BioSpectrum Asia May 2022

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4 BIO EDIT

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Dr Milind Kokje BACK TO SQUARE ONE?

Chief Editor Looks like we’re looking at another massive disruption of the active pharma
ingredients (API) supply chain due to a surge in COVID-19 and the strict
[email protected] shutdown of businesses in China, similar to the beginning of 2020. China leads
in global exports of Tetracycline/Doxycycline, accounting for 86 per cent and that of
Vitamin B1 at 63 per cent. By one estimate China produces little less than half of the
total APIs in the world. This reveals China’s crucial role in the pharma supply chain.
The pandemic has exposed the over dependence on China for APIs.

On the flip side, India is known as the pharmacy of the world due to its $42 billion
worth pharma sector, with 20 per cent of the total generic drugs being exported. But
its huge production depends on almost 70 per cent of APIs imported from China,
as over 65 types of pharma ingredients are sourced from China. For the produced
by India, the key starting material comes from China. About 90 per cent of the
antibiotics requirement of India is fulfilled by China. Not only India, even American
and Japanese drug producers are dependent on China for raw materials.

Learning a hard lesson, India began reducing its dependence on China by promoting
domestic production of APIs, key starting materials and other raw materials. The
government had launched a production linked incentive (PLI) scheme to that end.

At the same time, a huge infrastructure is also being created. A vast pharma city,
measuring 14,000 football grounds in area, is being set up by the State Government
of Telangana to attract $8.4 billion investment with a potential to create 560,000
jobs. The Union Government has also drawn out plans to allot land for three major
bulk drug parks, with and plans to provide more than $1 billion funding so companies
may manufacture ingredients domestically. All these efforts are to minimise the
dependence on China. But, till the projects are completed and companies start setting
up their plants, the situation remains unchanged.

Until then, not a major headway can be made in doing away with dependence on
China. Moreover, the difference in prices between Indian and Chinese APIs poses
a major challenge and the dependence on China continues. Thus, in the current
situation, the Himachal Drug Manufacturers Association (HDMA), representing the
Rs 40,000-crore drug industry in Himachal Pradesh, comprising 650 pharma units,
has urged the Government of India to set up an API-monitoring cell for regulating
prices of bulk drugs.

Naturally, with disruption in supplies due to lockdown in China, the prices have
gone up in India in just a month’s time. Prices have doubled from March to April.
For instance, the price of a Paracetamol has increased from Rs 300 per kg in March
to Rs 700 in April, while Cefixime trihydrate’s price increased from Rs 8,500 per
kg to Rs13,000 at present. As if the Chinese lockdown was not enough, the Russia-
Ukraine war broke out which also affected prices in India. Industry estimates reveal
that drug exports to Russia and Ukraine have plummeted by half as the payments are
not coming in. This seems to have also affected production cycles.

The very first casualty of the war was sales in the war zone. Sales are affected
due to two reasons. Economy suffers and people’s purchasing power shrinks. Second
is challenges caused by the war in uninterrupted supply of goods. It is applicable
to medicines also. Ensuring smooth supply of drugs becomes problematic at times.
With reduction in purchasing power, people focus on buying only the most essential
drugs. Sanctions over Russia and non-receipt of payment for the drugs already
supplied are also some hinderances caused by impacts of the war.

While efforts are ongoing to bring normalcy to the world on two fronts, the battle
against the pandemic and the ‘new war’ in Ukraine, only a united global consensus
and scientific approach can end both crises once and for all.

BIO MAIL 5

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Acknowledgements to specialised medical technology in all corners of
Thank you BioSpectrum Asia for the partnership the world, and revolutionise medical collaboration
and the editorial opportunity with MSD, in the April over distance and over time. A special thank you to
edition, with Aileen Dualan, Head of Global Medical BioSpectrum Asia and to our collaboration partners
Affairs (Asia Pacific). On our end, we think the topic at the National University Hospital and Das Pius
was timely, and we are pleased to be of contribution Hospital, to just name a few!
in any way, medically and by creating awareness
of pandemic management. We really appreciate - apoQlar team, Germany
your fast response and your help in providing BioSpectrum’s cover story on holomedicine
thorough background information so we can technology highlighted National University Health
provide newsworthy information and subject-matter System’s (NUHS) involvement in the area. In August
expertise promptly. You provided a clear brief and 2021, NUHS embarked on an R&D programme
insightful questions and were supportive throughout using holomedicine technology to enhance next-
the process. Thank you again. generation clinical applications study in both
undergraduate and postgraduate education. With
- Stephanie Yu, Singapore this, NUHS became the first Holomedicine Centre of
apoQlar is honoured to be in the cover story of Excellence in the world. The article also mentioned
BioSpectrum Asia’s latest issue and listed as one that a team of neurosurgeons at National University
of the key international players in the medical Hospital (NUH) is using holographic technology to
holography market. As an official partner of spatially locate brain tumours. NUH has extended
Microsoft, we look forward to driving innovation holomedicine to disciplines such as plastic surgery
in medical mixed reality forward with VSI and ophthalmology.
HoloMedicine! Medical MR technology has the
ability to improve surgical outcomes, increase access - NUH Team, Singapore

Vol 17; Issue 5; May 2022 MM Activ Singapore Pte. Ltd. Taiwan
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6 BIO CONTENT

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

COVER STORY 18

Oz BUDGET
BOLSTERS
HEALTHCARE

Circumstances have continued to evolve as the COVID-19 Omicron variant has added further
pressure to Australia’s healthcare sector, as well as increasing supply chain disruptions, bringing
about staff shortages and reducing household spending. With a Federal election due on May 21,

2022 to elect members of the 47th Parliament of Australia, Josh Frydenberg, Treasurer of the
Commonwealth of Australia presented the Federal Budget on March 29. The Coalition Government
led by Scott Morrison is investing in a stronger health system as part of its plan for a stronger future
through a record $132 billion in 2022–23 Budget, increasing to $140 billion in 2025–26, with a total

commitment of $537 billion over the next four years. This record funding will ensure Australians
have access to improved healthcare, when and where they need it, helping them to lead healthier

lives, with improved health outcomes and to provide ongoing protection against COVID-19.

BIO CONTENT 7

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com PATIENT VOICES

STARTUPS & SMEs 39

26 Bringing patient voices
into HTA, health policy
Is On-demand Healthcare Taking Off? development in Asia

CAR-T Ruth Kuguru,
Executive Director, Communications &
32 Engagement, Novartis Asia Pacific,
Middle East and Africa (APMEA)
Focusing on CAR-T
Cell Therapy for Solid Tumours REGULARS

BLOCKCHAIN BioEdit.........................................................................04
BioMail........................................................................05
35 Policy and Regulatory News...................................08
Company News........................................................10
5 Transformative Merits of Blockchain in Pharma Start-Up News...........................................................14
World News...............................................................15
SPEAKING WITH WHO NEWS...............................................................17
People News..............................................................44
37 R&D News..................................................................45
Academic News........................................................47
“Healthcare providers must Supplier News...........................................................48
invest in appropriate data Lets Talk Health........................................................50
fabrics that accelerate
agile access to data” CONNECT
ENGAGE
San Zaw, SHARE
Vice President
Solution Consulting, CONNECT WITH US
APJ, TIBCO
twitter.com/BioSpectrumMag
facebook.com/BioSpectrumMagazine

https://goo.gl/QY4nUp/BS-LinkedIn

W W W. B I O S P E C T R U M A S I A . C O M

8 REGULATORY NEWS

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

China approves Fosun Diagnostics’
COVID-19 antigen detection kit

Shanghai Fosun Pharmaceutical swab samples from patients cross-reactivity among viruses
(Group) has announced that with respiratory and fever- and bacteria. The kit is easy to
the novel coronavirus (2019- related symptoms within 7 days, use and quick to operate and
nCoV) antigen detection kit quarantine observers, and other deliver results in 15 minutes. It
(Colloidal Gold) developed by has a variety of reagents to meet
Fosun Diagnostics, a subsidiary antigen detection various testing needs at point
company of Fosun Pharma needs. Fosun Diagnostics’ Novel of demand whenever required.
has received approval from Coronavirus Antigen Detection Lately, the State Council of China
the China’s National Medical Kit is equipped with high under the Joint Prevention &
Products Administration (NMPA) sensitivity and specificity, strong Control for novel coronavirus
for the commercial and clinical anti-interference ability and no pneumonia has decided to
use of rapid antigen testing in include antigen detection as
COVID-19 screening. The kit has a key supplement to nucleic
adopted the in- vitro qualitative acid detection under the “New
detection method of Nucleocapsid Coronavirus Antigen Detection
antigen in nasopharyngeal Application Plan (Pilot Trial)”.

India lays foundation Australia launches
stone of Global Centre
for Traditional Medicine flagship biological

The Prime Minister of India Narendra Modi recently laid storage facility
the foundation stone of World Health Organisation (WHO)
Global Centre for Traditional Medicine (GCTM) in Jamnagar, ‘Biobanking Victoria’
Gujarat in the presence of the Prime Minister of Mauritius
Pravind Kumar Jugnauth and Dr Tedros Ghebreyesus, Monash University has officially
Director-General, WHO. GCTM will be the first and only launched Australia’s first industry-
global outpost centre for traditional medicine across the focused storage facility for biological
world. It will emerge as an international hub of global material to support medical research
wellness. According to WHO, and commercialisation opportunities.
the centre will focus on data, Biobanking Victoria is a state-
innovation and sustainability of-the-art facility that provides a
and will optimise the use of valuable link between researchers
traditional medicine. The centre’s and industry, generously supported
five main areas will be research by the Victorian Government. Led by
and leadership, evidence and Monash University in partnership with
learning, data and analytics, international leader Infinity BiologiX
sustainability and equity and (IBX, USA), the flagship facility is also
innovation and technology. the first in Australia and one of the
The first objective is to create a database of traditional few in the world to be accredited by
knowledge systems using technology; second, GCTM can the National Association of Testing
create international standards for testing and certification of Authorities (NATA). Located within
traditional medicines so that confidence in these medicines the Monash Health Translational
improves. Third, it should evolve as a platform where global Precinct in Clayton, Biobanking
experts of traditional medicines come together and share Victoria operates at international
experiences. Fourth, GCTM should mobilise funding for standards and provides a complete
research in the field of traditional medicines. end-to-end solution for any clinical
trial or research project that involves
biological material.

REGULATORY NEWS 9

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Japan approves Novavax’s Korea promotes
COVID-19 vaccine for
primary, booster immunisation vaccine development,

Takeda Pharma has received manufacturing and biomanufacturing
marketing approval from the Japan Ministry of
Health, Labour and Welfare (MHLW) for Nuvaxovid training for LMICs
Intramuscular Injection (Nuvaxovid), a novel
recombinant protein-based COVID-19 vaccine, for The International Vaccine Institute (IVI) &
primary and booster immunisation the Ministry of Health and Welfare (MOHW),
in individuals aged 18 and older. Republic of Korea, have agreed to strengthen
Novavax licensed and transferred its cooperation to promote the development
manufacturing technologies to enable & delivery of vaccines & biomanufacturing
Takeda to develop and manufacture the workforce training for low-and middle-income
vaccine at its facility in Hikari. Takeda countries (LMICs) to help advance global health.
will begin distribution of Nuvaxovid IVI and MOHW exchanged a memorandum of
doses purchased by the Government understanding (MoU), which replaces their
of Japan as soon as possible. The 2017 MoU to broaden areas of cooperation, at a
approval is based on Takeda’s New signing ceremony at IVI headquarters in Seoul
Drug Application (NDA) submission recently. Under the MoU, the two sides agreed to
which included interim results from a cooperate in all stages of vaccine development,
Phase 1/2 study conducted by Takeda ranging from discovery of vaccine candidates,
in Japan and several studies conducted by Novavax, pre-clinical testing & vaccine clinical trials
including two pivotal Phase 3 clinical trials in the U.K., (including overseas clinical trials). They
the U.S. and Mexico, and Phase 1/2 studies in Australia also agreed to jointly support development,
and the U.S. Interim results from the Phase 1/2 study manufacturing & delivery of these vaccines
in Japan were positive and consistent with previously to countries in need; facilitate joint research
reported clinical trial results. Nuvaxovid is stored at in vaccines & biopharmaceuticals between
a refrigerated temperature of 2 -8 degrees and will be businesses, universities, & laboratories in
transported using a conventional vaccine supply chain. Korea; & provide training & education of global
vaccine (and bio) workforce to enhance LMICs’
vaccine production capacity.

Taiwan announces establishment of
first biomedical supercomputer

The National Health Research supplemented by an AI-HPC shorten the processing time of the
Institutes (NHRI) in Taiwan cloud platform developed by Asus’ huge amounts of data that NHRI
has announced a partnership Computer Cloud Architecture has at its disposal. Through this
with Nvidia and Asus to deliver Software Centre. The system tripartite cooperation, the core
the nation’s first biomedical will enable developers and data technology of AI for medical and
supercomputer. According to scientists to develop, deploy and health information in Taiwan
NHRI, a non-profit foundation test applications for biomedical and the application of smart
established by the Taiwanese AI, and that it will medical care will be developed.
government to promote generally
biomedical research and health They will use the system to
policy, the system will be used to develop potential novel
support the NHRI’s application biomarkers; explore
of artificial intelligence (AI) in the mechanisms
biomedical fields. The system and diagnosis of
will leverage Nvidia’s latest- diseases; and promote
generation AI supercomputer. the development
These Nvidia systems will be of novel drugs and
vaccines.

10 COMPANY NEWS

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Australia’s SpeeDx Intas Pharma,
expands COVID-19
diagnostics to include Comera to develop
self-collected samples
bio-innovative
Australia-based SpeeDx has added saliva to the
list of validated samples for their PlexPCR SARS- biologic medicines
CoV-2 qPCR diagnostic for COVID-19 sales across
Europe. A preferred sample type for self-collection US-based Comera Life Sciences and
and compliance testing programmes, the saliva claim Indian firm Intas Pharmaceuticals have
will expand the utility of the SpeeDx COVID-19 announced a research collaboration to
workflow, and in partnership with the Molgen range of develop a new generation of bio-innovative
biologic medicines to improve patient
automation, will further support ultra- access, safety, and convenience. Under
high throughput testing markets. SpeeDx the terms of the agreement, Comera will
new head office facilities in Sydney have develop a differentiated formulation of an
expanded the company’s manufacturing Intas product using Comera’s innovative
capacity to support growth in export proprietary SQore formulation platform.
sales, and as international travel Intas will initially provide research funding
increases, demand for both COVID-19 with the option to acquire global rights to the
and other respiratory testing is formulation through an exclusive licence with
ongoing. PlexPCR RespiVirus, a highly responsibility for subsequent development
multiplexed 11-target Respiratory and commercialisation. This collaboration will
viral panel that includes Influenza A, accelerate Intas’ quest to develop innovative,
Influenza B, and Respiratory Syncytial value-added medicines that can make a
Virus, can be run in parallel with PlexPCR SARS-CoV-2 difference in patients’ lives globally.
for a more comprehensive testing solution and both
are compatible with the SpeeDx PlexPrep robotic liquid
handler, recently demonstrated to increase throughput
155 per cent and reduce hands-on time 19 per cent
compared with a sample-to-answer testing solution.

AmoyDx collaborates with AstraZeneca for
multiple companion diagnostics in China

Amoy Diagnostics, a China based patients with Homologous with BRCA gene mutations in
innovative molecular diagnostics Recombination Repair (HRR) the EU for Lynparza (olaparib)
company, has entered into a gene mutations in China, the monotherapy. HRR and BRCA
Master Collaboration Agreement EU and Japan, and a CDx to mutations are well-documented
with AstraZeneca. The agreement identify breast cancer patients targets for PARP inhibitor
enables the parties to collaborate treatment and are important
in the development and biomarkers that can inform
commercialisation of AmoyDx potential treatment options
assays that may cover any type including a PARP inhibitor.
of indication or biomarker for Lynparza (olaparib) is a first-
companion diagnostic (CDx) in-class PARP inhibitor jointly
use with AstraZeneca medicines developed by AstraZeneca and
globally. The first projects to be MSD and approved in a number
initiated under the agreement of countries for the treatment of
include the co-development of a advanced ovarian, breast, prostate
CDx to identify prostate cancer and pancreatic cancers.

COMPANY NEWS 11

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Canary Speech, SMK offer early
detection of dementia in Japan

US-based Canary Speech has individuals with dementia and using AI and machine learning
announced a collaboration with early-stage dementia. According techniques that use features in
SMK and Japan’s National to a survey by the Ministry of speech (biomarkers) enabling the
Cerebral and Cardiovascular Health, Labour and Welfare in possibility of replacing today’s
Center (NCVC) that will create 2015, the number of dementia subjective behavioural health
and validate artificial intelligence patients in Japan continues measurements with a standard
(AI) speech algorithms for early to increase as the population approach to objectively and
detection of mild cognitive ages, and it is estimated that comprehensively measure an
impairment (MCI) and dementia the number of patients will array of data points.
and other diseases in the exceed 7 million by 2025. This
Japanese language, such as research study is designed to
anxiety and stress. A key initiative explore the appropriate use of
in Japan is to create access to Canary’s patented technology.
care for their ageing population. Canary’s technology can enable
A critical aspect of doing this a new approach to capturing
is the ability to accurately and and measuring critical data,
cost-efficiently identify those through advanced analysis

Korean firms back European Wellness
strengthens medical
US-based Turn Bio care in UAE, Malaysia

for mRNA therapies European Wellness Biomedical Group (EW Group),
through its Malaysian subsidiary European Wellness
South Korea-based Daewoong Pharmaceutical and Academie, and Dubai-based healthcare distribution
HanAll Biopharma have announced expansion and technology group, AK International LLC, have
of their open collaboration strategy by investing signed a Memorandum of Understanding (MoU) that
in Turn Biotechnologies, a Silicon Valley based aims to strengthen the medical tourism linkages and
company focused on developing novel mRNA
medicines. The companies are supporting Turn access to Biological
Bio’s continued development of a high-potential Regenerative Medicine
platform and are considering future long-term services in the United
collaborations. Turn Bio is a pre-clinical-stage Arab Emirates
biopharmaceutical company focused on cellular and Malaysia.
repair via epigenetic reprogramming of cells. The strategic
The technological foundation for Turn Bio’s collaborations seek
proprietary Epigenetic Reprogramming of Age to setup two Centres
(ERA) methodology was developed by Turn Bio’s of Excellence, one
co-founders in the Sebastiano Lab, Institute for specialising in the
Stem Cell Biology and Regenerative Medicine, rehabilitation,
Stanford School of Medicine. The technology has education and holistic management of paediatric
since been patented and Turn Bio is currently neurodegenerative and neurodevelopmental
using it to complete pre-clinical research on disorders such as Autism Spectrum Disorder,
therapies targeting indications in dermatology and Cerebral Palsy, Down Syndrome and Global
immunology, as well as developing therapies for Developmental Delay, and another specialising in the
ophthalmology, osteoarthritis and the muscular management of untreatable and rare diseases such as
system. The proceeds from this round of financing CHARGE Syndrome, Multiple Sclerosis, Rheumatoid
will support Turn Bio’s advancement towards a Arthritis, Parkinson’s Disease etc.
phase 1 trial of its mRNA therapy candidate TRN-
001, which targets indications in dermatology.

12 PARTNER CONTENT

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

How to Comply with the
2017 Version of USP?

« « To help regulated laboratories fully comply
with 2017 <1058> requirements, Agilent has
Dr R D McDowall P A Smith, produced four White Papers with compliance
R D McDowall Limited, Agilent Technologies, consultant Bob McDowall, who has been
UK Inc. closely involved with the development of
<1058>.
Regulated laboratories must demonstrate
that the analytical instruments they The four White Papers include:
use are suitable for their intended use.
Analytical Instrument Qualification (AIQ) is What Has Changed with the 2017 Version of
fundamental to the success of all analytical USP <1058>?
work performed, including method development
and validation, as well as the application of a Many of the core components that are
validated method to the analysis of samples. part of the USP <1058> AIQ framework are
included in both the 2008 and 2017 versions.
It is important to ensure that analytical These consist of the Data Quality Triangle, 4Q
instruments are qualified and configured to qualification phases, and the classification of
ensure data integrity during intended use, instruments into Groups A, B, and C.
rather than using default software settings and
configurations that were applied during initial The first White Paper in this series (What
installation. Has Changed with the 2017 Version

Performing thorough instrument qualification of USP <1058>?) concentrated on
and software validation ensures that the explaining the changes to USP <1058>. To
method and analysis are reliable, and there is understand the impact of these changes more
lower exposure to possible regulatory action. If deeply, and recognise how to comply with the
the instrument is not qualified and any software 2017 <1058>, it is necessary to review <1058>
is not validated, the method validation and in greater detail.
sample analysis will not be effective and can
compromise data integrity. How to Comply with the 2017 Version of USP
<1058>?
The US Pharmacopoeia (USP) general
chapter <1058> on AIQ was first implemented The second White Paper in this series
in 2008 and remained unchanged for nine provides deeper insights into the significance
years. During 2017, the USP implemented of the changes and offers practical information
two updates to <1058>. These updates have about compliance.
a significant impact on AIQ, and as the only
major pharmacopeia with a chapter dedicated Because so much of the new version of
to AIQ, changes to USP <1058> are of global <1058> looks familiar to the 2008 version
significance. (for example, data quality triangle, groups A,
B, and C, and so on), there is a danger that
USP is the only major pharmacopoeia laboratories underestimate the significance of
to have a general chapter on AIQ, so many the changes and risk noncompliance.
companies use the approach as a basis for
qualifying their analytical instruments. The USP The key issue is that each laboratory must
general chapter <1058> on AIQ is an important review and, where appropriate, update their
document as it is the only risk-based regulatory AIQs, associated SOPs, and related policy
guidance on the subject. documents. It is essential to update the 4Qs
(DQ, IQ, OQ and PQ) life cycle to reflect the
2017 version of USP <1058>, otherwise a
laboratory does not meet compliance. The key

PARTNER CONTENT 13

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

stages of the 4Qs include User requirements The changes to USP <1058> in the 2017
specification (URS) • Design qualification (DQ) version are significant and require laboratories
• Purchase order (PO) and supplier quotation to fundamentally re-evaluate their AIQ
• Installation qualification (IQ) • Operational processes, or risk regulatory non-compliance.
qualification (OQ). The 2017 version contains many similarities
to the 2008 version, and there is a risk that
Each of these stages is discussed in more laboratories make the following erroneous
detail in this White Paper. The White Paper interpretation: “The changes appear to be small
also highlights the importance of performing and evolutionary in nature; we already complied
a preliminary risk assessment based on the with <1058>, so the changes have minimal
anticipated use of the instrument. This will impact on our laboratory.”
determine which USP <1058> group the
instrument belongs to. This is a requirement, The 2017 USP also brings an integrated
and helps the laboratory justify their decisions approach to AIQ and software validation.
about <1058> groups (A, B, and C). It is no longer a case of USP versus Good
Automated Manufacturing Practice (GAMP),
Role of AIQ in Data Integrity with 2017 USP but is an integrated approach of qualification
<1058> and validation. Computerised System Validation
(CSV), is a requirement of many regulatory
The third White Paper highlights the bodies around the globe.
importance of AIQ as a component of data
integrity and discusses what a laboratory To help labs comply with USP <1058>
must do to ensure that qualified analytical requirements, Agilent has developed four White
instruments and validated computerised
systems are set up and configured to help Papers. Through our Compliance Consulting
ensure data integrity. Services, we can also help you implement cost-
effective electronic qualification and align your
Data integrity is an increasing area of
concern for laboratories. In many regulated SOPs to comply with USP <1058>.
industries, laboratories must demonstrate
and document the suitability of analytical Scan the QR code below for more details
instruments and software for their intended
use. This focus on compliance extends to how
the instrument and software performance are
evaluated.

The 2017 version of USP <1058> brings an
integrated approach to AIQ and Computerised
System Validation (CSV). This integrated
approach closely aligns USP <1058> with
GAMP. CSV is a requirement of many
regulatory agencies around the globe. There
are many different guidance documents on
data integrity, and we have listed them in
the reference section of this White Paper.
The appendix of this White Paper includes a
Table of example laboratory data integrity non
conformances.

What Does Performance Qualification Really
Mean?

The fourth White Paper in this series
highlights the impact of the changes in the 2017
version of USP <1058> on the least understood
phase of the 4Qs model: Performance
Qualification (PQ). PQ ensures that the
instrument continues to perform as expected
against its intended use or the URS.

14 START-UP NEWS

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Pfizer supports GE Healthcare
breakthrough healthcare
innovations in India announces plan to

Atal Innovation Mission (AIM), NITI Aayog, support and accelerate
AGNIi, Foundation for Innovation and Technology
Transfer (FITT), Indian Institute of Technology Korean startups
(IIT)-Delhi, Pfizer and Social Alpha have come
together to launch the Pfizer INDovation GE Healthcare and Seoul National University
Programme to support breakthrough healthcare Bundang Hospital (SNUBH) in South Korea have
entered a memorandum of understanding (MoU)
innovations by startups in to explore opportunities for SNUBH to leverage
India. Social Alpha is the Edison Digital Health Platform and related
core implementation partner services from GE Healthcare. SNUBH and GE
responsible for executing the Healthcare aim to support and accelerate Korean
programme. This is Version startups in the development and deployment
2.0 of the Pfizer IIT-Delhi of clinical and operational applications on
Innovation and IP Programme the platform. This will be the first complete
and is one of Pfizer’s CSR deployment of Edison Digital Health Platform
initiatives. In Version 1, Pfizer for developers in Korea. The platform is GE
successfully incubated nine Healthcare’s application hosting and development
healthcare innovators and supported 19 IP filings. platform which offers a catalogue of healthcare-
Now, in the first year of Version 2.0, three winning specific services that enable rapid design,
startups each in the areas of Oncology and Digital development, and deployment of applications
Health, will receive a grant of up to Rs 65 lakh each and algorithms. SNUBH is considered as one of
for product trials, pilot studies, and product market the leading digital hospitals in Korea particularly
launches to accelerate the lab-to-market journey for its expertise in the clinical applications of
of their innovation. This is one of the largest such medical equipment. By installing Edison Digital
programmes, both by grant value and partnerships, Health Platform, SNUBH anticipates rapidly and
to focus on incubating and commercialising easily expanding upon its artificial intelligence
healthcare startups in the country. (AI) offerings across the enterprise. It plans to
become a global example of how to effectively and
efficiently develop and deploy AI models.

Juniper Biologics offers world’s first cell-
mediated gene therapy for knee osteoarthritis

Juniper Biologics, a Singapore- within these regions. Kolon Life therapy for osteoarthritis of the
based startup, has gained the Science will be responsible for knee, which is the most common
licensing rights to develop supporting the development as form of arthritis. A first-in-class
and commercialise TG-C LD well as supplying TG-C LD. TG-C cell-mediated gene therapy, TG-C
(TissueGene-C low dose) for the LD is a non-surgical investigational LD targets knee osteoarthritis
treatment of knee osteoarthritis. treatment that has been hailed as through a single intra-articular
The $600 million licensing deal the world’s first cell-mediated gene injection. Kolon TissueGene, the
which covers Asia Pacific, Middle licence holder for TG-C in the
East and Africa was signed with United States (not TG-C LD),
Kolon Life Science, and is Juniper has already completed a phase 2
Biologics’ second acquisition in as clinical trial in the United States,
many months. Under the terms of with initial data demonstrating
the partnership, Juniper Biologics sustained pain relief and mobility
will be responsible for developing improvement following a single
and commercialising TG-C LD to injection in the knee joint, for
medical professionals and hospitals possibly up to 2 years.

WORLD NEWS 15

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Argentina launches strategy for
comprehensive approach to mental health

Argentina President Alberto framework of the national perspective, and from respect
Fernández, together with the health system, based on a rights, for diversity. It will be based on
Nation’s Minister of Health, Carla community and violence-free specific lines that will include the
Vizzotti, led the presentation promotion of prevention activities,
of the National Mental Health the promotion of specific quality
Strategy that will seek to treatments, and the improvement
guarantee mental health care and in the quality and access to
attention at all stages of life, will primary care. In addition, the
increase the training of human healthcare portfolio will expand
resources in the area, and will the Telemedicine care network
provide devices for outsourcing system to guarantee professional
and labour insertion, with an inter-consultations in dealing
investment for the area that will with complex cases, in addition
go from 3,700 million pesos to favouring access to healthcare
to 7,700 million pesos. The where the person lives, and
initiative’s priority is to articulate promoting comprehensive care in
a series of policies within the all the regions of the country.

Sudan embraces MSc EpiBiostat
programme to establish
innovative approach African cohort of
epidemiologists
to malaria control
The Kinshasa School of Public Health (KSPH)
Sudan has adopted the “High burden to high has enrolled 15 students into its Master’s training
impact” (HBHI) approach to accelerate progress programme “MSc EpiBiostat” supported by the
against malaria. Through HBHI, countries Africa Centres for Disease Control and Prevention
hardest hit by malaria are reaching populations at (Africa CDC) and the European & Developing
greatest risk of malaria with tailored packages of Countries Clinical Trials Partnership (EDCTP).
interventions informed by local data and disease This highly anticipated
settings. According to the latest World malaria new training programme
report by the World Health Organisation (WHO), will establish an African
Sudan carried the heaviest burden of malaria in the cohort of epidemiologists
Eastern Mediterranean Region in 2020, accounting and biostatisticians through
for more than half of all cases (56 per cent) and ten grants supporting
deaths (61 per cent). Between 2015 and 2020, the institutions in sub-Saharan
country registered an increase of more than 40 per Africa and Europe. As one
cent in its malaria case incidence. The Ministry of the beneficiary countries,
of Health attributes the rise in cases to changes the Democratic Republic of
in rainfall patterns, frequent flooding, population Congo (DRC) and its neighbouring countries are
movement, and the emergence of an invasive faced with regular outbreaks of diseases such as
malaria vector, Anopheles stephensi, among other ebola, yellow fever, measles, cholera, poliomyelitis,
factors. Sudan now joins 11 other high burden monkey pox and, more recently, COVID-19. Serious
countries that have embraced the HBHI approach: funding and skills gaps place a high burden on its
Burkina Faso, Cameroon, the Democratic Republic health systems, restricting capacity to monitor and
of the Congo, Ghana, India, Mali, Mozambique, contain these outbreaks.
Niger, Nigeria, Uganda and the United Republic of
Tanzania. Together, they carry more than 70 per
cent of the global malaria burden.

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

USFDA DNDi accelerates life-saving drug
approves first discovery research in dengue
COVID-19
treatment for Geneva headquartered Drugs for Neglected Disease initiative (DNDi),
young children a not-for-profit research and development (R&D) organisation
focusing on neglected diseases, has announced a collaboration with
The US Food and Drug BenevolentAI for a joint research project to tackle dengue, one of the
Administration (FDA) has world’s most prevalent infectious diseases. The project will combine
expanded the approval of the the Benevolent Platform with
COVID-19 treatment Veklury DNDi’s expertise and global
(remdesivir) to include network of partners in dengue to
paediatric patients 28 days empower researchers to uncover
of age and older weighing at insights they would not have
least 3 kg (about 7 pounds) been able to find using human
with positive results of direct reasoning alone. Using a data
SARS-CoV-2 viral testing, foundation built from diverse and
who are hospitalised, or not independent data sources, such
hospitalised and have mild-to- as scientific literature, patents, genetics, chemistry, clinical trial data
moderate COVID-19 and are and more, scientists from BenevolentAI and DNDi will use AI tools
at high risk for progression to to interrogate the underlying mechanisms involved in dengue, better
severe COVID-19, including frame hypotheses and rapidly identify targets or therapies that could be
hospitalisation or death. This repurposed to prevent progression to severe dengue.
action makes Veklury, by
Gilead Sciences Inc., the first US creates 3D model for rare
approved COVID-19 treatment neuromuscular disorders
for children less than 12 years
of age. As a result of this, A scientific team supported by the National Institutes of Health (NIH)
the agency also revoked the in the US has created a tiny, bioengineered 3D model that mimics the
emergency use authorisation biology of chronic inflammatory demyelinating polyneuropathy and
for Veklury that previously multifocal motor neuropathy, a pair of rare, devastating neuromuscular
covered the paediatric diseases. The researchers used the organ-on-a-chip, or tissue chip, model
population. Before now,
Veklury was only approved to show how a drug could potentially
to treat certain adults and treat the diseases. They provided
paediatric patients (12 years key preclinical data for a drug
of age and older who weigh at company to submit to the US Food
least 40 kg, which is about 88 and Drug Administration (FDA) to
pounds) with COVID-19. get authorisation for testing in a
clinical trial. This work provides one
of the first examples of scientists
using primarily tissue chip data for
an FDA Investigational New Drug
application to test the efficacy of a
candidate drug in people with rare
diseases. The drug company Sanofi
started recruiting participants into
a Phase 2 clinical trial in April 2021.
The drug was tested for safety previously and approved by the FDA for
a different indication. The tissue chip research was led by Hesperos,
Inc., an Orlando-based company partially funded by a Small Business
Innovation Research grant from NIH’s National Center for Advancing
Translational Sciences (NCATS).

WHO NEWS 17

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com WHO issues

WHO launches report on guidelines for
integrated care for older people
treatment of
Rapid population ageing requires a transformation of health and
social care systems to enable the delivery of integrated and person- cryptococcal
centred care that responds to older people’s health and care needs,
goals, and preferences. To support this transformation, the World disease in
Health Organisation (WHO) has developed the integrated care for
older people (ICOPE) approach and a three-phase implementation HIV patients
pilot programme with the aim of supporting Member States to adapt
to the provision of integrated care. Cryptococcal disease is one of the
WHO has launched a report detailing most important opportunistic
the findings of the first ‘ready’ phase of infections among people living
this pilot programme. This phase aimed with advanced HIV disease
to evaluate readiness and feasibility to and is a major contributor to
implement the ICOPE approach. The illness, disability and mortality,
report summarises the findings from particularly in sub-Saharan
the implementation experiences across Africa. New guidelines developed
nominated Member States, including by WHO strongly recommend
enablers, barriers, and strengths for the a single high dose of liposomal
implementation of the ICOPE approach, amphotericin B as part of the
and learning on the preparation and adaptation needed to implement preferred induction regimen for
ICOPE. Findings and learning are drawn from the results of surveys the treatment of cryptococcal
with 260 health and care workers from 29 Member States and 259 meningitis in people living with
systems and service level actors from 35 Member States, including HIV. This new recommendation
from government, academia, and civil society. was made following the results
of a multicentre randomised
WHO backs Pfizer’s controlled trial conducted in
Paxlovid for patients with Botswana, Malawi, South Africa,
non-severe COVID-19 Uganda and Zimbabwe showing
that a simplified regimen with
WHO has made a strong recommendation for nirmatrelvir and ritonavir, a single high dose of liposomal
sold under the name Paxlovid, for mild and moderate COVID-19 amphotericin B paired with other
patients at highest risk of hospital admission, calling it the best standard medicines (flucytosine
therapeutic choice for high-risk patients to date. However, availability, and fluconazole) is as effective as
lack of price transparency in bilateral deals made by the producer, and the previous WHO standard of
the need for prompt and accurate testing care, with the benefits of lower
before administering it, are turning this toxicity and fewer monitoring
life-saving medicine into a major challenge demands. The single high dose
for low- and middle-income countries. containing regimen was also
Pfizer’s oral antiviral drug (a combination preferred by health care providers
of nirmatrelvir and ritonavir tablets) is because it took less time to
strongly recommended for patients with prepare, required less monitoring,
non-severe COVID-19 who are at highest and may shorten a patient’s length
risk of developing severe disease and of hospital stay. At this moment,
hospitalisation, such as unvaccinated, only a few suppliers have received
older, or immunosuppressed patients. This recommendation is based regulatory approval, and although
on new data from two randomised controlled trials involving 3078 a preferential pricing agreement
patients. The data show that the risk of hospitalisation is reduced by has been negotiated with the
85 per cent following this treatment. manufacturer of the originator
product, uptake has been low
across low- and middle-income
countries.

18 COVER STORY

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Oz BUDGET
BOLSTERS
HEALTHCARE

Circumstances have continued to evolve as the
COVID-19 Omicron variant has added further
pressure to Australia’s healthcare sector, as well
as increasing supply chain disruptions, bringing
about staff shortages and reducing household
spending. With a Federal election due on
May 21, 2022 to elect members of the 47th
Parliament of Australia, Josh Frydenberg,
Treasurer of the Commonwealth of
Australia presented the Federal
Budget on March 29. The
Coalition Government led by
Scott Morrison is investing
in a stronger health system
as part of its plan for a
stronger future through a
record $132 billion in 2022–23
Budget, increasing to $140
billion in 2025–26, with a total
commitment of $537 billion over
the next four years. This record
funding will ensure Australians have
access to improved healthcare, when
and where they need it, helping them to
lead healthier lives, with improved health outcomes
and to provide ongoing protection against COVID-19.

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‘‘The Federal government is committed to its Australia; $5.9 million for rapid cervical screening
Long Term National Health Plan, through testing and follow-up, including Aboriginal Torres
important and strategic investments to Strait Islander communities, and $4.1 million for a
deliver the world’s best health care system to the pilot of non-medical healthcare provider delivery of
Australians, including $537 billion over the next cervical screening.”
four years, up $34 billion compared to the 2021–22
Budget; $45.5 billion over four years to access more He further said “Part of this funding will also
affordable medicines through the Pharmaceutical remind Australians to refocus on their overall health
Benefits Scheme (PBS), and more than $2.4 billion with a new $15 million communication campaign
this Budget to add vital new medicines to the PBS,” encouraging people to stay up to date with their
said Greg Hunt, Minister for Health and Aged Care, health checks and to encourage continued uptake of
Government of Australia. telehealth.”

In his Budget remarks the Minister for Health and The Australia’s primary health care system is
Aged Care said “As we move to living with COVID-19, world class and has been the front line and first point
it is important that Australians refocus on their of contact for many Australians, including during the
overall health. We are investing $55.7 million to COVID-19 pandemic. Since committing to the release
encourage Australians to resume having their regular of Australia’s Primary Health Care 10 Year Plan, the
Government has implemented $1.1 billion in primary
health checks, diagnostic screening, and other care measures, with an additional investment of
preventive health activities. This investment $632.8 million in this Budget. This brings the total
includes: $10.2 million for a cervical cancer investment in the Primary Health Care 10 Year Plan
screening campaign promoting the rollout to $1.7 billion, far in excess of the initial investment
of self-collect tests; $10.2 million for objective of $448 million. Throughout the COVID-19
a colonoscopy triage nurse pilot to pandemic, the government has committed almost
help improve colonoscopy access; $4 billion through the COVID-19 primary care
$9.7 million for short term surge response. This record and ongoing investment is
capacity for BreastScreen
ensuring primary health care can deliver the
best contemporary health care, to meet the
challenges of today and tomorrow.
The government is building
on the 10-Year Stronger
Rural Health Strategy
within the Primary Health
Care 10 Year Plan, to
focus on improving health
outcomes by ensuring
there is quality health
workforce distributed across
the country according to
community need. The 10-Year
Stronger Rural Health Strategy
was unveiled in 2018–19 and the
Government originally invested $550
million in the Strategy. This investment

is built on through $296.5 million in the 2022–23
Budget. The government is continuing to improve
access to critical and life-saving diagnostic imaging
in regional and rural areas, with a $66 million
investment through the deregulation of Medicare
funded Magnetic Resonance Imaging (MRI) services
in MMM 2–7 areas.

The government is also announcing the
Biotechnology in Australia – Strategic Plan for
Health and Medicine to support the development
of a vibrant and thriving biotechnology sector in

20 COVER STORY

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COVID-19 RESPONSE PACKAGE *all figures in Australian dollars (AUD)

● $2.6 billion over 2 years for procurement and Digital (Connected) Health
distribution of RATs and PPE ● Further $32.3 million to the Australian Digital

● Includes RAT Concessional Access Program Health Agency for one year to support
allowing up to 20 free RATs for concession card Intergovernmental Agreement on Digital Health
holders to 31 July 2022 (this expires end of 2022)
● Some additional funding included in a larger
● Distribution of RATs to aged care and health measure for general practice to improve linkages
facilities, NDIS participants and workers of My Health Record and continue temporary
telehealth services
● Purchase of PPE for National Medical Stockpile ● Some funding for digital mental health services
for use in aged care facilities under larger initiatives

● Further $1.1 billion over 2 years for COVID Other health measures
emergency response including funding for TGA ● $66 million for removal of restrictions on MRI
and purchase and distribution of pulse oximeters
to community health practices machines in regional, rural and remote Australia
● $423.7 million over 5 years for facilities and
● $458.1 million over 5 years to support response
to COVID in aged care research for cancer
● $525.3 million over 4 years to reduce the
MBS New and Amended Listings
● $5.3 million for new items for TAVI in the low- Pharmaceutical Benefits Scheme (PBS) safety net
threshold
risk population and dual-filter cerebral embolic ● $40.7 million over 3 years for increased testing
protection system and screening for cancers to address reduction of
● $4.8 million including for cryoablation of renal cell these during COVID
carcinoma
● Additional MBS funding for PET and MRI testing Medical Research Future Fund
for cancers and genetic testing for genetic ● Continued investment already earmarked funds
conditions
● Reviewing and reprogramming of of $1.3 billion in medical research, translation and
neurostimulators for chronic pain by researcher skill development
videoconference
● Remote programming and monitoring new items Public Hospitals Funding
for deep brain stimulation and cardiac internal ● $28.1 billion in the 2022–23 Budget, and an
loop recorders
● There are other amendments that are updating increase of $9.8 billion since 2021–22 Budget.
and changing criteria for items that may involve
device technology Source: Medical Technology Association of Australia (MTAA)

Australia. Biotechnology, or technology based on many other key issues related to post COVID-19
biology, is one of the most promising developments management, mental health, aging care, women’s
of our times. Modern biotechnology is contributing health including $4.2 billion to continue protecting
to many areas of society, and in health it is creating Australians against COVID-19, through supply and
medicines and technologies that can combat access to safe and effective vaccines, treatments and
debilitating and rare diseases. support for our health workforce in primary care,
aged care and hospitals; $648.6 million for Stage
The government is investing $6.8 billion in 2 of the Government’s Mental Health and Suicide
medical research to drive world-leading research, Prevention Reform Plan, to ensure Australians can
which will improve health outcomes, as well as access appropriate mental health care when they
creating jobs and economic growth. This investment need it, taking total investment in the Plan to nearly
is being provided through three funding sources: $3.7 $3 billion and $333 million to increase outcomes in
billion for the National Health and Medical Research women’s health.
Council (NHMRC); $2.6 billion for the Medical
Research Future Fund (MRFF) and $500 million for Responding to the Budget, Medical Technology
the Biomedical Translation Fund (BTF). Association of Australia (MTAA) observed that
as expected, this year’s Budget health measures
Besides, the Federal Budget has covered

COVER STORY 21

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

particularly focused on pandemic recovery and “As we move to living with
response, with health announcements featuring late COVID-19, it is important
in the Treasurer’s speech.
that Australians refocus on
Overall, the Budget’s focuses were on economic their overall health. We are
growth and cost of living relief with a claim that
in the forward estimates the Budget deficit will investing $55.7 million to
be significantly reduced from its current levels. encourage Australians to
While there were no announcements specific to resume having their regular
the Prostheses List (PL), Minister Hunt’s Health health checks, diagnostic
Budget media release did make specific mention of
the co-signed PL agreement inked by MTAA and the screening, and other
Commonwealth, according to MTAA release. preventive health activities.”

Reacting to the Federal Budget, Stuart - Greg Hunt,
Babbage, Partner, Health Policy & Economics, Minister for Health and Aged Care,
ACT, PwC, Australia said “After the challenges of
funding significant spending on COVID-19, 2021’s Government of Australia
$17.7 billion aged care reform package and the
additional $2.1 billion for mental health, it was not “The government will
unreasonable to expect that 2022’s pre-election provide $1.1 billion over
Budget would be less exciting for health than two years from 2022-23 to
previous years.” support the government’s
emergency response to
Nevertheless, he pointed out that there are COVID-19. As part of this,
some notable areas of spending by the Federal $984 million will be invested
government during the year including $2.4 billion over two years from 2022-23
for new medicines being added to the PBS, including to extend activities under
treatments for breast cancer, cystic fibrosis, severe the National Partnership
eczema, asthma, human immunodeficiency virus on COVID-19 Response. A
(HIV) infection and heart failure. Establishing further $2.6 billion will be
Australia’s own onshore manufacturing plant for invested over two years from
mRNA vaccines (for an undisclosed amount) which 2021-22 to distribute free
will secure supply not just for vaccines related to rapid antigen tests (RATs) to
this pandemic but for a range of future vaccines priority population groups,
and therapeutics. $522 million added to the aged and $1 billion over two years
care reform package, with $345 million of this from 2021-22 to support the
focussed upon improving medication management continued distribution and
in residential aged care through on site pharmacists uptake of COVID-19 vaccines
and community pharmacy services. This could play
a significant role in better management of the health across Australia.”
of residents as medication management delivered - Evan Rawstron,
as part of multidisciplinary teamwork improves the
safety and quality of aged care. Partner in Charge, Policy, Programs & Evaluation
and Global Lead, Health Analytics, KPMG Australia
A further $547 million for mental health, with a
focus upon suicide prevention - an area where access “This is the first Budget since
to care on a timely basis, wherever and whenever 2016-17 where there is no
it is required, is vital. Separately, there is also a
commitment of $60 million related to the national new investment in growing
mental health workforce strategy, with a major focus home care services. This may
($28 million) on growth in the psychiatry workforce. have implications for meeting
consumer preferences to age
The other notable spending from the government
include $296.5 million over four years added to the in place and the ongoing
government’s investment in improving regional, demands for home-based
rural and remote health. This includes a focus on
workforce with almost $100 million for training and supports.”
education opportunities in rural areas. An investment - Nicki Doyle,

National Sector Leader,
Ageing, KPMG Australia

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“After the challenges of specific to women’s health, with $333 million devoted
funding significant spending to initiatives including specific support for women
experiencing endometriosis ($58 million) and health
on COVID-19, 2021’s $17.7 measures to prioritise women’s safety as part of
billion aged care reform the National Plan to End Violence against Women
package and the additional and Children ($137 million). Further confirmation
$2.1 billion for mental health, of the scale of cost related to an ongoing COVID-19
it was not unreasonable pandemic, with $4.2 billion covering supply and
to expect that 2022’s pre- access to vaccines, treatments and support for our
election Budget would be health workforce in primary care, aged care and
less exciting for health than hospitals.

previous years.” In addition to these health portfolio investments,
- Stuart Babbage, the health and wellbeing of Australians was also
supported by significant additional funding projected
Partner, Health Policy & Economics, for the NDIS (over $40 billion over the forward
ACT, PwC, Australia estimates). These investments illustrate a continued
focus upon sustaining our health - all Australians
“A perfect score would have benefit from a health system that is high-quality,
been given for a Budget accessible and relatively cost-effective. Just one
example - the listing of Trodelvy for the treatment
that avoided price pressure of triple negative breast cancer - illustrates how this
while giving business the balance is met, with this listing providing $80,000
per course of treatment: something few of the average
best possible platform from of 580 patients each year would be able to afford.
which to be as productive Babbage pointed out that the challenge, however, is
as possible. These policies that to truly invest in the things that matter, we need
would, in turn, lift the GDP to do more.
potential, make the COVID
debt easier to pay off and Sharing her views on Budget, Kerry McGough,
help address growing National Sector Leader – Health, Ageing & Human
demand for government Services, KPMG Australia said “Through
prioritising innovative models of care
funded health, disability, aged for specific conditions, expanding
care and defence.” onshore vaccine manufacturing
- Cherelle Murphy, capability and capacity, and
harnessing health technology,
Oceania Chief Economist, Director, EY Australia this Budget prioritises
maintaining the resilience
“Life Sciences organisations of the Australian
will welcome the features of healthcare system.
this Budget which facilitate The government has
also focused healthcare
translation of Australia’s investment on the extension
strong reputation for R&D of funding for existing programmes, providing
welcome additional funding for the health workforce,
into viable commercial mental health, and access to healthcare services.”
outcomes. The additional
support for critical issues Talking about the investments in post -COVID-19
pandemic period, Evan Rawstron, Partner in
facing the life sciences Charge, Policy, Programs & Evaluation and Global
industry (strengthening local Lead, Health Analytics, KPMG Australia said “The
government will provide $1.1 billion over two
manufacturing, addressing years from 2022-23 to support the government’s
supply chain and cash flow emergency response to COVID-19. As part of this,
$984 million will be invested over two years from
issues and investment 2022-23 to extend activities under the National
in medical research) is
encouraging, but businesses
will need to carefully assess
eligibility and timing criteria.”

- Kelly Chong,
Partner, Corporate Tax, KPMG Australia

COVER STORY 23

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Partnership on COVID-19 Response. A further $2.6 “Through prioritising
billion will be invested over two years from 2021- innovative models of care
22 to distribute free rapid antigen tests (RATs)
to priority population groups, and $1 billion over for specific conditions,
two years from 2021-22 to support the continued expanding onshore vaccine
distribution and uptake of COVID-19 vaccines across
Australia.” manufacturing capability
and capacity, and harnessing
Speaking on the investments related to mental
health space, Rawstron said “Every year, more than health technology,
3,000 people lose their lives to suicide, and suicide this Budget prioritises
remains the leading cause of death for Australians maintaining the resilience
between the ages of 15 and 44 years old. Mental of the Australian healthcare
Health remains a high priority in this Budget, with system. The government
the government providing $547 million over five has also focused healthcare
years from 2021-22 to implement reforms under investment on the extension
the National Mental Health and Suicide Prevention of funding for existing
Plan. This investment includes $285.5 million over programmes, providing
five years from 2021-22 for a range of mental health welcome additional funding
treatment initiatives. Priority areas include services for the health workforce,
for young Australians with severe mental illness, mental health, and access to
innovative pilot programs to address the needs of
people with eating disorders, and digital mental healthcare services.”
health services.” - Kerry McGough,

Sharing views on improving access to National Sector Leader – Health, Ageing &
health care Kerry observed that the government Human Services, KPMG Australia
will provide $2.4 billion over five years from
2021-22 for new and amended listings on the Net thresholds, which will mean patients will
Pharmaceutical Benefits Scheme (PBS) and other reach the Safety Net sooner each year. To support
pharmaceutical and consumable schemes. Within research and cancer care the government will
this funding, $525.3 million over four years will be invest $375.6 million over four years from 2022-23
to establish the WA Comprehensive Cancer Centre
provided to reduce the Safety and $28.1 million to establish Genomics Australia,
with a view to drive translation and integration of
genomics in the Australian health system.

Similarly on primary and preventative care,
Kerry noted that the government will provide
$230.7 million over five years from 2021-22 to

improve access to primary health
care services, including
better integration and
availability of services. This
includes $108.5 million
over two years from
2022-23 to extend
public dental services
and $56 million to
support Primary Health
Networks deliver after
hours care. With a focus on

preventative health, $170.2
million will be invested over five years
from 2021-22. This includes $31.6 million
over 4 years from 2022-23 to fund projects
under the National Ice Action strategy.

Life sciences industry

24 COVER STORY

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*all figures in Australian dollars (AUD) Therapeutic Goods.
Whilst the expansion of the patent box regime is a
Industry Announcements
welcome development, Kelly observed that there may
Modern Manufacturing be practical challenges in identifying eligible patents
Strategy and Supply Chain Vulnerabilities with sufficient links to research and development
● Overall funding is additional $328.3 million over in Australia and determining the quantum of
attributable profits subject to the concessional tax
4 years which includes for: rate of 17 per cent.
● Extension of Modern Manufacturing Initiative
Kelly further noted that the additional support
for 2 years for critical issues facing the life sciences industry
● Extension of Manufacturing Modernisation (strengthening local manufacturing, addressing
supply chain and cash flow issues and investment in
Fund for 4 years medical research) is encouraging, but businesses will
● Development of Manufacturing Investment need to carefully assess eligibility and timing criteria.

Plans over 2 years A further $1.3 billion has been committed to the
● Reference is made to addressing supply chain Medical Research Future Fund (MRFF), which will
provide research funding of $6.3 billion over 10 years
vulnerabilities but no specific information or from 2022-23 to support innovative treatments,
funding is provided advanced health care and medical technology.

Treasury Announcements Acknowledging industry comments regarding
commercialisation of medical research and
Patent Box (previously announced) development, the Government has announced
● Expansion of the 2021-22 Budget Measure additional funding of $328.3 million over five years
for the Modern Manufacturing Initiative (with
for medical and biotechnology innovations to
include patents granted or issues after 11 May
2021 to be eligible and also allow IP registered
with appropriate overseas jurisdictions to be
eligible
● Patent box has been expanded to the
agricultural and low emissions technology
sectors
Small business (up to $50M turnover)
technology and training support
● Small businesses can claim additional
deductions for employee training and digital
technology adoption

Source: Medical Technology Association of Australia (MTAA)

Talking about the Budget announcements
on life sciences industry Kelly Chong, Partner,
Corporate Tax, KPMG Australia, said, “Life Sciences
organisations will welcome the features of this
Budget which facilitate translation of Australia’s
strong reputation for research and development into
viable commercial outcomes.”

The government has made two significant
expansions to the patent box regime, which
taxes profits attributable to eligible patents at a
concessional rate of 17 per cent. Eligible patents
now include those granted or issued (rather than
only those applied for) after 11 May 2021, as well as
utility patents issued by the United States Patent and
Trademark Office, and European patents granted
under the European Patent Convention, to the extent
R&D occurred in Australia. Patents must link to a
therapeutic good entered in the Australian Register of

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medical products one of aged care providers in the management and
the National Manufacturing administration of medication, including the overuse
Priorities) and to address of antipsychotics, the government has committed
supply chain vulnerabilities. $345.7 million over 4 years to provide access to an
Kelly observed that in on-site pharmacist or a community pharmacy service
addition, small and medium life sciences businesses for all residential aged care facilities.
may benefit from lower pay-as-you-go (PAYG) tax
instalments (and improved cash flow) for eligible Nicki Doyle, National Sector Leader, Ageing,
businesses following a significant reduction in the KPMG Australia said that this is the first Budget
GDP uplift rate for PAYG and GST instalments for since 2016-17 where there is no new investment
the 2022-23 income year from 10 per cent to 2 per in growing home care services. This may have
cent. implications for meeting consumer preferences to
age in place and the ongoing demands for home-
Aged care based support.

The government continues to support reform in “Significant investment is focused on responding
the aged care sector, with $926.4 million committed to the impacts of COVID-19 and managing ongoing
in the Budget. Funding is split between continued outbreaks, with minimal investment directed at
implementation of the government’s response to the improving wages for the aged care workforce,” she
Royal Commission into Aged Care Quality and Safety said.
($468.3 million) and COVID-19 response packages
($458.1 million). Whilst the amount allocated in “After an unprecedented investment in last year’s
this Budget is relatively low, this follows a record Budget, minimal new funding has been allocated to
investment of $18.3 billion in last year’s Budget. address the ongoing financial and workforce issues
which are causing continued challenges throughout
There is continued support for aged care the aged care sector. The aged care sector continues
providers in managing their response to the to feel the impacts of widespread reform and financial
COVID-19 pandemic, with an extension to the and workforce pressures, however there is limited
Aged Care Surge Workforce programme and Aged funding allocated to address these pressing issues,”
Care Support Programme Extension Grant (which she added.
reimburses providers for costs associated with
managing the direct impacts of COVID-19) to Easier to do business
include aged care providers directly impacted by
floods. Funding is also extended to additional bonus From a business point of view, Cherelle Murphy,
payments of up to $800 to residential care and Oceania Chief Economist, Director, EY Australia
home care workers as a workforce retention strategy said, “the 2022-23 Budget had two tasks. One was to
($215.3 million over two years). avoid creating unwanted demand that might push the
Reserve Bank of Australia (RBA) to raise rates sooner
In recognition of the issues facing residential – or push them higher – and two was to unlock
supply constraints to increase the productive capacity
of the economy.”

“A perfect score would have been given for a
Budget that avoided price pressure while giving
business the best possible platform from which to be
as productive as possible. These policies would, in
turn, lift the GDP potential, make the COVID debt
easier to pay off and help address growing demand
for government funded health, disability, aged care
and defence; particularly important given the ageing
population and a geopolitically uncertain world. On
this basis, we give Treasurer Frydenberg a 6 out of
10. There are several welcome policies that will give
more incentives to work and help more people into
training, both of which make it easier to do business,”
concludes Cherelle.

Narayan Kulkarni
[email protected]

*all figures in Australian dollars (AUD)

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Is On-demand
Healthcare Taking Off?

Digital healthcare is converging technology with healthcare to deliver more efficient, personalised,
and innovative healthcare services through telemedicine, cloud-based mobile apps, wearable
devices, clinical management devices, artificial intelligence, algorithm software, diagnostic medical
devices, and more. Making use of the emerging opportunities, startups and Small and Medium
Enterprises (SMEs) in Asia Pacific are accelerating their research, development, and production
of emerging and disruptive technology tools. These small-scale innovators are gradually entering
mainstream opportunities through collaboration with government, academics, and large industries
for technological development as well as through partnership and investment opportunities. But,
how far have they been successful in making a leap to thrive in the industry and overcoming the
barriers? Let’s dig deeper.

When the pandemic crisis struck, as a mode SMEs are utilising the opportunity by combining
of business continuity, many Asia Pacific pioneering science, data, analytics, and technology
(APAC) countries accelerated digital to deliver better Personalised healthcare (PHC) at a
transformation creating new opportunities across reduced cost.
startup and SME communities. A recent survey
by Health-tech company Medtronic revealed that, Talking about the innovation in the region,
in around 15 markets of the APAC region, a major Dr Keren Priyadarshini, Regional Business Lead,
percentage of healthcare technology organisations Worldwide Health, Microsoft Asia said “There has
opine that COVID-19 had enabled the development been an explosion of technological innovation in
and implementation of innovative ideas, although
the positive impact on innovation differed markedly
across markets. Even in South-East Asia, telemedicine,
online pharmacy, and digital health mobile application
gained regional traction solving the long-time concerns
about access to a broader spectrum of healthcare
services, the need for affordable consultations, quicker
appointments, and a significant reduction in the
traveling efforts of the patients. Thanks to startups and
SMEs for their quick resolutions.

Enhancing Startup and SME success

The pandemic has removed multiple institutional
and cultural barriers to the adoption of digital
solutions in the healthcare technology setting.
Digitisation has grown far more rapidly than was
previously thought possible and ushered in an
acceptance of remote medical products and services,
and alternative care models, fostering greater
industry innovation. Despite current apprehensions
about data protection and regulatory concerns, the
healthcare system is uplifting digital healthcare
and MedTech capabilities, IoT infrastructure,
and cybersecurity strengths to increase workflow
efficiency and patient outcomes. Many startups and

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healthcare through startups and unicorns. I believe the benefits of increased innovation from the impact
we have entered a golden era; a pivotal point for of the pandemic, compared to those in South Korea
healthcare.” (17 per cent), Japan (40 per cent), and ASEAN (47
per cent). Companies that found themselves with
Medtronic, a global medical device company the right solutions at the right time, and which were
recently revealed its findings from a survey of over able to harness the people, funding, and networks
150 executives (healthcare technology companies, they needed to rapidly scale their business, turned
market executives, academics, and technology the pandemic into a unique business opportunity. In
pioneers) from healthcare technology organisations 2021, $8.7 billion of venture funding was deployed
operating in 15 markets in the APAC region. The study across 317 digital health deals in the APAC region,
which is presented as a white paper is commissioned an increase of 11.2 per cent as compared to 2020,
by Medtronic in support of Singapore’s Economic showing the growth in VC-backed startups in the
Development Board (EDB) aiming to explore the region and the willingness of venture capitalists to
challenges that early-stage startups and middle-stage invest in APAC”.
healthcare technology companies experience in the
APAC. The quantitative survey indicates challenges Some of the key factor that influences startups
APAC healthcare technologies companies face in and SMEs are;
improving healthcare accessibility.
Data privacy and security regulations
According to the report, “The APAC region is
expected to account for more than 40 per cent of the Healthcare technology has become one of
growth in global healthcare spending over the next the fastest-growing verticals regionally. The
decade— expanding at a rate almost double that of the opportunities for healthcare technology startups in
rest of the world. Other estimates indicate that digital the APAC region have never been so vast, nor the
health in the region could spike in value from $37 rate of change so swift. Despite the opportunities,
billion in 2020 to $100 billion by 2025. The region’s healthcare technology startups in the APAC
telemedicine market alone is expected to grow from region encounter challenges. Not all companies
$8.5 billion in 2021 to $22.5 billion by 2025.” saw innovation and investment thrive during the
pandemic. During Medtronic’s survey, around 35 per
Further, the study reveals that far more Indian (77 cent of survey respondents said that the impact of
per cent) and Australian (63 per cent) companies felt COVID-19 had resulted in the stagnation or demise
of an idea, and for them, the disruption often proved
hard to navigate.

“The challenges that these companies faced
were the result of the enormous strain placed on
healthcare organisations during the pandemic, as
well as the fragmentation of healthcare systems. A
large number of legacy technology systems proved
challenging to integrate because digital solutions take
time to implement. This is particularly an issue in the
public healthcare system where the scale is huge and
decisions need multiple approvals. This is reflected
in the difficulties faced by many startups regionally”,
says Dr Keren Priyadarshini.

Besides, data privacy and security regulations
are crucial concerns at early-stage startups and
SMEs, posing an obstacle. The regulatory framework
is therefore critical to the success of startups and
SMEs. The organisations working with patient
population health data might consider factors like
data privacy rules, data security, data transparency,
data interoperability, data sharing, data standard
benchmarks, Patient participation in data generation,
Peer-to-peer technical assistance as some of the
enablers or barriers in the delivery of patient
healthcare.

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“Regulation does not hinder “A strategic cybersecurity plan
innovation, but rather raises that manages risks and includes
a layered approach to the entire
standards, and therefore
increases value, for startups. organisation’s technology
Regulations exist for patient ecosystem, which oversees
safety. If you’re commercialising the four core disciplines of
digital health, the higher level security—identity management,
of regulatory clarity you have, vulnerability management,
the more competitive your threat management and trust
product is. Your technology is management is essential to offer
worth more when you have to MedTech and Healthtech
the evidence to back up your
claims—it triggers higher-value sectors. This ensures that
no backdoor is left open for
innovation.”
- Bronwyn Le Grice, malicious intervention.”
- Dirk Dumortier,
CEO, and Managing Director,
ANDHealth Head of Business Development Smart-City and
Healthcare, Asia-Pacific, Alcatel-Lucent Enterprise

Some healthcare organisations are worried about Data security should be a future focus for
the integrity of cybersecurity posture which might healthcare technology companies. Data security
arise due to digitisation. But, network vulnerability is a global and inter-sectoral issue, and over 45
can eventually cause hindrance in smarter per cent of respondents ranked data security as
communications across the care network. A smart the most significant barrier to the delivery of
communications system can make it considerably patient healthcare. Despite the magnitude of the
easier to coordinate resources across departments, challenge, data security could prove to be a lucrative
and even different clinics and hospitals – enabling opportunity for existing companies or those
the optimal management of resources. Startups and considering entering the healthcare technology
SMEs are greatly working towards convincing the sector, according to the Medtronic report.
end-users in these aspects.
Revamping pathways to commercialisation
“A strategic cybersecurity plan that manages
risks and includes a layered approach to the entire Healthcare technology startups and SMEs in
organisation’s technology ecosystem, which oversees APAC are better harnessing novel technologies and
the four core disciplines of security—identity innovations, but they need to more carefully consider
management, vulnerability management, threat the patient/disease pathways they focus on to ensure
management, and trust management is essential what they are developing meets an actual unmet
to offer to MedTech and Healthtech sectors. This need, not just what they believe is needed. This
ensures that no backdoor is left open for malicious approach will enable healthcare technology startups
intervention” says Dirk Dumortier, Head of Business to successfully commercialise technologies and
Development Smart-City and Healthcare, Asia- solutions. Some potential innovations do not get past
Pacific, Alcatel-Lucent Enterprise. the pre-clinical and clinical stages of development
because of challenges in attracting funding. These
Nevertheless, Medtronic’s study reveals that early exits from the innovation process detract from
healthcare technology startups and SMEs are the long-term success of the sector.
competing by driving innovation pathways and
adapting a wide technology range of innovations The Medtronic study reveals that ‘there is a gap
in their businesses, from big data and predictive between the patient/disease pathways that healthcare
analytics (used by 32 per cent of companies surveyed) technology companies are investing in, and what they
to AI (used by 29 per cent), polymer science/surface believe are the greatest unmet patient/ disease needs.
coating/ drug delivery (27 per cent), all the way This could be due to the lack of information sharing,
through to value engineering (7 per cent) to increase whether between private and public sectors or within
access to healthcare. Similarly, the application the sectors themselves, that distorts market signals,
of surgical robotics, Virtual reality, and wearable or perhaps the comparative profitability of sectors.
tracking devices is revolutionising the way many Government intervention can fix the failures in the
diseases are monitored and managed. startup domain while private companies can also

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collaborate to improve information sharing. “It is unclear what is causing
Eventually, experts in the study opine that the areas the mismatch, but part of
the problem could lie in
of research and application of these new technologies
will often be guided by patient/disease pathways, which the way that business deals
are standardised, evidence-based management plans have evolved in the APAC
for a patient or a disease. According to the executives market. Many successful
surveyed for the report, the greatest unmet needs of deals in recent times have
the patient/disease pathway are presently treatment involved a business-to-
(49 per cent), testing and screening (41 per cent), and business (B2B) model and
care delivery (33 per cent)”. This indicates a mismatch companies that become
between the company’s predictions on unmet patient
needs at present and the development and investment too customer-centric often
focus in healthcare technology ventures. According to ignore the overall health
the survey, healthcare technology companies presently ecosystem in which they
place too much attention on diagnosis (43 per cent), need to operate, to their
which ranks second in terms of focus, and not enough detriment.”
on testing and screening, care delivery, or awareness- - Jean-Luc Butel,
raising. Group President, International Medtronic

“It is unclear what is causing the mismatch, “There has been an
but part of the problem could lie in the way that explosion of technological
business deals have evolved in the APAC market.
Many successful deals in recent times have involved innovation in healthcare
a business-to-business (B2B) model and companies through startups and
that become too customer-centric often ignore the unicorns. I believe we
overall health ecosystem in which they need to have entered a golden
operate, to their detriment” explains Jean-Luc Butel, era; a pivotal point for
Group President of International Medtronic while healthcare.”
expressing the hit on a viable business model. - Dr Keren Priyadarshini,
Regional Business Lead,
He further emphasises that the startups should Worldwide Health, Microsoft Asia
understand the health economics of the model. A
new product needs to be adopted within a healthcare “The new trend of healthcare-
system by someone who can see where it will fit in the on-demand has ‘immense
patient and money flow. potential’ and it is a market
ripe for future growth.
Adding to the above, the investment models may
be part of the problem. But business environments Consumers of healthcare also
that promote innovation and facilitate access to want to access healthcare-
funding and collaboration can all help support on-demand anywhere,
innovation and deal-making for the region’s anyplace, anytime.”
healthcare technology start-ups and SMEs. - Lalitha Bhaskara,
Vice President, SAP.iO,
Support through mutual partnerships Foundries Asia Pacific Japan & China

The Medtronic Survey further identified that the can also help start-ups and SMEs expand beyond
collaboration with government, private industry, national borders, elucidates Medtronic’s analysis.
healthcare service providers, healthcare professionals, Further, it also proposes ‘fostering cross-domain
and other technology innovators is critical to market business relationships and collaboration models’ for
growth. While regulators and payor reimbursement healthcare technology startups.
organisations are perceived as providing the lowest
levels of support towards healthcare technology start- Experts believe that collaboration and improved
ups in the APAC region innovation. cooperation among all industry stakeholders,
enhance innovation and reduce systemic
Collaborating with private and public healthcare
organisations, as well as regulators, incubators and
other technology startups can enhance innovation
and open doors to new customers, funding,
knowledge, and talent. Cross-border partnerships

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POTENTIAL ROADBLOCKS FACED BY inefficiencies, often improving patient outcomes
EARLY-STAGE STARTUPS AND SMEs and reducing costs. Increasing accessibility should
be one of the key drivers for startups and SMEs.
● Talent acquisition Partnerships among stakeholders can promote
● Navigating data privacy and security regulations frequent efficacious investments, create new markets
● Regulatory compliance issues and revenue streams, and ensure that the impact
● Partnerships and collaborations concerns of change is shared more evenly across societies.
● Market saturation and established competitors Greater stakeholder collaboration can also enhance
● Difficulty accessing funding and financing the capacity and reshape the healthcare industry by
● Difficulty accessing manufacturing/capital goods building resilient healthcare technology ecosystems.
● Data privacy/security concerns
● Intellectual property disputes Regulation, registration,

Source: Medtronic and patent awareness

MOST SUPPORTIVE FACTORS Pandemic triggered local innovation and digital
ENHANCING INNOVATION AT acceleration in the APAC healthcare technologies
STARTUPS AND SMEs ecosystem. Yet, the digital healthcare regulations
in most APAC countries are still relatively young.
● Partnerships and collaborations with public and Though in most APAC countries there are no
private sectors/industry exclusive and separate laws regulating digital health,
the existing laws at pertinent regulatory bodies
● Support with networking/access to health related to medical services, pharmaceutical affairs,
system stakeholders (public sector org., medical devices, and Personal data protection are
investors, other technology innovators, other applied to the digital health wing.
industry players)
In most APAC countries the cross-border transfer
● Raise awareness of the potential value in such of technology and intellectual property (IP) rights are
partnerships territorial and do not provide protection overseas.
Small startup businesses and companies developing
● Cultivating cross-domain business relationships digital health technology products to enter the
● Collaborative support from private companies to market are likely to require overlapping forms of IP
protection in order to reach their full medical and
improve information sharing. economic potential. Managing this IP portfolio from
● Easing of regulatory guidelines the outset can be a challenge for small businesses,
● Help in navigating regulatory hurdles across as it is not always high on the agenda for startups.
The development of an effective IP strategy may
countries or regions therefore provide a competitive edge in digital health
● Providing access to competitive intelligence technology development and commercialisation.
Many government policies are gradually being
information flexible to integrate or connect academic R&D
● Funding/financing support with the industry to commercialise the products
● Government/Legislative support to foster originating from the research. Patenting by research
organisations and licensing of technologies to the
healthcare technology innovations private sector will increase the rate of commercial
● Government intervention to fix the failures in the application of inventions.

start-up domain Bronwyn Le Grice, CEO, and Managing
● Greater collaboration with private sector Director, ANDHealth - Australian digital health
commercialisation organisation, believes that
organisations on innovation regulation does not hinder innovation, but rather
● Platform to learn from other technology start- raises standards, and therefore increases value, for
startups. “Regulations exist for patient safety. If
up’s/SMEs innovation journey you’re commercialising digital health, the higher level
● Improvement in regulatory policies of regulatory clarity you have, the more competitive
● Support with talent/skills recruitment your product is. Your technology is worth more when
● Guidance on health technology assessment you have the evidence to back up your claims—it
triggers higher-value innovation,” he added.
processes
● Assistance with manufacturing/supply chain

problems, Creating robust supply chains
● Diversified investments locations by MNC’s to

tap into start-up innovation

Source: Medtronic

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What’s holding back Startups and SMEs? The recent turbulence in the healthcare
system has been both an enabler and
Though APAC countries offer a flexible regulatory an inhibitor of growth and development
ecosystem for the digital health sector, some in medical and healthcare technology
digital health technologies may find it difficult to startups and mid-growth organisations.
patent, exposing their creators to business risks. The global crisis has put healthcare
Inventors believe that the following concerns around systems and professionals under
patentability might slow down the performance of enormous strain and upended the
Startup and SMEs in Asia. healthcare systems relied upon. The
advent of the next health crisis is
 Not all inventions or ideas are patentable. unpredictable. Startups and SMEs can
Patentable subject matters should be novel and create massive opportunities by being
inventive. The highly competitive digital startup space agile and flexible with innovation
may encounter similar or identical products from and commercialisation harnessing
other startup inventors, pushing the startup idea to a the power of digitalisation which can
speculated zone to prove their proprietary model or enable ubiquitous access to quality
originality during the patenting process. This throws care and enhance operations through
significant stress on R&D investment by startups connectivity.

 Lack of law around patentability for the startup international jurisdictions.
invented MedTech technology or Apps in the zone  Need for Technology transfer practices to
intended for commercialisation
facilitate further development and commercialisation
 Most startup enterprises are at greater risk due of a technology to progress in the industry to further
to their often informal research and development development through patent / licensing. Patenting of
phase, in which sufficient protection of confidential R&D inventions and licensing of technologies to the
information may not be considered to be of high private sector will increase the rate of commercial
priority. application.

 Discussion of the idea with third parties with Way forward
a confidentiality agreement is a significant practice
to be followed by startups and SMEs which is often The recent turbulence in the healthcare system
skipped to conserve confidential information and has been both an enabler and an inhibitor of
to avoid unauthorised access via cyber-attacks. growth and development in medical and healthcare
Attempts to avoid reverse engineering of an idea or technology startups and mid-growth organisations.
invention from a prototype developed during the The global crisis has put healthcare systems and
R&D phase can also add to these setbacks. professionals under enormous strain and upended
the healthcare systems relied upon.
 Licensing may also be an issue between co-
inventors disputing the co-ownership and licensing “The new trend of healthcare-on-demand has
who develop different components of a particular ‘immense potential’ and it is a market ripe for future
digital health technology or contribute to different growth. Consumers of healthcare also want to
major aspects of a single product. access healthcare-on-demand anywhere, anyplace,
anytime,” says Lalitha Bhaskara, Vice President, SAP.
 Unlike the classical pharmaceutical drugs, the iO, Foundries Asia Pacific Japan & China.
digital health-tech sector faces concerns such as the
‘lifespan of the technology’ as health-tech undergoes The advent of the next health crisis is
constant upgrading and de-bugging during its field unpredictable. Startups and SMEs can create massive
application in a gradual process. This makes the opportunities by being agile and flexible with
patenting process challenging, as a single patent may innovation and commercialisation harnessing the
not cover different aspects of the technology for a power of digitalisation which can enable ubiquitous
long period of usage. With continuing advancements access to quality care and enhance operations
in the product technology, a patent during the early through connectivity.
commercialisation stage may not justify the validity
of the patent for long. Hithaishi C Bhaskar
[email protected]
 In most APAC countries the cross-border
transfer of technology and IP rights are territorial. To
penetrate the international market for their products,
patentees should consider applying for international
protection under the Patent Cooperation Treaty
(PCT) which can extend patentee protection in most

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Focusing on CAR-T Cell
Therapy for Solid Tumours

The USFDA (The U.S. Food and Drug Administration) approved the first ever CAR-T (A chimeric
antigen receptor- therapy) of Novartis’ Kymriah in 2017. Since then, the CAR-T landscape has
expanded rapidly, offering hope for life-changing benefits that the treatment provides for cancer
patients. BioSpectrum brings the latest and crucial trends pertaining to this crucial therapy.

Chimeric antigen receptor therapy (CAR-T) is the treatment of relapsed or refractory multiple
developing at a significant pace and is all set myeloma after four or more prior lines of therapy.
to revolutionise oncology with the potential Additionally, JW Therapeutics announced the
to treat autoimmune diseases, apart from a range NMPA (National Medical Products Administration)
of other conditions. There are currently 542 active approval of Relmacabtagene Autoleucel Injection
clinical trials globally. within China in September 2021. This is the first
CAR-T product independently developed in China
‘’Since the initial approvals of Kymriah and approved as a Category 1 biologics product.
(Novartis) and Yescarta (Kite/Gilead) in 2017,
CAR-T therapies have begun to transform the In February 2022, US FDA approved CARVYKTI
treatment landscape for patients with cancer, in (ciltacabtagene autoleucel), Janssen’s First Cell
many cases offering a chance at long-term disease Therapy, a BCMA-Directed CAR-T Immunotherapy
control, and in some cases a chance at a cure. for the Treatment of Patients with Relapsed or
Currently, the six commercially available CAR-T Refractory Multiple Myeloma.
therapies in the U.S. are approved for refractory
forms of blood cancer, including leukemia, All these therapies are approved for several
lymphoma, and myeloma. However, much work is hematological malignancies. CAR-T cells in B-cell
underway to move this modality into earlier forms non-Hodgkin lymphoma, acute lymphocytic
of cancer and to expand its reach into solid tumors. leukemia, and multiple myeloma, have been
The field has grown increasingly competitive with lucrative, with combined sales of over $1.7 billion
dozens of new biopharmaceutical companies globally, a figure that is projected to reach $28
advancing hundreds of developmental-stage CAR-T billion by 2027, according to GlobalData estimates.
candidates through clinical trials. Given the high
degree of investment and fast pace of innovation, ‘‘This commercial success has led to a highly
it is almost inevitable that multiple breakthroughs competitive early-stage R&D race, with the number
will follow,” said Dr Eric Schmidt, Chief Financial of Phase I/Phase II cell therapy products, including
Officer, Allogene Therapeutics, USA. CAR-T, surpassing any other immuno-oncology
modality. B-cell lymphomas remain the key focus
Allogene is pioneering this field of“off-the-shelf” of clinical development, and most CAR-T cells in
CAR-T cell therapy candidates with the goal of the clinic target the de-risked CD19 and BCMA
delivering readily available cell therapy faster, more antigens, raising questions about the sustainability
reliably, and at greater scale to more patients. of very similar approaches in a market that is getting
more crowded by the year,’’ said Dr Sakis Paliouras,
Current landscape Senior Oncology Analyst at GlobalData, UK.

The earliest approvals, Novartis’ Kymriah It’s worth noting that most of the approved
and Gilead’s Yescarta, have been commercially therapies and also the ones in late stage trials
available since 2017 and 2018, respectively. In currently are autologous therapies. That’s changing
July 2020, the US FDA approved a third CAR-T slowly. There is a shift away from autologous CAR-T
cell therapy, Kite Pharma’s Tecartus. In February therapies towards allogeneic CAR-T therapies.
2021, Breyanzi (Juno Therapeutics, Inc., a Bristol- Initially, the researchers focused on using gene
Myers Squibb Company) became the fourth to get editing tools to enable cells to be used in allogeneic
approval for CAR-T. In March 2021, the U.S. FDA settings. Gene editing increases the complexity and
approved Abecma (Celgene, a BMS company) for manufacturing cost. Hence currently, there is a shift
to looking for new types of immune cells that can

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be used in an allogeneic without the need for gene “The field has grown increasingly
editing. competitive with dozens

‘’We truly believe that the future of CAR-T is of new biopharmaceutical
allogeneic, and we are seeing the R&D landscape companies advancing hundreds
continue to trend towards an off-the-shelf approach.
Despite the approval of autologous CAR-T cell of developmental-stage CAR-T
therapies, the industry has been developing candidates through clinical
allogeneic cell therapies to solve many of the issues trials. Given the high degree
associated with the autologous approach, including
the difficulty of providing a way to treat a large of investment and fast pace of
population of patients, including those with solid innovation, it is almost inevitable
tumors, in a timely manner. We are seeing the that multiple breakthroughs will
industry not only push to find solutions for the
treatment of solid tumors but also develop new follow.”
technologies and strategies to further expand the - Dr Eric Schmidt,
reach of an allogeneic approach,” said Filippo Petti,
Chief Executive Officer, Celyad Oncology, Belgium. Chief Financial Officer, Allogene Therapeutics, USA

Celyad Oncology is using a single vector ‘‘Commercial success has
approach to generate CAR-T cells and its led to a highly competitive
proprietary non-gene edited technologies helps early-stage R&D race, with
expedite and expand patient access to these novel the number of Phase I/Phase
treatment options with a quicker turnaround time
from cancer treatment decision to infusion. II cell therapy products,
including CAR-T, surpassing
Key trends any other immuno-oncology

Let’s look at the key trends expected to influence modality.’’
CAR-T therapy research in 2022 and the near - Dr Sakis Paliouras,
future:
Senior Oncology Analyst, GlobalData, UK
Targeting solid tumours/ multi-target
CARs: CAR-T therapy has shown good results “We are starting to see patients
with haematological malignancies, but has yet to relapsing, with the cancer
demonstrate the same efficacy in solid tumours. shedding the CAR targets.

“Furthermore, we are starting to see patient Therefore the key trend is to
relapsing, with cancer shedding the CAR targets. develop CAR-T cell therapy for
Therefore the key trend is to develop CAR-T cell solid tumours, and also CARs
therapy for solid tumours, and also CARs that are
able to recognise multiple targets at a go,’’ said Dr that are able to recognise
Tan Wee Kiat, Chief Operating Officer, Cytomed, multiple targets at a go.’’
Singapore.
- Dr Tan Wee Kiat,
Incorporated in 2018, CytoMed Therapeutics Chief Operating Officer, Cytomed, Singapore
is a spin-off from Singapore’s Agency for Science,
Technology and Research (A*Star) and focuses on ‘‘We truly believe that the
translating its patented technologies into gamma future of CAR-T is allogeneic,
delta (γδ) T cell- and natural killer (NK) cell-based
“off-the-shelf” immunotherapeutics for a wide range and we are seeing the R&D
of cancers. landscape continue to trend

Majority of the research in this space is currently towards an off-the-shelf
in the discovery and preclinical stage. approach. Despite the approval

Off-the-shelf CAR-T cells : A trend that of autologous CAR-T cell
has been identified as the most eagerly-awaited therapies, the industry has
approach by physicians is the development of been developing allogeneic
allogeneic, off-the-shelf CAR-T cells. All currently cell therapies to solve many of
approved CAR-T therapies are “autologous” in the issues associated with the
nature. This means that manufacturing starts with
autologous approach.”
- Filippo Petti,

Chief Executive Officer, Celyad Oncology, Belgium

34 CAR-T

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

APPROVED CAR-T THERAPIES

S.No Company Drug Indication Approval in
1 Novartis Kymriah relapsed or refractory large B-cell lymphoma USFDA - 2017
2 Gilead Yescarta relapsed or refractory large B-cell lymphoma USFDA- 2018
3 Kite Pharma Tecartus mantle cell lymphoma or acute lymphoblastic leukemia. USFDA -2020
4 Bristol-Myers Squibb Breyanzi large B-cell lymphoma USFDA- 2021
5 Bristol-Myers Squibb Abecma multiple myeloma USFDA -2021
6 Janssen’s CARVYKTI multiple myeloma USFDA-2022
7 JW Therapeutics Carteyva relapsed or refractory large B-cell lymphoma NMPA - 2021

the collection of T cells from an individual cancer the sector.
patient. T cells are engineered to recognise a target All the approved CAR-T therapies are being
on the surface of cancer cells and subsequently
re-infused into the patient from which they were investigated from only as last line therapy to earlier
collected. (2nd or 1st) line treatment.

‘‘While autologous CAR-T therapies have Multiple Dosing: The aspect of multiple
been associated with unprecedented efficacy, the dosing has also started to come into the forefront
delivery of an individualised therapy is complex, when developing these therapies.
time consuming, and expensive. In fact, logistical
considerations often limit the number of patients ‘’Specifically, we predict multiple dosing around
who can reap benefits from CAR-T therapies. allogeneic CAR-T will become a more prominent
Despite unprecedented efficacy, modern CAR-T will industry conversation as companies are starting
need to address resistance which is very common later-stage trials and thinking about the opportunity
in many haematological diseases, and move this to maximise the treatment benefit and how that
modality into solid tumours where progress has may impact commercialisation of these cell
been lagging. The ability to genetically engineer therapies. These discussions will likely influence the
allogeneic (“off-the-shelf”) CAR-T products will development of CAR-T because we will be seeing
make this the modalities of the future as they can be more company refinement of clinical trial designs,
engineered a priori to be administered on demand,” including the impact on preconditioning in advance
Dr Schmidt. of these treatments, which will hopefully help to
expedite candidates to commercialisation and to
Allogenics drugs would eliminate the current the patients who will need these therapies the most.
manufacturing requirement for CAR-T cells which Given where the industry currently stands, we
take weeks before they can be administered to a expect to see this dynamic continue to unfold over
patient. the next few years as additional understanding of
the true potential of allogeneic CAR-T therapeutics
‘’While such molecules remain unproven in a emerges,’’ said Filippo.
large-scale clinical trial, if successful, they would
address the major hurdle of 1st generation CAR-T China’s dominance: With Chinese companies
cells, which is logistics and manufacturing,’’ said Dr undertaking the highest number of CAR-T cell
Paliouras. therapy trials, GlobalData anticipates the country
is likely to dominate the treatment landscape in
CAR-T as first line therapy: All the approved coming years. According to the GlobalData Pharma
CAR-T are indicated as a second line treatment. Intelligence Center, there are nearly 60 CAR-T
therapies in the overall clinical pipeline in China
‘‘Another trend is the clinical investigation which are being developed by domestic pharma
of moving current products into earlier lines of companies. Of which, there are 25 CAR-T therapies
therapy, with the goal to ultimately use CAR-T cells in Phase II pipeline.
for newly diagnosed patients or as a replacement for
stem cell transplant in certain blood cancers,’’ said CAR-T therapy is pharma’s most advanced
Dr Paliouras. and expensive treatment and is set to transform
cancer care. As the research evolves and
To that effect, in April 2022, Gilead won the regulations mature, we finally may have the
USFDA approval for Yescarta as a first in line elusive cancer cure.
treatment for Relapsed or Refractory Large B-cell
Lymphoma (LBCL)- a momentous milestone for Ayesha Siddiqui

BLOCKCHAIN 35

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

5 Transformative Merits
of Blockchain in Pharma

Blockchain is best known for its role in cryptocurrencies like Bitcoin. The tech’s inherent
transparency, security and reliability have numerous applications in the pharmaceutical space. Let’s
look at how this technology can prove crucial to pharmaceutical operations.

Blockchain - an open, decentralised, secure, ‘’All supply chain stakeholders will be able
public ledger and the technology behind to share and update data, ensuring that it is
crypto currencies like bitcoin and has caught accurate and timely. Pharmaceutical supply chain
the fancy of the traditional pharma sector. A management could benefit from distributed ledger
number of pharmaceutical companies are exploring technology in terms of legislation, logistics, and
its use as a more secure enterprise solution that patient safety as it can be used to trace the origins
can solve its major woes-including supply chain of medications, the transport of drugs, and the
disruption, data disparity, stagnation, and poor procurement of raw materials,’’ said Chrissa.
scientific productivity.
“As a result of malpractice and poorly
‘’Blockchain technology has the ability to change functioning supply chains, numerous
the sector significantly. The potential applications pharmaceutical companies have sought to use
of blockchain in pharma are vast, ranging from blockchain technology to optimise operations
streamlining existing supply chain procedures and streamline tracing and tracking, medical
to ensuring regulatory compliance to enabling transactions, and patient safety,” added Chrissa.
future discoveries. Many of them are already being
realised across the industry, and companies are The Pharma industry is keen to explore this.
coming up with more and more use cases for the The MediLedger Pilot Project, a consortium
technology,’ said Chrissa McFarlane, CEO and of leaders from 25 pharmaceutical companies,
Founder, Patientory, Inc, USA.’ Patientory is a is building an industry-owned permissioned
global population health management software that blockchain network for the pharmaceutical sector
gives users access to their health data. based on open standards and specifications.

Let’s look at how this technology could prove an In 2020, IBM, KPMG LLP, Merck & Co.
asset to the pharmaceutical sector. Inc., and Walmart Inc. successfully completed
an USFDA ( United States Food and Drug
1. Securing supplying chains: The most Administration) pilot program that demonstrated
obvious and widespread application of blockchain how blockchain technology can be used to help
in pharma, especially in the wake of COVID-19 the meet the Drug Supply Chain Security Act (DSCSA)
pandemic which has exposed the vulnerabilities requirements to verify, track, and trace prescription
in the supply chain. Lack of transparency, medicines and vaccines distributed within the
difficulty tracking supplies and the shipment of United States.
outdated products are among issues that plague
the traditional pharmaceutical supply chain. One 2. Counterfeit drugs: The WHO (World
of the solutions to these issues is the emerging Health Organisation) roughly estimates that 10
blockchain technology. Blockchain technology per cent of medicine worldwide is counterfeit.
has the potential to play a significant role in the The issue of counterfeit drugs is pressing, poses a
supply chain industry, as it can offer a variety of risk to patients, and has a huge economic impact.
potential solutions to the supply chain issues that Governments around the world are tightening the
the medical industry is now facing. This emerging supply chain integrity to slow down the global flow
technology allows for decentralised transaction of counterfeit medicines. Blockchain can help to
recording and tracking, as well as increased resolve current challenges in the supply chain, by
overall efficiency and the removal of unnecessary providing traceability until the point of delivery.
intermediaries.
Back in 2020, Singapore-based Zuellig
partnered with pharmaceutical company Merck
to deploy eQTracker in Hong Kong, where it was

36 BLOCKCHAIN

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

‘’Blockchain technology has identifiers by using SAP’s app, Advanced Track
the ability to change the sector and Trace for Pharmaceuticals. The app can track
the package and record whenever a transaction
significantly. The potential happens, allowing the manufacturer to verify its
applications of blockchain in authenticity when returned.
pharma are vast, ranging from
streamlining existing supply 5. Boost R&D: Blockchain in pharma can
chain procedures to ensuring be beneficial in the drug discovery process in a
number of ways. Blockchain provides the required
regulatory compliance to robust IP protection, transparency and verifiability
enabling future discoveries. in real time across globally dispersed teams. In
Many of them are already being combination with other emerging technologies
realised across the industry, and such as artificial intelligence and machine learning,
companies are coming up with blockchain in pharma could also improve data
more and more use cases for mining and analysis of information in published
and newly generated research.
the technology.’
- Chrissa McFarlane, The Machine Learning Ledger Orchestration for
Drug Discovery (Melloddy) is a three-year public-
CEO and Founder, Patientory, Inc, USA private consortium of ten major pharmaceutical
companies, academic researchers, data scientists,
used to trace vaccines for Human Papilloma Virus, and a major Artificial Intelligence company. The
Gardasil. Zuellig Pharma is also using eQTracker goal is to combine machine learning with blockchain
to track COVID-19 vaccinations to prevent technology to improve drug development.The
practitioners from administering expired vaccines. project involves sharing huge amounts of data on
the biological effects of billions of different small
In 2021, UNICEF tendered the development molecules. Each company would maintain control
of a blockchain solution for detecting counterfeit of its own data, but non-sensitive information
COVID-19 vaccines. It allows COVID-19 vaccines would be shared for processing by machine learning
to be scanned and verified so their serial number algorithms. It is hoped that this project will give
can be compared with a blockchain-secured list of companies a much larger set of molecules to explore
product codes generated by the manufacturers.\ for new treatments. Blockchain is a key to the
sharing, since it will allow for data sharing while still
3. Enhancing Clinical Research: Another allowing each company to protect its intellectual
important application of the technology is for property rights. The project started in June 2019
ensuring patient privacy and data protection during and will conclude in June 2022.
clinical trials.
Challenges
Pharma giants like Pfizer, Amgen, and
Sanofi are looking to streamline the process The technology is not without challenges
of developing and testing new drugs by using though. The cost of development and
blockchain technology. The companies believe the implementation, lack of expertise and industry
collaboration with blockchain technology may help standards are some of the key considerations for
to increase efficiency, accelerate the R&D process, the pharma industry.
and reduce drug development costs. Additionally,
Boehringer Ingelheim (Canada) has partnered with Scalability is also an issue with most blockchain
IBM to improve trust, transparency, patient safety, projects and storing data on a blockchain is
and patient empowerment in clinical trials by using expensive. Regulations around patient privacy
IBM’s blockchain platform. make it difficult to get stakeholders onboard or
provide third parties access to relevant but not
4. Validating Returned Drugs: In the identifiable information.
pharmaceutical industry, wholesalers often ask
for excess inventory and may need to return some However, solutions to these problems are being
products to the manufacturers. Returned drugs explored.
are then repackaged and resold. Globally, saleable
returns account for about two percent of the entire Chrissa concluded that there is a promising
commercial market. (Source: SAP) future of blockchain in the pharma sector. As it is an
emerging technology it is expected to open up new
Merck and American drug wholesale company avenues for various industries, including pharma.
AmerisourceBergen, is working with SAP to
develop a blockchain-based solution that validates Ayesha Siddiqui
returned drugs. They tag drug shipments with

SPEAKING WITH 37

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

“Healthcare providers must invest in appropriate

data fabrics that accelerate agile access to data”

Artificial Intelligence (AI) and its «
multitudinous applications have found
their way into clinical, diagnosis, hospital San Zaw,
administration, pharma-biopharma, and
healthcare sectors. The adoption of healthcare Vice President
innovation in the Asia Pacific (APAC) region
is driven by the surge in the demand for better Solution Consulting,
medical services as well as the shortage of medical
front liners and healthcare practitioners. San APJ, TIBCO
Zaw, Vice President Solution Consulting, APJ,
TIBCO shares insights into the best practices in What are the common challenges faced by
data governance and the gaps to be bridged to healthcare organisations to maximise the
accelerate AI adoption in Asian healthcare and benefits of AI in APAC healthcare?
clinical practices. Edited excerpts;
With the recent health crisis, AI played a
How essential is the integration and pioneering role in the control and management of
interoperability of fragmented healthcare COVID-19 cases through AI-enabled contact-tracing
records to streamline data flow in the applications. For example, in Singapore, NUHS
healthcare ecosystem? launched one of the very first AI initiatives that
integrates real-time medical data from EMR systems,
Getting the right data to the right people at which are then fed into AI models to produce
the right time is one of the biggest challenges insights.
the healthcare sector faces. With fragmented
healthcare records, data silos and the influx of Similarly, in Indonesia, acknowledging the lack
data from wearable and implantable devices, of data integration between data systems, healthcare
organisations within the sector must address this providers and government agencies, the government
complexity by leveraging tools and solutions that rolled out a long-term strategy to address the various
support data integration and seamless access healthcare issues the country is facing. To realise
to data. Integrating and efficiently analysing the nation’s digital health transformation goals, the
various data sources from hospitals, clinics, government identified data integration as the basis
laboratories, insurance companies, and other for decision and policy making to be one of their
relevant parties within the ecosystem enables key areas of focus. Mapping out Indonesia’s health
healthcare providers to leverage insights from transformation goals into three priority activities,
this information. the country is looking at implementing an AI-based
health analysis system by 2023, which underscores
Curated and analysed data should be easily the importance of creating integrated healthcare
accessible across healthcare ecosystems, otherwise it records.
will be difficult to realise the goal of providing holistic
and integrated healthcare services. By eliminating With the increasing adoption of digital
data silos across hospitals, care facilities and technologies, the role of AI in healthcare is ever
insurance providers, and integrating business and evolving, which requires professionals and service
clinical information, organisations are able to create a providers to rely on data to inform high-stakes
360-degree view of patients. decision making. However, many healthcare providers
are accessing varied data sets, making extracting
With meaningful insights from integrated data, valuable insights from data a challenge, thus limiting
organisations, healthcare providers and government their capacity to utilise the information effectively. For
agencies are able to predict population health instance, with data silos in diagnostic testing, tests
trends, improve the management of facilities, and may not reach the right medical professional on time
make better predictions on key metrics such as and put people’s lives at risk. This underscores the
probability of readmission, thus improving the need for agility as a priority in the modernisation of
quality of patient care.

38 SPEAKING WITH

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

data platforms. Poor data quality and lack of efficient data (codes, hierarchies, classifications, etc.) and
data analytics processes, resulting in underutilisation metadata (data context and lineage).
of data and lack of interoperability, can hamper
an organisation’s ability to extract the most value Compounding this are the data protection
from its assets and technology investments. Many requirements that are particularly important for
healthcare organisations miss the mark on evident healthcare data, which involves sensitive patient
interoperability to make the most of huge amounts data that needs to be secured and safeguarded so
of data. Healthcare data is regularly described by only authorised personas and profiles can access the
information clashes or exclusions, and deferrals in respective data.
manual cycles. The absence of real interoperability
between conventional stages can imperil the patient’s It is critical that, to be successful in this, data
wellbeing. governance is an organisation-wide initiative and
not something confined to a particular department
Decentralised IT organisations – where or function. Having a continuous data governance
information is caught, however challenging to share – process that ties in data quality, classification, tagging,
results in many complex components that contrarily mastering and distribution in a collaborative approach
sway the existence of patients, specialists and even involving both data professionals and healthcare
associations. To be truly interoperable, information stakeholders/practitioners is critical for success.
should be gathered in a single repository, cleaned
and democratised, and then made available in an Cognitive computing and AI platforms are
agile manner at every level of decision-making in a
healthcare organisation. Information access agility enabling a new era in data-driven decision
is the minimum required capability for healthcare
modernisation. support and dramatic market expansion.

With the demands of AI and its abilities What’s your observation of Asian market
continuously growing, it is then imperative that the
clinical AI models be trained with adequate data for dynamics?
the required efficacy in the required time budgets.
Hence, the timely and agile access to data by the By 2027, the Asia Pacific AI market in healthcare
data scientists is paramount for safe application of is predicted to hit $17,797.42 million. Part of this
high efficacy AI applications for medical services and increased growth is due to the public-private
clinical use. investments in the integration of AI and the flourishing
partnerships of market players. For example, Synyi,
It is also vital that the calculation is thought of a Shanghai startup, began with Natural Language
as fair. Likewise, because AI in medical services Processing (NLP) using Chinese language and had set
contains private and sensitive data, it is critical to their priorities in hospital scientific research data to
keep up with responsibility and best practices to develop a smart analytics platform. Tricog, which is
guarantee public trust, as organisations perceive the based in India leveraged artificial intelligence (AI) and
capability of AI programs. machine learning (ML) for medical analysis of acute
and chronic heart diseases.
What are some best practices in data
We already see AI playing a role in the enhanced
governance and security that organisations resource control of healthcare workers and
facilities, thereby increasing the care capacity. Also,
need to be mindful of? leading providers are also rolling out initiatives in
operationalising AI/ML on innovative use cases
Data governance has become a priority for many such as aiding/validating diagnosis, readmission
organisations to address regulatory compliance, prediction and population-scale breast cancer
operational improvements, report quality and detection.
customer experience. Fortunately, healthcare
organisations have been prioritising data governance As exciting as these use cases of AI driven
as part of their initiatives. This includes both legal applications are, the realisation of these applications
and regulatory compliance, as well as the upkeep of require access to large data sets, in a governed,
technical and structural governance best practices. shared and agile manner. Therefore, it is paramount
that healthcare providers invest in appropriate data
The challenge at hand is on data trust and data fabrics that accelerate and facilitate agile access
sharing to achieve better outcomes and patient care to data, shortening the time from hours or days to
quality across a given healthcare remit (e.g., national near-instantaneous access. These are the key success
level). Particular attention needs to be given to the drivers to facilitate larger operationalisation of AI
governance of master data (shared data), reference applications in healthcare.

Hithaishi C Bhaskar
[email protected]

PATIENT VOICES 39

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Bringing patient voices into HTA,

health policy development in Asia

Health technology assessment (HTA) «
is recognised as a crucial stage in the
introduction of new technology, new Ruth Kuguru,
medicines, and new clinical practices. HTA gives Executive Director,
evidence-based information to policymakers as well Communications &
as a systematic appraisal of this evidence to establish Engagement,
the value of any new healthcare solution in terms Novartis Asia Pacific,
of cost, quality, and most importantly, value to Middle East and Africa
patients. (APMEA)

The growing recognition of the value of this kind These invisible effects of a health condition
of systematic assessment has been driven as much are often not reflected in data used to formulate
by the increasing importance of effective healthcare healthcare policy and, if decision-makers consider
as by the need to contain healthcare costs, which patient concerns, they achieve vital insight into
are rising rapidly in line with ageing populations the wider impact of a disease and what kind of
and the associated burden of rising rates of cancer, care patients most value. It can often be difficult
cardiovascular disease and other chronic illnesses. for policymakers to engage with patients on an
individual level, and patient organisations are
Historically, HTAs have focused primarily on therefore obvious partners for policymakers, as they
the clinical research-based efficacy of a treatment represent the collective experience of a particular
and its cost, with less consideration given to the disease.
experiences and priorities of patients using it, or
their families and caregivers. It is encouraging to Patients engaged in their own care report
see that healthcare organisations and public health improved health, reduced healthcare use and
authorities in Asia are increasingly recognising associated cost. They also enjoy higher quality care
the need to bring patients’ voices into assessment overall and fewer diagnostic or prescribing errors,
processes for new treatments. While this progress the ACCESS report found.
has been hugely positive, there is still opportunity for
policymakers to involve patients much more actively As we move towards greater collaboration
at every step of the decision-making process.

Patient experiences go deeper than data

While clinical trials and cost-benefit analyses
remain crucial in the process of HTA decision-
making, work commissioned for a forthcoming
report from the independent think tank ACCESS
Health - international due to be published in June
has shown that better outcomes are achieved when
patients feel the specific problems associated with
their condition are fully understood by healthcare
policymakers and providers — and that patients
have been fully consulted about their treatment,
understand its purpose and have given informed
consent for its use.

A case in point is the treatment of psoriasis, an
incurable chronic autoimmune skin disease. Beyond
its severe physical symptoms, psoriasis also causes
depression, anxiety and low self-esteem, as well
as social isolation and employment difficulties as
sufferers attempt to hide their condition.

40 PATIENT VOICES

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

between policymakers and patient organisations, HTA committee. Patients are also invited to sit on
there are several important considerations for these PBRS appraisal committees to further explain
successful long-term partnerships. their perspective on managing the health condition
addressed by the drug under review.
Balancing breadth, depth and
These initiatives are a significant step forward in
efficiency in HTAs the HTA process and it is hoped that more countries
will follow Taiwan’s example in giving patients a
When you consider that every healthcare system voice when evaluating new healthcare technologies,
is different in terms of infrastructure, resources protocols and treatments that directly impact their
and priorities, and that every society has its own lives.
expectations and norms that may influence health
decision-making, it is clear that there can be no one- Public opinion in the Asia Pacific region is also
size-fits-all model for patient engagement in HTA. influencing the drive towards giving patients a
This means that policymakers looking to implement greater say in new treatment appraisal processes.
HTA systems need to consider the unique attributes Opinion polls have shown support in Australia
of the environment in which the system will operate. for patient involvement in HTA processes and the
Korean Organisation for Rare Diseases recently
A good first step in creating a HTA system that conducted a public survey on attitudes to the
works is for organisations such as public health provision of innovative cell and gene therapies for
authorities and individual hospitals to form steering people with rare diseases who are often denied
committees to investigate practice in other Asia effective treatments because of cost. The survey
Pacific HTA systems that have a high level of patient revealed significant support for reimbursement of
involvement. Australia’s Pharmaceutical Benefits these treatments. The findings were highlighted
Advisory Committee, for instance, invites public at subsequent National Assembly policy seminars
involvement in HTAs and conducts consumer in Korea and even included in a presidential
hearings to obtain the full picture of the potential candidate’s election pledge. Such initiatives are a
impact of any new intervention. In the Philippines, useful tool for policymakers to understand the real
patients are considered vital data sources and their views of the public on issues that may not affect
opinions are sought through in-depth interviews, them now but could be of huge significance if they
focus group discussions, and other methods
to determine the implications of any proposed
intervention.

It is also crucial for committees to consult key
stakeholders from within the organisations involved
in the HTA as well as from the wider healthcare
ecosystem. An engagement model can then be
developed and assessed with selected HTA projects
to evaluate its efficacy so it can be refined where
necessary.

Even when incorporating patient engagement
in HTA, we see that efficiency continues to be of
importance to healthcare systems. Taiwan has
achieved this delicate balance by taking a holistic
approach in involving patients while ensuring
that their HTA process is streamlined. Their HTA
framework includes two mechanisms for patient
engagement. The Pharmaceutical Benefits and
Reimbursement Scheme (PBRS) Committee
supports Taiwan’s National Health Insurance
Administration (NHIA) in designing reimbursement
policies for new drugs. A month before the PBRS
committee meets to discuss a new drug under
evaluation, patients, caregivers, and patient
groups are invited to submit opinions to an online
platform. The results are summarised in a final
report which is taken into consideration by the

PATIENT VOICES 41

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

The Alliance and Partnership for
Patient Innovations and Solutions
(APPIS) was launched in 2021 as
a collaboration between Novartis
and patient organisations to enable
targeted discussions around specific
local needs, and support the growing
capabilities and empowerment of
patient organisations in Asia Pacific
and beyond. The ultimate objective is
to bring patient organisations together
to align on challenges and priorities,
and build strong partnerships that drive
measurable benefits in healthcare.
Initiatives such as APPIS provide a
springboard for patient groups to
consolidate their knowledge, skills and
networks to drive policy change.

or a family member happen to be diagnosed with a growing capabilities and empowerment of patient
disease in the future. organisations in Asia Pacific and beyond. The
ultimate objective is to bring patient organisations
Capability drives capacity and credibility together to align on challenges and priorities, and
build strong partnerships that drive measurable
What we hear from patient leaders is that the benefits in healthcare.
lack of information about decision-making processes
and lack of opportunity for patient involvement Delegates at the recent APPIS 2022 Summit
have been barriers to identifying ways to make enjoyed a series of productive discussions on how
improvements. However, patient organisations can to take forward these concerns. Initiatives such as
develop capabilities that will allow them to argue for APPIS provide a springboard for patient groups to
a seat at the HTA table and maximise the benefits consolidate their knowledge, skills and networks
once they get there. A strong understanding of the to drive policy change. Health policy shaping is
local ecosystem and the views of other stakeholders also a category in the inaugural APPIS Innovator
will help ensure approaches and positions are Programme, which supports patient organisations
adopted which will achieve a consensus leading to to scale initiatives and tools to improve healthcare
the greatest patient benefit. outcomes for the people they represent. As
more countries in the region join the healthcare
United voices have the greatest impact and drive to listen to patient voices, there will be a
patient organisations in the same disease areas growing demand from patient groups for training
should collaborate as much as possible, prioritising opportunities offered by platforms such as APPIS.
the collection of integrated data through surveys,
focus groups and research to demonstrate the Partners for a healthier future
experience of an entire patient population which can
then be presented to an HTA. Value, quality, and equity of access are important
considerations for Asian countries as local systems
The Alliance and Partnership for Patient respond to rising public expectations and evolving
Innovations and Solutions (APPIS) was launched health requirements. There is a continuing necessity
in 2021 as a collaboration between Novartis and for robust and fully validated HTA processes, and a
patient organisations to enable targeted discussions parallel growing need for patients to be at the heart
around specific local needs, and support the of their own care and decisions that impact them.
Collaboration should underpin all these efforts as we
work towards a healthier future in Asia.



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non-adherent), protein production, virus production,
and transfections Can be used for viral production as well as scale up of cells

The next generation HYPER technology lets you grow large Even distribution of media across all layers for homogeneous
quantities of adherent cells in a compact space cell population

Reduces processing time and incubator storage space by Ability to mix in the Falcon Multi-Flask saves time and
handling one flask as compared to 10 traditional 175 cm2 reduces risk of contamination
flasks
Flexible design lets you pour or aspirate/recover cells using
Scalable to Corning CellSTACK® culture chambers a pipet

Cat. No. Description Surface Qty/Pk Qty/Cs Consistent surface treatments for predictable scale-up
10024 HYPERFlask vessel Corning CellBIND 4 24
10030 HYPERFlask M vessel Corning CellBIND 1 4 Manufactured in compliance to cGMP standards
10020 HYPERFlask M vessel Corning CellBIND 4 4
10034 HYPERFlask M vessel Corning CellBIND 4 24 Cat. No. Description Surface Area Cap Style Qty/Cs
353143 3-layer, TC-treated 525 cm2 Vented 12
353144 5-layer, TC-treated 875 cm2 Vented 8

India t 91 124 4604000 f 91 124 4604099 Check out the selection guide [email protected]

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

Tessa Rainer Burkard steps in
Therapeutics as Global President of
picks Wilson PENTAX Medical
W. Cheung as CFO
PENTAX Medical, a division of HOYA Group in Japan,
Singapore-based Tessa Therapeutics has announced the appointment of Rainer Burkard to the
has announced the appointment position of Global President of PENTAX Lifecare Division
of Wilson W. Cheung as its Chief (PENTAX Medical) as of April 1, 2022. Burkard joined HOYA
Financial Officer (CFO). Cheung Lens Deutschland GmbH in 2002 and served as Head of
brings to Tessa more than 25 years Marketing until 2007. He was then promoted to the HOYA
of experience in accounting and Vision Care global headquarters as General Manager, Business
corporate finance, compliance, and Development. In 2014, he was instrumental in integrating
corporate leadership at both public the European operations of SEIKO OPTICAL and led the
and private companies with presence development of the SEIKO Xchanger collection which won the
in both the US and China. He joins prestigious Silmo d’Or award for excellence
Tessa as the company is advancing the in optical innovation. He joined PENTAX
clinical exploration of its autologous Europe GmbH as Chief Executive Officer
CD30-CAR-T therapy (TT11) and (Europe, Middle East and Africa) in August
its allogeneic CD30.CAR EBVST 2015, and expanded his global role as Chief
therapy (TT11X) programs. As CFO, Commercial Officer of the Americas in
Cheung will lead Tessa’s overall fiscal July 2020. Moving forward the company is
management, as well as the company’s going to develop a unified global PENTAX
investor relations, and business Medical approach to its customers to provide
development strategy. He will initially enhanced competitiveness and growth
operate in the US before relocating potential while addressing relevant
to Tessa’s global headquarters in environmental aspects.
Singapore. Prior to Tessa, Cheung
served as EVP and CFO at Apollomics Edwards Lifesciences
Inc. where he led the efforts to Korea names Kwon
complete a $124 million Series C Chang-seop as new CEO
round. Prior to Apollomics, he was
the CFO at KBP Biosciences, Inc. and Edwards Lifesciences Korea has appointed Kwon Chang-seop,
served as SVP and CFO at SciClone the head of the clinical care and vascular business unit, as its
Pharmaceuticals, Inc. where he led new Chief Executive Officer (CEO). Kwon is a financial planning
the sale of SciClone to a private equity and business development expert with more than 20 years of
firm for more than $600 million. experience in the pharmaceutical industry, including MSD
Before SciClone, Cheung worked for Korea and MSD Asia Pacific. Kwon joined MSD Korea’s finance
Velti Plc as CFO and was responsible
for leading the company’s US IPO and division in 2000 and took charge of various
a follow-on offering that raised more tasks related to financial planning, operation,
than $340 million. tax, and accounting. Since 2011, Kwon has
led the company’s business development,
receiving recognition for his outstanding
capabilities through marketing alliances
and strategic ties with major business
partners. After joining Edwards Lifesciences
Korea as a finance director in 2017, Kwon
has led the clinical care and vascular business
division, contributing to new business
development and expansion.

R&D NEWS 45

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Japan develops Australia finds
photocatalyst for antiviral
coating against COVID-19 antimicrobial

Viral infections mainly occur in indoor environments resistance making
where many people gather. Antiviral chemicals, such
as alcohol and hydrogen peroxide, are often used to UTIs more deadly
decontaminate regularly touched surfaces. These
chemicals essentially render the virus inactive by A new study led by Australia’s national
breaking down their proteins. However, these chemicals science agency, Commonwealth Scientific and
are volatile in nature and, therefore, evaporate away. As Industrial Research Organisation (CSIRO),
a result, the disinfection has found the spread of drug-resistant
process has to be carried bacteria in the community is increasing the
out regularly. Now in a risk of death for common infections such
study published in Scientific as urinary tract infections (UTIs), which
Reports, a research team of affect around one in two women and one
Nara Medical University, in 20 men in their lifetime. Antimicrobial
Kanagawa Institute of resistance (AMR) occurs when bacteria and
Industrial Science and other microbes become resistant to the drugs
Technology, and Tokyo designed to kill them, generally through
Institute of Technology in Japan has developed a solid- misuse or overuse of the drugs. There are
state photocatalyst as an alternative defence against the two ways resistant bacteria can be passed
virus. Unlike chemical disinfectants, solid-state coatings between humans: hospital transmission and
remain for a long time, and since the viral outbreak, have community transmission. Hospital acquired
been the subject of intensive research around the world. resistance is well researched, but this study
Solid-state antiviral coatings have the advantage of being is one of the few that looks at the burden
non-toxic, abundant, and chemically and thermally of community transmission. The study, a
stable. To get the coating to work under visible light as collaboration between CSIRO, Queensland
well in the dark conditions, the team has developed a University of Technology (QUT) and the
composite consisting of titanium dioxide (TiO2) and University of Queensland, analysed data
copper oxide (CuxO) nanoclusters. from 21,268 patients across 134 Queensland
hospitals who acquired their infections in the
community.

Hong Kong PolyU builds portable
nucleic acid testing device for COVID-19

An interdisciplinary research samples at one time. Excluding one tests can be run on-site using the
team from The Hong Kong positive and one negative control device, without the need to return
Polytechnic University (PolyU), sample, up to four samples can the samples to the laboratory.
awarded over HK$2.7 million by be tested at the same time. Once The device provides a constant
the Health and Medical Research the samples have been collected, temperature of 65 degrees celsius,
Fund (HMRF), has successfully and the built-in optical system
achieved highly sensitive SARS- will monitor the precipitation or
CoV-2 viral RNA detection based dispersion of gold nanoparticles
on the combination of reverse (precipitate in positive samples,
transcription–loop-mediated while remaining dispersed in
isothermal amplification (RT- negative samples). Real-time data
LAMP) and gold nanoparticles will be sent to a mobile app via
(as amplification result Bluetooth, and the test results will
readout reagent). The device be analysed and displayed on the
accommodates up to six testing screen of the phone.

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

India unveils Korea designs COVID-19 detection
indigenously platform by ‘slowing down light’
developed
polycentric A research group led by Professor Young Min Song of the Gwangju
prosthetic knee Institute of Science and Technology in Korea has recently
developed a new technique to easily visualise viruses using an
Indian Institute of Technology, optical microscope. A recent study explains in detail the operating
Madras (IIT-M) researchers have principle of their detection platform, called the “Gires–Tournois
launched India’s first indigenously immunoassay platform” (GTIP). To ensure that their system only
developed Polycentric Prosthetic detects coronavirus particles, the researchers coated the top layer of
Knee, which aims to improve GTIP with antibody proteins specific to SARS-CoV-2. Interestingly,
the quality of life for thousands not only did the system enable the detection of viral particles, but,
of above-knee amputees. Called by using colorimetric analysis techniques, the researchers could even
‘Kadam,’ this ‘Made in India’ effectively quantify the number of virus particles present in different
product is a polycentric knee for areas of a sample depending on the colour of the light reflected locally.
Above Knee Prosthesis developed Given that optical microscopes are available in most laboratories,
in association with Society the method developed by the group could become a valuable and
for Biomedical Technology ubiquitous diagnostic and virus research tool.
(SBMT) and Mobility India.
Kadam makes it possible for Singapore makes
above-knee amputees to walk further advancement in
with a comfortable gait. Not cancer nanomedicine
just mobility, it also aims to
improve the quality of life A study led by researchers at the Yong Loo Lin School of Medicine,
of users through increased National University of Singapore (NUS Medicine), in collaboration
community participation, with the Lee Kong Chian School of Medicine, Nanyang Technology
access to education, livelihood University, Singapore (LKCMedicine, NTU Singapore) and
opportunities and overall A*STAR’s Genome Institute of Singapore (GIS), has demonstrated
well-being. It was developed that nano-sized vesicles released by red blood cells are a viable
by a team at TTK Centre for platform for delivering immunotherapeutic RNA molecules to
Rehabilitation Research and
Device Development (R2D2) at suppress breast cancer growth and
IIT Madras, which also developed metastasis. The study successfully
and commercialised ‘Arise,’ the delivered RIG-I-activating RNAs
country’s first standing wheelchair using small, lipid membrane-
and NeoFly-NeoBolt: active bound particles released by red
wheelchair and motorised add- blood cells, called red blood cell
on for seamless indoor-outdoor extracellular vesicles (RBCEVs), to
mobility. R2D2 is involved suppress cancer progression. The
in research related to human team had also discovered in earlier
movement, and the design and studies that these vesicles are ideal
development of rehabilitation and therapeutic carriers with a natural
assistive devices for people with ability to deliver bioactive molecules
movement impairments. to many cell types. To further examine the function of RBCEVs in
carrying a broader range of therapeutics to more cancer cell types,
the team plans to conduct further research in collaboration with the
National University Cancer Institute and Cancer Science Institute of
Singapore. Concurrently, RBCEV technologies are under intensive
research at Carmine Therapeutics, an EVX Ventures company
which aims to develop the next generation of gene therapy based on
RBCEVs for treatments of rare diseases and cancer.

ACADEMICS NEWS 47

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com India-Australia

Fujitsu launches new collaborate
research centre in India
for joint PhD
Japan-based Fujitsu has announced a key development in its global
innovation strategy with the establishment of a new research centre programme in S&T
‘Fujitsu Research of India Private Limited’ (FRIPL). It represents
the latest addition to Fujitsu’s global R&D network and will focus University of Melbourne in
Australia and Indian Institute of
on research and development Science (IISc), Bengaluru have
into artificial intelligence (AI) and joined hands for the first-ever joint
machine learning (ML) technologies, PhD programme in Science and
as well as quantum software. As one Technology which may be extended
of its first key initiatives, FRIPL will to Medical PhD programmes in
embark on joint research with the the near future. The programme
Indian Institute of Technology (IIT) is part of the Melbourne India
Hyderabad and the Indian Institute Postgraduate Academy (MIPA),
of Science (IISc), Bengaluru to a joint initiative consisting of
promote innovation in leading- established researchers and joint
edge AI technologies. The joint research activities will initially PhD candidates from the University
focus on improving the accuracy and resilience of AI and machine of Melbourne and a group of India’s
learning technology. R&D with the IIT Hyderabad will focus on AI top research institutions, engaging
technology to discover causal relationships with higher accuracy, in projects that address key issues
while collaboration with the IISc will centre on technology to in science and technology. The
automatically generate AI through autonomous training in programme aims to offer a preview
response to various environmental changes. of the two institutions’ academic
strengths and provide students with
NTU Singapore to award its mentorship from global experts,
own medical degrees from 2029 enable better adaptability to new
cultural and research environments,
Nanyang Technological University, Singapore (NTU Singapore) and provide access to the best
and Imperial College London will successfully conclude their facilities and resources. Under this
collaboration agreement to establish the Lee Kong Chian School partnership, IISc and the University
of Medicine (LKCMedicine) as planned in 2028. Students who of Melbourne will support up to
enrol this year or in 2023 and complete their Bachelor of Medicine 10 joint PhD candidates each year
and Bachelor of Surgery degree (MBBS) by 2028 will receive the for the next five years. Students
joint degree. Those enrolled in the programme can
who enrol in 2024 spend at least 12 and up to 24
or later will receive months in each institution, and
an NTU degree. The upon successful completion of
two universities are their PhD, graduate with one
exploring new areas joint testamur. In order to enroll,
of collaboration graduate researchers must satisfy
in postgraduate the entry requirements for PhD at
education and both Indian Institute of Science and
research in areas The University of Melbourne.
such as healthcare
devices and systems, public health, sustainability, and climate
change, drawing on both NTU Singapore’s and Imperial’s
strengths in engineering. In 2021, as a result of this collaboration,
LKCMedicine received the ASPIRE award for excellence in
curriculum development, the first medical school in Singapore
and the fourth in Asia to win this accolade.

48 SUPPLIER NEWS

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Thermo Fisher introduces Gibco CTS TrueCut Cas9 Protein

Thermo Fisher Scientific has solution for CAR T-cell therapy support researchers across the
introduced the new GMP- research using CRISPR-Cas9 autologous T-cell workflow. The
manufactured Gibco CTS TrueCut genome editing. With the addition Gibco CTS TrueCut Cas9 Protein
Cas9 Protein. TrueCut Cas9 of a GMP-manufactured Cas9 is part of the Thermo Fisher’s Cell
proteins are manufactured with protein and the recently launched Therapy Systems (CTS) product
United States Pharmacopoeia Gibco CTS Xenon Electroporation line, a comprehensive portfolio
standards in mind, including System, Thermo Fisher can now of GMP-manufactured products
traceability documentation, supported by traceability
aseptic manufacturing and
safety testing. Gibco CTS documentation. This product
TrueCut Cas9 Protein line is designed to work
provides consistent high- synergistically across the
editing efficiency in all entire workflow, from cell
tested cell lines and greater isolation/activation to cell
than 90 per cent efficiency engineering and expansion,
in human primary T-cells, to address cell therapy
making it a compelling developers’ manufacturing
needs.

PerkinElmer Agilent joins NIIMBL
to support for biologics
expands in vivo manufacturability and
Industry 4.0 initiatives
instruments portfolio
Agilent Technologies Inc. has joined the National
PerkinElmer, Inc. has announced the expansion Institute for Innovation in Manufacturing to Advance
of its in vivo imaging portfolio with the launch Biomanufacturing (NIIMBL). Membership in NIIMBL
of the Vega imaging system, a first-of-its kind demonstrates Agilent’s commitment to supporting
ultrasound platform that combines hands-free, biopharma and biotherapeutics customer challenges
automated technology with high-throughput through partnership and innovation using tools and
capability to accelerate non-invasive research workflows. The biomanufacturing industry is increasingly
& drug development studies of cancer, liver & interested in continuous
kidney disease, cardiology & more. PerkinElmer manufacturing solutions
is one of the leading providers of preclinical that can reduce the
imaging systems spanning multiple modalities manufacturing footprint
across ultrasound, optical & microCT, and improve supply
including the widely adopted IVIS optical chain logistics and
imaging platform. The Vega system eliminates biotherapeutic access by
challenges associated with conventional hand- enabling manufacturing
held ultrasound systems through the use of to move closer to
two automated transducers located below the patients, especially in
imaging stage. This innovative design results in underserved areas.
easy-to-use technology which can be operated The NIIMBL’s mission
without a dedicated sonographer, while is to accelerate biopharmaceutical innovation, support
producing more consistent results compared to the development of standards that enable more efficient
traditional ultrasound systems. and rapid manufacturing capabilities, and educate and
train a world-leading biopharmaceutical manufacturing
workforce, which will fundamentally advance US
competitiveness in the industry.

SUPPLIER NEWS 49

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Bio-Rad enhances Waters launches
Xevo TQ Absolute system
multiplex flow cytometry
Waters Corporation has introduced the new Xevo
with new dyes TQ Absolute system, the most sensitive and compact
benchtop tandem mass spec in its class. Waters’ newest
Bio-Rad Laboratories, Inc., has introduced high-performance mass spectrometer is
three StarBright Dyes designed for use up to 15X more sensitive for quantifying
with a 355 nanometer UV laser in flow negatively ionizing compounds than
cytometry applications. StarBright its predecessor and is 45 per cent
UltraViolet 510, 665, and 795 Dyes offer smaller and uses up to 50 per cent less
exceptional brightness with narrow electricity and gas supply than other
excitation and emission profiles for precise high-performance tandem quadrupole
resolution, expanding Bio-Rad’s range to mass spectrometers available on the
provide greater flexibility in multicolor market. The Xevo TQ Absolute is
flow cytometry panels. Bio-Rad’s line of designed to help pharmaceutical, food
StarBright Dyes offers researchers unique and beverage, and environmental
fluorescent nanoparticles conjugated to analytical laboratories meet regulations
highly validated flow antibodies, which requiring trace-level quantitative mass
are compatible with most experimental spectrometry analyses for a broad set of
protocols and flow cytometers, including applications. For optimal performance,
Bio-Rad’s ZE5 Cell Analyzer and S3e Waters pairs the Xevo TQ Absolute mass
Cell Sorter. The dyes are resistant to spectrometer with Waters’ ACQUITY Premier UPLC
photobleaching and are highly stable with System with MaxPeak HPS technology which eliminates
no loss of signal in fixation, and minimal lot- non-specific adsorption of compounds containing
to-lot variation helps to ensure consistent phosphate and/or carboxylate groups and improves their
staining and deliver reliable results. The recovery. It incorporates thoughtful design features that
unrivaled brightness of the dyes enables enable consistent and reproducible analyses, allowing labs
enhanced resolution of low-density antigens to maintain performance and uptime for longer periods in
and rare populations while maintaining between routine cleaning and service intervals.
consistent and reproducible staining
without the need for special buffers.

Beckman Coulter brings new automated
offering for clinical flow cytometry

Beckman Coulter Life Sciences to expand capabilities. The to analyse with full traceability.
introduces a powerful solution to CellMek SPS builds on a rich Another unique feature is the
manual sample preparation and history of lab automation and integrated cell wash modules that
data management bottlenecks incorporates features that enable enable an end-to-end sample
in clinical flow cytometry: lean workflows and bolster lab preparation workflow. Samples
the CellMek SPS. This fully can be washed, stained, and lysed
automated efficiency by streamlining without the need for manual
sample and automating intervention. A refrigerated liquid
preparation many outdated antibody carousel can hold up
system (SPS) and manual to 53 vials, including the option
offers on- preparation to run third-party reagents. The
demand methods. The flexible system allows users to
processing for innovative expand its capacity with the use of
a multitude new system preformulated reagent cocktails
of sample provides a in the new DURACartridge
types to help continuous format for the company’s DURA
laboratories output of Innovation dry reagents.
samples ready

50

BIOSPECTRUM | MAY 2022 | www.biospectrumasia.com

Target: Malaria-free World

There were an estimated 241 million attention to the critical role of innovation in
malaria cases and 627,000 malaria helping to achieve global elimination goals. The
deaths worldwide in 2020 as per the six countries of the Greater Mekong subregion,
World Malaria Report 2021, by the World including Cambodia, China (Yunnan Province),
Health Organisation (WHO). This represents Lao People’s Democratic Republic, Myanmar,
about 14 million more cases in 2020 Thailand and Vietnam continue to make
compared to 2019, and 69,000 more deaths. progress in eliminating malaria, reporting a 97
Approximately two-thirds of these additional per cent reduction in malaria between 2000
deaths (47,000) were linked to disruptions in and 2020.
the provision of malaria prevention, diagnosis
and treatment during the pandemic. There is a long way to go to eliminate
malaria in all countries. It calls for urgently
However, the situation in the South-East scaling up proven implementation strategies,
Asia Region is better in comparison with Sub- and adopting newer, innovative strategies such
Saharan Africa. In 2020, the region accounted as new investments, vector control approaches,
for about 2 per cent of the global malaria cases. diagnostics, antimalarial medicines, and other
Malaria cases reduced by 78 per cent, from 23 tools to speed up the pace of progress against
million in 2000 to about 5 million in 2020. malaria.
Malaria case incidence in this region reduced
by 83 per cent, from about 18 cases per 1000 Reaching global malaria targets will require
population at risk in 2000 to about three cases innovations in the way that currently available
in 2020. tools are deployed. At present, funding for
malaria-related R&D reached just over $619
India accounted for 83 per cent of cases, million in 2020. An average annual R&D
while Sri Lanka was certified malaria free in investment of $ 851 million will be needed in
2016 and remains malaria free. Maldives too, the period 2021–2030.
has maintained malaria-free status in the
region. Eliminating malaria by 2025 continues Today, no single tool is available to combat
to be a real possibility in Bhutan, DPR Korea, malaria. Innovative new tools are vital if the
Nepal, Thailand, and Timor–Leste, world is to achieve global elimination targets,
including innovations in new vector control
Even the WHO Western Pacific Region interventions and insecticides, improved
has witnessed reduction in the number of diagnostics, and more effective medicines,
new cases, as the region had an estimated 1.7 among other tools.
million cases in 2020, a decrease of 39 per cent
from the three million cases in 2000. Over the Innovation in new tools is also a critical
same period, malaria case incidence reduced strategy for accelerating progress. One
from four to two cases per 1000 population at important new prevention tool is RTS,S/
risk. AS01 (RTS,S), the first vaccine ever to be
recommended by WHO against a human
Papua New Guinea accounted for nearly parasite. As on April 21, 2022, more than 1
86 per cent of all cases in this region in 2020. million children in Ghana, Kenya and Malawi
China was certified malaria free in 2021 and have received one or more doses of the world’s
Malaysia had no cases of non-zoonotic malaria first malaria vaccine. If widely deployed, WHO
for three consecutive years. estimates that the vaccine could save the lives
of an additional 40,000 to 80,000 African
Celebrating World Malaria Day on April children each year.
25, the WHO underscored the collective
energy and commitment of the global malaria Besides vaccines, there is an urgent need to
community in uniting around the common goal develop more and better tools to save lives and
of a world, free of malaria. eliminate malaria for good.

Under the theme ‘Harness innovation to Narayan Kulkarni
reduce the malaria disease burden and save Editor
lives’, this year’s World Malaria Day draws
[email protected]