BioSpectrum Asia April 2022

PARTNER VOICE

www.biospectrumindia.com

Get a 360 degree exposure to the universe of Biotechnology
and Health Sciences industries.

PARTNER WITH BIOSPECTRUM INDIA TO TELL YOUR STORY

PARTNER VOICES ARE AN EXCELLENT WAY TO ENGAGE WITH OUR AUDIENCE AND
TELL YOUR STORY FROM A TRUSTED THIRD PARTY PERSPECTIVE.

Each Partner Voice is produced in cooperation between our clients
and our editorial team and includes several design elements to
support your messaging. The Partner Voices remain evergreen
on www.biospectrumindia.com for maximum ROI.

Deliverables

• Your story professionally edited by Biospectrum
editorial staff (1,000 - 1,500 words).*

• Up to two (2) relevant embedded links
• Up to two (2) relevant embedded images
• One (1) relevant embedded video
• Multiple “Road Block” Banners:
• A 728x90 or 970x60 banner ad.
• A 300x250 or 300x600 banner ad.
• A 88x31 or 120x60 logo.

Distribution

• Evergreen placement on www.biospectrumindia.com
• Up to three (3) placements in www.biospectrumindia.com

inBOX eNewsletter.
• Social channel distribution
• Additional market segment distribution is available through

our other brands.

* Biospectrum editorial staff is available to develop the content asset. The cost is

based on the individual requirements (single source, multi-source, word-count, etc.) and will
be priced accordingly.

To know more on Partner Voice please contact: [email protected] | [email protected]

"We Communicate
directly with
Life-Science
Leaders and
BioPharma
Executives
World-Wide"

www.biospectrumasia.com www.biospectrumindia.com

For More information , Please contact [email protected]

4 BIO EDIT

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Dr Milind Kokje RUSSO-UKRAINE
DOMINO EFFECT
Chief Editor
The ongoing conflict between Russia and Ukraine is worrying for the pharma sector,
[email protected] particularly those of India. Some major domestic drug manufacturers like Sun
Pharma, Glenmark Pharmaceuticals and Dr. Reddy’s Laboratories have a strong
presence in both the warring countries, as well as in Commonwealth of Independent
States (CIS).

Drugs constitute a major part of India’s exports to both the countries. India is the third
largest exporter of pharmaceutical products to Ukraine, which is growing. The leading
exporters to Ukraine are Germany and France. In FY21, India exported $182 million
worth drugs to Ukraine, 44 per cent more than the previous year. To Russia, the export
in 2020-21 was $591 million, registering growth of almost 7 per cent over the earlier year.

Dr. Reddy’s Laboratories, which has had a presence in the region for the last three
decades, showed receipt of Rs 4.7 billion revenue from Russia in nine months from April
to December 2021. Other Indian pharma majors like Ranbaxy and Sun Pharma, too, have
presence in Russia over little less than 30 years. Understandably, the Russo-Ukraine
deadlock is bound to rock the core of Indian pharma companies present in the region.

The effect could be varied. The first effect could be a price rise due to supply disruption
leading to a hike in price of raw materials and likely higher cost of transportation due to
mounting fuel prices. This may affect all pharma producers and not just the companies
located in the conflict zone. Solvents that are used for producing Active Pharmaceutical
Ingredients (APIs) and whose feedstock is crude oil or gas are already becoming costlier.
Just to take the case of gas, the price increased from Rs 35 in July 21 to Rs 65 in January
22 and further increased to Rs 150 in March 2022. Prices of other raw materials derived
from Benzene and other petroleum products are also expected to rise. The volatility in
API prices is likely to affect the financial performance of the companies.

The next problem is related to the sanctions imposed on Russia by the western
countries. So far, India has maintained a neutral stand and hence not participated in
the sanctions. Russia has welcomed the independent foreign policy of India. As a result,
companies exporting drugs to Russia will not face problems. In fact, the Russian envoy
to India has hoped that Indian pharma companies may replace western manufacturers
in Russia which are shutting their operations due to sanctions. With sanctions imposed
on it, Russia is looking to increase trade volumes with non-European countries and
Indian pharma could have a definite advantage. But the industry has two apprehensions.
One, losing export competitiveness due to price rise and secondly, obstacles in receiving
payments from Russia due to sanctions.

Even if the export to Russia is increased, receiving payments for exports could be
problematic due to the sanctions. Five Russian banks have been banned by the US
and Europe from the Society for Worldwide Interbank Financial Telecommunications
(SWIFT) messaging that makes payments in global trade possible. As a result, some
alternative payment mechanism will have to be evolved and till then the companies
exporting to Russia may face problems. About $400 million are yet to be received for the
products already exported.

The possible negative effects of the war are coming at the time when there are reports
of the Indian pharma market contracting after 17 months. The industry revenue declined
0.2 per cent over a year earlier in February. Volume declined 7.3 per cent year on year but
was partially offset by 5.1 per cent and 2 per cent increase in process and new products
respectively, as per Ratings and Research.

In such a situation, the industry may have to consider filling the gap in Russia by
increasing exports, facing the challenges of payments to make up for the loss of business
in the domestic market.

BIO MAIL 5

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

www.biospectrumasia.com S$ 5.00 Acknowledgements edition of BioSpectrum Asia.
- Dr Janice Jin, Singapore
Volume 17 | Issue 3 | March 2022 Thank you so much BioSpectrum India
and Asia. The editions have come out The coverage on PerkinElmer looks great
Breaking down well. All good wishes. in the March edition. Thank you so much.
DISPARITIES
- Dr Renu Swarup, India - Ruixin Zhu, US
“Women must follow their Psychedelic Trip to Wellness - 29
passion and take on any Thanks BioSpectrum Asia for your great Thank you BioSpectrum Asia for
opportunity that presents itself” How E cacious are support for gender diversity and equality the special feature on International
- Eva van Pelt, Digitalised Supply Chains? - 36 in Asia! Women’s Day.
Co-Chief Executive O cer &
- Eva van Pelt, Germany - Eunju Ryu, US
Chief Commercial O cer, Eppendorf AG - 25
The biggest challenge in 2021 is Great to see the highlight on women in
MCI (P) 014/06/2021 definitely the inconvenience caused by BioSpectrum India and Asia editions.
the pandemic. But everything was worth Thank you.
it, as it has brought me more experience
and personal success. Thank you for - Dr Gagandeep Kang, India
the good content in the Women special

Vol 17; Issue 4; April 2022 MM Activ Singapore Pte. Ltd. Taiwan
Media Representative:
Publisher & Managing Editor: Singapore Ms Christine Wu
Ravindra Boratkar MM Activ Singapore Pte. Ltd. Image Media Services Company
Editorial: Saradha Mani 2F-2, No. 35, Sec. 2, Flushing South Road,
Chief Editor: Dr Milind Kokje General Manager Taipei 10665, Taiwan
[email protected] #08-08, High Street Centre, Tel: +886-2-87734199
Advisor - Content: Vijay Thombre 1 North Bridge Road, Singapore - 179094 Fax:+886-2-87734200
Editor: Narayan Kulkarni Tel: +65-63369142 / Fax:+65-63369145 Mobile: 886-937890533
[email protected] Mobile: +65-90681202 E-mail: [email protected]
Executive Editor: Dr Manbeena Chawla [email protected] website: www.imagemediatw.com
[email protected] China
Sub Editor: Nitesh Pillai Asia Pacific & South East Asia Erika Cheng
[email protected] Ankit Kankar RFCOMMS
Asst. Manager Content Creation Senior Manager - E101, East Lake Villas, 35 Dongzhimenwai
and Coordination- APAC Region: Digital Strategy & Growth Main Street, Dongcheng District,
Hithaishi C. Bhaskar 1st Floor, CIDCO Convention Center, Beijing 100027, P. R. China
[email protected] Sector 30A, Vashi, Navi Mumbai, Mobile: +86 17375668063
Social Media Communications: Maharashtra-400703. E-mail: [email protected]
Ankit Kankar Mobile: +91-9579069369 India
[email protected] [email protected] Alok Srivastava
CFO & Special Correspondent: USA Business Head- Ad Sales &
Manasee Kurlekar BioSpectrum Bureau Marketing (India & APAC)
[email protected] MM Activ Sci-Tech Communications “NITON”, Block B, First Floor,
Production & Design: Mobile: +91-9579069369 11/3, Palace Road, Bangalore 560001
MM Activ Sci-Tech Communications [email protected] Tel: +91-80-41131912/13
Anil Walunj Europe Mobile: +91-9845128747
Cover Design: BioSpectrum Bureau [email protected]
Dominix Strategic Design Pvt. Ltd. MM Activ Sci-Tech Communications
Business Enquiry: Mobile: +91-9579069369 Photo: Shutterstock
Manasee Kurlekar [email protected] Go Digital:
[email protected] To request subscription
Subscription Services Chief Editor: Dr Milind Kokje email: [email protected]
Print Edition: Saradha Mani MCI (P) 014/06/2021
[email protected] Copyright: MMActiv Singapore Pte Ltd.
Digital Edition: Ankit Kankar
[email protected]
News Letter : Hithaishi C. Bhaskar
[email protected]
Database Executive: Sudam Walekar
Media Intern’s:
Apoorva Mahajan / Sarang Khele

Printed and published by Ravindra Boratkar
on behalf of MM ACTIV Singapore Pte Ltd.

Printed at Times Printers Private Limited
16 Tuas Avenue 5, Singapore 639340
Tel : +65-63112888

Reprinted in India for private Circulation

6 BIO CONTENT

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

COVER STORY 18

WHY

HOLOMEDICINE

IS RAPIDLY
GAINING GROUND

Medical holography has emerged as one of the most promising applications in
the medical industry. Holographic imaging technology is advancing healthcare, life
sciences, biomedical research as well as medical training and education. Mixed Reality
(MR) applications are gradually making a progressive impact on healthcare deliveries
with precise quantitative measurement of human internal anatomy elements in 3D
holograms geometries displayed in actual physical space. Holographic 3D technology
renders medical professionals with advanced diagnostic capabilities and surgical
planning, by allowing them to slice virtual tissue, organs, and other body parts at
various angles. Holomedicne advances access to percutaneous procedures without
invasive needle techniques. Surgeons across the world are now curious to explore
medical holograms to enhance the efficiency of complex surgeries.

BIO CONTENT 7

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

3D PRINTING OF DRUGS 34

27 “We are seeing strong
demand for antiviral
How personalised 3D-printed drugs small molecules in APAC”
can cut costs & eliminate fakes
Aileen Dualan,
THERAPIES Head of Global Medical Affairs
(Asia Pacific), MSD
31
36
Exploring the Possibilities
of RNA Therapeutics “We can only see
interoperability driving the
MYOPIA future of healthcare systems”

42 Antonio De Castro,
Senior Industry Consultant,
Burden of Uncorrected Global Health and Life Sciences Practice,
Myopia on APAC SAS Institute
Healthcare Systems
38
Hamish Thrum,
Senior Director, “Genomics has enormous
Myopia Asia Pacific (APAC), potential to support the Indian
CooperVision economy in the 21st century”

Dushyant Singh Bagel,
Managing Director, Chief Executive
Officer, Nucleome Informatics

REGULARS

BioEdit.........................................................................04
BioMail........................................................................05
Policy and Regulatory News...................................08
Company News........................................................10
Finance News............................................................12
Start-Up News...........................................................13
World News...............................................................15
WHO NEWS...............................................................17
People News..............................................................44
R&D News..................................................................45
Academic News........................................................47
Supplier News...........................................................48
Lets Talk Health........................................................50

8 REGULATORY NEWS

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

China approves first thermal vapour energy system

Broncus has announced that that can achieve sequential staged in clinics and no similar
the company’s thermal vapour treatment targeting the lung product has been approved in
treatment system InterVapor segment level, thereby leading China. InterVapor is also safe
has been granted approval by to a new era of interventional and effective for patients with
the National Medical Products pulmonary in China. InterVapor complete or incomplete fissure,
Administration of China is the first thermal
(NMPA), denoting the official vapour energy and offers a solution
commercialisation of the world’s ablation system with minimal invasion
only such product in China. in China and disruption
This is the first NMPA-approved approved for patients with
thermal vapour energy ablation for Priority advanced COPD. The
systems in China and in the world Approval for company has obtained
for the treatment of Chronic the treatment an exclusive patent
Obstructive Pulmonary Disease of COPD. It is a for the use of thermal
(COPD), and it is the only medical device vapour for pulmonary
minimally invasive interventional that is needed treatments with a
lung volume reduction product imminently state-of-the-art
technology.

Japan gives nod to Australia invests
Guardant Health’s
liquid biopsy test $28.1M to

The Ministry of Health, Labour and Welfare (MHLW) in establish new
Japan has granted regulatory approval of Guardant360
CDx, a liquid biopsy test for tumour mutation profiling, genomics agency
also known as comprehensive genomic profiling (CGP), in
patients with advanced solid cancers. The Guardant360 Through its 10-year Medical Research
CDx test was also granted approval as a companion Future Fund (MRFF) plan, the Australian
diagnostic to identify patients with microsatellite government is helping Australians live
instability-high (MSI-High) solid tumours who may longer and better lives by ensuring that
benefit from Keytruda (pembrolizumab) and patients our health system can embrace and benefit
with MSI-High advanced colorectal cancer (CRC) who from one of the most promising emerging
may benefit from Opdivo (nivolumab). This regulatory medical disciplines such as genomics. To
approval has taken on an added significance as CRC is the further this agenda, the government is
most commonly diagnosed cancer in Japan. Guardant360 investing $28.1 million to establish a new
CDx is offered by Guardant Health Japan, a precision agency, Genomics Australia, to support
oncology company based in Tokyo which is a wholly owned the integration of genomic medicine as
subsidiary of Guardant Health Asia, Middle East & Africa a standard of healthcare in Australia.
(AMEA). Additionally, in December 2021, MHLW granted Genomic health technologies have the
regulatory approval of the Guardant360 CDx liquid potential to reshape clinical practice and
biopsy test as a companion diagnostic change the way we prevent, diagnose,
for identifying patients with treat and monitor illness throughout each
metastatic non-small cell person’s life. Genomics Australia will be
lung cancer (NSCLC) chaired by Professor Kathryn North AC.
who may benefit from Genomics Australia, once established, will
treatment with LUMAKRAS also advise the government on operation
(sotorasib), a KRAS G12C of the $500 million 10-year genomics
inhibitor developed and mission. State and territory governments
manufactured by Amgen. will also be invited to partner with the
government on this initiative to ensure its
start from a nationally cohesive foundation.

REGULATORY NEWS 9

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

DCGI grants EUA for Australia, South
Novavax’ COVID-19
vaccine for adolescents Korea sign MoU

US-based Novavax, Inc. and Serum Institute of India on vaccine research
(SII) have announced that the Drugs Controller
General of India (DCGI) has granted emergency use The state of Victoria in Australia and South
authorization (EUA) for Novavax’ protein-based Korea have signed a Memorandum of
COVID-19 vaccine for adolescents Understanding (MoU) to collaborate on mRNA
aged ≥12 to <18 years in India. The vaccine research. The partnership will boost
vaccine, also known as NVX-CoV2373, the mRNA capabilities of both jurisdictions.
is manufactured and marketed in India The MoU is between mRNA Victoria and the
by SII under the brand name Covovax Korea Health Industry Development Institute
and is the first protein-based vaccine (KHIDI). KHIDI drives Korea’s innovation
authorised for use in this age group in plans for pharmaceuticals, medical devices
India. Covovax is the fourth vaccine and medical services. The MoU will bring
to receive EUA from the DCGI for together Victoria’s biotech research expertise
use among adolescents 12 and older. with Korea’s biomanufacturing specialisation.
The safety and efficacy of Covovax in Victoria and Korea will exchange information
adolescents aged less than 12 years and develop linkages between industry,
have not yet been established; however, research and government organisations. They
studies evaluating the safety and immunogenicity of will seek opportunities for joint early-stage;
Covovax for the age groups of ≥7 to <12 and ≥2 to <7 RNA research; clinical trials; and investment
years in India are underway. A Phase 2/3, observer- into the development and manufacture of new
blinded, randomised, controlled study in a total of 460 RNA-based therapies and vaccines. The MoU
Indian adolescents aged ≥12 to <18 years was conducted also considers government-to-government
to evaluate the safety and immunogenicity of Covovax. collaboration on policies for fostering
The study demonstrated that Covovax was well-tolerated innovation and supporting local industry
with a reassuring safety profile. development. These include cooperating on
capability-building initiatives in Victoria and
Korea.

Singapore recommends second
booster dose of mRNA vaccine for 80+

The Expert Committee on who are at increased risk of severe disease is sustained after
COVID-19 Vaccination (EC19V) severe disease due to significant the third dose mRNA booster.
in Singapore has been closely medical risk factors. Local data However, there can be a warning
reviewing the data regarding to date shows protection against of protection, particularly in the
the need for additional vaccine elderly and medically vulnerable.
doses, and recommends that International studies show
the persons aged 80 years that vaccine efficacy against
and above receive a second hospitalisation declines after a
booster dose (i.e. fourth dose third dose mRNA booster. In the
if receiving an mRNA vaccine) US CDC report for the Omicron-
from about five months after dominant period, vaccine efficacy
receiving their first booster against hospitalisation was 91 per
dose. This recommendation cent at 2 months after the third
is also applicable to persons dose and decreased to 78 per
living in aged care facilities, cent by the fourth month. Similar
such as nursing homes; and findings were also reported by
medically vulnerable persons the UK Health Security Agency.

10 COMPANY NEWS

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Astellas’ menopause Pfizer’s oral COVID-19
drug fails in Asia trial
drug to hit shelves in
Japan-based Astellas Pharma Inc. has announced
topline results from the ongoing Phase 3 MOONLIGHT 95 countries
1 clinical trial investigating the efficacy and safety of
fezolinetant, an investigational oral, nonhormonal The Medicines Patent Pool (MPP) has signed
compound being studied for the treatment of moderate to agreements with 35 companies to manufacture
severe vasomotor symptoms associated with menopause the generic version of Pfizer’s oral COVID-19
(VMS), in women in Asia. VMS, characterised by hot treatment nirmatrelvir, which in combination
flashes (also called hot flushes) and/or night sweats, are with a low dose of ritonavir can be supplied
common symptoms of menopause. Based on the 12-week in 95 low- and middle-income countries. The
data analysis in 302 participants, fezolinetant 30 mg companies that have signed the agreements
once daily (QD) in women in China, Korea and Taiwan span across countries such as India, South
did not meet the pre-defined endpoints for efficacy. Korea, China, Bangladesh, Vietnam, Israel,
While numerical improvements from baseline were Serbia, Pakistan, Mexico, Brazil. Nirmatrelvir,
observed in the fezolinetant 30 mg treatment group, which originated in Pfizer laboratories, is
the results did not meet statistical significance. The 12- designed to block the activity of the Mpro, an
week safety data in this study are aligned with what was enzyme that the coronavirus needs to replicate.
previously observed with fezolinetant. Detailed results Co-administration with a low dose of ritonavir
will be submitted for publication following completion helps slow the metabolism, or breakdown, of
of the 24-week analyses. nirmatrelvir in order for it to remain active in
the body for longer periods of time at higher
concentrations to help combat the virus.

World’s first lung scanner becomes available for Australians

Australians with lung by Australian company earlier and more accurately
conditions will be able to 4DMedical, at the Prince monitor chronic respiratory
of Wales Hospital, Sydney. conditions. The government
access the world’s first and Funded through the Morrison has provided $28.9 million
only dedicated lung Government’s landmark through the MRFF Frontier
scanner, which was Medical Research Future Health and Medical Research
developed Initiative to develop and
Fund (MRFF), the XV commercialise the scanner.
Scanner uses an automated The XV Scanner will be used
scanning process to produce by researchers and clinicians
detailed lung function from the University of New
information in real time. The South Wales (UNSW) and the
XV Scanner will change lives, Sydney Children’s Hospital,
bringing new hope and help including eminent lung
for people living with lung health expert Professor Adam
conditions such as chronic Jaffe, who is currently the
obstructive pulmonary John Beveridge Professor of
disease, cystic fibrosis and Paediatrics at UNSW.
asthma. It will detect disease

COMPANY NEWS 11

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Bharat Biotech, Biofabri to develop
and distribute novel TB vaccine

India-based Bharat Biotech been designed and discovered global TB vaccine pipeline. The
has announced the partnership by Carlos Martín team of the only currently available TB
with Biofabri, a Spanish University of Zaragoza. This vaccine, the Bacillus Calmette-
biopharmaceutical company, agreement between Guérin vaccine (BCG), was
to join forces to develop, Bharat Biotech developed 100 years ago and has
manufacture and market and Biofabri limited efficacy in preventing
a new tuberculosis vaccine would guarantee pulmonary TB in adults, who,
in more than 70 countries the worldwide along with adolescents, are the
in Southeast Asia and sub- production and biggest spreaders of the disease.
Saharan Africa. The vaccine the supply of the future vaccine
is being manufactured and in more than 70 countries with
developed by Biofabri, in close a high TB incidence, such as
collaboration with the University India which has the highest TB
of Zaragoza, International burden in the world, with a 25
AIDS Vaccine Initiative (IAVI) per cent of all cases. MTBVAC
and the Tuberculosis Vaccine is one of the most promising
Initiative (TBVI). MTBVAC has vaccine candidates in the current

Taiwan firms to develop iGene Lab introduces
global CDMO for
inhalation treatment drugs saliva-based COVID-19

Taiwan-based HCmed Innovations has formed PCR tests in Singapore
a strategic alliance with Formosa Laboratories
and Formosa Pharmaceuticals, Inc. to expand In a move towards easing the uncomfortable nature
its business in the inhalation treatment of nasal swabs, a new saliva-based COVID-19 PCR
field, providing contract development and test is now available at select iGene Laboratory
manufacturing services. By integrating HCmed’s partner clinics throughout Singapore. The test
vibrating mesh nebulizers, Formosa Laboratories’
drug development and manufacturing can detect all COVID-19
capabilities, and Formosa Pharmaceuticals’ variant strains among the
APNT nanotechnology platform, the three known to date, including
parties are expected to become a one-stop shop the recent Omicron
in the biopharmaceutical industry as a full- variant. The saliva-based
service contract development and manufacturing COVID-19 PCR test is
organisation (CDMO). According to statistics, the also accepted as a pre-
global inhalation drug market reached $25 billion departure traveller test to
in 2020. Moreover, as the COVID-19 pandemic countries such as Canada,
has driven demand for respiratory treatment Japan, Korea, Taiwan, and
drugs during the past two years, the demand the US. Serving medical
for developing respiratory drugs has also grown professionals and patients
stronger, prompting several well-known global across Southeast Asia,
pharmaceutical companies to take the initiative to iGene Laboratory is a wholly-owned subsidiary
incorporate HCmed’s proprietary mesh technology company of medical diagnostics developer, INEX
into the development of their inhaled products. Innovate headquartered in Singapore. The saliva-
This collaboration is expected to increase the based test uses the Polymerase Chain Reaction
number of CDMO orders, deepen customer (PCR) methodology to enable detection of viral
relationships, and contribute to revenue increase. Ribonucleic Acid (RNA), the genetic material of
COVID-19, thereby identifying those with an active
COVID-19 infection.

12 FINANCE NEWS

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

RedHill inks India’s Trivitron Healthcare acquires
The Kennedy Company, USA
$6M deal with
Indian firm Trivitron Healthcare has acquired 100 per cent shareholding
Kukbo for in the US-based The Kennedy Company, a leading manufacturer of
radiation protection X-ray shielding material and acoustic barrier
COVID-19 drug products. Trivitron intends to fully support all existing operations
and further expand manufacturing
in South Korea capabilities and develop a cutting-edge
Technology Park in Scottsboro, Alabama
RedHill Biopharma has focussed on the latest advancements.
entered into an exclusive The campus will soon house multiple
licence agreement with manufacturing and R&D facilities
Kukbo Co., a South Korean focusing on Trivitron’s core segments –
corporation, for oral Medical Imaging, In Vitro Diagnostics,
opaganib for the treatment of Intensive Care and Cardiology
COVID-19, in South Korea. Equipment & Consumables. This campus will act as the manufacturing
Under the terms of the licence hub for the United States of America operations of the Trivitron Group.
agreement, which follows Post integration, the new entity would become a part of Trivitron
the previously announced Healthcare Americas, operating as Kennedy Vinyl for the existing X-ray
strategic investment by Kukbo, shielding and acoustic noise control business and Kennedy Radiology for
RedHill will receive an upfront Radiation Protection Products manufactured in the US.
payment of $1.5 million and is
eligible for up to $5.6 million Huadong Medicine becomes
in milestone payments as well strategic partner for
as low double-digit royalties Heidelberg Pharma in Asia
on net sales of oral opaganib
in South Korea. Kukbo will German firm Heidelberg Pharma AG and Huadong Medicine in
receive the exclusive rights to China have entered into a strategic partnership with the signing of an
commercialise opaganib in exclusive licensing agreement as well as an investment agreement.
South Korea for COVID-19. The agreements were concluded with wholly owned subsidiaries
The partnership with Kukbo
also includes a right of first of Huadong, one of the leading
offer for RedHill’s late-stage pharmaceutical companies in China
clinical assets, opaganib, with a focus on oncology and antibody-
RHB-107 (upamostat) and drug conjugates (ADC) research,
Talicia, for one or more of the development and commercialisation.
territories of South Korea, Heidelberg Pharma has granted
Japan, Indonesia, Vietnam, Huadong exclusive development and
Thailand and/or Malaysia. commercialisation rights for oncology
The right of first offer has been products HDP-101 (BCMA-ATAC) and
extended as part of the new HDP-103 (PSMA-ATAC) for Asia and is
licence agreement until the eligible to receive an upfront payment
end of October 2022. of $20 million (EUR 17.5 million) and
milestone payments of up to $449
million (EUR 400 million), as well as tiered royalties ranging from single
to low double digit percentages for each candidate. Heidelberg Pharma
has also granted Huadong an exclusive option for the pre-IND research
candidates HDP-102 (CD37-ATAC) and HDP-104 (undisclosed target)
in Asia with a total deal value of up to $461 million (EUR 410 million),
plus tiered royalties ranging from single to low double digit percentages
for each candidate.

START-UP NEWS 13

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Singapore’s NDR Singleron acquires
Medical expands
APAC presence Proteona and extends

Singapore’s NDR Medical, an interventional reach outside China
robotics startup, has extended its Asia-Pacific
(APAC) presence with the launch of its fourth office Singleron Biotechnologies, a Chinese genomics
in Tokyo, Japan. The new office will be managed by startup that develops groundbreaking single-cell
Dr Kazumi Taguchi, NDR’s newly appointed Chief multi-omics platform technologies and promotes
Medical Officer in Japan & Assistant Professor their clinical translations, has announced the
and head of research in Nephro-urology at Nagoya acquisition of Proteona, a Singapore-based
City University. The new office will enable NDR precision medicine company offering single-cell
to strengthen its partnerships with hospitals & biomarker discovery services to translational and
collaborators in the Japanese market & adds to clinical researchers across the globe. By acquiring
the company’s presence in the region alongside Proteona’s existing network throughout greater
its headquarters in Singapore, as well as offices Asia, Europe, the US and Canada, the acquisition
in Malaysia and China. NDR will launch its first strengthens Singleron’s position outside China and
multi-site trial in Japan for Automated Needle provides Singleron access to Proteona’s technologies
Targeting (ANT)-X with two university hospitals for single-cell multi-omic analysis and expertise
to evaluate the puncture superiority of ANT-X in generating insights for the Biopharmaceutical
compared with conventional techniques. The trial is market. Founded in 2017, Proteona specialises
expected to commence in Q2 2022 & includes more in combining single-cell proteogenomic analysis
than 100 patients. The trial will assist in obtaining with machine learning methods to identify novel
Pharmaceuticals & Medical Devices Agency (PMDA) biomarkers and generate machine-learning based
approval for later commercialisation in Japan. predictive models of disease severity and therapeutic
response. To support these efforts Proteona has
developed innovative methods for single-cell multi-
omic analysis and data interpretation. These include
tools such as MapCell for cell annotation and
MapBatch for batch correction that have significant
advantages over conventional single-cell based
methods for data analysis.

Triastek, Siemens to jointly address pharma
needs and improve patient outcomes

Triastek, Inc. and Siemens Ltd., and Siemens will leverage pharmaceutical MED (Melt
China have signed a strategic their respective technological Extrusion Deposition) 3D printing
collaboration agreement to advantages, strengths, platform technology for R&D and
provide digital technologies and capabilities to address mass production integrated with
for the global pharmaceutical pharmaceutical industry the advanced automation and
industry. Combining Triastek’s needs and improve patient digital technologies provided by
industry-leading 3D printing outcomes. Triastek’s proprietary Siemens will accelerate product
and digital pharmaceutical R&D, and facilitate continuous
technologies and Siemens’ manufacturing approaches,
global leadership in automation paperless production, real time
and digitisation is expected product release, equipment
to lead to innovative and and facility maintenance.
transformative solutions for the These innovations are expected
development and manufacturing to improve production line
of pharmaceuticals. This throughput whilst maintaining
collaboration between Triastek the highest product quality.

14 START-UP NEWS

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Mylab opens new CoreTissue
facility for advanced
diagnostics in India BioEngineering to be first

India-based startup Mylab Discovery Japanese startup
Solutions has announced the opening of a
new manufacturing facility at Andhra Pradesh at JPOD @ Boston
MedTech Zone (AMTZ) in Visakhapatnam.
The brand-new facility will utilise the latest CoreTissue BioEngineering Inc., a medical device
technology to manufacture a wide range of company developing an artificial ligament derived
high-quality molecular diagnostic products and from decellularised animal tissue, has been accepted
increase the company’s manufacturing capacity. into Johnson & Johnson Innovation - JPOD @
Spread over 43,000 square feet, the facility will Boston. The startup will expand its footprint and
be set up to cater to the increasing demand for accelerate business development in the US through
transformative molecular testing in India and its support team and select key opinion leaders
across the world for early and accurate diagnosis. (KOLs). Based in Yokohama, Japan, CoreTissue
The new manufacturing facility is under BioEngineering, Inc. is a spinout company from
construction and will officially start operations Waseda University. It has a team of Harvard-trained
from June 2022 after receiving the necessary biomedical scientists, seasoned senior management
approvals. The new facility will increase the in medical device development, and experienced
existing production capacity to 500,000 per clinical research professionals. Following its success
day, and create new jobs for skilled workers who in developing artificial ligament for Anterior
will use advanced technology to produce life- cruciate ligament (ACL) reconstruction surgery,
changing diagnostics and therapeutics to make the startup plans to further apply its technology
life better for people around the world. platform to the development of medical devices
for the broader human musculoskeletal system.
CoreTissue BioEngineering has already validated
a proof-of-concept of the product in an ovine large
animal study with a prototype developed using these
technologies. The company has received strong
backing from the Japanese government, the Japan
Agency for Medical Research and Development
(AMED) for development from early feasibility
through pivotal trials.

Servatus commissions clinical trial of
live biotherapeutics on insomnia patients

Servatus, an Australia-based gut microbiome composition and solutions for insomnia. Improving
startup, has begun recruitment function and its association with sleep habits and behaviour therapy
for its Phase I/II clinical trial for healthy sleep patterns. There is a are typically the first approach
insomnia at the Sleep Disorders definable gap in the development in managing insomnia but most
Centre at The Prince Charles of safe and effective long-term people do not seek professional
Hospital in Queensland. This support and may turn to over-
is the first study to research the the-counter medications to self-
effects of live biotherapeutics on medicate. However, current
patients with clinically diagnosed medications, whether prescribed
insomnia in Australia. The study or over-the-counter are for
will examine the safety and efficacy short-term use only, may have
of the treatment across 50 patients undesirable side effects and do not
over a 35 day treatment period, treat the underlying cause. The
with the aim to assess the effect Servatus trial will run during 2022,
the live biotherapeutic has on with final results expected in 2023.

WORLD NEWS 15

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

UNICEF to procure 4M treatment
courses of Pfizer’s PAXLOVID

United Nations Children’s Authorisation for the use of the (WHO). This agreement will help
Fund (UNICEF) has signed a Pfizer drug for the treatment ensure that low- and middle-
supply agreement with Pfizer of mild to moderate cases income countries (LMICs)
for the procurement of up to of COVID-19. PAXLOVID is have timely access to this
4 million treatment courses of currently under assessment by novel COVID-19 therapeutic.
the new oral antiviral medicine the World Health Organisation Supply will be made available
nirmatrelvir/ritonavir
(PAXLOVID) in 2022. for procurement and
UNICEF procurement of delivery to 95 LMICs,
PAXLOVID is dependent which includes some
on country demand, upper-middle income
clinical recommendations countries. UNICEF will
and necessary approvals. work closely with WHO
In December 2021, and Access to COVID-19
the US Food and Drug Tools Accelerator (ACT-A)
Administration issued partners such as The Global
an Emergency Use Fund and Unitaid to ensure
equitable access to the drug.

NIH launches Firms form CGTA to
raise awareness on
biomarker testing for CardioGenomic Testing

CNS tumours in children Several leading genomics companies and
laboratories, including Illumina, Fulgent Genetics,
In support of President Biden’s Cancer Moonshot Invitae, GeneDx, and PerkinElmer Genomics,
goal of fostering data sharing in cancer research, have formed the CardioGenomic Testing Alliance
the National Cancer Institute, a part of the (CGTA), a collaborative group aimed at raising
National Institutes of Health (NIH), has launched awareness and utilisation of genomic testing in
the Molecular Characterisation Initiative for cardiology. CGTA will inform
paediatric tumours. This programme offers healthcare providers and other
tumour molecular characterisation, also called stakeholders to the value of
biomarker testing, to children, adolescents, such testing to assure adherence
and young adults with newly diagnosed central to existing guidelines from
nervous system tumours who are being treated professional medical societies,
at hospitals that are affiliated with the Children’s inform medical management
Oncology Group (COG), an NCI-supported and cascade testing, and
clinical trials group that includes more than improve clinical outcomes.
200 hospitals and institutions that treat most Genomic testing in cardiology is
children diagnosed with cancer in the United a powerful tool that can identify
States. The Molecular Characterisation Initiative those at-risk for specific cardiac conditions, such
is offered through NCI’s Childhood Cancer as arrhythmias, cardiomyopathies, and congenital
Data Initiative, which was launched in 2019 to heart malformations. Despite evidence and major
promote data sharing and collection of new data professional society recommendations, utilisation
among researchers who study childhood cancers. and awareness of cardiogenomic testing remains
Children, adolescents, and young adults diagnosed low. CGTA will strive to inform healthcare providers
with a central nervous system cancer across the about the current guidelines for the appropriate use
United States will be eligible to receive molecular of genetic testing in cardiology.
characterisation of their tumours free of charge
through this voluntary programme.

16 WORLD NEWS BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Peru, Brazil EU commits €24.5M for WHO’s
to mutually healthcare initiate in Africa
strengthen
and improve The European Commissioner technology transfer and capacity
health services for International Partnerships building for local production,
and WHO Director-General have and improving the consolidation
The President of the Republic signed a letter of intent for a € of the demand and strategic
of Peru, Pedro Castillo, and 24.5 million EU contribution to purchasing of such products. In
his Brazilian counterpart, the World Health Organisation 2020 - 2021, the EU consolidated
Jair Bolsonaro, have (WHO), to support the local its position as the 5th largest
signed health agreements, manufacturing of and access to WHO contributor with $466
including a Memorandum vaccines, medicines and health million, confirming its leading
of Understanding (MoU) technologies in Sub-Saharan role in global health.
to promote cooperation Africa. The new initiative is
between the Social Health designed to empower African
Insurance System (EsSalud) countries and partners such as
and the Ministry of Health the African Union to further
of the Federative Republic enable local manufacturing of
of Brazil. The agreement medical products and health
implies a series of joint actions technologies by advancing
to strengthen the health regulatory convergence across
services provided by both the continent, supporting
countries. EsSalud and the
Brazilian Ministry of Health Moderna to commence mRNA
will exchange information shots production in Kenya
on the social health security
policy; decentralisation of US-based biotech company Moderna, Inc., with the assistance of the US
health management; medicine government, has entered into a Memorandum of Understanding (MoU)
policy and the functioning with the Government of the Republic of Kenya to establish Kenya as the
of information systems at location for the company’s mRNA manufacturing facility. Moderna is
health facilities; as well as building this state-of-the-art mRNA facility in Africa with the goal of
financial regulation of health producing up to 500 million doses of vaccines each year. The company
services and human resource anticipates investing up to $500 million in this new facility which will
training in health. In addition, focus on drug substance manufacturing on the continent of Africa for the
they will share knowledge continent of Africa, and could also be expanded to include fill/finish and
about primary health care; packaging capabilities at the site. In parallel, Moderna is also working
prevention and treatment of on plans to allow it to fill doses of its COVID-19 vaccine in Africa as
cancer; as well as training early as 2023, subject to demand. In its prophylactic vaccines modality,
of health professionals who Moderna’s mRNA pipeline includes 28 vaccine programmes including
perform organ, tissue and cell vaccines against respiratory viruses, vaccines against latent viruses and
transplantation. vaccines against threats to global public health.

WHO NEWS 17

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com Investment

WHO issues guidelines towards TB
to ‘pandemic influenza’
services &
The World Health Organisation (WHO)’s new guidelines for the
clinical management of severe illness from influenza virus infections research must be
provide recommendations on the use of influenza antivirals,
adjunctive therapies and diagnostic strategies. The new guidelines increased: WHO
are intended to guide
clinicians in their care of The World Health Organisation
patients with or at risk of (WHO) calls for an urgent
severe illness from seasonal, investment of resources,
zoonotic or pandemic support, care and information
influenza. The guidelines into the fight against
were developed using a tuberculosis (TB). Although 66
robust method that included million lives have been saved
commissioning systematic since 2000, the COVID-19
reviews and evaluating the pandemic has reversed those
quality of evidence using the gains. For the first time in over a
Grading of Recommendations decade, TB deaths increased in
Assessment, Development and Evaluation (GRADE) framework. 2020. Ongoing conflicts across
Each guideline was reviewed by an external review group and Eastern Europe, Africa and
approved by WHO’s Guideline Review Committee. This guideline the Middle East have further
provides recommendations on treatment with antivirals, specifically exacerbated the situation for
neuraminidase inhibitors; treatment with adjunctive therapies, vulnerable populations. Global
specifically corticosteroids, macrolides and passive immunotherapy; spending on TB diagnostics,
and use of diagnostic testing strategies to guide treatment. treatments and prevention in
2020 were less than half of
WHO enhances lab the global target of $13 billion
biosafety in South East Asia annually by 2022. For research
and development, an extra
The World Health Organisation’s Regional Office for South East Asia $1.1 billion per year is needed.
(SEARO) is supporting countries to boost laboratory biosafety and Updated guidelines for the
biosecurity through regular training. Biological safety, also known management of TB in children
as biosafety, uses a structured and adolescents released by
approach to minimise infectious, WHO highlight new patient-
chemical, and physical risks centred recommendations
in clinical and laboratory for diagnosis, treatment and
settings. In this context, the 4th prevention. The most recent
edition of the WHO Laboratory recommendations are diagnostic
Biosafety Manual (LBM4), testing has expanded to include
which promotes a risk-based non-invasive specimens, such
and cost-effective approach to as stools; rapid molecular
biosafety, offers an economically diagnostics are recommended as
feasible and sustainable option the initial test for TB diagnosis
for scaling up biosafety practices in countries. To help implement the for children and adolescents;
LBM4 approach, SEARO developed a practical guide and a series of and two of the newest TB
bio-risk assessment templates. The new guide contains straightforward medicines to treat drug resistant
descriptions of recommended biosafety practices alongside stepwise TB (bedaquiline and delamanid)
illustrations of for example how to perform routine biosafety activities are now recommended for use
and how best to respond to a laboratory emergency. In addition, in children of all ages, making it
SEARO organised two regional trainings to support biosafety. possible for children with drug-
resistant TB to receive all-oral
treatment regimens regardless
of their age.

18 COVER STORY

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

WHY

HOLOMEDICINE

IS RAPIDLY
GAINING GROUND

Medical holography has emerged as one Typically, conventional 3D
of the most promising applications in the (3-Dimensional) imaging technologies
are not able to create a truly accurate
medical industry. Holographic imaging 3D rendition. Actually, these are 2D images
technology is advancing healthcare, gathered from MRI, CT scanner, ultrasound,
life sciences, biomedical research as and other devices, stitched together to create a
rough 3D image. Furthermore, it is extremely
well as medical training and education. laborious and time-consuming to create
Mixed Reality (MR) applications are 3D visualisations from these 2D images.
Treatment and diagnostic decisions based on
gradually making a progressive impact these images are rather challenging, plus their
on healthcare deliveries with precise accuracy is often questionable. As a solution to
quantitative measurement of human these challenges, novel revolutionary medical
internal anatomy elements in 3D holography technology renders 2D images into
holograms geometries displayed in 3D floating projections applying Mixed Reality
actual physical space. Holographic (MR), a blend of physical and digital worlds,
3D technology renders medical which unlocks natural and intuitive holograms
through 3D interactions.
professionals with advanced diagnostic
capabilities and surgical planning, by In contrast to AR/VR, in MR the real
allowing them to slice virtual tissue, environment remains visible at all times and
the holograms appear in the real space passing
organs, and other body parts at various through a holographic device. This enables
angles. Holomedicne advances access medical professionals to zoom in and zoom out
the magnified 3D hologram of an organ/tissue
to percutaneous procedures without under study. These visuals are indistinguishable
invasive needle techniques. Surgeons in a conventional scanning procedure and thus
holograms make treatments and surgeries a
across the world are now curious to seamless effort with live explicit interactions.
explore medical holograms to enhance

the efficiency of complex surgeries.

COVER STORY 19

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Trends and opportunities in approval and expanding their regional presence
across multiple regions, especially in Asia Pacific
the medical holography market: (APAC), according to Polaris Market Research, 2022
report.
The clinical application of holography is thriving
with the rising adoption of health-tech products Nevertheless, APAC is considered to be the
in the life science and healthcare sector. The fastest-growing region in the medical holographic
holography products can range from holography imaging market to emerge as a front-runner.
displays, holography microscopes, holography Numerous economies in APAC such as India,
prints, holography software and devices, holographic Singapore, Japan, South Korea, China, and Indonesia
headsets, and holoscopes. have huge potential to extrapolate holography. The
size of the medical holography market in the APAC is
Geographically, North America represents the estimated to grow to $474 million by 2026 from $120
significant manufacturing and commercialisation million in 2021 at a CAGR of 31.56 per cent during
segment of medical holographic imaging assets and the forecast period, says Market Data Forecast, 2022
is expected to account for the largest global market report.
share from 2020 to 2025. But, the European market
has been the slowest since 2019 and is expected to The growth in the region is driven by increasing
remain the same by 2024, says TechNavio Market investment in healthcare expenditure, medical
Research report. facilities, technological developments in surgical
rooms, and swelling demand for digitised health
Contributing to the largest revenue share in the services and tailored personalised regimens. With
global medical holography market, North America the rising investments, the market is offering various
owns major vendor bases while the region also opportunities to start-up vendors, leading MedTech
reports substantial ongoing research by the major companies, and the Internet of Medical Things
market players. In addition, increasing interest in (IoMT) networks.
healthcare institutions and growing funding for
the advancement and deployment of holography Describing the potential of various segments of
techniques in healthcare organisations are also the medical holography sector, experts at Polaris
driving the region’s medical holography market Market Research explain, “In 2021, based upon the
growth. Meanwhile, more players are working on product, the ‘holographic display’ segment dominated
seeking the US Food and Drug Administration (FDA)

20 COVER STORY BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Source: IndustryARC Medical Holography Market Size, By Region, 2016-2027
Medical Holography Market Share, By Product Type, 2021 (USD Million)

the market holding the largest share in the global a pair of mixed reality smart glasses coupled with
market. On the basis of application, the ‘medical holographic capabilities which enable efficient 3D
education’ segment is anticipated to witness the Holographic projections of human internal organs.
highest growth due to the growing use of holographic
techniques across medical operating procedures in Microsoft ‘HoloLens’ mixed reality glasses are
surgical rooms or hybrid operating rooms. Based currently the prime devices surviving this purpose
on the end-user, the ‘research laboratory segment’ in the medical arena. HoloLens is the first HMD
is expected to show the highest growth in terms of (head-mounted display) running the Windows Mixed
revenue contribution”. Reality platform under the Windows 10 computer
operating system. The wireless mixed reality HMD
Holomedicine transforms medical images and clinical workflows
into interactive holographic 3D projections in
Surgeons across the world are now curious to physical space which can be examined by merear
use medical holograms to improve the planning of physical gestures in the air like hand movements and
complex surgeries. The developers of the medical voice commands.
mixed reality platform are implementing MR tools
to create virtual 3D avatars for streamlining surgical “HoloLens manages to shift the cognitive load
planning, patients engagements, and assisting in from one area to another. This is because surgeons
medical academia. no longer have to spend energy trying to mentally
visualise a 3D scan of a given anatomic area (after
The term Holomedicine is derived from the word deeper analysis of 2D images). This visualisation
‘hologram’ and describes MR medical applications ability takes years for clinicians to acquire. While
where the holograms appear as floating images experienced surgeons may not need to use the
in the real physical ambiance. A consortium of HoloLens, the technology provides less experienced
clinicians, scientists, doctors, technical specialists, clinicians to be able to deliver the
policymakers, and industry partners has established same expertise and improve
an international organisation called, “Holomedicine the overall patient experience”
Association”, to nurture Holomedicine in the says Dr Gao Yujia, Vice-
healthcare sector. Chairman & Director of
Medicine, Science, and
Sharing his views about the association Dr Technology at Holomedicine
James Macalister Kinross, Association.
Senior Lecturer in Colorectal
Surgery, Consultant Adding to this, Microsoft launched ‘HoloLens
Surgeon, Imperial College, 2’ (second-generation holographic computer) that
London said “Holomedicine streams patient data through 3D-Virtual Surgery
Association is able to provide Intelligence (VSI), a medically certified cloud-
a platform to build cohesive based platform to generate real-time visuals for
registries and create new ways of Holomedicine applications. ‘HoloLens 2’ uses iris
recognition for a secure biometric framework to
using the cloud to share best practices globally. The sign in and protects patient confidentiality and data
biggest barrier in this process will be creating the privacy. Physicians, hospital networks, and industry
governance and ethical frameworks that will allow for partners can now interconnect through Holomedicne
this data and information to be shared”. technology to create a new ecosystem of collaborative
medicine and market engagement.
Microsoft has introduced the most matured and
comprehensive MR holographic tool - HoloLens,

COVER STORY 21

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Source: MarketsandMarkets Global association for Holomedicine

Medical Holography Market By Region, 2021 (USD Million) The Holomedicine Association is an
international organisation comprising expertise
“Microsoft is helping healthcare organisations such as clinicians, scientists, doctors, technical
navigate the future through innovation and specialists, policymakers, and industry partners
technology, to remotely monitor ICU patients, so who are engaged in active research and
medical professionals can manage more people with development of Holomedicine which enables
fewer resources. This improves workforce efficiency, them to share best practices. It is the first global
decreases the need to use scarce PPE, and most industry association for Holomedicine, created
importantly, decreases the spread of infection during to illustrate innovation in the field of digital health
pandemics. Real-time, virtualised, and to help shape the debate around digital
specialised medical care using the transformation. The association works to build
HoloLens can be revolutionary new methods for delivering mixed reality (MR) and
in medical applications,” said extended reality (XR) technologies in medicine
Andrea Della Mattea, and surgery, whilst setting standards for safety,
President (Asia Pacific), promoting harmonised public policies, addressing
Microsoft (Singapore). privacy concerns, creating funding streams, and
supporting the development of medical and
Furthermore, with the MR head- scientific evidence. The association is responsible
mount weighing only around 500 grams, it may for outlining existing policies and guidelines and
one day replace existing bulky operation theatre creating new ones.
equipment and even reduce the exposure to radiation
in procedures such as spine operations, where X-rays On November 27, 2021, the association held
are currently used to guide the insertion of metallic its inaugural global summit gathering speakers
implants. from Asia, Australia, Europe, and North America.
The association also establishes funding channels
Alliances with software developers and MR device to receive sponsorships from industry partners
manufacturers are encouraged by Microsoft who or people interested in investing. There are two
intern partners with enterprises, government sectors, possible streams of funding, directed funding,
and educational institutions to leverage Mixed where sponsors can invest money into specific,
Reality capabilities through HoloLense to deliver ongoing projects, or undirected funding, where the
futuristic healthcare practices. For example in APAC, association receives the funding and channels this
Microsoft’s Mixed Reality partner, HelloHolo has into projects.
collaborated with industrial partners like HiverLab
(Singapore), Vue Networks (Singapore), Immersively technologies effectively augment the learning
(South East Asia), Incamtec (Thailand), Huawei capabilities in medical education, surgery, advanced
(Singapore), DreamCore (Singapore) and more. Key medical training, clinical research, pharma/medical
players in this market are comprehensively analysing manufacturing, remote monitoring, and other
their market shares and core competencies. associated areas.

Similarly, ’Meta 2’ is another leading competitive ● Optimise healthcare deliveries and
holographic HMD computer extending the potential clinical operations: Holographic 3D technology
of MR holographic technology in the medical sector. renders medical professionals with advanced
diagnostic capabilities, surgical planning, and
Diversified Potential of 3D Holography interventional cardiology/radiology by allowing
them to slice virtual tissue, organs, and other body
The use of holographic imaging and projection parts at various angles. This enables the image
has resulted in tremendous changes in the specialists and interventionists/ surgeons to create an
multidisciplinary field. Holographic imaging unlimited number of in-depth cross-sections views to
investigate an organ or tissue in detail.

In a conventional medical procedure, to
understand and plan diagnosis or treatment for
an ailment, imaging methods such as CT and
MRI images are often used. Only an expert or

22 COVER STORY

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

professionals can interpret and evaluate the data to which hand gestures or voice commands are
by observing these 2D images and patients are sufficient to maneuver the patient data without
always informed by a printed report on their the struggle of handling many physical reports or
medical condition. Most patients remain ignorant extra surgical tools. The real-time vision from the
of their exact medical status and treatment regime. patient’s environment digitally annotates or overlays
Holomedicine bridges this gap through 3D hologram holographic models for instruction, where one can
illustrations which help a patient to understand pull in multiple relevant data for reference during
his/her medical condition, disease status, and a medical procedure. Plus, the realistic virtual
recovery process during the medical consultations. analysis of a 3D model of Holomedicine can create a
Multidimensional colourful models of human organs collaborative ecosystem for better decision-making
assist medical professionals in easy detection and among Key Opinion Leaders (KOLs) in the medical
probing of diseased areas. It even provides better community (physicians, hospital networks, and
information about cavities and deformities in internal industry partners). The ergonomics technology
organs (tissues, muscles, organs, bones, and even enhances better hand-eye coordination even in
blood vessels) and also aids in fitting implants. novices.
Precise and faster diagnoses further streamline
treatment regimens and surgeries. Referring to the classical benefits
of medical holography, Dr Meong
“During a series of case studies, Holomedicine Hi Son, Samsung Medical
technology significantly improved or altered the Centre, Sungkyunkwan
surgical procedures of patients. In one example, a University School of
patient seeking a second opinion had her treatment Medicine, South Korea
significantly altered: originally, she was told that 70 said, “Holomedicine technology
per cent of her liver would have to be removed. Upon is the ‘Emergency Department’ to
reviewing her condition and applying Holomedicine supervise training and aid younger doctors. The use
technology during pre-operative planning and of a holographic device saves both patient and doctor
intra-operative assistance, only 30 per cent of the a significant amount of time by adopting virtual
liver was removed. The use of HoloLens in complex consultations. This helps patients feel prioritised
liver surgery has proven to be of great intraoperative and increases the consulting abilities of doctors.
support with a reduced risk of complications. It Application of holographic devices during the
improved the focus of the entire surgical team, pandemic greatly reduced infection transmission
rates”.
enabled effective training on
realistic procedures for patients, The onset of the pandemic further boosted the use
and improved patient safety of Holomedicine devices to bridge the gap between
in complex procedures” said healthcare experts and the patients, assisted front-
Dr Dirk Weyhe, Director, line workers, and also reduced travel requirements.
University Hospital for
Visceral Surgery, Carl von ● Biomedical and bio-pharma research:
Holography microscopes have various applications
Ossietzky University, Germany. in biomedical research, such as real-time monitoring
Further, Holomedicne advances access to of living cells, cell-based assays (such as cytotoxicity
percutaneous procedures without invasive needle assays), defect inspection, and noninvasive analysis
techniques to dissect organs or tissues. This greatly of fluid tomography using living cells and more
assists in diagnosing congenital heart ailments which can aid in accelerating drug discovery and
without a major scalpel incision. Similarly, pharmacovigilance. The technology can also be
virtual colonoscopy can be an alternate solution deployed in the toxicological profiling of bioactive
for uncomfortable classical methods of inserting compounds and the identification of cytotoxic
colonoscopes inside the body. Additionally, agents in cancer research. Apart from the above
holography post-heart surgeries will guide doctors applications, digital holography microscopy
to analyse the post-operative conditions or plan a technology is also used to measure clinically relevant
new regimen that was earlier investigated solely from parameters of RBCs, such as hemoglobin content and
repetitive scans/diagnostic tests until the patient’s mean cell volume (MCV) of individual RBCs. Owing
recovery. Thus, medical holography adds value to the to various benefits, such as label-free monitoring of
medical practices and even enhances patient care. cellular functions and high-resolution, noninvasive,
Furthermore, considering the requirement of and real-time imaging, medical holography is
a sterile operating room, the holographic screen witnessing an increase in demand in the biomedical

COVER STORY 23

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Source:
The National
University Health
System (NUHS),

Singapore

IMPLEMENTATION OF MR TECHNOLOGY IN HOLOMEDICINE

● Improve medical procedure and treatment ● Assists in drugs development and testing
regimens while enhancing surgeons’ efficiency ● Holographic image creates effective learning by

● Holographic guided instructions can enhance improving the quality of medical education and
training speed/efficiency and thus reduce
research
associated unnecessary downtime and retain ● Can create multimedia libraries, interactive

information more effectively due to alluring and tutorials, Podcasts, and apps through holographic

memorable experiences. visualisations using wearable devices
● Reconstructs bright high-resolution 3D medical ● Precisely sensitive to biographical and

models in natural light space for effective analysis demographic details, location and movement, and

and learning of human organs and their intricate biometrics

parts without a projection screen Challenges and Restraints
● Stores, retrieves, and archives multiple 3D ● The technology is typically expensive, with high

prototypes and information costs driven by objective lenses and the use of
● Prevents misinterpretation of a specific medical
specialised digital imaging devices.
problem ensuring a better treatment ● Processing holograms involves high computational
● Provides real-time data of a complex physiological
cost until commercially viable solutions are
process in the body and thus facilitates remote
introduced.
patient monitoring ● Constructing holography 3D images consumes
● Provides non-destructive accurate location and
large amounts of processing power, memory, and
precise measurement of tissues, tumors, internal
data storage space
organs, microfluidic channels, valves, implants ● 3D technology is very data-intensive, requiring

without using needles and scalpels. Identifies and high bandwidth. Thus integrating HoloLens with a

explains the complex fracture in human soft and 5G network might be essential to boost the data

hard tissue. transmission speed.
● Evaluate patient progress during the recovery stage ● Data security and privacy could be a debatable

and assist in better treatment planning concern as holographic techniques perform by
● Creates an ergonomics operating rooms design
storing and sharing patient-sensitive biometric data
setup that can potentially reduce infrastructure
across the network.
planning costs, lessen the burden on the medical ● Policymakers should rethink reforming the current

staff, efforts, and errors regulatory landscape for data privacy by creating
● Facilitate collaborative remote learning and
an innovation-friendly regulatory environment. MR
evaluation through improved KOL engagements
● Hands-free telemedicine capabilities during surgery technology’s benefits overweigh its risks.
● Lack of clear guidelines might discourage
and consultations
● Guides in the design, manufacturing, and innovation, particularly in nascent fields with less-

maintenance of medical tools and devices. Detects straightforward regulatory guidance. This will leave

errors during manufacturing or usage. multiple stakeholders at different levels in a state of

regulatory uncertainty.

24 COVER STORY

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

KEY PLAYERS IN THE GLOBAL medical schools, various market players are focusing
MEDICAL HOLOGRAPHY MARKET on developing holographic prints and holography
software to be used for medical teaching and training
● DAQRI (US); applications. Both software providers and device
● RealView imaging Ltd (Israel), manufacturers are collaboratively developing 3D kits
● Holoxica Ltd. (UK)., for medical students and doctors that will help them
● EchoPixel, Inc. (US); practice surgeries and dissections without needing
● Mach7 technologies Pte Ltd. (Australia), actual human subjects and organs.
● WIMI Hologram Cloud (China),
● ApoQlar (Germany); In August 2021, Singapore’s National University
● Appnovation (Singapore); Health System (NUHS) embarked on an R&D
● Philips (US), programme with Holomedicine technology to
● Firsthand Technology (US); enhance next-generation clinical applications study
● Osso VR (US); in both undergraduate and postgraduate education.
● Surgical Theater (US); With this, NUHS became the first Holomedicine
● Atheer Inc., (US); Centre of Excellence in the world and is also the first
● Microsoft Corporation (US); institution in the Asia Pacific region that fulfills the
● Samsung Electronics Co. Ltd.(South Korea); eligibility criteria to receive this recognition.
● HTC Corporation (Taiwan);
● Holografika Kft. (Hungary).; A team of neurosurgeons at the National
● EON Reality (US), University Hospital (NUH), is using holographic
● 3DforScience (US), technology to spatially locate brain tumors. Using
● MetroLaser (US) holographic visors, a 3D hologram of patient’s brain
scan is projected and superimposed onto the patient’s
Exclusive academics and research-based players head during surgery. This hologram is generated from
● Zebra Imaging (zSpace) Inc. (US), the patient’s own brain CT scan using Holomedicine
● Ovizio Imaging Systems (Belgium), software. When the hologram is set in place on a
● Lyncée Tec (Switzerland),
● Nanolive SA (Switzerland),
● Phase Holographic Imaging (Sweden).

research sector.
Eventually, the pharma and bio-pharma sectors

are also inventing multiple applications with MR
solutions. Especially for reducing procedural non-
compliance and increasing yields via remote data
sharing to accelerate discovery and development,
support clinical trials, and for training purposes.
Medical technology firms are using it to do audits and
inspections remotely, increasing productivity, and
driving greater remote sales and service.

● Biomedical training and education:
Over the years holographic technologies are gaining
extensive acceptance in medical education and
hospital training. 3D holographic perception creates
an intriguing and intelligent learning environment
by adding rotation flexibility to images dimensions,
thus creating an interesting and interactive learning
atmosphere. Further, immersive holography
technologies help better knowledge retention among
learning groups compared to 2D visualisation on a
digital screen.

With a growing focus on structural biology in

COVER STORY 25

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

patient’s head, surgeons are able to view the 3D augmented reality holographic technology firm
holographic images of the brain from various angles. WiMi (China) demonstrated the successful use of 3D
Surgeons can also pull up patients’ information to holographic technology in the healthcare education
interact and control the images by gesture and speech sector. In December 2021, the Korea Institute of
recognition. With the potential of higher precision Science and Technology (KIST) licensed out the
and quicker identification of ailments, surgeons can technology to develop a medical hologram system for
improve treatment procedures. NUH has extended Ean Hitech through collaborative R&D. From April
Holomedicine to disciplines such as plastics surgery 2022, medical and nursing students at NUS Yong
and ophthalmology. Loo Lin School of Medicine in Singapore will also be
using 3D holographic technology to better hone their
“The aim of the NUHS Holomedicine programme skills and to enhance patient care.
is to leverage mixed reality technology to enhance
clinical capabilities, improve clinicians’ experiences Talking about opportunities
and patient outcomes. By using holographic devices, Andreas Fessler, Chief
patients can better understand their condition, Business Officer & CMO,
enabling better decision-making when it comes to the apoQlar said,“The opportunities
treatment programme. We believe this technology are truly limitless in Mixed
has the potential to transform the way we practice Reality as one can continue to
leverage the exponential growth of
medicine and healthcare” said this technology as a superimposed digital layer while
Dr Gao Yujia, Associate also experiencing the undeniable growth we see in
Consultant, Division of the real world around us. At Germany-based apoQlar,
Hepatobiliary & Pancreatic with our Asia HQ in Singapore, we have created
Surgery, National the VSI HoloMedicine software platform to enable
University Health System surgeons and medical schools to transform their
(NUHS), Singapore. medical data and workflows into volumetric 3D”.
Similarly, in April 2020, an
Removing stumbling blocks

The global medical holography market is valued
at $1011.9 million in 2021 and is estimated to grow
at a CAGR of 19.4 per cent, to reach $2938.1 million
by 2027, according to Research and Markets, 2021
report. The rising adoption of holography products
in medical education, biomedical research, and other
clinical applications is also attracting investments
from IT giants encouraging allied product and
software development. However, the requirement
for high capital investment and the cost of the
technology might hinder the growth of this market
during the forecast period.

Though the medical holography market is
anticipated to witness significant growth, the
computation cost of processing holograms can be
an influential factor to slow down the growth of the
medical holography market.

“The development of holograms is a considerable
cost-intensive process. It takes significant
investments in R&D to develop new products
that effectively cater to market needs. The high
costs associated with research and technology
development (which includes product development,
system engineering, software development, clinical
assessment, and concerned regulatory approvals for
the initiation of product manufacturing) increase
the cost of the final product. The most expensive

26 WCOOVMEERNSSTPOERCYIAL

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Medical education goes Holographic with mixed reality from Microsoft Singapore and NUS Yong Loo Lin School of Medicine.

component of a digital holographic microscope and of clinical examinations and thus working closely
digital hologram is the computer that is used to with AI diagnostic systems to attract clinicians and
reconstruct images. Various end-users, especially instigate educational transformation. Holography
academic institutes, cannot afford these high- will significantly disrupt 2D/3D imaging, as it offers
cost tools, which might strain medical holography better usability and addresses the shortcomings
growth in the market to some extent. However, of current 3D solutions. Progress in image-guided
with the availability of faster computers for image therapies and operational procedures has opened
processing, inexpensive semiconductor lasers, and new frontiers for minimally invasive, non-surgical
high-speed CMOS cameras, it would be possible to interventions.
build holographic products at lower costs in the near
future”, explains ‘Seeking Alpha’, a crowd-sourced “The immediate future will have some fascinating
financial market report. bright spots for those who are willing to be early
adopters. Similar to the path of VR, the industry
Furthermore, virtual technologies always needs to see more concrete evidence of how these
demand high bandwidth networks for operating solutions are put into practice safely and with
smoothly. Hence integrating the MR technologies evidence of success. Delivering real-world evidence
with 5G can boost the data transmission speed for of the practical use of Holomedicine
an uninterrupted holographic view. Features of 5G, can accelerate increased adoption
such as high transmission, large bandwidth, and low in healthcare communities”
latency, can enrich MR application scenarios. Thus, said Steve Peretz, Group
in a way, 3D holographic technology largely depends Director, Health Experience
on the high-speed internet for data-intensive tasks and Product Strategy,
and might experience substantial temporary glitches Appnovation.
in countries that are yet to adopt 5G network services.
Though 4G can support many holographic features, The possibilities and
capabilities are optimised with 5G. implications of Mixed Reality’s continuous growth
demonstrate that the future of Holomedicine is
Anticipating competitive landscape both realistic and limitless.

The fast-paced life is demanding expedited results Hithaishi C Bhaskar
[email protected]

3D PRINTING OF DRUGS 27

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

How personalised
3D-printed drugs can
cut costs & eliminate fakes

Although 3D printing in life sciences is mostly associated with organs, of late, 3D-printed drugs are
also gaining traction. Let’s find out the benefits of this fast growing tech solution that promises to
solve the industry’s manufacturing woes.

As the pharmaceutical industry moves away “By enabling pharmacies to 3D print drugs, we
from mass production towards a more could potentially de-risk the supply chain as well as
personalised model, 3D printing of drugs has cut costs of drug manufacturing and distribution. 3D
the potential to revolutionise the industry. printing offers additional manufacturing processes
and potentially new, safer, and cost-effective ways
The first 3D-printed pharmaceutical drug – of delivering drugs, such as the bio-availability of
Spritam (a levetiracetam tablet) by US’ Aprecia drug compounds. It also theoretically reinvents the
Pharmaceuticals – was approved by the US Food supply chain where drugs can be made onsite at
and Drug Administration (US FDA) in 2015. Spritam the pharmacy, which could cost much less than the
treats epilepsy symptoms. Since then, the segment mass manufacturing of drugs at major warehouses.
has seen a flurry of activities and interest. The Global Warehouses are expensive to build and operate, and
3D printed drugs market is expected to grow at a the e-pedigree to maintain supply chain safety from
CAGR of 15.2 per cent from 2021-2027 to reach the manufacturing plant to the distribution center
$2,064.8 million by 2027, according to UnivDatos to the patient is quite costly,” said Kevin Coker, CEO
Market Insights. of Proxima Clinical Research, a US based contract
research organisation guiding emerging MedTech,
What are the benefits? biotech, pharmaceutical and device companies
through regulatory, quality and clinical development
Personalised medicines is the most obvious
application of 3D printing. Sharing more on 3D “Bringing a new medicine
printing Dr Alice Melocchi, Co-Founder and to market is costly and time
CSO, Multiply Labs, US said “One of the main
advantages of 3D printing techniques in the context consuming. With a novel,
of pharmaceutics is the possibility to personalise the disruptive technology like
drug products based on the patients needs. By way 3D printing for personalised
of example, this entails type and dosage of the drug medicine it is even harder as
loaded as well as excipient selection, but would also standard regulatory routes
extend to the design of the drug products and the cannot be used. New regulation
patient-specific release profiles to be attained.” . is currently being written by
leading authorities for this field.
Multiply Labs helps pharmaceutical companies Once published, it will be able
produce drugs with its robotic manufacturing to advance more rapidly. An
platform. Its cloud-controlled robots are designed example of this is the point-of-
to autonomously manufacture small batches of care legislation being brought in
personalised, multi-compartment capsules.
by the MHRA, UK.”
Recent supply chain challenges and demand for - Dr. Anna Worsley,
worldwide stocks has also seen renewed interest in
3D printing. It helps overcome supply chain issues Director of Innovation, FabRx, UK
and provide stability in supply chains – seen as an
issue in the recent pandemic.

28 3D PRINTING OF DRUGS

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

LATEST DEVELOPMENTS employed as a rapid prototyping tool. For example, it
could be used for real-time manufacturing of samples
● In 2022, Germany’s Evonik partnered with US’ 3D to be tested to assess the validity of an experimental
drug delivery system. This approach can drastically
printed pharmaceutical firm Laxxon Medical to reduce R&D time and costs, especially in comparison
to more traditional and complex manufacturing
bring the mass production of 3D printed tablets approaches leaning on mass-production,” added Dr
Melocchi.
closer to reality. The aim of the partnership is
Challenges in printing pills
to improve drug delivery for patients while also
3D printing has the potential to revolutionise the
advancing the commercialization of 3D printed pharmaceutical manufacturing industry, however,
few 3D-printed products have been approved since
pharmaceuticals the first in 2015.
● In 2021, UK’s University of East Anglia (UEA)
“At the moment the industry is going from proof
researchers investigated technology to 3D ‘print’ of concept studies towards industrial applications.
The conservative pharma industry is hesitant to
pills. The team, including Dr Andy Gleadall and change to a new technology, as it could potentially
present more unknown risks in all fields of drug
Prof. Richard Bibb at Loughborough University, development and registration,” said Korinde van den
Heuvel, Senior Product Developer, DFE Pharma,
identified a new additive manufacturing method Germany. DFE Pharma develops, produces and
supplies excipients for use in oral solid dose and dry
to allow the 3D printing of medicine in highly powder inhalation.

porous structures, which can be used to regulate A new technology takes time to build real-world
evidence to prove its capabilities. Right now, Spritam
the rate of drug release from the medicine to the is serving as a proof of concept which will help other

body when taken orally
● In 2020, UK’s Fabrx, a specialist biotech company,

developed M3dimakertm, the world’s first

3D printer for the production of personalised

medicines
● In 2020, Chinese 3D printing technology startup

Triastek raised $15 million in Series A funding to

accelerate the research and development of its

3D printed drugs
● In 2020, South Korean pharmaceutical company

HK inno.N announced plans to use artificial 3D

printed skin to test new autoimmune and skin

disorder drugs

to bring their inventions to market.
Unlike the equipment in drug manufacturing

plants, the equipment for 3D-printed drugs is much
smaller and can print in small batches. There’s no
wastage of active or chemical ingredients, offering a
more sustainable way to produce drugs.

“3D-printed drugs also cut down on the
carbon footprint created from moving the supply
chain around the world. Currently, a lot of active
ingredients come from China, where they then would
go to another country, like India, to be put in pill
form. From there, it would then move somewhere
else to get repackaged. 3D printing drugs have the
power to eliminate these steps in the supply chain
with the ability to manufacture the drugs where
they’re actually being used,” said Susan L Lang,
founder and CEO, XIL Health, USA, a leading
strategic analytics and technology company in the
drug economics space. Also, with 3D printing, fast
novel dosage form production can reduce time and
costs in clinical trials.

“On the other hand, 3D printing could also be

3D PRINTING OF DRUGS 29

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

“One of the main
advantages of 3D printing
techniques in the context

of pharmaceutics is the
possibility to personalise the
drug products based on the

patients needs.”
- Dr Alice Melocchi,

Co-Founder and CSO, Multiply Labs, USA

molecules get approved quicker for 3D printing. “By enabling pharmacies
“As far as regulatory hurdles go, the issues are to 3D print drugs, we could
potentially de-risk the supply
not around FDA approval, but rather, distributing chain as well as cut costs of
technologies. The bigger challenge is whether the law
is able to keep up with the technology as there are a drug manufacturing and
lot of criminal activities within the drug supply chain distribution.”
we have to be careful about. Legal challenges aside, - Kevin Coker,
I think FDA approval will be much quicker now that
Spritam has been approved,” added Lang. CEO, Proxima Clinical Research,USA

Pharma is a heavily regulated industry. It’s easy “By putting a 3D printing
to approve a manufacturing facility which mass centre close to major hospitals
produces the drugs rather than approve all the
facilities where a drug can be printed. and distribution centres
around the world, drugs can
“Bringing a new medicine to market is costly and be manufactured on the spot
time consuming. With a novel, disruptive technology and as needed. Over time, 3D
like 3D printing for personalised medicine it is even printers will continue to get
harder as standard regulatory routes cannot be used. smaller, eliminating waste and
New regulation is currently being written by leading bettering quality control. By
authorities for this field, once published the field will shortening the supply chain,
be able to advance more rapidly. An example of this there will be less of a worry of
is the point-of-care legislation being brought in by contamination and fakes being
the MHRA, UK,” said Dr Anna Worsley, Director of
Innovation, FabRx Ltd, UK. introduced in the cycle.”
- Susan Susan L. Lang,
Since its inception in 2014, the startup has
become one of the leaders in 3D printing drug Founder and CEO, XIL Health, USA
manufacturing space. In 2020, the firm launched,
M3DIMAKER, world’s first pharmaceutical 3D “At the moment, the industry
is going from proof of concept

studies towards industrial
applications. The conservative

pharma industry is however
in general hesitant to change
to a new technology, as new

could potentially have more
unknown risks in all fields
of drug development and
registration.”
- Korinde van den Heuvel,

Senior Product Developer, DFE Pharma, Germany

30 3D PRINTING OF DRUGS

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

BIG PHARMA’S 3D PRINTING products, which would be, by definition, all different
from one another.”
Merck, USA, is at the forefront when it comes
Future of 3D printed drugs
to applying 3D printing in drug manufacturing. In
3D printing could revolutionise personalised
2020, the firm partnered with Germany’s AMCM, a medicine, impact drug distribution and tackle
sustainability issues.
sister company of 3D printing world-market leader
“By putting a 3D printing centre close to major
EOS to develop and produce 3D printed tablets, hospitals and distribution centres around the
world, drugs can be manufactured on the spot and
first for clinical trials and then later for commercial as needed. Over time, 3D printers will continue to
get smaller, eliminating waste and bettering quality
manufacturing. control. By shortening the supply chain, there will
be less of a worry of contamination and fakes being
In March 2022, US’ Johnson & Johnson also introduced in the cycle,” said Susan.

expanded its partnership with UK’s Midatech Pharma Echoing similar sentiments, Dr Worsley said, “In
the future we will see desktop 3D printers, like our
for 3D printing to better encapsulate drugs. UK’s M3DIMKAER, in hospitals and pharmacies around
the world, personalising formulations in many
GlaxoSmithKline (GSK) is also investigating the different ways, including dose, colour, flavour and
drug combinations. This will help patients adhere to
advantages 3D printing pharmaceuticals could bring their treatment plan as well as reduce the costs and
risks involved with current compounding techniques.
to the manufacturing of pills and tablets. In 2017, This will start happening in the next few years for
more troublesome treatment pathways as clinical
the firm partnered with scientists at the University trials are carried out and regulatory authorities start
to publish legislation for personalised medicine
of Nottingham in the UK and completed a study approaches, such as 3D printing.’’ It’s a long way
before personalised 3D printed products can become
in which inkjet printing and UV curing was used widely available. Challenges are not limited to
manufacturing, but also include significant regulatory
to produce 3D tablets in order to treat Parkinson’s hurdles. In that regard, the USFDA is working with
the National Institute of Standards and Technology
disease. to create guidelines for 3D pill printing.

printer for personalised medicines. “Understanding which regulatory paths apply
Spritam is 3D printed but in a mass manufactured to the different phases of the overall process (e.g.
approval of starting materials, printers, software,
scale and does not offer personalised dosage forms. control tools, environment, quality control)
This means it uses 3D printing in a less disruptive is probably the next-to-face challenge. In this
manner and it can be added to the market using respect, the effective collaboration between experts
standard regulatory routes. belonging to complementary fields such as academia,
regulatory affairs, and industry is essential to achieve
Dr Melocchi explains this in detail, “Spritam translational goals,” said Dr Melocchi
is the only 3D printed drug currently already on
the market. It is a fast-dissolving tablet containing A centralised database uniting industry, academia
levetiracetam, manufactured by a 3D printing and innovators would allow for the collaboration
technique called binder jetting. This technique and pooling of knowledge within the industry. This
was developed in the late 1980s in the labs repository would support better patient care and
of the Massachusetts Institute of Technology provide an invaluable tool to investigators.
(MIT, US) and then fully redesigned by Aprecia
Pharmaceuticals. This 3D printing technique was Overall, 3D printing has the potential to
selected to give a specific quality attribute to the revolutionise the drug manufacturing. However,
product, i.e. an extremely rapid disintegration, which we will have to wait and see whether the challenges
increases the dissolution rate and improves the facing the industry can be overcome to allow the
bioavailability of the drug, enabling better treatment technology to reach its full therapeutic potential.
of epileptic patients suffering from seizures.
Although Spritam is available on the market in a few Ayesha Siddiqui
different dosages, all the units belonging to a single
batch contain the same drug strength. Therefore,
it may not be considered a personalised medicine.
Indeed, it was approved by the FDA in 2015 through
a traditional regulatory pathway, after years of
research aimed at making the technology suitable
for mass manufacturing. Therefore, the idea of using
3D printing for the manufacturing of personalised
drug products still represents a challenge due to
difficulties in identifying a suitable regulatory
strategy to guarantee the quality standards of final

THERAPIES 31

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Exploring the Possibilities
of RNA Therapeutics

Fuelled by the successful utilisation of the mRNA COVID-19 vaccines, RNA therapeutics are
expected to make larger strides in the near future. Let’s look at some of the drugs in late stage trials
and the trends that will shape the RNA therapies landscape in 2022 and beyond:

The success of the mRNA vaccine against and Drug Administration (US FDA) approved
COVID-19 has skyrocketed the development RNA therapeutics, the bulk of which are antisense
of RNA therapies. In 2021, more than 600 oligonucleotides (ASO) and small interfering RNA
therapies were in development (from preclinical to (siRNA) candidates for genetic disorders. There’s
pre-registration stage), with 73 per cent of therapies no other mRNA drug/vaccine approved apart from
in preclinical development; 20 therapies were in COVID-19 vaccine. Trials with more than two dozen
Phase III clinical studies (including COVID-19 novel RNA therapeutics or vaccines are expected to
vaccine). Trials evaluating vaccines for COVID-19 start in 2022, as per a GlobalData analysis.
infections predominated but there are also trials
initiated for dyslipidemia and hepatitis B infection. Here we look at some of the drugs in late stage
The top therapeutic areas being targeted by RNA clinical trials that are expected to be approved
therapeutics are for rare diseases and oncology, by 2023 or sooner. Please note phase III trials of
according to a report from Informa Pharma coronavirus vaccine have been excluded:
Intelligence.
AKCEA-APO(a)-LRx is an antisense drug referred
‘‘The biotechnology industry is in agreement to by Novartis as TQJ230, was discovered by Ionis
as to the power and benefit of RNA therapeutics. and co-developed by Akcea and Ionis. It is a drug to
There has been a lot of work done in delivering treat patients with elevated levels of lipoprotein(a),
RNA within various nanoparticles directly into the or Lp(a), and established cardiovascular disease. The
body. However there’s an untapped, and potentially firms began phase III trials in 2020.
larger, opportunity in using the cell (instead of a
nanoparticle) as the vehicle to deliver, and the factory Oncotelic’s lead anti-brain tumor drug OT101, a
to produce, a combination of RNA therapeutics right first-in-class RNA therapeutic designed to abrogate
at the site of disease: that’s the power of RNA cell the immunosuppressive actions of TGFB2. The
therapy. In contrast to conventional nanoparticle- firm began the phase III testing in 2019. Oncotelic
based RNA therapies, RNA cell therapy may have Therapeutics is also investigating this for COVID-19
minimal immunogenicity with repeat dosing. It can and has reported that its lead drug candidate, OT-
also be easily engineered with tissue-specific homing 101, met the safety and efficacy goals of phase II C001
proteins. Compared to conventional DNA-based cell clinical trial in individuals with severe COVID-19 who
therapies, RNA cell therapy has a predictable half-
life and avoids the risk of genomic integration: two “Compared to conventional
attributes that are expected to make it safer. RNA DNA-based cell therapies, RNA
Cell Therapy is also less expensive and enables true
combination therapy without vector cargo limits,’’ cell therapy has a predictable
said Dr Murat Kalayoglu, President and CEO of half-life and avoids the risk
Cartesian Therapeutics, USA. of genomic integration, two

Founded in 2016 and with three assets in clinical attributes that are expected to
trials, Cartesian is the leader in RNA cell therapy. In make it safer. RNA Cell Therapy is
January 2022, the firm started the Phase 1/2a trial
of the first allogeneic RNA cell therapy for multiple also less expensive and enables
myeloma. true combination therapy

There are only a handful of United States Food without vector cargo limits.’’
- Dr Murat Kalayoglu,

President and CEO, Cartesian Therapeutics, USA

32 THERAPIES

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

APPROVED RNA THERAPEUTICS been granted Orphan Drug Designation in the US and
the European Union (EU) and Japan.
Despite the number of RNA therapeutics in
Quark Pharmaceuticals, QPI-1002 is the first
clinical trials for various diseases, only a few have systemic siRNA drug to enter human clinical trials,
for the prevention of acute kidney injury (AKI). QPI-
been approved for public use by the USFDA. The first- 1002 has been granted Orphan Drug Designation
in the USA and Europe for prophylaxis of delayed
ever RNA therapy that was approved by the USFDA graft function following kidney transplantation.
Phase III trial began in 2018. Under an August
is Ionis’ Nusinersen approved in 2016 for spinal 2010 agreement, Novartis has an exclusive
worldwide license option for the development and
muscular dystrophy. Most of these drugs approved commercialisation of QPI-1002.

are for diseases. Although, recently Novartis received Sylentis’ Tivanisiran is a drug based on RNAi
that is administered as preservative-free eye drops;
both EU and USFDA approval for (inclisiran), first-in- it selectively inhibits production of the transient
receptor potential cation channel (TRPV1). The firm
class siRNA to lower cholesterol. It’s worth noting announced positive results from phase III in 2019
and the study is still ongoing.
that Ionis’ Volanesorsen received EU approval in 2019
Alnylam Pharmaceutical’s Fitusiran is an
but is still at the NDA (new drug application) stage in investigational, subcutaneously administered small
interference RNA therapeutic in development for the
the US. prophylactic treatment of people with hemophilia A
or B, with or without inhibitors. In December 2021,
are admitted to the hospital. the firm announced positive phase III data and the
Volanesorsen, a product of Ionis’ proprietary study is ongoing.

antisense RNA drug technology, is in development Biogen, licensed tofersen from Ionis in 2018.
for two rare metabolic disorders: familial Tofersen is an antisense RNA medicine being
chylomicronemia syndrome (FCS) and familial evaluated for the potential treatment of SOD1-ALS.
partial lipodystrophy (FPL). The firm started the In October 2021, Biogen announced that the drug
phase III trial in December 2019. failed to meet the primary goal in the Phase III ALS
trial. However, in light of the critical unmet need, the
ProQR Therapeutics’ Sepofarsen QR-110 is a first- firm said it will expand eligibility for its ongoing early
in-class investigational RNA-based oligonucleotide access program (EAP) to all people with SOD1-ALS,
designed to address the underlying cause of in countries where such programmes are permitted
Leber’s congenital amaurosis. It is intended to be by local regulations and future access may be secured.
administered through intravitreal injections in the
eye and has been granted orphan drug designation in Tominersen (previously IONIS-HTTRx and
the United States and the European Union (EU) and RG6042), is a potential treatment for Huntington’s
received fast-track designation and rare paediatric disease that Roche is developing. The therapy,
disease designation from the FDA as well as access designed by Ionis Pharmaceuticals, was the first
to the PRIME scheme by the EU. In February 2022, treatment in clinical development that sought
the firm announced that the study did not meet to target the underlying cause of Huntington’s
primary endpoint nor notable secondary endpoints disease. Roche stopped dosing in most clinical trials
– no benefit observed in either treatment arm versus evaluating tominersen in May 2021, after interim
sham. ProQR will conduct additional analyses. data from the Phase 3 GENERATION HD1 clinical
trial indicated the therapy was not benefiting
Alnylam Pharmaceuticals’ Vutrisiran is an participants. Roche has stated that it is continuing
investigational RNAi therapeutic in development to collect and analyse data on tominersen to look for
for the treatment of transthyretin-mediated (ATTR) possible paths forward.
amyloidosis. In January 2022 the firm announced
positive results from all secondary endpoints Trends
measured at 18 months in patients. Vutrisiran is
under review by the USFSA, the European Medicines Let’s look at the key trends expected to influence
Agency (EMA), the Brazilian Health Regulatory RNA research in 2022 and the near future:
Agency (ANVISA) and the Japanese Pharmaceuticals
and Medical Devices Agency (PMDA). The drug has From rare to common disease: RNA
therapeutics have demonstrated most success in the

THERAPIES 33

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

RNA THERAPIES IN LATE STAGE CLINICAL TRIALS

S.No Drug Company Indication
1 TQJ230 (AKCEA-APO(a)-LRx) Ionis/Akcea/Novartis Hyperlipoproteinaemia with cardiovascular risk
2 Trabedersen (OT-101) Mateon (Oncotelic) Brain cancer
3 Volanesorsen Ionis/Akcea FPL(Familial partial lipodystrophy)
4 QR-110 ProQR Leber’s congenital amaurosis
ATTR/hATTR (Hereditary Transthyretin
5 Vutrisiran Alnylam Amyloidosis (hATTR)
Renal disease/failure, delayed graft function
6 QP-1002 Quark Dry eye
7 Tivanisiran (SYL1001) Sylentis Haemophilia A and B
8 Fitusiran Alnylam/Sanofi Genzyme SOD1-driven ALS ( structural destabilisation
and/or oxidative damage amyotrophic lateral
9 Tofersen Ionis/Biogen sclerosis)
Huntington disease
10 Tominersen Ionis/Roche

FDA APPROVED RNA THERAPIES

S. No Drug Type Company Indication Approval
Spinal muscular atrophy FDA, 2016
1 Nusinersen ASO Ionis Pharmaceuticals, USA Duchenne muscular dystrophy FDA, 2016
Familial amyloid polyneuropathy FDA, 2018
2 Eteplirsen ASO Sarepta Therapeutics, USA Familial chlomycronemia
syndrome EU, 2019
3 Inotersen ASO Akcea Therapeutics, USA Polyneuropathy
Acute hepatic poryphyria FDA, 2018
4 Volanesorsen ASO Ionis Pharmaceuticals, USA Low-density lipoprotein FDA, 2019
cholesterol EU, 2020 and
5 Patisiran SiRNA Alnylam Pharmaceuticals, USA FDA, 2021
6 Givosiran SiRNA Alnylam Pharmaceuticals, USA

7 Inclisiran SiRNA Swiss Novartis AG

treatment of rare diseases. The focus of R&D will now SiRNA boom: Alnylam achieved the first siRNA
be expanded from orphan drug to wider therapeutics drug approval by US FDA for Patisiran for the
area, like oncology and fibrosis therapeutics. A look treatment of ATTR in 2018, and this subcategory of
at the planned studies in 2022, as per GlobalData, RNA therapies is expected to make bigger strides in
indicate a broader landscape of RNA-focused the future as well. “As of the end of December 2021,
vaccines and therapeutics that look at oncology, there are over 50 on-going clinical trials of siRNA
ophthalmology, and infectious diseases. therapeutics in the US, and six trials in China. We
believe there will be more new drugs coming to the
Delivery tech: The main issues affecting market,” said Sirnaomics’s Asia representative.
the safety and efficacy of RNAi therapeutics are
stability, cellular uptake, endosomal escape, and “Targeted delivery of RNA therapeutics is an
pharmacokinetics. ‘’In recent years, the technological active area of research. So is delivering combinations
advancements of nanotechnology-based siRNA of RNA therapeutics. There’s also renewed interest
delivery technologies, chemical modification,and in increasing the length of RNA expression through
others, have significantly increased the efficacy and various strategies. I anticipate these trends will
reduced the off-target effect of RNAi therapeutics. continue in the coming years,” said Dr Kalayoglu.
In the coming years, we will see more innovative
delivery technologies coming to the market,’’ RNA Based Therapeutics Market to reach $25.12
Sirnaomics’s Asia representative. Sirnaomics is a billion, globally, by 2030 at 17.6 per cent CAGR, says
clinical-stage RNA therapeutics biopharmaceutical Allied Market Research. No wonder, pharma and
company with a strong presence in both China and biotech firms are scrambling to get the bigger piece of
the U.S. the pie.

Ayesha Siddiqui

34 SPEAKING WITH

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

“We are seeing strong demand for
antiviral small molecules in APAC”

« evade immune protection conferred by the vaccine.
Antiviral agents include monoclonal antibodies
Aileen Dualan, that may be given as infusions in early or
hospital settings, and these often require medical
Head of Global supervision. There are also oral small-molecule
antivirals, such as molnupiravir, which can be
Medical Affairs taken like any other prescription oral medication
in an outpatient/home setting.
(Asia Pacific),
With regards to development, small molecule
MSD antivirals take less time than vaccines to develop,
which typically take more than 10 years. And as
While vaccines have been rapidly they are either in pill or capsule form, they are also
developed and rolled out, there remains more stable and simpler to transport and store.
a dearth of small molecule treatment For low and middle income countries (LMICs) that
options that are designed specifically to combat may struggle with cold chain and logistics, and
COVID-19. These treatments are critical for those lack human resources and expertise to administer
who are unresponsive to vaccines, cannot be injection-based treatments, small-molecule
vaccinated, or are unable to access vaccines. It has antiviral pills offer a solution that is easy to store,
recently discovered several small molecules that administer and, in the case of molnupiravir, simple
have shown to be effective against SARS-CoV-2 for physicians to prescribe and the patient to take
and other coronavirus strains. Recently, the global due to no known drug-drug interactions (DDIs) or
firm MSD, a trade name of Merck & Co., Inc., dose adjustment for existing medications.
has contributed to the small molecule regimen to
counter COVID-19 for those patients, for whom Can Asia Pacific prepare for future
alternative COVID-19 treatment options are not
accessible or clinically appropriate. Aileen Dualan, pandemics beyond the need for
Head of Global Medical Affairs (Asia Pacific), MSD
shared further insights on the company’s efforts in vaccination?
introducing small-molecule antiviral treatment to
tackle the novel coronavirus. Edited excerpts; Yes, absolutely. We’ve learnt from our experience
with COVID-19 that we must develop a more holistic
How effective are oral small-molecule strategy to tackle a pandemic, including quickly
antiviral products against SARS-CoV-2? implementing contact tracing, rapid diagnostic tests,
frequent hand washing, and mask wearing.
More than two years on from the first case, it is
clear that the response to COVID-19 is complex From an industry point of view, we must
and challenging. We believe a range of medicines consider other modalities besides vaccines to
and vaccines is needed to make an impact on contain the pandemic. Vaccines have been proven
the pandemic, including a need for multiple to prevent infection, serious illness and death,
therapies due to a variety of patient, pathogen and but breakthrough infections do happen, and there
environmental factors. are those to whom the vaccine cannot be given.
So they need to be complemented with other
Vaccines are undoubtedly the backbone of any measures that treat and prevent the virus from
pandemic response and have been a first line of spreading. Antiviral oral pills such as molnupiravir
defence for the prevention of COVID-19. However, play a critical role in the early treatment of
antiviral therapies that prevent transmission and patients with mild to moderate disease. These
disease progression also have a role to play, as we same oral agents, including molnupiravir, are also
observe that the virus continues to mutate and currently in trials to evaluate efficacy and safety as
postexposure prophylaxis.

Looking to the future, it is also crucial for the
industry to continue to invest in research and
development to ensure that we have a range of

SPEAKING WITH 35

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

tools to combat future pandemics. Small molecule antivirals take less
time than vaccines to develop, which
How do you foresee the scope and market typically take more than 10 years. And
as they are either in pill or capsule form,
dynamics for antiviral small molecules in they are also more stable and simpler
to transport and store. In the case of
the APAC pharma market? molnupiravir, simple for physicians to
prescribe and the patient to take due
We are already seeing strong demand for to no known drug-drug interactions
antiviral small molecules in Asia Pacific as or dose adjustment for existing
these medicines complement the COVID-19 medications.
treatment landscape in this diverse region.
Given that oral antiviral pills are comparatively Can you describe MSD’s efforts
easy to store and administer, there is an in introducing small molecules,
opportunity to rapidly expand the production complementing vaccines to counter
and transfer manufacturing knowledge to capable COVID-19?
manufacturers to ensure the treatment can
reach as many patients as possible, including in Since the start of the pandemic, we have been
those markets where resources are limited. This committed to deploying our expertise and
is where our access strategy made a significant resources to have the greatest impact on the
difference for the COVID-19 patients in LMICs. pandemic. As the pandemic and the need for
medicines and vaccines continued to evolve, we
As part of our commitment to enabling global adapted our approach with a focus on addressing
access for molnupiravir, if authorised or approved, unmet needs where we can add the most value.
MSD has been actively engaging in discussions
with governments to purchase molnupiravir Our decades of research in infectious diseases
through supply agreements. We have also entered have led to profound scientific advances.
into non-exclusive voluntary licensing agreements
for molnupiravir with established Indian generic From developing one of the first antibiotics to
manufacturers to accelerate the availability of pioneering research in HIV science, our focus has
molnupiravir in more than 100 LMICs following always been on the prevention and treatment of
approvals or emergency authorisation by local diseases that threaten people and communities
regulatory agencies. We signed agreements with around the world. Currently, we also have more
these eight well-established generic manufacturers than 40 investigator-initiated antimicrobial
before we knew we had successful phase 3 clinical stewardship programmes funded across the globe.
trial outcomes.
On the pandemic, MSD has been fully
In addition to the non-exclusive voluntary committed to developing an effective response to
licensing agreements, we have an agreement the pandemic since it was first recognised, and we
with the medicines patent pool as part of our know that success requires continued collaboration
ongoing commitment to facilitate the availability among countries, companies, and more.
of molnupiravir to countries globally. The
license includes more than 75 per cent of all That was why we pursued a partnership
LMICs as defined by the World Bank, and with Ridgeback Biotherapeutics to develop our
this means that new medicines will be made investigational oral antiviral therapy molnupiravir.
available as rapidly as possible and at affordable
prices in LMICs. MSD has invested billions in our COVID-19
research, development and manufacturing efforts,
To further support access to molnupiravir, mobilising our scientific expertise and resources to
MSD signed a long-term supply agreement with contribute to the global pandemic response.
the United Nations Children’s Fund (UNICEF) to
facilitate broad global access for molnupiravir in We produced 10 million courses of
January 2022. Under the agreement, MSD will molnupiravir by the end of 2021, with at least 20
allocate up to 3 million courses of molnupiravir million additional courses expected to be produced
to UNICEF throughout the first half of 2022 in 2022. This estimate is based on the 800 mg
for distribution in over 100 LMICs following every 12 hours for five days’ dose that is currently
regulatory authorisation. being evaluated.

We are able to strategise and implement broad Hithaishi C Bhaskar
and affordable patient access because of the [email protected]
feature and value of small molecules.

36 SPEAKING WITH

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

“We can only see interoperability driving
the future of healthcare systems”

« between platforms in the healthcare system is
not an easy challenge to tackle. The healthcare
Antonio De Castro, system needs to be more adept at exchanging data
among the different systems and devices. This is
Senior Industry where interoperability comes in, connecting all the
sources of information and the clinical outcomes of
Consultant, Global treatments. Interoperability is the ability of different
information systems, devices and applications
Health and Life (systems) to access, exchange, integrate and
cooperatively use data in a coordinated manner,
Sciences Practice, within and across organisational, regional and
national boundaries, to provide timely and seamless
SAS Institute portability of information and optimise the health of
individuals and populations, globally.
The need for having data sharing in healthcare
through electronic records is more prevalent How will interoperability impact the
than ever. For the healthcare industry, big healthcare system?
data can help lower rate of medication errors,
facilitate preventive care, streamline staffing, As with other industries, there’s an increasing
among others. However due to the increasing interest in creating data-driven systems to help or
number of cybersecurity attacks on healthcare even automate decision making throughout the
systems, there is going to be more scrutiny regarding healthcare system. We will only see a growing need
health data sharing, consent, and monetisation to collaborate among various players from care
after recurring incidents exploiting interoperability. providers, operational staff, executive leadership
International Data Corporation (IDC) predicts that and other upcoming players in healthcare. Data
by 2023, 70 per cent of Healthcare Organisations’ consistency and accessibility is paramount for
attempts to scale value-based care models will a successful healthcare system. At a hospital
fail unless they invest in data-driven governance, operations level, for example, patient data from
operations, and organisational infrastructure. Electronic Health Records, as well as inventory data
Antonio De Castro, Senior Industry Consultant, for the drugs and equipment and staff availability
Global Health and Life Sciences Practice, are needed to ensure continuity and quality of care.
SAS Institute shares further insight on data
interoperability in healthcare systems and the This requires interoperability between the
evolution of Healthcare information technology systems in order to have the right information
(HCIT) in upcoming days. Edited excerpts; reach the right people as fast as possible. It goes
beyond the hospital as governments would also be
What is interoperability in the healthcare interested in assessing hospitals at a regional level
system? and would potentially integrate other sources of
data such as environmental and social determinants
With increasing digital transformation in data.
healthcare, the number and scope of connected
systems in a healthcare organisation has increased As the healthcare industry looks more into
significantly. Today, for example, a hospital can holistic approaches (whole-person care) and
have more than a hundred systems that need to with new systems being created, adoption of
communicate with one another. Novel electronic interoperability standards, such as FIHR HL7, will
health record systems, cloud technology and need to be prioritised for healthcare organisations to
adoption of sophisticated medical devices, fully take advantage of their different data sources.
‘Internet of Medical Things’, for instance adds We can only see interoperability driving the future
to the complexity of managing all systems in the of healthcare systems.
healthcare industry.
How will healthcare evolve in 2022?
This surge of data and the ability to share data
The healthcare industry will evolve in three main

SPEAKING WITH 37

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

areas: We will see increased investment
a. A data-driven infrastructure- Data in cloud technologies to support
innovations and applications to allow
without insight is unrealised value patients to access their health data and
Healthcare players are realising the benefits play a more active role in managing
their chronic conditions through API-
of a data driven infrastructure. When the silos are led initiatives. There will be more
broken and when you can combine and access your interoperability between Healthcare
data seamlessly, data analytics and better decisions information technology (HCIT) and
can be taken easily. A data-driven infrastructure connected health technology and
makes it possible for healthcare providers to devices. The ecosystem will allow
compare trends to past performance, allowing them patients to play a more active role in
to make data-driven improvements. managing their health conditions and
have the options and flexibility to choose
These will allow healthcare players to have suitable care providers.
better long-term strategies to improve outcomes
and care journeys (e.g. reduce readmissions). As increasing number of cyberattacks particularly on
the number and scope of connected systems in a healthcare systems is a critical challenge. Protecting
healthcare system continue to rise, data privacy and patients’ data and their privacy is a big issue that
governance are critical. According to IDC, by 2023, healthcare providers face when moving towards data
70 per cent of healthcare organisations’ attempts to sharing. As a result they tend to stick to keeping
scale value-based care models will fail unless they their data in silos and different systems that can be
invest in data-driven governance, operations, and easily restricted or protected.
organisational infrastructure.
Sticking to legacy systems - Sticking to older
b. Better patient care legacy systems can be a big hindrance to adopting
We will see increased investment in cloud a data-driven approach. They need to start to
technologies to support innovations and modernise their systems to meet interoperability
applications to allow patients to access their health requirements.
data and play a more active role in managing their
chronic conditions through API-led initiatives. How can the healthcare landscape protect
There will be more interoperability between against cyber attacks?
Healthcare information technology (HCIT) and
connected health technology and devices. The Key points of interest in cybersecurity include:
ecosystem will allow patients to play a more active Data privacy and security is paramount
role in managing their health conditions and have - Establishing adequate data access according to
the options and flexibility to choose suitable care different roles within a healthcare organization
providers as patients will have full visibility of their is important in ensuring privacy and security are
health data and medical information. protected.
c. The rise of AI in healthcare Transparency of patient data - A patient
Deep Learning, Machine Learning, and Natural must be comfortable with sharing his health
Language Processing will be used in the future to be data with his/her doctor but if this data needs
applied to unlock the value of clinical data. to be shared beyond the doctor, the healthcare
According to IDC Futurescape: Worldwide organisations need to be transparent about potential
Healthcare Industry, 2022 Predictions, this will other use of this information (e.g. for Research)
also include the rise of ambient interfaces powered Balancing personal information and
by intelligent speech recognition, sensors, and/ analysis - Population Health Analysis should
or gesture-based controls in both hospitals and always look at data at an aggregate level and
households to support better patient interaction and never at an individual level. When analysing these
act as a driver for better patient experience. data, they should be anonymised, and personal
information should not be part of the analysis.
What are some of the challenges in adopting
Hithaishi C Bhaskar
health data sharing? [email protected]

As healthcare organisations realise the benefits
of being data driven, they also face the following
challenges:

Security - One of the main challenges when
it comes to health data sharing is security. The

38 SPEAKING WITH

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

“Genomics has enormous
potential to support the Indian
economy in the 21st century”

« we can sequence smaller genomes like bacteria and
viruses, whereas it can also sequence complex plant,
Dushyant Singh Bagel, animal, and human genomes.
Managing Director,
Chief Executive Officer, Genome sequencing of COVID SARS-CoV-2 for
Nucleome Informatics pandemic surveillance and novel variant discovery
is crucial. Short read sequencing has been used
Nucleome Informatics, one of India’s widely for this purpose. Due to shorter reads, we
leading genomics service organisations, get viral genome sequences with gaps. The genome
has launched its most advanced genomics sequence gaps make it difficult to identify the new
lab NKC Centre for Genomics Research in variants. We need long reads to capture the entire
Hyderabad in August 2021. Nucleome offers DNA length of viral genomes without gaps. PacBio Sequel
and RNA Sequencing services with data analysis II based HiFi viral SARS-CoV-2 sequencing solution
support. It has advanced sequencing platforms uses molecular inversion probes for enrichment that
and bioinformatics servers with bioinformatics is distinct from PCR and highly accurate long-read
pipelines to offer genomes, transcriptomes, HiFi sequencing to sequence the entire viral genome
metagenomes and epigenetic sequencing and data without gaps.
analysis support for research. It will set up the
next laboratory in Indore and will be hiring 250 The assay can use 1000 MIPs to tile the viral
scientists, biotechnologists, bioinformaticians, and genome so that ~22 probes cover each base. This
business professionals in the coming three years. high dense tiling design can ensure deeper coverage
In an interaction with BioSpectrum Asia, Dushyant across a wide range of sample Ct Values and makes
Singh Bagel, Managing Director, Chief Executive the assay an obvious choice for novel variant
Officer, Nucleome Informatics shared more details discovery than PCR based sequencing methods. We
about the centre and the market opportunities that have requested the Department of Biotechnology
they see in the coming years. Edited excerpts; to use this technology to discover novel variants.
Nucleome can sequence 24 to 384 RNA samples in
How important has the NKC Centre been one sequencing run, and Nucleome can deliver the
in sequencing the genome of the novel data in just one week.
coronavirus and its mutants?
Can you share with us the encouragement
Nucleome’s NKC centre for genomics research
is the only centre in South Asia to house a unique and the support that you have so far
combination of advanced genomics technologies
like PacBio Sequel II, NovaSeq 6000, GeneTitan, received from government of India? How
Femtopulse, Megaruptor 3, DNA size selection
system and HPC to develop full-length genomes, has this support been important for the
discover novel genes present in any tissue, discover
mutations by Resequencing, and design SNP chips development and growth of the company?
for genotyping larger populations. In this facility,
When we started Nucleome in Ahmedabad,
I was surprised to receive a call from the
Gujarat Government offering their support to
help Nucleome grow faster. We next moved to
Hyderabad as we sensed a positive market potential
and we received tremendous support from the
Telangana government too. We are mentored by the
Research Innovation Cluster of Hyderabad.

We received the DSIR certification and financial
support from the Department of Science and
Technology to develop an Inherited Retinal Disease
Panel under the Indo-Korean project of the GITA

SPEAKING WITH 39

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

scheme. We have also received mentorship from and Datura leichhardtii with The University of
the Ministry of Agriculture, especially from ICAR Queensland.
scientists Dr T Mohapatra Ji, Dr N K Singh, and Dr
R K Vijh. The Department of Animal Husbandry We are also doing a few genomes with a Dubai-
gave the mentorship and opportunity to build SNP based research centre and 23 more genomes from
chips for Milk production with ICAR NBAGR and India in 2022.
NDDB. We also assisted the DBT NIAB Institute
in developing the SNP chip to identify Indigenous Could you share more details about the
cattle breeds in India. company’s involvement in the Vertebrate
Genome Project?
Genomics has enormous potential to support
the Indian economy in the 21st century, as the Nucleome is the official partner of the
Defense Minister said during the inauguration prestigious the Vertebrate Genome Project (VGP),
of the NKC Centre for Genomics Research. We led by Rockefeller University, USA, Sanger Institute,
need support from the government to grow this UK and Max Planck Institute, Germany. The VGP
industry. Government can help us by reducing consortium aims to sequence 70,000 vertebrate
the GST to 5 per cent on genomics services, and genomes. Nucleome will assist them in sequencing
waiving off the import duty on NGS consumables, genomes from Asia using PacBio Sequel II
kits, and instruments. DBT should develop a technology, optical mapping, HiC and ISO seq based
scheme to support private NGS Service providers full-length Transcriptome Sequencing for genome
in buying advanced NGS equipment. This annotation. We have completed two chromosome
scheme will undoubtedly help the NGS service level genomes, and now we are working on a third
providers to build the labs in various parts of the vertebrate genome from India.
country. The inclusion of NGS service providers
in big genome sequencing projects like the Indian Has the company raised funds from external
Genome sequencing Project or the proposed Earth investors? What would be the turnover
BioGenome project can speed up the research in expected in the upcoming financial year?
India.
Nucleome has not taken any investment from
We, as private labs, are still treated differently, any private investors so far. Our clients are the only
and that mind set has to be changed for the growth investor we have, and we are delighted with this
of this industry. Nucleome works on DrSeq suite arrangement. We took a business loan from ICICI
of predictive genomics products to improve the Bank to purchase genomics instruments and build
understanding and uptake of personalised/precision our new laboratory. We want to thank ICICI Bank
medicine. for believing in our business plan and supporting us
in creating an Indian genomics startup capable of
Last year, Nucleome was said to be the accomplishing international level research projects
in India. If we keep our focus, listen to our clients
first laboratory in South Asia to procure the and execute as planned, we will be the first investor
free genomics company from India to reach Rs 100
third-gen long-read sequencing platform crore by 2025.

‘Sequel II’ from PacBio. How has this The global bioinformatics market is
projected to reach $21.8 billion by 2026.
been a much-needed resource for Indian How do you plan to capture a place in this
competitive market?
scientists?
Genomics and Bioinformatics are the fastest-
With the world’s largest and most accurate growing fields, and technology change is the biggest
long-read sequencing Pacbio Sequel II, we can challenge. We invest in new technologies and ensure
develop genome sequences of organisms without our bioinformaticians are exposed to advanced
any prior data. We call this service de novo genome datasets early to adapt. We are not competing with
sequencing. Recently, we completed Indian White anyone but ourselves—our only goal is to build
Shrimp Genome with ICAR CIBA, Mango Genome quality data and offer advanced analysis support to
with ICAR NIPB, Murrah Buffalo with NDDB, Gyr our clients. My role in the company is to keep my
Cattle with ICAR NBAGR, Pomegranate Genome team happy so that our clients are delighted. Results
with ICAR NRCP, Mosquito Genome with the will follow if we keep that going.
University of California and Tata Institute of
Genetics and Society, Little Millet Genome and Anusha Ashwin
Cattle Genome with DBT institutes. We sequenced
seven plant genomes, including Avocado, Wild Rice,
Jojoba, Duboisia myoporoides, Duboisia hopwoodii

40 PARTNER CONTENT

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Leveraging Academia-Industry
Collabs to Scale-up S&T Innovations

« Impact of academia-industry collaborations
Academia and industry collaboration comes in
Chow Woai Sheng,
Vice President / many forms, covering a broad range of research
General Manager, areas from small co-funded projects to multi-million-
Agilent Technologies, dollar projects with the establishment of iconic
Singapore analytical facilities that push scientific boundaries to
enhance the quality of life for the communities.
Global challenges are too large to tackle in
isolation. The creation of new shared value Over the years, Agilent has achieved robust
in public research through academic-industry collaborations with academia in Singapore that focus
collaborations are gaining momentum in innovations on moving basic research to an outcome that can
in the science, life science, biotechnology, and be used commercially or for the greater good of the
pharmaceutical industries. communities.

There is a need to recognise and value the To empower researchers, Agilent’s solutions
contributions that academic-industry collaborations helped tackle fundamental laboratory challenges.
have on both current research and the future of For example, in the field of synthetic biology, a
science. As a global leader in the life sciences, collaboration with Associate Professor Matthew
diagnostics, and applied chemical markets, Chang of Yong Loo Lin School of Medicine in
Agilent’s long-term partnerships with academia Singapore enabled the exploration of potentially
and universities have helped shape a sustainable making synthetic biology more systematic, cheaper
innovation ecosystem in Singapore. and more efficient.

Technology is a key driver of research In 2019, Agilent, National University of
and innovation Singapore (NUS) and National University Hospital
(NUH) launched a new translational research and
New technology and systems are now an development (R&D) hub, a S$38 million research
important area of concern to governments, and facility that aims to boost clinical diagnostics
scientific research success increasingly depends and testing through biochemical innovation and
upon advanced technology and sustainable techniques. The partnership demonstrated Agilent’s
innovation. When academic researchers explore strong commitment to increase R&D access and
problem statements, it is crucial that they have the outcomes across the regional scientific ecosystem.
freedom to pursue different solutions with the help
of industries with technology innovation to develop The collaboration represents a unique and
those solutions. innovative approach to conducting joint research
into important health issues and medical science.
This is the emergence of a new paradigm in The ‘hub and satellite model’ allows research to be
academia-industry collaborations where a space is conducted centrally in Singapore, and shared broadly
created for professional connections to boost idea in the local, regional and global platforms through
sharing, research outcomes and training. The drive key partnership and alliances supported by NUS and
for collaboration was further fueled by the Singapore Agilent. This hub is a continuation of an established
government’s Research, Innovation and Enterprise and significant partnership that has existed for many
(RIE) 2025 plan, part of the National Research Fund years between NUS and Agilent. By extending
(NRF) program in committing S$25 billion to take its substantial investments in R&D with Agilent’s
Singapore’s science and technology to the next stage work alongside top universities, Agilent is able to
of development. accelerate its mission of enhancing the human
condition.

Over the last two years, the pandemic has
spurred industrial-scale production of mRNA, causing
the biology modality to take on renewed importance.
To make an impact on biopharma and life sciences,
the Institute of Bioengineering and Bioimaging (IBB),

PARTNER CONTENT 41

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Agilent Employees working in a lab

a research institute under the Agency for Science, The translation of basic research into a high-value
Technology and Research (A*STAR), partners with output of societal benefit is often driven harder where
Agilent to study the efficient translation of mRNA and an industry partner is involved. This is seen in the
lipid nanoparticles (LNP). Lipids can be optimised pharmaceutical, biotech and other health-related
to facilitate endosomal escape, enhancing protein industries that work on tight timelines and saw the
translation. application of academic research to accelerate that
goal.
Agilent’s technology will support IBB with
innovative thinking, multidisciplinary technology Investing in the next generation of scientists
expertise, and training on world-class analytical For more than 20 years, Agilent has been working
development to help develop workflows and solutions
to address LNP quality attributes. This collaboration hand-in-hand with local scientists, researchers, and
is supported by Agilent’s Global Solutions healthcare professionals to accelerate knowledge
Development Center (GSDC), a hub launched in advancement to enable scientific breakthroughs and
Singapore to advance integrated methodologies and discoveries in Singapore.
novel applications working for projects worldwide.
As part of the company’s commitment to
With the Singapore government announcing its developing local science talent, Agilent adopts
‘30 by 30’ ambitious plan to produce 30 per cent of the Industrial Postgraduate Program (IPP), a
the nation’s nutritional needs by 2030, Agilent has collaborative initiative with the Singapore Economic
signed two research collaboration agreements with Development Board (EDB), to build capabilities
the Singapore Institute of Food and Biotechnology among PhD students on critical R&D skill sets and
Innovation (SIFBI), a research institute under the industrial experience. For eight consecutive years,
A*STAR and the Future Ready Food Safety Hub the program saw Agilent harness a community of
(FRESH), a research platform under the National next-generation scientists in Singapore.
Technological University (NTU). These agreements
outlined the collaboration on developing food The company has also opened an Agilent
research knowledge advancement aims to bring University in Singapore, housing a 10,000 sq ft
science the technology to drive innovation in food, training facility equipped with three revolutionary
nutrition, ingredients, industrial biotechnology, and laboratories and offering more than 200 courses
related applications. to support local capabilities building. Since 1999,
Agilent Singapore has grown its local team to over
Agilent’s state-of-the-art technologies will 800 scientists, skilled engineers, and employees to
help develop better food process engineering to deliver trusted answers for Singapore, Asia Pacific
create novel and sustainable future food safe for and globally. It has bolstered its presence by
consumers. This initiative will drive the future of expanding its manufacturing capabilities, from high
science in support of Singapore’s growing food precision automation solutions to mass spectrometry
innovation ecosystem, ultimately satisfying the instruments made for global markets, supporting
demand for safer, healthier, and more sustainable Agilent’s vision in growing strong local roots in key
food locally, regionally and globally. growth markets.

42 MYOPIA

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Burden of Uncorrected Myopia
on APAC Healthcare Systems

Odds ratios for myopia-associated pathology

« -1.00 Posterior Glaucoma Retinal Myopic
to subcapsular 2.3 detachment macular
Hamish Thrum, 3.3 degeneration
Senior Director, -3.00 cataract 3.3 3.1
Myopia Asia Pacific -3.00 2.1 9.0 2.2
(APAC), 21.5
CooperVision to 3.1 9.7
-6.00 5.5 40.6
Uncorrected myopia remains the leading cause of Over
distance vision impairment globally, and its rising -6.00
prevalence could cost billions of dollars in lost
productivity in the coming decades. Source: Flitcroft

A hallmark study by the Brien Holden Vision Myopia in the Asia Pacific
Institute (BHVI) in Australia predicts that by 2050,
over half the world’s population or 52 per cent will Studies have shown the increased intensity
be myopic. Moreover, management and control of educational pressures in young children has
of myopia is a relatively new concept in many coincided with the rapid rise in myopia cases in
countries. Let’s explore what possible steps can be Asian countries in recent decades. In many East
undertaken to address this affliction. Asian countries, myopia is a major public health
concern that affects between 80 and 90 per cent of
The World Health Organisation (WHO) recently high school graduates, of which about 10 to 20 per
flagged myopia as a global public health issue, cent have sight-threatening pathologic myopia.
estimating annual global costs of productivity
losses associated with vision impairment from The early onset and rapid progression of
uncorrected myopia at $244 billion in 2015. This myopia in Asia has been linked to increased time
will increase significantly in the future if it is not spent on near work activities and classwork,
addressed. Individuals with high myopia (-5.00 coupled with limited time spent outdoors; both
diopters or more) face a greater risk of sight- of which have been exacerbated by the Covid-19
threatening disorders later in life including glaucoma, pandemic. According to one Hong Kong study,
cataract, retinal detachment, and myopic macular during the COVID-19 pandemic, the estimated
degeneration, which is an irreversible condition that one-year incidence of myopia is 28 per cent, 27 per
can cause severe vision impairment or permanent cent, and 26 per cent for six, seven and eight-year-
blindness. The risk of visual impairment increases 3.4 olds respectively, compared to 17 per cent, 15 per
times with myopia between 6.00 diopters and 10.00 cent, and 15 per cent before the pandemic.
diopters, and 22 times when above 10.00 diopters.
Higher prevalence of myopia tends to occur in
high-income countries who place a high priority
on academic performance such as South Korea,
Singapore, China, and Japan. Elsewhere in East
and Southeast Asia the numbers are lower but
rising rapidly.

Global Standard of Myopia

Management in the Next Five Years

With the publication of the BHVI research
paper and the clarion call from WHO,
governments are waking up to the fact that if they
do not address myopia during childhood, they will
be facing an enormous burden to public healthcare
systems in future decades. They will have to treat
millions of adults with much higher complication

MYOPIA 43

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

rates and more serious eye conditions which could focus contact lenses.
have potentially been avoided had their myopia In East Asia especially, children requiring
been managed in childhood.
vision correction through contact lenses or
Other organisations have also called for spectacles is not a serious concern. Many
more coordinated action on myopia. The Asia parents do not realise that myopia, like high
Optometric Management Academy (AOMA) blood pressure or diabetes, if left unchecked and
and Asia Optometric Congress (AOC) recently untreated can lead to more serious issues later.
collaborated to create a single region-wide
consensus on myopia management. The standard The good news is ECPs now have new tools in
practice model provides a systematic approach their artillery to manage myopia, such as myopia
for practitioners to treat myopic patients, using management lenses that have been proven to
a holistic approach in the myopia management not only provide clear vision but also slow down
process. The World Council of Optometry has the progression of the disease. They enable ECPs
made a similar announcement, and in Australia, a to address vision impairment issues caused by
white paper written by the Child Myopia Working myopia at a very early stage. Early management
Group is also advocating adopting a standard of reduces the risk of myopia-associated vision
care. impairment and helps retain the eye health of
children as they age.
It is likely that within the next five years,
most countries will implement a minimum Early intervention is crucial in the
standard of care requirement for the treatment of control of myopia, and the latest findings
children with myopia. This means that regardless from CooperVision’s seven-year clinical trial
of whether or not eye care and healthcare demonstrate myopia management contact
practitioners (ECPs and HCPs) are ready for lenses can help slow down the rate of myopia
myopia management, at some stage in the near progression. The pivotal MiSight 1 day contact
future, it will be the standard of care. Now is the lens clinical trial demonstrated that 12 months
time for ECPs who have yet to incorporate myopia following treatment cessation, mean axial
management into their practice to prepare for this elongation data, which is used to measure myopia,
important shift in how the profession manages showed no evidence of rebound effect; only
myopia. MiSight 1 day is proven to retain myopia control
benefits after treatment has ended. The study is
Nipping myopia in the bud the longest-running soft contact lens study among
children for myopia control.
Low levels of myopia may not ring alarm bells
for many parents. However, because myopia is Previously, CooperVision reported that MiSight
a progressive condition, the younger the child is 1 day cuts myopia progression by half across
when myopia sets in, the higher the risk of severe multiple years of treatment. This was observed in
sight-related complications later in life, if the the children that wore MiSight 1 day for the study’s
myopia is untreated. Even a 1.00 diopter increase first six years as well as the children who wore the
in myopia has been associated with a 67 per cent single vision Proclear 1 day lens for the first three
increase in the prevalence of myopic maculopathy. years and were subsequently refitted into MiSight
Conversely, slowing myopia by just 1.00 diopter 1 day.
should reduce the individual’s likelihood of myopic
maculopathy by 40 per cent. Results from the first three years of the same
seven-year trial show that in spite of 52 children
Several studies suggest that myopia wearing myopia management contact lenses for a
progression can be controlled and slowed with mean number of around 13 hours per day, there
a combination of lifestyle modifications and were no serious or significant ocular-adverse
treatment approaches. A randomised clinical trial events.
of children aged six to 12 years old in Guangzhou,
China showed that children who spent additional As myopia management and control is a
time outdoors from 40 minutes to an hour each relatively new concept in many countries, the
day, had a reduced rate of myopia onus is on ECPs to detect, report, and manage
childhood myopia. By increasing awareness of
In addition to lifestyle modifications, some of myopia management tools, enlisting the support
the tools and treatments used in the management of ECPs and other healthcare professionals and
of myopia include atropine eye drops, spectacles, equipping them with myopia management tools,
orthokeratology or ‘ortho-k’ lenses and soft dual- we hope to help children see well now and as they
grow and age.

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

China’s Zai Royal Society of
Labs appoints Edinburgh elects Kiran
Josh Smiley Mazumdar-Shaw as Fellow
as COO
Kiran Mazumdar-Shaw, Executive Chairperson of Biocon and Biocon
China-based Zai Lab Biologics, has been elected as the Fellow of the Royal Society of
Limited has announced Edinburgh (RSE), Scotland’s National Academy established in 1783, for
the appointment of Josh the advancement of learning and useful knowledge. Kiran will be joining
Smiley as its Chief Operating RSE’s current Fellowship of around 1,700 Fellows who are recognised
Officer (COO). Smiley brings as being some of the greatest thinkers, researchers and practitioners
over 26 years of experience working in or with Scotland today. Kiran is among
working within the the 80 luminaries to be appointed to the RSE’s
biopharmaceutical industry, Fellowship this year. Fellows are elected to
including experience leading join the RSE from across the sciences, arts,
finance, corporate strategy, education, business, and public life in
business development, recognition of their impact in improving the
venture capital and the world around them. Kiran is a pioneering
Global Business Services biotech entrepreneur, a healthcare
operations at Eli Lilly and visionary, a global influencer, and a
Co (Lilly). Smiley will report passionate philanthropist. As Founder
directly to Dr Samantha of Biocon, an innovation-led global
Du, CEO and Chair of the biopharmaceuticals enterprise,
Board of Zai Lab, and will be her vision and work have drawn
a key member of Zai Lab’s global recognition both for Indian
executive committee. He industry and her company.
will oversee all aspects of
business, finance, and global Takeda Pharmaceutical appoints
operations. Smiley will be Serina Fischer as GM for India
COO of Zai Lab beginning
on August 1, 2022, following Japan headquartered Takeda Pharmaceutical Company has announced
the completion of his leave the appointment of Serina Fischer as its General Manager for India
with his current employer. operations. The appointment is effective as of March 1, 2022. In her
He began his career at Lilly new role, Serina will lead the company’s business in India, ensuring
in 1995, holding leadership
positions across the patient access to the company’s highly innovative
organisation culminating in medicines. Serina has over 17 years of experience
his most recent role of Senior in the biopharmaceutical industry and is an
Vice President and Chief accomplished, dynamic leader with expertise in
Financial Officer. Smiley strategy, sales, marketing, and operations. She
will relocate to the Boston joined Takeda in 2017 and has held various
area and be based in Zai leadership roles in its US affiliate. Before
Lab’s office in Cambridge, Takeda, Serina was working as an Advisor for
Massachusetts, US. Global Marketing Capabilities at Eli Lilly. She
spearheaded the overall strategic direction for
the global commercial organisation to leverage
the recently formed insourcing centre in
India. She worked cross-functionally to
understand the needs of the business
while benchmarking other companies
to express potential benefits/risks
associated with capability centres.

R&D NEWS 45

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Korea develops mind- New Zealand to
reading system for
decoding brain signals develop mRNA

Researchers from the Korea Advanced Institute of vaccine for Staph bug
Science and Technology (KAIST) have developed a mind-
reading system for decoding neural signals from the brain A group of scientists at the University of
during arm movement. The method can be used by a Auckland in New Zealand are working
person to control a robotic arm through a brain-machine towards developing an mRNA-based vaccine
interface (BMI). A BMI is a device that translates nerve against Staphylococcus aureus, commonly
signals into commands to control a machine, such as a known as S. aureus. Staph is the most
computer or a robotic common cause of hospital-acquired, surgical,
limb. There are two main and medical implant infections. It can also
techniques for monitoring cause bloodstream infections, bone and
neural signals in BMIs: joint infections, toxic shock, pneumonia and
electroencephalography infective endocarditis, a life-threatening heart
(EEG) and infection. Around the world, the commonest
electrocorticography form of antibiotic resistance is Methicillin-
(ECoG). The EEG exhibits resistant Staphylococcus aureus (MRSA), a
signals from electrodes ‘superbug’ that’s highly resistant to commonly
on the surface of the scalp used antibiotics. Making an mRNA vaccine
and is widely employed for staph is trickier than making one for
because it is non-invasive, relatively cheap, safe and easy the coronavirus that causes COVID-19. The
to use. However, the EEG has low spatial resolution and SARS-CoV-2 virus makes few proteins and
detects irrelevant neural signals, which makes it difficult has an obvious target for a vaccine – the spike
to interpret the intentions of individuals from the EEG. protein that initiates binding to host cells.
On the other hand, the ECoG is an invasive method that Staph, being a bacterium rather than a tiny
involves placing electrodes directly on the surface of the virus, consists of thousands of proteins. While
cerebral cortex below the scalp. Compared with the EEG, the team has shown that its vaccine stimulates
the ECoG can monitor neural signals with much higher a robust neutralising antibody response in
spatial resolution and less background noise. mice, it’s still working to understand which
immune cell populations contribute most to
the protective immunity seen in the animals.

Aussie Institute combines statins with
Evolocumab to lower heart attacks

A novel new therapy has been available to patients. Using a new size but changing it from hot to
found to reduce harmful plaque imaging method, researchers were cold, rendering it effectively scar
in arteries and change its able to view a change in the biology tissue and stable. The degree to
composition so it is less likely to or composition of the harmful which this was successful was
rupture and cause a heart attack, plaque in the arteries following also directly related to how much
following a clinical trial led by treatment, not only reducing its the patient’s bad cholesterol was
the Victorian Heart Institute lowered. Lowering cholesterol is
(VHI) at Monash University. The an important strategy in helping
HUYGENS study treated high-risk mitigate risk factors, but the new
patients over a 12-month period therapy was highly effective in
and was successful in a number reducing cholesterol ratios down
of ways by combining commonly to 0.7mmol/L, which is lower than
used statins together with a the current clinical guidelines of
cholesterol-lowering drug called less than or equal to 1.8 mmol/L
Evolocumab, which is already suggested in the first instance.

46 R&D NEWS BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Thailand unveils NTU Singapore patents ‘direct
urine HPV paper- to cell’ drug delivery platform
based DNA sensor
testing kits for Scientists from Nanyang Technological University (NTU), Singapore
cervical cancer have developed a novel method of delivering drugs into human cells
using large biological molecules, by first encasing them in a protein-
The Department of Chemistry, based microdroplet. This discovery promises to be faster, safer,
Faculty of Science, Chulalongkorn more effective, and better suited for gene therapy, cancer treatment,
University’s research team, in and vaccine delivery, including mRNA-based vaccines such as those
Thailand, has invented the urine currently used for COVID-19 vaccinations by Pfizer and Moderna.
HPV paper-based DNA sensor These microdroplets, made up of small proteins named peptides, can
testing kits for cervical cancer encase large biomacromolecules that carry drugs inside them. In doing
that would allow a simpler and so, they allow these biological molecules to enter cells, something
pain-free procedure that can be the molecules cannot do by themselves. In lab experiments, the
done frequently. The urine HPV team was able to successfully deliver fluorescent proteins, which are
paper-based DNA sensor testing commonly used to demonstrate the efficiency of drug carriers, as well
kits are easier and much faster as the protein drug saporin through this method. By themselves, these
than the Pap Smear. It eliminates proteins cannot enter the cell. The research team has filed two patents
the need to insert a tool and based on their published study. They are working to commercialise
hold the vaginal walls open. The their drug delivery platform method through NTUitive, the University’s
less-than-500-Baht HPV Testing innovation and enterprise company.
Kits are not for home use and
must be administered by health India opens research centre
centres and community hospitals. for Duchenne Muscular
According to the researchers, Dystrophy treatment
urine samples are mixed in a
solution, then dropped onto The Indian Institute of Technology (IIT) Jodhpur has established
the paper sensor, so the colour a research centre for Duchenne Muscular Dystrophy (DMD) in
change can be observed. The collaboration with Dystrophy Annihilation Research Trust (DART),
normal colour is bright red, and Bengaluru and the All India Institute of Medical Sciences (AIIMS),
it gets lighter according to the Jodhpur. The current therapeutic options available to treat DMD
amount of the virus detected. are minimal and highly expensive i.e. over Rs 2-3 crore per child a
Urine has fewer DNA materials year. Drugs are mostly imported from abroad, accelerating dosing
than tissues, so a smartphone costs and putting them out of reach for most families. DMD is a
colorimeter app amplifying the
DNA level is used alongside to rare and incurable genetic disease
make colour change more visible. and it is the most common and fatal
Test results show the test kit’s type of muscular dystrophy, marked
high accuracy with a sensitivity of by gradual muscle deterioration.
85 per cent, specificity of 78 per The centre at IIT Jodhpur aims to
cent, and reproducibility rate of develop affordable therapeutics for
100 per cent. DMD and enhance the efficacy of
Antisense Oligonucleotide (AON)-
based therapeutics. The AON-based
therapeutics’ idea is to hide or
mask specific exons (a segment of a
DNA or RNA molecule containing
information coding for a protein) in a gene sequence. In DMD
patients, one or more exons can be masked with specific molecules
called AON or molecular patches. Due to these challenges, DMD
patients need personalised medicine.

ACADEMICS NEWS 47

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com New Aussie

Peking University launches National
PKU Medicine 2022 Overseas
Excellent Youth Project Academic Centre

China-based Peking University has launched PKU Medicine 2022 to help ensure
Overseas Excellent Youth Project for those with a formal teaching
or research position in overseas universities, scientific research healthy ageing
institutions or R&D institutions of enterprises with more than
36 consecutive months of working experience. Since 2016, PKU Research into issues affecting
Medicine has fully implemented the reform of personnel and talent older Australians has taken
systems. Facing the national strategic needs, PKU Medicine has another step forward with the
adhered to the strategy of strengthening the university with talents, new national academic centre at
combined talent recruiting with talent training, provided favourable Frankston Hospital which will
support conditions and academic environment for young talents house the National Centre for
with medical innovation potential and capacity, and helped young Healthy Ageing opening its doors.
talents realise their dreams on the PKU Medicine platform and Through a partnership between
become scholars and doctors with excellent scientific innovation the government, Peninsula
ability and humanistic quality and noble professionalism as well. Health and Monash University,
the academic centre will work
IISc, Bengaluru to set up towards transforming health service
Isaac Centre for Public Health development, implementation,
research and evaluation for older
The Indian Institute of Science (IISc) has entered into a Memorandum people, as well as those with
of Understanding (MoU) with Ajit Isaac, Founder and Chairman of addiction and mental health
Quess Corp, and Sarah Isaac, for establishing a Centre for Public issues. One of the key research
Health at the IISc campus, Bengaluru in India. Isaac has committed points of the centre will be to
a sum of Rs 105 crore towards setting up this Centre, which will be explore new and innovative ways
called the Isaac Centre for Public Health (ICPH), and will be a part of to harness technology and data
the postgraduate Medical School soon to be established on campus. to help senior Australians remain
The centre will be operational by 2024 and is expected to encourage independent. The Centre will
aspirants to pursue careers in clinical research to develop new deliver better ways to care for
treatments and healthcare solutions driven by a bench-to-bedside elderly Australians, with successful
philosophy. It is poised to create world-class postgraduate education models then able to be rolled out
and research programmes in public health to redefine healthcare nationally. The government has
models for India and for the rest of the world. It will offer dual degree invested $32 million in the healthy
programmes such as Master of Public Health (MPH)-PhD (5-6 years) ageing component of the centre,
and Master of Public Health (MPH)-MTech Research (3 years). The delivered through the $1.25 billion
total annual student intake will be about 10 per year with a steady- Community Health and Hospitals
state student population of about 40 over time. Programme. Supported by state-
of-the-art ‘living labs’ for research
activities and the latest technology,
the new centre will help deliver
the government’s commitment to
ensuring all Australians can access
quality healthcare, when and where
they need it.

48 SUPPLIER NEWS

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Waters introduces automated solution for
mass and purity analysis of biomolecules

Waters Corporation has biomolecules and their subunits. loss of sample analytes due to
introduced new software and The ACQUITY Premier and adsorption of phosphorylated and
analytical columns to aid XBridge Premier carboxylated molecules between
biomolecule drug discovery and Protein BEH C4 the sample and metal surfaces of
development. The new Waters 300Å Columns both the LC system and column.
Intact Mass app on waters_ for the This enables up to 3X greater
connect allows scientists using BioAccord
the BioAccord LC-MS System to LC-MS sensitivity for low-
confirm the mass of biomolecules System level intact mass
and impurities made by synthetic feature analysis and 2X
or recombinant processes MaxPeak High greater sensitivity
nearly twice as fast as other Performance for the intact
commercially available options. Surfaces
Complementing the introduction (HPS) mass analysis of
of the Intact Mass app is a new technology phosphorylated
line of analytical columns that that proteins and
are essential for analysing intact prevents the low-level subunits
of monoclonal
antibodies.

Thermo Fisher Agilent opens 4th Centre
for Excellence in India
introduces new
Agilent Technologies Inc. has announced the opening
large-volume of its Centre for Excellence (CoE) lab facility in Gujarat
Technological University’s (GTU) premises in India. The
electroporation system facility will be available for faculty members of GTU,
their students, and Agilent team to study and develop
Thermo Fisher Scientific has introduced a novel application workflows in the areas of analytical
new large-volume electroporation system chemistry, biopharmaceuticals, and life science research.
that allows cell therapy developers to more This new CoE instrumentation laboratory is intended as
easily move from clinical development to a shared educational and research space that will offer
commercial manufacturing. The Gibco CTS tremendous opportunities to advance scientific discovery
Xenon Electroporation System leverages and validation, while also serving as a valuable technology
a closed, highly flexible design to facilitate resource to academia. Agilent India also achieved a
gene modifications without the use of significant milestone in strengthening its footprints in
traditional viral vectors. The electroporation India with the inauguration of its new office in the city
approach enables the introduction of a of Ahmedabad. This new workspace encourages design
payload into a cell by temporarily increasing thinking elements, brings vibrancy, and has an efficient
cell permeability using an electrical pulse. layout to serve their customers even better. Due to the
Unlike existing large-volume cell therapy rapid speed of technological innovation, universities and
electroporation solutions on the market, other educational and research institutions may find it
the Gibco CTS Xenon Electroporation difficult to keep up with the latest technology and training
System features programmable, flexible requirements. The suite of Agilent instrumentation
electroporation conditions, offering cell housed in the GTU facility – backed by Agilent application
therapy developers full control to optimise expertise – will advance long-term technical and scientific
a variety of hard-to-transfect cell types and goals in the state of Gujarat and support economic and
payloads. The system may be used as a technological sustainability throughout the region.
standalone technology or integrated with the Agilent in India has three other CoE facilities at Mumbai,
Gibco CTS Rotea Counterflow Centrifugation Bengaluru, and Manesar.
System as part of a modular, closed and
automated cell therapy manufacturing
workflow.

SUPPLIER NEWS 49

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Eppendorf MilliporeSigma acquires
Exelead and to invest €500M
invests in Swiss to scale-up technology

startup BigOmics MilliporeSigma, the US and Canada Life Science business sector
of Merck KGaA, Darmstadt, Germany, have announced the
Eppendorf has made a strategic closing of the transaction to acquire Exelead, following regulatory
investment in BigOmics Analytics clearances and the fulfilment of other customary closing
SA, a software company from conditions, for approximately $780 million in cash. The business
Switzerland that develops digital combination is expected to enable the Life Science business to
cloud-based self-service tools to provide its customers with
analyse molecular biology research comprehensive end-to-
data. The investment was initiated end contract development
and carried out by the Eppendorf and manufacturing
Innovation Company (EpIC), which organisation (CDMO)
serves as Eppendorf’s interface to services across the mRNA
innovative startups. EpIC is tasked value chain. The Life
with identifying and successfully Science business plans
implementing novel business to further invest over €
models and promising partnerships 500 million to scale up
for Eppendorf. To this end, EpIC Exelead’s technology over
is in close contact with the very the next ten years. As per
dynamic international startup scene the company, with the addition of Exelead’s leading capabilities
in the life science and biotechnology and highly experienced team, the Life Science business at
sector. EpIC’s scope includes areas MilliporeSigma achieves an important milestone in becoming one
such as liquid biopsy, innovative of the leading CDMO players in mRNA vaccines and therapeutics,
approaches to sample preparation offering an integrated CDMO across the mRNA value chain from
for multi-omics and digital pre-clinical to commercial.
solutions for improving laboratory
processes.

Shimadzu releases new IRXross Fourier
Transform Infrared Spectrophotometer

Japan-based Shimadzu can easily measure what types easy operation that meets the
Corporation has released of materials a sample contains, demands of the pharmaceutical
the IRXross, a new Fourier therefore they are widely used and chemical industries. In
Transform Infrared (FITR) in the pharmaceutical and terms of sensitivity, (an index
spectrophotometer. This model chemical industries for research, of particular importance when
has approximately twice the development, and quality control selecting a model) the IRXross
sensitivity and resolution of its applications. The new IRXross provides an S/N ratio of 55,000:1,
predecessor, the IRAffinity-1S. offers high performance and the highest in its class. It is also
Usability has also improved compliant with data integrity
with the addition of the
IR Pilot, an analysis regulations required in the
support programme that pharmaceutical field. On top
can be utilised even by of that, this model comes with
inexperienced users. FTIR the IR Pilot analysis support
spectrophotometers are
suitable for analysing high programme, and as a result,
polymer materials and accurate measurement results
organic materials. They can be easily obtained even

by users without extensive
analysis experience.

50

BIOSPECTRUM | APRIL 2022 | www.biospectrumasia.com

Enhanced Budget for American Indians

The Biden-Harris Administration on March 28, services. Several tribes are actively involved in
2022 submitted to Congress the President’s IHS programme implementation. Many tribes also
Budget for fiscal year 2023. The President’s operate their own health systems independent of
FY 2023 Budget request for the U S Department of IHS. It also provides support to students pursuing
Health and Human Services (HHS) proposes $127.3 medical education in order to staff Indian health
billion in discretionary Budget authority and $1.7 programmes.
trillion in mandatory funding for FY 2023.
The Budget takes a historic first step toward
Responding to the submission the HHS Secretary addressing stark health disparities faced by
Xavier Becerra said, “From addressing health American Indian and Alaska Native communities
disparities to strengthening behavioural health to by proposing all IHS funding as mandatory
investing in our children, this Budget will help turn beginning in FY 2023. Mandatory funding allows for
hardship into hope for millions of families. And it growth beyond what can be accomplished through
will ensure we can fulfil our department’s crucial discretionary spending and provides the much-
mission of improving the health and well-being of needed predictability and stability that will improve
the American people.” the operations of IHS, Tribal Health Programmes,
and Urban Indian Organisations. The Budget
The Budget includes $81.7 billion in mandatory includes $9.3 billion in FY 2023 – this is a $2.5
funding over five years across the Office of the billion or 37 per cent increase above the FY 2022
Assistant Secretary for Preparedness and Response level. Funding would grow to $36.7 billion by FY
(ASPR), Centers for Disease Control and Prevention 2032, an increase of 296 per cent across the Budget
(CDC), National Institutes of Health (NIH), and window, to begin closing documented funding gaps
Food and Drug Administration (FDA) to support for direct health care services and infrastructure.
President Biden’s plan to transform US capabilities The Budget is informed by the long-standing
to prepare for and respond rapidly and effectively recommendations of tribal leaders as well as
to future pandemics and other high consequence numerous tribal consultations and will have a lasting
biological threats. impact on the health status of IHS patients across
Indian Country.
The Budget also includes $9.9 billion to build
capacity at CDC and state and local levels to improve Since its beginnings in 1955, the IHS has been
the core immunisation programme, expand public criticised by those it serves in medical deserts and by
health infrastructure in States and Territories, public officials. Native Americans who are not of a
strengthen the public health workforce, support federally-recognised tribe or who live in urban areas
efforts to modernise public health data collection, have trouble accessing the services of the HIS.
increase capacity for forecasting and analysing future
outbreaks, including at the Center for Forecasting Life expectancy for Native Americans is
and Outbreak Analytics, and conduct studies on approximately 4.5 years less than the general
Long COVID to inform diagnosis and treatment population of the United States (73.7 years versus
options. 78.1 years). Native communities face higher rates of
chronic diseases like cancer, diabetes, and kidney
The HHS invests over $470 million in funding disease. This is contributed to by the lack of public
across the Agency for Healthcare Research and health infrastructure as well as the considerable
Quality (AHRQ), CDC, the Health Resources and distance to healthcare facilities for rural residents.
Services Administration (HRSA), NIH, and Indian
Health Service (IHS) to reduce maternal mortality Reacting to the Budget submission, Liz Fowler,
and morbidity. Acting Director, Indian Health Service said “Today’s
announcement also acknowledges the need to
The IHS provides healthcare in 37 states identify long-term solutions to address IHS funding
to approximately 2.2 million out of 3.7 million challenges, which directly impact the health of
American Indians and Alaska Natives (AI/AN). As American Indian and Alaska Native people.”
of April 2017, the IHS consisted of 26 hospitals,
59 health centers, and 32 health stations. Thirty- Narayan Kulkarni
three urban Indian health projects supplement Editor
these facilities with a variety of health and referral
[email protected]