BioSpectrum Asia - 01 July 2022

52 Pages·2022·48.1 MB·English

www. biospectrumasia.com

the business of J Bio & Health Sciences

How Is BioManufacturing

Driving CDMO Market?

ry

tay il a Ni

ST EL

it

“° 2. ce
n = — SS ES SS SS. =. SS = 2 a ia 5 =
! = J i= 7 > i = ge —— =a. o ———— ———— : ™ Eee =a re i ¢ - am i r L =. .
= ed ee — - - = i — af Sie — ac Ge pie — all, — at a Sk ee oe re et ine
= = Te = = a —_ = an, = =
7 =n ‘el a rT. i cs Ye DB h Bb "tx ¥
7 k ‘f i By "|S Pe
| } | ] Se i a
= = = = 2 2 = 2 | » <i = 2 a = =
, y . ~ oh, io

"Regulatory bottlenecks such as local QC testing and pre-approval of GMP inspections must go"
- Eileen Ang, Head of Regulatory Affairs, Takeda APAC - 37

Is Biotech Headed for Bear Run? - 16

BioSpectrum is an MM ALTA publication; MCI (P) 020/06/2022
Superb Performance,
Flawless Reliability

Your Reliable Choice for Cargo Services

EVA Air Cargo has upgraded shipping capacity by adding more Boeing 777 freighters to our fleet.
We deliver rapid, secure, on-time and reliable cargo services
through our extensive route network.

EVA AIR Cargo

Visit www.breargo.com for routes, reservations and tracking information.
PlasmidFactory

The Minicircle Company

High Quality Grade
Plasmid and Minicircle DNA

“ ae

Rr oS yy i
met g

= a

'
Now ‘e n LARGE scales
“Starting material for
“GMP production of mRNA,

“viral ‘vectors be CAR- T cells

a ‘

PlasmidFactory.com

PlasmidFactory GmbH & Co. KG
MeisenstraBe 96 | D-33607 Bielefeld | Germany | Fon [phone]
BIO EDIT

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

GREEN LIGHT TO
MEDICAL MARIJUANA

[Pest has decriminalised marijuana for medical and other purposes. It is

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
Dr Milind Kokje severe weight loss. In addition, cannabinoids are helpful in managing chronic pain, aid
Chief Editor insomniacs to sleep and treat two types of severe epilepsy among children. More research
[email protected] i ; ‘ : , ‘ :

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.
BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

BIO MAIL

Bi
Targeting Optimal
Drug Delivery

ASIA EDITION

Acknowledgements
I would like to thank you for giving me
an opportunity to publish my article on
behalf of the National Institution for
Transforming India, better known as NITI
Aayog, in BioSpectrum and reach a wide
audience. Iam very much satisfied with
the current coverage and look forward to
publishing more with your publications.

- Ranjan Das, India

Both the print and online versions of the
Abcam interview look fantastic — thank
you so much for covering this story. The
team is delighted. Looking forward to
working with you again in the future.

- Alex Bannister, UK

The Bayer team is really happy with
the coverage. Thank you so much
for the interview with the newly
appointed Bayer Pharmaceuticals Head
of Commercial Operations for Asia-
Pacific, Dr Ying Chen.

- Ambuja Kashyap, India

Thank you so much for an interview
feature with OnQuality Pharmaceuticals.
It looks fantastic. We look forward to
working with you again soon on other
stories.

- Ignacio Guerrero-Ros, PhD, US

Vol 17; Issue 7; July 2022
Publisher & M: ing Editor:
avindra B. oc MM Activ Singapore Pte. Ltd.

Ravindra Boratkar
Editorial:

Chief Editor: Dr Milind Kokje Singapore

[email protected]

Advisor - Content: Vijay Thombre

Editor: Narayan Kulkarni

[email protected]

MM Activ Singapore Pte. Ltd.
Saradha Mani

General Manager

#08-08, High Street Centre,

1 North Bridge Road, Singapore - 179094

Executive Editor: Dr Manbeena Chawla Tel: [phone] / Fax:[phone]
[email protected] Mobile: [phone]

Sub Editor: Nitesh Pillai
[email protected]

[email protected]

Asst. Manager Content Creation 2 ; ;
and Coordination- APAC Region: Asia Pacific & South East Asia

Hithaishi C. Bhaskar
[email protected]

Ankit Kankar
DY. General Manager

Social Media Communications: Digital Intell. & Growth

Ankit Kankar
[email protected]

ist Floor, CIDCO Convention Center,
Sector 30A, Vashi, Navi Mumbai,

CFO & Special Correspondent: Maharashtra-400703.

Manasee Kurlekar

[email protected]

Operations and HR
Asmita Thakar

[email protected]

Mobile: [phone]
[email protected]

USA
Production & Design: BioSpectrum Bureau
MM Activ Sci-Tech Communications MM Activ Sci-Tech Communications
Anil Walunj Mobile: [phone]

Cover Design:

[email protected]

Dominix Strategic Design Pvt. Ltd.

Business Enquiry:
Ankit Kankar
[email protected]

Subscription Services

Print Edition: Saradha Mani
[email protected]

Europe

BioSpectrum Bureau

MM Activ Sci-Tech Communications
Mobile: [phone]
[email protected]

Digital Edition: Ankit Kankar

[email protected]

News Letter : Sudam Walekar
[email protected]

Database Executive: Sudam Walekar

Subscription Services:
Apoorva Mahajan

[email protected]

Bio Spectrum Jobs:
Poonam Bhosale

on behalf of MM ACTIV Singapore Pte Ltd.

Printed at Times Printers Private Limited
16 Tuas Avenue 5, Singapore 639340
Tel : [phone]

[email protected] Reprinted in India for private Circulation

Printed and published by Ravindra Boratkar

Taiwan

Media Representative:

Ms Christine Wu

Image Media Services Company
2F-2, No. 35, Sec. 2, Flushing South Road,
Taipei 10665, Taiwan

Tel: [phone]
Fax:[phone]

Mobile: [phone]

E-mail: [email protected]
website: www.imagemediatw.com

China

Erika Cheng

RFCOMMS

E101, East Lake Villas, 35 Dongzhimenwai
Main Street, Dongcheng District,

Beijing 100027, P. R. China

Mobile: [phone]

E-mail: [email protected]

India

Apoorva Mahajan

Key Account Executive

“NITON’, Block B, First Floor,

11/3, Palace Road, Bangalore 560001
Tel: [phone]

Mobile: [phone]
[email protected]

Photo: Shutterstock

Go Digital:

To request subscription
email: [email protected]

Chief Editor: Dr Milind Kokje
MCI (P) 020/06/2022

Copyright:
MMaActiv Singapore Pte Ltd.
— BIO CONTENT

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

rf cover storY fj

ee u/ |
AY,
UW UL

rm ity

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

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

16 3/

Is Biotech Headed for Bear Run? “Regulatory bottlenecks
such as local QC testing
and pre-approval of

CDMO GMP inspections must go”

Eileen Ang,
? 6 Head of Regulatory Affairs,
Takeda APAC

Why Indian Pharma Must Evolve As ‘Value Creator’ 2 9

“Leveraging big data

MYOPIA to create transparency,
r mitigate risks and operate
in real-time is critical”

Edwin Ng,

Senior Vice President,

General Manager (Asia-Pacific),
Medidata Solutions

A]

Eschewing Myopic From Hazy to Crystal
Attitude Towards Eye Health Clear Picture of
Compensation Trends

Kayleigh Regan,
Head of EPM
Scientific, Asia-Pacific

SPEAKING WITH

33

REGULARS
“Obstructive Sleep Apnea 4
brings about a severe BiOECit..cccscsccssseccssssseessssecsvssseessvsseeesesseneestevee 04
economic burden on ;

f Ce 05
the country
Carlos Montiel, Policy and Regulatory NEWS... 08
Vice President: Latin America, Company NEWS u.....cssssecsesssssseesssssseesssssssessssssssesseees 10

and South Asia, ResMed
Finance News

TULLE EUROPEU CLUE CUCEL CECE OCOEC

3 5 Start-Up NOWS ....ccccccccccccccecsccsseessetetecsetetsesesesenseees LS
World NWS ou. ecssescessecseestesseesecseessessecsnecueanecteeanenneenes 15
“Spending on TB control People NOWS......eeceeescesseeesseessieesnesssnssnieseseneeens 43
programmes had dropped = R&D NOWS varccesccssssessesssinstsnenivesstesinnsttnnnenvetee 45
to 201 6 levels in 2020 and = ACAGEMIC NEWS. .vvscccssessessssesssessssseevesessssenssseeeee 47
remains unchanged :
Patrick Che, = Supplier NEWS oo... cece testes es teeteseeseesteeneenees 48
Sales Development Manager, : Lets Talk Healt ooo... cece cee cee ieseesseeeneeeiee 50

Te

QuantiFERON, South East Asia, QIAGEN

THC eee

7]
REGULATORY NEWS

Australia recommends COVID-19

booster for eligible 12-15 year old

People aged 12 to 15 who are at
most at risk of severe disease
are recommended to receive a
COVID-19 booster vaccination
from June 14, 2022. The
government has accepted advice
from the Australian Technical
Advisory Group on Immunisation
(ATAGI) to make a booster

dose of the Comirnaty (Pfizer)
COVID-19 vaccine available to
around 120,000 children aged
12-15 years old, who are most

at risk of severe disease. To be
eligible for a booster dose, the

children must have completed a
primary course of vaccination 3 or
more months ago, and meet one
or more of the criteria such as be
severely immunocompromised;
have a disability with significant
or complex health needs; have
complex and/or multiple health
conditions that increase the risk
of severe COVID-19. ATAGI is not
recommending a booster dose for
all adolescents aged 12-15 years

at this stage. Evidence shows
otherwise healthy adolescents who
have received two primary doses

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

of a COVID-19 vaccine remain
well protected against severe
disease. The recommendation
only applies to the Comirnaty
(Pfizer) booster. Other vaccines
such as Spikevax (Moderna) and
Nuvaxovid (Novavax) are not
registered for use as a booster for
this age group.

Hong Kong opens Centre
for Eye and Vision Research

At the forefront of the population’s health and aging
imperative and with its mission of generating innovative
technologies and unique solutions designed to prevent
vision loss and preserve healthy vision, the Centre for Eye
and Vision Research (CEVR) has announced its official
launch. It is the first global hub to conduct ground-breaking
research in five key areas — myopia and eye growth, ocular
drug discovery and delivery, vision enhancement, tear film
and ocular surface, and advanced optometric technology.
Supported by InnoHK, the flagship innovation and
technology initiative of the HKSAR Government, CEVR is
committed to becoming a global leader in eye and vision
research as well as a magnet for attracting and training elite
researchers, harnessing Hong Kong’s research expertise
and entrepreneurial ecosystem. With the collaboration
between the Hong Kong Polytechnic University (PolyU)
and the University of Waterloo (UW) in Canada, CEVR
represents a significant step in enhancing the research
capacities and innovation applications aimed at addressing
eye and vision health challenges, by bringing together
multiple scientific disciplines based on the excellent
credentials of two leading academic institutions in vision
science and eye health research.

South Korea
approves Agilent’s
diagnostic platform
for NSCLC patients

Agilent Technologies Inc. has announced that
the South Korea Ministry of Food and Drug
Safety (MFDS) has approved the company’s
PD-Li IHC 22C3 pharmDx as a companion
diagnostic (CDx) to identify patients with
non-small cell lung cancer (NSCLC) who

are suitable for first-line monotherapy

with KEYTRUDA (pembrolizumab) on

the Dako Omnis platform. This marks the
third approval of the CDx for Agilent in the
context of treatment with KEYTRUDA to
enable metastatic NSCLC patients’ access

to targeted immunotherapy for improved
patient outcomes. Dako Omnis is Agilent’s
fully automated solution for staining tumour
samples that supports lean and flexible
workflows integrated into the core of the
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.
BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

REGULATORY NEWS

Singapore launches new
centre to strengthen
pandemic preparedness

Leveraging the research, collaborations and
commercialisation successes that have contributed to
Singapore’s fight against the COVID-19 pandemic, Duke-
NUS (National University of Singapore) has launched

a new centre to further strengthen regional research
capacity, cooperation and preparedness against future
pandemics and public health threats. Deputy Prime
Minister and Coordinating
Minister for Economic Policies
Heng Swee Keat joined some 100
guests at the launch of the Centre
for Outbreak Preparedness

or COP. Introducing the new
Centre, its director Professor
Paul Pronyk highlighted that the
Centre will leverage Duke-NUS’
strong partnerships around

the world, with particular focus on research institutes

in South and Southeast Asia to increase the region’s
research capacity and capabilities. In addition to its close
ties with Duke-NUS’ parent university, the National
University of Singapore, the Centre will also work closely
with Singapore government agencies and key partners
such as Singapore’s National Programme for Research
in Epidemic Preparedness and Response (PREPARE),
A*STAR’s Bioinformatics Institute (BID), the National
Centre for Infectious Diseases (NCID) and the World
Health Organisation (WHO).

India renews MoU
with Bill & Melinda
Gates Foundation

The Department of Biotechnology (DBT),
Government of India and the Bill & Melinda
Gates Foundation have renewed the
Memorandum of Understanding (MoU),
originally signed in 2012, to support
innovative approaches for developing new
preventions, therapies and interventions
needed to solve health (human and animal),
food and nutritional inequities on June

7, 2022 in New Delhi. The renewed MoU
pledged a combined $50 million investment
to the joint initiative, to continue to explore
and expand funding arenas and mechanisms
to support innovators, focused on early-mid
stage research and product development

to tackle health and developmental issues.
The event also saw the announcement of the
latest open call for funding on Diagnostics for
Neglected Tropical Disease (NTD)- Lymphatic
Filariasis (LF). The call focuses on developing
point-of-care, novel cost-effective diagnostics
for lymphatic filariasis for use in national
Lymphatic Filariasis elimination programs.
The goal of this challenge is to have a
reasonably inexpensive, durable and accurate
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
national survey on substance
use by the Taiwan Food and
Drug Administration (TFDA)
done once every four years, the
lifelong prevalence rate of drug
abuse in 2018 was 1.15 per cent
(aged 12-64 years). There were
about 204,000 people who had

prevention, how to recognise
illegal drugs, how to refuse use

of drug and community teaching
skills, also practical experiences
shared. A total of 108 people have
been trained in 2021. To prevent
the use of camouflaged drugs that
looked like jello, coffee pact, tea
bag and candy out of curiosity,

used illegal drugs. TFDA has
over the years disseminated drug
abuse prevention information in
various communities, workplaces
and enterprises. In recent years,
more active cooperation has been
enforced to engage indigenous
people in resource-lacking,

remote and rural areas. In order
to raise drug abuse prevention
capability of indigenous people,
TFDA entrusted Tzu Chi
University with the Community
Personnel Training Project on
Drug Abuse Prevention. Course
subjects included drug abuse

TFDA trained local seed teachers
to help indigenous tribe people
to recognise new psychoactive
substances (NPS) as well as how
to refuse using them, to be more
alert, and to notice the suspicious
signs of drug abuse, thus reduce
the risk of exposing to drugs.
COMPANY NEWS

BIOSPECTRUM | JULY 2022 | www.biospectrumasia.com

Standigm signs MoU
with Merck Korea for AI
drug discovery research

South Korea-based Standigm Inc. has announced
the signing of a Memorandum of Understanding
(MoU) with Merck Korea, for artificial intelligence
(AI)-based drug discovery research. The MoU
signing took place at the headquarters of Standigm,
attended by Sojeong Yun, Chief Executive Officer

of Standigm, and Stephen Namkoo Lee, the Head
of Science and Lab Solutions,
Life Science business sector

of Merck Korea. Under the
MoJU, Standigm will accelerate
its drug discovery research by
adopting Merck’s AI software
SYNTHIA. which can help
Standigm’s novel compound
synthesis. SYNTHIA is a
computer-aided retrosynthetic
design tool and unites network
theory, modern high-power computing, and expert
chemical knowledge to rapidly design synthetic
pathways. As a leading workflow AI drug discovery
company, Standigm has actively conducted research
on AI technology in organic synthesis at its own
Synthetic Research Centre, established last year.

Shionogi expands
access to Cefiderocol

in 135 countries to treat
bacterial infections

Japan-based Shionogi & Co. and the Global
Antibiotic Research and Development Partnership
(GARDP) have announced the execution of a
licence and technology transfer agreement and,
with the Clinton Health Access Initiative (CHAI),
a collaboration agreement that aim to significantly
transform the landscape of access to antibiotics
for countries around the world. The agreements
will provide access to cefiderocol, an antibiotic

for the treatment of serious Gram-negative
bacterial infections, which may be resistant to
other antibiotic treatments. Cefiderocol was
recently added to the World Health Organization
(WHO) Model List of Essential Medicines and
targets a number of Gram-negative WHO priority
pathogens. This is the first licence agreement for
an antibiotic to treat serious bacterial infections
between a pharmaceutical company and a
non-profit organisation driven by public health
priorities. Under this agreement, GARDP will
manufacture and commercialise cefiderocol
through sub-licensees in a large range of countries
that have delayed access to newer antibiotics.

WuXi Biologics launches commercial

research, development and
manufacturing organisation
(CRDMO) service company,

has successfully launched the
GMP operation of its new drug
product facility DP5 located in
Wuxi, China. The DP5 is the
ninth operational drug product
facility in the global network of
Wuxi Biologics. The DP5 facility
features an advanced isolator
filling line for continuous and
steady filling services, which
offers multiple volume delivery
options for pre-filled syringes
(PFS), including 1 mL Long, 1 mL,
2.25 mLand 3 mL. The maximum

filling speed can reach 400 PFS/
min to support 17 million syringes
of drug products manufacturing
every year. The increased
manufacturing capacity at DP5
allows WuXi Biologics to provide

global partners with faster

and more robust end-to-end

drug product services for their
innovative products at different
scales and stages. Compared to

a traditional drug product filling
line, DP5’s state-of-the-art design
and layout, single-use technology
and automated equipment,
significantly decrease the risk

of contamination and maintain
aseptic control required in the
filling process. This process
supports clients’ products scale
up to commercial capability and
reliably delivers to patients under
the highest quality standards
which WuXi Biologics represents.