BioSpectrum Asia August 2021

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in your country?

We ranked countries on strength of their supply chains,
talent, R&D collaboration, manufacturing and government
regulation and policy

Dive into the
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Global Biopharma
Resilience Index at
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CY 20065-31Mar21-AD

4 BIO EDIT

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Dr Milind Kokje EXIT COVID-19, ENTER AMR

Chief Editor The pandemic is far from over and done with. On the face of it, it seems that the
number of people affected with the novel coronavirus has dwindled to a satisfactory
[email protected] figure at several places in the world. But, still there is a looming threat of another
wave of infections, possibly with a new deadly or more virulent variant. The major fallout
of the global battle against the pandemic has been the reports of antimicrobial resistance
(AMR), stemming from the overuse of antibiotics.

The World Health Organisation (WHO) has already warned several times over the
growing number of infections getting harder to treat due to antibiotics becoming less
effective. The world would face a ‘post-antibiotic era’ in which common infections can once
again kill, it warned.

Recently, a joint study by scientists in Bangladesh and the US, published in Open
Forum Infectious Diseases, showed resistance to all routinely used antibiotics in around
18 per cent of all bacterial isolates from children with pneumonia in Bangladesh. Children
with multidrug-resistant blood-borne bacterial infections were 17 times as likely to die as
those without bacterial infection.

Around the world, hospitals are reporting more and more drug-resistant infections.
Even before COVID-19, outbreaks of drug-resistant typhoid were not uncommon in
South Asia, East Asia, and South America. In the US, over two million people suffer from
antibiotic-resistance infections annually. Increasing mortality has opened ways for pharma
companies to develop novel antibiotics. As a result, the global antibiotic resistance market
share is expected to be worth $ 12.6 billion at a CAGR of 4 per cent in a decade from now,
according to Persistence Market Research.

Washington University School of Medicine and McGill University in Canada have jointly
conducted a study about the use of antibiotics in India during the first wave of COVID-19.
Its outcome has been published in the PLOS Medicine journal. The Indian Council of
Medical Research (ICMR) also did a similar study from June to August 2020 and has come
to the same conclusion of overuse of antibiotics leading to deaths of COVID-19 patients.

Researchers in the US and Canada have found that 16.29 billion doses of antibiotics
were sold in India in 2020. Though this was slightly less than 2018 and 2019 when adult
doses and some specific antibiotic drugs were studied further their usage was found to have
been increased. They estimated that COVID-19 contributed 216 million excess doses of
antibiotics for adults and 38 million excess doses of azithromycin from June to September
2020, a peak of the COVID-19 first wave.

The adult doses usage increased from 72.5 per cent in 2019 to 76.8 in 2020. Sales of
azithromycin increased from 4.5 to 5.9 per cent during the same period. Sales of doxycycline
and faropenem, which are commonly used in respiratory infections treatment, showed
notable increase.

A study by the ICMR of COVID-19 patients in 10 hospitals in India has shown that when
the overall COVID-19 mortality rate was 10.6 per cent, it was as high as 56.7 per cent in 3.6
per cent patients with secondary bacterial or fungal infections. ICMR has attributed it to
‘overuse of antibiotics and superbugs.’

Antibiotic overuse is currently more prevalent in lower and middle-income countries,
with India being the epicenter. With an alarming increase in antibiotic resistance, surgeons
may not be able to perform organ transplants. Even minor surgeries and treatments like
chemotherapy will become an impossible proposition.

A research study published in BMJ Global Health journal last year showed that in
India there were alarmingly high levels of antibiotics over prescriptions in India. 2392 of
4798 Standardised Patients (SP) provider interactions resulted in at least one antibiotic
prescription. Use of an anti-malaria drug hydroxychloroquine, for treatment of COVID-19
was prevented by the government and then its sale decreased.

Health authorities, government research institutes, and regulatory bodies in all countries
should resolve to put an end to the overuse and unnecessary prescription of antibiotics.

BIO MAIL 5

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Acknowledgements ‘Improve patient care through optimising
healthcare assets’ looked great in the July
Thank you so much for the coverage on 2021 issue.
National University of Singapore.
- Jasmine Lim, Singapore
- Carolyn Fong, Singapore

Thank you BioSpectrum Asia for Siemens Healthineers is very pleased
showing interest in having Bio-Rad’s to be able to work together with
biopharmaceutical marketing team BioSpectrum Asia. We appreciative your
contribute an article about the challenges help in the content requirement context.
and implications of getting gene therapy
doses right. - Gladys Tan, Singapore

- Ben Marcus, US It’s been lovely working with
BioSpectrum Asia for the opportunity
It was great and easy working with for GE Healthcare. Appreciate your
BioSpectrum Asia, fast responses as consideration!
always. The final published article titled
- Simone Phople, Singapore

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6 BIO CONTENT

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

COVER STORY 18

Technology

disrupting

APAC

endoscopy market

Over the years, endoscopy has altered the viewpoint of recognising diseases and how
surgeries were performed earlier. In particular, endoscopy for biopsies and endoscopic
ultrasound are among the procedures preferred for cancer diagnosis today. Although
North America holds the largest share of the global endoscopy devices market, the
Asia-Pacific (APAC) region is expected to exhibit the highest compound annual growth
rate (CAGR) in the coming years, owing to growth in geriatric population, increase in
prevalence of chronic diseases, and improvement in healthcare facilities. With numerous
developments and announcements taking place in the endoscopy space, there are tons of
opportunities in store for the industry, both old and new players, in the APAC region.

5G 5G SAGA

24 26

5G’s healthcare Is the 5G health
implications to watch for scare unfounded?

BIO CONTENT 7

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com MENTAL HEALTH

DIGITAL HEALTH 40

29 Changing face of mental
health assistance in Asia
DTx: A powerful
arsenal in healthcare Devin Partida,
Medical and Health
SPEAKING WITH Tech Writer, USA

33 DIGITAL HEALTH

“We see great potential 42
for mRNA technology
to address a broader APAC lays focus on
range of diseases” medical waste management

James Choi, Senior VP, Hrishikesh Kadam,
Chief Information & Marketing Officer, and Senior Research Content Developer,
Head of Investor Relations, Samsung Biologics, South Korea Global Market Insights, India

34 REGULARS

“Transparent partnerships, BioEdit.........................................................................04
will enable emerging biotech BioMail........................................................................05
and biopharma companies Policy and Regulatory News...................................08
to deliver innovative solutions” Company News........................................................10
Finance News............................................................12
Dr Senthil Sockalingam, Start-Up News...........................................................13
Head of IQVIA Biotech World News...............................................................15
(Asia Pacific), Singapore WHO NEWS...............................................................17
People News..............................................................44
36 R&D News..................................................................46
Academic News........................................................48
“Keep investing in Supplier News...........................................................49
expanding manufacturing
capacity is our commitment
to customers”

Francis Van Parys,
Vice President,
Asia Pacific, Cytiva, South Korea

38

“DCT reduces patient and
sponsor burden, while
increasing accrual and
retention of a more diverse
trial population”

Edwin Ng,
Senior Vice President,
APAC, Medidata Solutions

8 REGULATORY NEWS

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Australia announces 3-year pact of $140M for diabetes management

The Australian government has KeepSight, a programme to professionals, so students with
announced a new three-year $140 help prevent diabetes-related type 1 diabetes can be supported
million agreement with Diabetes blindness by making it easier for to manage their condition at
Australia to continue delivering people with diabetes to get their school; and FootForward, a
the National Diabetes Services eyes checked; Diabetes in Schools, new programme to help people
Scheme (NDSS). The NDSS which provides nationally with diabetes understand the
currently supports nearly 1.4 consistent information and importance of getting their feet
million Australians with diabetes. training for parents and families, checked, to avoid foot problems
It delivered more than 5.7 million principals, school staff and health that can lead to amputation. Work
diabetes products in 2019–20, at is also under way on an updated
a cost of more than $188 million. Australian National Diabetes
The new agreement with Diabetes Strategy to outline the national
Australia secures the future of response to diabetes and better
successful programmes which coordinate and target existing
are making a real difference for resources across all levels of
people with diabetes, including: government.

Malaysia grants China approves first
conditional registration for
effective hepatitis C treatment CAR T-cell therapy

The National Pharmaceutical Regulatory Agency (NPRA) Kite, a Gilead Company, has announced
of Malaysia has granted a conditional registration that Fosun Kite Biotechnology Co., Ltd., a
for a safe, effective hepatitis C treatment developed joint venture between Kite and Shanghai
by a public-private partnership bringing together the Fosun Pharmaceutical (Group) Co., Ltd, has
Malaysian Ministry of Health, not-for-profit research received approval from the China National
and development organization Drugs for Neglected Medical Products Administration (NMPA)
Diseases initiative (DNDi), Egyptian pharmaceutical for axicabtagene ciloleucel for the treatment
company Pharco, Malaysian pharmaceutical company of adult patients with relapsed or refractory
Pharmaniaga Berhad, and non-governmental- large B-cell lymphoma (LBCL) after two or
more lines of systemic therapy, including
organization Médecins Sans Frontières/ diffuse large B-cell lymphoma (DLBCL) not
Doctors Without Borders (MSF). This is otherwise specified, primary mediastinal large
the very first drug for HCV to be developed B-cell lymphoma (PMBCL), high-grade B-cell
through South-South collaboration and with lymphoma and DLBCL arising from follicular
funding and clinical support from non-profit lymphoma. Axicabtagene ciloleucel is the first
organizations. This partnership was formed and only commercially available chimeric
to address one of the more intractable public antigen receptor (CAR) T-cell therapy
health challenges of the past decade: the lack approved in China. Axicabtagene Ciloleucel,
of access to affordable direct-acting antivirals FKC876, is an autologous CD19-directed
(DAAs), a newer generation of powerful HCV treatments CAR T-cell therapy manufactured in China
that can cure patients in three to six months. The approval under a license to YESCARTA (Axicabtagene
concerns a new drug, ravidasvir, for the treatment of Ciloleucel) from Kite.
chronic HCV infection in adults in combination with
other medicinal products. Ravidasvir was developed by
the partnership for use with sofosbuvir, an existing DAA,
as an affordable, simple, and efficacious public health
tool. Ravidasvir is an oral NS5A inhibitor discovered and
owned by Presidio Pharmaceuticals. It was licensed to
Egyptian drug manufacturer Pharco Pharmaceuticals and
DNDi for clinical development and commercialization.

REGULATORY NEWS 9

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

India caps trade Singapore buys
sotrovimab from GSK,
margin of five Vir Bio to treat COVID-19

medical devices GlaxoSmithKline (GSK) Singapore and Vir Biotechnology
have signed an agreement with the Government of
The National Pharmaceutical Pricing Agency Singapore for the supply of sotrovimab, an investigational
(NPPA) in India has capped the trade margin single-dose monoclonal antibody, for the treatment
up to 70 per cent on Price to Distributor (PTD) of patients with COVID-19 who do not require oxygen
level on the pulse oximeter, blood pressure supplementation and who are at risk of progressing
monitoring machine, nebulizer, digital to severe COVID-19. GSK Singapore has submitted an
thermometer and glucometer. Earlier, in application under the Pandemic Special Access Route
February 2019, NPPA had previously capped (PSAR) for sotrovimab to the Health Sciences Authority
the trade margin on anti-cancer drugs and of Singapore (HSA). Sotrovimab is currently undergoing
on June 3, 2021, for oxygen concentrators. regulatory review for interim authorization under the
Based on the notified trade margin, NPPA PSAR. Preclinical data suggest sotrovimab targets a
has instructed the manufacturers/importers conserved epitope of the SARS-CoV-2 spike protein which
to report revised MRP within seven days. is less likely to mutate over time. Data from several in vitro
Revised MRPs will be informed in the public studies demonstrated that sotrovimab maintains activity
domain thereafter by NPPA. Every retailer, against multiple circulating variants of concern, including
dealer, hospital and institution shall display the Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), and Delta
price lists of these medical devices as furnished (B.1.617.2) variants, based on in vitro data from live virus
by the manufacturer, on a conspicuous part of and pseudotyped virus assays. The clinical impact of these
the business premises in a manner to be easily variants is not yet known.
accessible to any person wishing to consult
the same. State Drug Controllers (SDCs) shall
monitor the compliance of the order.

Taiwan reformulates COVID-19 vaccine policy as per priority groups

The Central Epidemic Command fourth extraordinary meeting members of the public who are
Center (CECC) has pointed of the Advisory Committee not the above-mentioned three
out that to increase the first- on Immunization Practices groups of people will be extended
dose coverage rate among the (ACIP) at the Ministry of Health to 10-12 weeks. The policy will
Taiwanese public, to achieve and Welfare held on July 11. be adjusted on a rolling basis
herd immunity and to meet According to the resolutions, based on vaccine supply. In
the needs of the vaccine policy, the period between two doses addition, the CECC announced
the interval between the first of the Moderna vaccine will that the Japanese government
dose and second dose of the remain to be at least 28 days for is providing an additional 1.13
Moderna COVID-19 vaccine at pregnant women, individuals in million doses of the AstraZeneca
this phase will be adjusted for the first priority group and crew vaccine to Taiwan after it had
some groups of people starting members of Taiwanese airlines, offered a batch of 1.24 million
July 12 onwards, according to whereas, the interval between doses of the vaccine to Taiwan in
the resolutions adopted in the the two shots of the vaccine for June.

10 COMPANY NEWS

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Technovalia, partners Kyalio unveils Asia’s
first Endo-Laparoscopic
begin first Australian VR Surgical Library

COVID-19 DNA vaccine trial Singapore-based Kyalio and the Endoscopic and
Laparoscopic Surgeons of Asia (ELSA), a leading
Australian researchers are commencing the first surgical association with over 2,600 members, have
Phase I human trial of a COVID-19 gene-based jointly launched the Day-to-Day Endo-Laparoscopic
DNA vaccine, delivered via a needle-free system. Virtual Reality Surgical Library. A first in Asia, the
Led by the University of Sydney, Scientia Clinical multi-platform VR Surgical Library, which utilises
Research (Sydney), Telethon Kids Institute real-scene Virtual Reality, addresses the importance
(Perth) and the Women’s and Children’s Hospital of continuous surgical training and enables cross-
(Adelaide), the COVALIA trial uses a gene-based border surgical education to be sustained even in
vaccine with DNA sequences from the SARS-CoV2 the face of COVID-19. The library also supports
long distance surgical training for young surgeons
virus. The researchers have in developing countries and remote areas. VR
partnered with Australian technology allows learners from around the world
biotech company Technovalia to gain exposure to a wide range of cases by placing
and its international them beside leading experts in the operating
vaccine partner BioNet who theatres, enhancing their knowledge and skills to
developed the DNA vaccine. improve surgical outcomes in their own practices.
It uses similar technology to More than half a million young surgeons in Asia
other genetic vaccines, like stand to benefit from this technology.
mRNA, in use in Australia
and internationally. This
potential next-generation
vaccine has no additives or preservatives. It will
be given using a needle-free device that penetrates
the skin with a jet spray and is designed to make
sure the vaccine gets inside the cells to encourage
good uptake by the immune system. While not
approved outside research studies in Australia,
this needle-free device is already being used to
give influenza vaccines in the United States. The
trial will also look at whether a lower vaccine dose
may work better following vaccination into the
skin rather than muscle, which is important as it
could enable more people to be vaccinated with
the available vaccine supply.

China’s Sinovac inks deal to supply COVID-19 vaccine to COVAX

Sinovac Biotech, based in China, an additional 150 million doses financing participants of the
has signed an advance purchase in the fourth quarter of 2021 and Facility as well as those supported
agreement (APA) with Gavi, the 180 million more doses in the by the Gavi COVAX Advance
Vaccine Alliance, which is on behalf first half of 2022. In total, up to Market Commitment (AMC).
of COVAX Facility, to provide up 380 million doses of CoronaVac COVAX, the vaccines pillar of
to 380 million doses of inactivated will be available to both self- the Access to COVID-19 Tools
COVID-19 vaccine, CoronaVac for (ACT) Accelerator, is co-led by
distribution through the COVAX CEPI, Gavi and WHO – working
Facility. According to the APA, in partnership with UNICEF
Sinovac will supply 50 million and PAHO as delivery partners,
doses of CoronaVac by the end of developed and developing country
September of 2021. In addition, vaccine manufacturers, the World
Gavi has the option to purchase Bank, and others.

COMPANY NEWS 11

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Takeda introduces Taiwanese
rare disease diagnostic
programme in India firm UBI-Asia,

Japanese firm Takeda has announced ILLUMINATE - a rare disease Paraguay ink

diagnosis programme in India to support improved clinical results for COVID-19

patients with Lysosomal Storage Disorders (LSD), independently run Vax deal

and managed by PerkinElmer and sponsored by Baxalta Bioscience Vaxxinity, a US-based
company pioneering the
India (part of Takeda group of companies). The programme will support development of a new class of
immunotherapeutic vaccines,
improved diagnostic pathways for patients with LSDs such as Gaucher in close collaboration with
Taiwanese firm UBI-Asia, has
disease, Fabry disease, and announced a purchase order
for its COVID-19 vaccine, UB-
mucopolysaccharidosis Type 612, with the Government of
Paraguay, contingent upon
II (MPSII; Hunter Syndrome). issuance of an Emergency
Use Authorization (EUA)
Considerably reducing by the Taiwanese Food and
Drug Administration (TFDA),
diagnostic time through the which will trigger an EUA
in Paraguay. Vaxxinity, in
programme, physicians could close collaboration with
its partner, UBI-Asia, is
timely initiate the therapy. completing a large Phase 2
clinical trial of UB-612 in
Following initial recognition of Taiwan, with support from
Taiwan’s Ministry of Health
symptoms that might indicate and Welfare, and will soon
begin its Phase 2/3 efficacy
the diseases, Dried Blood trial in India in partnership
with Aurobindo. Vaxxinity
Spot (DBS) testing enables has also announced a global
logistics partnership with
physicians to confirm their Maersk, the world’s largest
shipping and integrated
diagnosis by taking a blood sample on a filter card and sending this to logistics provider, that
creates a framework for all
the laboratory for analysis. Reports are then available to the physicians, transportation and supply
chain services that will be
which can be accessed anytime on a password-based portal. In its first needed to deliver UB-612
around the world. The
phase, the programme will be implemented by PerkinElmer at specific Vaxxinity UB-612 vaccine is
the first Multitope protein/
centres in Delhi, Haryana, Uttar Pradesh, Madhya Pradesh, Gujarat, synthetic peptide vaccine to
fight the SARS-CoV-2 virus.
Rajasthan, Maharashtra, West Bengal, Tamil Nadu, and Karnataka. The UB-612 vaccine elicits
broad humoral or cellular
Malaysia flags off Ph III trial of immune responses against
BioKangtai COVID-19 vaccine several viral proteins to
protect against COVID-19.
Phase III clinical fieldwork of the inactivated COVID-19 vaccine
(vero cells) independently developed and manufactured by China-
based Shenzhen Kangtai Biological Products has been officially
initiated in Malaysia. In February this year, BioKangtai
and Malaysia’s Yong Tai Berhad signed an
agreement on Phase III Clinical Trial of Inactivated
COVID-19 Vaccine and Product Procurement,
reaching a consensus to further carry out the
phase III clinical trials and commercialization of
the agreed products in Malaysia. On May 31, the
National Pharmaceutical Regulatory Agency
(NPRA), Malaysia, approved the clinical
trial of the vaccine. Subsequently,
on June 11, clinical samples of
the vaccine were delivered
from Shenzhen,
China to
Malaysia.

12 FINANCE NEWS

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Agilex Biolabs invests $1.5M in vaccine and immuno-biology lab

Australia-based Agilex Biolabs immune responses, which is molecule/novel chemical entity
has invested $1.5 million in its coupled with its state-of-the-art laboratory and implementation
new vaccine and immuno-biology BD FACSymphony 5 laser, 20 of the latest 6500+ Sciex LC/
laboratory. The facility will colour flow cytometer, offers MS/MS platforms to enable the
attract biotechs and pharma from unparalleled sensitivity for development and validation of the
around the world for advanced immunology and vaccine trials. highest sensitivity assays in the
clinical research. Premier of This Agilex Biolabs facility adds to region for regulated bioanalysis.
South Australia, Steven Marshall the recent expansion of the small The laboratory will be completed
launched the new facility on July in the next few months with
15, 2021. This new facility adds international clients already
digital droplet quantitative RT- booked to access the advanced
PCR analysis for RNA, siRNA and technology and scientific
miRNA clinical trials, including excellence. Agilex Biolabs has
vaccines and gene therapy trials. more than 130 staff which
The company is also installing includes 85 dedicated laboratory
an EliSPOT/FluoroSPOT multi- staff, and supports client pharma
spot reader for vaccine studies and biotech companies from US,
to enable extrapolation of recall Europe and APAC.

Eight Roads launches Japan’s Fujifilm pumps
new $400M healthcare in $850M to increase
fund for China capacity for biologics

Eight Roads, the global investment firm backed by Fujifilm Corporation, based in Japan, has
Fidelity, has announced the launch of its latest healthcare
fund for China, Eight Roads China Healthcare Fund announced a $850 million investment
V. The $400 million fund will follow Eight Roads’ core
strategy of healthcare investments in China, which is to package to accelerate the growth of its core Bio
develop a comprehensive healthcare ecosystem across the
Contract Development and Manufacturing
industry value chain and
around critical diseases. Organization (CDMO) subsidiary,
The new fund will invest in
and build innovative and FUJIFILM Diosynth Biotechnologies.
transformational healthcare
and life science companies Fujifilm Corporation is steadily expanding
with disruptive technologies
and innovative business its Bio CDMO business by investing in
models that address the
unmet market demand. It FUJIFILM Diosynth Biotechnologies’
will primarily focus on early-
stage investment opportunities in the healthcare industry, strength in contract development and
covering therapeutics, med tech, healthcare services and
healthcare IT/digital health. Eight Roads has backed manufacturing to increase capacity to meet
over 50 healthcare companies in China which sit across
the healthcare industry value chain and have formed an the market demands for biopharmaceuticals.
ecosystem with strong synergetic effect. These investments
span drug discovery and development, med-tech, traditional This announcement brings the total
and innovative healthcare services and digital solutions that
improve the efficiency of medical payment and health care. investments made by Fujifilm in FUJIFILM

Diosynth Biotechnologies since 2011 to $5.5

billion. The $850 million investment will

significantly increase FUJIFILM Diosynth

Biotechnologies’ manufacturing capacity.

The expansions will double cell culture

production for recombinant vaccines in the

United States.

START-UP NEWS 13

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Australia’s Japanese startup
B dot Medical promotes
BiomeBank spread of proton therapy

develops B dot Medical Inc., a startup based in Japan, has confirmed
the superconductivity of a bending magnet designed and
world-first biologic manufactured at its factory by cooling and conducting an
energisation test on a compact proton cancer therapy system
drug product under development, and confirmed the generation of a high
magnetic field. That means a big step closer to the development
The startup behind Australia’s first concept of the product,
facility for the manufacturing of which is to make the system
microbial therapies has set its sights significantly smaller and less
on global impact, applying to the expensive. The next step will
Therapeutic Goods Administration, be a pattern operation test
Australia’s regulatory authority, for to quickly control the strong
approval of their world-first biologic magnetic field generated by
drug product. BiomeBank has the superconducting magnet,
submitted for Market Authorisation and then B dot Medical will
of their product for the treatment proceed to a proton beam
of recurrent Clostridioides difficile test to apply for PMDA
(C-diff) and Ulcerative Colitis in a (Pharmaceutical and Medical
bid to meet unmet medical need Device Act) approval. With
across Asia Pacific. The drug product the aim of commercialising
is already used in Australia to treat the product as soon as
C-diff through faecal microbiota possible, B dot Medical will
transplantation (FMT) and has been promote the spread of proton
positioned as an alternative to existing therapy with the proton cancer therapy system, which has
biologic therapies for Ulcerative been significantly downsized using breakthrough technology.
Colitis. Backed by a world-leading To promote the spread of proton therapy, B dot Medical is
team of translational microbiome developing the device with national grants i.e. from the New
experts, BiomeBank’s platform uses Energy and Industrial Technology Development Organization
a unique combination of machine (NEDO), the Japan Agency for Medical Research and
learning and microbiology to identify Development (AMED).
bacterial strains which influence
disease, leading to the discovery and
development of new therapies.

China-based 3D printing pharma startup secures funding worth $50M

Triastek, Inc., the first 3D printing the proceeds will also be used to
pharmaceutical company in expand the 3D printed drug product
China, has completed its Series B pipeline and advance Triastek’s
financing, raising $ 50 million. This vision of creating a new era of
round of investment was co-led by global intelligent pharmaceutical
Matrix Partners China and CPE, manufacturing. The startup
with participation from Shanghai will leverage the advantages of
Sci-Tech Innovation Center Capital 3D printing of pharmaceuticals
(SSICC) and existing investors, as a digital manufacturing
Morningside Ventures, Dalton technology and incorporate
Venture and Yunqi Partners. In emerging technologies such as
addition to supporting the ongoing artificial intelligence to lead off a
development of the first IND- new era in advanced, intelligent
approved product in clinical trials, pharmaceutical manufacturing.

14 START-UP NEWS

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Korean firm Standigm Indian startup
to expand AI-drug
development capacity bags grant for

Standigm Inc., a workflow artificial intelligence cannabis-based
(AI) drug discovery startup, and SK Chemicals,
both based in South Korea, have signed a strategic medicinal remedies
partnership contract for collaboration regarding
clinical development of Standigm’s AI-driven drug Indian startup HempStreet has become
candidate for non-alcoholic steatohepatitis (NASH) the first-ever venture to receive the
and the foundation of Standigm’s Synthesis Research Biotechnology Ignition Grant (BIG) from
Centre within the headquarters of SK Chemicals. BIRAC (Biotechnology Industry Research
This partnership was made in conjunction with SK Assistance Council), Government of India,
Chemicals’ participation in Standigm’s pre-IPO round for a medicinal cannabis solution. The
of fundraising. Under the contract, SK Chemicals will company has plans to utilise the funds to
collaborate with Standigm on the clinical development patent and commercialise a recent research
of the NASH drug candidate discovered by Standigm breakthrough around transdermal delivery
Insight, an AI-aided drug-repurposing platform, which technology that could disrupt a $7 billion
is expected to enter clinical stage next year. Moreover, global industry. HempStreet aims to tackle
Standigm plans to open its Synthesis Research Centre in mass-ailments utilising researched and
the headquarters of SK Chemicals. Standigm will be able responsibly dispensed medicinal cannabis
to synthesize its AI-driven drug candidates directly and for pain relief to an addressable patient base
efficiently. of over 35 million. In less than six months,
the startup claims to have marked the fastest
roll-out witnessed by the industry across over
2,000 clinics in 24 states in India that are
now prescribing HempStreet medicines.

Amaroq Therapeutics in NZ secures
funding to develop cancer treatments

Amaroq Therapeutics, a new biotech NZ$14 million investment was led
startup spun out of the University of by the life science investor, Brandon
Otago in New Zealand (NZ), with Capital along with Otago Innovation
one of the world’s most advanced Ltd, NZ Innovation Booster and
programmes in next-generation Cure Kids Ventures. Amaroq is
RNA therapy to target cancer, has the first recipient of investment
secured NZ$14 million investment from Brandon Capital under the
to accelerate development. The study programme and the investment also
of long non-coding RNAs (lncRNAs), stands as the largest investment
often referred to as “dark matter” of ever secured by Otago Innovation.
the genome, are molecules naturally Otago Innovation is one of six New
present in cells. The startup will Zealand members able to access
be working on therapies to treat capital, expertise, and networks
common cancers such as breast, to take biomedical discoveries to
colorectal and liver cancer. The market.

WORLD NEWS 15

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CEPI launches global marketplace for COVID-19 vaccines

Norway-based Coalition indicate their needs or available
supplies to CEPI, in its role as
for Epidemic Preparedness facilitator. CEPI will identify
matching offers and requests
Innovations (CEPI) and COVAX and connect potential matches,
prioritising based on objective
(COVID-19 Vaccines Global criteria including whether the
manufacturer has a COVAX
Access) partners are launching advance purchase agreement and
WHO Emergency Use Listing
an innovative marketplace to (EUL) in place, as well as dose
volumes and delivery timings.
accelerate the global production Future versions of the Marketplace
may include supplies required
of COVID-19 vaccine doses for to manufacture other life saving
therapies and vaccines which are
COVAX by matching suppliers also being affected by current
global supply shortages.
of critical inputs with vaccine COVAX Marketplace is designed
to address short-term bottlenecks
manufacturers who urgently by facilitating access to supplies
needed to produce COVID-19
need them to produce vaccines vaccines intended for distribution
through COVAX. It will provide
for fair and equitable distribution a secure platform for vaccine
manufacturers and suppliers of
through COVAX. This initiative is critical inputs to confidentially

a key deliverable of the COVAX

Manufacturing Task Force,

which is co-led by COVAX and

industry partners. The new

World’s largest UK accelerates innovation
browsable resource
linking genetic variants with Life Sciences Vision
to human health sets in
The UK government has launched its Life Sciences
Access to the world’s largest browsable resource Investment Programme worth £200 million
linking rare protein-coding genetic variants to to unlock the potential of innovative UK life
human health and disease was launched through sciences companies. It will focus on preventing,
a genetic exome sequence analysis collaboration diagnosing, disease monitoring & treating disease
between AbbVie, Biogen Inc. and Pfizer. Managed by early; development of breakthrough products
the Broad Institute of MIT and Harvard, the browser and treatments through innovative clinical
gives access to results from analyses of whole exome trials; and to accelerate the
sequencing data from 300,000 UK Biobank research development and adoption
participants. These genetic data have been paired with of new drugs, diagnostics,
detailed health information to create this browsable medical technology
resource. The collaboration between AbbVie, Biogen and digital tools. The
and Pfizer to make these data available highlights the UK Life Sciences
importance of working together to advance science. Vision considers itself
The companies engaged with the Broad Institute for as a bold ambition
data processing and to conduct single variant and for the next decade
gene-based association testing with nearly 4,000 UK to ensure scientific
Biobank phenotypes to identify associations between excellence, partnered with
distinct genes or genetic variants and disease. In the dynamics of industry
line with the collaboration members’ commitment essentially repurposed to
to openness, these results can now be accessed augment the national health
freely via the new browser. This browser will enable system (NHS) to solve
scientists worldwide to explore and utilise the data the pressing healthcare
for their respective areas of interest in accordance challenges. In total, £1 billion
with UK Biobank’s terms of use. of new funding is available for
the UK’s most promising life
sciences companies, with the
potential to crowd in further
funding from other investors.

16 WORLD NEWS

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South Africa to establish first
COVID-19 mRNA vaccine tech transfer hub

The World Health Organization transfer hubs are training
(WHO) and its COVAX partners
are working with a South African facilities where the technology is
consortium comprising Biovac,
Afrigen Biologics and Vaccines, established at industrial scale and
a network of universities and the
Africa Centres for Disease Control clinical development performed.
and Prevention (CDC) to establish
its first COVID-19 mRNA vaccine Interested manufacturers
technology transfer hub. The
move follows WHO’s global call from low- and middle-income
for Expression of Interest (EoI)
to establish COVID-19 mRNA countries can receive training
vaccine technology transfer hubs
to scale up production and access and any necessary licenses to the

to COVID-19 vaccines. Over technology. WHO and partners
the coming weeks, the partners
will negotiate details with the will bring in the production know-
Government of South Africa
and public and private partners how, quality control and necessary
inside the country and from
around the world. Technology licenses to a single entity to

facilitate a broad and rapid

technology transfer to multiple

recipients.

Africa ramps up Korea, Ghana bring first-
of-its-kind collaborating
training on SARS- centre for vaccine R&D

CoV-2 genomics and South Korea-based International Vaccine Institute (IVI)
and the Kwame Nkrumah University of Science and
bioinformatics Technology (KNUST) in Ghana, Africa have opened the
KNUST-IVI Collaborating Centre during a ceremony
The Africa Centres for Disease Control that took place at KNUST/Agogo Presbyterian Hospital
and Prevention (CDC) and the African in Ghana. The KNUST-IVI Collaborating Centre will be
Center of Excellence for Genomics of a research and training site to implement ongoing and
Infectious Diseases (ACEGID) have new collaborative projects, including disease surveillance,
started a continent-wide training vaccine clinical development, vaccination campaigns,
series on SARS-CoV-2 sequencing. The and vaccine effectiveness and health economics studies
comprehensive hands-on training aims for infectious diseases prevalent to the region such as
to strengthen Member States capacity to
track the emergence and spread of SARS- typhoid and invasive non-typhoidal
CoV-2 variants of concern. 17 candidates Salmonella. The KNUST-IVI
from 12 African Union Member States Collaborating Centre is the first of
are currently attending the training at its kind, initiated by IVI to enable
ACEGID, Redeemer’s University, Ede, joint research, development, and
Osun State, Nigeria. As part of its vision capacity-building activities to
to integrate pathogen genomics into the achieve regional health objectives as
public health surveillance and diseases well as the UN’s global goals. Both
outbreak response, the Africa CDC parties are also beginning a mass vaccination campaign as
through the Africa Pathogen Genomics consortium members of the Typhoid Conjugate Vaccine
Initiative (Africa PGI) is collaborating Introduction in Africa (THECA) programme, which aims
with African Society for Laboratory to assess the effectiveness of a typhoid conjugate vaccine
Medicine (ASLM), WHO Regional (TCV) through two clinical studies, including a cluster-
Office for Africa, Centers of Excellence randomized trial in Ghana, to support the introduction of
in genomics and bioinformatics to train TCV into routine immunization programmes in typhoid-
a network of national public health endemic countries in Africa.
laboratories in the generation and
analyses of SARS-COV-2 genomic data.

WHO NEWS 17

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WHO launches first WHO calls for
investments in TB
guidelines on hepatitis vaccine development

C virus self-testing The World Health Organisation (WHO) is joining
partners, civil society and affected people and
New guidelines from the World Health communities around the world in calling for increased
Organisation (WHO) strongly recommend and sustained investments in tuberculosis (TB) vaccine
offering self-testing for hepatitis C virus development. A new vaccine that is effective across all
(HCV) as an additional approach to HCV age groups, particularly adults and adolescents will
testing services. WHO releases the new be critical if we are to reach End TB targets. Vaccines
guidelines – its first on HCV self-testing. The also offer the best chance to contain the spread of
multidrug resistant TB. The BCG vaccine is currently
new guidelines the only licensed vaccine for TB and provides moderate
highlight key protection against severe forms of TB in infants and
considerations young children. It has been made widely available
for policy- across countries through immunization programmes
makers, national and has played a vital role in saving many young lives
programmes, and preventing serious illnesses. However, there is no
providers and vaccine that is effective in preventing TB disease in
implementers adults, either before or after exposure to TB infection.
of HCV testing services. These considerations While results from a Phase II trial of the M72/AS01E
for HCV self-testing include designing TB vaccine candidate are promising - from among 14
appropriate and context-specific messages, vaccine candidates in clinical trials, these vaccines are
service delivery models and support tools expected to be ready only in the coming years.
through engagement with communities;
setting up efficient pathways for people who
self-test to obtain confirmatory testing and
treatment or prevention services; training
providers; creating a supportive and enabling
policy environment; and using quality-assured
products. To help assure quality, WHO
has published technical specifications for
prequalification of HCV self-testing products,
which are likely to be available soon.

WHO links HIV with COVID-19 severity

A new WHO report confirms for COVID-19. It was found that
that HIV infection is a significant the risk of developing severe or
independent risk factor for fatal COVID-19 was 30 per cent
both severe/ critical COVID-19 greater in PLHIV compared to
presentation at hospital people without HIV infection.
admission and in-hospital Underlying conditions such
mortality. Overall, nearly a as diabetes and hypertension
quarter (23.1 per cent) of all are common among PLHIV.
people living with HIV who were Among male PLHIV over the
hospitalised with COVID-19, age of 65 years, diabetes and
died. The report is based on hypertension were associated
clinical surveillance data from with an increased risk of more
37 countries regarding the risk severe and fatal COVID-19.
of poor COVID-19 outcomes These conditions are known to
in people living with HIV put people at increased risk of
(PLHIV) admitted to hospital severe disease and death.

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Technology

disrupting

APAC

endoscopy market

Over the years, endoscopy has altered the viewpoint of recognising diseases and how
surgeries were performed earlier. In particular, endoscopy for biopsies and endoscopic
ultrasound are among the procedures preferred for cancer diagnosis today. Although
North America holds the largest share of the global endoscopy devices market, the
Asia-Pacific (APAC) region is expected to exhibit the highest compound annual growth
rate (CAGR) in the coming years, owing to growth in geriatric population, increase in
prevalence of chronic diseases, and improvement in healthcare facilities. With numerous
developments and announcements taking place in the endoscopy space, there are tons of
opportunities in store for the industry, both old and new players, in the APAC region.

With the capability to visualise or analyse endoscopy) examination. On the whole, endoscopy
the diagnostic target in vivo, endoscopy has altered the viewpoint of recognising diseases and
has gradually developed as a potential how surgeries were performed earlier. Furthermore,
candidate to challenge histopathology which remains the rising incidence of cancer has fueled the adoption
the gold standard for diagnosis. Currently available of endoscopes for various diagnosis and treatment
in three forms namely rigid, flexible and capsule, processes across the globe. Endoscopy for biopsies
the procedure is more commonly used for colon and endoscopic ultrasound are among the procedures
(colonoscopy) and gastro-intestinal tract (upper GI preferred for cancer diagnosis.

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According to a recent market report by Grand “Japan is the second
View Research, North America dominated the global largest endoscopy
market of endoscopy devices with a revenue share
of 42.5 per cent in 2020 owing to the improved market in the world
healthcare infrastructure, the rising adoption of and we are happy to be
advanced technologies, and the growing preference able to supply Japanese
for minimally invasive surgeries to curb healthcare
spending. urologists and their
patients with a single-
On the other hand, the Asia Pacific (APAC) region
is expected to witness lucrative growth in this space use cystoscope.”
owing to the high demand for endoscopic technologies - Juan Jose Gonzalez,
in this region. Some of the major factors contributing
to the regional market growth are improving health Chief Executive Officer, Ambu, Denmark
infrastructure and the growing geriatric population.
Recent market reports have pointed out that the APAC “The industry needs to
endoscopy devices market was worth $4.94 billion in address the medical
2020 and is estimated to be growing at a CAGR of 7.32 device hygiene
per cent to reach $7.03 billion by 2025.
challenges by continually
The major players operating in the APAC innovating products,
endoscopy devices market include, Boston Scientific optimizing processes,
Corporation (US), Pentax Medical (Japan), 3NT
Medical (Israel), AnX Robotica Corporation (US), and integrating feedback
Conmed Corporation (US), Olympus Corporation from the market.”
(Japan), KARL STORZ Endoscopy-America, Inc. (US), - Rainer Burkard,
Cook Medical Incorporated (US), NEC Corporation
(Japan) and Fujifilm Holding Corporation (Japan). On Chief Executive Officer, Pentax Medical, Europe,
the whole, Japan is the major shareholder in the APAC the Middle East and Africa (EMEA), Germany
region, accounting for more than 50 per cent of the
endoscopy devices market. “Companies that invest in
the development of robotic
Although competition is strong among the or magnetically controlled
existing players owing to the increase in demand for
endoscopes for various diagnostic and treatment capsules will remain
procedures, the entry of new companies in the future competitive with such
will also play a major role in boosting this space. superior devices that also
Further, mergers and acquisitions, and increasing reduce the risk of capsule
R&D in the area of endoscopic technologies are key retention in patients.”
initiatives being undertaken by leading players to
increase their share in the market. - Dr Eric Chapman,
Medical Devices Analyst, GlobalData, Canada
Emerging technologies
“Very few of the existing
Maintaining endoscopy equipment is of vital towers have 4K vision
importance as improperly reprocessed endoscopes
can lead to cross-contamination and can potentially monitors, to which surgeons
expose patients to infections. This can further add to look at and do the surgery.
the already high costs. Moreover, the constant heating Due to the exorbitant cost
and cooling during disinfection procedures can of buying or replacing
cause wear and tear of the insertion and light guide the existing towers, many
tubes, which can hamper the durability of endoscopy surgeons continue to
equipment. Also, owing to the high capital, training,
and maintenance costs, endoscopy procedures are compromise with the quality
generally expensive. As a result, companies are of image they are looking at.”
developing models with newer technologies such as
artificial intelligence (AI), 3D-printing, robotics etc. to - Sunil Singh,
counter such bottlenecks. Founder and Chief Executive Officer,

UnivLabs Technologies, India

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UPSKILLING WORKFORCE As a part of another training initiative for
endoscopists in India, Olympus and US-based
In collaboration with Japan based Cybernet Systems, Boston Scientific are assisting the Society of
Olympus has developed a project in Thailand to enhance Gastrointestinal Endoscopy of India (SGEI)
experiences of AI in endoscopy and assist the next and Healthcare Sector Skill Council (HSSC)
generation of endoscopists for gaining new knowledge to upskill gastroenterology (GI) endoscopy
and skills in the latest AI technology for a diagnostic technicians, primarily physicians with various
endoscopy. endoscopic procedures.

Olympus has also established an AI diagnostic “There is a growing need in India
support system at the Asian Institute of Gastroenterology for skilled manpower and to reduce the
(AIG) based in Hyderabad, India. Specialist lecturers and existing demand and supply of skills gap,
physicians from Showa University Northern Yokohama especially in the healthcare sector. India
Hospital in Japan are providing expert guidance to AIG currently has a pool of close to 3000
doctors. In addition to training AIG doctors in techniques Gastroenterologists. Every year nearly 150
for detecting diseases and differential diagnosis by new gastroenterologists and hepatology
colonoscope, they are also training the doctors on how to graduates complete their training and
instruct the next generation of endoscopists. start practice. Endoscopy technicians
have job opportunities with this increasing
“Especially in AI, we recognize the power of elevating pool of Gastroenterology and Leptology
endoscopic imaging to uncharted levels. Considering physicians in India. There are currently over
ENDO-AID as a first step, we are planning additional 6000 endoscopy centres in the country.
AI-powered applications for image detection and Established clinics and hospitals will continue
characterization, not only for colonoscopy. For India, we to hire endoscopy technicians as
will be releasing endoscopic diagnostic support software the number and complexity
equipped with AI. The endoscopic diagnostic support of the procedures increase”,
shares Ashish Jain,
software EndoBRAIN and EndoBRAINEYE will Chief Executive Officer,
be utilized for physician training in India. Healthcare Sector Skill
We intend to assist in the development Council, India.
of physicians and promote the use of
endoscopic diagnostics”, says Frank
Drewalowski, Head of Endoscopic Solutions
Division, Olympus Corporation, Germany.

Commanding the world’s highest market share developing single-use endoscopes since 2009. Having
in gastrointestinal endoscope operations, Japanese the richest single-use endoscopy pipeline with 12
firm Olympus has recently launched a cutting-edge new products set for launch by 2022, the company
platform powered by AI that includes the endoscopy has recently obtained market clearance for single-use
application ENDO-AID CADe (computer-aided cystoscope Ambu aScope 4 Cysto, for urinary tract, in
detection) for the colon. This new AI platform enables the Japanese market.
real-time display of automatically detected suspicious
lesions and works in combination with Olympus’ “Japan is the second largest endoscopy market
recently introduced EVIS X1, its most advanced in the world and we are happy to be able to supply
endoscopy system to date. Japanese urologists and their patients with a single-
use cystoscope. There is a great interest in exploring
Another player in Japan, NEC Corporation has a single-use scope because it eliminates the risk of
launched an AI diagnosis-support medical device cross-contamination and the need for reprocessing of
software for colonoscopies, which is being released in scopes, cutting healthcare costs and freeing staff from
Japan and is expected to soon be available in Europe. exposure to chemicals during reprocessing. Our single-
This software connects with existing endoscopy use cystoscope received market clearance in the US in
equipment as part of using AI to automatically mark April 2020”, says Juan Jose Gonzalez, Chief Executive
potential lesions from images taken during endoscopic Officer, Ambu, Denmark.
procedures.
A single-use bronchoscope, developed by Pentax
Further, in order to address the growing concern Medical, a division of Japan-based Hoya Group, is the
of acquired infections due to the usage of endoscopes, latest entrant in the global market. This innovative
Danish firm Ambu has been at the forefront of product has recently obtained a CE mark for its entry

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in Europe. “Until now, we couldn’t make
Sharing his perspective on the advantages offered high quality endoscopes

by single-use endoscopes, Rainer Burkard, Chief very small. Using 3D micro-
Executive Officer, Pentax Medical, Europe, the Middle printing, we are able to print
East and Africa (EMEA), Germany says “The industry complicated lenses that are
needs to address the medical device hygiene challenges too small to see with the naked
by continually innovating products, optimizing
processes, and integrating feedback from the market. eye.”
Single-use scopes eliminate wait times between
procedures, simplifying overall workflow and patient - Dr Simon Thiele,
throughput.” Group leader, Optical design and
simulation, University of Stuttgart, Germany
3D printing is another emerging technology
being explored in the field of endoscopy. A team “Endoscope has a high
of researchers led by the University of Adelaide in technical barrier, and the
Australia and University of Stuttgart in Germany
has used 3D micro-printing to develop the world’s domestic market has
smallest, flexible optical coherence tomography (OCT) long been monopolized
imaging catheter for looking inside blood vessels. The
research collaboration also included researchers from by foreign giants.”
the South Australian Health and Medical Research
Institute, the Royal Adelaide Hospital and Monash - Dr Eric Yu,
University. Partner, Matrix Partners, China

“Until now, we couldn’t make high quality “White-light endoscopy is the
endoscopes this small. Using 3D micro-printing, we most common method for
are able to print complicated lenses that are too small
to see with the naked eye. The entire endoscope, with a visually diagnosing early signs
protective plastic casing, is less than half a millimeter of gastric cancer in hospitals.
across”, explains Dr Simon Thiele, Group leader, But there is a delay in diagnosis
Optical design and simulation, University of Stuttgart, because conventional white
Germany.
light endoscopy cannot
Likewise, a group of researchers in South Korea accurately differentiate normal
has designed a new endoscope-assisted spine
surgery system, and using a 3D printer, attempted to vs cancerous tissues.”
create a complex surgical instrument. During their
experiments, the researchers were able to develop - Peter Cheng,
and demonstrate the usefulness of a new endoscope- Chief Executive Officer, Endofotonics, Singapore
assisted spine surgery system relying on 3D printing
technology. But of course more studies and further Medical Solutions that has developed the world’s first
improvements are required before the instrument magnetically controlled capsule endoscope capable of
enters the market. completely examining the upper digestive tract (EGD).
Since capsule endoscopy, which involves swallowing
Another team of scientists in South Korea has a small pill comprising a tiny wireless camera to take
designed a flexible robotic platform for scar-free images as it passes through the small intestine, can
endoscopic surgery. The initial prototype of the often lead to certain complications, the EGD system
proposed robot showed the possibility of advanced has been built to offer a better experience.
endoscopic surgery with improved payload capability.
“Increase in the number of gastrointestinal
Counting in more innovations, researchers from disorders and aging populations, the endoscopy
the Chinese Academy of Science have developed an market is experiencing advances in technological
endoscope capable of acquiring 3D visible light and developments involving imaging and wireless
near-infrared fluorescence images at the same time. capacities. Companies that invest in the development
This 3D endoscope not only provides surgeons with of robotic or magnetically controlled capsules will
real-time feedback on the location of tumor tissue and remain competitive with such superior devices that
lymph nodes but also creates an immersive experience
for surgeons without impeding surgical workflow.

Not to forget Taiwan-based startup Insight

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MAJOR PLAYERS OF innovative endoscopic technologies on the table. For
GLOBAL ENDOSCOPY instance, China-based Scivita Medical Technology
MEDICAL DEVICES MARKET has raised nearly RMB 0.4 billion in Series A
funding round, which has become one of the highest
● Boston Scientific Corporation (US) financing projects in the field of endoscope in China
● 3NT Medical (Israel) in recent years. The company’s product range covers
● AnX Robotica Corporation (US) both flexible and rigid endoscopy, and has unique
● Conmed Corporation (US) advantages in the research and commercialisation of
● Olympus Corporation (Japan) all cutting-edge technologies in the field of medical
● KARL STORZ (Germany) endoscopes.
● Cook Medical Incorporated (US)
● NEC Corporation (Japan) “Endoscopes have a high technical barrier, and
● Fujifilm Holding Corporation (Japan) the domestic market has long been monopolised by
● Stryker (US) foreign giants. According to Frost & Sullivan, it is
● Ethicon (US) estimated that by 2024, the overall scale of the global
● Medtronic (Ireland) endoscopy devices market will grow to $26.98 billion,
● Hoya Corporation (Japan) and the Chinese endoscope market size will reach
● Richard Wolf GmbH (Germany) $6.5 billion, becoming one of the fastest growing
● Smith & Nephew (UK) medical device sub-industries in the world. With
● B. Braun (Germany) the popularisation of minimally invasive diagnosis
and treatment technology worldwide, the endoscope
DIFFERENT TYPES OF industry has also entered a stage of rapid development.
ENDOSCOPY PROCEDURES Given that the endoscope industry has entered into
the era of consumables, startups like Scivita Medical
Procedure Organ Type Technology are set to compete with international
Rigid brands in the global market with its disruptive single-
Anoscopy Anus, rectum Rigid use technology and leading technological advantages”,
Flexible says Dr Eric Yu, Partner, Matrix Partners, China.
Arthroscopy Joints
Flexible On the other hand, Singapore and China-based
Bronchoscopy Trachea, or startup Endofotonics has developed a system called
windpipe, and the Rigid Spectra IMDx, which enables real-time detection of
lungs Rigid early gastric cancer during endoscopy. It is offering
Rigid/ Flexible the world’s first and only in-vivo molecular diagnosis
Colonoscopy Colon, large Flexible using Raman Spectroscopy for early gastric cancer
instestine diagnosis.
Rigid
Colposcopy Vagina, cervix The startup has recently raised S$12 million in
Flexible a Series B round led by executives from Singapore
Cytoscopy Bladder Rigid Medical Group. The funding will be used to drive
Rigid/ Flexible commercialisation of its early gastric cancer detection
Esophagoscopy Esophagus system in the Asia Pacific, and to expand the coverage
Rigid/ Flexible of its cancer detection technology to other organs.
Gastroscopy Stomach,
duodenum “White-light endoscopy is the most common
method for visually diagnosing early signs of gastric
Laparoscopy Stomach, liver, cancer in hospitals. But there is a delay in diagnosis
uterus, ovaries because conventional white light endoscopy cannot
accurately differentiate normal vs cancerous tissues.
Laryngoscopy Larynx So, we are using Raman Spectral Analysis that is
capable of capturing molecular information associated
Neuroendoscopy Brain areas with the cellular metabolic constituents when the
tissue molecules are excited by light energy directed
Proctoscopy Rectum, sigmoid at the tissue. With the technology, the system is able
colon to help identify tissue with high probability of having
gastric cancer”, says Peter Cheng, Chief Executive
Thoracoscopy Chest cavity lining Officer, Endofotonics, Singapore.

also reduce the risk of capsule retention in patients”, On the other hand, an Indian startup UnivLabs
says Dr Eric Chapman, Medical Devices Analyst,
GlobalData, Canada.

Startups- Turning the table

Apart from the established players of the endoscopy
market, a number of startups are also bringing

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LATEST ENDOSCOPY TECHNOLOGIES IN APAC REGION

Company/ Institute Technology

Olympus (Japan) AI-based colonoscope

NEC Corp (Japan) AI-based colonoscope

Ambu (Denmark) Single use cytoscope

Pentax Medical (Japan) Single-use bronchoscope

University of Adelaide (Australia) and 3D micro-printed endoscope
University of Stuttgart (Germany)

Seoul Barunsesang Hospital (South Korea) 3D printed endoscope-assisted spine surgery system

Korea Advanced Institute of Science and Robotic platform for scar-free endoscopic surgery
Technology (South Korea)

Chinese Academy of Science (China) Endoscope acquiring 3D visible light and near-infrared

Insight Medical Solutions (Taiwan) Magnetically controlled capsule endoscope

Endofotonics (Singapore) Raman Spectral Analysis- based endoscope

UnivLabs Technologies (India) Connected 4K endoscope tower

Technologies has developed the country’s first development, production, and sale of devices for the
connected 4K Endoscope Tower. All the individual minimally invasive treatment of benign prostatic
components of the tower like the Body Cavity hyperplasia (BPH).
Illuminator, Co2 Insufflator, Hysteroscopy Pump,
Laparoscopy Pump have been conceived and Hitachi is another prominent medtech player
manufactured by the startup in India and the advanced in Japan that has recently entered into a five-year
4K Camera has been developed in collaboration with a contract with Olympus for joint development of the
Japanese imaging company. endoscopic ultrasound (EUS), used in examinations
to evaluate the stage of cancer in the liver, pancreas
The startup has also introduced the ‘Pay per use’ and bronchus. Hitachi has inked a similar five-year
model whereby hospitals can own the Endoscope contract with Japanese firm Hoya Corporation
tower with an initial investment of one-third of the simultaneously. These developments are in accordance
total cost thus reducing early ownership cost. Sharing with the Fujifilm Corporation’s announcement in
more details about this innovative product, Sunil 2019 to acquire Hitachi’s diagnostic imaging-related
Singh, Founder and Chief Executive Officer, UnivLabs business for $1.6 billion.
Technologies, India says “Very few of the existing
towers have 4K vision monitors, to which surgeons Further, Pentax Medical, a division of Hoya Group
look at and do the surgery. Due to the exorbitant delivering endo-imaging solutions, has established
cost of buying or replacing the existing towers, many a joint venture with China-based Jiangsu Vedkang
surgeons continue to compromise with the quality of Medical Science and Technology to develop single-use
image they are looking at. The 4K system and monitor therapeutics products in the field of flexible medical
would improve the way a surgeon visualises the endoscopy. The new company will offer innovative
surgical field and in turn the outcome of laparoscopic single-use devices to global customers through
surgery.” the Pentax Medical sales network strengthened by
Vedkang’s production and R & D infrastructure.
Strategizing mergers & acquisitions
With numerous developments and announcements
In order to bolster endoscopy capabilities in the taking place in the endoscopy space, there are tons
global market, many players in the APAC region are of opportunities in store for the industry, both
adopting the strategy of mergers and acquisition. A old and new players, in the APAC region. Due to
recent example is that of Olympus Corporation which improvement in health awareness, development in
has acquired Quest Photonic Devices, based in the healthcare infrastructure, rise in number of hospitals
Netherlands, for up to EUR 50 million to strengthen & ambulatory surgical centers equipped with advanced
its surgical endoscopy portfolio. medical facilities, and increasing adoption of new
technologies, the APAC endoscopy medical device
Olympus has also acquired Israeli medical device market has a bright future ahead.
company Medi-Tate to drive global urology business
growth. Medi-Tate is engaged in the research and Dr Manbeena Chawla
[email protected]

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5G’s healthcare
implications to watch for

From remote diagnosis, remote surgery, real-time monitoring to expanded telehealth etc.
5G represents a host of opportunities for healthcare. Let’s look at the possibilities of this
technology for healthcare and how it can help bring a paradigm shift in the sector.

Fifth-generation (5G) has gained much 5G can take it a step further by providing sensors
importance, development and investment in and virtual reality for teleconferencing, and enabling
recent years. This technology has the potential healthcare workers to remotely monitor vital signs
to transform all the components of healthcare, which during calls.
is especially important as the COVID-19 pandemic
has put unparalleled stress on healthcare systems Additionally, because 5G can transmit sizable data
around the world. packages, testing patients with conditions for changes
in their heartbeat, blood sugar and blood pressure
Network providers and healthcare institutions are multiple times a day using cloud-linked scanners is
figuring out how best to incorporate this technology also possible. These advances, in turn, would unlock
into the ecosystem. A new private 5G network from more insights into the day-to-day health of patients
AT&T is helping to revolutionise the way patients according to a report by PricewaterhouseCoopers
and researchers connect at the Lawrence J. Ellison (PwC), UK.
Institute for Transformative Medicine of USC,
USA. The on-site 5G network is providing ultra-fast Real-time monitoring
connectivity for patient-centred cancer research,
treatment, and wellness education. The Ellison Health monitoring through connected medical
Institute is among the first medical facilities in the devices can generate real-time data about patients
USA using 5G to help advance cancer research. that providers can use to improve health outcomes.
At scale, analytics applied to these massive volumes
South Korea’s KT Corporation and the Samsung of patient data could lead to new or improved
Medical Center (SMC) are working to build a smart treatments. Through 5G collaborations with King’s
hospital. They have jointly developed an innovative, College in London, Ericsson has shown how low-
5G-powered medical service as an initial step to latency and ultra-reliable communication enable
establishing a 5G smart hospital. new use cases based on sight, hearing and touch with
real-time video feed sent without the time needed to
Sharing his thoughts, Joe Drygas, AT&T VP of compress and encode.
Healthcare Industry Solutions, USA said, “5G has
the potential to offer massive connection power, fast Remote Diagnostics
speeds and low latency that can help transform how
healthcare is delivered. Think remote robotic surgery To improve diagnostic capabilities, 5G can increase
and quick downloads and transference of massive
data files of medical imagery. 5G not only has the
capacity to impact the Internet of Medical Things,
but it also will help enable medical innovations
using augmented reality, virtual reality, artificial
intelligence, remote medical learning, remote patient
monitoring, and more. Healthcare providers will be
able to build an entire ecosystem that creates highly
responsive, effective, patient-centric experiences”.

Upgraded Telehealth

The most obvious application of 5G is in telehealth,
especially in the context of the COVID-19 pandemic.

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access to essential data and expedite the process “5G has the potential to offer
of identifying and treating certain conditions. In massive connection power,
January 2020, when the COVID-19 outbreak started, fast speeds and low latency
West China Hospital and Chengdu Public Health
Clinic Center of Sichuan University utilised 5G to that can help transform how
remote diagnosis of new coronavirus pneumonia. healthcare is delivered. 5G not
only has the capacity to impact
Ericsson, University Hospital Birmingham NHS the Internet of Medical Things,
Foundation Trust (UHB) and King’s College London it also will help enable medical
also collaborated on the 5G Connected Ambulance. innovations using augmented
The ambulance provides an innovative new way to
connect patients, ambulance workers and remote reality, virtual reality, artificial
medical experts in real-time. Through a live 5G intelligence, remote medical
network in Birmingham, healthcare workers have
performed the UK’s first remote diagnostic procedure learning, remote patient
over 5G. The demonstration showcases how 5G monitoring, and more.”
technology can enable clinicians and paramedics to
collaborate haptically, even when they are miles apart. - Joe Drygas,
VP, Healthcare Industry Solutions, AT&T, USA
This revolutionary use of 5G has the potential
to transform how future healthcare is delivered, Research Institute, and the operation signal was
enabling crucial efficiencies and reducing the need for transmitted in real-time through 5G technology
some patients to visit hospitals. to perform remote hepatic lobectomy for the
experimental animals of Mengchao Hepatobiliary
Clinical Trials Hospital 50 km away. The entire procedure takes
about 60 minutes and the operation delay is
Clinical trials greatly depend on a constant flow of extremely low. The surgical wounds were neat, and
data detailing patients’ responses to the therapies there was no trace of blood in the whole process. The
under investigation. 5G infrastructure and vital signs of the experimental animals were stable
connectivity may now provide drug manufacturers after surgery.
with the incentive and opportunity to place IoT-
connected monitoring devices in the participants’ Challenges
homes during clinical trials.
The biggest hurdle in the widespread applications of
‘This would reduce administrative overhead and 5G is privacy. Especially in light of the recent hacking
processing costs, in turn bringing down the price of incidents related to healthcare such as WannaCry in
each trial and enabling pharma companies to trial 2017 which affected hospitals throughout the world
more drugs each year. And the availability of the data or the major cyber attack on one of Singapore’s
in real-time might shorten the cycle time of a trial largest group of healthcare institutions, SingHealth’s
from, say, eight months to six, meaning the company database containing patient personal particulars and
can get the drugs to market faster or more quickly outpatient dispensed medicines in July 2018. These
halt trials that aren’t working,’ as per a PwC report. instances brought to light the privacy challenges
and vulnerabilities of these smart technologies. The
Remote Surgery privacy concerns also cast a dark shadow over the
adoption of 5G for this sector.
‘5G can meet data-intense , millisecond-latency
requirements necessary for telesurgery, allowing For it to succeed, the entire infrastructure, from
doctors to remotely operate responsive, high- hospitals to equipment, etc., need to be 5G enabled
precision surgical robots,’ highlighted a report from which would increase the cost and may hinder its
Booz Allen, USA, a consulting firm with expertise in adoption further.
analytics, digital, engineering, and cyber solutions.
And of course, it is important to have appropriate
This may sound a bit far-stretched but pilot policies to regulate internet-based diagnosis and
projects are already underway. Huawei and China treatment, to better leverage its full potential. China
Unicom Fujian Branch, Fujian Medical University has already started to draft standards on hospitals’
Mengchao Hepatobiliary Hospital, Suzhou Kangduo internet construction based on 5G. This is an exciting
Robot Co., Ltd. implemented the world’s first 5G time for 5G players and healthcare firms as the
surgery animal experiment in Fujian China Unicom opportunities to thrive are abundant, delivering
Southeast Research Institute. The operation end better outcomes, faster and with a global reach.
of the operation was placed in the China Southeast
Ayesha Siddiqui

26 5G SAGA

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Is the 5G
health scare
unfounded?

The introduction of the 5G network has mobile phones may lead to headaches, heart diseases,
been mired in numerous controversies. and sometimes fertility issues. With COVID-19 on the
Governments across the globe, activists and loose, things have changed for good. With little option
telecom operators are embroiled in a bitter in hand, the urban and rural areas have seen a surge in
fight, filing lawsuits and protesting in large the demand for Internet connectivity.
numbers. Although most of the available
research on electromagnetic fields (EMF) Now, on one hand, we need good Internet service
reveals that there are no harmful effects for online classes and webinars and online conferences
from mobile radiation, some studies do happening in large numbers and on the other, we are
reveal that it has the potential to damage the concerned about the health hazards due to radiation
very structure of the DNA. Cancer, impaired being emitted from mobile phones and other gadgets.
reproductive health and numerous other
disorders, including psychiatric, have been The Stewart report in 2000 by the UK Independent
attributed to 5G. Will the implementation Expert Group on mobile phones declared that children
may be more vulnerable to electromagnetic fields
of the 5G network have serious health (EMF) than any other age group. The conductivity of
implications, or are these fears unfounded? children is higher due to higher moisture and ionic
content compared to adults and more than adults,
We try to weigh-in the opposing sides. children’s head absorbs a lot of RF energy.

The COVID-19 pandemic has opened new Now the question remains, what is the way out
avenues of how people do their day-to-day and what effect will 5G implementation have on one’s
work and how children as young as three are health outcome.
undertaking online lessons. Though a handful of
offices have opened, a majority of the workforce is Possible health hazards
somehow managing to work from home. And all this
has led to increased consumption of the Internet. Till now a handful of studies have been conducted
The high demand for the Internet has forced telecom on the effects of 5G radiation. Though some studies
operators to look out for an advanced form of have been undertaken in western nations, there is no
technology to cater to the demands. concrete proof as to what will be the health outcome
when 5G is implemented in India wholly.
We are all aware of the harmful radiation being
emitted from mobile phones and not only adults but Talking about the possible health hazards 5G
even children are always hooked to mobile phones. might bring in, Dr Harish P, Senior oncologist,
The introduction of the fifth generation or 5G network Cytecare Cancer Hospitals, Bengaluru (India)
has made many cautious about the harmful effects of said, “Excessive screen time associated with easy
mobile radiation. However, healthcare experts and the availability of media in a handheld device makes
government have been able to allay some fears among for longer viewing hours. This in turn has many
the general public, as there is no concrete evidence to psychological impacts. The power of concentration is
prove that mobile radiation can cause health hazards. reduced. This is especially important for very young

A few years back health specialists have raised
concerns and believed that too much handling of

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children whose brain has just started developing. This 5G DAMAGES DNA … A MAJOR
can lead to poor scholastic performances. Adults, as HEALTH HAZARD: SCIENTISTS
well as children, may develop anxiety, restlessness,
depression and addictive habits. The habits could be Last year, in an appeal to the European Union
so strong that increasing suicides especially in the (EU), more than 180 scientists and doctors
younger population are ascribed to overexposure to from 36 countries warned about the danger
screen time. But as such, 5G radiation has not been of 5G, which will lead to a massive increase in
ascribed as a cause for all these changes.” involuntary exposure to electromagnetic radiation.
The scientists have urged the EU to set up an
Likewise, Dr Madhuchanda Kar, Senior Consultant independent task force to reassess the health
and Clinical Director, Department of Oncology, effects of 5G radiation.
Peerless Hospital, Kolkata (India) opined, “There
are short-term consequences like tissue heating and Numerous studies have been conducted since
suspected long-term consequences like brain tumours. the last decade on the harmful effects of radiation
The largest retrospective study by IACR (International from 2G, 3G and 4G technologies. Studies have
Agency For Cancer Registries) conducted in 13 shown that stress, sperm and testicular damage,
countries did not show any increase in brain tumours neuropsychiatric effects, including changes to
even after 10 years of the follow-up study.” electrical activity in the brain, cellular DNA damage
and calcium overload can occur in humans as a
Currently, exposure from 5G infrastructures result of exposure to nonionizing electromagnetic
at around 3.5 GHz is similar to that from existing fields (EMFs).
mobile phone base stations. The extent of any change
in exposure to radiofrequency fields is still under According to Sarah Driessen, Research Center
investigation. for Electromagnetic Environmental Compatibility
at Germany’s University of Aachen, a US-based
Tissue heating is the main mechanism of study shows a clear connection between strong
interaction between EMF and the human body. radiofrequency fields of existing radio standards
However, Radio-Frequency (RF) exposure levels from and cancer in rats.
current technologies result in negligible temperature
rise. IACR has classified EMF as possibly carcinogenic Researchers believe that young children tend
as chance or bias can’t be ruled out with confidence. to be more exposed to radiation as they have
smaller skulls and skull thickness.
According to Dr Kar, “To date, no definite health
effect has been causally linked to exposure to these A blog by Joel M Moskowitz cites research
technologies. There are very few studies on 5G as yet. undertaken by more than 240 scientists who have
Provided that the overall exposure remains below published peer-reviewed research on the biological
international guidelines no consequences for public and health effects of nonionizing electromagnetic
health are anticipated as of now. In this context WHO fields (EMF) signed the International EMF Scientist
is promoting further research and developing public Appeal, which calls for stronger exposure limits.

Cancer risk is predominant besides cellular
stress, increase in harmful free radicals, genetic
damages, structural and functional changes of
the reproductive system, learning and memory
deficits, neurological disorders, and negative
impacts on general well-being in humans. Apart
from human beings and animals, the blog also
points out ill effects on plant life.

Sources: www.jrseco.com, www.dw.com, blogs.scientificamerican.com

information materials. 5G may be hazardous if only
we can prove it.”

Allaying fears

Recently there was news about a certain link between
the 5G technology and the spread of COVID-19.
The Department of Telecommunication (DoT),
government of India sprung into action and clarified

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ANTI-5G MOVEMENT safe limits prescribed by International Commission
on Non-Ionizing Radiation Protection (ICNIRP) and
US-based Environmental Health Trust (EHT), a recommended by WHO.
think tank that promotes a healthier environment
through research, education, and policy, is quite In addition, DoT has approved a financial grant
vocal about the ill effects of radiation from mobile in 2020 for a multi-institute collaborative project to
towers. The think tank has been instrumental in set up the ‘Indigenous 5G Test Bed’ in India at a total
bringing policymakers on a common platform to cost of Rs 224.01 crore over 36 months. The eight
create awareness of the health impact of the 4G/5G collaborating institutes in the project are the Centre
densification. of Excellence in Wireless Technology (CEWiT), IIT
Bombay, IIT Delhi, IIT Hyderabad, IIT Madras,
According to the EHT website, over 600 cities IIT Kanpur, IISc Bangalore and Society for Applied
in Italy have passed resolutions to halt 5G, as have Microwave Electronics Engineering & Research
cities throughout Europe, such as Trafford, the UK, (SAMEER).
Lille, France, Ormideia (Cyprus), Balchik, Bulgaria.
Bermuda has halted 5G pending a safety report. Precautions
Switzerland’s report on 5G health effects resulted
in the Parliament’s refusal to loosen their radiation However less radiation is being emitted from gadgets,
limits despite heavy industry lobbying efforts. The one should always remember that studies are still
Netherlands issued a 5G report that recommended going on and the human body is going to have an
measuring radiation levels and also recommended impact due to radiation. With fewer options in hand,
against using the 26 GHz frequency band for 5G certain preventive measures can be adopted to
“for as long as the potential health risks have not minimise the risk.
been investigated.
According to Dr Harish P, “Fifth-generation (5G)
It may also be noted that Indian actress Juhi cell phones are anticipated to use the frequency
Chawla has spearheaded a movement against spectrum up to 80 GHz. These frequencies all fall
the implementation of 5G and its implications on in the non-ionizing range of the spectrum, which is
health. Recently, Chawla also filed a lawsuit to low frequency and low energy. The energy is too low
protest against 5G technology in India and the case to damage DNA. DNA damage can cause changes to
is still going on. genes that may increase the risk of cancer. So there
is no risk of any cancers with the current frequency
EHT claims that 5G will increase ambient levels spectrum.”
of wireless radiofrequency radiation. Peer-reviewed
research has demonstrated a myriad of adverse On the other hand, Indian Society for Clinical
effects from wireless radiofrequency radiation Research (ISCR) has classified that electromagnetic
including increased brain cancer, DNA damage, fields (EMF) is possibly carcinogenic and so the
oxidative stress, immune dysfunction, altered concern remains. The World Health Organisation
brain development, damaged reproduction, sleep is encouraging more studies to be conducted and
changes, hyperactivity, and memory damage. promoting further research besides developing public
information material to create awareness among the
that several misleading messages were being circulated public.
on various social media platforms claiming that the
second wave of coronavirus has been caused by the At present, telecom operators are facing the brunt
testing of the 5G mobile towers. amidst the fear of radiation lurking in the minds of the
common man. Activists and NGOs have jumped into
As per a press statement issued by DoT, the the fray to convince the government across the world
messages are false and not correct and have no against the harmful impact it will have on health.
scientific basis. Moreover, the department informed Though a lot of research still needs to be undertaken,
that the testing of the 5G network has not yet started only time will tell whether a 5G network is really bad
anywhere in India. for us or it will help economies flourish due to better
Internet connectivity. While we are tackling the 5G
Mobile towers emit non-ionizing radio frequencies health scare, speculations are rife about the impending
having very minuscule power and are incapable of launch of 6G. Already launched in countries like China
causing any kind of damage to living cells including and Japan, and Canada presently implementing it, the
human beings. DoT has prescribed norms for exposure 6G network will, most likely, unleash newer concerns
limit for the Radio Frequency Field (i.e. Base Station and fears of even more severe health hazards.
Emissions) which are 10 times more stringent than the
Sanjiv Das
[email protected]

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A new class of drugs
called digital therapeutics
(DTx) is on the rise. What
is DTx, how is it different
from wellness/fitness
apps/wearables, how
can these be regulated,
and most importantly
can it successfully and
sustainably integrate into
the current healthcare
system? Let’s find out.

DTx: A powerful
arsenal in healthcare
Digital therapeutics (DTx) is defined as
products that ‘deliver evidence-based DTx vs wellness apps
therapeutic interventions that are driven by
high quality software programs to prevent, manage, Compared to products that track fitness, encourage
or treat a medical disorder or disease. medication adherence, or monitor patient activity,
DTx products deliver medical interventions directly
This is not to be confused with digital medicines to patients. As such, digital therapeutics undergo
or ‘smart pills’ which combine a prescription rigorous testing and are held to the same standards of
medication with an ingestible sensor that is designed
to communicate with a software application to track “The difference between
compliance. They are also different from non- DTx and nonprescription
prescription wellness apps/devices in a way that therapeutics is the capacity to
these are heavily regulated much like the traditional make medical claims backed
drugs. by robust, FDA reviewed clinical
evidence, which in turn means
DTx is a booming field. There are currently the difference is that with DTx
4236 studies registered in digital therapeutics on patients, and payors have the
clinicaltrials.gov as of July 19, 2021. Majority of these assurance that the global gold
are for psychiatric indications followed by diabetes standard of safety and efficacy
and respiratory health. USFDA has determined that
a therapeutic is providing a
Changing medical protocols, alongside the need meaningful improvement in
to bring down the cost of care is driving an upsurge
in investments in digital therapeutics, which is care”.
projected to grow at the rate of 26.7 per cent to reach - Everett Crosland,
$6.9 billion for the period 2020-2025, according to
MarketsandMarkets. Chief Commercial Officer, Cognito Therapeutics, USA

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LATEST DEVELOPMENTS “Digital therapeutics delivers
IN DIGITAL THERAPEUTICS medical interventions directly to
patients using evidence-based,
● In April 2021, leading Japanese medical VR
clinically evaluated software to
company Jolly Good has recently established treat, manage, and prevent a

a specialised DTx Division to develop digital broad spectrum of diseases and
disorders. Depending on the
therapeutics using VR and AI technologies type of medical claims made
● In December 2020, Neuroglee Therapeutics, a and the level of regulatory
oversight required, these
Singapore-based healthtech startup that builds
products can be regulated and
evidence-based, prescription digital therapeutics accessed either as prescription

for neurodegenerative diseases, raised $2.3 or non-prescription”.
- Hannah Fairman,
million in pre-seed funding. The funding will be
Engagement Manager,
used to advance the product pipeline for their Digital Therapeutics Alliance (DTA), USA

lead product NG-001 – intended for treatment patients and payors have the assurance that the
global gold standard of safety and efficacy USFDA
and management of patients with early stages of (The United States Food and Drug Administration)
has determined that a therapeutic is providing a
Alzheimer’s disease meaningful improvement in care”, said Everett
● In September 2020, Sanofi partnered with Crosland, Chief Commercial officer at Cognito
Therapeutics, USA.
Taiwan’s Health2Sync to deliver digital
Cognito Therapeutics is a clinical-stage company
therapeutics in diabetes developing a pipeline of disease-modifying digital
● In November 2019, Japan headquartered Astellas therapeutics targeting neurodegenerative disorders.
The company’s lead digital therapeutic reported
Pharma and US based Welldoc, Inc. partnered for positive Phase 2 results in Alzheimer’s, and was
awarded USFDA breakthrough device designation.
the development and commercialisation of digital
A parallel to this distinction would be wellness-
health solutions including digital therapeutics focused vitamin supplements that are available over
● In October 2019, US’ Pear Therapeutics the counter versus prescription medicine that is
approved by regulators for safety and efficacy.
collaborated with Ironwood Pharma for GI-
Evolving policies
focused digital therapeutics
● In March 2019, US’ Akili and Japan’s Shionogi Digital therapeutics are regulated as medical devices.
They are most frequently categorised by regulatory
partnered to develop and commercialise digital jurisdictions as a subset of Software as a Medical
Device (SaMD), a framework developed by the
therapeutics in key Asian markets International Medical Device Regulators Forum
(IMDRF). It is important to note that not all DTx
evidence and regulatory requirements as traditional products qualify as SaMD, and not all SaMD products
medical treatments. qualify as a digital therapeutic.

Wellness and fitness apps that consumers The regulatory landscape for DTx is still evolving,
download to their smartphones are not typically and regulators around the world are working towards
regulated, nor do they need to prove product claims developing appropriate policies.
by scientific testing or clinical evidence.
The USFDA in 2017 launched a Pre-Cert Pilot
“Digital therapeutics deliver medical interventions Program which is meant to explore a reimagined
directly to patients using evidence-based, clinically regulatory paradigm that will help determine how to
evaluated software to treat, manage, and prevent a tailor a total product lifecycle approach to oversight
broad spectrum of diseases and disorders. Depending of software. The modeling phase has continued in
on the type of medical claims made and the level of 2019 and 2020, as it builds, iterates, and tests the
regulatory oversight required, these products can be
regulated and accessed either as prescription or non-
prescription”, said Hannah Fairman, Engagement
Manager, Digital Therapeutics Alliance (DTA), USA.

Founded in 2017, DTA is a non-profit trade
association of industry leaders and stakeholders
engaged in the evidence-driven advancement of
digital therapeutics.

“The difference between DTx and nonprescription
therapeutics is the capacity to make medical claims
backed by robust, FDA reviewed clinical evidence,
which in turn means the difference is that with DTx

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proposed Pre-Cert Pilot Program framework. The “Given the capacity of these
next phase will be the assessing phase where the therapeutics to delay or
FDA will identify infrastructure needs and plans for change the trajectory of
statutory authority. The regulator plans to follow this
with beta testing which will focus on scaling up the disease progression, a new
testing of the program. And then, the regulator would emerging class of digital
look to transition from pilot to program.
treatments stand to realise
In Europe, Germany has passed the Digital significant value and
Care Act in 2019, which allows doctors to prescribe
digital therapeutics and patients can reimburse such return on investment for
therapies in the same way as traditional drugs. health plans, patients, and
providers, only recently seen
Australia’s Therapeutic Goods Administration with other historic advances
(TGA) amended the Therapeutic Goods (Medical
Devices) Regulations 2002 to clarify the regulation of in care such as curative
software-based medical devices. The changes which treatments in infectious
came into effect in February 2021 include; clarifying
what are regulated software products; introducing disease and long-term
new classification rules; and providing updates to progression free survival
the essential principles to more clearly express the achieved via recent advances
requirements for software-based medical devices.
in immuno-oncology”.
In 2018, South Korea’s regulatory body The - Kimberly Ha,
Ministry of Food and Drug Safety (MFDS), which
is the regulatory agency for medical devices, first CEO, KKH Advisors, USA
enacted guidelines relating to the examination and
approval of digital therapeutics in August 2020. The APPROVED DIGITAL THERAPEUTICS
country has simplified the licensing procedure for
DTx. Product/ Indication USFDA
company
DTx in current healthcare
BlueStar/ Diabetes USFDA
Though there has been a steady upsurge in the Welldoc (USA)
digital therapeutics space, the biggest challenge is
its successful integration into the current healthcare Deprexis/ Depression USFDA
system. Orexo
(Sweden) Panic USFDA
“Digital therapeutics can be successfully and Disorder and
sustainably integrated into the healthcare system Freespira/ Posttraumatic
if the integration is done via thoughtful planning Freespira, Inc. stress disorder
and infrastructure. This is different from launching (US) (PTSD) symptoms
traditional therapeutics”, said Jaydev Thakkar, Chief
Operating Officer (COO) at Biofourmis, a fast-growing Insulia/ Diabetes USFDA
virtual care and digital therapeutics company that was Voluntis
founded in Singapore (and has offices there) and is (France)
now headquartered in Boston, USA.
Kaia Health/ Back pain USFDA
Everett Crosland echoes the same sentiments, Kaia Health
“Yes, digital therapeutics can integrate into (US)
Healthcare systems and workflow at scale. The key
to doing so is patient-centered and HCP (healthcare Propeller/ Asthma USFDA
professional)-centered design from the earliest Propeller
possible stage of development”. Health (US)

Digital therapeutics represent a quickly evolving reSET/Pear Substance Use USFDA
category of evidenced-based therapeutic technologies Therapeutics Disorder (SUD)
that support clinicians and healthcare decision (US) Ministry of Health,
makers (HCDMs) in the delivery of high-quality Labour and
patient care. reSET-O/Pear Opioid Use Welfare (MHLW),
Therapeutics Disorder (OUD) Japan
“Currently, there are no commonly used, (US)
Rigid
CureApp SC/ Smoking
CureApp Inc
(Japan)

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“Digital therapeutics can be ● Manage technology lifecycle – Many DTx
are designed to be used on smartphones or have a
successfully and sustainably mobile app component. It is essential to keep the
mobile app component of the DTx upgraded and
integrated into the healthcare tested to ensure it works well with a wide range of
smartphones and operating system versions (iOS,
system if the integration is done Android) commonly in use.

via thoughtful planning and ● Drive patient adherence – Consider who
will track and drive adherence to ensure patients are
infrastructure. This is different continuing to use and engage with a DTx solution.
While adherence remains a challenge for non-digital
from launching traditional therapies, for digital therapies, ensuring adherence
can be even more challenging. It is fairly easy for a
therapeutics”. patient to download an app and forget it after a few
days. A typical patient may have hundreds of apps
- Jaydev Thakkar, on their smartphone. It’s important to implement a
well-planned patient engagement strategy to drive
Chief Operating Officer, Biofourmis, USA adherence. One of the greatest drivers of adherence
for DTx is the improved outcomes patients see when
standardised frameworks for payors, providers, they faithfully use them. It’s also important to focus on
and other healthcare decision makers to rely on as technology that draws patients in, helps them see their
they work to implement, use, and benefit from DTx progress, and gets them excited about using the DTx.
products in practice. Instead, these stakeholders
- ranging from single-payor government systems ● Integrate with clinical workflows –
to multi-payor public/private settings - face the Consider how the DTx solution will interact with or
challenge of developing their own evaluation be integrated with existing clinical workflows and
pathways to assess and implement health pathways. Does it need to surface data back to the
technologies. This is resulting in a diverse patchwork prescribing doctor? Does it need to be integrated
of frameworks across health systems and regions with the EHR? It’s important to ensure seamless
with greatly differing clinical, security, and scalability integration so that the DTx enhances the clinician
requirements for DTx products”, said Hannah. workflow rather than disrupting it.

The DTA is therefore leading the development of ● Demonstrate outcome in real world –
a ‘DTx Value Assessment and Integration Guide’ to Beyond the evidence generated in clinical research
both enhance and refine assessment processes within phase, partnering closely with regulators and payers
existing systems, and provide a foundational template is important in order to demonstrate sustained
for organisations undertaking the development of clinical and economic outcomes in a real-world
new pathways to evaluate and assess DTx products. setting.
DTA hopes that this framework will enable greater
consistency and confidence in how DTx products are “Given the capacity of these therapeutics to delay
evaluated and implemented across practice settings or change the trajectory of disease progression, a
and regions. new emerging class of digital treatments stand to
realise significant value and return on investment for
For successful DTx integration, Thakkar health plans, patients, and providers, only recently
expounded the following: seen with other historic advances in care such as
curative treatments in infectious disease and long-
● Earn the trust needed for data privacy term progression free survival achieved via recent
and security - DTx may include obtaining patient advances in immuno-oncology”, said Kimberly Ha,
data digitally. Data privacy and security must be very CEO, KKH Advisors, a strategic consulting firm for
well managed and communicated to patients and life sciences and digital health companies, USA.
physicians. DTx companies need to earn that trust by
following best practices and meeting all regulatory As with most digital things, privacy is of
requirements. paramount importance when it comes to digital
therapeutics and the firms developing these must
● Avoid burdening prescribers with take that into consideration. But, no doubt, digital
training and tech support – While swallowing a therapeutics is a promising field and will play an
pill doesn’t require patient training, DTx solutions important role in the evolution of healthcare.
usually involve software applications that need to
be used by the patient or caregiver. It is essential Ayesha Siddiqui
to keep the technology extremely easy to use,
with considerations for technology-naïve patient
populations as part of the design. Also, appropriate
training and support should be made available
to avoid putting the burden of “tech support” on
prescribers.

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“We see great potential for mRNA technology
to address a broader range of diseases”
In sync with the recent vaccine trends, South Korea-
based contract development and manufacturing «
organization (CDMO), Samsung Biologics is all set
to add mRNA vaccine drug substance manufacturing James Choi,
suite to expand its portfolio of services. In conversation Senior VP,
with BioSpectrum Asia, James Choi, Senior VP, Chief Chief Information &
Information and Marketing Officer, and Head of Marketing Officer,
Investor Relations, Samsung Biologics, South Korea, and Head of Investor
talks in detail about the company’s growth plans. Relations, Samsung
Edited excerpts; Biologics, South Korea

What big plans are in store to enhance the sales discussions. Our US R&D Center in South San
global production of mRNA vaccines? Francisco is fully equipped and operational to support
our global clients.
As part of our long-term growth strategy, we’ve been
expanding our business portfolio and production What investments are you planning for 2022?
capacity to meet the growing demand in mRNA
manufacturing services. Apart from the agreement We recently began substantial investments in further
in late May this year for the aseptic fill-finish as well expansion of biologic drug substance and aseptic
as packaging and labeling of Moderna’s COVID-19 filling capacities. Our business planning currently
mRNA vaccine, we recently announced plans to add includes three areas of expansion: capacity expansion,
an mRNA drug substance suite to our site by the first such as adding additional capacities and capabilities
half of 2022 to diversify our service offerings. We see to our second Bio Campus next to our headquarters,
great potential for mRNA technology to address a geographical expansion to improve client support on
broader range of diseases, beyond COVID-19. a global scale as demonstrated by the opening of our
US R&D Center last year, and platform expansion as
What could be the bottlenecks associated previously mentioned to provide more diversified,
with mRNA vaccine manufacturing? multimodal state-of-the-art infrastructure.

Bio-manufacturing has a high barrier to entry as it We also published our annual sustainability
requires extensive investment in GMP-compliant report, which consolidates our policies for an
facilities, equipment, and procedures. Managing a enhanced ESG management system as well as
talent based skill in mRNA along with state-of-the-art showcasing our ongoing commitment and long-term
technology are imperatives to ensure the consistent strategy for social responsibility. In the next ten years,
delivery of safe and high-quality products. At Samsung we plan to expand our environmental investments
Biologics, our team of experts are ready, and our aim in response to climate change, focus on reducing
is to have everything in place to commence drug corporate energy consumption, and participate in the
substance manufacturing of mRNA vaccines by the Carbon Disclosure Project. We also will strengthen
first half of 2022. our collaborative efforts with domestic bio-ventures
for the localisation of raw materials and fostering of
What is the projected growth for FY 21-22? bio-talent.
What’s being planned for the year?
How do you foresee the growth of the CDMO
Our first-quarter financial performance was in line sector within Asia in years to come?
with our expectations and provided us with a strong
start to 2021. Since then, we have maintained solid In recent years, we’ve seen exceptional growth in
performance and momentum from our expanding the CDMO sector within Asia, especially in South
CDMO business globally, while stably managing our Korea. Despite being in its early stages, the Korean
ongoing projects across our plants 1, 2, and 3, which biotechnology industry continues to invest, build, and
have been at near full operation amid the pandemic. establish a robust bio-cluster.

For the rest of the year, the construction of our Dr Manbeena Chawla
new Plant 4 will remain on track with active pre- [email protected]

34 SPEAKING WITH

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“Transparent partnerships, will enable
emerging biotech and biopharma
companies to deliver innovative solutions”

« are a lot of biotech companies coming to JAPAC
to run their clinical programmes and wanting to
Dr Senthil Sockalingam, launch their drugs in the region given the attractive
market dynamics. Given the rise of the region and
Head of IQVIA Biotech the globalisation of drug development, especially
around emerging biopharma (EBPs), it was a good
(Asia Pacific), time to launch IQVIA Biotech in JAPAC.

Singapore The clinical development needs of emerging
biotech and biopharma companies across Japan and
IQVIA has announced the Japan and Asia Asia Pacific, are different to those that make up the
Pacific (JAPAC) expansion of IQVIA Biotech, more established pharmaceutical industry. We know
a tailored approach to delivering integrated that emerging biotech and biopharma companies
clinical solutions at an accelerated pace. As stated need high flexibility, rapid turnaround timelines for
in a recent white paper by IQVIA Biotech, the total faster and smarter decisions, competitive pricing,
pipeline of emerging biopharma (EBP) companies predictable cash flows and a research organisation
in JAPAC is equivalent to roughly two-thirds of the that provides a transparent partnership in clinical
entire global biopharma industry pipeline. In JAPAC development. Therefore, the IQVIA Biotech offering
alone, just under 7000 studies were launched is a custom-built delivery model that mirrors
by mid- and small-size EBPs between 2016 and biotech organisations to offer simplified operating
2020. Indeed, the expansion is complemented with procedures, reduced complexity and specialised
IQVIA Biotech’s advanced analytics and technology teams with deep local expertise to provide a more
solutions for clinical research programmes which agile way for emerging biotech and biopharma
assist in clinical progress of biologics, drugs, and companies to reach their clinical and commercial
vaccines. Speaking with BioSpectrum Asia, Dr milestones. With our regional headquarters for
Senthil Sockalingam, Head of IQVIA Biotech (Asia IQVIA Biotech in Singapore and offices in 15
Pacific), Singapore shares the aspirations and goals countries, we have specialised teams collaborating
of new JAPAC expansion dedicated to biotech and across 16,000+ sites, to provide custom-built,
emerging biopharma industries. Edited excerpts; fit-for-purpose clinical and commercial solutions
specifically tailored to fit the unique needs of
How significant is the recent expansion to dynamic and fast-moving emerging biotech and
JAPAC and what are the key performance biopharma companies in JAPAC. By harnessing the
goals? power of unparalleled data, innovative technology,
advanced analytics, and domain expertise to create
JAPAC (Asia Pacific and Japan) is an increasingly intelligent connections, IQVIA Biotech solutions
important location for clinical trials. The region can accelerate clinical and commercial success for
accounts for close to 60 per cent of the world’s local and multinational emerging biopharma clients
population and presents high disease burdens, fast operating in JAPAC, and ultimately also improving
improving infrastructure, clinical trial recruitment patient health outcomes.
and regulatory efficiencies, globally leading data
management innovation, and, increasingly, greater Can you share insights on the current
government support of clinical research.
potential therapeutic portfolio and clinical
Clinical trial sites set up by biotech and
biopharma companies in JAPAC have increased by assets at JAPAC clinical development
over 40 per cent each year on average, compared to
just 11 per cent across the rest of the world. There operations? How do you foresee market

access and commercialisation prospects in

the region?

Our focus in JAPAC is to provide tailored clinical
development expertise and highly customised

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solutions for the distinct needs of emerging biotech cent of late-stage research globally. We know their
and biopharma client partners. needs are different and they require high flexibility
and custom-built clinical and commercial
JAPAC is a diverse region that has different solutions.
stages of maturity and business objectives. Oncology
is a big trend amongst biotech companies in the IQVIA Biotech’s offerings are dedicated to
region. There’s an increased trend in neurology, removing the complexities in the way of emerging
particularly around psoriasis and osteoarthritis biotech and biopharma companies and specifically
treatment, and immunology. designed to meet their regional and global
aspirations. Transparent partnerships, a superior
Having a team with expertise in specific level of quality and a deep commitment to each
therapeutic areas is crucial to the success of study, will ultimately enable emerging biotech
clinical development programmes. Our therapeutic and biopharma companies to deliver innovative
focus areas for IQVIA Biotech are: Oncology, solutions to those who need them most.
Cardiovascular, Central nervous system conditions,
Dermatology and Rare diseases. Partnering will be critical going forward and in
JAPAC, IQVIA pays special attention to ensuring
In addition to our clinical solution, our offerings that our partnering and delivery teams have the
also include asset valuation and due diligence, cultural/language capabilities appropriate to their
drug development strategy and analytics, launch EBP partners and the countries/regions involved in
strategy and planning to help develop a market- each respective development-launch programme.
backed, evidence-driven commercial plan. Our local The expectations to deliver on unmet medical needs
and global experts provide actionable insights and – as well as continuing to innovate in new business
resources to help accelerate commercial success by models – is paramount. With a wide variety of
offering Contract Sales and Medical Solutions to outsourcing models now well established in the
provide new capabilities by building and deploying industry, EBP organisations can explore a host of
contract sales and/or medical teams, and free up arrangements with varying levels of engagement and
resources for more innovation. integration. Fully partnered options can improve
integration of partners’ processes and technology,
Can you elaborate on IQVIA’s integrated help ensure resource and development forecasting
clinical and commercial strategies to and planning through earlier engagement, enhance
accelerate the drug innovation spectrum? real-time escalation of issues and more swift
resolutions and provide clearer accountability
We partner with emerging biotech and biopharma for outcomes leading to significantly improved
companies to help them streamline operations predictability and downstream productivity.
and gain valuable visibility into market forces.
A long-term strategy from the outset that helps How has the strategic partnerships and
to avoid costly amendments down the road is
critical. IQVIA Biotech in JAPAC partners with investor relations in IQVIA Biotech been
emerging biotech and biopharma companies to
develop comprehensive plans at an early stage to affected by COVID-19?
provide a roadmap for key activities – including
cost and timeline factors – with investors and other The ongoing pandemic has forced us to virtualise
key stakeholders in mind. Our experts provide and do things differently. In JAPAC, the
actionable insights and resources to help accelerate virtualisation has increased so rapidly that the
drug development, commercial success, maximize regulatory framework is still catching up. Sales and
value through an evolving commercial model and scientific engagement with healthcare providers has
get the product into the hands of the patients who virtualised, allowing broader outreach and faster
need it. feedback, adaptation of education, and quicker
understanding of the commercial value of a product.
How do you describe IQVIA Biotech’s This helps companies make more data driven
partnering solutions tailored for emerging decisions, and gain more exposure to innovative
biopharma (EBP) companies in the JAPAC therapeutics, which are driven out of biotech. We
biopharma industry? are constantly monitoring these developments and
adjusting our execution plans to provide bespoke
Emerging biopharma (EBP) companies are proving solutions and meet the distinct requirements of
to be a disruptive force, representing a significant customers in the light of these challenges.
portion of innovation and development in life
sciences with 84 per cent of early-stage and 73 per Hithaishi C Bhaskar
[email protected]

36 SPEAKING WITH

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

“Keep investing in expanding
manufacturing capacity is
our commitment to customers”

« talent, R&D collaboration, supply chain resilience,
manufacturing models, as well as government policy
Francis Van Parys, and regulation.

Vice President, The index shares the perspectives of 1,100
industry experts in 20 countries – nearly half of them
Asia Pacific, in the Asia Pacific region— on current biopharma
needs in five areas: supply chain, talent, government
Cytiva, South Korea policy, collaboration and manufacturing agility. The
index further serves as a consistent guide for us to
Responding to the increased demand for ascertain areas for evaluation, and determine which
products that are used in emerging modalities aspects of the industry require the most support.
such as gene therapy, and are currently in
high demand for the manufacture of COVID-19 The Asia Pacific region is incredibly diverse and
vaccines and therapies, Cytiva is investing $1.5 demands equally diverse solutions. Each country in
billion over two years to meet growing demand for the region faces its own set of difficulties, pertaining
biotechnology solutions. Investment follows five to governmental support, economic growth and
strategic acquisitions made by the companies this innovative capabilities. Accordingly, Cytiva is
year and is in addition to Cytiva’s continuing capacity accelerating solutions that leverage on regional
investments estimated at $500 million through advantages and circumvent geographic shortcomings.
2022. With this announcement, Cytiva is enhancing Looking into our pipeline – From the biopharma
the global supply chain so customers in Asia Pacific resilience index, we see manufacturing in-region
region should feel the benefit. Francis Van Parys, Vice for-region is a growing trend because our customers
President, Asia Pacific, Cytiva, South Korea reveals require more flexibility and adaptability. Therefore,
more during a conversation with BioSpectrum Asia. we are looking forward to having more “in-region, for
Edited excerpts; region” efforts and results in the Asia Pacific to help
our customers improve the manufacturing resilience.
What are the new initiatives being planned
for the APAC market? Are there any launches Furthermore, a significant part of our localised
or announcements in the pipeline in 2021? support is talent development. Cytiva built its Fast
Trak centers and Experience labs in China, South
I would love to share our latest ongoing strategic Korea, India, Japan and Singapore. These facilities are
growth plan - Cytiva and Pall Corporation will intended to provide hands-on training for thousands
expand manufacturing capacity and services across of professionals each year, empowering them with the
geographies for global life sciences customers. The skills they need to drive this industry forward. We offer
investment, already underway, includes new sites, world class courses on the technologies and equipment
expansion at existing factories, and is additional in both upstream and downstream biomanufacturing
to previously announced investments. It follows – key to discovery research organisations, as well as
five acquisitions made by the companies so far this mature biopharmas.
year. This investment also addresses some of the
key challenges highlighted in the Global Biopharma By understanding the APAC region’s varied
Resilience Index, conducted by Longitude, a environments and tailoring our approaches, we are
Financial Times company, and published by Cytiva well-positioned not only to enrich the talent pools
in March 2021. These include hiring and training of countries, but also contribute to each nation’s
biopharmaceutical aspirations and goals.

Please share more details on the recent

sustainability plans being set by Cytiva.

Sustainability is integral to the state of global health

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and business, and remains a cornerstone of Cytiva’s by PNI in the area of mRNA therapies, particularly
commitment to creating innovative medicines. On through its Genetic Medicine Toolkit which enables
May 13, 2021, we released our global sustainability rapid development and increased efficacy of genetic
plan, “Designing in Sustainability”, with the aim of medicines, will be an invaluable addition to Cytiva in
building the foundation for a resilient company and advancing our therapies and improving our patients’
to create long-lasting positive impact across multiple lives. Given its trajectory, mRNA technology shows
facets of society. The plan includes 2025 targets to great promise as a mode of treatment for other
increase inclusion and diversity, reduce energy and conditions such as cancer and genetic diseases, which
emissions, optimise plastics, packaging, and water have not yet found effective therapeutics.
use. Thus far, we have seen a 1.2 per cent absolute
reduction of CO2 emissions, and 6.5 per cent On June 29, 2021, Cytiva announced the
reduction of water consumption despite increases in acquisition of Intermountain Life Sciences, a
demand and deliveries. Looking ahead to 2025, we manufacturer of high-purity water, buffers, and liquid
target 100 per cent of sites to be exclusively powered cell culture media. Cytiva sees the demand for buffers
by renewable electricity, and are committed to and cell culture media has grown substantially
ensuring that 50 per cent of single-use products are in recent years, we will use Intermountain’s
acceptable for recycling. Within the past six months, manufacturing site in Utah to rapidly boost its liquid
20 per cent of Cytiva’s suppliers have completed a cell culture production by millions of liters.
sustainability assessment, and more are expected
to do so in the future. Cytiva is also a founding All of those initiatives are about evolving and
member of the Bio-Process Systems Alliance (BPSA), accelerating deliveries to our customers.
which specialises in improving single-use product
manufacturing, and has aligned its goals with the How do you foresee the growth of lab
United Nations Global Compact, so as to contribute
positive change and ensure a sustainable future. automation & digitised R&D in the coming

Beyond our own borders, Cytiva has partnered years?
with TerraCycle, a creative social enterprise that
repurposes common non-recyclable materials, to As the mechanisms for manufacturing and
reuse previously un-recyclable plastic syringe filters. bioprocessing evolve, companies must be invested
We have also begun collaborating with the Biomedical in improving efficiency and overcoming pitfalls.
Science Careers Program (BSCP) to increase access to Laboratories and manufacturing facilities across
scientific education, and invested $3.8 million via the the globe are beginning to embrace the potential of
Innovation Accelerator into projects aimed at reducing digital solutions in managing huge amounts of data,
single-use waste and implementing sustainable through mechanisms such as digitalised laboratory
manufacturing practices. The success of such projects informatics systems and AI-based data analysis
indicates that sustainable practices are necessary for a algorithms. By leading the trend in automation and
company to be resilient. digitising lab processes, we hope to improve our
methods of manufacturing and production that yield
What are the key plans behind the recent more efficient results while reducing time and costs
that have accompanied traditional methods.
acquisitions made by Cytiva?
The process of integration has already begun:
In the first half of 2021, we have successfully Cytiva recently acquired German scientific
completed five strategic acquisitions to build capacity software maker GoSilico, which accelerates
and the therapeutic development workflow to process development through simulations.
advance and accelerate the work of our customers. Unlike traditional methods which can take up to
On June 1, 2021, Danaher announced its acquisition approximately 13 weeks, GoSilico’s simulation
of Precision NanoSystems (PNI). The Canada-based software produces a robust solution within about
company has long been a renowned global leader 1 week, and reduces experiment material use,
in the development and manufacturing of lipid while ultimately allowing for more confident
nanoparticles for the delivery of genetic medicines, decision-making. Cytiva has also collaborated with
including mRNA. mRNA technology has seen Multiply Labs to develop a robotic manufacturing
wide uses in recent years, most significantly as a system that will automate parts of the cell therapy
component in COVID-19 vaccines, and the overall manufacturing workflow. Advanced robotics and
mRNA therapeutics market is growing rapidly at digital solutions mark the future of biopharma’s
an accelerated pace. We believe that the work done processes, from optimising process development to
automating manufacturing systems.

Ankit Kankar
[email protected]

38 SPEAKING WITH

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

“DCT reduces patient and sponsor
burden, while increasing accrual and
retention of a more diverse trial population”

« and inefficient on-site practices. The potential
benefits of a DCT model range from reduced patient
Edwin Ng, and sponsor burden, to increased accrual and
Senior Vice President, retention of a more diverse trial population. In this
APAC, way, the entire clinical trial life cycle is improved
Medidata Solutions due to efficiencies at each step of the process. With
continual digital oversight with our platform,
Medidata, the first company in the world to sponsors and CROs can continually monitor patient
unify direct patient data capture technology safety and data quality, without waiting weeks or
redefining end-to-end decentralisation for months for an on-site visit. DCTs have the potential
sponsors and CROs. A Dassault Systèmes company, to change the entire clinical trial process as we know
Medidata announced the launch of Decentralised it today.
Clinical Trials (DCT) Program, a comprehensive set
of unified, secure technologies that enable complete Medidata DCT Program is the only unified
decentralisation across the clinical trial continuum. platform that enables full, end-to-end clinical trial
Headquartered in New York City, Medidata has decentralisation — all on Medidata Clinical Cloud.
locations in China, Japan, Singapore, South Korea, This means sponsors and CROs do not need to
the United Kingdom, and the United States. integrate multiple vendors or solutions. Data is
Medidata DCT technologies equip drug, vaccine, and shared natively across products, allowing sponsors
medical device developers (sponsors) and CROs with and CROs to decentralise as much or as little of the
a platform which leverages technology for workflows trial process as they choose, without worrying about
virtualisation, trial oversight tools, patient safety compromising data integrity. The result is a more
reports, data quality checks, including facilitation of efficient, more secure route to decentralisation that
home delivery of trial drugs. BioSpectrum Asia brings only Medidata can provide.
more insights on the recent surge in decentralised
clinical trials in the APAC region while conversing How is Medidata redefining end-to-end
with Edwin Ng, Senior Vice President, APAC,
Medidata Solutions. Edited excerpts; decentralisation standards for sponsors

How do you describe the economic and (drug, vaccine, and medical device
operational benefits of adopting DCT unified
platform to minimise data discrepancies, developers) and CROs?
transfer lags, security concerns and trial
disruption risk? To be successful, DCTs cannot just be about
patient participation. Medidata is redefining
Sponsors and CROs are turning to decentralised how sponsors and CROs manage their
trial models in an effort to bring increased efficiency, activities not just at the site but off
security, and accessibility to the clinical research the site as well, giving them the
process. The Medidata DCT Program revolutionises flexibility to support any level
sponsor study oversight by supporting sponsors and of decentralisation required in a
CROs easy adoption of risk-based approaches to protocol.
study execution, rather than historically reactionary
The Medidata DCT Program’s
embedded capabilities for risk
identification, monitoring, and
mitigation allow for true digital
oversight, where physical and virtual
interactions with sites can be optimised
while maintaining patient safety and
data quality. The program also allows for powerful
workflows driven from patient-centric data, such as
shipping the investigational product directly to the
patient or making automated dosage adjustments.

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BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Medidata Digital Oversight enables continuous and bringing novel therapies to market in record
data monitoring from anywhere, allowing sponsors time. With APAC fast becoming the preferred choice
and CROs to innovate and optimise approaches for clinical trials, it is crucial that we provide the
to trial design, physical and virtual interactions area with cutting-edge tools. We want to ensure
with sites, and support a holistic portfolio strategy. that sponsors and CROs in APAC have access to the
Because patient data collection does not happen in leading end-to-end, unified and secure life sciences
a typical controlled environment, DCT models have platform.
inherent data quality risks, and when point solutions
are cobbled together instead of using a unified Globally, Medidata has more than 90 accredited
platform, there’s an additional layer of risk involved. partners with 24,000 studies conducted. Of these
Which is why the Medidata DCT Program being fully 7,700 of these studies are in APAC. We recognise
integrated and hosted on a unified platform is so APAC’s great growth potential. Several sponsors
significant. in Korea and China are using our solutions, such
as eConsent and eCoA in advanced clinical trials.
Technology needs to be integrated into the To ensure the growth of the region, we are also
operational and decision-making processes. aggressively expanding our team in the region to
Interoperability is critical. We can put all these better support our partners and customers in their
capabilities to DCT the entire trial on one data trial studies.
platform and tune them up or down based on
the specific customer protocol design. With these How does Medidata plan to leverage the DCT
flexibilities, Medidata is able to support sponsors and
CROs in research areas ranging from cardiovascular Program to accelerate research in the APAC
disease, neurology and oncology, to rare diseases and
infectious diseases such as COVID-19. region and bring novel therapies to market in

How do you foresee major DCT markets for record time?

Medidata in the APAC region and its edge At the industry level, there is a struggle to efficiently
manage clinical trials due to a fragmented and
over the other players in the market? rapidly changing trial ecosystem. As a result, clinical
operations, in APAC or any other part of the world,
The DCT Program marks an important evolution must evolve at the pace of the research it supports.
in Medidata’s vision for how we can better serve There are three key areas where clinical operations
patients and customers, by accelerating research must evolve to meet the needs of today’s complex
trials. The first is trial execution. Optimised trial
operations require effective communication and
information sharing. Traditional clinical operations
practices require data entry within multiple siloed
locations, which creates a high risk that key activities
and actions will be missed.

The second is the ability to evolve the strategy for
clinical operations towards risk-based approaches
using risk-based quality management (RBQM)
principles. While it’s clear from recent regulatory
guidance and learnings from the pandemic that
companies who adopted risk-based approaches
towards study design and execution fared better
during COVID-19, most RBQM technologies are
essentially cobbled together point solutions, rather
than holistic end-to-end solutions.

Finally, we know that future trials will not look or
perform the same as they have in the past. Today’s
technologies must be able to support all manner of
brick and mortar as well as decentralised trials. At
the intersection of these areas is digital oversight,
Medidata’s unique set of capabilities to drive the next
generation of clinical operations.

Hithaishi C Bhaskar
[email protected]

40 MENTAL HEALTH

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Changing face of mental
health assistance in Asia

conduct clinical research studies. It’ll use the seed-
round funding to finance those efforts and further its
expansion in Asian markets.

« ThoughtFull

Devin Partida, ThoughtFull is another Singapore-based mental
Medical and Health health startup that uses digital resources and
Tech Writer, USA strategies to improve outcomes via various themed
ventures. For example, ThoughtFull Education is a
The Asian mental health industry is still relatively consulting arm that partners with organizations such
new, largely due to barriers like stigma and limited as colleges to provide interactive programmes about
access to care. However, there are several startups mental health literacy.
that have made major strides in addressing those
challenges and attracting investor attention. We Another endeavour gaining attention is
shall take a look at a few companies that reinforce ThoughtFullChat. While using it, people pay a flat
the idea that life can be challenging, and that it’s monthly fee to text with certified mental health
normal to sometimes seek mental health support. professionals at any time. Those experts also engage
with users once per weekday to coach them towards
Mental health assistance was not always so their goals.
accessible in Asian countries, particularly
in more remote areas with few trained According to Joan Low, the company’s 32-year-
providers. That’s starting to change, as few startups old founder, most people will try to make time
are playing a substantial part in making that happen. between their Zoom meetings to exercise and build
physical resilience, for example, but they may not do
Additionally, since these businesses significantly that for their emotional well-being and psychological
expand access to care, people who need help don’t resilience. However, if staying mentally healthy is
have to work very hard to find it. Feeling better takes as easy as launching a smartphone app, that could
commitment, but starting the process can be as easy change soon.
as logging in to a portal or app.
MindFi
Intellect
In the US, many employers experience cost savings
Intellect is a Singapore-based startup that aims to by switching from fully insured to self-insured
use technology to improve mental healthcare. It has employee coverage. Similarly, company leaders view
both a consumer-facing and enterprise segment. At better health insurance benefits as instrumental in
the end of 2020, the company announced that it had attracting employees. The same trends show up in
1 million users and closed its seed-funding round. Singapore, too.

The product for consumers centers around For example, across 2018 and 2019, self-
taking people through themed modules that teach funded maternity care jumped from 16 to 37 per
them how to address undesirable behaviours, work cent. Additionally, Singaporean employers have
habits, or mental health issues, such as anxiety. started taking a more holistic approach to keeping
Then, the enterprise-level offering makes it easier for employees well, which often means focusing on
employers to provide mental health benefits for their mental health.
workers while increasing utilisation rates.
MindFi is a startup to help them do that. It
The company is working with universities in provides a meditation app geared for workplaces.
Australia, the United Kingdom, and Singapore to CEO Bjorn Lee launched the company after
experiencing stress-induced chest pains at 29 and
finding that meditation helped him get back on
track.

The early days of the coronavirus pandemic led to
a 250 per cent boost in the app’s user base. Lee also

MENTAL HEALTH 41

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

mentioned an increase in the number of companies the Best In Singapore website’s marriage counseling
signing up for the offering. category in 2020.

The app’s content understands the needs of new Mindpeers
meditators or people with busy schedules. Some
meditation sessions are only one minute long, Mindpeers caters to both individuals and
making them suitable for people who want to start a workplaces, providing one-on-one remote therapy
healthy habit gradually. sessions. People can sort through a directory of
therapists who make themselves available on the site
Ooca and immediately see when they have appointments.

Normalising mental health struggles is a significant Since its launch in January 2020, the company
part of helping people feel open about seeking help has attracted 15 corporate clients and more than
if they need it. That’s the goal of Ooca, a Thai startup 5,000 individuals. Additionally, the startup raised
that features a headline reading, “It’s okay. Let’s $200,000 in a pre-seed round that included
talk” on its homepage. Besides assuring visitors investors from Indonesia, Singapore, India, and the
that there’s no shame in seeking help, the company United States.
makes that assistance available from a person’s
home. Besides helping people with identified mental
health challenges, Mindpeers puts a significant
Telehealth was one of the most prominent focus on self-care. Once someone signs up
trends in 2020, spurred by the COVID-19 pandemic. individually or through their workplace, they get
Remote visits rose by 50 per cent in the first quarter access to a personalized dashboard that gives daily
of the year. They continued climbing from there, and recommendations for staying mentally healthy.
now people are well-accustomed to seeing a doctor
through the internet. The company also equates mental health
with physical health, reminding people how it’s
Ooca enables people to book appointments with commonplace to train one’s body at the gym. It urges
psychiatrists and psychologists via a telehealth people to see mental health similarly, setting aside
service, making it easy for them to fit sessions into time for mind fitness and well-being and getting into
their schedules. The company started in 2017 after a healthy habit as they do.
its then-30-year-old founder experienced mental
healthcare access struggles first-hand. By late 2019, Wysa
about 60,000 people had used the app.
Wysa is a startup based on the idea that mental
In 2020, it expanded to six other markets — health help should be as accessible as typing to a
including Germany, the United States, and Japan chatbot. That’s an activity many people are familiar
— specifically to serve Thai expatriates living with already, which could make them more willing
elsewhere. Statistics indicate that more than 1.6 to reach out without feeling nervous or embarrassed.
million Thais reside outside of Thailand. Those engaging with the Wysa chatbot communicate
with a friendly penguin.
Safe Space
The company’s research also shows that
Finding a therapist who’s a good fit for a patient isn’t this therapy method is impressively efficient.
always easy. However, Safe Space aims to make it For example, people can complete a cognitive
easier with a matching algorithm that gives real- behavioural therapy exercise in about 10 minutes
time results based on a user’s responses to an online with Wysa, but doing it through office visits would
questionnaire. People can get individual, couples, or take three appointments. The artificial intelligence
family counseling from home. There’s an option to algorithms working in the background also recognize
purchase therapy sessions for someone else, too. more than 70 emotional subtypes that a person
might display during a chat session.
The startup raised $250,000 in a seed round
during 2020. Business leaders will use that money to Although the app was developed and launched
expand across the Asia-Pacific region, plus broaden in India, it has a global reach. In the spring of 2021,
its corporate program that operates on a freemium Wysa announced a $5.5 million Series A financing
model. round. It also highlighted how the well-reviewed
chatbot had guided people through more than 100
Safe Space also partnered with the Ngee Ann million conversations so far. Plus, more than three-
Polytechnic educational institution to create and quarters of users have more than five sessions, which
launch an online course that helps people build indicates they like the experience and want it to
mental resilience by strengthening their growth continue.
mindsets. Moreover, the company got recognized on

42 MEDICAL WASTE

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

APAC lays focus on
medical waste management

« various economies upside down, but also affected the
environment and lives of people severely. How is the
Hrishikesh Kadam, environment overwhelmed dumping of biomedical
Senior Research wastes. The Hubei province of China saw a prolific
Content Developer, surge in infectious medical waste generation to 240
Global Market Insights, tonnes a day in 2020.
India
Calculating this, the Asian Development Bank had
Development and introduction to new medical then estimated that 5 major cities across Southeast
devices and equipment is good. However, what Asia including Jakarta, Manila, Bangkok, Hanoi,
is not good is the unhealthy state of these being and Kuala Lumpur could be dealing with a total of
dumped in landfills causing adverse effects on the 1,016 tonnes more medical waste daily, given the rise
environment and human health. This calls for an in COVID cases. Various authorities were warned
urgent need for waste management. of severe consequences in case the waste was left
untreated for a longer period of time.
Medical waste management market has been
expanding phenomenally over the recent Owing to this, several large facilities across
years, and mounting heaps of biomedical various APAC economies have been commissioned by
waste worldwide is expected to be a fundamental government-backed initiative for purposes of safely
driver for this! Various economies with high collecting and disposing of huge volumes of medical
disposable incomes generate up to 0.5 kg of toxic waste.
waste per hospital bed every day, while low-income
countries generate nearly 0.2 kg on an average. For instance, Indonesia’s health company-
Medika, had in 2019 contracted Inciner8 to
In fact, the press conference study of the Joint help dispose the waste generated by a number
Prevention and Control Mechanism of the State of healthcare centers, clinics, hospitals, and
Council of China presented facts that nearly 468.9 laboratories.
tonnes of medical waste are generated almost daily,
given the ongoing COVID-19 pandemic outbreak. In recent times, large facilities have been built up
by government-backed initiatives for the purposes
Meanwhile, in Indonesia, the medical waste of safe collection and disposal of great volumes of
generated, scaled up to 12,740 tonnes just within medical waste. The company supplied their most
2-months after individuals were first infected by the advanced high capacity medical incinerator- i8-M700
dreaded pandemic in the area in 2020. Medical Incinerator with a loading procedure which
is highly autonomous.
This implies that COVID-19 is apparently not
the only health crisis the world is struggling with Role of incinerators
currently, the waste generated by it is also raising
alarming concerns, paving the way for medical waste Medical waste incineration involves the burning of
management. It has been estimated that global wastes produced by veterinary facilities, hospitals,
medical waste management market size would reach and medical research facilities. These wastes include
an unprecedented valuation of $9.6 billion by 2026. both infectious medical wastes as well as non-
infectious, general wastes.
Asia’s medical waste challenge
In May 2021, Himachal Pradesh in India had
The dreaded coronavirus pandemic that surfaced publicised its plans of revamping its bio-medical
from the Wuhan district of China, has not only turned waste incineration volume, up from 2.4 metric
tonnes (MT) per day to massive 6.4 MT per day
by authorising a new Common Bio-medical Waste
Treatment and Disposal Facility to curb the burden of
medical waste generated.

Although medical waste incineration has come
out to be a key in Asia’s challenges towards managing
medical waste, the World Health Organisation

MEDICAL WASTE 43

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(WHO) policy paper of 2004 and Stockholm Management Rules of 2016’, the quantity of
Convention, has stressed the need to consider the biomedical waste generated in the healthcare
risks associated with the process in the form of heavy facilities is nearly 10 to 15 per cent of the total waste.
metals, acid gases, particulate matter, and carbon It consists of materials which have been in contact
monoxide emission, which is a health hazard in itself. with the patient’s blood, infected parts, secretions,
and biological liquids.
Practicing waste management
Moving ahead, the 2016 guideline categorises the
& long-term care settings bio-medical waste coming in from the healthcare
facilities into 4 different categories based on the
Across Southeast Asia, the geriatric population colour code and segregation pathway. Diverse types
is growing at a notable pace and indicates the of bio medical waste are further assigned to each of
considerable future demand for nursing homes and the categories as enlisted:
long term care facilities. It would not be incorrect
to state that the dreaded coronavirus pandemic  Yellow Category: includes human anatomical
outbreak has added to the mounting heaps of medical waste, chemical waste, expired or discarded
waste being generated from long term cares and medicines, microbiology, biotechnology, and other
nursing homes. laboratory wastes

Medical care in nursing homes is often not  Red Category: includes waste generated from
complicated as in hospitals, but the amount of waste disposable items
generated is quite similar or less. Most facilities in
long term care ink contracts with trained, licensed,  White Category: includes waste sharps along
and professional medical waste management with metals
companies to make sure that all of the waste being
disposed adheres to the federal, local, and state  Blue Category: consists of discarded or
guidelines. broken and contaminated glass such as medicine
vials and ampoules.
Speaking on managing medical waste in such
facilities, it is imperative to note that segregation is Talking about the transportation of biomedical
the key for regulating disposal costs and ensuring the waste generated, the Guidelines highlight that
safety and health of staff. All the staff members in the waste must be transported in covered trolleys
nursing homes and large care settings are required to through a route which has low traffic flow of visitors
be trained on the methods of differentiating medical and patients, in an attempt to reduce the contact of
waste. toxic chemicals with patients.

The United Nation has estimated that almost 60 So, what more can be done? Practicing 3Rs:
per cent of the global geriatric population will be in Reduce, Reuse, and Recycle.
Asia by the year 2030. A significant number of adults
are unable or unwilling to care for elderly family  Reduce: limiting or reducing the generation
members, owing to various reasons, while hiring an of waste to focus on working with medical staff to
in-home caretaker is also not a booming trend in the make possible changes towards less wasteful clinical
region. practices.

According to June 2020 reports, privately  Reuse: making use of non-disposable products
owned residential aged care facilities in Australia for health services can potentially aid in minimising
have witnessed considerable growth since 2012, waste quantities. Importantly, the reusable items
while the rate of occupancy throughout the segment should be periodically sterilised to prevent the risk of
was around 88 per cent during 2019-2020. The infection.
tremendous demand for elderly care across Asia
Pacific will augment medical waste management  Recycle: recycling all possible items to cut
industry share. down landfill pollution.

Medical waste management policies While one cannot restrict the generation of
biomedical waste coming from hospitals, vet cares,
Various state and central governments have created and other healthcare settings, incorporation and
guidelines to promote the proper waste management implementation of better waste management policies
tactics and practices. Consider the example of the and tactics would prove out to be a considerate move
Indian government: towards building a stress free environment, adding to
positive growth curve for medical waste management
According to the ‘Guidelines for Management industry in 2021 and beyond. In fact, it is high time
of Healthcare Waste as per the Biomedical Waste now that the medical staff and professionals are
trained regarding proper disposal of medical waste
while guiding them through the proper routes of bio
medical waste transportation.

44 PEOPLE NEWS BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Fujifilm Cheng Wai Keung takes charge
appoints Koji as Chairman at SingHealth
Wada as new
MD for India Cheng Wai Keung has been appointed as the Chairman of the
Board of Singapore Health Services (SingHealth), Singapore’s
Fujifilm India, a pioneer in largest group of healthcare institutions, from July 1, 2021 to June
diagnostic imaging technologies, 30, 2024. Keung is the Chairman and Managing Director of Wing
has announced the appointment Tai Holdings and has been a member of the SingHealth Board
of Koji Wada as the new Managing since August 1, 2013. He is an accomplished business leader with
Director (MD) for Fujifilm vast experience across various sectors. He also serves on various
India, effective from June 29, private and public sector Boards including as Deputy Chairman
2021. Taking over the baton of Temasek Holdings and the Vice-Chairman of the Singapore-
from Haruto Iwata as he moves Suzhou Township Development, amongst
to his new role as Managing others. As Chairman of SingHealth, Keung
Director for the Asia-Pacific will helm the cluster’s drive to enhance
region in Singapore, Wada will clinical outcomes through research,
spearhead Fujifilm’s operations innovation and education and to provide
and business strategy in India. value-driven care to patients. He will
In his new role, Wada will be lead SingHealth in its continued focus on
responsible for organizational providing a continuum of care that is holistic
growth and profitability with an and integrated, while advancing new models
integrated approach towards of care that are patient-centric, with an
sales, marketing, and business emphasis on population health.
policies. Wada has been associated
with Fujifilm since 2001 and TVM Capital Healthcare
contributes to the businesses strengthens leadership
across corporate offices in Japan, in Southeast Asia
Myanmar, Thailand and India. He
brings a vast experience of over UAE headquartered TVM Capital Healthcare has announced that
20 years and before taking over Farid Fezoua has joined the firm as a Managing Partner. Fezoua
his role as Managing Director, comes to TVM Capital Healthcare following the successful exit of
he was responsible for leading Cambridge Medical and Rehabilitation Center (CMRC) in March
the medical business of the 2021 for $232 million, which represented a 4.6x return on capital
company in India as a General
Manager. This is Koji Wada’s invested, the largest MENA (Middle East
second stint in India. Wada was and North Africa) healthcare deal in recent
Marketing Manager for Fujifilm years. He joins the firm from GE where he
India in 2007. Post that Wada held several senior positions as Managing
was appointed as the Secretary to Director, GE Capital Markets Middle East
Global CEO Komori. Later from Africa, Central Asia & Turkey, President
there, Wada was made the General & CEO GE Healthcare Africa, and more
Manager for Fujifilm Thailand in recently served as President & CEO of GE’s
2014 and then Managing Director operations in Sub-Saharan Africa across
for Fujifilm Myanmar in 2017. all GE businesses including Healthcare.
With a career across Financial Services and
Infrastructure Industries within Europe,
Middle East and Africa, Russia, Turkey and
Central Asia, Fezoua has developed a strong
track record of infrastructure project development and financing,
strategic equity investment in the field of healthcare, power,
transportation as well as business operations and management.

PEOPLE NEWS 45

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com Waters

Andy Hu joins Avance Corporation
Clinical to support APAC growth
appoints Wei
Avance Clinical, a clinical research organization based in Australia,
has announced the appointment of APAC expert Andy Hu as Business Jiang to Board
Development Manager APAC to support increasing biotech clinical trial
of Directors
demand from the region. Andy Hu, formerly
with international biopharma data firm Waters Corporation has
Informa Pharma Intelligence, will head- announced the appointment
up the business development program in of Wei Jiang to its Board
APAC for Avance Clinical. An experienced of Directors, effective July
specialist with a demonstrated history of 14, 2021. Jiang currently
working in the pharma intelligence services serves as Executive Vice
sector, Hu is skilled in negotiation, account President and President, Bayer
management, training, presentation, client Pharmaceuticals Region China
services and relationship management. He & APAC and President, Bayer
is dedicated to providing consistent support Group Greater China. He
and strategic solutions to client’s workflow previously held various senior
including commercial strategy, market positions at AstraZeneca,
research and data validation. Avance Clinical has grown significantly culminating in his role as
over the past two years with an increasing number of clients coming Senior Vice President, China
from APAC to conduct their trials in Australia. In his new role, Hu will operations. Prior to that,
further support the company’s growth and strengthen relationships with Jiang served as Managing
its clients in the region. Director, China operations
at Guidant Corporation and
Ramesh Subrahmanian in various roles at Eli Lilly &
steps into Everlife Board Company including Marketing
Director, China Operations.
Singapore-based Everlife Holdings, a leading manufacturer and He currently serves on the
distributor of medical devices and laboratory equipment and boards of China Red Cross and
consumables in Asia, has appointed Ramesh Subrahmanian to the R&D Based Pharmaceuticals
company’s Board of Directors. Subrahmanian is a seasoned leader in association. Jiang has
the healthcare industry with over 25 years of global senior management an outstanding record of
experience in the pharmaceuticals, vaccines, and driving results in regions
medical devices sectors. He currently serves on that represent key growth
the Board of Directors at Healthium, a fast- opportunities for Waters,
growing global medical devices company, while including China and other
also managing his own advisory firm Alchemy Asia-Pacific markets.
Advisors, which helps global clients optimise
their growth strategies and organisation
models to deliver superior performance. In
his new role as a member of the Board at
Everlife, Subrahmanian will work closely with
the company’s Board, CEO, and leadership team
to support the development of the company’s
strategic plan including defining the key
growth levers, acquisitions, digital
footprint, and organisational construct
in order to extend Everlife’s current
leadership position in the markets and
product segments in which it operates.

46 R&D NEWS BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

NZ brings China develops blood test for early
world-first detection of Alzheimer’s disease
intra-oral
weight loss A research team led by Hong Kong University of Science & Technology
device (HKUST) in China has developed a simple but robust blood test from
Chinese patient data for early detection and screening of Alzheimer’s
University of Otago in disease (AD) for the first time, with an accuracy level of over 96 per cent.
New Zealand (NZ) and UK The researchers have identified 19 out of the 429 plasma proteins associated
researchers have developed with AD to form a biomarker panel
a world-first weight-loss representative of an “AD signature”
device to help fight the in the blood. Based on this panel,
global obesity epidemic. the team has developed a scoring
DentalSlim Diet Control is system that distinguishes AD
an intra-oral device fitted by patients from healthy people with
a dental professional to the more than 96 per cent accuracy.
upper and lower back teeth. This system can also differentiate
It uses magnetic devices among the early, intermediate, and
with unique custom- late stages of AD, and can be used
manufactured locking bolts. to monitor the progression of the
It allows the wearer to open disease over time. These exciting
their mouths only about findings have led to the development of a high-performance, blood-based
2mm, restricting them to a test for AD, and may also pave the way to novel therapeutic treatments for
liquid diet, but it allows free the disease. The work was conducted in collaboration with researchers at
speech and doesn’t restrict University College London and clinicians in local hospitals including the
breathing. According to Prince of Wales Hospital and Queen Elizabeth Hospital.
the researchers, the device
will be an effective, safe, Korea builds brain-
and affordable tool for mimicking interface to
people battling obesity. It study neurological diseases
is fitted by a dentist, can
be released by the user in A research team and collaborators at the Korea Advanced Institute of
the case of an emergency Science and Technology has revealed a newly developed hydrogel-based
and can be repeatedly flexible brain-machine interface. To study the structure of the brain or
fitted and removed. The to identify and treat neurological diseases, it is crucial to develop an
tool could be particularly
helpful for those having to interface that can stimulate the brain
lose weight before they can and detect its signals in real time.
undergo surgery, and for However, existing neural interfaces
diabetes patients for whom are mechanically and chemically
weight loss could initiate different from real brain tissue. This
remission. causes foreign body response and
forms an insulating layer (glial scar)
around the interface, which shortens
its lifespan. To solve this problem, the
research team has developed a ‘brain-
mimicking interface’ by inserting a
custom-made multifunctional fiber
bundle into the hydrogel body. The device is composed not only of an
optical fiber that controls specific nerve cells with light in order to perform
optogenetic procedures, but it also has an electrode bundle to read brain
signals and a microfluidic channel to deliver drugs to the brain.

R&D NEWS 47

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

India designs AI- Australia develops
quick test to detect
powered COVID-19 test jaundice in infants

Indian Institute of Technology Hyderabad A fast, cheap paper test that can detect jaundice
(IIT-H) has developed an Artificial Intelligence in newborns is on the verge of bedside validation
(AI)-powered COVID-19 test that can be and commercialisation, and distribution to health
performed at an affordable cost at home after practitioners across the world. The joint-development
commercialisation and required approval by Australia-based Monash University’s Faculty
from the Indian Council of Medical Research of Engineering, the Monash Institute of Medical
(ICMR). The test kit can produce results Engineering and Monash Health, has the potential
within 30 minutes for both symptomatic and to be commercialised for point-of-care diagnosis of
asymptomatic patients. The major benefit of neonatal jaundice in both homecare and hospital
this testing kit is that it does not require settings. Monash researchers have developed a paper
RT-PCR (Reverse Transcription Polymerase test for bilirubin levels,
Chain Reaction), an expert human resource, and which provides results
a BSL 2 lab facility for the extraction of RNA, so in less than 10 minutes
it has potential for one to take the test at home at a cost of about
without expert supervision. The validation 60 cents each. The
report confirmed the kit’s efficiency 94.2 per method developed by
cent, Sensitivity 91.3 per cent, and Specificity the research team uses
98.2 per cent. Each test costs around Rs 400 tape-paper sensing and
now. However, mass production of the testing involves blood being
kit will help to reduce the cost to around Rs applied directly onto
300 per test. The researchers have already filed paper which is capable
a patent for the device and are now looking for of separating plasma from whole blood and measuring
industry partners for technology transfer for bilirubin by a colorimetric diazotization method. The
mass production. small volume of samples and reagents needed and a
simple kit could one day mean babies in remote and
regional areas, and under-resourced poorer countries,
could have their bilirubin levels easily monitored and
life-changing treatment administered. The use of this
device could release the strain on hospital resources in
major cities, including the pressure of bed shortages in
hospitals.

Singapore’s new malaria test kit delivers results in 30 mins

A team of scientists from Nanyang hindered by high cost and the lack
of infrastructure. Rapid diagnostic
Technological University, tests (RDTs) for malaria are unable
to detect infections during the
Singapore (NTU Singapore) has early stages of the disease, but
can give false positive or negative
developed a test kit for malaria that results. They also do not determine
the severity of the infection. The
delivers results in 30 minutes. The researchers estimate that each test
would cost roughly $1 per chip
kit works by detecting hemozoin, to manufacture and at this price
would facilitate low-cost point-of-
a by-product formed from the care field testing on a large scale.

digestion of blood by malaria

parasites, which is a unique to be lightweight, easy-to-use,
and able to detect the disease in
indicator of the disease. The kit its early stages. Efforts to treat
and control malaria in developing
could facilitate the diagnosis countries and rural areas are

of malaria in the field, as the

equipment needed is anticipated

48 ACADEMIC S NEWS BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

China’s Fresenius Medical Care
online-only opens first healthcare
journal training centre in Korea
Health Data
Science US-based Fresenius Medical Care has recently announced the grand opening of
goes live its first training centre in Korea, to offer comprehensive education programmes
and share its knowledge and experience in renal care, critical care, and
A new online-only treatment strategies with healthcare professionals. The training programmes
open-access English-
language journal, and other events at the centre will help
Health Data Science, strengthen the collective knowledge within
hosted by China-based the industry, unlocking the potential for
Peking University and improvement in patient care. The Fresenius
undertaken by National Medical Care Training Centre, the first
Institute of Health healthcare education facility in Korea to
Data Science (NIHDS) be run by a dialysis product provider, was
recently published established to support doctors, nurses,
its first article – an and clinical technicians in accessing the
editorial from its Editor- latest knowledge and skills within their
in-Chief, President professional practice. The centre offers a
Zhan Qimin of the dedicated education hub for healthcare
NIHDS. The journal is professionals to undertake training and
committed to improving upskilling programmes in Yeouido, the city centre of Seoul, providing an
data and evidence- opportunity to have hands-on experience with Fresenius Medical Care’s
based decision-making, most advanced medical equipment used for hemodialysis (HD), automated
promoting the ethical peritoneal dialysis (APD) and continuous renal replacement therapy (CRRT).
application of cutting-
edge technologies and Japan brings data scientist training
analytic approaches, programme for pharma industry
advancing the horizon
of health data science, Japanese firms Chugai
and creating value
in real-world health Pharmaceutical and Albert Inc
practice. As part of the
Science Partner Journal have jointly developed a data
programme, the newly
launched journal is scientist training programme for
aimed at closely working
with the international the pharmaceutical industry. The
academic community to
maintain high-quality training programme is part of
and ethical standards
for research, translate Chugai Digital Academy, a digital
the value of health data
to benefit patients’ talent training initiative. In addition
health and populations’
wellbeing, and achieve to basic statistical analyses and
the journal’s mission –
data for better health. programming techniques required

to data scientists, this programme

enables the acquisition of knowledge

and skills for data utilization digital talent development. Albert,
with over 250 data scientists, has
specific to the pharmaceutical provided each industry with a more
practical programme, Data Scientist
industry, such as clinical statistics Training Support, by utilizing the
expertise cultivated through in-
and epidemiology fundamentals. house human resource training
and having active data scientists as
Chugai has set “Strengthen the instructors.

digital platform” as one of the basic

strategies of its Digital Vision 2030

and started the digital academy in

April 2021, a structured initiative for

SUPPLIER NEWS 49

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Sysmex Corp teams up with Qiagen
for global cancer companion diagnostics

Qiagen has announced a drug treatments for cancer adoption of ultra-
global strategic alliance with and promote early clinical sensitive liquid biopsy
Japan’s Sysmex Corporation companion diagnostics.
for the development and Qiagen and Sysmex
commercialisation of cancer have a longstanding
companion diagnostics, which partnership, which, for
will leverage both Qiagen’s example, provides the
leadership in this field and ipsogen JAK2 blood-
Sysmex’s Plasma-Safe-SeqS cancer test in Japan.
technology for next generation Cancer companion-
sequencing (NGS). The alliance diagnostics products will
aims to foster collaborations be launched by Qiagen
with pharmaceutical companies and Sysmex in various regions of
for the development of the world.

PHC Corp launches Univercells, VectorBuilder
next-gen sequencer
DNBSEQ series in Japan to jointly optimise custom

PHC Corporation has announced that China-based MGI viral vector production
Tech that develops and manufactures next-generation
sequencer DNBSEQ series and the sales rights for Belgium-based Univercells Technologies has
sample pretreatment equipment and related reagents formed a worldwide strategic partnership with
and consumables in Japan have been acquired, and sales VectorBuilder, a global leader in vector design,
have started for the purpose of supporting the analysis optimisation and manufacturing. Univercells
of genetic information by researchers and medical Technologies will work with VectorBuilder’s
professionals. The newly released DNBSEQ series is a manufacturing centre in Guangzhou, China to
next-generation sequencer that reads a large amount of develop and optimise platform processes using
DNA and RNA base sequences and accurately analyses best-in-class technologies for the production of
gene mutations and expression levels. By adopting custom viral vectors for cell and gene therapies
MGI’s original DNBSEQ technology and utilising DNB as well as vaccine applications. Demand for
(DNA nanoball) technology, DNA is stably amplified, viral vectors, especially GMP-grade vectors, has
resulting in more accurate sequencing and excellent significantly increased amidst the pandemic.
cost performance. In addition, PHC collaborates with Yet traditional manufacturing technologies
Japanese firm Amelieff Corporation, a group affiliated lack the cost-effectiveness and scalability to
with the most advanced bioinformatics technology, to accommodate this growing demand. With this
propose an analysis system optimised for the DNBSEQ partnership, both companies aim at combining
series and a gold standard analysis pipeline. capabilities, services, and existing technologies
to develop a portfolio of optimised viral vector
manufacturing protocols maximising customers’
performance and commercialisation success.

50 SUPPLIER NEWS

BIOSPECTRUM | AUGUST 2021 | www.biospectrumasia.com

Seegene expands Shimadzu unveils lab
diagnostic biz in
partnership with Bio-Rad business intelligence

Seegene Inc., a South Korean leading biotechnology application
firm, has signed a partnership agreement with American
biotechnology company Bio-Rad Laboratories, Inc. to Shimadzu (Asia Pacific)’s Software
support entering the US market. Seegene has signed a Development Centre (SDC) in Singapore has
partnership with Bio-Rad for the clinical development launched the world’s first comprehensive
and commercialisation of infectious disease molecular web-based application which can provide
diagnostic products. Under the terms of the agreement, users with accurate and timely laboratory
Seegene will provide diagnostic tests for use on Bio-Rad’s analytics, from a laboratory, at home or
CFX96 Dx Real-Time PCR System for the US market, from a remote location around the world.
pending clinical development and approval from the U.S. The Analytically Intelligent LabSolutions
Food & Drug Administration (FDA). Seegene intends to BiX collects data from all kinds of Analytical
seek US FDA clearance for clinical assays on Bio-Rad’s instruments, processes the data Analytically
real-time PCR system ‘CFX96 Dx Real-Time PCR System’. or logically, and showcases the analysed
This includes an intent to clear Seegene’s ‘AllplexTM output into various Analytics dashboard
SARS-CoV-2/FluA/FluB/RSV Assay’, a multiplex real- reports. LabSolutions BiX laboratory
time PCR assay. Business Intelligence application makes
informed decisions based on detailed and
critical analysis of the productivity and
efficiency of all assets in the laboratory, be it
instruments or the people operating them.
LabSolutions BiX is designed for efficient
usage by lab chemists, managers, and senior
management. Its Brilliant Graphical User
Interface (GUI) enriches the total laboratory
experience of one and all. It also provides
detailed analytics on the instrument and
user efficiency in the lab. Its expandable
modules and ability to connect to a diverse
range of instruments allow the users to
spread their Enterprise Digital Footprint.

Waters collaborates with Singapore’s Bioprocessing Technology Institute

Waters Corporation has biologics manufacturing. Waters biopharmaceuticals, namely the
announced an expansion and BTI are engaging in data identification and quantitation
of its joint work with the analytics research meant to of complex biomolecules such
Bioprocessing Technology eliminate a major bottleneck as released N- and O- glycans
Institute (BTI), a research in the characterisation of and metabolites that influence
institute of Singapore’s Agency therapeutic function. Isomerism
for Science, Technology and of both glycans and metabolites
Research (A*STAR). Among is particularly troublesome and
their new collaborative projects, can be tackled using Waters’
Waters and BTI have started advanced instruments. As
work on applying analytics that part of the project, Waters will
can rapidly identify and visualise contribute scientific expertise and
complex molecules within the use of Waters instruments
glycomics and metabolomics including the SYNAPT series
data to help ensure overall mass spectrometry system along
safety, accuracy, and speed of with a BioAccord LC-MS System.