BioSpectrum Asia July 2022

High Quality Grade grafeting gmbh | visuals: stock.adobe.com
Plasmid and Minicircle DNA

Now in LARGE scale!
Starting material for
GMP production of mRNA,
viral vectors & CAR-T cells

The better way to DNA!

PlasmidFactory.com

PlasmidFactory GmbH & Co. KG
Meisenstraße 96 | D-33607 Bielefeld | Germany | Fon +49 521 2997 350

4 BIO EDIT

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Dr Milind Kokje GREEN LIGHT TO
MEDICAL MARIJUANA
Chief Editor
Thailand has decriminalised marijuana for medical and other purposes. It is
[email protected] significant to take note of this move since it is the first Asian country to join
almost 50 others in the world which allow patients to use prescription medical
marijuana. Marijuana plant, which otherwise is considered to be a harmful substance
as it is addictive, contains some chemicals that are used as a medicine in some health
conditions as it is helpful to provide relief to the patients. For this medical purpose the
two main cannabinoids, the chemicals in marijuana, tetrahydrocannabinol (THC) and
cannabidiol (CBD) which have been scientifically studied, have been found to be useful.

They treat and relieve the vomiting and nausea in cancer patients caused by
chemotherapy. They are helpful in increasing appetite in AIDS patients who suffer from
severe weight loss. In addition, cannabinoids are helpful in managing chronic pain, aid
insomniacs to sleep and treat two types of severe epilepsy among children. More research
is ongoing to detect more ingredients in the plant that could possibly treat more diseases.
As a result, the growing number of countries are legalising, or thinking of legalising, use
of medical marijuana pushing the cannabis use into therapeutic applications.

Thus marijuana is seen as a new business opportunity. The global medical marijuana
market was worth $13.2 billion in 2021 and the Global Cannabis Report expects it to
grow till 2030 at 21.6 per cent CAGR. With availability of more products following
the research treating more medical conditions the market may grow even more. In
Thailand itself marijuana related market is estimated to be 40 billion Baht ($1.15
billion) and it is expected to grow to 70 billion Baht in the next two years. Its marijuana
and hemp business is attracting over 1.2 billion Baht ($35 million) investment since it
is decriminalised.

With decriminalisation of marijuana, it is not a crime to grow and trade marijuana
and hemp products or use parts of the plant to treat illness in Thailand. Restaurants and
cafes can also serve cannabis-infused food and drinks. However, the products should
have less than 0.2 per cent of THC, the main psychoactive compound of the plant. But
Thai authorities have repeatedly clarified that smoking weed for fun is still illegal.

Thailand has a history of using cannabis plants and their ingredients for treatment
of diseases since ancient times. But in 1979, Thailand totally banned use of cannabis.
However, in 2018 the Thai government started working towards loosening the laws
and even unveiled its first legal cannabis greenhouse in February 2022.

Now it is welcoming tourists for treatment using medical marijuana, albeit with
a strict warning that its use for any other purpose is not allowed. However, a country
which attracts a large number of tourists, controlling the misuse of marijuana will be a
challenge. The concerned government agencies will have to intensify a vigil to prevent
any misuse. Even the people are worried over the decision as was reflected in the Suan
Dusit Poll. Only 13 per cent respondents were not worried at all and 33 per cent were
very worried while 38 per cent were fairly worried.

Some countries in Asia, will be watching the effects of Thailand’s decision as they
too would like to join it in due course. The Indian state of Tamil Nadu is considering
allowing hemp cultivation for medical and industrial purposes. South Korea has
already done it to some extent by legalising medical marijuana in November 2021.
Singapore and China are doing research into medical applications of cannabis. Japan
has approved clinical trials for Epidiolex, which is a cannabis compound. The Malaysian
Health minister has also stressed the need for decriminalisation of drugs as legalising
medicinal cannabis would be a ‘game changer’.

The use of marijuana for medical purposes, although a blessing for most patients
deriving benefit, it still remains a double-edged sword and must be handled with
mindful caution.

BIO MAIL 5

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Acknowledgements The Bayer team is really happy with
the coverage. Thank you so much
I would like to thank you for giving me for the interview with the newly
an opportunity to publish my article on appointed Bayer Pharmaceuticals Head
behalf of the National Institution for of Commercial Operations for Asia-
Transforming India, better known as NITI Pacific, Dr Ying Chen.
Aayog, in BioSpectrum and reach a wide
audience. I am very much satisfied with - Ambuja Kashyap, India
the current coverage and look forward to
publishing more with your publications. Thank you so much for an interview
feature with OnQuality Pharmaceuticals.
- Ranjan Das, India It looks fantastic. We look forward to
working with you again soon on other
Both the print and online versions of the stories.
Abcam interview look fantastic – thank
you so much for covering this story. The - Ignacio Guerrero-Ros, PhD, US
team is delighted. Looking forward to
working with you again in the future.

- Alex Bannister, UK

Vol 17; Issue 7; July 2022 MM Activ Singapore Pte. Ltd. Taiwan
Media Representative:
Publisher & Managing Editor: Singapore Ms Christine Wu
Ravindra Boratkar MM Activ Singapore Pte. Ltd. Image Media Services Company
Editorial: Saradha Mani 2F-2, No. 35, Sec. 2, Flushing South Road,
Chief Editor: Dr Milind Kokje General Manager Taipei 10665, Taiwan
[email protected] #08-08, High Street Centre, Tel: +886-2-87734199
Advisor - Content: Vijay Thombre 1 North Bridge Road, Singapore - 179094 Fax:+886-2-87734200
Editor: Narayan Kulkarni Tel: +65-63369142 / Fax:+65-63369145 Mobile: 886-937890533
[email protected] Mobile: +65-90681202 E-mail: [email protected]
Executive Editor: Dr Manbeena Chawla [email protected] website: www.imagemediatw.com
[email protected] China
Sub Editor: Nitesh Pillai Asia Pacific & South East Asia Erika Cheng
[email protected] Ankit Kankar RFCOMMS
Asst. Manager Content Creation DY. General Manager E101, East Lake Villas, 35 Dongzhimenwai
and Coordination- APAC Region: Digital Intell. & Growth Main Street, Dongcheng District,
Hithaishi C. Bhaskar 1st Floor, CIDCO Convention Center, Beijing 100027, P. R. China
[email protected] Sector 30A, Vashi, Navi Mumbai, Mobile: +86 17375668063
Social Media Communications: Maharashtra-400703. E-mail: [email protected]
Ankit Kankar Mobile: +91-9579069369 India
[email protected] [email protected] Apoorva Mahajan
CFO & Special Correspondent: Key Account Executive
Manasee Kurlekar USA “NITON”, Block B, First Floor,
[email protected] BioSpectrum Bureau 11/3, Palace Road, Bangalore 560001
Operations and HR MM Activ Sci-Tech Communications Tel: +91-80-41131912/13
Asmita Thakar Mobile: +91-9579069369 Mobile: +91-7724025888
[email protected] [email protected] [email protected]
Production & Design:
MM Activ Sci-Tech Communications Europe Photo: Shutterstock
Anil Walunj BioSpectrum Bureau
Cover Design: MM Activ Sci-Tech Communications Go Digital:
Dominix Strategic Design Pvt. Ltd. Mobile: +91-9579069369 To request subscription
Business Enquiry: [email protected] email: [email protected]
Ankit Kankar Chief Editor: Dr Milind Kokje
[email protected] Printed and published by Ravindra Boratkar MCI (P) 020/06/2022
Subscription Services on behalf of MM ACTIV Singapore Pte Ltd. Copyright:
Print Edition: Saradha Mani Printed at Times Printers Private Limited MMActiv Singapore Pte Ltd.
[email protected] 16 Tuas Avenue 5, Singapore 639340
Digital Edition: Ankit Kankar Tel : +65-63112888
[email protected] Reprinted in India for private Circulation
News Letter : Sudam Walekar
[email protected]
Database Executive: Sudam Walekar
Subscription Services:
Apoorva Mahajan
[email protected]
Bio Spectrum Jobs:
Poonam Bhosale
[email protected]

6 BIO CONTENT BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

COVER STORY 18

HOW IS
BIOMANUFACTURING

DRIVING
CDMO MARKET?

A successful business model for the pharmaceutical industry is driven by the
outsourcing trend, making contract development and manufacturing organisations

(CDMOs) an integral component of drug development value chains. Increasing
regulatory complexity, high development costs, and fierce competition have driven
drug companies to leverage CDMOs to accelerate their go-to-market strategy, and
Asia Pacific (APAC) is not an exception. Let’s navigate through prime achievements
and potential trends in the APAC CDMO arena which helped the world heal during

the pandemic and is further helping to build a resilient health system.

BIO CONTENT 7

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com SPEAKING WITH

ANALYSIS 37

16 “Regulatory bottlenecks
such as local QC testing
Is Biotech Headed for Bear Run? and pre-approval of
GMP inspections must go”
CDMO
Eileen Ang,
26 Head of Regulatory Affairs,
Takeda APAC
Why Indian Pharma Must Evolve As ‘Value Creator’
39
MYOPIA
“Leveraging big data
28 to create transparency,
mitigate risks and operate
Eschewing Myopic in real-time is critical”
Attitude Towards Eye Health
Edwin Ng,
SPEAKING WITH Senior Vice President,
General Manager (Asia-Pacific),
33 Medidata Solutions

“Obstructive Sleep Apnea SALARY
brings about a severe
economic burden on 41
the country”
From Hazy to Crystal
Carlos Montiel, Clear Picture of
Vice President- Latin America, Compensation Trends
and South Asia, ResMed
Kayleigh Regan,
35 Head of EPM
Scientific, Asia-Pacific
“Spending on TB control
programmes had dropped REGULARS
to 2016 levels in 2020 and
remains unchanged” BioEdit.........................................................................04
BioMail........................................................................05
Patrick Che, Policy and Regulatory News...................................08
Sales Development Manager, Company News........................................................10
QuantiFERON, South East Asia, QIAGEN Finance News............................................................12
Start-Up News...........................................................13
World News...............................................................15
People News..............................................................43
R&D News..................................................................45
Academic News........................................................47
Supplier News...........................................................48
Lets Talk Health........................................................50

8 REGULATORY NEWS

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Australia recommends COVID-19
booster for eligible 12-15 year old

People aged 12 to 15 who are at children must have completed a of a COVID-19 vaccine remain
most at risk of severe disease primary course of vaccination 3 or well protected against severe
are recommended to receive a more months ago, and meet one disease. The recommendation
COVID-19 booster vaccination or more of the criteria such as be only applies to the Comirnaty
from June 14, 2022. The severely immunocompromised; (Pfizer) booster. Other vaccines
government has accepted advice have a disability with significant such as Spikevax (Moderna) and
from the Australian Technical or complex health needs; have Nuvaxovid (Novavax) are not
Advisory Group on Immunisation complex and/or multiple health registered for use as a booster for
(ATAGI) to make a booster conditions that increase the risk this age group.
dose of the Comirnaty (Pfizer) of severe COVID-19. ATAGI is not
COVID-19 vaccine available to recommending a booster dose for
around 120,000 children aged all adolescents aged 12-15 years
12-15 years old, who are most at this stage. Evidence shows
at risk of severe disease. To be otherwise healthy adolescents who
eligible for a booster dose, the have received two primary doses

Hong Kong opens Centre South Korea
for Eye and Vision Research
approves Agilent’s
At the forefront of the population’s health and aging
imperative and with its mission of generating innovative diagnostic platform
technologies and unique solutions designed to prevent
vision loss and preserve healthy vision, the Centre for Eye for NSCLC patients
and Vision Research (CEVR) has announced its official
launch. It is the first global hub to conduct ground-breaking Agilent Technologies Inc. has announced that
research in five key areas – myopia and eye growth, ocular the South Korea Ministry of Food and Drug
drug discovery and delivery, vision enhancement, tear film Safety (MFDS) has approved the company’s
and ocular surface, and advanced optometric technology. PD-L1 IHC 22C3 pharmDx as a companion
Supported by InnoHK, the flagship innovation and diagnostic (CDx) to identify patients with
technology initiative of the HKSAR Government, CEVR is non-small cell lung cancer (NSCLC) who
committed to becoming a global leader in eye and vision are suitable for first-line monotherapy
research as well as a magnet for attracting and training elite with KEYTRUDA (pembrolizumab) on
researchers, harnessing Hong Kong’s research expertise the Dako Omnis platform. This marks the
and entrepreneurial ecosystem. With the collaboration third approval of the CDx for Agilent in the
between the Hong Kong Polytechnic University (PolyU) context of treatment with KEYTRUDA to
and the University of Waterloo (UW) in Canada, CEVR enable metastatic NSCLC patients’ access
represents a significant step in enhancing the research to targeted immunotherapy for improved
capacities and innovation applications aimed at addressing patient outcomes. Dako Omnis is Agilent’s
eye and vision health challenges, by bringing together fully automated solution for staining tumour
multiple scientific disciplines based on the excellent samples that supports lean and flexible
credentials of two leading academic institutions in vision workflows integrated into the core of the
science and eye health research. laboratory interface, providing diagnostic
confidence for the right NSCLC patients
to facilitate greater choice and accelerate
patient care. The new approval in the Asia
Pacific region reinforces the proven efficacy
of this companion diagnostic test for cancer
therapy and enables further immunotherapy
options for NSCLC patients, who previously
had few and inefficient therapy options.

REGULATORY NEWS 9

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Singapore launches new India renews MoU
centre to strengthen
pandemic preparedness with Bill & Melinda

Leveraging the research, collaborations and Gates Foundation
commercialisation successes that have contributed to
Singapore’s fight against the COVID-19 pandemic, Duke- The Department of Biotechnology (DBT),
NUS (National University of Singapore) has launched Government of India and the Bill & Melinda
a new centre to further strengthen regional research Gates Foundation have renewed the
capacity, cooperation and preparedness against future Memorandum of Understanding (MoU),
pandemics and public health threats. Deputy Prime originally signed in 2012, to support
Minister and Coordinating innovative approaches for developing new
Minister for Economic Policies preventions, therapies and interventions
Heng Swee Keat joined some 100 needed to solve health (human and animal),
guests at the launch of the Centre food and nutritional inequities on June
for Outbreak Preparedness 7, 2022 in New Delhi. The renewed MoU
or COP. Introducing the new pledged a combined $50 million investment
Centre, its director Professor to the joint initiative, to continue to explore
Paul Pronyk highlighted that the and expand funding arenas and mechanisms
Centre will leverage Duke-NUS’ to support innovators, focused on early-mid
strong partnerships around stage research and product development
the world, with particular focus on research institutes to tackle health and developmental issues.
in South and Southeast Asia to increase the region’s The event also saw the announcement of the
research capacity and capabilities. In addition to its close latest open call for funding on Diagnostics for
ties with Duke-NUS’ parent university, the National Neglected Tropical Disease (NTD)- Lymphatic
University of Singapore, the Centre will also work closely Filariasis (LF). The call focuses on developing
with Singapore government agencies and key partners point-of-care, novel cost-effective diagnostics
such as Singapore’s National Programme for Research for lymphatic filariasis for use in national
in Epidemic Preparedness and Response (PREPARE), Lymphatic Filariasis elimination programs.
A*STAR’s Bioinformatics Institute (BII), the National The goal of this challenge is to have a
Centre for Infectious Diseases (NCID) and the World reasonably inexpensive, durable and accurate
Health Organisation (WHO). point of care testing method(s) that can be
used in developing/remote geographies.

Taiwan engages indigenous partners for drug abuse prevention

According to the results of the remote and rural areas. In order prevention, how to recognise
national survey on substance to raise drug abuse prevention illegal drugs, how to refuse use
use by the Taiwan Food and capability of indigenous people, of drug and community teaching
Drug Administration (TFDA) TFDA entrusted Tzu Chi skills, also practical experiences
done once every four years, the University with the Community shared. A total of 108 people have
lifelong prevalence rate of drug Personnel Training Project on been trained in 2021. To prevent
abuse in 2018 was 1.15 per cent Drug Abuse Prevention. Course the use of camouflaged drugs that
(aged 12-64 years). There were subjects included drug abuse looked like jello, coffee pact, tea
about 204,000 people who had bag and candy out of curiosity,
used illegal drugs. TFDA has TFDA trained local seed teachers
over the years disseminated drug to help indigenous tribe people
abuse prevention information in to recognise new psychoactive
various communities, workplaces substances (NPS) as well as how
and enterprises. In recent years, to refuse using them, to be more
more active cooperation has been alert, and to notice the suspicious
enforced to engage indigenous signs of drug abuse, thus reduce
people in resource-lacking, the risk of exposing to drugs.

10 COMPANY NEWS

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Standigm signs MoU Shionogi expands
with Merck Korea for AI
drug discovery research access to Cefiderocol

South Korea-based Standigm Inc. has announced in 135 countries to treat
the signing of a Memorandum of Understanding
(MoU) with Merck Korea, for artificial intelligence bacterial infections
(AI)-based drug discovery research. The MoU
signing took place at the headquarters of Standigm, Japan-based Shionogi & Co. and the Global
attended by Sojeong Yun, Chief Executive Officer Antibiotic Research and Development Partnership
of Standigm, and Stephen Namkoo Lee, the Head (GARDP) have announced the execution of a
licence and technology transfer agreement and,
of Science and Lab Solutions, with the Clinton Health Access Initiative (CHAI),
Life Science business sector a collaboration agreement that aim to significantly
of Merck Korea. Under the transform the landscape of access to antibiotics
MoU, Standigm will accelerate for countries around the world. The agreements
its drug discovery research by will provide access to cefiderocol, an antibiotic
adopting Merck’s AI software for the treatment of serious Gram-negative
SYNTHIA. which can help bacterial infections, which may be resistant to
Standigm’s novel compound other antibiotic treatments. Cefiderocol was
synthesis. SYNTHIA is a recently added to the World Health Organization
computer-aided retrosynthetic (WHO) Model List of Essential Medicines and
design tool and unites network targets a number of Gram-negative WHO priority
theory, modern high-power computing, and expert pathogens. This is the first licence agreement for
chemical knowledge to rapidly design synthetic an antibiotic to treat serious bacterial infections
pathways. As a leading workflow AI drug discovery between a pharmaceutical company and a
company, Standigm has actively conducted research non-profit organisation driven by public health
on AI technology in organic synthesis at its own priorities. Under this agreement, GARDP will
Synthetic Research Centre, established last year. manufacture and commercialise cefiderocol
through sub-licensees in a large range of countries
that have delayed access to newer antibiotics.

WuXi Biologics launches commercial
drug product facility for PFS in China

WuXi Biologics, a global contract filling speed can reach 400 PFS/ global partners with faster
research, development and min to support 17 million syringes and more robust end-to-end
manufacturing organisation of drug products manufacturing drug product services for their
(CRDMO) service company, every year. The increased innovative products at different
has successfully launched the manufacturing capacity at DP5 scales and stages. Compared to
GMP operation of its new drug allows WuXi Biologics to provide a traditional drug product filling
product facility DP5 located in line, DP5’s state-of-the-art design
Wuxi, China. The DP5 is the and layout, single-use technology
ninth operational drug product and automated equipment,
facility in the global network of significantly decrease the risk
WuXi Biologics. The DP5 facility of contamination and maintain
features an advanced isolator aseptic control required in the
filling line for continuous and filling process. This process
steady filling services, which supports clients’ products scale
offers multiple volume delivery up to commercial capability and
options for pre-filled syringes reliably delivers to patients under
(PFS), including 1 mL Long, 1 mL, the highest quality standards
2.25 mL and 3 mL. The maximum which WuXi Biologics represents.

BioSpectrum Asia Excellence Awards 2022

Brought to you by:

Jury Special

- Emerging company or startup of the year 2022

- Company of the year 2022

- Lifetime achievement award 2022

- Entrepreneur of the year 2022

- Woman Entrepreneur of the year 2022 Entries
- Technology/ product of the year 2022 Open
- Person of the year 2022 June 24th,

Editors' Choice 2022

- Top company for bioprocessing
- Top company in Manufacturing Technology and Equipment
- Top company for API development
- Top company for Analysis, Tes�ng, and Quality Control
- Top company in Packaging & Drug Delivery services
- Top company in Supply Chain, Logis�cs, and Distribu�on
- Top company in clinical research-based development
- Best Vaccine efforts of the year

-- Industry Partners --

Jury Special Nominate Now Editors' Choice Nominate Now

For more details, visit : www.biospectrumasia.com/bsa-awards

12 FINANCE NEWS BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Cipla buys Boston Scientific buys $230M
worth stake in Korean medtech firm
21% stake in
Boston Scientific has entered into a 2015. The agreement consists of
Achira Labs definitive agreement with Synergy a purchase price of KRW 14,500
Innovation to purchase its majority per share, which represents a
for Rs 25 Cr stake (approximately 64 per cent) of total of KRW 291.2 billion or
M.I.Tech, a publicly traded Korean approximately $230 million at
Indian pharmaceutical manufacturer and distributor of current exchange rates, subject to
firm Cipla has signed medical devices for endoscopic closing adjustments. Non-vascular
definitive agreements for and urologic procedures. The gastrointestinal and airway stents
the acquisition of 21.05 company expects to complete the are used to help clear occlusions
per cent stake (on a fully transaction in the second half of or strictures in various areas of
diluted basis) for Rs 25 2022, subject to customary closing a patient’s anatomy, including
crore (approximately) conditions. M.I.Tech is the creator the biliary tree, pancreatic duct,
in Achira Labs engaged of the HANAROSTENT technology, esophagus, colon and duodenum.
in the development a family of conformable, non- In many cases, stent placement is
and commercialisation vascular, self-expanding metal minimally invasive and may aid
of point of care (PoC) stents, which have been distributed faster patient recovery compared to
medical test kits in India. by Boston Scientific in Japan since surgery.
The investment will
facilitate a Cipla entity’s MiRXES invests S$8M in 4.0
strategic participation in IVD manufacturing facility
the PoC diagnostics and
AMR space through the MiRXES, a Singapore-headquartered biotechnology company, and A*STAR
design, development, spinoff, focused on saving and improving lives with miRNA-powered cancer
and manufacturing of early detection tests, has announced the opening of the first industry 4.0
microfluidics-based
technologies. A PoC (i4.0) in vitro diagnostic (IVD) manufacturing facility
that enables rapid in Southeast Asia. This S$8 million facility at JTC
identification of the bug MedTech Hub is the largest i4.0 IVD manufacturing
causing an infection would site in Southeast Asia at 15,000 square feet. This
be extremely helpful in brand new I4.0 manufacturing facility will greatly
choosing the appropriate advance the IVD productisation and manufacturing
antibiotic early in the capabilities as MiRXES accelerates the development
treatment process. and commercialisation of maturing pipeline of
Achira is developing multi cancer early detection tests, pulmonary and
PoC immunoassays cardiovascular disease tests, as well as life sciences
and molecular assays and infectious disease portfolio. This first-of-its kind
across the clinical areas facility in Southeast Asia will equip MiRXES to address
of infectious diseases, the next big challenge in healthcare – cancer, and stay prepared should we
anti-microbial resistance need to combat another epidemic. The setup of this Industry 4.0-compliant
(AMR) and hormone IT infrastructure was supported by A*STAR’s ARTC.
analysis among others.
The transaction is
expected to be complete
within 60 days from
the signing of definitive
agreements or such other
date mutually agreed
between the parties
and will be subject to
conditions precedent
set out in the definitive
agreements.

START-UP NEWS 13

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

New South Wales Insilico Medicine raises
$60M to launch drug
invests $143.3M in discovery robotics lab

Sydney Biomedical US and Hong Kong-based startup Insilico Medicine
has completed a $60 million Series D financing from a
Accelerator syndicate of global investors with expertise in investing in
the biopharmaceutical and life sciences sectors. Insilico has
The University of Sydney has announced developed a growing portfolio in frontier areas empowered by
that the New South Wales (NSW) its proprietary AI platform. Seven programmes in its internal
government is providing $143.3 million pipeline have progressed to the IND-enabling stage, including
over four years towards the establishment a novel 3CL protease inhibitor for COVID-19 treatment, and
of a first-of-its-kind Australian health two synthetic lethality programmes targeting MAT2A and
and technology complex in Sydney. The USP1 for oncology. It also successfully completed a Phase
Sydney Biomedical Accelerator (SBA) 0 microdose study and entered a Phase I clinical trial with
will be a state-of-the-art biomedical its first internally developed programme targeting fibrosis.
research complex that will fast track Capital raised in the round will further bolster Insilico’s
real-world health outcomes by integrating financial position and fuel the growth of its advancing
fundamental, clinical and patient-centred pipeline, including its lead programme which is currently in
research. Located within the Tech a Phase I study, and continued development of its Pharma.AI
Central precinct it will be a partnership platform.
between the NSW Government, Sydney
Local Health District and University of
Sydney in collaboration with a leading
medical research institute, the Centenary
Institute. The SBA will offer a unique
global concentration of biomedical
research talent and research facilities
and will be positioned to dynamically
collaborate with industry and startups
as part of a hospital, university and
technology innovation ecosystem.

Japanese LUCA Science secures $30.3M in Series B funding

Japan-based startup LUCA Science is pioneering a new class the research and development
Science, a global innovator in the of mitochondrial therapy to of the company’s proprietary
development of a novel class of restore cellular bioenergetics in pipeline toward IND submission.
mitochondria biopharmaceutical dysfunctional or damaged tissues In addition, LUCA Science is
agents, has announced the and organs. The funds from this rapidly advancing its existing
closing of a ¥3.86 billion ($30.3 round will be used to accelerate pipeline with a view to target
million) oversubscribed Series additional therapeutic areas
B financing. The round was in collaboration with leading
co-led by DCI Partners, 4BIO academic and industry partners.
Capital and existing investor Fast Proceeds from the financing will
Track Initiative and supported also be used to establish a robust
by an international syndicate manufacturing system based on
of existing investors including its proprietary Mitochondrial
Remiges Ventures and Nippon Isolation Technology (MIT)
Venture Capital Co, and new platform, a novel method for
investors including Nissay intact, shelf-stable and highly
Capital, Asahi Kasei Pharma, QB functional isolated mitochondria
Capital/NCB Venture Capital and as a quality-controlled
SMBC Venture Capital. LUCA biopharmaceutical agent.

14 START-UP NEWS

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Bayer Pharma, ILIAS Biologics, HK inno.N
join hands for new
DoctorOnCall biomedicines in Korea

launch South Korean startup ILIAS Biologics has signed a Memorandum of
Understanding (MoU) with HK inno.N for joint research to develop
platform for new biomedicine candidates. With this MoU, the two companies
plan to collaborate - to discover and develop new drug candidates
endometriosis using exosomes, known as the next game-changer in the drug
delivery system. The MoU raises expectations on the synergy of
in Malaysia
ILIAS’s versatile exosome platform
Bayer Malaysia has launched a technologies with enormous
telehealth platform dedicated to expandability and HK inno.N’s
endometriosis, in collaboration extensive new drug development
with Endometriosis Association know-how. ILIAS Biologics has an
of Malaysia (MyEndosis) and exosome platform technology that
DoctorOnCall, a Malaysian can load a polymer drug in a free
startup. Endometriosis, a form inside the exosome and deliver
condition that affects one in 10 it stably inside the target cell. It
women worldwide, occurs when has related technology patents
the endometrium grows outside in five countries including the
the womb in other tissues or United States, Japan, and China, and has recently been approved
organs. The new telehealth service for a phase 1 clinical trial in Australia for an exosome-based anti-
will provide online consultations inflammatory drug candidate. HK Inno.N, another startup based
with obstetrician-gynaecologists in South Korea, plans to develop an exosome treatment for chronic
from DoctorOnCall. For a three- diseases and acute respiratory infections, centred on the bio
month period from June, free research centre, and strengthen the new biopharmaceutical pipeline.
teleconsultations will be offered
to patients.

C-CAMP kicks off flagship startup
investment initiative ‘TiE India Angels’

Centre for Cellular and Molecular sciences research and innovation
Platforms (C-CAMP) in India
has inked a Memorandum of in India, C-CAMP has an
Understanding (MoU) with TiE
India Angels (TIA), an initiative established translational research
of TiE global, represented through
TiE India Foundation, to kick off programme, the Discovery to
an ambitious entrepreneurship
cum technology transfer initiative, Innovation Accelerator (DIA)
C-CAMP Lab Ventures. C-CAMP
Lab Ventures aims to transfer which through validation, de-
C-CAMP’s formidable portfolio
of cutting-edge, market-ready risking and licensing, bridges
and translated technologies to
select early-stage or aspiring bio exciting scientific discoveries
entrepreneurs against a significant
investment funding of up to Rs to mature technologies with
100 lakh annually from TIA.
Under its mandate to foster bio strong commercial and impact

potential. The DIA portfolio has bio entrepreneurs from diverse
backgrounds like management,
several key technologies in the engineering, clinical & other
domains. Selected entrepreneurs
areas of Healthcare, Agriculture from this programme will receive
seed funding by TIA as well as
and Environment ready for hand holding and mentorship by
C-CAMP to increase their chances
commercialisation. Through of success as bio-businesses.

C-CAMP Lab Ventures, this

portfolio will be up for grabs by

seasoned startups, entrepreneurs

across India as well as aspiring

WORLD NEWS 15

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

US picks interdisciplinary teams
to address major challenges in cancer

The Cancer Grand Challenges to launch the Cancer Grand from around the world whose
programme will award $100 Challenges programme. Cancer novel ideas have the greatest
million to four interdisciplinary Grand Challenges aims to provide potential to advance cancer
teams from around the world multiple rounds of funding for research and improve outcomes
to solve some of the toughest multidisciplinary research teams for people affected by cancer.
challenges in cancer research. The research being conducted by
Each team will receive $25 million the four selected teams includes
over five years. The teams were investigation of 1) a muscle-
announced at the Cancer Grand wasting condition in cancer
Challenges Summit on June 16, patients known as cachexia, 2)
2022, in Washington, D.C. The the biology of extrachromosomal
National Cancer Institute (NCI), DNA in cancer 3) new therapies
part of the National Institutes for solid tumours in children,
of Health, and Cancer Research and 4) what triggers normal
UK, the world’s leading funders cells harbouring cancer-causing
of cancer research, partnered mutations to become tumour cells.

US FDA authorises CEPI, Oxford Vaccine
Group evaluate fractional
COVID-19 COVID-19 booster vaccines

vaccines for The Coalition for Epidemic Preparedness Innovations (CEPI)
in Norway, the University of Oxford’s Oxford Vaccine Group
children down to – UK, and the Oxford Vaccine Group – Brazil, based at the
Carlos Chagas Institute, have partnered to conduct a clinical
6 months of age trial in Brazil to investigate the impact of administering reduced
COVID-19 booster shots instead of full doses. CEPI will provide
The US Food and Drug up to $6.4 million to fund a clinical trial to evaluate the safety
Administration (FDA) has
authorised emergency use of the and immunogenicity of
Moderna COVID-19 vaccine and fractional heterologous
the Pfizer-BioNTech COVID-19 boosters in populations
vaccine for the prevention of which have previously been
COVID-19 to include use in vaccinated with the Sinovac/
children down to 6 months of Butantan COVID-19 vaccine
age. For the Moderna COVID-19 (CoronaVac). Enrolment of
vaccine, the FDA amended the participants in the clinical
emergency use authorisation trial began in March 2022 and
(EUA) to include use of the vaccine approximately 700 healthy
in individuals 6 months through adult volunteers will take part
17 years of age. The vaccine had in the trial, which is being
been authorised for use in adults conducted in Natal and Belem, Brazil. Trial participants include
18 years of age and older. For those who already have received a primary regimen of two doses
the Pfizer-BioNTech COVID-19 of CoronaVac at least six months prior to joining the study.
vaccine, the FDA amended the Participants will then receive either a full or reduced booster
EUA to include use of the vaccine dose of the AstraZeneca/Fiocruz recombinant COVID- 19
in individuals 6 months through 4 vaccine or a reduced dose of the Pfizer/ Wyeth mRNA COVID-19
years of age. The vaccine had been vaccine and will be followed up for a period of six months.
authorised for use in individuals 5
years of age and older.

16 ANALYSIS

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

IS BIOTECH HEADED

FOR BEAR RUN?

2020 and 2021 were remarkable for biotech startups as the financing smashed all records.
Venture Capital financing hit an all-time high of over $35 billion globally in 2021. Now, as the
pandemic weakens, inflation is on the rise, and the impact of the Russo-Ukraine conflict is
intensifying. Let’s find out whether these global events are setting the stage for a ‘bust phase’.

Fundraising across the biotech sector rocketed of 38 per cent. Why has that happened? A variety of
off the charts in 2020 and 2021. In 2020, factors, such as: rising interest rates; lack of favourable
VC (Venture Capitalists) funding grew to data from clinical trials; a decline in M&A activity in
$36.6 billion from $14 billion in 2019. In China, the biotechs; investors are in a ‘risk off’ mentality; cash
number of funding rounds grew four times faster burn in biotech; ‘tourist investors’ came in to invest in
than in Europe and the US, according to McKinsey companies fighting COVID-19 but have now exited the
report. Following an unprecedented pandemic- sector; the US Government is renewing calls to regulate
driven investment surge in 2020, investment figures drug prices; & of course, Russia’s invasion of Ukraine,”
remained resilient through 2021 and garnered almost said Ben McLaughlin, Partner, Baker & McKenzie,
the same with $36.3 billion (PitchBook). Australia. Some experts, however, feel that the
downturn is short-term & the sector will likely rebound.
Asia has become an increasingly active biotech
geography. CipherBio data demonstrates that in 2020 “Like all other industries, the biotech sector goes
by far the largest biotech funding location in Asia is through cycles. However, looking past any short-term
China, with 10 out of 16 Asian deals being sealed in swings, I think that the long-term trajectory for the
this country. sector has been and is trending upwards as healthcare
spending has grown continuously and spending is
Chinese companies, investors and markets also at ~10 per cent of GDP. As the population ages, the
became more prominent during 2020. Nearly a third demand for better healthcare and medicines also
of the $100-million-plus private rounds of 2020 increases, and this demand is fundamental to lives, not
were raised by Chinese companies—up from just a linked to market conditions,” said Daphne Teo, CEO
seventh in 2019. Shanghai-based Mabwell Bioscience and Founder of NSG BioLabs, Singapore.
($278.5M) and D3 Bio ($200M) raised the two
largest A rounds anywhere. This reflects the country’s Echoing the same sentiments Srikant Sastri,
burgeoning investment in more innovative biotech. Governance Board Member, BioAngels, India,
said, “Not at all. Biosciences and biotech are clearly
In addition to enterprises developing RNA recognised as sunrise industries with the ability to
medicines, developers of adoptive immune cell make a big impact in different spheres of our economy
therapies, and PROTAC (proteolysis-targeting and life. COVID-19 -merely brought this potential into
chimera) approaches were prominent in fundraising sharp focus and caught the attention of policy makers
and partnering. Financing also rolled into machine and investors. During the pandemic, the industry
learning ventures. Mergers were down, as pharma proved that they are best-in-class and came forward
showed a greater interest in partnerships. with a slew of innovations that were widely recognised.
This momentum will now provide ongoing impetus to
VC funding peaked in the first quarter of 2021, this sector.”
and has declined slightly since – with market research
firms claiming anywhere between 10 and 30 per cent Pandemic pivots
dip in the sector. The first quarter of 2022 was the
slowest in three years for new stock offerings signalling COVID-19 has been the catalyst for countless
a tougher financing environment. pivots. Many startups pivoted their missions and
offerings or added services tailored to the pandemic
“Yes, the budget has burst. The biotech bull-run
started in 2020. The Nasdaq Biotechnology Index For example, Indonesia’s Nusantics, a genomics
hit a high on September 17, 2021 of 5392 points & technology company, was focused solely on the field
as on June 13, 2022 it was at 3368 points, a decline

ANALYSIS 17

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

of microbiome analysis. The company changed course “The biotech bull-run
in 2020 to produce COVID-19 testing kits when they started in 2020. The Nasdaq
were needed most. Biotechnology Index hit a high
on September 17, 2021 of 5392
“Startups which have pivoted and survived this points and as on June 13, 2022
tough period have developed creativity and become it was at 3368 points, a decline
more resilient. This puts them in a great position to of 38 per cent. Why has that
apply such strengths and capabilities to continue to
innovate and build winning positions. As a founder of happened? A variety of
a company, NSG BioLabs, that started only months factors, such as: rising interest
before COVID-19, I believe our team has grown
stronger by adapting our business and operations rates; lack of favourable data
quickly, and we were able to thrive and become a from clinical trials; a decline in
leading platform for biotech innovation. Now and in
the coming years, there will be more challenges and M&A activity in biotechs.”
opportunities to face as part of our ever-changing - Ben McLaughlin,
industry and world, and we need to continue to have
our nimble and creative mindset,’’ said Daphne. Partner, Baker & McKenzie, Australia

Another wave or low tide? “Biosciences & biotech are
clearly recognised as sunrise
This is a reset time for the sector. First time industries with the ability to
fundraisers or early-stage companies will find it hard make a big impact in different
to raise capital. Investors would shy away from riskier spheres of our economy & life.
business for some time and prefer stable businesses. COVID-19 -merely brought this
potential into sharp focus and
“There has been much value destruction, so we caught the attention of policy
should expect a flight to quality. I expect investors
to redeploy capital from microcap startups into makers and investors.”
companies that are already in commercialisation. As - Srikant Sastri,
one investor said, once markets stabilize, they will look
at firms in Phase 3 trials, which also have significant Governance Board Member, BioAngels, India
addressable markets. VCs will continue to look at
health tech, as this is a rapidly expanding sector, with “Asia is an incredibly exciting
huge potential in the long-term. With the fall in prices, area for biotech funding.
we may see bigger pharma acquisitions of publicly- We see the ecosystems
traded biotech. This has been predicted for some time,
but is yet to materialise,” said Ben. coming to greater maturity
in terms of the quality of
Not all is lost though. Experts are confident the
sector will bounce back and the funds won’t dry up science, research and clinical
completely. infrastructure, and talent
pools.”
“Asia is an incredibly exciting area for biotech - Daphne Teo,
funding. We see the ecosystems coming to greater CEO and Founder of NSG BioLabs, Singapore
maturity in terms of the quality of science, research
& clinical infrastructure, & talent pools. Also, there other therapies can be developed—have benefited the
are many diseases with immense unmet needs, most and VCs will continue to bet on such emerging
for example in oncology, cardiology, immunology, technologies. Cell therapy 2.0, next-generation
neurology, & others, which means that the market gene therapies, precision medicine, new delivery
opportunities are also immense. VCs will be looking methods etc. are some of the areas where VCs will
for innovation that stands good chances at delivering continue to pump money. The business of biotech is
transformational impact for patients. Significant not expected to return to its pre-pandemic ‘normal’
areas of interest include those that are changing the Companies will need to adapt to many new challenges
pharmaceutical industry and medical landscape, like in the rapidly evolving business environment. Yet,
AI, precision medicine, nucleic acid & gene therapies, as 2021 demonstrated, there are also huge potential
and synthetic biology, as examples,” said Daphne. opportunities for biotech as it faces the future,
according to EY’s Beyond Borders 2022 report.
Startups with cutting-edge platform technologies—
which constitute a base or infrastructure on which Ayesha Siddiqui

18 COVER STORY

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

HOW IS
BIOMANUFACTURING

DRIVING
CDMO MARKET?

A successful business model for the pharmaceutical industry is
driven by the outsourcing trend, making contract development and

manufacturing organisations (CDMOs) an integral component of
drug development value chains. Increasing regulatory complexity, high
development costs, and fierce competition have driven drug companies to
leverage CDMOs to accelerate their go-to-market strategy, and Asia Pacific
(APAC) is not an exception. Let’s navigate through prime achievements and
potential trends in the APAC CDMO arena which helped the world heal during
the pandemic and is further helping to build a resilient health system.

Companies in the pharmaceutical sector have Development, Jabil Healthcare.
been facing fierce competition, cost pressure, Through CDMO outsourcing, companies can cut
technological innovations, and increased
consolidation activities. Though the demand for down substantial capital investments in building
generic medicines and biologics is exponential, high in-house technical strengths and focus on pipelines
capital expenditures to set up complex manufacturing and commercial priorities. Thus, CDMO is destined
requirements and state-of-the-art technologies can to share the major segment of pharma/Biopharma
not be ignored. To overcome these scenarios, the production stage activities owing to the factors such
pharmaceutical sectors are progressively relying as the high demand for end-to-end services in big
on CDMOs for clinical candidate development, pharmaceutical companies, execution costs, growing
manufacturing, candidate registration, and market pricing pressures, and pipeline challenges.
authorisation. Pharmaceutical companies are
revisiting their cumbersome production processes Fragmented market Landscape
by exploring CDMO facilities to manage company with diversified offerings
resources and assets effectively with regulating
expenditure. The APAC region remains the preferred CDMO
growth market due to lower manufacturing costs
“CDMOs like us have the technical expertise, than in North America and Europe, though the US
knowledge, and GMP facilities to deliver cost- continues to be the primary hub for pharmaceutical
effective development and manufacturing services. development outsourcing. Several factors, including
Outsourcing to a CDMO means you can expand large amounts of funding and the presence of
your technical capabilities without the burden and university-affiliated pharmaceutical research clusters,
associated risks of investing in expensive equipment” could be the possible reasons.
says Rutger Vandiest, Director of Business
The one-stop destination for pharma covering
the entire value chain, from drug discovery,

COVER STORY 19

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

product development, and manufacturing services High-potency active pharmaceutical ingredients
to commercialisation, the global CDMO market is (HPAPIs) like small molecules have been the long-
expected to grow from $168 billion in 2021 to $215 time essentials for drug development. Though
billion by 2026, at a CAGR of 5 per cent during the small molecules constitute 90 per cent of drug
forecast period of 2021-2026., as per the BCC report. sales being the primary active substance choice for
pharmaceuticals, the emergence of CDMOs has
The dominant top players controlling the global brought focus on complex large molecules for better
stage are just under 25 per cent of the market profit. The rise in popularity and importance of the
with approximately 500 small and medium-scale development of large molecule drugs has introduced
CDMOs around the world, says market research ‘biologics’ to the industry.
and intelligence platform, MarketsandMarkets.
Nevertheless, pandemic has created a growing Driving factors
demand for vaccines and biosimilars, which are
creating opportunities for SMEs in the CDMO space, The size of the ASEAN CDMO market is reported
mainly, in key market niches. to be $9.43 billion in 2020 and is projected to grow
from $11 billion in 2021 to $22 billion in 2028,
Among standard portfolios, Solids (tablets, reflecting a CAGR of 10.9 per cent during the 2021-
capsules), Sterile liquids, Semisolids, and non- 2028 period, as per the recent analysis by ‘Fortune
sterile liquids (creams/gels), the sterile liquids business insights’. CDMOs exhibiting a higher growth
sector holds a larger share in CDMO services with rate than in previous years as a positive impact of
increasing demand, whereas solid dosage forms pandemics.
have been the most dominant sector of all time.
Growth in the sterile liquids segment is primarily During the pandemic, Asian CDMOs played a
driven by the growing demand for biologics in the crucial role in scaling vaccine production and refilling
post-pandemic era. operations, reflecting on the valuable partnership

20 COVER STORY

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

ATTRIBUTES THAT FACTOR INTO CDMO ENGAGEMENT (IMPORTANCE)

INITIAL EVALUATIONS POST-ENGAGEMENT

Regulatory Compliance 72% 75% Good Communication & Transparency

Understanding of Customer Requirements 72% 74% On Time Delivery

Operational, Methodological & 72% 74% Quality Compliance

Therapeutic Experience 74% Responsiveness in Case Source: pharmas almanac

CDMO/CMO Industry Reputation 71% of Troubleshooting

Cost 71% 74% Safety Audits

Contractual Approach - 70% 73% Willingness to Go Above

Assured IP Protection Si Beyond the Requirements

Risk Adherence 70% 73% Meeting Project Deliverable(s)

between the pharmaceutical sector and CDMOs. Pharm Co. Ltd., a CDMO for Active Pharmaceutical
Pandemic helped biologics to dominate the pharma Ingredient (API) announced the establishment of
market with a keen focus on monoclonal antibodies the second oligonucleotide manufacturing plant by
(mAb), vaccines, and therapeutic antibodies, as the investing $126 million, which has the capacity (14
CDMO market leveraged pioneer solutions. mole per year) to be the world’s largest CDMO in
oligonucleotide production by 2025.
Similar to biologics, CDMOs in Asia are highly
focused on biosimilars, owing largely to the upcoming Korean pharmaceutical companies inked a total
expiration of patents for the most popular biologics of 33 technology transfer deals between 2020 and
(antibodies, immunosuppressants, anticancer drugs, 2021, worth 13.4 trillion Won, with a record high of
and some vaccines) and increasing demand for low- 32 per cent on the year, according to data from Korea
cost, high-efficiency drugs due to market depression. Pharmaceutical and Bio-Pharma Manufacturers
Asian countries own established CDMO services and Association and predict growth continuity.
are leading both regional and global markets.
Focusing on China, WuXi Biologics and
Asia’s biggest CDMO, Samsung Biologics, a Transcenta have been the major pharma firms
leading global CDMO in South Korea owns three involved in CDMO services by investing in
CDMO plants and will be constructing a fourth continuous bioprocessing platforms in China. WuXi
plant soon to boost its capacity. Once completed, it Biologics, a dominant CDMO leader in China with
will have nearly 30 per cent of the global contract a 63.5 per cent market share, accounts for 35 per
manufacturing capacity for biopharmaceuticals, cent of total revenue in the region and has made
beating Germany’s Boehringer Ingelheim and rapid business progress across the US, Europe, and
Switzerland-based Lonza. Thus, in terms of capacity, Singapore.
Samsung Biologics will have the biggest capacity in
the world for the CDMO business. Elucidating China’s emerging CDMO ecosystem,
Vicky Qing Xia, Sr Project Manager at BioPlan
Similarly, in November 2021, Korea-based ST

“Investors are pouring “M&As are expected to
funds into early-stage drug become an inevitable trend
discovery companies. Some
of them lack the means to sweeping the sector and a
move a product from its first growth strategy for CDMOs
globally. With private funds
phases to production and
commercialisation. CMOs and and precisely targeted
M&As (which will facilitate
CDMOs are stepping in to the growth of the portfolio
take on those functions” companies by enhancing the
- Daniel Ferzoco, quality of their technologies)”

Associate Director, Life Sciences at Michael Page - Bobby Sheng,
Chairman, Bora Pharmaceuticals

COVER STORY 21

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Associates, a leading biopharmaceutical and life US, UK, and India.
sciences analytical company says, “China’s contract Furthermore, Asia’s one of the major biologics
manufacturing space is growing at over 15 per
cent year-on-year but only WuXi Biologics has CDMO platforms, GenScript Biotech Corp, operates
seen success in attracting global clients. Despite its business in over 100 countries and regions
Wuxi Biologics, being the dominant player in worldwide with Asian locations in Mainland China,
China, transnational companies such as Lonza and Hong Kong, China, Japan, and Singapore. Built
Boehringer Ingelheim have already been investing upon its solid gene synthesis technology, GenScript
in the market, yet China’s CDMO business appears ProBio (a subsidiary), provides end-to-end CDMO
nascent. Third-party drug manufacturing is relatively service from drug discovery to commercialisation
new in China”. with proactive strategies and solutions in gene and
cell therapy (GCT), vaccine, biologics discovery, and
“Since 2015, through its market authorisation antibody protein drugs.
holder (MAH) system China has been facilitating
foreign investments through further reforms of In the Southeast Asia market, Singapore and
commercial CDMOs policies to strengthen China’s Thailand are leveraging a considerable number of
presence in the global market. There is also a high CDMO services through notable alliances with global
preference for single-use technology at CDMOs in pharmaceuticals.
China, and we also see several CDMOs exploring
continuous bioprocessing to increase manufacturing The ‘National Biopharmaceutical Facility
efficiency,” she adds. (NBF)’ is Thailand’s first state-owned contract
manufacturing facility that produces clinical
Taiwan-based Bora Biologics Co., Ltd., is another research-grade biopharmaceuticals. In June 2021,
leading CDMO for small molecules and biological Thailand’s first and only biopharmaceuticals
macromolecules. Bora’s strategic acquisition of manufacturer, Siam Bioscience Co., Ltd., entered
Eden Biologics CDMO assets in 2022 will help Bora into the biopharmaceutical business by launching
Group rapidly build a presence in the Asian biological AstraZeneca’s COVID-19 vaccine supply chain in the
macromolecules and cell and gene therapy markets. country. Thailand looks forward to capitalising on
similar opportunities to become a production base for
India’s Serum Institute of India (SII) entered a vaccines, rapid tests, and genomic products in South-
similar alliance with AstraZeneca to manufacture and East-Asia and has already attracted investors such as
supply COVID-19 vaccines early in the pandemic. AstraZeneca, KinGen Biotech, and Apsalagen in this
Similarly, another Indian-origin full-service CRO- direction.
CDMO (contract research, development, and
manufacturing organisation) Sai Life Sciences Singapore with its strong policies and well-
partners with pharmaceutical and biotech companies
globally to accelerate the R&D, development, and “China’s contract
manufacture of complex small molecules across the manufacturing space is
growing at over 15 per cent
“CDMOs like us have year-on-year but only WuXi
the technical expertise, Biologics has seen success
in attracting global clients.
knowledge, and GMP Despite Wuxi Biologics, being
facilities to deliver cost- the dominant player in China,
effective development and transnational companies such
manufacturing services. as Lonza and Boehringer
Outsourcing to a CDMO Ingelheim have already been
means you can expand your investing in the market, yet
technical capabilities without China’s CDMO business
the burden and associated appears nascent. Third-
risks of investing in expensive party drug manufacturing is
relatively new in China”
equipment”
- Rutger Vandiest, - Vicky Qing Xia,
Sr Project Manager, BioPlan Associates
Director of Business Development, Jabil Healthcare

22 COVER STORY

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Major trends boosting CDMO evolution curated infrastructure in APAC has attracted
many multinational biopharma firms to invest
● Implementing advanced digital manufacturing in its burgeoning ecosystem. Singapore’s mature
and analytical technologies biomanufacturing industry is hosting global
manufacturers such as Merck, Thermo Fisher, Sanofi,
● Accelerating development by effectively and BioNTech from the opportunities created by
leveraging technology transfers and the pandemic. The country’s strategy is to invest
in state-of-the-art production, robust regulatory
streamlining validation pathways policies, a skilled workforce, and conducive foreign
● To bring forth standardized processes, investment policies. Singapore has dedicated around
280 hectares of land exclusively for high-level
streamlined protocols, and templated pharmaceutical manufacturing at Tuas Biomedical
Park (TBP).
documentation to drive speed and efficiency as
Singapore’s Tuas Biomedical Park has facilitated
part of tech transfer Lonza to operate a mammalian cell culture
● Providing a more adaptive accelerated End-to- manufacturing facility for the contract development
and production of biopharmaceutical products,
End solution including monoclonal antibodies (mAbs), cellular
● Adopt integrated process flows between late- therapeutics, and other recombinant proteins. The
multi-product facility commenced cGMP production
stage technology transfer and robust process in early 2011 with bioreactor production systems for
both clinical and commercial operations.
validation
● Regularise Single-Use Technology (SUT) by Evolving M&A trends

deploying automated equipment to avoid According to PricewaterhouseCoopers (PwC)
analysis, the CDMO market remains highly
bioreactor contamination fragmented, with more than 75 per cent of
● Strengthening biologics capacity by investing participants having revenues below $50 million and
only 15-20 per cent CDMOs holding leading/major
in new lines and facilities to pace with the market share. The number of publicly announced
global CDMO deals is increasing by 12 per cent per
booming Biologics market year, adds ‘Fortune business insight’ analysis. To
● Adopt Multi-Attribute Methodology (MAM) compete effectively with established firms, limit costs
and risks, and expedite the market reach, CDMOs
workflow to replace multiple product assays are the preferred choices of SMEs that lack in-house
manufacturing capabilities. Additionally, moderate
with a single assay, resulting in lower costs and revenue companies undergo strategic mergers and
acquisitions (M&A) with established firms that
shorter timelines have in-house CDMO services to extend/grow their
● Increasing focus on “oral solid dose (OSD)” product range.

forms for cancer treatments to harness highly A notable M&A in recent days is Bora
Pharmaceuticals’ completion of three M&As over the
potent active pharmaceutical ingredients past decade in order to strengthen its international
competitiveness while significantly increasing its
(HPAPIs) to enhance bio-availability market capitalisation from NT$1.2 billion (approx.
● Further scrutinizing and defining the policies, $43.2 million) in 2017 to the current around NT$13.5
billion (approx. $486 million). In December 2021,
have well-documented regulatory guidance, Bora deployed private equity funds in partnership
with Taishin Healthcare whereby the two parties will
offers low and pre-defined licensing costs jointly invest up to NT$3 billion (approximately $108
● Identify and quantify critical quality attributes million) to assist forward-looking CDMOs and CROs
in Taiwan.
(CQAs) with novel tools to define a pharma
“M&As are expected to become an inevitable
product trend sweeping the sector and a growth strategy for
● Demonstrating expertise to scale a large

bioproduction process that can yield high titer,

shorter timeline deliveries
● Collaboration across the CDMO continuum

with cloud connectivity to identify gaps and

implement innovative technologies.
● Revolutionizing data management and making

data-driven decisions to seamlessly improve

bioprocessing process development
● Streamline processes to deliver the highest

quality product, reducing cost, and shortening

timelines, High-quality standards verified by

audits
● Enhance pharma capacity and capability needs

in light of potential supply chain disruptions,

geopolitical considerations, and the

competitive landscape as a result of pandemic

COVER STORY 23

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

CDMOs globally. With private funds and precisely Source: IMPAC
targeted M&As (which will facilitate the growth of
the portfolio companies by enhancing the quality of Leading CDMOs with APAC presence
their technologies),” says Bobby Sheng, Chairman of
Taiwan’s Bora Pharmaceuticals. ● Samsung BioLogics - South Korea
● WuXi Biologics -China, Singapore
While discussing M&A activity in the CDMO ● Catalent -China, Japan, Singapore
sector, the launch of Thermo Fisher Scientific ● Bora Biologics Co., Ltd., -Taiwan
Patheon over the acquisition of Patheon by Thermo ● Hilleman Laboratories-India, Singapore
Fisher for $7.2 billion in 2017 remains a notable one. ● Adjutor Healthcare -Australia
Following this, in December 2021, Thermo Fisher ● Abbvie Contract Manufacturing - China, Japan
Scientific acquired the global contract research ● Bluegum Pharma Holdings -Australia
organisation (CRO), Pharmaceutical Product ● Eden Biologics -Taiwan
Development (PPD) for $17.4 billion which provides ● Kyongbo Pharmaceutical -South Korea
comprehensive, integrated drug development, ● Boryung Pharmaceutical - South Korea
laboratory, and lifecycle management services ● Transcenta -China
globally including all the major APAC countries. ● Boehringer Ingelheim-China
● Bloomage BioTechnology-China, Japan
Owing to lower manufacturing costs, Asian ● Pharmaron -China
countries have been a preferred choice of outsourcing ● Novasep -India, Thailand, China
services for global therapeutic firms to expand ● PCI Pharma Services -Australia
their reach and portfolio. Several western CDMOs ● Piramal Pharma Solutions -India
expanded operations to ASEAN economies with ● Jubilant Biosys - India
prominent regions being South Korea, China, ● Suven Pharmaceuticals -India
Singapore, Japan, India, Thailand, and Malaysia. ● Merck BioReliance-China
Outsourcing to Asian regions has become a popular ● Eurofins Advinus Limited -India
cost-effective option and competitive alternative to ● Bioworkshops -China
several western pharma manufacturing firms, mainly ● Recipharm- India
for producing bulk drug volumes. ● Esco Aster- India, Chian, Singapore
● Vetter Pharma - South Korea, Japan, China,
For instance, Lonza expanded into China,
partnering with GE Healthcare to bring a biologics Singapore
facility to China (Guangzhou) in 2020. A strong ● West Pharmaceutical Services, Inc.- Australia,
partner in global alliances, AstraZeneca has
established a global supply network, with 16 distinct China, India, S.Korea, Taiwan, Singapore
supply chains and 25 manufacturing partners across ● Thermofisher Scientific Patheon - India, China,
more than 15 countries.
South Korea, Singapore, Japan, Australia
Likewise, the M&A trend is vigorous also with ● GenScript Biotech Corporation (GenScript
global firm Catalent. In October 2021, Catalent
opened a 6,000-square-meter clinical supply facility ProBio)- China, Japan, Singapore, South Korea
in Shiga, Japan. In 2012 Catalent gained three sites ● Lonza Capsules & Health Ingredients
in the US, two in the UK, and one in Singapore
as part of a major M&A with local firms. In 2013, (Capsugel) -India, Australia, China, Thailand,
Catalent continued the global expansion of its Softgel
capabilities through a joint venture with Zhejiang Indonesia, Japan
Jaing Yuan Tang Biotechnology Co, a China-based
company, and Relthy Laboratories in Brazil.

During the pandemic, CDMOs took the
center stage helping companies in developing,
manufacturing, and most importantly packaging
vaccines on a global scale to meet the demand and
supply ratio. Thus in the past two years, many small
and mid-size injectable CDMOs are building new
clinical and commercial capacities to fill a void left
by the largest CDMOs, which would otherwise need
extensive inbuilt injectable operations.

Despite being a lucrative region for the CDMO

24 COVER STORY

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Recent Developments in APAC CDMO Market

● June 2022: WuXi Biologics, a global States companies to obtain clinical approvals
CRDMO service company, launches the first in South Korea and Japan.
commercial drug product facility for Pre- ● December 2021: GenScript ProBio (US)
Filled Syringes. GMP operation of its new opened China’s most prominent commercial
drug product facility DP5 (ninth operational GMP plasmid manufacturing facility. The
drug product facility in the glWuXi Biologics) 6,400 sqm manufacturing plant offers a one-
located in Wuxi, China. Increases pre-filled stop service for plasmids - from the preclinical
syringes (PFS) capacity to 17 million units per study (IIT) to the investigational new drug
year (IND) filing to clinical trial and commercial
manufacturing. Also produces high-quality cell
● May 2022: Taiwan-based CDMO Bora and gene therapy mRNA drugs.
Pharmaceuticals established Bora Biologics ● December 2021: Merck’s Hilleman
Co., Ltd., a CDMO platform for biologics for Laboratories ties up a $58 million investment
innovative drug development. As part of its at new Singapore vaccine hub
5-year growth plan, Bora will be investing ● July 2021: Samsung BioLogics (South
up to $100 million in the acquisition of Eden Korea) entered into a Development and
Biologics’ CDMO assets in Taiwan Manufacturing Agreement with Kineta (US) for
Anti-VISTA Antibody Immunotherapy
● May 2022: India’s CDMO, Piramal Pharma ● April 2021: Global firm Lonza and Chinese
Limited, announced the launch of a new pharma company Junshi Biosciences
production block with an $11 million announced plans to expand their collaboration
investment to expand its global oral solid for biologics development and manufacturing.
dosage form (OSD) capabilities, bringing the ● March 2021: Germany- based Vetter, a global
facility’s total capacity to 4.5 billion doses CDMO (prefilled drug-delivery systems),
announced the opening of a new business
● May 2022: South Korean multinational, Lotte entity in Shanghai, China. The new fourth
Corporation, acquired Bristol Myers Squibb’s office in the APAC region, following business
manufacturing facility in East Syracuse, New development activities in the Singapore office,
York. The deal is reportedly worth $160 million sales offices in Japan and South Korea,
with the new unit focusing on biologics CDMO. further strengthening its footprint in the Asia
The plant can annually make 35,000 liters of Pacific region
drug substances. ● March 2021: Chinese pharma services firm
Pharmaron Beijing Co.; bought a facility in
● April 2022: Japan-based Asahi Kasei Medical Europe recently from AbbVie for $118.7 million
announced the acquisition of Bionova taking over Allergan Biologics Limited (ABL)
Scientific, LLC, a CDMO for developing next- business, located in Liverpool, UK. So China
generation antibody-based drugs and other with its perception to grow with USA and
biopharmaceuticals Europe big pharma entities is establishing
China-based CDMOs in these international
● February 2022: China-based CDMO business markets.
Asymchem Inc. plans to buy Snapdragon ● February 2021: ICON plc, a global provider
Chemistry, a US-based company focused on of outsourced drug and device development
continuous manufacturing and early-stage and commercialization services acquired
chemical process development services for Singapore local firm PRA Health Sciences, Inc.
$57.94 million. This transaction is aimed at for $12 billion helping ICON plc to penetrate
the expansion of the business of the Chinese the ASEAN economies.
CDMO in the US. ● January 2021: Sanofi as a mega-CDMO
helped Pfizer produce its COVID-19 vaccine,
● January 2022: GenScript ProBio, the while Bayer and CureVac entered into a
gene therapy CDMO division of GenScript multifaceted partnership in order to roll out
announced the construction of its newest 160 million vaccine doses for 2022.
34,000 sqm plasmid and viral vector state-
of-the-art manufacturing facility. GenScript
ProBio supports many mRNA vaccine
enterprises in China to obtain clinical
approvals by NMPA and helped mRNA vaccine
projects from South Korea and the United

COVER STORY 25

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

CDMO Process

API ● Extraction Drug ● Formulation: Finished Packaging ● Primary, Commercialisation
Manufacturing ● Synthesis product Dosage Formulation (FDF), Secondary
● Manufacturing Development Solid Dose, Liquid Dose, Teritiary packaging
Injectable Dose Formulation
and ● Labeling
manufacturing ● Commercial production

market, western firms face regulatory hurdles allocate resources, international pharmaceutical
in APAC due to varying and distinct regulatory makers have moved towards CDMO services. The
requirements in each of the APAC countries, unlike global CDMO market is expected to reach $242.64
the universal regulatory system in the US (FDA) or billion by 2026, representing an investment
EU (EMA) market. Thus, to make wise investment opportunity significantly more attractive than
decisions, global firms must track each APAC region’s the average of 4.5 per cent for the traditional
regulatory record. But, with the growing support pharmaceutical sector. According to current
from the government, countries such as Singapore, statistics, the CDMO market still has much potential
Malaysia, Thailand, and Indonesia are creating for growth as it now only represents 26 per cent of
conducive foreign investment policies to augment the pharmaceutical sector, with small and medium-
pharmaceutical research and manufacturing in sized molecular drugs accounting for 91 per cent of all
ASEAN. Yet, in certain developing Asian countries drugs manufactured by CDMOs”.
issues related to quality, skilled workforce, logistics,
regulations, and rigid IP policies are opined as Furthermore, with the robust pipeline of drug
unattractive scenarios for global players. candidates across APAC, and regional legislation
cooperation in encouraging foreign investments in
Strategic investments CDMO ecosystem, there will be a continuing growth
in biologics drug markets along with small and large
To remain competitive, CDMOs are investing in molecule drugs due to increasing patent expectation,
data-driven proprietary technology platforms that rise in patent expiries and generics competition.
consistently improve processes across development Thus the time is ripe with the pandemic scenarios for
phases and global networks of manufacturing aspirant players from both established and startup
facilities with reduced costs and timelines. In order firms to penetrate the CDMO market either through
to lead process innovation, operational efficiency is driving a greater need for cost efficiencies and access
essential for biopharmaceutical CDMOs to be agile to novel, proprietary technologies for achieving
in adopting technological transformation, including product differentiation and highly potent compounds
single-use technologies and continuous bioprocessing will all continue to drive growth in the contract
solutions. manufacturing market exponentially.

Daniel Ferzoco, Associate Director- Life Sciences Hithaishi C Bhaskar
at Michael Page USA, opines “investors are pouring [email protected]
funds into early-stage drug discovery companies.
Some of them lack the means to move a product from
its first phases to production and commercialisation.
CMOs and CDMOs are stepping in to take on those
functions”.

“The rise of biologics is evident in the number of
CDMOs investing heavily in new biomanufacturing
facilities including the biopharma Fujifilm Diosynth
Biotechnologies ($2 billion), Samsung Biologics’
($1.7 billion), Lonza ($935 million), Boehringer
Ingelheim’s ($827 million) as well as Therma Fisher
and Catalent in recent times,” reports The Marwood
Group, a healthcare-focused advisory and consulting
firm.

Sheng when talking about the surge of interest in
investment in CDMOs says “In order to effectively

26 CDMO

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Why Indian Pharma Must
Evolve As ‘Value Creator’

« Source: Biopharma outsourcing goes international

Dr Mahesh Bhalgat, The Indian CRO/contract development and
Chief Operating Officer, manufacturing organisations (CDMOs) industry has
Syngene International also started moving towards integration of services.
Earlier companies started out with standalone,
As the third-largest drug producer in the world, siloed services. Consequently, piece-meal activities
India is already a major global pharmaceutical in chemistry, biology were outsourced, but most
player. However, when it comes to the value of of the value creation work remained within the
production, India ranks fourteenth. A deeper dive pharma companies. Over time, CROs and CDMOs
into the details reveals an important fact: India is the have started integrating services in the value chain.
largest producer and supplier of generic medicines This helps in plotting a course through innovation,
globally, delivering a 20 per cent share. India’s solving problems and moving a molecule through
pharmaceutical sector has the highest number of discovery into development and manufacturing,
USFDA-approved manufacturing plants outside the ultimately, for the benefit of patients. This has
USA, 3,000 pharmaceutical companies, a network been an essential factor that is driving more
of 10,500 manufacturing facilities and a rich talent collaborations between the pharma/biotech
pool. So, why does it lag so significantly in deriving companies and CRO/CDMOs.
value from its assets? Is there an opportunity for the
Indian pharmaceutical industry to evolve in a way Innovation in this space is increasingly driven by
that moves India up on the value scale by increasing small and medium-sized biotechs, with few molecules,
innovation – and what will it take? Let’s find out. a very limited pipeline and limited resources with no
desire to set up their own large scale R&D facilities.
Contract Research Organisations (CROs) CROs in the emerging world have been successful
constitute one such opportunity. Focusing in advancing molecules along the discovery and
on the early years of drug discovery and development value chain by providing qualified
development, CROs offer a smart avenue for scientific talent, laboratory capacity and quality
pharmaceutical companies to conduct their research assurance combined with a cost advantage.
activities by outsourcing to a competent entity that
specialises in pharmaceutical research. The dynamics However, for the strategic partnering brought
are similar to the journey of the IT services industry by strong CRO’s cost is no longer seen as a deciding
in India that has evolved with time, and today, they factor; Globally cost over the years have seen an
partner around sophisticated end-to-end solutions upward trend. The rise in attrition as an example
that add value to the sector in many ways. The has increased manpower costs in the east and the
pharmaceutical companies today appreciate the value west. Cities such as Bangalore offer the adjacency
that Indian CROs can add by critiquing, challenging for the pharma-biotech industry to the IT industry,
and adding to their scientific ideas and hypotheses. which help drive innovation and offer technological
They expect their outsourcing partner to bring in their solutions for problem solving and bringing in
own experience and expertise to the table. It’s about efficiencies. Today pharma and biotech companies
the intellectual added value that segues perfectly. are willing to offer a higher rate for CROs/CDMOs

CDMO 27

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

that deliver world-class quality, innovative solutions are clear: educational institutions committed to
and delivery commitment to continuously grow the nurturing world class researchers, a well-established
research pipeline and supply the market. IP framework, and funding to attract research and
investment incentives.
A big differentiator for the Indian market is its
abundant availability of scientific educated talent According to the Brookings report, India has
pool. A work force graduating from close to 1000 a mere 216.2 researchers per 1 million population
universities and around 40,000 colleges in India is as against 1200 in China, 4300 in the US, and
reflective of India’s young population. It is estimated 7100 in South Korea. The Indian Government has
that 70 per cent of the workforce in India is under 40, shown intent to reverse the brain drain with the
and this key factor needs to be leveraged further to New Education Policy, 2020. This is certainly an
drive growth of the pharma-biotech sector. important step towards creating a better academic
ecosystem but there is more to do to incentivize
India emerging in the forefront academia to build educational environments and
curricula that produce talent that are industry ready
The COVID-19 pandemic changed attitudes to hit the ground running.
towards pharmaceutical research. It has
demonstrated the value of exploring novel Then there is funding. To date, the percentage
therapeutic approaches, conducting complex of GDP invested in R&D in India has been very
clinical trials and nurturing specialised skills and low at 0.7 per cent, which is among the lowest.
expertise to navigate through the drug discovery and Countries, like Israel (4.6 per cent), South Korea
development process. India has played a crucial role (4.5 per cent), Germany (3 per cent), or Brazil (1.3
in the pandemic as the largest vaccine manufacturer per cent) have consistently invested more. The
in the world. However, the sources of innovation have biologics-fueled pharmaceutical ecosystem requires
been the traditional players in the US and Europe. significant additional investment in facilities to
drive a step change in capacity and capability
While battling COVID-19 and struggling to get while the talent pipeline builds. Although private
the vaccines approved, the key was speed. The role investment is growing, it may not be enough for
of Indian providers in facilitating speedy trials is the top 10 pharmaceutical majors of India (7.8 per
now widely acknowledged: AstraZeneca’s vaccine cent) to equal half the amount of the top 10 global
development programme included a clinical research pharmaceutical companies (16.5 per cent) spends on
organisation from India to expedite efforts and R&D, as a percentage of their revenue.
generate reliable data for regulatory approvals.
Similarly, ICON provided clinical trial services to Nearly 80 per cent of all new drugs are biologics,
the Pfizer and BioNTech COVID-19 vaccination so, CROs - particularly those working with large
programme. The biopharma industry has also molecules as well as small molecules - can play a
played a role in developing and deploying vaccines critical role in building greater value for the Indian
closer to home. India tackled the pandemic with a pharmaceutical industry. Collaborating with the
record-breaking vaccination campaign and the effort government to build an attractive ecosystem, a
continues as companies like Akston Biosciences supportive education system, a legal and regulatory
are conducting human trials of second generation environment aligned with global practices; and
COVID-19 vaccines in India. sustained research funding, will be imperative. The
pandemic has provided an inflection point. It is time
With the COVID-19 as a template, CROs and to realign priorities and build momentum to foster
CMOs have put India front and center of the global pharmaceutical innovation and move the industry
stage for their agility, capability and quality in from a volume provider to a position of value creator
supplying effective vaccines in large quantities. for India.
It will be important not to stop here. The Indian
pharmaceutical sector must continue to focus on
moving upstream following the path of companies like
Syngene International that deliver discovery research,
development and manufacturing of small and large
molecules to create the next generation of medicines
and materials while building value for investors.

The path ahead

Building R&D capabilities is a path well travelled
in other parts of the world and the requirements

28 MYOPIA

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

ESCHEWING place during the onset of COVID-19 and children
MYOPIC attending online classes over electronic devices, the
ATTITUDE rise in myopia has been sharp. According to a recent
TOWARDS study, more children have developed myopia as an
EYE HEALTH unexpected side-effect of the pandemic.

In many East Asian countries, myopia is a Although higher prevalence of myopia tends to
major public health concern that affects occur in high-income countries who place a high
between 80 and 90 per cent of high school priority on academic performance such as South
graduates, of which about 10 to 20 per cent Korea, Singapore, China, and Japan, the numbers in
have sight-threatening pathologic myopia. East and Southeast Asia are rising rapidly too.
Thus, early intervention is crucial in the control
of myopia and the onus is to be equally On this note, Ken Tong, President, Singapore
distributed between the stakeholders of the Optometric Association says, “An increase in myopia
eye healthcare ecosystem. Studies have shown compromises the structure and health of the eye,
that the increased intensity of educational meaning a greater risk of eye disease and vision
pressures in young children has coincided loss. As such, myopia control methods must be
with the rapid rise in myopia cases in Asian implemented to curb preventable eye diseases from
countries in recent decades. Let’s explore progressing. If there is no intervention in a myopic
the available early interventions that could child’s visual system, myopia will continue to worsen
effectively tackle the rising incidents of myopia, and present greater threats to eye health over an
especially in the young. individual’s lifetime.”

Uncorrected myopia remains the leading cause China
of distance vision impairment globally, and
its rising prevalence could cost billions of A study by The Faculty of Medicine at The
dollars in lost productivity in the coming decades. A Chinese University of Hong Kong (CUHK) in 2021
hallmark study by the Brien Holden Vision Institute showed that the unprecedented level of quarantine,
(BHVI) in Australia predicts that by 2050, over half
the world’s population or 52 per cent will be myopic.

Direct costs of myopia in Asia alone have
been estimated at $328 billion every year, with
an additional $244 billion in productivity losses
associated with myopia.

Studies have shown the increased intensity
of educational pressures in young children has
coincided with the rapid rise in myopia cases in Asian
countries in recent decades. In many East Asian
countries, myopia is a major public health concern
that affects between 80 and 90 per cent of high
school graduates, of which about 10 to 20 per cent
have sight-threatening pathologic myopia.

In particular, with quarantine practices in

MYOPIA 29

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

As a result, PolyU has signed a five-year

Memorandum of Understanding (MoU) with

C-MER Eye Care Holdings to advance optometry

development and eye and vision health in Hong Kong

and Mainland China.

About 60 students of PolyU’s School of Optometry

will receive up to three weeks of clinical training

in C-MER hospitals, clinics and optical centres in

Hong Kong and other Greater Bay Area (GBA) cities

every year; while researchers and specialists from

the School and C-MER will collaborate on scientific

studies about myopia management and ageing eyes.

In addition, the Centre for Eye and Vision

Research (CEVR) has been launched in 2022 with the

collaboration between PolyU and the University of

Waterloo in Canada. This development is supported

InnoHK, the flagship innovation and technology

initiative of the HKSAR Government,

Direct focusing on myopia and eye growth, ocular

costs of drug discovery and delivery, vision
myopia in Asia enhancement, tear film and ocular
alone have been surface, and advanced optometric
estimated at $328 billion technology.
every year, with an French firm EssilorLuxottica has
joined forces with representatives
additional $244 billion
from both the central and local
in productivity losses
governments in China to promote the

associated with idea of ‘spending more time outdoors

prohibiting outdoor activities and myopia. in order to stay away from myopia’.
The company has also launched two key

restricting daily routines to indoor products, MiSight and Diffusion Optics

activities, has triggered a “myopia boom” Technology, to prevent and control myopia for

in school children in Hong Kong. children and youth in the country.

The Department of Ophthalmology and Visual

Sciences conducted a prospective population-based Singapore

study to evaluate the impact of the COVID-19 Myopia is the most common eye condition

pandemic on myopia incidence and progression affecting children in Singapore today. More than

among school-aged children in Hong Kong and found half of the children in Singapore develop myopia

a 2.5-fold increase in myopia incidence. by the age of 12 years old. A 2021 global study with

According to Professor Calvin C.P. PANG, S. H. Singaporean researchers, linking the use of digital

Ho Research Professor of Visual Sciences, CUHK, smart devices with myopia in children, has revealed

“High myopia (-6.00 diopters or above) can lead to that high levels of smart device screen time were

sight-threatening complications, including glaucoma, associated with almost a 30 per cent higher risk of

macular degeneration, retinal detachment and myopia, and when excessive computer screen time

cataract. Wearing glasses or having laser refractive was added, this increased to almost 80 per cent.

surgery can help improve vision, but cannot resolve In conjunction with public health programmes, a

the eyeball elongation problem or reduce the risk of locally developed mobile application called Plano has

complications, therefore prevention should be given been established in Singapore to manage the use of

top priority.” smartphones and tablets among children. The first

In sync with these findings, researchers from the spin-off from the Singapore Eye Research Institute

Hong Kong Polytechnic University (PolyU) found (SERI) - Singapore National Eye Centre (SNEC)

that not only did the rate of myopia progress faster Ophthalmic Technologies Incubator Programme,

in school children, but the rate of astigmatism also Plano has partnered with US-based Jobson Optical

increased by nearly 50 per cent, in the last two years. Group to produce new educational content designed

30 MYOPIA

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

RECENT INITIATIVES TO TACKLE MYOPIA BURDEN IN APAC

Country Initiatives in 2021-2022 Sector
China (Hong Kong Polytechnic University) Opened Centre for Eye and Vision Research Public
China (Hong Kong Polytechnic University) Providing clinical training for myopia management Public
Singapore (Singapore Eye Research Institute) Developing educational content for eye care professionals Public
South Korea (Seoul Semiconductor) Using natural light technology called SunLike to imrpvoe myopia Private
Japan (Keio University) Using violet light against myopia growth Private
Japan (Kubota Pharmaceutical) Designed special glasses to reverse myopia Private
Japan (Menicon) Launched disposable and orthokeratology contact lens Private
Australia (Aspen Pharmacare) Launched low dose atropine eye drop Private
New Zealand (University of Auckland) Launched country’s first mobile optometry clinic Public
India (Entod Pharmaceuticals) Soon to launch low dose atropine eye drop Private

specifically for eye care professionals worldwide. “It is important to select natural light that has

Dr Mohamed Dirani, Managing Director, Plano, been optimised for human DNA for millions of

says, “Myopia is a worsening global issue and there years. SunLike technology can reduce myopia and

is a pressing need to act as a global community help people fall asleep well at night when cells are

to implement strategies at all levels to reduce the regenerated”, says Chung Hoon Lee, Chief Executive

burden of myopia. Through education and awareness, Officer, Seoul Semiconductor.

innovative solutions that help parents to control their Adding on, MiSight 1 day, child-friendly daily

children’s screen time, and disposable contact lenses proven to slow the

ensuring that children progression of nearsightedness

undergo regular and The in children aged 8-12

timely eye exams, prevalence APAC at the initiation of
we can intervene of myopia among is treatment, by US-
early to prevent 8-year-old children is based CooperVision
myopia.” 36.4 per cent in Taiwan, anticipated has recently been
to dominate the approved in the
Korea followed by 34.7 per cent global myopia country.
in Singapore, 30.8 per
According treatment devices Adding his

to a recent cent in Shanghai and market during thoughts on nipping

report, the 14 per cent in 2022-2027. myopia in the bud,
prevalence of Malaysia. Hamish Thrum, Senior
myopia in children
Director, Myopia Asia

and adolescents in Pacific (APAC), CooperVision

Korea ranges from 50 says, “Low levels of myopia may not ring alarm bells

per cent in children aged 5–11 years to 78.8 per for many parents. However, because myopia is a

cent in children aged 12–18 years. This prevalence progressive condition, the younger the child is when

is comparable to that in China (70.9 per cent in myopia sets in, the higher the risk of severe sight-

children aged 6–18 years), and higher than that in related complications later in life, if the myopia is

Japan (43.5 per cent in 12-year-old children and 66 untreated. Even a 1.00 diopter increase in myopia

per cent in 17-year-old children). has been associated with a 67 per cent increase in

In an interesting development, South Korea- the prevalence of myopic maculopathy. Conversely,

based firm Seoul Semiconductor has revealed that slowing myopia by just 1.00 diopter should reduce

SunLike, a natural lighting technology, can improve the individual’s likelihood of myopic maculopathy by

myopia. Developed through years of R&D, Seoul 40 per cent.”

Semiconductor has been conducting experiments

with Seoul National University, Basel University, and Japan

Harvard University since 2017. The company has Back in 2019, a research team at the Keio
University School of Medicine had conducted Japan’s
recently collaborated with SERI to further confirm first prevalence study on myopia in 20 years. The

this observation.

MYOPIA 31

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

study looked at approximately 1,400 elementary and “If there is no
junior high school students in the Tokyo area and intervention in a myopic
found a possible correlation between myopia and dry
eye. Results showed that the prevalence of myopia in child’s visual system,
689 elementary school students was 76.5 per cent, myopia will continue
while the prevalence of high myopia was 4 per cent. to worsen and present
In 727 junior high school students, the prevalence
of myopia was 94.9 per cent, higher than existing greater threats to
reports abroad, and the prevalence of high myopia eye health over an
was 11.3 per cent. individual’s lifetime.”

Determined to fight this growing burden of eye - Ken Tong,
health, researchers at Keio University are currently President,
exploring the use of violet light to stop myopia
progression. Singapore Optometric Association

On the other hand, the Education Ministry in “Wearing glasses or having
Japan plans to conduct a near sightedness survey laser refractive surgery can
involving 9,000 students amid concerns over the
increasing use of digital devices and their potential help improve vision, but
impact on children’s health. cannot resolve the eyeball
elongation problem or reduce
Besides these surveys, Japan is indeed riding the risk of complications,
high on innovation by developing unique smart therefore prevention should
glasses to slow down or even reverse myopia. Kubota
Pharmaceutical has designed a special pair of glasses be given top priority.”
that aims to treat and control the progression of - Prof. Calvin C.P. PANG,
myopia with its built-in mechanism to project
an image onto the retina. The device is currently S. H. Ho Research Professor of
undergoing clinical trials and will be soon launched Visual Sciences, Chinese University of
in Asian markets.
Hong Kong
Another Japanese player Menicon has launched
a treatment plan for myopia control in multiple “Through education &
countries such as the United Kingdom, France, awareness, innovative
Spain, Italy, Austria, Australia, and Singapore. The solutions that help parents to
comprehensive treatment plan for childhood myopia control their children’s screen
features two contact lenses that are CE-approved time, & ensuring that children
specifically for myopia control: Menicon Bloom undergo regular & timely eye
Night, a specially designed orthokeratology contact exams, we can intervene early
lens, and Menicon Bloom Day, an extended depth of
focus soft daily disposable contact lens. to prevent myopia.”
- Dr Mohamed Dirani,
Australia & New Zealand
Managing Director, Plano
Like many other Asian countries, cases of myopia
have increased among children in Australia and New “SunLike
Zealand as well in the past two years. In fact, surveys technology can
are showing that 91 per cent of Australian parents reduce myopia
were not aware of the role excessive screen time could and help people
play in myopia development and 73 per cent did not
know that genetics might also play a role. fall asleep
well at night
Addressing this concern, the regulatory body when cells are
Therapeutic Goods Administration (TGA) has listed regenerated.”
a new medication by Aspen Pharmacare in 2022 to
slow the progression of myopia in children and young - Chung Hoon Lee,
teenagers. Chief Executive Officer,

“Childhood myopia is an emerging public health Seoul Semiconductor
concern. We are providing a low dose atropine eye

32 MYOPIA

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Myopia rates in Singaporean children India

Age (years) Myopia rate (%) Myopia in India and its understandings are still
6 25 evolving. The diverse nature of the country has
9 40 differing prevalence rates, and the technological
12 55 advancement has unequivocally added many novel
18 83 insights including factors such as genetics, imaging,
morbidities, and management. However, due to lack
Source: Myopia Control- Singapore of public awareness, social stigmatisation, and lack
of personal care, the intended goals have not been
“Even a 1.00 achieved yet.
diopter increase in
“Myopia is the most important cause of visual
myopia has been impairment in children and as per a study by All
associated with a 67 India Institute of Medical Science, 17 per cent of
children or 1 out of 6 children in India between the
per cent increase ages of 5 and 15 years are suffering from myopia”,
in the prevalence says Nikkhil K Masurkar, Executive Director, ENTOD
Pharmaceuticals.
of myopic
maculopathy.” The company, ENTOD Pharmaceuticals, has very
recently got the approval to carry out phase 3 trials
- Hamish Thrum, across India for their 0.05 per cent atropine eye
Senior Director, Myopia Asia Pacific, CooperVision drops from the Drugs Controller General of India
(DCGI). This higher strength of low-dose atropine
“We are providing a eye drops is not available commercially anywhere
low dose atropine eye in the world, and ENTOD Pharmaceuticals would
be the first company to launch this in India subject
drop treatment to to a successful demonstration of safety & efficacy in
Australia that has been clinical studies. Low-dose atropine has emerged as an
effective approach to slow the progression of myopia
studied in children in children and has recently garnered a lot of interest
and adolescents, 4 to from ophthalmologists.

14 years, to slow the Countermeasures and Strategies
progression of myopia.”
Myopia, although a fairly innocuous eye defect,
- Trevor Ziman, has the potential to transform into a major, life-
Chief Executive Officer, Aspen Asia Pacific changing disorder that affects a person’s efficiency
and lifestyle immensely. The rise of myopia in
“As per a study by All children across the Asian subcontinent is that of
India Institute of Medical concern and alarm, especially the deterioration
observed since the pandemic. it appears crucial
Science, 17 per cent of and cost-effective to take urgent and effective
children or 1 out of 6 actions to halt further progression and to prevent
the emergence of expected challenges. This could
children in India between be achieved through various countermeasures
the ages of 5 and 15 and strategies, such as human resources building,
appropriate distribution of eye care health
years are suffering from professionals and collaboration among the countries
myopia.” within APAC.
- Nikkhil K Masurkar,
Introduction of advanced technologies and
Executive Director, ENTOD Pharmaceuticals experience from developed countries could be one of
the fastest ways to help promote the eye care services
drop treatment to Australia that has been studied in capacity in the developing and underdeveloped parts
children and adolescents, 4 to 14 years, to slow the of the region.
progression of myopia”, says Trevor Ziman, Chief
Executive Officer, Aspen Asia Pacific. Dr Manbeena Chawla
With inputs from Sakura Koner
On the other hand, New Zealand has launched its
first mobile optometry clinic to improve access to eye
healthcare, since cost is a significant barrier in the
country.

SPEAKING WITH 33

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

“Obstructive Sleep Apnea

brings about a severe

economic burden on the country”

Arecent consensus by the Research Society «
for the Study of Diabetes in India (RSSDI)
highlights the importance of screening for Carlos Montiel,
obstructive sleep apnea (OSA) in patients with type Vice President-
2 diabetes mellitus (T2DM). The report reveals Latin America, and
that over 50 per cent of patients diagnosed with South Asia,
T2DM suffer from sleep disturbances, many of ResMed
which may require treatment. In addition, OSA can
occur together with chronic obstructive pulmonary Bharat Digital Mission will go a long way in digitising
disease (COPD) leading to so-called overlap citizens’ healthcare records and building the
syndrome. To gather more information about the backend infrastructure for advancing telehealth and
treatment for such conditions, BioSpectrum spoke telemedicine in communities across India.
to Carlos Montiel, Vice President- Latin America,
and South Asia, ResMed, a sleep therapy and
respiratory equipment maker. Edited excerpts;

What are the challenges facing the OSA and How is ResMed addressing these

COPD market in India? challenges?

In India, awareness is the primary challenge ResMed provides the world’s most modern,
for Obstructive Sleep Apnea (OSA) and Chronic next-generation and cloud-connected solutions
obstructive pulmonary disease (COPD). India is a for respiratory and sleep care patients. ResMed
sleep deprived country, and most people don’t even solutions and therapy devices help keep patients
know about it. As per a recent ResMed’s survey of out of the hospital, improve their quality of life, help
over 5000 individuals, about 55 per cent of Indians clinicians monitor and care for them more efficiently.
have trouble sleeping. However, most have not During the COVID-19 pandemic, ResMed continued
considered consulting a sleep specialist or resorting research, collaboration, and innovation that was
to home sleep tests and therapies. Therefore, the needed to drive the development and adoption of
foremost and the most important step is to generate digitally connected health services to improve out-
awareness about the importance of sleep for overall of-hospital care. Significant health issues also stem
well-being. Secondly, even though telemedicine from the lack of awareness, diagnosis, and treatment
is increasingly becoming mainstream and making of sleep-related disorders. To bridge the awareness
diagnosis and treatment accessible to some extent, it gap for both the consumers and the medical fraternity
remains a challenge to remotely treat patients with of India, ResMed launched awareness initiatives such
chronic symptoms. as the #WakeUpToGoodSleep campaign, highlighting
the benefits of good sleep hygiene and the availability
Moreover, India is a vast country with a lagging of home sleep tests in India. ResMed regularly
healthcare infrastructure and a population not commissions sleep surveys to increase awareness
equipped to depend entirely upon telemedicine. about the benefits of sleep and inform the healthcare
Companies in the private sector and the government community.
are investing to increase the adoption of digital
health and build awareness. However, it will be a In conjunction with the World Sleep Awareness
gradual process for a country like India and will Day in March 2022, ResMed released the findings of
be beneficial for all stakeholders and patients. For its latest ALA Sleep Survey focused on determining
example, the Digital Health ID (DHID) launched by what keeps Indians up and understanding sleep
the Government of India as a part of the Ayushman health-related challenges. The study pointed out

34 SPEAKING WITH

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

India has over 50 million sleep apnea MyAir is one more such patient friendly platform
patients, 80 per cent of whom are designed to empower patients to stay engaged with
undiagnosed, as per the Lancet CPAP therapy, which may help reduce call backs and
Respiratory Medicine 2019 study. improve efficiency.
Considering the prevalence, OSA brings
about a severe economic burden on Moreover, we have launched a variety of new
the country in such a situation. When it products to help Indians sleep better, including:
comes to COPD, it is the second leading
cause of death worldwide, affecting • Eye masks (Silk and Contoured) to block white
more than 53 million from India. Due light,
to the vulnerability of the lungs, COPD
patients become prone to developing • Dreampad – a pillow to induce relaxing sleep,
cardiovascular issues, and lung cancer, • Dodow – a device emitting blue light to help
in case of acute exacerbations and even soothe a racing mind,
premature death. • A sound machine that blocks background noises,
and
that Indians take over 90 mins to fall asleep, which • CPAP Wipes for a fast and easy way to clean
is the longest globally in comparison to other survey CPAP (Continuous Positive Airway Pressure) masks.
countries (Japan: 25 mins, China: 42 mins, Korea:
30 mins, Brazil: 44 mins, and Mexico: 34 mins), What are your expectations from the Indian
confirming the pandemic’s severe impact on the
sleeping habits of India and the need for diagnosis. government to enhance awareness about
ResMed’s focus is to help people sleep, breathe, and
live healthier, high-quality lives through better access OSA and COPD?
to treatments and innovative solutions. The insights
from the ResMed’s India survey underline the factors The pandemic has surely pushed digital health
impacting sleep and highlight the need for more and telemedicine adoption, with the Ministry of
awareness around sleep disorders so that people Health, and Family Welfare (MoHFW) issuing the
struggling with insufficient sleep or poor sleep quality Telemedicine Practice Guidelines in March 2020 to
can get diagnosed and seek the right treatment if aid the healthcare community during the pandemic.
needed. By enabling better care, ResMed can improve The guidelines created by NITI Aayog included
sleep habits and reduce the impact of chronic diseases. information on the available technology platforms
and tools and can ease healthcare delivery. It had
Are you planning to launch new products for frameworks for practising telemedicine in various
the Indian market, for OSA and COPD this scenarios including patients, registered medical
year? Please share details. practitioners, caregivers, health workers and
emergencies. It was a step in the right direction which
ResMed focuses on continuing its endeavour to enabled doctors to effectively help patients; however,
improve the life quality of Indians. We constantly a lot more is required.
innovate and generate content to help people with the
right solutions and awareness around improved sleep For OSA, beyond the policies, the Government of
health. Additionally, to help healthcare professionals India (GOI) should undertake a pan India national
effectively diagnose and manage patients, ResMed campaign to educate Indians about the importance of
has launched multiple products and solutions to sleep. India has over 50 million sleep apnea patients,
support out of hospital care (OHC). For diagnosis, 80 per cent of whom are undiagnosed, as per the
ResMed OneSleepTest is an ideal solution to measure Lancet Respiratory Medicine 2019 study. Considering
key indicators such as heart rate, oxygen desaturation the prevalence, OSA brings about a severe economic
and body movements to determine sleep quality. For burden on the country in such a situation. When
treatment, ResMed’s remote monitoring solutions it comes to COPD, it is the second leading cause of
such as AirView enables healthcare professionals to death worldwide, affecting more than 53 million
proactively identify patient issues and address them from India. Due to the vulnerability of the lungs,
early on or through the treatment journey. ResMed’s COPD patients become prone to developing
cardiovascular issues, and lung cancer, in case of
acute exacerbations and even premature death. The
rising AQIs and dipping temperatures coupled with
COVID-19 have spotlighted our respiratory health.
Given the enormous public health burden, driving
awareness around the symptoms, plausible causes
and treatment is essential.

Dr Manbeena Chawla
[email protected]

SPEAKING WITH 35

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

“Spending on TB control

programmes had dropped to 2016

levels in 2020 and remains unchanged”

Contrary to popular opinion, tuberculosis «
(TB) has not been eliminated in Singapore.
In fact, TB is an endemic disease, and Patrick Che,
in 2020, Singapore detected 1,370 cases of
active TB. The burden of active TB cases in Sales Development
Singapore has continued to hover around 30-
40 cases per 100,000 persons each year for the Manager,
past decade, and nearly 80 per cent of the new
cases of TB, in 2020, are from persons born QuantiFERON,
in Singapore. QIAGEN recently collaborated
with the Tuberculosis Control Unit (TBCU) South East Asia,
of Singapore to light up the TBCU building in
support of the “Light up RED for TB” campaign. QIAGEN
QIAGEN’s goal is to gradually shift the focus
in the direction of preventive testing and demographics, international travel, and most
treatment in order to protect individuals from recently, the COVID-19 pandemic. The WHO
TB reactivation, and therefore prevent the spread recognised, in their 2021 Global TB Report, that
of TB to others. To find out more about the many countries in the APAC region faced many
company’s initiatives towards TB detection in challenges during the COVID-19 pandemic such
APAC, BioSpectrum Asia spoke to Patrick Che, as reduction of access to TB preventive therapy.
Sales Development Manager, QuantiFERON,
South East Asia, QIAGEN. Edited excerpts; South East Asia includes many countries on
the WHO list with the highest TB burden in the
How is QIAGEN helping to reduce the world (apart from Africa). Most countries in
growing burden of TB in APAC? the region remain focused on case finding and
treatment for active TB disease and the National
QIAGEN promotes TB prevention (Test and TB programmes do not have policies or clinical
Treat strategy for individuals who are at risk practice guidance to support TB prevention.
of developing active TB) as a means to reduce
overall active TB burden in APAC. It is estimated COVID-19 presented unique challenges to
that 1.5 million people died from TB in 2020 and TB control programmes across the region due
over 1.4 billion people are currently infected with to the shift in government spending away from
TB. The US CDC (Centers for Disease Control TB and other diseases in order to support the
and Prevention) estimates that 1 in 10 with TB management of COVID-19. In the midst of the
infection will go on to develop active TB disease pandemic situation, we have developed and
at some point in their lifetime. It is important launched the QIAreach QFT solution, which is an
to emphasise that preventive treatment for TB, interferon-gamma release assay (IGRA) developed
particularly for individuals who carry a higher in partnership with Ellume. The solution was
than normal risk of developing active disease, designed with many of the regional challenges
is the only way to stop TB before it spreads to in mind, specifically to support decentralised TB
others. The World Health Organisation (WHO) infection screening in high TB burden and low
also identifies Latent TB Screening (LTBI) as a resource countries.
key pillar in their global EndTB Strategy.
What are the major products developed by
Each country in the APAC region presents QIAGEN to enhance TB detection?
unique challenges for TB control programmes due
to many variables such as government policies, QuantiFERON-TB Gold Plus (QFT-Plus)
remains the flagship IGRA test which is globally
recognised as the market leader for supporting
TB infection screening and contact tracing
programmes. QIAreach QuantiFERON-TB (QFT)

36 SPEAKING WITH

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

is the latest product developed by QIAGEN to Are you planning new investments or
improve access to IGRA technology in high TB
burden and low resource countries. collaborations to increase availability of

Are you planning to launch new products TB detection assays?
in 2022 for the APAC region?
StopTB Partnership is supporting lower
We are launching QIAreach QFT in the APAC pricing for public health and broader access to
region this year, with country level registrations TB screening technology via the Global Drug
on-going. Apart from QIAreach QFT, we are Facility (GDF) catalogue. Ending Workplace TB is
also launching NeumoDx – a high-throughput promoting TB elimination and prevention in the
automatic PCR platform - and a number of workplace.
other products supporting the detection of other
infectious diseases. Results Australia is working with local NGO
to call on the government to take action and
What are the current challenges facing the promote TB elimination efforts through education
TB diagnosis market in APAC? and TB preventive screening. Each country in the
region has specific focus areas for TB prevention,
Government resources allocated to public and local activities depend on the demographic
health have been redirected to support the of the country and the segments which the local
management of the COVID-19 pandemic. In most government and associations are interested to
countries, the resources continue to be focused support. Generally speaking, across SEA, we
on this area even as the countries are gradually are collaborating with local organisations for
relaxing their restrictions and international TB education/awareness in high risk patient
travel is slowly returning to the “new normal”. segments (i.e. diabetes, pediatrics, dialysis
Allocation of resources to support TB control patients (ESRD), migrant workers, occupational
programmes remains a challenge as spending on health (including healthcare workers), and
TB had dropped to 2016 levels in 2020 and up till PLHIV), with the goal of promoting TB preventive
now has not recovered. screening and treatment as a means to reduce TB
burden.
Improving access to the latest diagnostic
technologies in high burden and low resource The QIAreach QFT test was developed in
settings where access to centralised laboratory partnership with Ellume, a diagnostics company
infrastructure is limited, remains challenging. based in Brisbane, Australia. QIAGEN is always
This is why QIAreach QFT was developed – to interested in exploring novel ways (including
provide a more decentralised testing option collaborations) to leverage our technology and
while still offering most of the benefits from our platform expertise to support the development
QuantiFERON technology platform. of better tests and technologies which can lead to
better patient outcomes and more efficient disease
Most TB control programmes continue to management.
focus on active TB case finding and treatment.
The challenge is to change the mindset to favour Which other infectious diseases are a
TB prevention as a way to reduce active case
burden. priority area for QIAGEN? What are the

plans in the coming years?

QIAGEN has a very broad portfolio of
solutions spanning life science/research, next-
generation sequencing, to molecular IVD
solutions. Within the QuantiFERON family,
apart from tuberculosis, the IGRA technology
has also been expanded to include immunoassays
for SARS-CoV2 (COVID-19), cytomegalovirus
(CMV), lyme disease, as well as innate/adaptive
immunity. Note that not all products are available
in the APAC region. The introduction of the
NeumoDx platform will further expand QIAGEN’s
ability to support detection of other infectious
diseases.

Dr Manbeena Chawla
[email protected]

SPEAKING WITH 37

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

“Regulatory bottlenecks such as local QC testing

and pre-approval of GMP inspections must go”
The APAC pharma and biopharma landscape
is rapidly evolving and the market
access landscape is increasingly turning
complex with the intricate regulatory system. «
Companies in APAC deal with rapidly changing

risk and compliance challenges to remain Eileen Ang,

competitive in the market. While identifying Head of Regulatory

opportunities and roadblocks, it’s essential Affairs,

to sharpen regulatory landscape conditions, Takeda APAC

encourage government initiatives, and nurture

the regulatory ecosystems for harmonisation

and bilateral relations that can close-nit the

markets. Eileen Ang, Head of Regulatory Affairs, This allows us to:
Respond to urgent global needs: COVID-19,
Takeda APAC shares the latest APAC regulatory

ecosystem insights while navigating through H1N1, and H5N1 were global pandemics that required

Asia-Pacific markets to understand trends, companies, regulators and industry stakeholders to
requirements, and regulations. Edited excerpts;
rapidly convene to deploy the necessary solutions

to individuals across the globe. Regulators facilitate

expedited and rolling submissions, allowing

Can strategic regulatory reforms empower reviewing processes to take place quickly and as more

a company to mitigate market access risks research data becomes available.
Support rare disease patients in getting the
to promote its commercialisation, trade, and treatment required: Given Takeda’s commitment

investment capabilities? to addressing the unmet medical needs of patients
Regulatory agencies should continue working

towards harmonising their guidelines with with rare and complex diseases, priority approvals

internationally recognised standards or move and expedited pathways are fundamental in ensuring

towards regulatory convergence whereby regulatory that patients can get the necessary treatment in the

requirements become more aligned over time shortest possible time.

through the gradual adoption of internationally

recognised technical guidance documents and How essential is international legislative

standards. Flexibility should be adopted to allow cooperation in accelerating regulatory

for reliance on or recognition of the assessments reforms to reduce the cost and time required

already performed by stringent authorities such as to bring products to the market?

the US FDA and EMA in order to accelerate product International legislative cooperation and

approvals. Regulatory bottlenecks such as local collaboration where regulatory bodies share or

QC testing and pre-approval Good Manufacturing perform joint regulatory assessments are essential

Practices (GMP) inspections should be removed. to facilitating accelerated market access of new

The implementation of expedited regulatory therapies to patients.

pathways is specifically important for therapies Examples of such collaborations include Project

addressing high unmet patient needs, for example Orbis and the Access Consortium which provide

in orphan products treating rare diseases. Adopting a framework for the involved authorities to share

a values-based and patient-first approach, can mean workload, resources and expertise. By carrying out

working closely with regulators and continually concurrent regulatory evaluations of new medicines,

exploring priority pathways to get innovative authorities are able to efficiently use their resources

treatments and vaccines to patients at speed. As and time, consequently increasing each agency’s

expedited review processes and joint assessment capacity to ensure patients have timely access to safe

pathways form the backbone of delivering smarter and effective medicines. In Asia Pacific (APAC), both

and accelerated market access, at Takeda we Therapeutic Goods Administration, Australia (TGA)

prioritise collaboration and cooperation at every step and Health Sciences Authority, Singapore (HSA) are

of the approval process. participating members of these two initiatives.

38 SPEAKING WITH

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

How complex is the market penetration for allowed us to articulate our position and ensure that
we had a strong case to put forth for accelerated
pharma and biopharma companies in the regulatory approvals.

APAC region? Work-in-progress frameworks: Regulatory
processes for novel treatments involving advanced
It is incredibly crucial for countries in APAC therapy medicinal products (ATMPs) such as cell and
to adopt international regulatory standards. This gene therapeutics are a work-in-progress in APAC.
is becoming commonplace in developed countries The evolving regulatory environment and lack of
like South Korea, Taiwan and Singapore where a harmonised regulatory framework may result in
regulatory guidelines align with those set out by the longer review timelines.
International Council of Harmonisation (ICH).
Reliance on approval in major/developed
On the contrary, submissions for regulatory markets: Many Asian countries require approval
approvals may be deprioritised in lower-income first in major markets or approval in the country of
countries due to the longer approval times despite origin or source country before accepting marketing
high patient demands. This causes a large disparity in authorisation applications. This requires the
access amongst neighbouring countries. submission of the Certificate of Pharmaceutical
Product (CPP) with certain countries requiring
Economic disparity: One of the largest issues the legalisation of this document. Though some
that APAC faces is the wide economic disparity improvements have been made in recent years
among countries in the region, with some being where such a document is required only at the
developed countries, and others identified as time of approval instead of being a prerequisite for
developing low to middle-income nations. submission, it still results in a significant time lag for
patients in Asia to have access to new treatments/
This can translate into differing resources, therapies as compared to developed countries like
expertise, and skills available within each country Europe and US.
to support quick and effective regulatory approvals.
Focusing on ensuring access to COVID-19 Can country-specific and customised
vaccinations has also caused a bottleneck in
approval processes and deprioritised other product regulatory regimens, as well as lower
submissions, particularly for smaller, resource-
constrained agencies. New Drug Application (NDA) review

Diverse regulatory requirements across fees, boost APAC biopharma regulation’s
Asia: In the ASEAN region, despite regional
harmonisation efforts to have common technical competitiveness compared to a western
requirements and a common dossier, there are still
country-specific requirements that need to be fulfilled regulatory system, such as US FDA?
to obtain successful approvals. As a consequence,
timelines for approval vary significantly. The cost of product registration which
includes regulatory review fees is only one of the
In Taiwan and Korea, local data is required to considerations for market entry. Other equally
support product registrations. Companies often important considerations include regulatory
need to prepare bridging study reports to convince requirements, predictability and consistency in the
regulators that the treatment will work similarly regulatory assessment and decision-making process
across different patient demographics, including as well as the timelines. Regulatory agencies need
ethnic backgrounds. to balance the need for timely approvals of products
whilst ensuring that they meet the required standards
At Takeda, we prioritise patient diversity of quality, safety, and efficacy. This can be challenging
throughout our clinical studies, to ensure a robust for smaller agencies with limited resources.
inclusion of Asian patients. Likewise, we also Registration fees will help the agencies to strengthen
place a lot of emphasis on real-world evidence to their regulatory capacity, but they should also work
understand the real-world clinical translation of our towards continued international cooperation and
clinical data and identify opportunities to further collaboration with other regulatory authorities, which
enhance patient care. This supports us in expediting includes relying on the assessments and inspections
market entry and bridging gaps in patient access in from the more developed and stringent authorities.
the region. This can improve operational efficiency and facilitate
quicker access to new medicines and treatments in
An example would be our pipeline product for a APAC.
niche type of non-small cell lung cancer (NSCLC).
Given the disease’s prevalence in East Asia, it was Hithaishi C Bhaskar
critical for us to secure relevant patient data from [email protected]
that region and understand key patient needs. This

SPEAKING WITH 39

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

“Leveraging big data to create

transparency, mitigate risks and

operate in real-time is critical”
With the innovation boom in Asia and many
early-stage assets emerging, the time «
is ripe for Asian economies to establish
cross-border business relationships by systematically Edwin Ng,
tapping potential markets for successful market
penetration. Regulatory compliance and patient Senior Vice President,
protection are simultaneously enhanced by
increasing investments in technology to meet General Manager
quality and efficacy which are paramount in the
pharma/biopharma and clinical trial space. Yet, (Asia-Pacific),
with the rapidly changing regulatory expectations,
certain regions in APAC experience regulatory Medidata Solutions
inertia which can hinder development and bilateral
trade. Despite the challenges, Asian economies due to globalisation and advancements in technology,
are adopting evolving policies and regulations along with improvements for patient outcomes
supporting operations. However, can regulatory and safety. Increasing demands from patients,
reforms bring down the cost and time required consumers, and regulators have led to an evolution
to bring a product to market? Edwin Ng, Senior in the world of the patient experience, which now
Vice President General Manager (Asia-Pacific) sees patients at the heart of the process. The medical
at Medidata Solutions shares more insights device industry for instance has been significantly
with Biospectrum Asia. Edited excerpts; affected by recent events. The level of regulatory
change over the past few years and to date is
What are the most challenging market access unprecedented, further emphasised by the COVID-19
issues pharma and biopharma companies are pandemic, where we have experienced a plethora
facing across the APAC region? of new regulatory updates for medical devices as a
result. Companies need to constantly adapt to the
One of the biggest challenges in market access of new regulatory landscape to accurately and effectively
life science and healthcare solutions are regulatory meet compliance or potentially risk financial and
hurdles in clinical trials. Only 10 per cent of drugs reputational ramifications.
that complete Phase I trials ever reach patients –
this low success rate is largely a result of a highly How essential is it for an Asian country
inefficient clinical trial process. The risks presented to bring its regulation standards closer
by regulatory non-compliance, and the associated to international norms to encourage
significant delays, have a substantial impact on transnational businesses and investors alike?
any company’s business and outputs. Sponsors
that preempt regulatory obstacles can gain an As an industry, to be able to bring new drugs
advantage by reducing time-to-market, creating and devices to patients faster, we need to advocate
significant shareholder value, and getting their drug for a universal regulatory ecosystem that is more
to patients faster. The ability to use big data to create harmonised and not fragmented. Today, we have
transparency, mitigate risks and operate in real-time the tools to digitise and run clinical trials in multiple
is critical for life science leaders. countries simultaneously – where practitioners can
see the data coming in from multiple sources in real-
The life science and healthcare industries are time. As soon as data is entered into the system, all
among the most heavily regulated industries in the users have access; a principal investigator is able to
world. Regulations and guidelines change constantly sign off the data, a CRA is able to review it remotely
without coming into the site, a data manager can then

40 SPEAKING WITH

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

The primary concern of the regulatory important to understand what the current
authorities is patient safety, so bottlenecks are? The primary concern of the
implementation of any new policy must regulatory authorities is patient safety, so
benefit patients, while at the same time implementation of any new policy must benefit
maintaining a wide range of regional, patients, while at the same time maintaining a
national, and international compliance wide range of regional, national, and international
standards. This has prevented the compliance standards. This has prevented the
regulatory ecosystem from being agile regulatory ecosystem from being agile for changes.
for changes. The industry could certainly The industry could certainly do with more
do with more harmonisation. The harmonisation. The differences, not just in the rules
differences, not just in the rules but also but also the punishments, are vast.
the punishments, are vast.
In the current dynamic regulatory landscape,
approve the data, and the sponsor or CRO is able to some of the future changes will need to adhere to
track the study’s progress. The benefits of electronic regard data and how data is used to drive meaningful
data capture systems and cloud platforms during insights and trends. As technology keeps advancing,
the pandemic cannot be overstated - many clinical the national regulatory authorities will need to align
trials were able to continue due to electronic and on issues such as use of wearable devices to collect
remote data capture. Medidata’s support brought one data, remote monitoring of patient volunteers, etc.
of the leading COVID-19 vaccines through the full
clinical trial lifecycle in under one year—enrolling How critical is it for startups and SMEs to
30,000 subjects in just 12 weeks. With a unified or
harmonised regulatory framework which streamlines comply with the regulatory framework in
efforts, we will be able to unleash a new era of clinical
discoveries that the industry had never seen before. order to raise standards of innovation and

Preempting the practical hurdles to comply thereby increase value for startups?
with stringent regulations and using appropriate
technology solutions can be beneficial for the In this environment, companies that preempt
companies. For example – device manufacturers, regulatory obstacles in clinical trials can gain an
with increasing frequency, are being required by FDA advantage by reducing time-to-market, creating
to implement a tracking system for certain types of significant shareholder value, and getting their drug
devices. This requires devices to be tracked from the to patients faster. In such an environment, it is not
time of manufacture through the entire distribution uncommon for startups and SMEs to be boggled
chain. The purpose of device tracking is to ensure with the regulatory obstacles with detrimental delays
that these manufacturers will be able to promptly on project timelines. In addition, the ability to use
locate devices in commercial distribution to facilitate big data to create transparency, mitigate risks in
notifications and recalls ordered by the FDA in the navigating regulatory hurdles and operating in real-
case of serious risks to health. Today, most medical time is critical for life science leaders.
device trials are still relying on manual efforts to
track devices and perform product accountability; Many solutions are now available today that can
there is a possibility of increased risk and decreased benefit an inexperienced startup or a budding SME.
regulatory compliance. Randomisation and trial The solutions, developed after years of experience
supply management solutions can be implemented to in regulatory requirements, minimise the chances
reduce that risk and address the common regulatory for risks and delays. A common theme with many of
challenges associated with medical device trials. the new regulatory requirements is data—data and
system integrity, data standards, data and evidence
How do you outline strategic transformative generation, and data transparency and traceability.
solutions in a regulatory ecosystem to deliver Electronic data collection and cloud-based data
a smarter and accelerated market access storage can immediately solve or mitigate these
regimen? issues. AI and advanced analytics can help companies
confidently manage regulatory submissions and
To evolve the regulatory ecosystem, it is significantly reduce risk. These are important
industry developments that can help companies
navigate the existing regulatory frameworks and
accelerate speed-to-market – these are a boon for
executives, employees, shareholders and most
importantly, patients in need of care.

Hithaishi C Bhaskar
[email protected]

SALARY 41

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

From Hazy to Crystal Clear
Picture of Compensation Trends

The Life Sciences industry is, indeed, growing at «
a rapid speed, with every region reporting bonuses
and salary increments, as well as a high demand Kayleigh Regan,
in recruiting new talent. With the talent market Head of EPM
becoming increasingly hot, it is critical for industry Scientific,
hiring managers and companies to stay highly Asia-Pacific
aware of compensation trends in the Asia Pacific
(APAC) region. Let’s assess the current scenario to
get a handle on ‘what’s changed’.

Compensation is always tricky to determine, enough for your preferred candidate, not only so you
both as a professional and for organisations. can hire in a timely manner, but so you can avoid
Across all markets, individuals and businesses counter offers which are increasingly happening.
regularly ask for the very latest compensation trends
to benchmark and identify where they stand in the Hong Kong
market. We have surveyed over 400 life sciences
professionals across APAC, and the results are From Q4 of 2021 to Q1 2022, Hong Kong adapted
insightful. well during the pandemic and saw a healthy recovery
despite political issues. There was a significant
Australia increase in exporting of medical and healthcare
equipment to other cities in Asia, Europe and the US.
Australia’s life sciences sector has been a long However, exports have dropped to mainland China.
success story for its economy - employing over
240,000 people and accounting for AUD 3 billion From a talent pool perspective, despite a dip in
in exports each year. The ASX-listed Australian 2021 where functional roles faced redundancies, early
life sciences sector is worth AUD 100 billion and 2022 displayed a speedy recovery in talent demands.
comprises about 100 companies. With world-leading And due to the lack of experienced life sciences talent,
medical and scientific research bases, excellent we are seeing more companies open to the idea of
institutions, a growing biotech sector, as well as an relocating talent from other countries to Hong Kong.
adaptive healthcare system, government initiatives
and strong workforce, Australia’s life sciences market According to the latest research, the Hong Kong
is remaining on track for huge potential growth. life sciences commercial market sentiment is quite
positive. More than 86 per cent of commercial
The majority of life sciences professionals in professionals in Hong Kong have received their yearly
Australia have received a 0-5 per cent salary yearly increments and bonuses. Bonuses are scattered from
increment in 2021. However, with a small talent 5 to 30 per cent, where the majority received bonuses
pool, we are seeing companies willing to offer up to between 11 and 15 per cent. On the salary increment
a 20 per cent salary increase to candidates to move
on from their existing employers. Especially with the
scarcity of talent, more counteroffers are given by
existing companies to limit leavers.

Most of the life sciences talent in Australia are
comfortable with where they are and will only move if
the opportunity is attractive enough. The advice to life
sciences professionals is to keep an eye on the market
trends and to understand the market average rate. To
hiring managers, it is highly recommended to work
closely with your talent partner to make sure your
offer is attractive to the right people and competitive

42 SAL ARY

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

As packages continuously get driven to overseas who are looking to expand into APAC.
higher numbers, observing candidate Salaries amongst Singapore’s life sciences
motivation and catering to their non-
cash needs is suggested. Companies and industry is highly competitive. As most candidates
professionals should keep close to the receive a yearly salary increment upon adjustment,
market trends and partner with a talent Singaporean professionals are swayed by noncash
specialist. Ultimately, compensation benefits when making a career switch. We find
packages are unique for each individual, candidates expecting a base salary increase of 15-20
clients and talent work with us to quickly per cent when switching. Singaporean companies
identify opportunities, knowing exactly offer flexible working hours to a high percentage
what the key drivers are for both sides. of their employees, resulting in many candidates
So individuals should stay close to the reporting that they are working longer hours on
market and keep the conversations open average because of this, which has been a common
with your talent and career partner. response with talent working from home. This in
turn, could be seen as the driving force that executive
side, more than 57 per cent of those surveyed leadership level candidates are receiving at least 21-
received an average of 6-10 per cent increments. 27 paid annual leave days to compensate.
Because of this, we are seeing a trend where more
candidates are requesting a minimum of a 20 per South Korea
cent salary increase and 15 per cent annual bonus
when they seek new opportunities. Hand in hand with South Korea’s effective
measures on controlling the spread of COVID-19, the
Malaysia health sector receives continuous support from its
government. It is predicted that from 2021 to 2027,
According to the 2022 Milken Institute Global the country will see massive growth in the In-Vitro
Opportunity Index, Malaysia ranks first in the list Diagnostics (IVD) and Respiratory segments. The
of emerging Southeast Asian countries with the biotechnology industry is growing fast, and most
highest potential in attracting foreign investment. multinational corporations are looking to hire.
However, it has yet to receive enough attention when
it comes to employment and investment from foreign South Korea’s biopharma and biotech sectors
companies compared to its neighbour Singapore. are projected to grow to $23.2 billion by 2022 and
are likely to attract foreign investment. As talent
While 50 per cent of life sciences commercial competition is high, companies provide regular
professionals in Malaysia have received a bonus, and salary increments, commission and up to 30 per cent
77 per cent have received a yearly salary increment, annual bonuses to help retain their talent. 67 per cent
both of these results are less when in comparison to of South Korean life sciences professionals earn 21-30
other APAC countries, such as Singapore. Companies per cent of their base salary in commission.
are hiring local talent, but they need to be mindful
of such hiring trends, as more and more senior Beside salary and benefits, life science hiring
level professionals are being actively headhunted to managers in South Korea should also take note
relocate to other, well-paying APAC countries. of talents’ career motivations. Newly introduced
flexible working arrangements and opportunities
Singapore to work with a company that has global exposure
continuously come up in conversation with our South
Singapore is a popular destination for Korean professionals.
international life sciences companies looking to
expand their business. Pathosmics Health, an Looking forward
advanced precision medicine diagnostics & digital
healthcare solutions company, announced its As packages continuously get driven to higher
expansions on laboratory operations in Singapore. numbers, observing candidate motivation and catering
Hilleman, a Delhi-based vaccine research group, also to their non-cash needs is suggested. Companies
recently announced that it has begun construction and professionals should keep close to the market
to open a plant in Singapore. Singapore is an ideal trends and partner with a talent specialist. Ultimately,
location as a regional hub for most companies compensation packages are unique for each individual,
clients and talent work with us to quickly identify
opportunities, knowing exactly what the key drivers
are for both sides. I highly recommend individuals to
stay close to the market and keep the conversations
open with your talent and career partner.

PEOPLE NEWS 43

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com Prof. Lyu Aiping

2022 Tang Prize honours becomes
scientists for developing
COVID-19 mRNA vaccines Foreign Member

After the 2014 and 2016 winners for the Tang Prize in Biopharmaceutical of Academia
Sciences were crowned the Nobel Prize in 2018 and 2020 respectively, this
category has continued to garner much attention worldwide. This year’s Europaea
award went to three scientists who played a critical role in the development
of SARS-CoV-2 mRNA vaccines: Katalin Kariko (a Hungarian-American Professor Lyu Aiping, Dr
biochemist), Drew Weissman (an American physician-scientist), and Kennedy Y.H. Wong Endowed
Pieter Cullis (a Canadian physicist and biochemist), for the discovery Professor in Chinese Medicine
of key vaccinology concepts and approaches, leading to the successful and Dean of the School of
development of mRNA-based COVID-19 vaccine. While Dr Kariko and Chinese Medicine at Hong
Dr Weissman found a way to reduce the immunogenicity of mRNA, Dr Kong Baptist University
Cullis is credited with designing lipid nanoparticles for the delivery of (HKBU), has been elected
mRNA vaccines. Dr Samuel Yin established the Tang Prize in December as a Foreign Member of the
2012 in Taiwan. It consists of four award categories, namely Sustainable Academia Europaea in 2022
Development, Biopharmaceutical Science, Sinology, and Rule of Law. in recognition of his sustained
academic excellence in systems
Prof. Jun YU receives China’s medicine. Founded in 1988,
most prestigious honour in S&T the Academia Europaea is
the pan-European Academy
Professor Jun YU, Choh-Ming Li Professor of Medicine and of Sciences, Humanities
Therapeutics and Assistant Dean of The Chinese University of Hong and Letters. Professor Lyu’s
Kong (CUHK)’s Faculty of Medicine (CU Medicine) received the 14th research interests focus
Guanghua Engineering Science and Technology mainly on translational
(S&T) Award from the Chinese Academy of research in Chinese
Engineering for her distinguished achievements medicine, including the
in and contribution to gastrointestinal cancer pharmacological and clinical
studies. The biennial award is regarded as the evaluation of rheumatoid
most prestigious award in Chinese engineering arthritis with re-classification
science and technology and engineering and interventions, and the
management. Professor Jun YU is an expert development of new drugs
in gastroenterology research. She joined the based on Chinese medicines.
Department of Medicine and Therapeutics Notably in the field of
at CU Medicine in 2005, and is currently the bone and joint diseases,
Director of the Institute of Digestive Disease, Prof. Lyu has outstanding
the State Key Laboratory of Digestive achievements in precision
Disease and the Research Laboratory of the medicine research focusing
Institute of Digestive Disease. on disease reclassification
and combination therapy
based on the concepts of

traditional Chinese medicine
and modern science and
technology.

44 PEOPLE NEWS BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Sanofi India Ascletis picks industry
appoints Preeti veteran John P. Gargiulo
Futnani as GM, as Chief Business Officer
Vaccines
Ascletis Pharma Inc. has years of successful experience in
Sanofi India has announced announced the expansion of marketing strategies, business
the appointment of Preeti its management team with the integration and commercial
Futnani as the Company’s appointment of John P. Gargiulo, operations in the global pharma/
General Manager (GM) – former North America President biotech industry. He has held
Vaccines, with effect from and Chief Executive Officer various senior positions with
June 1, 2022. Her transitions (CEO) of Daiichi Sankyo, as increasing responsibility for
from Sanofi’s Greater Gulf Chief Business Officer. Gargiulo 18 years at Daiichi Sankyo,
MCO (a cluster of six countries will lead Hong Kong-based where he made a transformative
including Saudi Arabia, the Ascletis’ corporate business contribution in driving Daiichi
UAE, and Kuwait) where development and alliance Sankyo’s U.S. business from the
she was the Franchise Head management in this new role and very beginning to an established
for Dupixent Dermatology. report to Dr Jinzi J. Wu, PhD, pharma when he served as North
Preeti has over two decades Founder, Chairman and CEO of America President and CEO of
of experience in delivering Ascletis. Gargiulo has over 30 Daiichi Sankyo.
growth and transformation
that spans several therapeutic Insilico Medicine appoints
areas and functions within Dr Feng Ren as co-CEO
healthcare (primary and
speciality care, medical Hong Kong and US-based Insilico Medicine, a global clinical-stage
technology) and finance. She artificial intelligence (AI)-powered drug discovery and development
started her journey with Sanofi company, has announced the appointment of Dr Feng Ren as a co-
over six years ago in Specialty Chief Executive Officer (CEO). Dr Ren is currently Insilico Medicine’s
Care Gulf, after various roles Chief Scientific Officer and Head of Global Research and Development.
of increasing responsibility He will retain those titles following the appointment and will also
in Novartis marketing and oversee clinical development with full control over discovery,
commercial operations across development, and infrastructure. In addition, he will further drive
Switzerland, the UK, and Insilico’s business development in the new role. The appointment
India. She has held leadership solidifies Insilico’s commitment to both artificial intelligence and drug
roles in marketing, sales, and development. Alex Zhavoronkov, Ph.D., will continue to serve as CEO
management across several and focus on global expansion and next-generation AI
geographies from mature platforms while Dr Ren will drive the company’s
markets in the UK and the EU drug development efforts. After obtaining
to emerging markets in Asia a Ph.D. in organic chemistry from Harvard
and the Middle East. Preeti University, Dr Ren spent 15 years in drug
succeeds Annapurna Das, discovery and development in the healthcare
who is elevated to Head of industry, including with a top multinational
Vaccines, Asia. Preeti will be pharmaceutical company and a global contract
based in Mumbai. research organisation (CRO). He joined Insilico
Medicine from Medicilon, a global CRO, where
he served as Senior Vice President and Head of
Drug R&D, leading the chemistry and biology
departments. Prior to joining Medicilon,
Dr Ren served in various drug discovery
leadership roles at GlaxoSmithKline
(GSK) in both Philadelphia and Shanghai.

R&D NEWS 45

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Australia develops digital Japan conducts
tool to give surgeons a
pre-theatre rehearsal COVID-19 research

Researchers at Australia-based University of Sydney’s using bronchial
School of Aerospace, Mechanical and Mechatronic
Engineering are developing a surgical planning tool organoids
to assist surgeons in planning complex jawbone
reconstruction procedures using new generation devices. A group of researchers at Kyoto University,
Using advanced computational technology and decision- Japan has developed two in-vitro models to
making algorithms, the tool works by generating a study SARS-CoV-2, a bronchial-organoids
‘digital twin’ of the model (BO) and a BO-derived air-liquid
patient using CT interface model (BO-ALI), and showed
scan data. It then that they can be used for drug screening for
rapidly simulates infectious diseases including COVID-19. An
different designs of in vitro lung model that faithfully reproduces
the implant before the human respiratory organ is essential for
3-D printing the conducting COVID-19 drug screening. BO
final, optimal design, and alveolar organoids are excellent tools for
allowing surgeons faithfully mimicking the human respiratory
to perform a digital organ and are expected to be applied to
‘rehearsal’ prior to COVID-19 research. In this study, the research
theatre. Jawbone reconstruction or orthognathic surgery team developed two human bronchial models,
is a complicated medical procedure whereby a person’s BO and BO-ALI. SARS-CoV-2 infection
jaw is treated for significant trauma, such as from a car experiments confirmed that the infection
crash or gunshot wound, or diseases like oral cancer. efficiency in BO-ALI was more than 2,000
The surgical planning tool combines computer-aided times higher than that in BO. The researchers
design (CAD) tools with high-fidelity computer-aided confirmed the anti-viral effect of therapeutic
engineering models and optimisation algorithms that agents such as remdesivir, molnupiravir, and
can accurately simulate the medical device while under camostat, using BO-ALI. Comparative analyses
physiological load. of eight SARS-CoV-2 variants, including the
omicron strain, showed that the infection
efficiency in BO-ALI of the Omicron was
slightly lower than those of the other variants.

Singapore enables doctors to optimise
personalised chemotherapy dose

A team of researchers from trial, called PRECISE.CURATE, metastatic colorectal cancers,
National University of Singapore involving 10 patients in Singapore clinicians accepted close to 97 per
(NUS), in collaboration with who were diagnosed with advanced cent of doses recommended by
clinicians from the National solid tumours and predominantly CURATE.AI, with some patients
University Cancer Institute, receiving optimal doses that
Singapore (NCIS) which is were approximately 20 per cent
part of the National University lower on average. CURATE.AI
Health System (NUHS), has is an optimisation platform that
reported promising results in harnesses a patient’s clinical data,
using CURATE.AI, an artificial which includes drug type, drug
intelligence (AI) tool that identifies dose and cancer biomarkers, to
and better allows clinicians to generate an individualised digital
make optimal and personalised profile which is used to customise
doses of chemotherapy for the optimal dose during the course
patients. Based on a pilot clinical of chemotherapy treatment.

46 R&D NEWS

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

India develops footwear to help
prevent diabetic foot complications

Researchers in the Department may lead to complications that developed by the IISc-
of Mechanical Engineering, require amputation in extreme led team is 3D printed
Indian Institute of cases. The footwear, a pair of and can be customised
Science (IISc), in specially-designed sandals,
collaboration with the to an individual’s foot
Karnataka Institute dimensions and walking
of Endocrinology and style. Unlike conventional
Research (KIER), have therapeutic footwear, a
developed a set of snapping mechanism in
unique self-regulating these sandals keeps the feet
footwear for persons well-balanced, enabling
with diabetes. Foot faster healing of the injured
injuries or wounds in region and preventing
persons with diabetes heal at injuries from arising in other
a slower rate than in healthy areas of the feet. The team
individuals, which increases is collaborating with startups
the chance of infection, and Foot Secure and Yostra Labs to
commercialise their product.

Korea gives new hope to New Zealand focuses
patients suffering from
chronic shoulder pain on risk-prediction tool

A research team at Pohang University of Science and for asthma patients
Technology, South Korea has developed a complex tissue
platform that can restore damaged rotator cuffs through a A project to develop a real-time risk-
joint study with Harvard Medical School. Tissue-specific prediction tool that takes information
extracellular matrix bioink is used to 3D-bioprint this from the environment and smart devices
and uses it to help patients predict asthma
platform, which can accurately attacks is one University of Auckland (New
mimic the complex structure of Zealand) project to gain a Health Research
rotator cuffs. This research outcome, Council (HRC) Emerging Researcher First
which can give new hope to patients Grant. School of Pharmacy senior clinical
suffering from chronic shoulder research fellow Dr Amy Chan is getting the
pain, was recently published in project under way with $249,984 over three
the international journal Bioactive years from the HRC to develop the model.
Materials. The research team In the first stage, Dr Amy Chan will work
transplanted this platform to rats out an algorithm that draws on data from
with full-thickness tears of the rotator mobile phones and devices, such as smart
cuffs, and observed regeneration watches. These could include step counts,
of their tissues and shoulder sleep patterns, breathing rate, medication
function recovery. As a result, it was use, peak flow and weather information.
confirmed that this platform, which includes stem cells, An important part of the research will be
can indeed regenerate rotator cuffs. Notably, the team ascertaining what information is most
succeeded in visualising this process by using near- predictive of the risk of asthma attacks.
infrared fluorescence imaging coupled with tissue-specific Dr Amy Chan will also seek feedback from
bioimaging agents. With this, the researchers were able to patients, clinicians and health providers.
monitor anatomic change and regeneration processes in She will then test the prediction tool by
the animal model in real time in a non-invasive manner. integrating it into a smartphone app and
testing it in a clinical trial.

ACADEMICS NEWS 47

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com GenScript

Korea designs master’s Biotech
degree to strengthen
competitiveness in AI collaborates

With the digital transformation accelerating across many industries with Singapore
including healthcare, medical, biotech, finding digital experts
equipped with the right practical skills in the new fields, such as Institute of
artificial intelligence (AI), has become a pressing task. KT, a leader
in strengthening Korea’s AI competitiveness and cultivating human Technology
resources in the digital sector, has announced that it will work with
Pohang University of Science and Technology (POSTECH) to raise GenScript Biotech and the
AI experts together. Based on this partnership, the KT-POSTECH Singapore Institute of Technology
AI Expert Programme will enroll its first class of students in 2023. (SIT) have signed a Memorandum
The programme is a full-time master’s degree curriculum linked with of Understanding (MoU) to
job opportunities. In the second half of this year, the programme develop Continuing Education and
will begin accepting applications from (prospective) candidates who Training (CET), work-study degree
have completed their bachelor’s degrees at home and abroad. Based programmes and explore applied
on a customised curriculum, the students will be taught key areas research project opportunities.
of artificial intelligence, including voice recognition, voice synthesis, This partnership allows students
natural language processing, graphics, and computer vision. KT will from SIT to gain global exposure
provide registration and tuition fees and research stipend for the in biotechnology and equip them
entire period of the programme for the enrolled students. with industry-relevant skills.
Under the agreement, GenScript
India announces MTech programme will provide internship, full-
in ophthalmic engineering time employment, industry
networking and field service
Centre for Interdisciplinary Program (CIP), Indian Institute of project opportunities for SIT
Technology, Hyderabad (IIT-H), in collaboration with the LV students across several disciplines.
Prasad Eye Institute (LVPEI), is launching a blended Master of As a global biotechnology
Technology (MTech) programme in Ophthalmic Engineering company, GenScript will leverage
through their combined expertise in ophthalmic care and its extensive network and deep
engineering and technology from this academic year (August expertise to provide SIT students
2022). The collaborative MTech with opportunities to gain solid
programme aims to bridge the gap real-world experience. Through
between clinicians and medical the collaboration, SIT students
practitioners working in eye care will gain opportunities to work
with qualified technologists from in GenScript China or Singapore,
related engineering streams. The allowing them to gain a greater
programme intends to create a pool understanding of the global
of qualified ophthalmic engineers biotechnology industry, and
who could take up the pressing develop effective interpersonal
challenges in eye care and develop skills and behaviours to work in a
technology products. This unique, cross-cultural setting. SIT students
promising programme is expected will also have opportunities to
to create professionals who can take up technology challenges in network and establish professional
ophthalmology as a startup. The programme is ideal for medical contacts within the sector, and
school graduates, ophthalmologists, optometrists, and engineers emerge industry-ready when they
interested in advancing their careers in areas of technology-enabled graduate.
eye care and vision science. The programme requires the students to
complete 52 credits across two years, consisting of two semesters in
the first year with 14 credits/semester.

48 SUPPLIER NEWS

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Waters unveils high resolution mass spec products

Waters Corporation has unveiled source for the high-resolution System to confirm the nucleic
new instruments, software and Waters SELECT SERIES Multi- acid sequence of therapeutics
product enhancements to drive Reflecting Time of Flight (MRT) and identify impurities that
drug discovery and development. mass spectrometer. The new could compromise product
The products include the Xevo G3 QTof system is a high- safety and efficacy. The Waters
new Xevo G3 quadrupole SELECT SERIES MRT System is
time-of-flight (QTof) performance, benchtop now compatible with UPLC-MS
mass spectrometer, mass spectrometer for with an available electrospray
CONFIRM characterising and quantifying ionisation (ESI) source. Coupling
Sequence - a new molecules in applications such the high resolution MRT System
oligonucleotide as biotherapeutics, forensics, with the ESI source enables
sequencing metabolite identification, scientists to accurately resolve
confirmation app and measure low (<200 ppb)
for the waters_ metabolomics and concentrations of sample analytes
connect software extractables and at UPLC acquisition speeds
platform and leachables. The CONFIRM for metabolomics, metabolite
an electrospray Sequence app on the identification or peptide mapping
ionisation waters_connect software applications.
platform helps scientists
using a Waters LC-MS

Agilent launches Thermo Fisher improves
proteomics research productivity
oligonucleotide
Thermo Fisher Scientific Inc. is helping proteomics
analysis software for researchers increase productivity and free up time for
more value-added activities when generating high quality
biopharma research samples for analysis, using a new automated sample
preparation system that integrates within any LC-MS
Agilent Technologies has announced the workflow. The Thermo Scientific AccelerOme Automated
release of its MassHunter BioConfirm Sample Preparation Platform eliminates the need for
12.0 software, which now supports data
generated by Agilent high-resolution LC/ labour-intensive,
MS for oligonucleotide purity analysis and manual sample
sequence confirmation. Agilent MassHunter preparation for
BioConfirm 12.0 software introduces LC-MS analysis,
enhancements to existing capabilities including the
for protein analysis and adds support for associated method
oligonucleotide analysis. The addition of development and
oligonucleotide support significantly extends reagent sourcing.
the capabilities of MassHunter BioConfirm, This allows users
adding critical functionality for assessing to focus on higher
oligonucleotide purity and sequence value tasks.
confirmation – important analytical Automated sample
steps in the use of oligonucleotides for preparation also
biotherapeutics and vaccine research overcomes the challenge of maintaining reproducibility
and development. The new MassHunter with manual methodologies, and the new platform’s
BioConfirm 12.0 workflows allow pre-built validated methods and kit format reagents
researchers to identify full-length products further reduce any risk of user error. The resulting peptide
and potential impurities. The innovative samples are of consistent high-quality. A novel built-in UV
MS/MS-based sequence confirmation measurement of final peptide concentration prior to LC-MS
enables confirmation of oligonucleotide analysis allows the standardisation of sample peptide input
sequences in minutes instead of days or for LC-MS analysis, another metric that adds to the quality,
weeks of manual interpretation. reliability and robustness of the final experimental result.

SUPPLIER NEWS 49

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

PerkinElmer brings BioQule Eppendorf
NGS System to automate
library preparation opens pipette

PerkinElmer has launched the research use only (RUO) BioQule NGS lab, service
System – an automated benchtop solution for next-generation sequencing
(NGS) library preparation of up to eight samples. By incorporating hub in India
automated thermocycling, integrated quality control through optical
quantification and robust liquid handling technology into a single device, Eppendorf India has
the BioQule NGS System enables researchers to produce high-quality NGS inaugurated a Sophisticated
libraries that yield reliable, reproducible results in a variety of applications Pipette Laboratory and
requiring genomic analysis. Unlike existing solutions for NGS library Service Hub (SPLASH)
preparation, which are expensive and rely on external solutions to at its facility in Ambattur
perform concentration measurements Industrial Estate, Chennai.
on their libraries, the The state-of-the-art, world-
BioQule NGS System class pipette calibration
provides in-built facility of 1700 sq ft has
quantification of several first-in-India
the NGS libraries features. The facility can
it creates. Methods calibrate up to 100,000
and kits used with the pipettes in a year. With
BioQule NGS System eight workstations, the
are predeveloped Turnaround Time (TAT) will
and pre-verified, and be reduced substantially.
the entire system can The facility houses, for the
be installed, set up and run by the user first time in India, ‘Speedcal
without any specialised vendor support. In addition to its simple mobile’ the multichannel
design and walk-away automation capabilities, the BioQule NGS System pipette calibration balance.
expands opportunities in NGS library preparation by requiring as little The calibration happens
as 10 ng of starting material to create libraries, while others require 50 the same way as the
ng or more. PerkinElmer currently offers two DNA library prep kits that pipettes are used in the
are automated on the system – the NEXTFLEX Rapid XP DNA-Seq Kit laboratory. SPLASH also
and the NEXTFLEX Rapid DNA-Seq Kit 2.0. Additional library prep kits houses the tools’ calibration
compatible with BioQule NGS System are currently in development. for epMotion, Eppendorf
automated liquid handling
workstations.

Shimadzu releases high-performance LC-MS-2050

Japan-based Shimadzu systems are easier to use and less in this field. To ensure
Corporation has announced expensive than triple quadrupole user friendliness even for
the release of the LCMS- LC-MS systems, so they have inexperienced users, the LCMS-
2050 high-performance been in strong demand, and 2050 can be controlled via
liquid chromatograph mass the international Shimadzu’s LabSolutions analysis
spectrometer (LC-MS). This market is growing
single quadrupole LC-MS by at least 5 per software, which
achieves user friendliness, cent annually. is highly
heightened basic performance, Shimadzu regarded for
and a compact design. Shimadzu entered the single its usability,
is aiming to double LC-MS unit quadrupole LC-MS thereby
sales by acquiring a wide range market in 1997 and achieving
of first-time LC-MS system has become the ready access on
users. Single quadrupole LC-MS top manufacturer par with an LC
system.

50

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Multipronged Approach to
Treat Parkinson’s Disease
Globally, the prevalence of Parkinson’s disease
(PD) has doubled in the past 25 years with Looking at the situation, in May 2022, the World
global estimates in 2019 showing over 8.5 Health Assembly endorsed the Intersectoral global
action plan on epilepsy and other neurological

million individuals living with PD. Disability and disorders 2022–2031. The action plan will

death due to this degenerative brain condition address the challenges and gaps in providing

are increasing faster than any other neurological care and services for people with epilepsy and

disorder. Current estimates suggest that, in 2019, other neurological disorders such as PD that exist

PD resulted in 5.8 million disability-adjusted life worldwide and ensure a comprehensive, coordinated

years, an increase of 81 per cent since 2000, and response across sectors. This includes raising

caused 329,000 deaths, an increase of over 100 policy prioritisation and strengthening governance,

per cent since 2000, according to a World Health providing effective, timely and responsive diagnosis,

Organisation (WHO) report. treatment and care, implementing strategies for

Despite the significant impact of PD, there promotion and prevention, fostering research and

is inequality in the availability of resources and innovation and strengthening information systems.

services to provide treatment and care especially And on June 14, 2022, the WHO also released

in low-and middle-income countries (LMIC). The a technical brief entitled ‘Parkinson disease: a

WHO Neurology Atlas (2017) provides estimates of public health approach’ for policy-makers, health

0.03 neurologists per 100,000 population in low- programme managers and planners, healthcare

income countries and 4.75 per 100,000 population providers, researchers, people with PD, carers and

in high-income countries. other stakeholders. As with many degenerative

In 2017, PD was estimated to cost $52 billion per neurologic disorders, nonpharmacological
year in the USA, which will continue to increase as management such as rehabilitation can offer

the incidence and prevalence of PD rise. Large scale, relief. Specific types of physiotherapy including

rigorous economic data on the cost of PD in LMIC is strength training, gait and balance training,

lacking. Despite substantial development of drugs to and hydrotherapy can help improve functioning

treat PD, none have proven to be effective in slowing and quality of life for people with PD and other

progression. movement disorders. They can also reduce the strain

Levodopa remains the most effective drug for on carers. Telemedicine can also be used to increase

improving most motor and various non-motor the access to care for people with PD.

symptoms of PD and for improving functioning Risk factors for PD include increasing age,

and quality of life, although it cannot halt the although younger people can be affected as

neurodegenerative process. Data on the potential well. Men are more affected than women. As

causes of PD and opportunities for risk reduction the prevalence of PD is increasing globally, it

are, however, accumulating. The possible causes is a challenge to many populations. Political

include environmental (e.g.: exposure to pesticides, commitment will be required to develop strategies,

solvents and air pollution throughout life) and programmes and services that are effective for

genetic risk factors (e.g., LRRK2 polymorphisms or people with PD and their families and carers.

mutations). Levodopa is on the WHO Model Lists of The key actions identified in the technical

Essential Medicines. brief released by WHO: global health policies to

According to CenterWatch.com there are 13 implement PD strategies; advocacy and awareness-
drugs that received approval by the Food and raising; prevention and risk reduction; ensuring

Drug Administration (FDA) for sale in the United the availability of basic drugs and interdisciplinary

States for PD. They include Apokyn, Comtan, therapies such as rehabilitation and palliative

Duopa enteral suspension, Exelon Patch, Gocovri, care; strengthening health and social systems and

Kynmobi, Mirapex, Neupro, Nourianz, Nuplazid, building capacity; and research on PD, will go a long

Ongentys, Rytary extended-release capsules and way in bringing some relief to people with PD.
Xadago. However, many medications and surgical Narayan Kulkarni

resources are not accessible, available or affordable Editor

to all the needy. [email protected]