
cardiovascular and metabolic diseases. Every country support of government initiatives. The number of stem
and company is trying to find its niche. Currently, the cell banks is increasing in developing countries, which
latest trend that is growing is exosomes and small is aiding the growth of the market. Also, increasing
molecules, which is very popular because it gets awareness about stem cell storage among the people
into the idea of potentially very targeted forms of has positively affected the market. Currently, the
therapies, especially in neurodegenerative diseases market is not well established in many therapeutic
where crossing the blood-brain barrier is key,” says areas and has shown nascent success in history.
Kunasekaran. However, it holds great potential in both the diagnosis
and therapeutic fields.

Ayesha Siddiqui
[email protected]
(With inputs from Hithaishi CB)



Recognise lung cancer
as Healthcare problem

Despite important progress in recent years, lung cancer remains amongst the most deadly
types of cancer with a high disease burden and variability in medical need. In spite of new
treatments, survival rates vary significantly between countries. Many companies are conducting
research in lung cancer space trying to understand the mechanism of lung cancer development
and how to prevent or stop tumor from progression. MSD, one of the global companies
investing on cancer R&D, is supporting a study by Economist Intelligence Unit (EIU) to
encourage constructive discussion between stakeholders on policies that might improve lung
cancer outcomes across the Asia-Pacific (APAC) region.

Cancer remains one of the greatest global health cancer remains amongst the most deadly types of
challenges of our time and this transcends cancer with a high disease burden and variability in
geography. By 2040, it is estimated that this medical need. In spite of new treatments, survival rates
incidence and mortality will rise to 80.3 per cent and vary significantly between countries. Many companies
85.6 per cent, respectively. The rising incidence of lung are conducting research in lung cancer space trying to
cancer in Asia Pacific is a cause for concern. Not only understand the mechanism of lung cancer development
is it the most common cancer in this region, it has the and how to prevent or stop tumor from progression.
highest mortality rate of all cancers worldwide. And
yet, it receives only 7 per cent of the funding breast According to in about 1563 studies
cancer receives in the US – and this is representative related to lung cancer, patients are being recruited in
of the rest of the world. the industry sponsored projects across the world as on
July 31, 2019. In India, patients are being recruited
Among all cancers, lung cancer is the deadliest in 14 studies related to lung cancer. Singapore (24
one, killing nearly 1.8 million people globally in 2018, studies), Thailand (16), Vietnam (8), Japan (62),
according to statistics compiled by the International China (111), Hong Kong (22), South Korea (78) and
Agency for Research on Cancer (IARC). Of that number,
59.3 per cent of the world’s new lung cancer cases and
61.4 per cent of lung cancer deaths occur in Asia Pacific.

The rising incidence of lung cancer in Asia Pacific
is a concern. Innovative medicines and improvements
in behaviour, diagnosis, and care have led to dramatic
increase in cancer survival rates over the past forty

The five-year survival rate has increased 22 per
cent for breast cancer, 46 per cent for prostate cancer,
33 per cent for colon cancer, and 63 per cent for lung
cancer since 1975. It is important for the patients that
lung cancer is recognized as a healthcare problem
for governments in Asia Pacific given the growing
prevalence of the disease and the progress being made
in treating it.

According to NCBI report, between 2013 and 2017, registered 270 international clinical
trials using PD-1/PD-L1 therapies for Non-small cell
lung cancer (NSCLC), of which 61 studies involved
sites in Asia and 14 had sites in China.

Despite important progress in recent years, lung



“DESPITE RECENT Taiwan (62) are some of the leading nations in Asia
PROGRESS IN where patients are being recruited for lung cancer
DIAGNOSTICS AND research. According to Research And Markets report
TREATMENT OF LUNG CANCER, by F. Hoffmann-La, Roche, Bristol-Myers Squibb,
INCIDENCE AND MORTALITY Janssen, Amgen, AstraZeneca PLC, Pfizer, Inc., Eli
RATES ACROSS APAC ARE Lilly & Company, and Novartis AG are some of the key
QUITE POOR. THESE RATES players operating in this field.
AND WITHIN APAC COUNTRIES.” Besides MSD (known as Merck & Co., Inc. within
- DAVID HUMPHREYS, the United States and Canada) has also been investing
HEAD OF HEALTH POLICY, EIU in cancer research globally. MSD has invested more
than $60 billion in R&D since 2010. This includes
HEALTHCARE. involvement in over 1,000 immunotherapy trials
covering over 30 tumor types.
WITH GOVERNMENTS AND OTHER MSD also supports policy research and advocacy
STAKEHOLDERS TO HELP PATIENTS GAIN efforts, such as lung cancer in the Asia Pacific region
ACCESS TO THE ONCOLOGY MEDICINES THEY NEED study that the Economist Intelligence Unit (EIU) has
AND TO INVEST IN HEALTH SYSTEMS TO EXPAND THE announced during a conference on ‘War on Cancer Asia
PROVISION OF QUALITY CANCER CARE. WE ARE 2019’. The study aims to present a comprehensive picture
PARTNERING WITH ALL STAKEHOLDERS TO CREATE of all the policies that can support good outcomes for
SUSTAINABLE SOLUTIONS THAT HELP FACILITATE lung cancer. MSD is supporting this study to encourage
ACCESS, OPTIMIZE PATIENT OUTCOMES AND constructive discussion between stakeholders on policies
PROMOTE INNOVATION. WE HAVE IMPLEMENTED that might improve lung cancer outcomes across the
ACCESS PROGRAMMES IN CERTAIN COUNTRIES THAT Asia-Pacific (APAC) region. “By completing these studies
HAVE REDUCED THE OUT OF POCKET COSTS THAT in Asia Pacific and beyond, we hope to compare results
PATIENTS HAVE TO COVER IN RECEIVING THESE and generate insights that can help policymakers adopt
TREATMENTS. THERE IS NO ‘ONE BEST WAY’ best practices in fighting cancer,” said Dorthe Mikkelsen,
President, Asia Pacific, MSD.
THAT A COLLABORATIVE “We are working across the world with
APPROACH BETWEEN governments and other stakeholders to help patients
DIFFERENT STAKEHOLDERS gain access to the oncology medicines they need and
HAS THE BEST CHANCE OF to invest in health systems to expand the provision
ENSURING THAT PATIENTS of quality cancer care. We are partnering with all
WHO NEED INNOVATIVE stakeholders to create sustainable solutions that
TREATMENTS ARE ABLE TO help facilitate access, optimize patient outcomes and
RECEIVE THEM.” promote innovation. We have implemented access
- DORTHE programmes in certain countries that have reduced
MIKKELSEN, the out of pocket costs that patients have to cover in
PRESIDENT, ASIA receiving these treatments. There is no ‘one best way’
PACIFIC, MSD to do this, but we are convinced that a collaborative
approach between different stakeholders has the best
chance of ensuring that patients who need innovative
treatments are able to receive them,” observed Dorthe.

“Despite recent progress in diagnostics and
treatment of lung cancer, incidence and mortality
rates across APAC are quite poor. These rates vary
significantly between and within APAC countries,”
noted David Humphreys, Head of Health Policy, EIU

Humphreys further said that all countries except
Hong Kong have national clinical guidelines and
cancer control plans, although most do not have a
specific lung cancer plan. All countries have some form
of smoking cessation laws and regulation regarding
e-cigarettes, although this is weakest in China and



Indonesia. There have been randomized controlled “WE HAVE A COMPREHENSIVE CLINICAL
trials (RCTs) on screening in Japan, South Korea, DEVELOPMENT PROGRAMME IN LUNG
Taiwan, Australia and China. Patient organisations CANCER AND ARE CONTINUING TO STUDY
are only regularly included in decision making in PEMBROLIZUMAB ACROSS MULTIPLE
Australia, Japan and the Philippines. He further SETTINGS AND STAGES OF LUNG
pointed out that late diagnosis is common and most CANCER. OUR CLINICAL PROGRAMME
countries (Australia being the notable exception) do IN THIS AREA IS COMPRISED OF MORE
not have fast track diagnostic referral pathways. THAN 10,000 PATIENTS ENROLLED
Dr Alena Reznichenko, Pan Asia Pacific, Medical ACROSS 20 MSD SPONSORED
Lead Oncology-Global Medical Affairs, MSD said “MSD CLINICAL STUDIES. ”
is leading the research of immunotherapy in over 1,000 - DR JONATHAN CHENG,
trials, including more than 600 trials that combine our VICE PRESIDENT, ONCOLOGY
anti PD-1 therapy with other cancer treatments, these CLINICAL RESEARCH,
trials cover over 30 tumor types, including lung cancer. MERCK RESEARCH
In the recent published KEYNOTE-042 trial, majority LABORATORIES
of the patients enrolled were from Asia Pacific and 29
per cent were from East Asia. The median survival “MSD IS LEADING THE RESEARCH OF
was 20 months in the pembrolizumab group and 12.2 IMMUNOTHERAPY IN OVER
months for chemotherapy. 1,000 TRIALS, INCLUDING
Dr Jonathan Cheng, vice president, oncology clinical COMBINE OUR ANTI PD-1
research, Merck Research Laboratories said “We have THERAPY WITH OTHER
a comprehensive clinical development programme in CANCER TREATMENTS,
lung cancer and are continuing to study pembrolizumab THESE TRIALS COVER OVER
across multiple settings and stages of lung cancer. Our 30 TUMOR TYPES,
clinical programme in this area is comprised of more INCLUDING LUNG CANCER.”
than 10,000 patients enrolled or expected to be enrolled - DR ALENA REZNICHENKO,
across 20 MSD sponsored clinical studies. ” PAN ASIA PACIFIC, MEDICAL
Dr Jonathan said “The research community across MEDICAL AFFAIRS, MSD
the world has accumulated a lot of knowledge on
lung cancer. We have learned that certain types of
lung cancer such as epidermal growth factor receptor
(EGFR)-positive lung cancer are more prevalent in Asia.
The EGFR mutation rates in Asia can be as high as 50
per cent in some countries compared to 5-15 per cent in
western world. Having this information and knowledge
allow companies to plan their research accordingly
and to conduct certain trials in those parts of the world
where the prevalence of the disease is the highest.”

“More studies in lung cancer space are currently
ongoing. We are investigating various combinations of
molecules across many types of lung cancer as well as
other thoracic cancers such as small cell lung cancer,
mesothelioma, thymoma. We also collaborate with our
partners across Asia and across the word to strengthen
our knowledge and research further in the quest to
find a cure for lung cancer,” added Dr Jonathan.

It is important to note that there can also be other
barriers for patients accessing treatments, including
the lack of health system readiness for new treatments
or inadequate training/ technology for healthcare
professionals to administer new therapies.

Sharing his views Humphreys pointed out that
access to cancer medicine remains an issue in
many countries as these countries do not reimburse



DTP strategy helping players to expand patient volumes

The global lung cancer drugs market will grow the overall revenues globally.
at a CAGR of 13.6 per cent during the forecast North America has been accounted for the
period. The market has witnessed steady growth in
the past few years with the introduction of novel largest share of the global lung cancer drugs
products, which have augmented the acceptance of market in 2018 and will retain a high position
immunotherapy drugs in the market. The market during the forecast period 2019-2025. According
is fuelled by upsurge in the incidence of lung to World Health Organisation, cancer accounted
cancer cases across the globe - owing to increasing for an estimated 9.6 million deaths in 2018 and
diagnosis rate and mainly due to increasing tobacco the most common cancer among all types is lung
consumption, increase in the lung cancer treatment cancer (2.09 million cases). An estimated 234,030
rates, increasing rate of effective drug approvals as new cases of lung cancer were diagnosed in
first-line therapies, strategic deals to develop new 2018, representing about 13 per cent of all cancer
products, increasing R&D spending, and rapid diagnoses in the country.
industrialization leading to increased pollution.
Europe is the second major shareholder of the
The leading global pharmaceutical companies global lung cancer drugs market. There were an
are focusing on product approvals as first-line estimated 3.91 million new cases of cancer and 1.93
treatment therapy and combination treatment million deaths from cancer in 2018. Lung cancer
with chemotherapy, collaborations, and regulatory is the third most common cancer type of cancer
submission of already matured cancer treatments (470,000) after the female breast cancer and
in the developing countries as a major strategy to colorectal cancer (500,000). In the UK, around
increase their revenue. Many of the global players 46,700 new lung cancer cases are recorded annually
are also focusing on providing home infusion and it is the third most common cancer. The Asia
services in the developed markets with secured and Pacific is expected to grow at a high double digit
safe cold chain logistic infrastructure. This Direct- CAGR during the forecast period, owing to factors
to-Patient (DTP) strategy is also helping market such as the increasing prevalence of cancer cases,
players to expand their patient volumes and thus growing healthcare expenditure, and increased
healthcare awareness.


molecular diagnostic testing or personalised Patient advocacy groups, healthcare providers and
medicines, and all countries have fewer radiotherapy diagnostics companies to identify the type of patient
machines than they need. He said “Supportive care most likely to benefit from targeted treatments. Local
could be improved in China, Indonesia and Hong stakeholders to implement Patient Access Programs
Kong. Australia, Hong Kong, Japan, South Korea and to support out of pocket costs for patients.”
Taiwan have good quality national cancer registries,
but for many, more work needs to be done.” Increasing incidence of the disease globally,
promising drug pipeline, and enormous R&D activities
There is a perception that innovative therapies for lung cancer drug development are the major factors
are the main cost drivers, whereas, they are a small driving the market growth. The pipeline of oncology
portion of the overall budget that plays a significant drugs in the clinical development has expanded by
role in health outcomes. Welfare bodies benefit as 45 per cent over the past 10 years; 87 per cent of the
patients are often well enough to require less social late-stage pipeline is targeted therapies, which include
service support. The economy benefits from the small molecule protein kinase inhibitors and biologic
ongoing livelihood of the patient, as well as increased monoclonal antibodies.
earnings and productivity potential. Reimbursement
agencies do not always account for all these important “I believe that by working together and developing
indirect benefits in their decisions. robust plans with multiple stakeholders, we can ease
the burden for lung cancer patients in Asia Pacific.
Reacting to this Dorthe said “We are working with Different stakeholders can do this by increasing
stakeholders to address these barriers in order to funding for lung cancer, tackling inefficiencies in the
improve patient access in the future. In short, we work patient-care pathway and providing rapid access to
with: Government and other stakeholders to accelerate innovative treatment,” concluded Dorthe.
regulatory and reimbursement timelines to ensure
patients have safe and quick access to our medicines. Narayan Kulkarni
[email protected]




Rare Cancers Australia Ltd (RCA) is a charity
whose purpose is to improve the lives and
health outcomes of Australians living with rare
and less common (RLC) cancers. RCA, founded by
Richard Vines and his wife, Kate Vines in 2012 and
classified as a Health Promotion Charity by the Federal
Government of Australia, has a number of key areas of
focus: Creating a Patient Community, Patient Support
Programmes, Fundraising, Treatment & Research,
and Early Diagnosis. As distinct from common cancers
(breast, prostate, bowel, lung and melanoma) there
is very little patient support offered to RLC cancer
patients. BioSpectrum Asia spoke to Richard Vines,
Chair & Chief Executive of Rare Cancers Australia
about the role patient advocacy groups can play in
policy shaping or advocating patient access.
Edited excerpts;

What role the companies / industry/ government Richard Vines, Chief Executive Officer of Rare Cancers
agencies are playing to partner with or support Australia (RCA) with Kate Vines, co-founder, RCA.
Patient Groups in the region? How are these
At Rare Cancers Australia (RCA) we see a marked HAVE MET IN ASIA EARLY DIAGNOSIS LINKED TO
increase in the willingness of industry, government DISEASE AWARENESS IS A REGULAR PRIORITY: MANY
agencies, clinicians and research institutes to partner OF THE RARE CANCERS AND RARE DISEASES THAT
with and engage with patient groups: recently I was in ARE EMERGING AS THE REGION’S WEALTH GROWS
Malaysia, introducing representatives from industry to HAVE LOW AWARENESS. SO MAKING PEOPLE AWARE
12 patient groups from across South East Asia as part OF THE PRESENCE OF NEW DISEASES AND CANCERS
of RCA’s Summit Asia program. We are encouraging IS A MEANS TO EARLY DIAGNOSIS AND GREATER
them to collaborate on projects that improve outcomes SURVIVAL RATES – OR THAT PATIENTS GAIN EXTRA
for patients in an impactful way. For example, seeking TIME WITH THEIR FAMILIES.”
the reimbursement for testing for rare diseases which
shows a direct correlation to early diagnosis.

From research RCA conducted in 2016 amongst
300 regional patient groups we know there is a growing
desire and need in the region for patient voices to be
heard more prominently in the development of the
solutions that are ultimately destined for them. For
too long, the patient voice has tended to be the last
to be heard. Now, with the call to arms for “patient-
centricity”, the drive is to ensure that patients are
involved early and have a direct influence in the
development of therapies and the formation of
policies that will make a real difference and impact
wider groups of patients.



From our own experience in Australia, when we tied to a lack of access, resources or funds. We see the
formed the National Oncology Alliance (NOA) in 2018 overwhelming pre-occupation of most regional patient
to develop policy positions that address the issues groups is sustainability – how they can keep the lights
of cancer treatments, we deliberately gave strong on, keep operating, keep serving and supporting
weighting to the role of patient groups and patient patients? With the groups that RCA mentors in the
members in the alliance. region we dedicate a lot of time to raising funds from
traditional, online and corporate sources – and still
Without the presence of patient groups and patients they would like more learnings in this domain.
NOA would not have been considered representative or
inclusive of the whole cancer community questioning What role can patient advocacy groups play in
its credibility. Because NOA included patients, patient policy shaping or advocating patient access?
groups, industry and clinicians when it spoke to the I think the most immediate contribution from patient
government the government was more willing to listen. groups is to highlight to policy makers the real human
story of patients. It is impossible to understand the
With regards to governments partnering with
patient groups – that differs from country-to- “I THINK THE MOST IMMEDIATE CONTRIBUTION
country. In Australia, we have been fortunate to have FROM PATIENT GROUPS IS TO HIGHLIGHT TO POLICY
clear channels for engagement with ministers, their MAKERS THE REAL HUMAN STORY OF PATIENTS.
advisors and the civil servants influencing healthcare IT IS IMPOSSIBLE TO UNDERSTAND THE NEED AND
policy. This has allowed us in the case of rare and BENEFITS OF A TREATMENT OR MEDICINE BY
less common cancers to take them from an unknown LOOKING SOLELY AT A SPREADSHEET. PATIENTS
quantity, to a mainstream consideration in Australian ARE THE EXPERTS IN THEIR DISEASE AND ENGAGING
cancer policy. Governments and health ministries who THEM PROVIDES UNIQUE INSIGHTS INTO THE VALUE
do not engage with patient groups are missing out on AND IMPACT OF A TREATMENT.”
the quickest and most direct route to hear from larger
numbers of patients, and therefore form good policy
that has the prospect of delivering the greatest good,
to the greatest number of patients.

What kind of programmes/ campaigns are
patient advocacy groups focusing on such
as: promote disease awareness, patriation to
clinical trials, patient access, etc.?
From the patient advocacy groups that we have met
in Asia early diagnosis linked to disease awareness is
a regular priority: many of the rare cancers and rare
diseases that are emerging as the region’s wealth
grows have low awareness. So making people aware
of the presence of new diseases and cancers is a means
to early diagnosis and greater survival rates – or that
patients gain extra time with their families.

But it is impossible to generalize on the programmes
and campaigns that patient groups are focused on
– there is such a variation of needs. Recently, I met
groups using publishing to both generate revenue
and help patients; I met groups from Malaysia and
Thailand who are focusing on gaining tax-exemption
status so that more patients can be treated; A group
seeking more counsellors for cancer patients at the
early diagnosis stage; And a group seeking to facilitate
testing for rare diseases earlier in their country again
to increase the percentages of early diagnosis. And in
Australia we see a growing need for increased public
awareness of clinical trials and facilitating access to
those trials.

So the demands are many and varied – but most




need and benefits of a treatment or medicine by looking, and in all likelihood more externally focused
looking solely at a spreadsheet. Patients are the experts to ensure they can continue to serve patients with the
in their disease and engaging them provides unique most appropriate and current treatments.
insights into the value and impact of a treatment.
What do patient groups usually expect from the
From your perspective as a patient advocate, industry and/or government agencies?
how can we ensure healthcare systems are able There is no expectation, the hope of patient groups
to absorb medical innovation, both now and in is for an understanding of the needs of the patients
the future? that they represent and a willingness to listen. What
The ability to flex and change to meet the emerging dominates patient groups thoughts? Three things:
technologies are the most important qualities that all gaining access to treatments or medicines for their
healthcare systems need now and looking forwards. In patients, resources to help them care for more patients
the domain where RCA is focused i.e. rare cancers this or access to the funds that will allow them to continue
is particularly true. New technologies such as immuno- with the care and guidance of patients. It really boils
therapies, CAR-T cell therapy, molecular screening are down to these three things.
becoming newly available, but our systems struggle to
cope with their rapid advance, and of course their cost. If treatments or medicines are available in the
United States but are not funded in your country,
Whilst Australia might be considered an advanced patient groups hope that through engagement and
economy its healthcare systems were designed over advocacy we can jointly find a mechanism to treat the
50 years ago now: they are not structured to deal patient. So we would encourage all parties to engage
with the rapid evolution and technological advance and find sensible affordable pathways.
of pharmaceuticals. For example, a cancer drug may
offer a cure for multiple cancer indications, but the We would also encourage recognition from all
Australian system only provides subsidy for one of the parties that patient groups need support for projects
indications. The outcome is an inequality in the system and other initiatives that they undertake. We have
for patients requiring the drug that is not subsidised. been awe struck at what these groups achieve in the
region with very limited resources. They are amazing
So as well as being flexible and open to change, and deserve everyone’s support.
health systems are going to need to be more forward
In which novel areas has patient involvement
made a difference in shaping policy, benefitting
patients in the long term?
I think the most striking example of patient
involvement is the increasing awareness and need
for availability of immune-oncology drugs. These
treatments have given new hope to patients and the
patient groups have been extremely proactive in
demanding access for their patients.

Our work in this area in Australia is helping
increase availability and we are confident that in the
near future this access will expand much further.

Narayan Kulkarni
[email protected]



“We are evolving our supply
chain to support innovation”

facility will allow for the introduction of additional
production modules.

« What are the strategic plans of GSK’s
pharmaceutical supply chain to supply
Regis Simard, breakthrough medicines to global patients?
President, This is an exciting time to work in GSK. Our approach
Pharmaceuticals to Pharmaceutical Research and Development (R&D)
Supply Chain, GSK, focuses on science related to the immune system, the use
United Kingdom of human genetics and advanced technologies. As GSK
moves at pace to build a strong differentiated pipeline
On 5 July GSK, opened new state-of-the- and develop its presence in speciality care, we are
art manufacturing facilities in Singapore evolving our supply chain to support innovation, which
following an S$130 million investment. The makes it a fascinating place to work. It means investing
new facilities are located in GSK’s Jurong site and in the right supply chain capabilities and capacity to
include two continuous manufacturing facilities and bring medicines to people who need them around the
an expansion of one of the site’s production buildings. world. For example, the continuous manufacturing
The developments will enable the site, a leading facility facilities that are part of Jurong’s R&D Pilot Plant will
within GSK’s pharmaceutical supply chain, to accelerate strengthen the site’s capability in drug manufacture by
the supply of new breakthrough medicines to patients allowing faster production of APIs for clinical trials.
globally. The investment behind the new facilities is part
of the GSK- Singapore Economic Development Board How GSK’s new digital technologies contributes
(EDB) 10-year Singapore Manufacturing Roadmap. in leveraging drug manufacturing facility?
BioSpectrum Asia spoke to Regis Simard, President, In the UK we have a team dedicated to seeking,
Pharmaceuticals Supply Chain, GSK, United Kingdom developing and industrialising new manufacturing
about the strategic plans of GSK’s pharmaceutical technologies. We’re collaborating with leading tech
supply chain to supply breakthrough medicines to companies, both those familiar with pharmaceuticals
global patients. Edited experts; and those from un-related industries, such as the
gaming industry, to give us new insights into how we
What are the individual plant wise investments can bring together science, technology and business to
from the total S$130M on the new facilities? find smarter ways to work. In line with this approach,
The investment in Continuous Manufacturing facilities Jurong’s production building one (PB1) has become
is approximately S$40 million. The investment in a testbed for the digitalisation of manufacturing
the expansion of the production building (PB1) is operations and processes to drive process optimisation
approximately S$90 million. and productivity improvement. For example, data
analytics are applied in PB1 in real-time. Using a
Are there any Active Pharmaceutical Ingredients Digital Performance Board, the analytics support
(APIs) and New Chemical Entities (NCEs) in problem solving and process optimisation.
pipeline at the new plant apart from the one for
HIV and chronic kidney diseases? How GSK’s global pharmaceutical business is
The NCEs in the pipeline at GSK’s new facilities, influencing APAC health care market?
located in the Jurong site, are Dolutegravir, a key GSK was the first global healthcare company to establish
GSK asset for HIV treatment and Daprodustat, a a presence in Singapore nearly 60 years ago and we
new treatment for anaemia associated with chronic remain one of the biggest contributors to its biomedical
liver disease. In addition to these, GSK manufactures sciences industry. In that time, GSK has invested over
APIs for a range of medicines prescribed for the US$1.2 billion in Singapore. APAC continues to be a key
treatment of respiratory, oncology, allergy, anti-viral market for our pharmaceuticals business.
and neurological conditions. Looking ahead, the new
Hithaishi CB
[email protected]



Tsai Ing-Wen, President of Taiwan (in the centre) with dignitaries at the inaugural ceremony.

BIO Asia-Taiwan 2019

We are showing the world that
Taiwan can help: Tsai Ing-Wen
One of the largest events on this year’s Asian
biotechnology calendar brought together the current and future direction of the industry, “The
more than 1,500 people from 25 countries to science is galloping right now. In such fields as gene
meet and explore business opportunities in Taiwan’s therapy, cell therapy, immunotherapy, CAR-T therapy,
emerging biotech sector. United under the Conference the science has never been better. All of the trend lines
theme, “Biotech as the Next Growth Engine for Asia,” are towards blending microbiological expertise with
companies spanning Asia, Europe and the US came information technology. To be able to mine healthcare
together for four days of meetings, seminars, workshops, data using artificial intelligence, to make clinical trials
partnering meeting and an exhibition featuring over more efficient, and so on. What Taiwan is good at is it
600 companies from July 25-28 in Taipei. has massive amounts of healthcare data; sometimes you
can use this data in place of a clinical trial. And AI is now
The President of Taiwan, Tsai Ing-Wen kicked being utilized to design molecules. Rather than trying
off the opening ceremony for the conference and ten thousands molecules on a particular target, use AI
exhibition. “Taiwan has long been internationally to theorize what the construction of a molecule might
lauded for its achievements in healthcare,” President be to be most effective on a therapeutic target. These are
Tsai noted. “We are making contributions to the ways Taiwan can bring its strengths to the table. ”
world and showing the world that Taiwan can help.”
President Tsai further stated that Taiwan’s biomedical Maintaining the scale of previous years, the
R&D capabilities and strengths in the ICT sector will exhibition attracted 20 countries to establish national
help spur Taiwan into a major hub for biomedical pavilions in countries including the United States,
research and development in the Asia-Pacific. Canada, Britain, Switzerland, Belgium, Italy, South
Korea, India, Australia, New Zealand, Poland,
For the first time, the event brought the BIO Thailand, Austria, Hong Kong, Germany, Singapore,
One-on-One Partnering system, powered by the Philippines, Malaysia, and more. The exhibition
Biotechnology Innovation Organization (BIO), to included over 20 themed zones, 60 listed companies,
facilitate business meetings throughout the week. 100 multinational companies, 600 exhibitors, and
More than 1700 partnering meetings were scheduled 1700 booths, unquestionably unveiling a new chapter
using the system, enabling participants to move of Taiwan’s biotechnology industry!
efficiently from identification of prospective partners
to discussion and negotiation. Showcasing String of Success

The conference Plenary Session opened with The new pharmaceutical industry, which serves as the
remarks by Johnsee Lee, Chairman of the Taiwan Bio most promising part of the biotechnology industry in the
Industry Organization (Taiwan BIO), and President eyes of investors, has secured remarkable achievements
and CEO of BIO, James Greenwood. In his main in the international arena, despite enormous challenges
presentation entitled ‘Biotech as the Next Growth in their development. This year’s exhibition was
Engine for Asia’, Greenwood expressed optimism for be dominated by “Pharmaceutical Development”



Assistive Technology make instant response, thereby avoiding frequent head
for Life (ATLife) turning to watch the monitoring screen and significantly
reducing operation time by over 30 per cent. Besides,
ATLife was the one and only professional the glass solution introduces digital medical treatment
international exhibition featuring assisted living into the operating room and facilitates accuracy of
equipment and long-term caring held at Taipei surgery operation, turning out to be a key tool that leads
Nangang Exhibition Center from July 25 to July to the great progress of surgery. In addition, National
28. There were more than 12 themed exhibitions, Defense Medical Center demonstrated its mass casualty
200 domestic and international brands, 550+ incident handling simulation system that uses virtual
booths and 2000+ products to browse and reality to simulate the situations of mass casualty
experience during the event. incidents and allow users to pose as a commander.
Therefore, it can be widely used to train the professional
Doctor Li Shu-jen, the founder of ATLife and on-the-scene commanders of mass casualty incidents.
the first physical therapist and expert to promote The Smart Healthcare, Cell Therapy and Regenerative
exercise and rehabilitation in Taiwan stated, Therapy Hall provided visitors the opportunity to see
“Smart Caring Technology is a thriving field the posture of Taipei Medical University, Shin Kong
around the world. Various innovative products Memorial Wu Ho-Su Hospital, Lukas Biomedical, etc.,
have been invented to improve long-term care and which are drawing together a blueprint for Taiwan’s
nursing from health care, suboptimal health care, Biomedical Science.
disabilities caused by aging and long-term care.’’
Experts’ insightful speeches
and “Innovative Medical Materials”. The exhibitors
included Taigen, Syncore, Pharmaessentia, Golden Nearly a hundred of exhibitor showcased and
Biotechnology, OBI Pharma, Pharmacore, Foresee InnoPitches were present, whose themes ranged from
Pharmaceuticals, Eirgenix, Applied BioCode, Keyence, Asia Pacific clinical strategies, clinical liability risks,
Biotegy, Zoetek, Bionovax, Sigknow Biomedical, Aulisa globally popular immunotherapy, RESI Fundraising
Medical Device, JHL Biotech, Magus Biotechnology, Boot Camp that aims at new drugs, medical diagnosis
Kagro Biotech and many more. These exhibitors by devices or digital health and new ventures, and the
shared the major progress that is highly likely to be recruitment and retention of biotech talents in urgent
incorporated into international licensing negotiations need, to the hot topics in Taiwan and Mainland China
or early acquisition of market authorization. like the much concerned Mainland China investment
market, status of China’s drug development, and
Reshaping Healthcare Landscape regulations of China’s drug registration.

The most eye-catching keywords of biotechnology in Sharing breakthrough treatment technologies
2019 are undoubtedly cell therapy, immunotherapy,
regenerative medicine, and precision medicine. With The Medical Seminars during July 27- 28 were
such an overwhelming therapeutic momentum, gene jointly organized in a relay manner by the major
technology, high-end precision instruments, and medical associations including The Chinese Society
preventive medicine supporting services, now and of Immunology, Taiwan Oncology Society, Taiwan
again, set off a wave of discussion. At the Precision Pancreas Society, Taiwan Association for Cellular
Medical and Genetic Testing Theme Pavilion that Therapy, Taiwan Precision Medicine Society, and
covered nearly 50 booths, the leaders biotechnological Chinese Health Care Association. On the occasion, they
service field, such as Quark Biosciences, Kim Forest, discussed the breakthrough treatment technologies in
Bionet Corp, Cold Spring Biotech, released the latest the medical field, search for commercial opportunities
trends in the field of preventive health risk analysis, of Chinese health care industry under the background
and assist the public in understanding the information of uprising global pancreatic cancer trend and
contained in their genes, thereby following-up for health international trade war. The exhibition provided
management and risk tracking innovation services. visitors a precious opportunity to look for potential
technology transfer authorization and to negotiate
Contributing to Smart Healthcare business opportunities, and it attracted thousands of
applicants thanks to its exciting agenda.
Taiwan Main Orthopedic Biotechnology in the
Innovation Cultivation Zone exhibited the world’s first (Saradha Mani was in Taipei for the
smart medical glasses, which immediately displays four day BIO Asia-Taiwan 2019 on an
X-ray images in front of the doctors, so that doctors can invitation from Taiwan External Trade

Development Council (TAITRA))





Impressed with the success of Stanford phase - the subsequent development of business and
Biodesign, brainchild of Dr Paul Yock, a commercialization plans to bring them into patient
cardiologist, and bioengineer, Singapore has care. Biodesign helps with understanding the nuances
joined hands with it to launch Singapore-Stanford of commercializing a medical device innovation from
Biodesign (SSB) in 2010 and renamed it as a user perspective, including overcoming potential
Singapore Biodesign (SB) Programme in 2016. regulatory and reimbursement hurdles.
From 2011-2018, SB has trained more than 500
students and professionals via the Fellowship “As Singapore was just starting on its journey with
Programme, Innovation Classes and Biodesign a nascent ecosystem in 2010, Biodesign was seen as
Workshops. SB fellows and class alumni have a way to boost a future innovation economy riding
also impacted over 100 projects, resulting on the rich biomedical research and manufacturing
in an additional S$30 million raised in health foundations,” said Dr Mary Kan, Deputy Programme
tech project funding. Nearly a decade since its Director, SB.
inception, we look at how this programme has
impacted Asia’s health tech. In its first phase, the programme focused on
talent development, inculcating the design thinking
Stanford University launched Stanford Biodesign methodology into its flagship fellowship programme
in 2000 as a multidisciplinary educational which consists of 4 multi-disciplinary (engineers,
programme dedicated to the training of aspiring clinicians, business and industry professionals) fellows
medical technology innovators. It was the brainchild each year. These fellows were trained in Stanford, and
of Dr Paul Yock, a cardiologist, and bioengineer who then returned to Singapore to teach the first joint-post
runs Stanford’s Byers Center for Biodesign. To date, graduate programme to multi-disciplinary students
Stanford Byers Center for Biodesign having launched from universities across Singapore, achieving a
more than 50 companies, and impacted over 2.7 multiplier talent training effect. The SB Fellowship is
million patients worldwide. an intensive 1-year training.

Impressed with what this programme has done In addition, SSB ran Biodesign workshops for
for the US MedTech ecosystem, Agency for Science, academia, healthcare institutes and industry from all
Technology and Research (A*STAR) in Singapore, over the Asia region.
the Economic Development Board (EDB), Singapore
and Stanford University jointly launched Singapore- “The field of medicine has been one of the slowest to
Stanford Biodesign (SSB) in 2010 and renamed it as be disrupted by technology and digitalization. And for
Singapore Biodesign (SB) Programme in 2016. good reason - many industries can afford to ‘move fast
and break things’, which is contrary to what traditional

A launchpad for health tech innovation

Modeled after the established Biodesign Programme
at Stanford University, this capability development
initiative was aimed at training and nurturing the
next generation of medical technology innovators for
Singapore and Asia for the then-nascent ecosystem.

Biodesign originates from the design thinking
process. It is essentially a play of 3 I’s Identification of
important unmet healthcare needs, Innovation of novel
technologies to address them, and the Implementation



medicine teaches of an evidence-based, more cautious In particular, SB has received recognition from the
approach. However, we know that we have to embrace industry and the region with seven corporate members
and lead this disruption, rather than be forced to and 10 established regional clinical parties in three
adopt it later on. The Biodesign fellowship program regional countries.
has been instrumental in helping this disruption by
training clinicians like me, who are interested in this “Locally, SB has witnessed and participated in the
intersection of healthcare and technology, to identify growth of the MedTech ecosystem. Through Biodesign
technological solutions to patient-centric needs,” said training and knowledge creation, SB has built an
Dr Ian Matthews, Assistant Group Chief Technology extensive partnership network with the various
Officer, National University Health System; Chief stakeholders of the local ecosystem such as educational
Medical Officer to AEvice health; Co-founder, Aardvark institutions, clinical and industry partners,” said Dr
labs; SB Fellow 2017. Kan.

He further added, “The opportunities that I have A decade of fostering innovation
had post-programme, in helping MedTech start-
ups, working with the hospital technology office, and For eight years from 2011 to 2018, SB has trained more
helping to build the medical technology ecosystem than 500 students and professionals via the Fellowship
have been incredible and exciting. This would not have Programme, Innovation Classes and Biodesign
been possible for me without the learning, experience, Workshops. SB fellows have continued to assume key
and networks established during the fellowship.” leadership positions in organizations like innovation
centric Singhealth, and the National University Health
SB is able to leverage on the global Biodesign System (NUHS), National Health Innovation Centre
community that has been forged through the various Singapore (NHIC), assisting to build the ecosystem,
official international programmes originating out whilst contributing to the training of talent locally. In
of Stanford, and the satellite nodes through the particular, its alumni have made an impact on health
Global Faculty Training Programme. Collectively, tech innovation with clinicians continuing to innovate
these centres form the larger Biodesign community through active projects, supported by alumni who have
that allows SB and its partners to reach out for joined health tech innovation outfits such as the NHIC,
collaborations. In addition, SB has jointly organized A*STAR’s A*ccelerate, NUHS, Medical Engineering
the Biomedical Engineering – Innovation, Design and Research & Commercialisation Initiative (MERCI) and
Entrepreneurship Alliance (BME-IDEA) Asia-Pacific SingHealth’s Medical Technology Office (MTO).
(APAC) annual forum with Stanford Biodesign from
2016 - 2018 to promote best practices in bioengineering Many of them have started their own companies.
training and innovation for Asia. One such firm is Privi, founded by fellows from the
fourth SB batch and is currently led by PrusothmanSina
Increasingly, there has been a greater demand Raja, Dr Benjamin Tee CK, Dr Rena Dharmawan and
for Asian-centric health technology solutions to Cecilia Wang. The firm has identified the unmet need
increase patient access and improve the quality of for a treatment to manage haemorrhoids safely and
care. Since 2014, SB has actively reached out to China,
the Indonesia, and South Korea and has formed “COLLECTIVELY, WITH THE WHOLE STRENGTH OF
partnerships that allow for: i) Needs identification ii) OUR FELLOWS AD STUDENTS, WE HAVE MOBILIZED
Validation of market relevance iii) Forging pathways OVER S$30 MILLION IN PUBLIC AND
for commercialization. e.g. clinical trials. PRIVATE SECTOR FUNDING FOR THE





effectively at home and developed Instalief, safe and “THE FIELD OF MEDICINE HAS BEEN ONE OF THE
drug-free solution to relieve the symptoms of this SLOWEST TO BE DISRUPTED BY TECHNOLOGY AND
condition. The FDA-approved product is expected to DIGITALIZATION. AND FOR GOOD REASON - MANY
reach the market by the end of this year or early next INDUSTRIES CAN AFFORD TO ‘MOVE FAST AND
year. Privi has achieved US FDA clearance and recently BREAK THINGS’, WHICH IS CONTRARY TO WHAT
completed a major clinical study. TRADITIONAL MEDICINE TEACHES OF AN EVIDENCE-
There have been a total of seven spin-offs from WE KNOW THAT WE HAVE TO EMBRACE AND LEAD
the programme with a combined start-up valuation of THIS DISRUPTION, RATHER THAN BE FORCED TO
over S$35 million. A*STAR’s commercialization arm, ADOPT IT LATER ON. THE BIODESIGN
A*ccelerate Technologies, owns the IP created by the FELLOWSHIP PROGRAM HAS BEEN
fellows during their fellowship year. Separately, tech INSTRUMENTAL IN HELPING
disclosures and IP originating from the joint post- THIS DISRUPTION BY TRAINING
graduate innovation class programme are owned by the CLINICIANS LIKE ME, WHO
universities participating in the module. Collectively, ARE INTERESTED IN THIS
the technology transfer offices from A*STAR and the INTERSECTION OF HEALTHCARE
various universities have filed 31 tech disclosures with AND TECHNOLOGY, TO IDENTIFY
a selection going through to provisional and eventually TECHNOLOGICAL SOLUTIONS TO
National Phase Entry patent status. PATIENT-CENTRIC NEEDS,”

“Collectively, with the whole strength of our fellows - DR IAN MATTHEWS,
ad students, we have mobilized over S$30 million in ASSISTANT GROUP
public and private sector funding for the local MedTech CHIEF TECHNOLOGY
ecosystem, filed over 30 patents from their training OFFICER, NATIONAL
projects since 2011, with at least 20 of these projects UNIVERSITY HEALTH
having received funding,” said Dr Kan.
She further added, “SB fellows and class alumni
have also impacted over 100 projects since 2011 “Our talent development initiatives will feature
through mentorship and other engagements, resulting more hands-on and experiential training to benefit
in an additional S$30 million raised in health tech translational project teams. In particular, the
project funding.” programme will emphasize the need to contextualize
innovations by understanding global market needs,
Building on the talent initiatives, SB recognized supplemented by real-world industry mentors for
its unique geographical position in Asia/ASEAN and successful startup creation and healthcare adoption.
launched more initiatives to create awareness for Finally, SB will continue to increase interactions with
the region. For example, since 2015, SB initiated a the Singapore community & regional networks through
regional immersion in Indonesia, Korea or China, talent placement and collaborations to advance
to better understand unmet Asian healthcare innovations,” said Dr Kan.
needs. Subsequently, it also launched the corporate
membership programme to introduce Biodesign “A vibrant ecosystem is vital in order to continue
training into local and regional R&D/upstream nurturing talent, both during and post-training. With
marketing teams from the industry. this view in mind, SB will continue to play the role of
an enabler bringing together various players of the
“SB also played an instrumental role as an enabler of MedTech ecosystem in Singapore and Asia,” she added.
an evolving local MedTech ecosystem. The programme
invited thought leaders from established domain areas The Asian medical market is booming. McKinsey
related to the MedTech innovation process to Singapore predicts that Asia will become the second-highest
to share their experience with the local community and medical technology market in the world by 2020, and
encourage open interaction and collaboration through it could account for a third of global sales by 2025. No
our networking events,” said Dr Kan. doubt, SB will have a notable contribution to this.

Road ahead Ayesha Siddiqui
[email protected]
Moving forward, SB aims to be a high-touch HealthTech
talent development platform centered on a needs-
based approach and quality industry mentoring to
accelerate health technology innovation and adoption
for Asia’s (Singapore, China, and ASEAN) unmet
healthcare needs.



“We have 30 major
launches planned this year”

« Janssen and calls all team members to work towards
‘creating a future where disease is a thing of the past’.
Ai Hua Ong, In order to deliver on ‘Our Promise’, I’m focused on
Company Group overcoming the challenges to timely and affordable
Chairman, Asia access to innovative medicines. Whether operating
Pacific, Janssen in reimbursed or user pay markets, we are focused on
Pharmaceutical getting our medicines to patients in need. To deliver
Companies, Singapore on this commitment and ensure long-term success,
I am focused on nurturing a diverse and inclusive
Ai Hua Ong, Company Group Chairman of workforce. Our workforce includes people differing
the Janssen Pharmaceutical Companies of in age and ethnicity, expertise and experience from
Johnson & Johnson in Asia Pacific, began her inside and outside the pharmaceutical sector in order
career at Johnson & Johnson (J&J) 28 years ago and to harness unique perspectives.
has held leadership roles across strategic marketing,
sales management, and licensing and acquisition. In What major business changes have you brought
her current role, she oversees operations that deliver about under your leadership at Janssen Asia Pacific?
pharmaceutical innovation in Australia, China,
Hong Kong, India, Japan, Korea, New Zealand and In 2018, I introduced a new way of thinking and
Taiwan. In her previous role as President of One acting that has helped galvanize our diverse region.
J&J Southeast Asia, Ai Hua was instrumental in the We call this our ‘Win One, Win All strategy’. This new
successful implementation of Johnson & Johnson’s approach places responsibility on every individual,
first-ever one-company enterprise business model every team, every function and every operating
encompassing pharmaceuticals, consumer products company to win in their respective markets and area
and medical devices. She nurtured a business with of focus, because when one of us wins, we all win.
strong growth and enhanced efficiency across 10 Importantly, it calls on us to win for patients today
countries the Association of Southeast Asian Nations – our immediate opportunity; while investing for
(ASEAN). She is one of the few female leaders in tomorrow’s patients – our longer term strategy. I
the pharmaceutical industry to date. Having had have also championed agility as the critical ingredient
the opportunity to work with various leaders during to navigating healthcare reform and evolving policy
her career, Ai Hua is also committed to mentoring environments in markets like China and Japan. Of
and developing leaders of the future. In a chat with course, I continue to advocate for investment in Asia
BioSpectrum Asia, Ai Hua talks about her future plans Pacific and act as a trusted interface for our global
for the company. Edited excerpts; leaders on this dynamic region.

What are your key focus areas as the Group “REGION WIDE, THE NUMBER ONE CHALLENGE IS
Pharmaceutical Companies of Johnson & Johnson in IN ORDER TO DELIVER ZERO-GAP WITH THE US AND
Asia Pacific, I oversee a rapidly growing business in EUROPE. WE ARE ALSO EXPLORING AND TESTING
one of the most dynamic and diverse regions in the NEW ACCESS MODELS THAT WILL LESSEN THE TIME
world. My focus is on ensuring our 7,000-strong team FROM REGISTRATION TO FUNDED ACCESS. WE ARE
located in eight markets works as one to deliver on ‘Our ALSO PURSUING STRATEGIC PARTNERSHIPS THAT
Promise’. This is our global statement of who we are as INCREASE OUR ABILITY TO DELIVER MEDICINES TO



With over 25 years of experience, what are your “COMPANIES MUST ALSO LOOK TO THE FUTURE AND
views on the growth of the pharma industry in MAINTAIN A PIPELINE OF INNOVATIVE MEDICINES
An ageing population, a rise in non-communicable OUTCOMES AND CAN BE COMMERCIALIZED AT
disease, a burgeoning middle-class and increasing SPEED. AT JANSSEN, WE ARE COLLABORATING
demand for quality healthcare are drivers for growth WITH EXTERNAL SCIENTISTS, RESEARCHERS AND
in Asia Pacific. That said, we face stagnant drug ENTREPRENEURS, ALONGSIDE OUR OWN R&D TEAMS.
budgets in many markets and need to better articulate THIS FOCUS INSPIRED JLABS – DEDICATED PRECINCTS
the value of pharmaceutical innovation. THAT CONNECT JOHNSON & JOHNSON INNOVATION
Companies must also look to the future and THESE JLABS HAVE ONLY OPERATED IN NORTH
maintain a pipeline of innovative medicines that will AMERICA AND EUROPE, BUT THAT CHANGED LAST
truly contribute to better patients’ outcomes and MONTH WHEN WE LAUNCHED ASIA PACIFIC’S FIRST
can be commercialized at speed. At Janssen, we are JLABS IN SHANGHAI – OUR LARGEST JLABS FACILITY
collaborating with external scientists, researchers WORLDWIDE, ACCOMMODATING UP TO 50 LIFE
and entrepreneurs, alongside our own R&D teams. SCIENCES AND HEALTHCARE START-UPS.”
This focus inspired JLABS – dedicated precincts that
connect Johnson & Johnson Innovation with the Mochida Pharmaceutical and Taiho Pharmaceutical
entrepreneurial R&D community. These JLABS have to improve access to several of our medicines. Of
only operated in North America and Europe, but that course, we face increased competition, not just
changed last month when we launched Asia Pacific’s from multinationals but through the rise of Chinese
first JLABS in Shanghai – our largest JLABS facility biotechnology innovators; rising operating costs;
worldwide, accommodating up to 50 life sciences and increasing complexities in regulatory environment;
healthcare start-ups. and strong competition for talent. The solution
to these challenges lies in our ability to accelerate
What are the basic challenges facing the pharma innovation and expand access while advocating the
industry in the Asia Pacific region today, and value of our medicines. Our high-performing team is
how can those be addressed? up to the challenge and is working to reshape access
Region wide, the number one challenge is timely and environments, deliver superior customer engagement
affordable access to innovative medicine. We are and become a scientific partner of choice.
addressing this through efforts to accelerate regulatory
approval in order to deliver zero-gap with the US and What are the major plans in store for 2019
Europe. We are also exploring and testing new access at Janssen Asia Pacific? Are there any new
models that will lessen the time from registration announcements or launches in the pipeline?
to funded access. We are also pursuing strategic 2019 is a big year for Janssen in Asia Pacific. First
partnerships that increase our ability to deliver and foremost, our medicines will be used by more
medicines to more patients, in a quicker timeframe. than 60 million people. We are focused on increasing
In Japan, we collaborate with Mitsubishi Tanabe, this impact, with 30 major launches planned, each
with the ability to set new standards in care. A great
example is the recent launch in Japan of our new
medicine that helps men with prostate cancer that
continues to grow despite treatment with hormone
therapy. In China, we are focused on adding as
many of our innovative medicines to the National
Reimbursement Drug List. This is paramount to
securing access for patients, with our immediate
focus on inflammatory bowel disease, inflammatory
arthritis and a number of cancer types.

Dr Manbeena Chawla
[email protected]



Scientists in India invent detection
device for early diagnosis of heart attack

A team of researchers from the Indian Institute of Technology (IIT)
Hyderabad has developed a microfluidic device for early diagnosis
of heart attack. A cardiac biomarker — cardiac troponin I — that is
widely used for early diagnosis of acute heart attack can now be
detected in about three minutes and even when present at very low
concentration. The heart cells that get damaged during heart attack
cause the expression of cardiac muscle proteins such as the biomarker
cardiac troponin I, which get released into the blood. Detecting the
biomarker in the blood serum helps in early diagnosis of heart attack.
The researchers have successfully integrated the microfluidic device
with chitosan-coated nickel vanadate nanospheres to enable rapid
detection and better sensitivity. The team plans to undertake large trials
involving many patient samples before it can be used commercially.

Researchers in China KIAST team studies
use nanoparticles for mutations associated
breast cancer treatment with Alzheimer’s

A group of researchers at the Nanjing University in Researchers from Korea Advanced Institute of
China has invented imprinted nanoparticles that Science & Technology have identified somatic
can be used to target aggressive breast cancer. About mutations in the brain that could contribute to
20-30 percent of breast cancer cases belong to the the development of Alzheimer’s disease (AD). The
very poorly treatable HER2-positive variety. HER2 team developed a bioinformatics pipeline that
stands for human epidermal growth factor receptor enabled them to detect low-level brain somatic
2, a protein that recognizes and binds to a specific single nucleotide variations (SNVs), mutations
that involve the substitution of a single nucleotide
growth factor to trigger with another nucleotide. Brain somatic SNVs have
cell division, metastasis been reported on and accumulate throughout our
and the formation lives and can sometimes be associated with a range
of blood vessels that of neurological diseases. The number of somatic
supply the tumor with SNVs did not differ between individuals with AD
nutrients and oxygen. and non-demented controls. Interestingly, somatic
Existing therapies for SNVs in AD brains arise about 4.8 times more
HER2-positive breast slowly than in blood. When the team performed
cancer include using gene-set enrichment tests, 26.9 percent of the AD
antibodies that bind brain samples had pathogenic brain somatic SNVs
HER2 to prevent the known to be linked to hyperphosphorylation of tau
activation of downstream cellular processes. In proteins, which is one of major hallmarks of AD.
this study, researchers have devised an alternative
approach to target HER2-positive cancers using
molecularly imprinted biocompatible polymer
nanoparticles that recognize HER2 just as
specifically as an antibody. The researchers endowed
their nanoparticles with specificity by carrying out a
polymerization reaction in the presence of HER2—
the biomolecules act as a kind of stamp, leaving
nanoscopic ‘imprints’ in the spheres. In contrast
to antibodies, the nanospheres are easy and
inexpensive to produce and are chemically stable.



NUS scientists develop
artificial nervous system

Robots and prosthetic devices to damage, and can be paired Japanese
may soon have a sense of with any kind of sensor skin researchers use
touch equivalent to, or better layers to function effectively AI to design
than, the human skin with the as an electronic skin. The novel endoscopy
Asynchronous Coded Electronic innovation has been achieved
Skin (ACES), an artificial by Assistant Professor Benjamin Researchers at Okayama
nervous system developed by Tee and his team from NUS University in Japan have
developed an early gastric
a team of researchers at the Materials Science cancer endoscopic diagnosis
National University of Singapore and Engineering. system using artificial
(NUS). The new electronic ACES can detect intelligence (AI). First the
skin system has ultra-high touches more prototype of the system to
responsiveness and robustness than 1,000 times obtain the depth of early
faster than the gastric cancer was constructed
human sensory with GoogLeNet to match
nervous system. purpose (metastatic learning)
For example, by using the image recognition
it is capable of ability of CNN (Convolutional
differentiating Neural Network) published
physical contact by Google on numerical
between different sensors in less analysis software MATLAB.
than 60 nanoseconds, the fastest Next, the researchers used the
ever achieved for an electronic ResNet, which is a 152-layer
skin technology, even with large convolutional neural network,
numbers of sensors. to conduct intramucosal
endoscopic resection among
NTU team develops probes to patients treated for early
detect acute kidney failure early gastric cancer at Okayama
University Hospital. Using
Scientists from Nanyang Technological University, Singapore (NTU endoscopic images of 100
Singapore) have developed a type of imaging probe that allows for earlier cancers (M group) and 50
detection of acute kidney failure, a rapidly-developing condition that submucosal invasion cancers
can be fatal. The new renal (SM-ESD group) and 50
probes, which have been submucosal invasion cancers
tested in mice, are injected (SM-OPE group) who had
into the blood-stream. undergone surgery from the
They ‘light up’ when they beginning, the researchers
detect molecular changes built the AI system and
caused by the onset of acute verified its diagnostic accuracy.
kidney failure. Developed by
Associate Professor Pu Kanyi
and his team from NTU
Singapore, these probes
could potentially be used in
test strips for urine samples,
making it a non-invasive method of detecting acute kidney failure.
Assoc Prof Pu envisions the use of these probes in an intensive care unit
setting, where early detection of acute renal failure is paramount to a
patient’s survival.



Servier Australia, BioCurate to accelerate drug discovery

Servier Australia, (MoU), whereby they will work BioCurate was
the subsidiary of together, both directly and via established with
Servier Group, participation in BioCurate’s a specific focus
an international Industry and Scientific Advisory on addressing
pharmaceutical Committee, in providing advice the barriers
company, and and assessing new therapeutic that limit the
BioCurate, a joint candidates arising from translation and
venture company BioCurate’s academic partners. commercialisation
of Monash of early stage
University and research. With the
The University of aim of increasing
Melbourne with the number of
support from the ‘Investment-
Victorian State ready’ projects,
Government, BioCurate is
have struck an agreement to committed to engaging closely
share commercial and scientific and collaboratively with
expertise with the aim of industry and other potential
accelerating the discovery of investors to ensure promising
new therapeutics and drugs. projects receive critical
Servier and BioCurate will expert advice and assessment
collaborate under the terms of a throughout the drug discovery
memorandum of understanding process.

GSK to develop new Tsinghua University launches
scientific doctoral Amgen Scholars Programme
programmes in India
The Amgen Scholars Program (ASP) at Tsinghua University,
The Regional Centre for Biotechnology funded by the Amgen Foundation, held its opening ceremony
(RCB), an academic institution of national recently at Tsinghua campus. Tsinghua University is a major
importance established by the Department research university in Beijing, and a member of the elite C9
of Biotechnology, Government of India, League of Chinese universities. Last September, Tsinghua
under the auspices of UNESCO, and University was selected as the first and only Chinese host
GlaxoSmithKline Pharmaceuticals have
launched the Trust in Science Programme institution for ASP, one
to develop doctoral programs (PhDs) in the of the 24 world-leading
fields of biostatistics and bioinformatics. universities including
Under this initiative, the RCB will develop Harvard University,
programme content, manage logistics Stanford University, the
and oversee the running of the full-time University of Cambridge
programs. GSK Pharmaceutical will provide and others. ASP is an
funding and ensure all course content undergraduate summer
is shaped to address current industry research programme,
needs and opportunities. Students with initiated and supported
a master’s degree in biostatistics, maths, by the Amgen
and bioinformatics are eligible for the PhD Foundation through a 16-year, $74 million commitment.
courses. GSK Pharmaceutical’s “Trust in This 8 to 10-week practice-based programme aims to recruit
Science” initiative is a novel public-private outstanding undergraduates from across the globe, who
partnership model to build R&D capacity have strong interests in biomedical research, life sciences or
for development and discovery in science. related fields, to conduct cutting-edge research at world-class
laboratories and institutions.



Agilent announces BioTek acquisition for $1.16B

Agilent Technologies Inc. has announced that it has signed
a definitive agreement to acquire privately-owned BioTek
Instruments for $1.165 billion. With anticipated tax benefits for
Agilent, the net purchase price is expected to be approximately
$1.05 billion. BioTek is a global leader in the design, manufacture
and distribution of innovative life science instrumentation.
Its comprehensive product line includes cell imaging systems,
microplate readers, washers, dispensers, automated incubators
and stackers. These products enable life science research by
providing customers with high performance, cost-effective
analysis across diverse applications. BioTek generated revenues
of $162 million in fiscal year 2018 ending December 31 and
is expected to grow approximately 10 per cent in 2019. The
transaction is expected to be completed in Agilent’s fiscal
fourth quarter of this year, subject to regulatory approvals and
customary closing conditions. Agilent expects the acquisition will
be accretive to non-GAAP earnings per share, contributing $0.02-
$0.04 for fiscal year 2020, and compounding growth thereafter.

Abcam acquires cell lines Sartorius unveils
new bioreactor vessel
portfolio from EdiGene
Sartorius Stedim Biotech (SSB), a leading international
Abcam plc, a global innovator in life partner of the biopharmaceutical industry, has
science reagents and tools, is pleased to launched a new vessel for its ambr 250 modular
announce the acquisition of the entire benchtop automated mini bioreactor system. The
live cell line and lysates portfolio of China single-use vessel has been specially designed for
based EdiGene Inc, a leading company therapeutic cell lines and offers the potential for
focused on developing genome editing accelerated process development of cell and gene
technologies into novel therapeutics therapy applications and scale-up into cGMP single-
for a broad range of diseases and into use bioreactors and bags. The new unbaffled vessel
creative solutions to advance drug design with a large pitched blade impeller has a
discovery. Using their proprietary high working volume of 100-250 mL and provides an
throughput cell editing platform, EdiGene environment for gentle agitation and mixing without
developed the industry’s largest off-the sedimentation, allowing optimal growth of single
shelf diploid library of over 2,800 single cell suspensions, cell aggregates or adherent cells
clonal knockout (KO) cell lines targeting on microcarriers. In trials with leading regenerative
over 2,600 genes in commonly used medicine companies, the new mini bioreactor has
human cancer cell lines (including HeLa, shown better cell culture performance compared with
HEK293-T, A549, HCT116, Hep G2 and less predictive spinner or T-flask models, enabling
MCF7). Ready-made diploid KO cell- rapid process optimization and improved
lines are an important tool for antibody scalability to larger bioreactors.
validation. They also play a significant
role in the study and understanding of
biological pathways and disease models
and can be used in screening and cellular
assays. EdiGene’s cell lines and lysates are
used by top academic researchers, global
biopharmaceutical companies, and leading
antibody companies.


NEB opens Bio-Rad launches multiplex
8th subsidiary assay for immunotherapy research
in Australia
Bio-Rad Laboratories, Inc. has targets. The Bio-Plex Pro Human
New England Biolabs (NEB), a Immunotherapy Panel 20-plex
world leader in the production launched Bio-Plex Pro Human covers biologically-researched
of reagents for the life science cytokine targets that are
industry, extended its global Immunotherapy Panel 20-plex, associated with immunotherapy
subsidiary network with the research. The Bio-Plex Pro
opening of New England a multiplex immunoassay that Human Immunotherapy Panel
Biolabs Australia Pty Ltd. 20-plex is a ready-to-use, 1 x 96-
Australia’s Life Sciences offers a targeted approach for well kit that contains premixed
industry is home to more magnetic capture beads and
than 230,000 life science Immunotherapy Research. detection antibodies, standards,
researchers, working towards and buffers that produce results
advancing discoveries across Messenger molecules such for 20 different cytokines using
the academic, agricultural, only 12.5uL of sample. The Bio-
clinical and biotech industries. as cytokines are involved in Plex Panel maximizes laboratory
Australian researchers have efficiency by generating key
been instrumental in many the communication within actionable data in a single
scientific breakthroughs that experiment.
have had significant global the immune system and play
impact on both clinical
outcomes as well as our a vital role in a variety of
fundamental understanding of
biology. The Melbourne based conditions including cancer and
office will provide the scientific
research community in both autoimmune diseases. Advancing
Australia and New Zealand
with more efficient access to discoveries in immunotherapy
the latest NEB products and
technical support in the local can be time consuming as
time zone. NEB also maintains
subsidiary offices in Canada, existing immunoassay tools may
China, France, Germany,
Japan, Singapore and the not be tailored to cover specific
United Kingdom.
targets including cytokine

Thermo Fisher introduces
new formats for antimicrobial
susceptibility testing

Comprehensive antimicrobial susceptibility testing (AST) for Gram
negative and multidrug-resistant organisms (MDRO), including
the antimicrobials eravacycline, omadacycline and plazomicin, is
now available in the U.S. in off-the-shelf, standard plate formats.
By providing an accurate MIC
result, microbiology laboratories
can reduce offline testing and
improve workflow while providing
the information clinicians
need to help guide appropriate
therapeutic decisions. The Thermo
Scientific Sensititre AST System
is the first to offer eravacycline,
omadacycline and plazomicin
on an FDA-cleared, IVD-labeled
microbroth dilution susceptibility
plate for comprehensive AST using second-line MDRO therapies
with expanded dilution ranges for Gram negative organisms to
better detect emerging resistance. A research-use-only format is also
available with the inclusion of colistin. In addition, the new FDA-
cleared, IVD-labeled Thermo Scientific Sensititre Gram Negative
GN7F AST Plate includes 24 common first-line therapies, as well
as ceftazidime/avibactam and ceftolozane/tazobactam and lower
dilution ranges for ciprofloxacin and levofloxacin to better test
susceptibilities of Enterobacteriaceae and Pseudomonas aeruginosa.



Dr Mahesh Bhalgat Terns Pharma
joins Syngene as COO appoints Dr
Ankang Li as CFO
Syngene International, a leading global Contract Research
Organisation, has announced the appointment of Dr Mahesh Terns Pharmaceuticals, Inc.,
Bhalgat as Chief Operating Officer (COO). Dr Bhalgat has
taken charge as COO with effect from July 1, 2019. He comes to a US and China based global
Syngene from Shantha Biotechnics, a Sanofi company, where
he was responsible for all manufacturing operations, supply biopharmaceutical company
chain, engineering projects, HSE, manufacturing excellence and
administrative services. In a career spanning over 25 years in focused on discovering and
the field of biotechnology and biologics, Dr Bhalgat is recognised
for his contribution to the commercialization of diagnostic kits, developing innovative therapies to
biopharmaceuticals and WHO pre-qualification of vaccines. He
has rich experience in diverse areas of biotechnology such as treat non-alcoholic steatohepatitis

biotherapeutics, vaccines, ag-biotech, and (NASH) and cancer, has announced
research reagents and has been associated
with companies such as Amgen, Monsanto, the appointment of Ankang Li,
Celera Genomics, Thermo Fisher, Biological
E. A Ph.D. in Medicinal Chemistry from the Ph.D., J.D., CFA as Chief Financial
University of Utah, he is the Co-Chair of
CII’s National Committee of Biotechnology Officer (CFO). At Terns, Dr Li will be
as well as a member of the Biomeriux
Scientific Advisory Board, France, United responsible for corporate financing,
States Pharmacopeia, GCBA committee
and the Indian Pharmacopeia financial reporting, accounting,
risk management, business
Pfizer brings Dr Scott
Gottlieb on Board development, and investor relations.

Pfizer has announced the election of Dr Scott Gottlieb to its Board Prior to joining Terns, Dr Li was the
of Directors, effective immediately. Dr Gottlieb, age 47, was also
appointed to the Regulatory and Compliance Committee and Executive Director of Healthcare
the Science and Technology Committee of Pfizer’s Board. Dr
Gottlieb, a physician and medical policy expert, is currently a Investment Banking at Goldman
Special Partner of New Enterprise Associations, Inc.’s healthcare
investment team and a Resident Fellow of the American Sachs, where he was responsible
Enterprise Institute. He served as the 23rd Commissioner of the
U.S. Food and Drug Administration (FDA) from 2017 for Asia ex-Japan investment
to 2019. Prior to serving as Commissioner, Dr
Gottlieb held several roles in the public and banking and led many high-profile
private sectors, including serving as the
FDA’s Deputy Commissioner for Medical IPOs for biotechnology and other
and Scientific Affairs and as a Senior
Adviser to the Administrator of the Centers healthcare clients. Before that, Dr
for Medicare and Medicaid Services,
where he helped implement the Medicare Li was a Director at the Asia Pacific
drug benefit, advance policies to improve
healthcare quality and promote the effective Innovation Hub at Merck (known as
use of new medical technologies.
MSD outside the U.S. and Canada),

overseeing business development

and licensing transactions in the

region. Dr. Li also worked at both

Davis Polk and Ropes & Gray,

advising clients on capital markets

and M&A transactions. Early in his

career, he conducted biomedical

research at the Salk Institute.



New WHO Goodwill HighTide
Ambassador for UHC Therapeutics expands
leadership team
WHO has announced the appointment of Professor
Keizo Takemi as WHO Goodwill Ambassador for HighTide Therapeutics Inc., a clinical-stage
Universal Health Coverage (UHC). Professor Takemi biopharmaceutical company based in China
is an internationally renowned advocate on global and the US, has announced that Adrian M.
health and development. He was the State Secretary for Di Bisceglie, M.D., has been appointed as
Foreign Affairs of Japan in 1998-1999 and the Senior Chief Medical Officer. In this new role, Dr
Vice Minister of Health, Labour and Welfare of Japan in Di Bisceglie will lead clinical development of
HighTide’s novel therapies. Dr Di Bisceglie
2006-2007. As the son of will join the executive team and report to Dr
prominent physician and Liping Liu, Founder, Chief Executive Officer
scientist Dr Taro Takemi, & Chief Scientific Officer of HighTide. Dr Di
he has a strong interest in Bisceglie is board-certified in internal medicine,
health and welfare, and gastroenterology and transplant hepatology. A
played an important role thought leader in hepatology, he has authored
negotiating reform of the over 400 publications. He is the past president
Japanese health system (2014) and governing board member (2010-
and the introduction of 2015) of the American Association for the Study
the elderly care insurance of Liver Disease (AASLD). Dr Di Bisceglie has
scheme in 2000. served as a member of the editorial board of
Professor Takemi taught the AASLD journal Hepatology. Additionally,
international politics at he has served as an advisor and committee
Tokai University, Japan, since 1995 and was Harvard member with the US FDA, CDC, and NIH. Most
School of Public Health Research Fellow from 2007- recently Dr. Di Bisceglie served as Professor
2009. Since 2007, as a senior fellow of Japan Center for of Internal Medicine and Chief of Hepatology,
International Exchange (JCIE), he has led a high-level Division of Gastroenterology and Hepatology at
working group advocating for Japan’s collective action Saint Louis University.
on global health.

Noven hires Andrew J. Purcell as Marketing Head

Noven Pharmaceuticals, Inc., a the United States. launch of several
wholly-owned subsidiary of Japan- Purcell joins Noven products including
based Hisamitsu Pharmaceutical with over 25 years TOUJEO®; Vice
Co., Inc., has announced the of commercial President, Global
appointment of Andrew J. Purcell experience in the Commercialization
as Noven’s Head of Marketing U.S. pharmaceutical for BYDUREON®
& Sales. In this new role, Purcell industry, at AstraZeneca/
will develop and lead Noven’s including Vice Bristol-Myers
marketing and sales team as President, Head Squibb, with
Noven prepares for the potential of U.S. Diabetes responsibility
launch and commercialization of Business Unit for for leading the
HP-3070 (asenapine) transdermal Sanofi where he development
drug delivery system (TDDS), a was responsible of commercial
new investigational patch product for portfolio strategies for new
for the treatment of schizophrenia. strategy, customer products; Positions
A New Drug Application (NDA) is engagement, market of increasing
currently under review by FDA for development and the leadership of responsibility at Novo Nordisk,
HP-3070, which was developed by the cross-functional U.S. Diabetes including Vice President, Strategic
Hisamitsu and, if approved, will Leadership team and where his Business Development and Vice
be commercialized by Noven in team was responsible for the President, Diabetes Marketing.



Visitors at the INTERPHEX Week Japan


42057 visitors &
1176 Exhibitors participate

The 21st Interphex Japan including (PHARMA INTERPHEX Week Tokyo
JAPAN, BioPharma Expo, PharmaLab JAPAN consists of 4 exhibitions for
and an inaugural edition of Regenerative pharmaceutical technologies
Medicine Expo) which were concurrently held from
July 03-05, 2019, at Tokyo Big Sight, Japan attracted  INTERPHEX JAPAN (Manufacturing &
42057 visitors and 1176 Exhibitors. Packaging)

The exhibitions have established it as one of the  In-Pharma Japan (Ingredients)
most significant business platform where the whole  BioPharma Expo (Biopharmaceutical)
Japanese pharmaceutical industry gets together and  PharmaLab Japan: formerly BIOtech Japan
this was evident from the number of participants who
took part in the joint event. (Drug Discovery)

The event was focused on covering the whole lab devices, contract services, packaging and other
process of pharmaceutical R&D and manufacturing industry solutions.
and featured technical conferences and exhibitions
associated with all kinds of life science equipment, The exhibition, which was spread across six (East)



Highlights of VIP attendees at the evening reception
Week Tokyo

 Asia’s Leading Pharma &
Biotech Shows

 42,057 Visitors from around
the world visited the stalls at
the expo

 1176 Exhibitors from 34
countries displayed their

 Industry leaders spoke at
over 300 sessions

 Around 1,000 specialists
from pharmaceutical industry
shared their experience at the
keynote sessions

halls and 51,380 square meters at Tokyo Big Sight Physiology, Keio University School of Medicine,
convention center, showcased different exhibitors sharing about ongoing clinical trials of iPSCs-based
located in different strategic zones like the Materials cell therapy for spinal cord injury and patients-
Process Zone, Supplies and Transfer Zone, BioPharma based drug development for ALS said “There is an
Zone, Sterilizing Equipment and Clean Room Zone, increasing interest in regenerative medicine and
Plant Engineering Zone, Water Production and drug development as medical application of iPSCs-
Control Zone, Laboratory Measurement and Analysis technology.”
Equipment Zone, Logistics Zone, IT Solutions Zone
Contract Services Zone, and Process Inspection and Talking about innovation happening in Japan,
Testing Equipment Zone. Masaki Soda, Show director Reed Exhibition, said
“The definition of innovation keeps changing from one
The experts at the keynote address, emphasized country to another. Innovation is only as good as the
on how life science firms in Japan are venturing in to customers, who are willing to pay for it.”
expand in the emerging markets of China, India, Brazil
and Russia (BRIC) among other nations because He further said, “Raise in consumption tax on
of stifled innovation in the ‘land of the rising sun’. drugs from April 2019, influx of generics, premium
However, the environment in the technical sessions on Japan’s new drug pricing policy and substantial
was ‘let’s innovate and help Japanese life sciences reductions in operating profits will only make the
industry’ to get out of its stifled phase. prevalent scenario worse for the pharma industry in
During the three day conference speakers spoke
many topics including Pharma industry’s hot Although the high levels of energy, enthusiasm
topics including AI/IoT in pharma manufacturing, and display of technology at the mega event portrayed
continuous manufacturing, CAR-T Therapy and CMC that the Japanese are very serious about fuelling
strategy, etc. innovation in their life science industry, the fact that it
is facing several hindrances from the point of view of
Yoshihiko Hatanaka, Representative Director, policy and will face many such challenges in the near
Chairman of the Board, Astellas Pharma Inc. who future is certainly a cause of concern.
delivered key note address noted that Healthcare
needs are drastically changing with economic and Keeping a cause of concern in future, Reed
social structure transition due to aging. Astellas Exhibition promised to have something much bigger
strives to create medical solutions that provide value and interesting in future event to deliver a purpose to
to society through new modality / technology and business of bioscience and healthcare.
digital transformation, including cell therapy and
digital health programmes. (Ankit Kankar was in Tokyo on an
invitation from Reed Exhibition as a part of
Hideyuki OkanoDean, Keio University Graduate Media Delegation for Biopharma Expo 2019
School of Medicine/ Professor, Department of and 21st Interphex Week Japan 2019 from
July 3-5, 2019).

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