Discover the boundless poten�al of medical technology at MedTech Spectrum. Explore MedTech Spectrum to get useful knowledge, inves�gate emerging trends, and stay informed about the revolu�onary impact of technology or healthcare MedTech Spectrum: Your Compass in the World of Medical Technology Maintain a leading posi�on in the realm of medical technology with MedTech Spectrum. Explore our comprehensive media portal for exclusive ar�cles, expert insights and breakthrough innova�ons in healthcare technology. Join the forefront of medical advancements today. For more informa�on and collabora�on: ankit.kankar@mmac�v.com apoorva.mahajan@mmac�v.com
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Go Digital: To request subscription email: [email protected] Taiwan Media Representative: Ms Christine Wu Image Media Services Company 2F-2, No. 35, Sec. 2, Flushing South Road, Taipei 10665, Taiwan Tel: +886-2-87734199 Fax:+886-2-87734200 Mobile: 886-937890533 E-mail: [email protected] website: www.imagemediatw.com China Erika Cheng RFCOMMS E101, East Lake Villas, 35 Dongzhimenwai Main Street, Dongcheng District, Beijing 100027, P. R. China Mobile: +86 17375668063 E-mail: [email protected] India Apoorva Mahajan Marketing and Communication Specialist “NITON”, No. 11/3, Block “C”, Second Floor, Palace Road, Bangalore, Karnataka- 560052 Tel: +91-80-41131912/13 Mobile: +91-7724025888 [email protected] Photo: istockphoto Vol 18; Issue 12; December 2023 Publisher & Managing Editor: Ravindra Boratkar CEO: Manasee Kurlekar [email protected] Editorial: Chief Editor: Dr Milind Kokje [email protected] Advisor - Content: Vijay Thombre Editor: Narayan Kulkarni [email protected] Executive Editor: Dr Manbeena Chawla [email protected] Assistant Editor: Nitesh Pillai [email protected] Asst. Manager Content Creation and Coordination- APAC Region: Hithaishi C. Bhaskar [email protected] General Manager (Strategy and Marketing) Ankit Kankar [email protected] Operations and HR: Asmita Thakar [email protected] Production & Design: MM Activ Sci-Tech Communications Anil Walunj Cover Design: Dominix Strategic Design Pvt. Ltd. Business Enquiry: Ankit Kankar [email protected] Subscription Services Print Edition: Saradha Mani [email protected] Digital Edition: Ankit Kankar [email protected] News Letter : Sudam Walekar [email protected] Database Executive: Sudam Walekar Subscription Services: Apoorva Mahajan [email protected] Bio Spectrum Jobs: Poonam Bhosale [email protected] MM Activ Singapore Pte. Ltd. Singapore MM Activ Singapore Pte. Ltd. Saradha Mani General Manager #08-08, High Street Centre, 1 North Bridge Road, Singapore - 179094 Tel: +65-63369142 / Fax:+65-63369145 Mobile: +65-90681202 [email protected] Asia Pacific & South East Asia Ankit Kankar General Manager - Strategy & Marketing 1st Floor, CIDCO Convention Center, Sector 30A, Vashi, Navi Mumbai, Maharashtra-400703. Mobile: +91-9579069369 [email protected] USA BioSpectrum Bureau MM Activ Sci-Tech Communications Mobile: +65 90150305 [email protected] Europe BioSpectrum Bureau MM Activ Sci-Tech Communications Mobile: +65 90150305 [email protected] Printed and published by Ravindra Boratkar on behalf of MM ACTIV Singapore Pte Ltd. Printed at Times Printers Private Limited 16 Tuas Avenue 5, Singapore 639340 Tel : +65-63112888 Reprinted in India for private Circulation Chief Editor: Dr Milind Kokje MCI (P) 028/06/2023 Copyright: MMActiv Singapore Pte Ltd. 4 BIO MAIL BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com Acknowledgement/ Feedback Thank you very much for publishing the interview with the Industrial Technology Research Institute at Taiwan! It’s been a pleasure working with BioSpectrum Asia. - Stephanie, Taiwan Thank you for posting P&G Health’s perspective on diabetes in your November edition. - Karen, Singapore Ageing population in many Asian countries will hopefully be seen by the governments as a sign for urgent support to companies developing therapies to slow down ageing. Thank you so much for the feature in your story- Pushing the Age Barrier! - Maxim Kholin, Singapore
Looking for a job? See open roles at www.biospectrumjobs.com premier source of pharma healthcare & bio jobs n Find Talent n Post Jobs n Attract Candidates Find the right people no matter what your hiring needs are... TALENT SOLUTIONS Letter from Publisher Ravindra Boratkar Publisher & Managing Editor, MD, MM Activ Sci-Tech Communications Pvt. Ltd. Dear Readers, As we bid farewell to another eventful year in the world of life sciences, it’s time to look back and review the whirlwind of advancements and changes that have shaped the industry in 2023. Our content team started this process at the beginning of 2023. In the first issue of the calendar year in January 2023, the team interacted with leaders from various market segments who shared their insights into what the year held for their respective particular spheres. As the year is coming to an end, we will recap those 23 predictions and find out if they are panned out as projected. Some of those 23 predictions include how Artificial Intelligence (AI) dominance has guided the life sciences sector, the ascent of mRNA therapies which have been a driving force promising groundbreaking treatments, and China’s dominance in CAR-T therapy. The reign of AI in drug discovery remains unabated, shaping the industry’s future. China’s continued dominance in CAR-T therapy has further solidified its position as a global powerhouse in the field. In another article, our content team has given an overview of the leadership changes in the pharma and biotech sector as a slate of top pharma companies have announced leadership changes in recent times. You will be interested in knowing about the Global Resilience Index which provides valuable insight into the industry’s strengths and potential for growth. Based on a survey of pharma and biotech executives, the index is important to understand the sector’s strength during turbulent times. As in every edition, in this one too, we have a thought leadership article exploring the development and deployment of cutting-edge technologies in India backed by requisite government policy support and direction. This is expected to help in bolstering the fight against cardiovascular diseases (CVDs) and thus improving, not just the quality of the individuals’ heart but also their lives. I am sure this edition will be informative and interesting, lending closure to an eventful 2023. Thanks & Regards, Ravindra Boratkar Publisher & Managing Editor 5 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
2 Strategic Trends Driving APAC How has 2023 panned out for the life sciences industry in Asia Pacific? Asia Toughing Out the Uncertainties and Challenges 24 27 29 Jeff Weisel, Managing Director, Policy, Access, Value and Evidence APAC, Avalere Health Andrew Martin, Principal, Baker McKenzie Wong & Leow’s Mergers & Acquisitions practice, Singapore Ben McLaughlin, Partner, Baker McKenzie, Australia Bruce Liu, Partner, Life Sciences, Simon-Kucher, Greater China As we bid farewell to another eventful year in the world of life sciences, it’s time to look back at the whirlwind of advancements and changes that have shaped the industry in 2023. Back in January this year, we interacted with leaders from various market segments who shared their insights into what the year held for their particular spheres. Let’s recap the 2023 predictions and find out if they panned out as predicted. Buoyant Life Sciences Sector Emerges Stronger COVER 17 6 BIO CONTENT BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
Scan QR code to access BioSpectrum Asia Digizine REGULARS BioMail .............................................................04 Letter from Publisher ....................................05 BioEdit ..............................................................08 Policy and Regulatory News ........................09 Finance News .................................................11 Company News ..............................................13 Start-Up News ................................................15 Academics News............................................43 People News....................................................44 R&D News ........................................................46 Supplier News .................................................48 Lets Talk Health ..............................................50 BIO CONTENT 7 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com Leadership Pharma Heads Pass Leadership Baton 31 Biopharma Resilience Biopharma’s Evolution and Future Resilience in Asia 41 SPEAKING WITH “The cancer diagnostics industry is on the cusp of substantial growth, attributed to an aging population” Dr Nitin Malekar, Director, Harae Dx Inc., California, USA 33 Cancer in Women Focusing on Women’s Cancers Dr Heather White, Executive Director, TogetHER for Health 35 Cardiovascular Disease Can Cutting-edge Tech Reduce Rising CVD Burden? Neeraj Nitin Jadhav, Industry Analyst, Medical Devices and Imaging-TechVision, Frost and Sullivan 37
8 BIO EDIT BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com Dr Milind Kokje Chief Editor [email protected] PROMOTING INDIAN TRADITIONAL MEDICINE Myanmar and India have been planning joint efforts for the promotion of traditional healthcare systems and medicine in both countries. Recently, in Myanmar, India proposed to set up a Joint Working Group (JWG) to promote cooperation between the two countries in teaching and researching the traditional system of medicine. A bilateral meeting was held in March 2023 in India where possibilities of cooperation in the field of traditional medicines were discussed. Later, in August, a memorandum of understanding (MoU) was signed between the countries in New Delhi on cooperation in the field of traditional medicine when U Kyaw Tin, Myanmar’s Minister of State for Foreign Affairs, was visiting India. At the recent function in Myanmar where the JWG was proposed, as a concrete gesture to move ahead in this direction, Vinay Kumar, Indian Ambassador to Myanmar presented a set of books on the traditional medicine system to the health minister for the Library of the University of Traditional Medicine (UTM) at Mandalay. He also informed UTM faculty and students about Ayush scholarships and Fellowships available in India. Thet Khaing, Myanmar’s Health Minister, reciprocated by promising all support for furthering cooperation in traditional systems of medicine. Despite a dramatic increase in the use of modern medicines in Myanmar, traditional medicines play an important role due to various reasons including prohibitive cost and limited availability of modern medicines and reluctance to use modern medicines due to cultural differences and concerns over side effects. The traditional healthcare system recognises 96 diseases that afflict humans. Traditional medicines are believed to cure all of them by judicious use. India is proud of its over 5000-year-old Ayurveda and other traditional healthcare systems like Sidhha, Yunani, Yoga, etc. In its efforts to focus its attention and efforts on promoting the Indian traditional medicine systems, the government even created a separate Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy. After China and Japan, India holds the third-largest market share of Asia and ASEAN herbal medicines production. India co-hosted with the World Health Organisation (WHO), the first WHO traditional medicine global summit in Gujarat in August. It also organised the IndoASEAN conference on traditional medicines in October in Delhi. A global conference on Ayurveda tourism was also organised in Kerala recently. India seems to be moving ahead in promoting its traditional medicine system and cooperating with the neighbouring countries in this direction at an appropriate time. Experts are pointing out that China has been using its 2015 Health Silk Road (HSR) initiative for health diplomacy. The declared objective of HSR is to generate ‘soft power and influence in the field of regional and global health governance,’ and to increase China’s ‘status as a major country’. Treatment camps of Traditional Chinese Medicines (TCM) are being organised in Myanmar. Returned Overseas Chinese Federation of Fujian Province and the Fujian General Chamber of Commerce in Myanmar established the charity clinic which provided free medical consultation, acupuncture and different TCM treatments. India can use its strength in traditional medicines to create a huge business across the world for herbal medicines, medicinal plants, and other traditional drugs. Management consulting firms predict the next global trend in medicine could be among the many traditional remedies in Indonesia, Vietnam, Myanmar, India and China. They represent new sources of value, and inspiration, in an otherwise saturated consumer health market. In such a situation, co-operating with Myanmar for joint research in traditional medicine, and offering fellowships to students from Myanmar for research in Ayurveda, Siddha, among others, is the right step and may help spread the influence of Indian traditional medicines in the region.
The Australian Government has released the landmark Australian Cancer Plan, which aims to improve prevention, screening, treatment, and management of all cancers for all people in Australia regardless of their background or where they live. The Plan has been developed by Cancer Australia, in consultation with the states and territories, First Nations communities, clinicians, researchers, people affected by cancer and support organisations. The Plan covers all cancer types, across the whole cancer journey, from prevention and early detection to treatment, recovery and end of life care. The government will work with Movember to integrate patient-reported experiences and outcomes into service performance monitoring and Cancer Council Australia to develop a national cancer data framework to improve the accessibility, consistency and comprehensiveness of cancer data. Cancer Australia has also started working on several actions identified in the Plan. Singapore extends cooperation with China in traditional chinese medicine Singapore will further its cooperation in several areas of Traditional Chinese Medicine (TCM) with the People’s Republic of China (PRC), with the signing of the 7th Plan of Cooperation (POC) in TCM between Singapore’s Ministry of Health (MoH) and the PRC’s National Administration of TCM (NATCM) recently. The 7th POC will build on the bilateral cooperation to further strengthen TCM-related collaborations between both countries for the benefit of patients. Areas include research, teaching, practice and regulation of TCM in both countries. The collaboration with NATCM has contributed significantly to the development of TCM education and research in Singapore. Since 1999, NATCM’s experts have worked with MoH’s TCM Practitioners Board on the qualifying examinations and training courses for TCM physicians and acupuncturists. NATCM has also provided advice for the evaluation of research proposals under the TCM Research Grant. As part of the collaboration, MoH has conducted Health Management Training Programmes for PRC government officials, as well as senior hospitals and universities administrators, to share on various aspects of Singapore’s healthcare system, including healthcare financing, regulations and hospital management. The Health Sciences Authority (HSA), Singapore; the Ministry of Food and Drug Safety (MFDS), Republic of Korea; and the Swiss Agency for Therapeutic Products (Swissmedic), Switzerland are the first three countries to be listed as World Health Organisation (WHO)-Listed Authorities. A WHO-Listed Authority (WLA) is a regulatory authority or a regional regulatory system which has been documented to comply with all the indicators and requirements specified by WHO for the requested scope of listing based on an established benchmarking and performance evaluation process. Members of the technical advisory group on WHO-Listed Authorities (TAG-WLA) met for the first time, September 11-12, 2023, at WHO headquarters in Geneva, Switzerland and reached a consensus to recommend the listing of HSA, MFDS and Swissmedic as WHO-Listed Authorities, after discussing the findings of the performance evaluations of these three regulatory authorities. This represents a significant milestone for the Republic of Korea, Singapore and Switzerland, as the designation and public listing of MFDS, HSA and Swissmedic as WLAs, is a global recognition that these three regulatory authorities meet WHO and other internationally recognised regulatory standards and practices. Singapore, Korea become WHO-listed regulatory authorities Australia releases landmark cancer plan to improve screening, treatment REGULATORY NEWS 9 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
The Ministry of Health in New Zealand has published a new National Poliomyelitis Response Framework, responding to the increased risk of poliovirus globally. In November 2022, the World Health Organization (WHO) advised of an increase in polio activity in areas which have previously seen polio eradicated. This is partly because of global decline in immunisation rates, including in New Zealand. The National Poliomyelitis Response framework was developed by the Public Health Agency, within the Health Ministry, in collaboration with the National Public Health Service, Environmental Science and Research (ESR) and Ministry of Disabled People. It is one of the several measures recently developed to prepare for a polio outbreak. Others include the introduction of wastewater surveillance testing for poliovirus, and updated guidance for public health services in the polio chapter of Health New Zealand’s Communicable Disease Control Manual. The framework considers four scenarios: detection of poliovirus through wastewater surveillance, detection of poliovirus in an acute flaccid paralysis case (which is essentially rapid weakening of a person’s muscles), identification of a contact of known polio case overseas and exposure to poliovirus in a lab facility. New Zealand launches national polio response framework 10 REGULATORY NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com New Jersey’s life sciences trade association BioNJ inks MoU with Taiwan BIO The Biotechnology Industry Research Assistance Council (BIRAC), a Government of India enterprise, has partnered with WomenLift Health to launch a leadership development programme to empower women leaders working in Science, Technology, Engineering, and Mathematics (STEM) in India. The Women Leadership in STEM (WLS) programme, under the Grand Challenges India (GCI) initiative, aims to catalyse a systemic change towards gender equity in STEM leadership by investing in mid-career women professionals and providing them with the tools, networks, and mentorship needed to excel in their chosen fields. This part-time programme will bring together a cohort of 20 mid-career women leaders working in STEM institutions in India for three fully funded, five-day residential leadership workshops over the course of a year. The sessions have been designed, in collaboration with the Center for Creative Leadership, to support these women to realise their potential and grow as leaders and decisionmakers as well as foster a strong network of champions and institutional partners. India announces women leadership in STEM programme New Jersey Governor Phil Murphy recently visited Hsinchu Biomedical Science Park in Taiwan during the Choose New Jersey Governor-led economic mission to East Asia where a Memorandum of Understanding (MoU) was signed between life sciences trade associations BioNJ and Taiwan BIO. The MoU between the leading life sciences associations in New Jersey and Taiwan seeks to promote collaboration between the two organisations to support life sciences companies in both regions. BioNJ is the life sciences trade association for New Jersey, representing for nearly 30 years close to 400 researchbased life sciences organisations across the healthcare ecosystem from the largest biopharmaceutical companies to early stage startups. Taiwan BIO is a non-for-profit organisation founded in 1989 by members from industry, academia, and officials in Taiwan.
FINANCE NEWS 11 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com China-based Biotheus Inc., a clinical-stage biotech company dedicated to the discovery and development of biologics for oncology and inflammatory diseases, has entered into an exclusive global license and collaboration agreement under which German biotechnology company BioNTech will be developing, manufacturing and commercialising PM8002 globally for ex-Greater China, whereas Biotheus retains the rights to exploit PM8002 in Greater China. PM8002 is currently being tested in Phase 2 studies in China to evaluate the efficacy and safety of the candidate as a monotherapy or in combination with chemotherapy in patients with advanced solid tumours. PM8002 is a bispecific antibody candidate with humanised anti-PD-L1 single heavy-chain variable (VHH) domains fused to an anti-VEGF-A IgG1 antibody containing Fc-silencing mutations. Under the terms of the agreement, Biotheus will receive an upfront payment of $55 million, and is eligible to receive additional development, regulatory and sales milestone payments potentially totalling over $1 billion as well as tiered royalties on potential future product sales. The transaction is expected to close in Q4 2023, subject to customary closing conditions. Celltrion announces business merger for achieving KRW 12 Tn in sales by 2030 South Korea-based Celltrion Group has announced that the merger agreement between Celltrion, Inc. and Celltrion Healthcare Co. has been approved at the extraordinary general meeting of shareholders (EGM) of the two companies. According to Celltrion Group, this development allows the company to move one step closer to achieving its vision of achieving KRW 12 trillion in sales by 2030 and making a leap to become a global biopharma. Under the merger plan, Celltrion will merge Celltrion Healthcare and issue Celltrion shares to Celltrion Healthcare shareholders. Celltrion Healthcare shareholders will receive 0.4492620 shares of Celltrion for each Celltrion Healthcare share they own. The merger price per share is KRW 148,853 for Celltrion and KRW 66,874 for Celltrion Healthcare. Hilleman Labs invests $20M to bolster resilience in vaccine manufacturing in Singapore BioNTech inks $1B oncology deal with Chinese firm Biotheus Hilleman Laboratories has officially opened its $20 million ACES current Good Manufacturing Practices (cGMP) facility in Singapore. The 30,000 sq ft manufacturing facility, which broke ground in February 2022, is now fully operational and can produce affordable, high-value vaccines and biologics that comply with local and international regulations. The facility will primarily focus on supplying clinical trial materials for development up to the Phase II stage and has the built-in capability to pivot to producing vaccines and biologics for Singapore’s use during future pandemics and public health emergencies. Through the ACES facility, Hilleman Laboratories can supply scaleup batches and clinical trial materials to local and global research and development (R&D) partners to facilitate early phase clinical development of new and cost-effective vaccines and biologics. Hilleman Laboratories is also facilitating technology transfers to larger manufacturers in low- and middle-income countries (LMICs) to improve access to vaccines for populations in the region.
12 FINANCE NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com India-based Biocon Biologics has entered into a definitive agreement with Eris Lifesciences for the divestiture of its Dermatology and Nephrology branded formulations business units in India that mostly comprises its legacy small molecules’ brands. The transaction is a Slump Sale that will enable a seamless transfer of the product brands and employees associated with these businesses. Total transaction value of the divestment is Rs 366 crore, inclusive of working capital conveyed as part of the deal, and represents an accretive multiple of 4x on Revenues and 22x on EBITDA. Post deal close, over 120 employees of the two business units are expected to transition to Eris, ensuring continuity for both employees and patients. The divestment of the non-core branded formulations business units in India is in line with Biocon Biologics’ strategy to sharpen focus on core therapy areas as a fully integrated biosimilars company. Ajinomoto buys Forge Biologics for $620M Biocon Biologics divests 2 branded formulations to Eris for Rs 366 Cr Japan-based biotechnology company Ajinomoto Co., Inc. and US-based Forge Biologics have entered into a definitive agreement by which Ajinomoto Co., will acquire Forge, a leading manufacturer of genetic medicines, in an allcash deal for $620 million. Forge is a viral vector and plasmid contract development and manufacturing organisation (CDMO) and clinical-stage therapeutics company, enabling access to potentially life-changing gene therapies by bringing them from concept to reality. Forge brings to Ajinomoto an entirely new capability that will vitally enhance the company’s biopharma services business and help create new value through innovative solutions. East Ventures opens first healthcare fund of $30M in Indonesia East Ventures, a pioneering and leading venture capital firm in Indonesia and Southeast Asia, has announced the firm’s first healthcarefocused fund with the amount of $30 million, which is dedicated to supporting innovative healthcare solutions in Indonesia. With a strong commitment to fostering innovation and improving healthcare access in Indonesia, the “East Ventures Healthcare Fund” aims to empower and support promising Indonesian startups that address the unique challenges and opportunities in the Indonesian healthcare landscape. Before the creation of this fund, East Ventures has been active in investing in healthcare startups and companies in the region, making the firm has 30 portfolio companies in the healthcare vertical today. It includes recent investments such as Mesh Bio, AMILI, Aevice Health, Etana, Diri Care, etc. Moreover, while investments in genomicsrelated ventures were relatively novel in 2018, East Ventures has invested in genomics startups, such as NalaGenetics and Nusantics, which is now leading the genomics-based healthcare revolution in Indonesia and Southeast Asia.
British medtech company Smith+Nephew has announced the launch of its REGENETEN Bioinductive Implant allowing access to thousands of patients in Japan. With more than 100,000 procedures completed globally since its introduction in the US and Europe, REGENETEN has had a transformative impact on the way surgeons approach rotator cuff repair. The biocompatible and purified collagen-based REGENETEN Bioinductive Implant induces new tendon-like growth by taking advantage of natural wound healing processes which can help create an environment conducive to healing. Delivered arthroscopically through a small incision over the location of the damaged rotator cuff, the implant is about the size of a postage stamp and is completely resorbed within six months. With more than 18 published clinical studies conducted globally, the REGENETEN Bioinductive Implant arrives in Japan with extensive clinical evidence covering the entire spectrum of rotator cuff disease, from partial thickness tears to large (3-5cm) and massive (5cm+) fullthickness tears. COMPANY NEWS 13 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com XtalPi & CK Life Sciences to develop cancer molecular diagnostic models using AI in China XtalPi, a leading global technology company in combining artificial intelligence (AI) and robotics to drive the discovery of groundbreaking medicine and innovative materials, has announced the signing of a new agreement with CK Life Sciences, a member of the CK Hutchison Group. Expanding upon their existing partnership, the two companies will combine AI algorithms with anonymised clinical and biomarker data from cancer patients and healthy individuals in CK Life Sciences’ data repository to jointly explore and develop microRNA or miRNA-based postoperative molecular diagnostic models for prognostic risk prediction. With the help of AI and machine learning models, this collaborative engagement will hopefully lead to the development of more advanced and intelligent solutions for the processing and modeling of holistic multidimensional biomedical data, biomarker discovery, and postoperative recurrence risk prediction. US-based biotech firm Moderna, Inc. has announced the launch of the mRNA Platform Incubator Network, a pioneering initiative in collaboration with key Australian organisations with specialist expertise in translational and pharmaceutical science, early phase clinical trials and regulatory science. The mRNA Platform Incubator Network aims to advance mRNA medicine, foster scientific excellence in clinical translation in Australia and further the therapeutic potential of the mRNA platform. The Platform Incubator Network brings together Australia’s leading minds in mRNA research from Monash University and Monash Institute of Pharmaceutical Sciences (MIPS), the Peter Doherty Institute of Infection and Immunity, a joint venture of The University of Melbourne and The Royal Melbourne Hospital, Peter MacCallum Cancer Centre, the Murdoch Research Children’s Institute and Doherty Clinical Trials Limited. Moderna’s Regional Research Centre in Melbourne will serve as a hub for the Platform Incubator Network enabling regular crossfunctional collaboration, exploration and execution of translational research projects, contributing new insights to the broader scientific and regulatory community through publications and discussions and supporting development of the next generation of researchers. Moderna launches mRNA Platform Incubator Network in collaboration with Australian organisations Smith+Nephew introduces REGENETEN Bioinductive Implant in Japan
Zydus & Guardant Health promote use of next-gen genomic tests for advanced solid cancers in India and Nepal Flagship Pioneering expands into APAC region with new hub in Singapore Flagship Pioneering, an American life sciences venture capital (VC) company based in Cambridge, Massachusetts that invests in biotechnology, life sciences, health and sustainability companies, has announced its expansion into the APAC region, with the opening of a regional hub in Singapore. Flagship Pioneering creates & builds platform companies designed to generate multiple products that secure a healthier & more sustainable future. For more than 20 years, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $90 billion in aggregate value. The current Flagship ecosystem comprises 43 impactful companies spanning human therapeutics, agriculture, & nutrition. The global expansion of Flagship’s presence into the APAC region follows the opening of the company’s office in London earlier this year. The current Flagship ecosystem comprises 43 companies, including Denali Therapeutics, Foghorn Therapeutics, Generate:Biomedicines, Inari, Indigo Agriculture, Moderna, Omega Therapeutics, Sana Biotechnology, Seres Therapeutics and Tessera Therapeutics. Samsung Biologics, South Korea-based contract development and manufacturing organisation (CDMO), and Kurma Partners, a European venture capital firm in healthcare and biotechnology, have announced a strategic partnership for the development and manufacturing of biologics for Kurma Partners’ portfolio companies. Under the terms of the multi-year agreement, Samsung Biologics will provide customisable chemistry, manufacturing, and control (CMC) development services for Kurma Partners’ portfolio companies to streamline the gene to Investigational New Drug (IND) process, de-risk uncertainties in CMC, and accelerate the lead candidate selection through entry into first-in-human studies with seamless transitions along further clinical development. The portfolio companies will be able to leverage Samsung Biologics’ state-of-the-art facilities, proprietary technology platforms, and CMC-related expertise. Samsung Biologics expands footprint into European market Indian firm Zydus Lifesciences and US-based Guardant Health have signed a comarketing agreement to jointly promote the Guardant360 portfolio of liquid and tissue biopsy tests across India and Nepal. The tests to be promoted include the Guardant360 and Guardant360 TissueNext tests for comprehensive genomic profiling and the Guardant360 Response test for monitoring response to treatment. By combining resources and expertise, both organisations aim to empower oncologists with the necessary tools to help inform treatment decisions for patients with advanced cancer. Guardant360 is a minimally invasive liquid biopsy test that provides comprehensive genomic profiling (CGP) of all solid tumours by analysing circulating tumour DNA (ctDNA) from a simple blood draw. Guardant360 TissueNext provides CGP results from a tumour tissue biopsy to give doctors actionable information when tissue testing is appropriate. 14 COMPANY NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
Porton Advanced, BioMap jointly develop gene therapies based on AAV vectors China-based startup Porton Advanced has announced the establishment of a strategic partnership with BioMap. Founded in 2020, BioMap is a disruptive life science AI company responsible for building xTrimo, the first and largest protein-centric large language model platform. BioMap will leverage Porton Advanced’s unique AdenoAssociated Virus (AAV) vector technology platform and research data to develop AAV assembly efficiency models and an assembly distribution model. The goal is to harness the power of large-scale life science models, accelerating the design of AAV vectors, and expanding the application of artificial intelligence (AI) models in the field of gene therapy. Over the past decade, the development of gene therapies based on AAV vectors has significantly propelled a new round of biotechnology revolution. Despite many great achievements in research on the construction and assembly of AAV vectors, the creation of tissue-specific AAV coat proteins, a key step towards unlocking their therapeutic potential, remains a longstanding challenge. I Peace, Inc., specialising in induced pluripotent stem cells (iPSCs) and iPSCderived cell therapies based in US, and Heartseed Inc. a Tokyo-based biotechnology startup developing iPSC-derived cardiomyocytes for heart failure, have collaborated to generate cardiomyocytes using multiple donor-derived GMP grade iPS cell lines by I Peace, and Heartseed’s proprietary cardiomyocytes differentiation and purification methods. Heartseed has successfully produced high-purity cardiomyocytes consistently from all I Peace manufactured iPS cell lines used in this study. This achievement marks a significant step forward in the realisation of autologous cardiac regenerative medicine with I Peace’s personal iPS cell banking service (My Peace), to manufacture and store iPS cells, and induce them into cardiomyocytes for use in autologous cell therapy. I Peace will continue to work together with Heartseed towards establishing regenerative medicine for heart failures using patients’ own iPS cells. I Peace will also collaborate with various institutions in other fields. I Peace, Heartseed collaborate to generate cardiomyocytes Lunit, a South Korea-based provider of artificial intelligence (AI)-powered solutions for cancer diagnostics and therapeutics, has announced its full-fledged participation in the ‘Saudi Vision 2030’ Healthcare Sandbox. Lunit’s involvement in the Sandbox signifies a broader commitment to advancing the Saudi Arabian healthcare sector. The Healthcare Sandbox, initiated by the Saudi Arabian Ministry of Health in line with the Saudi Vision 2030 strategy, is designed to facilitate the digital transformation of the Kingdom’s healthcare industry. As part of the Sandbox, Korean startup Lunit has signed a Memorandum of Understanding (MoU) with Seha Virtual Hospital (SVH). The collaboration aims to strengthen the partnership and contribute significantly to the Kingdom’s national cancer screening programme. Under the MoU, Lunit will provide SVH and its network of approximately 150 connected hospitals with the Lunit INSIGHT suite, an AIpowered solution for timely cancer detection. The initial deployment will start at King Saud Medical City in Riyadh, and Al mashaier hospitals (group of 8 hospitals) in Makkah. Lunit joins hands with Seha Virtual Hospital in Saudi Arabia for cancer screening START-UP NEWS 15 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
India’s Molbio Diagnostics has announced the launch of a strong collaboration with Niramai Health Analytix, a deep-tech startup. This partnership aims to accelerate the adoption of Niramai’s innovative artificial intelligence (AI)-based non-invasive breast cancer screening solution in developing countries around the world. Portable point of care (POC) breast cancer screening solutions that enable efficient screening of large populations, especially in low resource settings, is a critical healthcare need across many geographies today. Niramai’s Thermalytix is able to bridge these crucial gaps through its unique features. Considering the high prevalence of breast cancer cases, it is important to screen populations at a large scale, which is possible only by deploying portable, noninvasive diagnostic devices like Thermalytix at point of care. Through this collaboration, Molbio will promote and distribute Thermalytix in both public and private healthcare markets globally. The partnership builds on the strengths of the two companies to bring cutting-edge technology which would make highquality diagnostics accessible to everyone. Molbio forays into breast cancer screening through partnership with Niramai Mesh Bio, a Singapore-based health deep tech startup transforming chronic disease management through predictive analytics, has raised an undisclosed amount of funding from East Ventures, a pioneering and leading sectoragnostic venture capital firm focusing on Southeast Asia. The funding will be allocated to further develop the digital twin technologies in chronic disease management and to expand its services across Southeast Asia, mainly Indonesia, Malaysia, and the Philippines. Founded in 2018, Mesh Bio has the vision to deliver cutting-edge digital solutions to address challenges in patient management and rising chronic diseases in the region. The startup presents cutting-edge digital solutions to address challenges in patient management and rising chronic diseases in the region. Mesh Bio’s Health Intelligence Platform, named DARA, provides real-time, multidimensional patient data, which includes health history, lab tests, and medical images. DARA delivers a patient-centric visual report, helping doctors counsel patients and allowing patients to understand their laboratory reports and the diseases they live with. Mesh Bio secures investment from East Ventures Fapon Biotech, a leading lifescience organisation, has signed a strategic cooperation agreement with Halodoc, a telehealth startup in Indonesia. This partnership brings together Fapon’s expertise in in-vitro diagnostics (IVD) technologies and integrated solutions with Halodoc’s strong sales channels and local service provisions. The partnership aims to enhance the healthcare standards in Indonesia, benefit local communities, and propel the country’s IVD industry. Under the agreement, Fapon will partner with Halodoc in the IVD field by establishing a joint venture to grow the IVD business, and deliver high-quality and user-friendly diagnostic products and health solutions in Indonesia. With 22 years of IVD experience under its belt, Fapon boasts a solid technological foundation and a comprehensive and innovative product portfolio. Through this collaboration, Fapon will support Halodoc in local IVD product research and manufacturing by providing essential raw materials, reagent solutions, and open-instrument platforms. As the largest telehealth company in Indonesia, Halodoc will leverage its strengths in channels, academia, and industry connections to expedite market expansion, drive consistent business growth, and achieve a win-win result. Fapon, Halodoc to drive development of Indonesia’s IVD industry 16 START-UP NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
2023 was the year when the world finally emerged from the grips of COVID-19. The biopharma industry looked beyond the pandemic. Artificial Intelligence (AI) based drug discovery was a hot topic, with the industry’s billions on AI finally paid off. Insilico Medicine, based in China, achieved a significant milestone with its lead drug for Idiopathic Pulmonary Fibrosis (IPF) – INS018-055. This is the first drug designed for an AI-discovered target and created by generative AI to advance to phase 2 clinical trials with patients. The other important topic that garnered attention was - ageing. The reality of the ageing population is finally catching up in the region and the countries are scrambling to deal with it. China continues its As we bid farewell to another eventful year in the world of life sciences, it’s time to look back at the whirlwind of advancements and changes that have shaped the industry in 2023. Back in January this year, we interacted with leaders from various market segments who shared their insights into what the year held for their particular spheres. Let’s recap the 2023 predictions and find out if they panned out as predicted. Buoyant Life Sciences Sector Emerges Stronger COVER 17 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
winning streak to be recognised as a biopharma innovative powerhouse, while Singapore emerged as a manufacturing powerhouse for the industry. The region also held onto its rank as a preferred destination for clinical trials. Some of the trends observed were predictable with a few surprises thrown in. Let’s take a deep dive into the year gone by. AI drug discovery AI has become a cornerstone technology in the drug discovery process, with virtually all companies, regardless of size, incorporating it into their drug discovery life cycles. According to a CPHI report, AI is expected to revolutionise all aspects of drug development by 2026, and by 2030, over 50 per cent of FDA approvals are anticipated to involve drugs discovered and developed through AI. Insilico Medicine, a China-based company, achieved a noteworthy breakthrough with its lead drug for Idiopathic Pulmonary Fibrosis (IPF) – INS018-055. This marks a pivotal moment as it is the first drug designed for a target discovered by AI and created through generative AI to progress to phase 2 clinical trials involving patients. “The power of artificial intelligence (AI) has had a massive influence on drug discovery and development, with players like Huawei, Merck S D and Takeda Pharmaceuticals investing heavily in the capability to discover superior novel lead compounds in months rather than years, as well as to better engage with patients. It is expected that the global market for AI in biopharma will increase to $3.88 billion by 2025 at a 52.9 per cent compounded annual growth rate (CAGR), thus we can expect to see more of these deals,” said Dr Maud Eijkenboom, CEO, Lixa. Established in 2021, Lixa is an Australian biotechnology company developing revolutionary, broadly applicable and scalable solutions for Antimicrobial Resistance (AMR). All eyes are on China China continued its impressive streak as a biopharmaceutical innovator, solidifying its leadership position in the field. The country has become a sought-after destination for groundbreaking therapies, attracting major deals with prominent global pharmaceutical and biotech firms. Notable deals include Novartis’ $100 million deal for CAR-T therapy with China’s Legend Biotech. Merck, aiming to bolster its oncology pipeline, partnered with Hengrui Pharma. GSK also made a significant move by securing an $85 million ADC (antibody-drug conjugate) deal with Hansoh Pharma. German mRNA major BioNTech, has been actively partnering with Chinese startups. It inked a substantial $1 billion oncology deal with Biotheus. Additionally, BioNTech collaborated with Doer Biologics in a biotherapeutics agreement. The firm also inked a deal with MediLink Therapeutics to develop next-generation anti-cancer ADCs. “China has emerged and evolved significantly, especially in the past decade. International biopharmaceutical manufacturers have been adapting to the value and opportunity there, moving beyond an earlier focus on marketing established products to now regarding China as a potential market for their latest innovative medicines and a strategic global opportunity alongside their home markets in the US and Europe,” said Jeff Weisel, Managing Director, Policy, Access, Value and Evidence APAC, Avalere Health, USA. Mental Health Mental health continues to be an important sector in the region. Asia is home to several innovative digital mental health companies and the governments are also taking various initiatives to improve well-being. Australia, in particular, is strategically enhancing its mental healthcare landscape. The Australian government has crafted a comprehensive 10-year National Mental Health Workforce Strategy. This strategic roadmap aims to ensure that Australians have timely and accessible mental healthcare by 18 COVER BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
“The power of AI has had a massive influence on drug discovery and development, with players like Huawei, Merck S D and Takeda Pharmaceuticals investing heavily in the capability to discover superior novel lead compounds in months rather than years, as well as to better engage with patients. It is expected that the global market for AI in biopharma will increase to $3.88 billion by 2025 at a 52.9 per cent CAGR, thus we can expect to see more of these deals.” - Dr Maud Eijkenboom, CEO, Lixa, Australia “China has emerged and evolved significantly, especially in the past decade. International biopharmaceutical manufacturers have been adapting to the value and opportunity there, moving beyond an earlier focus on marketing established products to now regarding China as a potential market for their latest innovative medicines and a strategic global opportunity alongside their home markets in the US and Europe.” - Jeff Weisel, Managing Director, Policy, Access, Value and Evidence APAC, Avalere Health, USA “The development of a national project for precision medicine and to support the development of new drugs and enable new markets for existing drugs is picking up. Several countries are officially working on national programmes or about to declare it publicly.” - Nino da Silva, Managing Director, APAC, BC Platforms, Switzerland guiding coordinated efforts over the next decade. Additionally, the government is allocating $8 million for 10 projects under the fifth grant opportunity for the Medical Research Future Fund’s Million Minds Mental Health Research Mission. In Singapore, the Inter-agency Taskforce has rolled out the National Mental Health and Well-being Strategy. This strategic initiative aims to establish an effective mental health ecosystem, combining accessible clinical care with strong community support. Adding to the momentum, ThoughtFull, Asia’s first digital mental health company, secured $4 million in an oversubscribed pre-series A funding round, led by Sheares Healthcare Group, a whollyowned entity of global investment firm Temasek. Another Singaporean digital mental health company Intellect secured significant investments from IHH Healthcare, an international healthcare leader. Ageing 1 in 7 individuals in Asia Pacific were aged 60 or older. This demographic trend is accelerating, with projections suggesting that by 2050, 1 in 4 people in the region will fall into this age group, according to the United Nations, Economic and Social Commission for Asia and the Pacific (ESCAP), 2022. To address the growing concern of an ageing population, the APAC region is actively taking steps to tackle longevity-related issues. In August 2023, Singapore marked a significant milestone by inaugurating the world’s very first Healthy Longevity Medicine Clinic. This achievement is part of a broader wave of developments in the region that focuses on the science of ageing and longevity. This is also expected to increase further in the coming year. Singapore manufacturing Singapore emerged as a hotbed for biopharma manufacturing. Last year almost all the big pharma firms announced plans to advance biologics manufacturing in the region. This year too there has been a spate of developments in this sector. Notable developments include Hilleman Lab’s $20 million investment to launch a new ACES cGMP Facility, Leica Microsystems’ $60 million investment for a next-gen facility, and Thermo Fisher Scientific’s expansion of sterile manufacturing and research capabilities in the Asia-Pacific region. Further contributing to Singapore’s prominence in biopharma manufacturing, several companies have inaugurated new facilities and expanded capabilities. SCG has opened a new cell therapy manufacturing facility and research and development (R&D) centre, while West Pharmaceutical Services has inaugurated COVER 19 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
the frontline management of CLL,5 ” said Frances Chang, Vice President, Medical Affairs, Pharmaceuticals, Janssen Asia Pacific. BTKis transformed the treatment paradigm for CLL The introduction and subsequent approvals of oral kinase inhibitors signified a major milestone in the treatment of CLL. Ibrutinib, a first-in-class BTKi, was approved in 2014 and has significantly transformed the treatment regimen of CLL.6 “In the last decade, ibrutinib has had an unprecedented impact on both survival and quality of life for more than 290,000 patients. Ibrutinib is proven to deliver patients with treatment naïve CLL the The last few decades have been an exciting period of therapeutic transformation for CLL treatment. Credit: Image by Freepik 20 PARTNER CONTENT BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com The treatment and management of blood cancers, in particular CLL, has advanced greatly in the last decade. Physicians and patients now have an armamentarium of targeted treatments to choose from to aid in the achievement of individual treatment goals. The approval of rituximab in the late 90s, a chimeric anti-CD20 antibody, ushered in the era of chemoimmunotherapy (CIT) and culminated in the establishment of the fludarabine, cyclophosphamide, and rituximab (FCR) regimen as a gold standard for the first-line treatment of CLL.1,2 However, the FCR combination is known to be significantly myelosuppressive and immunosuppressive, which can result in a heightened risk for opportunistic infections in some patients that could persist for several years following treatment.3 “Today, CIT is being rapidly displaced by oral targeted inhibitors such as Bruton’s tyrosine kinase inhibitors (BTKis), which have demonstrated significantly better efficacy than CIT.4 Given the now consistent observations of improved progression free survival (PFS) and overall survival (OS) with the use of novel agents compared to CIT, regimens such as FCR are no longer recommended for Advancements in chronic lymphocytic leukemia (CLL) treatment bring new hope to patients Produced by 1 Robak T, et al. J Clin Oncol 2010;28:1756-1765. 2 Hallek M, et al. Lancet 20610;376:1164-1174. 3 Shanafelt TD, et al. N Engl J Med. 2019;381:432-443. 4 Seiffert M, et al. Cancers (Basel) 2021;13(13):3134. 5 Hampel PJ and Parikh SA. Blood Cancer J 2022;12(11):161. . 6 Brem EA and O’Brien S. Blood Adv 2022;6(4):1361-1364.
PARTNER CONTENT 21 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com chance of a similar life expectancy to that of the general population,7 ” said Chang. Long-term follow-up from RESONATE-2 reported sustained benefit with first-line ibrutinib treatment for CLL, including for patients with high-risk genomic features (TP53 mutation, del[11q], and/or unmutated IGHV). Importantly, the long-term follow-up of RESONATE-2 observed that at 7 years, ibrutinib-randomized patients demonstrated an unprecedented OS rate of 78%, confirming the long-term value of first-line ibrutinib treatment, including for patients with high-risk disease features.8 RESONATE-2 represents the longest phase 3 survival data ever reported for any BTKi in CLL. To date, ibrutinib is the only therapy to have demonstrated significant PFS and OS benefit for the first-line treatment of CLL across multiple randomized phase 3 studies. “Ibrutinib is also the BTKi with the most extensively studied tolerability profile,” said Chang. “The primary results from the pivotal RESONATE-2 phase 3 study demonstrated the superior efficacy and tolerability of once-daily ibrutinib versus chlorambucil chemotherapy for the first-line treatment of patients with CLL.9 ” 7 Ghia P, et al. . Blood (2022) 140 (Supplement 1): 4159–4161 8 Barr PM, et al. Blood Adv 2022;6(11):3440-3450. 9 Burger JA, et al. N Engl J Med 2015;373(25):2425-2437. 10 Eichhorst B, et al. Ann Oncol 2021;32(1):23-33. 11 The Japanese Society of Hematology. Practical Guidelines for Hematological Malignancies, Ver. 3, 2023. 12 Zhu J, et al. Chin J Cancer Res 2021;33(3):289-301. BTKis as first-line CLL therapy The European Society for Medical Oncology (ESMO) guidelines on CLL recommends the continuous use of BTKis such as ibrutinib for first-line therapy of CLL, until progression. These guidelines note that treatment decision should include an assessment of IGHV and TP53 status, as well as patient-related factors such as comedication, comorbidities, preferences, drug availability and potential of treatment adherence.10 Similarly, the Japanese Society of Hematology’s 2023 Practical Guidelines for Hematological Malignancies recommends the use of BTKis, such as ibrutinib, for the first-line treatment of symptomatic or active CLL, with or without the del(17p)/TP53 mutation. In the second-line setting, BTKis are also recommended in patients who had not received prior BTKi therapy. 11 The 2021 Chinese Society of Clinical Oncology (CSCO) diagnosis and treatment guidelines for malignant lymphoma noted that BTKIs are recommend in first-line therapy of CLL patients with or without the del(17p)/TP53 mutation.12 Towards the next breakthrough “BTKis have created a new era of chemotherapy-free treatment for CLL. At Janssen, while we are inspired by the progress to-date, we also have a singular focus – the elimination of cancer. With three decades of innovation in oncology, we are driven by the enormous global unmet medical needs that continue to persist in disease treatment,” said Chang. “No single company can solve the challenges of cancer. This is why Janssen continues to collaborate with experts from across academia and industry to advance science and deliver innovative therapies to patients in the region and around the world.” Ibrutinib has had an unprecedented impact on both survival and quality of life for more than 290,000 patients. Credit: Getty Images Grandfather and grandson fishing stock photo (Getty #169279757)
an advanced manufacturing facility. ACTRIS and Biosyngen have also unveiled new cell therapy facilities, emphasising Singapore’s growing prowess in cell and gene therapy capabilities. Biosyngen, specifically, has opened a new cell therapy GMP facility, further solidifying Singapore’s position at the forefront of the biopharma industry. Genomic testing and precision medicines In a rapidly evolving landscape of healthcare, precision medicine took centre stage. “The development of a national project for precision medicine and to support the development of new drugs and enable new markets for existing drugs is picking up. Several countries are officially working on national programmes or about to declare it publicly,” Nino da Silva, Managing Director APAC, BC Platforms, Switzerland. BC Platforms is a global leader in building data networks for the life sciences industry and provides versatile technology platforms for personalised medicine, accelerating the translation of innovations into clinical practice. Singapore’s Precision Health Research (PRECISE) leads the implementation of phase II in the 10-year National Precision Medicine (NPM) strategy. Focused on leveraging Asian genome insights, it aims to transform healthcare with data-driven solutions for improved patient outcomes. “Multi-omic technologies are fueling the next wave of precision medicine, ranking them as the first among the five healthcare trends to watch this year. While genomics technologies have paved the way for precision medicine, current efforts aim to overcome the limitations of genomics technology and advance precision medicine by utilising next-generation technologies, such as proteomics. Consequently, large-scale projects are being pursued to secure multi-omics data. In China, the government has launched the Proteomic Navigator of the Human Body (π-HuB) project, aiming to systematically map and analyse protein profiles related to human cells and major diseases over the next 30 years,” said Seungman Han, CEO, Bertis, South Korea. Bertis, specialises in the development of proteomics-based precision medicine technology. Riding on this trend and responding to market demands, Bertis launched the multi-omics analysis service PASS in Korea last year and expanded its reach to the United States this year. The PASS service has experienced remarkable growth, continually receiving service orders from national government agencies, government-funded research institutes, and private companies. Non-communicable diseases are rising in “It has been very much a buyer’s market, with incoming investors being able to take their time and pick and choose the best deals. This environment has forced companies to reduce expenses to make their existing cash last longer, as well as cut back on the scope of their fundraising activities. For many, the focus for 2023 has been on survival, with the hope that the financing environment will improve in 2024.” - Dr Ian Nisbet, Chief Operating Officer, Cartherics, Australia “2023 has been a difficult year for biotechs and health techs seeking funding. Of course, biotechs and the like are generally unsuitable for ‘bricks and mortar’ traditional bank funding. We’ve seen macroeconomic headwinds, stock market volatility, and spiking interest rates. Moreover, VC and PE investment and deal value globally have declined by 30 per cent. The global PE industry ended 2022 with a record $3.7 trillion in ‘dry powder’; and that amount has not been substantially reduced in 2023.” - Ben McLaughlin, Partner, Baker & McKenzie, Australia 22 COVER BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
the region, which can be addressed by precision medicine, leveraging genomics. “We saw the proliferation of genomic technologies across the Asia Pacific, attracting investors’ investments. Based on engineered or bacterial nucleases, the development of genome technologies has opened up the possibility of directly targeting and modifying genomic sequences. The impact of the application of genomics extends beyond increasing healthcare standards for the citizens. Indonesia stands to benefit from further economic benefits totalling $100+ billion, as indicated in our white paper on genomics, titled “Genomics: Leapfrogging into the Indonesian healthcare future”. The benefits are the combination of incremental productivity and healthcare savings incurred through genomics,” said Wesley Tay, Principal at East Ventures, Indonesia. New Diagnostic Tech “The impact of the COVID-19 pandemic has led to a broader consensus on the importance of diagnostic technology, resulting in a rapid growth of the diagnostic market. Companies in the diagnostic and vaccine sectors have achieved impressive sales results. They are now compelled to actively engage in the development and commercialisation of new diagnostic technologies, leveraging their business expertise and financial resources accumulated during the COVID-19 period, given the sharp decline in sales due to the COVID-19 endemic. Governments worldwide are also making continuous investments in diagnostic research to enhance public health and mitigate medical costs,” says Seungman Han. In October, Bertis entered a contract with SaudiVax Inc., a Saudi biotechnology firm, to supply MASTOCHECKTM—a blood test for the early detection of breast cancer developed using proteomics technology—to seven countries in the Middle East. Given the focus on health policies and industrial demands, the heightened interest and active investments in new diagnostic technologies are expected to persist, further evidenced by recent partnerships such as Boehringer Ingelheim’s agreement with a Chinese startup Burning Rock Biotech for oncology companion diagnostics, Fapon and Halodoc driving the development of Indonesia’s in-vitro diagnostics industry, and Japan’s GHIT collaborating with Institut Pasteur de Dakar in Africa to develop new diagnostics and vaccines. Funding Drought 2023 turned out to be a difficult year for biotech funding as the funding avenues dried up. “Multi-omic technologies are fueling the next wave of precision medicine, ranking them as the first among the five healthcare trends to watch this year. While genomics technologies have paved the way for precision medicine, current efforts aim to overcome the limitations of genomics technology and advance precision medicine by utilising next-generation technologies, such as proteomics. Consequently, large-scale projects are being pursued to secure multi-omics data.” - Seungman Han, CEO, Bertis, South Korea “Based on engineered or bacterial nucleases, the development of genome technologies has opened up the possibility of directly targeting and modifying genomic sequences. The impact of the application of genomics extends beyond increasing healthcare standards for the citizens. Indonesia stands to benefit from further economic benefits totalling $100+ billion. The benefits are the combination of incremental productivity and healthcare savings incurred through genomics.” - Wesley Tay, Principal, East Ventures, Indonesia COVER 23 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
24 COVER BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com In the Asia-Pacific region, we see two key strategic trends within Policy, Access, Value, and Evidence: 1. Continuing and increased use of Health Technology Assessment (HTA) in public payer decisions with increasing convergence of policies and processes 2. The impact of China is being felt in two ways: i. In the market, National Reimbursement Drug List (NRDL) decisions driving strategic options for companies, impacting pricing, access models, and even launch go/no go decisions ii. In global markets, the increasing presence of Chinese biotechs launching products in the US and Europe. 1. Continuing and increased use of HTA in public payer decisions with increasing convergence of policies and processes This is especially within mature markets such as Australia, New Zealand, Japan, Korea, and Taiwan, but also in some newer markets as well - China and most of Southeast Asia, including Thailand, Indonesia, the Philippines, Malaysia, Vietnam, and India. The mature Asia-Pacific markets, in many respects, have systems and levels of economic development and patient expectations that are similar to those in Europe. They also have universal healthcare systems and national, government-led reimbursement. The expectations and requirements of governments in these developed markets is around getting the best technologies and the best outcomes for what they’re spending. In other words, “How do we get the best value?”. These markets are also more focused on ageing populations, and treatments for cancer and chronic diseases; people here also expect high-quality care, so anything less than that 2 Strategic Trends Driving APAC « Jeff Weisel Managing Director, Policy, Access, Value and Evidence APAC, Avalere Health would be unacceptable and may well become an issue at election time. In the newer Asia-Pacific markets, healthcare funding systems are still in various stages of evolution. For example, many of these countries such as Thailand, China, and Indonesia already offer some kind of universal coverage, but this coverage is often limited by cost constraints to older treatments. They have large populations to enrol and millions living away from major urban centres. They lack the resources and funding to progress at pace. Patients often need to combine multiple funding sources and mechanisms to pay for innovative medicines – including private insurance, employer benefits, self-pay options, and aid. This patient funding journey is seeing a lot of innovation to address the needs of patients to access the necessary funding. Consequently, for these countries, the emphasis is not yet primarily on maximising and optimising the universal healthcare system, it’s still around expanding the system – building hospitals and clinics and training healthcare professionals – especially outside the main cities. Health ministries in emerging markets are also still grappling with infectious diseases as well as managing the rapid growth of cancer and lifestyle-driven chronic diseases. Of course, infectious diseases have come back on the agenda of both emerging and developed markets with the COVID-19 pandemic, which emerged first in the region. Historically, many biopharmaceutical manufacturers would often simply overlook the smaller newer markets, but more recently we see more innovative approaches to address affordability and availability for patients in these markets. Patient access programmes, collaborations with private insurance companies, and even dedicated separate brands are among the strategies being deployed in the region. These innovations will likely continue even as countries move towards universal coverage, and some may even be adopted in mature markets as pressures on costs continue to increase. 2.The impact of China is being felt in two ways: i. In the market, NRDL decisions driving strategic options for companies, impacting pricing, access models, and even launch go/no go decisions ii. In global markets, the increasing presence
COVER 25 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com of Chinese biotechs launching products in the US and Europe. While some Asia-Pacific markets, such as Japan and Australia, have been on the industry radar for decades and have mature healthcare and payer systems, China has emerged and evolved significantly, especially in the past decade. International biopharmaceutical manufacturers have been adapting to the value and opportunity there, moving beyond an earlier focus on marketing established products to now regarding China as a potential market for their latest innovative medicines and a strategic global opportunity alongside their home markets in the US and Europe. The increasing attention on China from the global industry has illuminated several implications for evidencegeneration and launch strategy: ● Volume-based procurement and National Reimbursement Drug List (NRDL): the policy shift towards volumebased procurement for off-patent products has significantly impacted the established business in China for many international companies, leading to different risk calculations when approaching NRDL listings for new products when considering trade-offs between price levels and patient volumes ● Complex access and regulatory pathways: unlike in Europe, regulatory harmonisation across Asia-Pacific is still in early days. While some mature markets, such as Australia and Japan, conduct their regulatory process in parallel with the US or EU, most others still follow on from FDA or EMA approvals to start their process. As mentioned, China has instituted reforms to speed up what was previously one of the world’s longest approval timelines for innovative products and now offers early access schemes that can enhance submissions for the NRDL ● The importance of partnerships: partnerships between Chinese and multinational manufacturers are becoming more common, ensuring deep expertise in the complex commercialisation processes in different regions, including insights on the market landscape, expertise in the regulatory and access pathways, and valuable connections with key stakeholders, such as payers, physicians, key treatment centres, and patient groups to drive advocacy. “A very obvious trend has been the ongoing difficulty for life sciences companies, particularly smaller and private companies, to raise new capital. Larger, publicly traded companies have been able to raise capital but often at a significant discount to a share price that has already been squeezed over the past couple of years. The impact is that existing shareholders have seen the value of their investment shrink (through both share price reduction and dilution of their holdings), while incoming investors have been able to get more ‘bang for the buck’. It has been very much a buyer’s market, with incoming investors being able to take their time and pick and choose the best deals. This environment has forced companies to reduce expenses to make their existing cash last longer, as well as cut back on the scope of their fundraising activities. For many, the focus for 2023 has been on survival, with the hope that the financing environment will improve in 2024,” said Dr Ian Nisbet, Chief Operating Officer, Cartherics, Australia. Cartherics’ is developing novel, ‘off-theshelf’ (allogeneic) immune cell therapy products for the treatment of cancer. Echoing similar sentiments, Ben McLaughlin, Partner, Baker & McKenzie, Australia said “2023 has been a difficult year for biotechs, health techs, and other companies seeking funding. Of course, biotechs and the like are generally unsuitable for ‘bricks and mortar’ traditional bank funding. We’ve seen macroeconomic headwinds, stock market volatility, and spiking interest rates. The IPO market has been extremely quiet across Asia-Pacific. Moreover, venture capital and private equity investment and deal value globally have declined by 30 per cent. The “During the five-year period (October 2019-October 2023), over 74,000 new clinical trials were registered in the APAC, US, and EU5 (France, Germany, Italy, Spain and the UK). The APAC region accounted for more than 60 per cent of the trials, the largest contributor, followed by the US and the EU5, and this trend is expected to continue in the future. Among all the countries, China registered the largest number of new trials during the assessed period, followed by the US and India.” - Nadim Anwer, Managing Consultant, Healthcare, GlobalData
global private equity industry ended 2022 with a record $3.7 trillion in ‘dry powder’; (uncommitted funds), and that amount has not been substantially reduced in 2023.” Venture capital (VC) funding, especially earlystage, is at its lowest level since 2019. VCs have battened the hatches as they triage their portfolios, with their portfolio companies making survival cuts to pipelines and staff. With VCs shifting focus from growing to surviving, more of their capital is reserved for their existing portfolios – meaning less is available for investment, says a report from ICON plc. Another report by Bay Bridge Bio estimated there to be an $8 billion shortfall of follow-on capital for series A in 2023 companies compared to a year ago in 2022. A study co-led by The University of Queensland (UQ) has found Australia is lagging behind similar countries in funding basic research, particularly in the medical, biotechnology and pharmaceutical sectors. APAC is the favoured destination for clinical trials The global clinical trial landscape has changed significantly, and the Asia-Pacific (APAC) region has emerged as the hot spot for conducting clinical trials and the region continues to be the global hub for clinical trials. According to GlobalData’s Clinical Trials Database, during the five-year period (October 2019-October 2023), over 74,000 new clinical trials were registered in the APAC, US, and EU5 (France, Germany, Italy, Spain and the UK). The APAC region accounted for more than 60 per cent of the trials, the largest contributor, followed by the US and the EU5, and this trend is expected to continue in the future. During this period, the APAC region registered the highest growth, followed by the US and EU5. Among all the countries, China registered the largest number of new trials during the assessed period, followed by the US and India,” said Nadim Anwer, Managing Consultant, Healthcare, GlobalData. The high growth in the APAC region was due to the ease of regulatory compliance, the growing patient population, the low cost of conducting studies, and the presence of a few top clinical institutions acting as sites. Innovations in CAR T-Cell Therapies Cancer continues to remain a health concern in the APAC region due to the ageing population, changes in lifestyle associated with economic development, and epidemiologic transition. Chimeric Antigen Receptor (CAR) T-cell therapy can be very effective against some types of hard-to-treat cancers and is the established treatment for a variety of blood cancers, such as CD19 CAR-T for B-cell malignancies and BCMA CAR-T for MM. “APAC is emerging as a key region in the development of CAR-T therapies, with China leading the race. There are four approved CAR-T therapies in China and one in India. China is expected to dominate research and development in this space, with more than 50 companies involved in the development of CAR-T therapies. Notably, there are four CAR-T therapies in late-stage clinical development in China. According to GlobalData’s Clinical Trials Database. China is the largest contributor to CAR-T clinical trials, accounting for more than 50 per cent of global CAR-T clinical trials. The reason for the high number of trials in China could be attributed to government initiatives to ensure new treatments come to market. Moreover, as part of Healthy China 2030 and other pharma and healthcare visionary programs, China enhanced its focus on innovative therapies,” said Nadim. India, too, is not behind in the race. ImmunoACT received the approval of India’s first CAR-T cell therapy, NexCAR19 (actalycabtagene autoleucel), for the treatment of r/r B-cell lymphomas and leukaemia. Immuneel Therapeutics’ IMN-003A CAR-T is also in Phase II for B-cell lymphomas and leukaemia. With the approval of NexCAR19, ImmunoACT has set the standard for indigenous CAR-T cell therapy in India. While 2023 was marred by uncertainties, widespread conflicts, economic downturns, and an overall sense of gloom, the life sciences sector in APAC region exhibited remarkable resilience and persistence. Ayesha Siddiqui 26 COVER BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
Asia Toughing Out the Uncertainties and Challenges « Bruce Liu, Partner, Life Sciences, Simon-Kucher, Greater China For many looking back at 2023, the word of the year would probably be “uncertainties.” There have been lingering uncertainties about another pandemic, the ongoing wars and atrocities, and the precarious footing of the global economy. Asia’s life sciences industry has not been immune to the headwinds and uncertainties. For most sectors, ranging from pharmaceuticals to medical devices to CROs and CDMOs, there have been ever more cost pressures from customers and payers. These strains are coupled with capital market volatilities, uncertain demand outlooks, and many last-minute cancellations. Welcome to the era of the New Normal. As much as we wish otherwise, many of the uncertainties will not vanish. In fact, there could be more geopolitical, social, economical, and industry specific challenges on the way. But it’s not the end of the world. Indeed, the life sciences industry in Asia has weathered the storm with remarkable resilience and resourcefulness over the past year. For one thing, Asia continues to be an important engine for cutting-edge innovations. Take CAR-T for example. Legend Biotech scored regulatory approvals across all major markets over the past year. And by joining force with JNJ, its Cilta-cel has achieved $3.4 billion global sales in the first three quarters of 2023. More recently, Legend signed another CAR-T deal with Novartis for $100 million upfront and over $1 billion milestones, making a bold bid for solid tumors. Striving to emulate Legend’s successes, IASO Bio launched its BCMA CAR-T in China and making progress in the states, having been granted Regenerative Medicine Advanced Therapy, orphan drug, and fast track designations from the US FDA. Another CAR-T therapy, Inati-cel from Juventas, recently crossed the finish line with approval in China for refractory or relapsed B cell acute Licensor Licensee TA MoA/Modality Up front/Deal Size ($ mn) Daiichi Sankyo MSD Oncology 3 ADCs 5,500/22,000 LianBio BMS Cardiovascular Myosin/small molecule 350 OncoC4 BioNTech Oncology CTLA-4/mAb 200/NA ECCOGENE AZ Metabolism GLP-1/small molecule 185/2,000 DualityBio BioNTech Oncology 2 ADCs 170/1,670 Hengrui Merck Oncology PARP, CLDN- 18.2/small molecule, ADC 160/1,400 EURO Legend Novartis Oncology DLL3 CAR-T 100/1,110 Orum BMS Oncology CD33/small molecule 100/180 Hansoh GSK Oncology B7-H4/ADC 85/1,570 Chong Kun Dang Novartis Neurology HDAC6/small molecule 80/1,310 MediLink BioNTech Oncology HER3 ADC 70/1,000 Biotheus BioNTech Oncology PD-L1/VEGF 55/1,000 2023 top deals of Asian pharma out-licensing (as of Nov. 13, 2023) COVER 27 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
lymphoblastic lymphoma. Other cell therapies like TCR-T holds great promise for conquering solid tumors, and a number of Asian players are blazing the trail in the field. Biosyngen’s BST02 and BRG03 received IND approvals in the US and China, bringing new hopes to cancers like primary liver cancer and lung cancer, which are of high prevalence and relevance in Asia. On the gene therapies front, Belief Biomed recently struck up a collaboration with Takeda for the commercialization of its promising hemophilia B therapy. RRGener made headlines at the ESGCT with its world-first dual vector AAV gene therapy to treat auditory neuropathy, which is music to the ears of those in the field of hearing loss. Asia also turns out to be a hotbed for deal making, and the optionality that comes with the biotech deals is especially valuable in the age of uncertainty. Among the deals aiming at tapping into innovations from Asia, ADC stood out as a key modality and oncology remained the major TA that attracted both old and new money. BioNTech alone has made seven licensing deals with Asian biotechs in 2023 to date, using its war chest to cherry pick oncology assets at the trough. The strategy of arbitrage and diversification may prove to be well-timed for the current downcycle. More importantly, industry players have been resourceful in revamping business models and innovating go-to-market approaches. Roche, for example, has been revisiting the traditional sales approaches, which were already cracking during the pandemic and lockdowns. To enhance access for its flu product Xofluza, the company has taken a different thrust by resorting to strategic collaborations with private hospital chains like United Family Healthcare and online health platforms alike. In particular, online platforms have shown strong momentum in the era of the New Normal. The number of JD Health’s active users has reached 150 million for online consultations, prescriptions, and pharmacies, and Ali Health has seen revenue and users growing at 30 per cent and 47 per cent respectively in 2023. More recently, online dispensing started to enjoy reimbursements in pockets of the market like Shanghai, making online platforms more attractive for patients and pharma majors alike. As Sun Tzu, Chinese general and strategist once quipped, when the going gets tough, the tough gets going. Asia’s life science industry has been toughing out the uncertainties and challenges from 2023, pivoting for new growth in the year ahead. (Inputs from Miranda Wang, Consultant, Life Sciences Practice, Simon-Kucher Partners, Greater China) 28 COVER BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
Many of the trends in 2023 in life sciences in Asia Pacific were predicted, but there have been some unexpected events, which have caught market participants off-guard. It’s been the year of the expected and the surprises. China Volume-Based Procurement (VBP) Policy In 2018, China introduced VBP for pharmaceuticals, as an attempt to reduce the price of pharmaceuticals, and in 2019 introduced VBP for medical devices. Under VBP, Chinese Provinces tender out the supply of products on a large-scale. Procurement decisions have shifted from individual clinicians to hospital administrators. This has resulted in price cuts of 70 per cent and a shift in market share from Western manufacturers to Chinese manufacturers. Nevertheless, Westernmade products are considered by Chinese consumers to be higher quality than Chinesemade products. Recently, some of the Chinese manufacturers are expanding sales into AsiaPacific, with reported success in New Zealand. China plus one A consequence of the pandemic and closed borders, western companies are adding new manufacturing facilities in Vietnam or elsewhere, to supplement existing manufacturing in China. Regional headquarters (RHQ) for multinational life sciences companies (MNCs) Singapore is the favourite location for a RHQ for MNCs, ahead of its rivals in Hong Kong and Shanghai. 140,000 people left Hong Kong from 2020 to 2022, including many executives who relocated from Hong Kong to Singapore. More recently, with surging real estate costs in Singapore notably in the residential tenancy sector where rents have doubled in the last 1 to 2 years for expatriates, some corporates are looking to return to Hong Kong or relocate some of their staff back to the city. Government support for R&D and medical research Governments have announced funding R&D and medical research, particularly for vaccines. For example, in May 2023, the Australian Federal Government committed to spending $4.5 billion over four years for medical research. The Australian Government also provides a generous R&D Tax Incentive, to encourage companies to conduct R&D and clinical trials in Australia. In addition, following the success of the mRNA vaccines for COVID-19, Australian State Governments have announced programmes to support the development of RNA research and manufacturing. It is hoped that viruses, cancers and genetic diseases can be treated with RNA technologies. In Japan, the Japan Agency for Medical Research and Development (AMED) has established a centre for vaccine research, to strengthen government response to an infectious disease emergency. With over 400 staff, AMED’s budget in 2023 exceeds $800 million. Global divestitures There have been a number of large-scale divestitures, with announcements up by 30 per cent year-on-year. Following high growth over the How has 2023 panned out for the life sciences industry in Asia Pacific? « Ben McLaughlin, Partner, Baker McKenzie, Australia « Andrew Martin, Principal, Baker McKenzie Wong & Leow’s Mergers & Acquisitions practice, Singapore COVER 29 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
pandemic, companies have reviewed their product lines and in some cases have decided to separate out non-core divisions. A number of pharma companies, including Merck, GSK, Sanofi, Pfizer, and Johnson & Johnson, have sold or spun off their consumer health divisions. Others have divested their off-patent portfolios and we have players in the distribution chain looking to snap these up as well private equity funds looking at pharma carve outs as they build up their operational due diligence skills. There has also been a wave of divestitures by medical device companies including Medtronic, GE Healthcare, and Baxter. Baker McKenzie has advised on many of these carveouts and divestitures. A global trend, the impact has been felt in Asia-Pacific, with companies restructured and new players emerging, such as Haleon and Kenvue. Funding drought 2023 has been a difficult year for biotechs, healthtechs, and other companies seeking funding. Of course, biotechs and the like are generally unsuitable for “bricks and mortar” traditional bank funding. We’ve seen macroeconomic headwinds, stockmarket volatility, and spiking interest rates. The IPO market has been extremely quiet across Asia-Pacific. Moreover, venture capital and private equity investment and deal value globally have declined by 30 per cent. The global private equity industry ended 2022 with a record US$3.7 trillion in “dry powder” (uncommitted funds), and that amount has not been substantially reduced in 2023. In addition, private equity sponsors have been looking at continuation funds as they try to find the right time to run the exit process. With expensive and hard to secure bank debt, we are also seeing a rise in private credit as an alternative financing mechanism both from specialist providers but also as an additional product line from some sponsors. From a deals perspective, some markets in Asia have bucked the trend a little including in healthcare so whilst China/HKG may have been much quieter, we see pockets of activity in Vietnam as well as India and a lot of interest in Indonesia but good assets at the right price are still challenging to find. Quiet quitting One of the consequences of the funding drought has been the shuttering of many biotechs and healthtechs around Asia-Pacific. I applaud the entrepreneurs who have given it a go, and hope that many of the companies can spring back once funding improves. Takeover opportunities The Nasdaq biotech total return index was flat in 2021, down 10 per cent in 2022, and down 6 per cent to end September 2023. One consequence of the falling stock prices has been an increase in tender offers for publicly-traded biotechs by strategics. Many biotechs have sought advice on the steps to take were they to receive an unsolicited takeover offer. Those companies are also looking to enter into collaboration or licensing deals, partly as a takeover defence. The GLP-1 drug phenomenon GLP-1 drugs, such as Novo Nordisk’s Ozempic, are medicines which combat type 2 diabetes, but also help in weight loss. Early trials also indicate that they may delay the progression of kidney disease in diabetes patients. This has affected a range of companies based in Asia-Pacific, including those producing kidney disease treatments, and those which treat sleep disorders. Those companies have said that they do not expect GLP-1 drugs to have a material impact on their business. Artificial Intelligence Of course, a round-up of 2023 must mention AI. R&D for a new drug is notoriously time-consuming (sometimes taking up to 12 years) and expensive (circa $6 billion). By analysing data on disease pathology, AI may short-cut the identification of the most promising new drugs. There are many companies employing AI in other fields too, such as pathology and diagnostic imaging. For example, I-MED Radiology and Harrison.ai use AI to support the identification of chest disease. 30 COVER BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
LEADERSHIP 31 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com The pharmaceutical industry is evaluating and adapting to the Great Reset, set in motion back in 2020. One key strategy in this regard has been the change of management structure, with several high-profile leadership changes in 2023. As the euphoria of pandemic-induced record revenues subsided in 2023, the pharmaceutical industry had to reevaluate its strategies and has undergone significant structural changes. Companies adapted their approaches, implementing measures such as job cuts, mergers and acquisitions (M&A), and a comprehensive overhaul of top management to navigate the evolving landscape effectively. Big Pharma elites, including Pfizer, Sanofi, Novartis, Astellas, among others, have announced a slew of leadership changes in recent times. Let’s explore these further. I n March 2023, Pfizer announced a $43 billion merger with Seagen, one of the most substantial M&A deals in recent times. Fast-forwarding to July 2023, Pfizer had already initiated strategic leadership changes, preparing itself for the impending mega-merger. Dr Chris Boshoff joined Pfizer’s executive leadership team as chief oncology research and development officer and executive vice president (VP). Boshoff will be the single point of accountability for the entire oncology pipeline – from discovery to early and late-phase clinical development. Previously, Dr Boshoff oversaw clinical research and product development activities for Pfizer’s oncology portfolio. In addition to his expanded role, Dr Boshoff is leading the integration planning for Seagen’s Pharma Heads Pass Leadership Baton medicines and team. Chief Scientific Officer (CSO) Dr Mikael Dolsten will expand his role to become CSO and president of R&D. William Pao, chief development officer and Executive VP, is leaving the company to pursue new opportunities outside. Pfizer believes the changes will benefit the company in its current stand-alone structure, and also aligns with Pfizer’s vision for the potentially combined organisations. Novartis recently witnessed a series of leadership changes. Marie-France Tschudin, the president of innovative medicines international and chief commercial officer, has chosen to leave the company after nearly seven years. Consequently, she will step down from the Executive Committee of Novartis (ECN). Dr Patrick Horber, (Former VP, AbbVie) has been appointed as the new president, International. Dr Horber will also assume a position on ECN. Sanofi also revealed significant leadership changes, with Houman Ashrafian taking on the role of head of R&D. Madeleine Roach is appointed as the head of business operations, while Emmanuel Frenehard is the new chief digital officer. Bill Sibold, head of the specialty care GBU, has departed the company. Bristol Myers Squibb (BMS) has disclosed a change in leadership, with Dr Giovanni Caforio, chairman, and CEO, choosing to retire. Dr Christopher Boerner, formerly EVP and chief commercialisation officer is the new CEO. Astellas also reshuffled its management structure. Naoki Okamura, the company’s former chief strategy officer has been appointed as president and CEO while Adam Pearson has been appointed as chief strategy officer (CStO). Claus Zieler, president of established markets, was named as the new chief commercial officer. Closer home, in the Asia Pacific region, Korean firm SK Biopharmaceuticals and China’s Everest Medicines have appointed new CEOs, signalling a strategic shift for the next phase of company growth. Gilead
32 LEADERSHIP BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com Sciences has also made a notable leadership change, with Jae Yeon Choi taking on the role of general manager (GM) for Korea. Meanwhile, Japan’s Kyowa Kirin, announced the appointment of Steve Schaefer as president, North America to manage the next phase of growth. It’s interesting to note that almost all the companies who have announced new leaders have also furloughed the staff. Pfizer, for instance, has reportedly laid off around 500 positions, at its Kent site in the UK. Similarly, Sanofi is set to review operations at two vaccine-making facilities in Hyderabad, India, potentially letting go of all 800 employees through a voluntary retirement scheme. Novartis is undergoing a significant organisational makeover, with reports suggesting potential job losses for some top executives and approximately 8,000 employees in a restructuring move. Leadership changes and layoff sort of go hand in hand. “A significant shift in leadership and strategic direction within a company sparks feelings of insecurity among professionals, resulting in a talent drain. The uncertainty created by these changes has led to a loss of skilled individuals seeking stability in their career paths. On the flip side, the company’s adoption of a broader product portfolio presents newfound career development opportunities for professionals looking to diversify their skill sets and broaden their experience. However, the drive to boost operational efficiency and performance may paradoxically lead to a reduction in manpower, potentially resulting in layoffs as the organisation seeks streamlined processes and cost-effectiveness. This juxtaposition of career development prospects and the threat of layoffs highlights the complex dynamics at play during periods of significant organisational transformation,” said Shermaine See, Principal Consultant, EPM Scientific. Newer Pastures Top executives from big pharmaceutical companies are now making strategic moves to biotech startups. These experts bring valuable skills to the table, helping with commercialisation and exploring new business opportunities. Australian startup Vaxxas, a clinical-stage biotechnology company commercialising a novel vaccination platform technology, appointed Dr Rochelle Chaiken as Chief Medical Officer. Dr Chaiken joins Vaxxas following a 23-year career at Pfizer, bringing extensive experience designing and executing late-stage clinical trials and successfully launching new products in markets. Taiwan’s HCmed Innovations, a contract development and manufacturing organisation (CDMO), has announced the appointment of Dr Gunilla Petersson as the new CSO. Former science and innovation director of inhaled drug delivery at AstraZeneca, Dr Gunilla joined HCmed with more than 29 years of experience in the pharmaceutical industry. Another Australian startup, Cartherics, a biotechnology company developing immune cell therapies for the treatment of cancer, appointed Dr Walid Azar as CSO. Dr Azar worked as a molecular biologist at CSL Limited, where he was part of the international R&D team. Dr John Lepore, former Head of R&D at GSK, has joined Flagship Pioneering, a bioplatform innovation company, and ProFound Therapeutics, a trailblazing company in the discovery of an extensively expanded human proteome. Dr Lepore will assume the role of CEO-Partner at Flagship Pioneering and CEO at ProFound. US-based genome editing startup Editas Medicine, appointed Biogen veteran Dr Linda C. Burkly, as the company’s executive VP and CSO. Dr Burkly will lead Editas’ drug discovery team. “Restructuring, Spinoffs, acquisitions, layoffs happening in big pharma companies – with these, we have more talents seeking for opportunities but with limited options in the market,” said Shermaine See. McKinsey’s Helix report argues that for companies to make another leap forward, they may need to recalibrate their formula for success. Perhaps evaluating and implementing structural changes is indeed the right step. Ayesha Siddiqui “A significant shift in leadership and strategic direction within a company sparks feelings of insecurity among professionals, resulting in a talent drain. The uncertainty created by these changes has led to a loss of skilled individuals seeking stability in their career paths. On the flip side, the company’s adoption of a broader product portfolio presents newfound career development opportunities for professionals looking to diversify their skill sets and broaden their experience.” Shermaine See, Principal Consultant, EPM Scientific
SPEAKING WITH 33 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com “The cancer diagnostics industry is on the cusp of substantial growth, attributed to an aging population” « Dr Nitin Malekar, Director, Harae Dx Inc., California, USA Headquartered in California, USA, Harae Dx, a medical diagnostics company is all set to introduce the next generation Artificial Intelligence (AI) enabled automated multi-cancer early detection system in India, China and the US in three years-time period. Harae Dx has already secured seed funding from global investor SOSV and is in the process of securing Series A funding of $12 million. The company holds strategic patents in its core technology platform, and the development and manufacturing of the entire diagnostics system will be executed through strategic partnerships using an outsourced model. In an exclusive interview with BioSpectrum Dr Nitin Malekar, Director, Harae Dx Inc., shared his views on the effectiveness of the new technologies being offered and regulatory challenges. Edited excerpts; What are the new technologies you are offering? Our game-changing, non-invasive, portable rapid cancer diagnostic system delivers reliable test results in just 30 minutes. The heart of our innovation lies in a multi-application platform, harnessing proprietary lab-in-the-box centrifugal microfluidic technology, expressly designed for the early and precise detection of an extensive array of protein and genetic biomarkers present in blood, each pertinent to various cancer types. Harae Dx Corp.’s visionary project overcomes the inadequacies that have plagued traditional cancer screening methodologies. First and foremost, it offers a safe, non-invasive, and cost-effective alternative, abolishing the need for cumbersome procedures that often invoke anxiety and discomfort. Secondly, our system incorporates AI-powered algorithms that have demonstrated unparalleled accuracy, dramatically reducing the prevalence of false positives and negatives that have plagued conventional screenings. Moreover, our solution is not just cutting-edge; it’s accessible and scalable, ensuring that a broader population can benefit from the tremendous advantages of early detection. In doing so, it has the potential to save countless lives. The Harae Dx System is more than just a medical innovation; it’s a catalyst for transformative change in cancer care. It offers the essential tools to bridge existing healthcare gaps, making mainstream and portable cancer diagnostics the new standard. Physicians, hospitals, and laboratories now have a dependable ally, enhancing decision-making, diagnostic efficiency, and screening accuracy, all while keeping costs at a minimum. Together, we can reshape the future of healthcare, one breakthrough at a time. We stand at the precipice of a new era in cancer detection, by leading the change, being united in our mission to improve the lives of countless individuals battling this relentless disease. Let this be a New Dawn in Cancer Detection. How cost effective are these new technologies? When it comes to cutting-edge diagnostic technologies, cost-effectiveness is not just a measure; it’s a game-changer. The surging demand for rapid and precise biomarker diagnostics is propelled by the global increase in infectious diseases, the growing embrace of personalised medicine, heightened focus on biomarker research, and a rising need for noninvasive diagnostics. Leading this charge is cancer biomarker testing, which stood at the forefront of the biomarker test market in 2019. Are there any regulatory challenges associated? Regulatory challenges are part of our journey, and we embrace them as we work tirelessly to save lives and improve healthcare worldwide. Harae
34 SPEAKING WITH BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com Dx is fully aware of the hurdles that lie ahead as we embark on our mission to revolutionise cancer diagnostics, starting with a particular focus on breast cancer—the world’s most prevalent cancer among women, causing 2.3 million new cases and 1.2 million deaths each year. It’s a sobering fact that in India, every second woman diagnosed with breast cancer succumbs to this disease. While navigating Regulatory Challenges, we are committed to provide Safe, Innovative Cancer Testing. As a cancer research and technology organisation, Harae Dx is unwavering in its commitment to adhere to regulatory requirements in the United States, India, and other target countries. We understand that the future of healthcare hinges on both innovation and compliance. Our initial focus centres on detecting cancer biomarkers for specific anatomical sites, and we have ambitious plans to develop specific cancer tests, including those for breast, prostate, lung, cervical, colorectal, and others. We will do this through strategic collaborations with biopharmaceutical companies and medical laboratories in subsequent phases of our business plan. Transparency and rigorous validation are at the core of our operations. Our project undergoes extensive testing and clinical trials to ensure its reliability, efficacy, and safety. We are committed to actively collaborating with global regulatory authorities, notably seeking the highest regulatory clearances, including approval from the US FDA. Our pledge is to not only revolutionise cancer diagnostics but to do so with the highest standards of safety and effectiveness. Please highlight the value and opportunity it brings by investing in this project. At this juncture, we are currently designing the prototype which will pass through a rigorous validation. Our project will undergo extensive testing and clinical trials to guarantee its reliability, efficacy, and safety. We are committed to actively collaborating with global regulatory authorities, including seeking the highest regulatory clearances, such as from the US FDA. Now, let’s delve into the value and opportunity that investing in Harae Dx represents. The demand for rapid and accurate biomarker diagnostics is soaring, driven by the global increase in infectious diseases, the adoption of personalized medicine, and a growing focus on biomarker research. Cancer biomarker testing stood at the forefront of the biomarker test market in 2019, underscoring the transformative power of such diagnostics. The cancer diagnostics industry is on the cusp of substantial growth, attributed to an aging population susceptible to disease and the proliferation of technologically advanced products delivering precise test results. What sets Harae Dx apart is our portability, affordability, and efficiency. Our AI-enabled, automated multi-application platform rapidly analyses protein and genetic biomarkers for a wide range of cancers at an early stage. While prominent players exist in the liquid biopsy early cancer detection field, none offer our unique automated portable Lab in a box technology. This distinctive advantage positions us as potential partners for the future. Current offerings in the next-generation diagnostics market are scarce, creating a void in early cancer detection, progression management, and post-treatment recurrence monitoring. Harae Dx plans to seize this opportunity as an early mover in the market, potentially establishing an unparalleled brand in the global healthcare community. From a funding perspective, investing in Harae Dx isn’t just an opportunity; it’s a chance to be part of a healthcare revolution that can save lives and transform the industry. It’s a call to action, an invitation to join us in reshaping the future of healthcare. Bhagwati Prasad
CANCER IN WOMEN 35 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com Breast and cervical cancer are pressing threats to women and health systems in the Asia Pacific (APAC) region. A new multisectoral collaboration and a powerful analysis of six countries’ breast and cervical cancer prevention and care capacity are generating momentum to save lives and contribute to a global health movement. Asia accounts for 45 per cent of global breast cancer cases and 58 per cent of global cervical cancer deaths. New cervical cancer diagnoses in the region are projected to rise by 18.9 per cent by 2030, with deaths increasing by almost 25 per cent, while breast cancer diagnoses in the region are projected to rise by 20.9 per cent and deaths by 27.8 per cent in that same period. These rates are tracking higher than anticipated global rates of increase, sounding the alarm for policy makers, funders and civil society partners alike to act, as behind these alarming statistics lie the disheartening individual stories of women and their families. In addition to grappling with the physical challenges of cancer, women also confront significant emotional, psychological, and financial strains. Because these diseases also carry the risk of stigma, they place a burden on women who are unable or unwilling to share their health challenges with others. Beyond these psychosocial impacts, women who must leave the workplace due to illness, or as caretakers, must contend with financial constraints resulting from lost income and compounded by catastrophic out of pocket payments on health care. Such scenarios can often pull families into cycles of poverty and impact future generations. Investing in women’s cancer When diagnosed too late, breast and cervical cancer drive up direct and indirect healthcare costs related to factors like productivity and socioeconomic impact. The costs of late diagnosis often fall on individuals and their families. In Vietnam, out-ofpocket costs for breast cancer are 66 per cent higher for Stage II disease and 148 per cent higher for Stage III disease compared to Stage 0/I disease. These personal tragedies add up to financial calamity at the country level. In Indonesia alone, an estimated 246,000 years of life were lost to cervical cancer mortality in the year 2018, resulting in a total productivity cost of $1.7 billion. Focusing on Women’s Cancers « Dr Heather White, Executive Director, TogetHER for Health Conversely, investing in services that enable prevention, screening, early detection, and timely treatment for breast and cervical cancers not only benefits the health of women but also strengthens the nation’s economic foundation. For example, for every one dollar invested in the global cervical cancer elimination targets, there will be $3.20 returned to the economy due to the increased participation of women in the workforce. Addressing these women’s cancers makes moral and economic sense. Thankfully, the tools and strategies exist to save millions of women’s lives from cervical and breast cancer. Reducing the burden of these two women’s cancers is possible through enhanced political will and expanded awareness and access to prevention, treatment, and care. For example, we can prevent cervical cancer through widespread vaccination against the human papillomavirus (HPV) responsible for almost all cervical cancers, as well as preventive screening and, where necessary, safe and effective removal of precancerous cervical lesions. The promotion of risk reduction, regular screening, and comprehensive management of invasive disease can all contribute to reversing the rising tide of breast cancer mortality. The availability of these interventions has inspired new global goal-setting. Recently released global targets from the World Health Organization for massive reductions in breast cancer mortality (“60- 60-80”) and, more ambitiously, the elimination of cervical cancer (“90-70-90”) were constructed on the basis of global scientific consensus and endorsed by Member States. Tackling the challenge Multi-stakeholder partnership will be critical to achieving these targets given that women’s cancer is a multidimensional challenge for both health systems
36 CANCER IN WOMEN BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com and society in Asia. The Asia Pacific Women’s Cancer Coalition – a collaboration among CAPED India, Jhpiego, Roche and TogetHER for Health – formed to identify areas for collaboration to advance prevention, early detection and timely treatment in the Asia Pacific and align regional priorities with the WHO’s global targets for breast and cervical cancer. Achieving these global targets need to start at the country and regional level, and now is an opportune time to align national cancer control plans and strategies to these global initiatives. The Asia Pacific Women’s Cancer Coalition views the regional pharma, biotech and medtech sectors as key partners in championing the effort to save lives from breast and cervical cancer. In health policy as with medicine itself, improvements start with solid evidence. To that end, the Coalition commissioned Economist Impact to produce a new report – Impact and opportunity: the case for investing in women’s cancers in Asia Pacific – to provide an in-depth analysis of the state of cervical cancer prevention and breast cancer prevention and care in six focus countries in the Asia Pacific: India, Indonesia, Malaysia, the Philippines, Thailand, and Vietnam. The report provides a regional analysis as well as situational reports and a policy scorecard for each of the six countries, which compares the quality and readiness of national programmes to effectively address breast and cervical cancer control, via five critical domains: policy and planning; prevention and screening, diagnosis and resource capacity, treatment and access, and awareness and education. The scorecards represent a key stepping-off point for country advocates and policymakers to advance national goals for breast and cervical cancer control across the region. It also summarises key recommendations and opportunities for national leaders and decision makers to prioritise & act upon to advance & support women’s cancer care in the region: ● Building immunisation, screening and patient outcome registries for cervical and breast cancer to enhance performance tracking; ● Accelerating rollout of national immunisation programmes for HPV and universal cancer screening to provide more effective prevention; ● Demonstrating greater political will and leadership to implement and update national elimination plans and strategies to align with WHO targets for cervical and breast cancer ● Designing and implementing effective and sustainable funding models; and ● Supporting people diagnosed with cancer by ensuring that referral and treatment pathways are clear and well-defined. This report is an essential resource for scaling up cost- effective, patient-centric strategies to improve breast and cervical care in the Asia Pacific region, and ultimately, save lives. Countries in the Asia Pacific can demonstrate leadership in global women’s health by acting on this report’s recommendations and inspiring similar efforts in countries throughout the region and even the world.
CARDIOVASCULAR DISEASE 37 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com Each year World Heart Day is observed to increase awareness about cardiovascular diseases (CVDs), after all defeating them is something that matters to every beating heart. CVDs are disorders of the heart and blood vessels and are often referred to as “silent killers” because most of the patients with underlying heart ailments do not exhibit any obvious symptoms. Development and deployment of cutting-edge technologies backed by requisite government policy support and direction will help in bolstering the fight against CVDs and thus improving the quality of the individuals’ heart and also their lives. Let’s take a closer look. I ndia is rapidly becoming the global CVDs epicentre which is primarily attributed to a mix of genetics, poor cultural practices and lifestyle factors among Indians such as increased trans fatty acids content in foods due to repeated use of cooking oil, unique pattern of atherogenic dyslipidaemia, consumption of processed and read-to eat foods, physical inactivity, obesity, high tobacco use, and increased stress levels that have contributed towards the increased prevalence of CVDs. According to the Lancet’s Global Burden of Disease study, India has an age-standardised CVD death rate of 282 per 100,000 population which is remarkably higher than the global average of 233 deaths per 100,000. The key to managing CVDs is early detection which can help identify the risk of cardiovascular diseases before it becomes too late. The industry is making tremendous efforts to reduce the disease burden, technology advancements in digital health and MedTech have enabled disease detection at an early stage, and also helped disease management of high-risk patients. Technologies such as artificial intelligence (AI)- based medical imaging analysis and precise screening solutions, continuous monitoring wearables and digital therapeutics have emerged as key enablers for the prevention and management of CVD in India. These technologies can play a vital role in lowering CVD risk and reducing the associated mortality rate which is especially important for a country that accounts for 60 per cent of the world’s disease burden. Some of these technologies to reduce cardiac disease burden are given below. Can Cutting-edge Tech Reduce Rising CVD Burden? « Neeraj Nitin Jadhav, Industry Analyst, Medical Devices and Imaging-TechVision, Frost and Sullivan AI-based medical imaging analysis and screening solutions AI-based medical imaging analysis solutions can precisely analyse and interpret cardiac-related abnormalities on medical imaging outputs including chest X-rays, computed tomography (CT) and ultrasounds. The AI algorithms in the solutions can quantify heart function, fluid buildup, valve anatomy, carotid artery stenosis grading, atherosclerotic plaque identification and characterisation which can help in the detection of CVDs such as heart failure, heart attack and stroke. These algorithms can rapidly process chest X-rays, CT and echocardiogram images within 60 seconds thus enabling early diagnosis of CVDs in the patients which can greatly enhance the chances of successful treatment in them. Furthermore, the AI algorithms can detect cardiac-related anomalies with high accuracy and are less prone to manual errors which can reduce misdiagnosis risk which is of paramount importance as delayed treatment can negatively affect health outcomes in the patients and also lead to potentially serious medico-legal consequences for the clinicians. Startups, such as Mumbai-based Qure.ai, have successfully deployed solutions for early detection of heart failure, heart attack and stroke. Furthermore, companies such as Aarthi Scans and Labs are leveraging AI-Rad Companion, a state-of-the-art CT coronary calcium scanning technology developed by Siemens Healthineers to detect early signs of coronary artery disease in patients. Besides CVDs detection, market participants have also developed AI-based screening solutions that leverage patients’ historical lifestyle attributes including smoking and tobacco preferences, psychological stress, anxiety, diet, and physical
38 CARDIOVASCULAR DISEASE BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com activity to predict the risk of CVDs among them. Apollo Hospitals, among India’s biggest hospital chains, has developed the Apollo AI-powered Cardiovascular Disease Risk tool that provides risk scores to the doctors based on all contributor factors allowing them to offer pre-emptive, proactive and preventive care for at-risk cardiac patients. Nonindustry bodies such as the Cardiological Society of India, are focusing on developing preventive cardiology solutions that use deep neural networks which can accurately identify patients who can potentially develop heart disease in the future. Wearable devices Continuous Remote Cardiac Monitoring Wearables including smartwatches have already gained popularity among individuals in India endeavouring to improve their physical fitness and overall well-being. However, the use of medical-grade wearables such as electrocardiogram (ECG) and cardiac patches and smart wearables including smart rings and smart bands for enabling 24x7 remote cardiac monitoring are also rapidly gaining traction in the country. These devices are equipped with an array of sensors including triaxial accelerometers, biomechanical, heart rate and rhythm sensors for monitoring physical activity, heart rate, electrocardiography, photoplethysmography, heart rate variability, cardiac output, blood pressure and heart rhythm measurement. The prominent advantage of these wearables is their ability to continuously track the above parameters, automatically detect cardiac anomalies using AI and share the data with the clinicians thus enabling them to detect underlying cardiac conditions and accordingly initiate early intervention and treatment. SmartCardia’s 7L Patch launched in India in August 2022, is a 7-Lead ECG patch that continuously monitors P-wave, QRS beat morphology along with vitals such as pulse rate, oxygen saturation and heart rate of the patient. The data is analysed by AI algorithms to detect cardiac arrhythmia events and accordingly, the information is transmitted in realtime to the cloud allowing the clinicians to make wellinformed decisions to prevent clinical deterioration in the patients. Impacting Lifestyle Choices Another benefit of the wearables is their ability to impact the individual’s lifestyle choices and overall well-being by providing insights and healthy recommendations about daily habits. These devices can track the physical activity levels of the user and accordingly provide gentle nudges if prolonged periods of inactivity are detected to break the individual’s sedentary habit. Furthermore, these devices also allow users to log in food intake and calorie consumption and subsequently provide insights about their dietary habits thus empowering them to make healthier choices and achieve their nutritional goals. India-based wearable companies such as boAt and Noise have launched smart rings that can monitor a range of health parameters of the user including heart rate, blood oxygen and physical activity levels and accordingly provide insights to the individual to help them live a healthier life. GOQii Technologies has launched GOQii Heart Care in India Though AI-based medical imaging and screening solutions offer an invaluable diagnostic tool to healthcare professionals, they have their share of limitations. Difficulty faced by clinicians in interpreting the decision-making process of the AI algorithms coupled with the lack of access to a large number of curated datasets for the training of the models has hampered the widescale adoption of the tools in cardiac care. Through the implementation of explainable modelling or post-hoc explanations, the internal functioning of the algorithms can be provided to clinicians to improve their trust levels.
CARDIOVASCULAR DISEASE 39 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com through which individuals using its GOQii tracker can share heart rate and other health data with cardiac specialists allowing them to provide specific nutrition advice and personalised coaching to the users to maintain good heart health. Digital therapeutics Digital therapeutics (DTx) uses evidence-based software that is clinically validated to prevent and manage chronic conditions including mental health, diabetes, and CVDs. In India, DTx are increasingly taking centre stage owing to their ability to improve patient-reported outcomes through monitoring, medication reminders, real-time customised health recommendations and personalised health coaching. Enabling Behavioural Modifications The DTx solutions use disease-specific programmes to encourage positive behaviour and lifestyle changes in individuals to mitigate heart ailments in them. The solutions offer disease-specific health education videos, recipes, and daily tasks to allow the individuals to respond better to symptoms, optimise their diet and adopt a positive physiological approach to improve sleep, reduce stress and enhance overall mental well-being. Through behavioural changes, the DTx solutions empower users to build positive daily habits which significantly improve their quality of life. Bengaluru-based Credo Health’s Cardiac Wellness and Rehabilitation programme enables the users to adopt heart-healthy behaviours including following a healthy diet, maintaining optimal weight, curbing habits such as smoking, and managing their stress levels to reduce the risk of heart disease. Mumbaibased Wellthy Therapeutics multi-lingual clinically validated DTx platform leverages behavioural science, and real-world clinical evidence to provide personalized recommendations and actionable information to the users to facilitate meaningful, sustainable behaviour change to better manage their conditions. Improving Patient Engagement One of the substantial advantages of DTx is its potential to improve patient engagement and compliance levels. Through multi-channel targeted outreach including reminders, motivational messages and rewards, DTx bolsters the patients’ commitment towards their health goals. This approach to enabling structured lifestyle changes in patients is essential for the prevention and management of CVDs. Lyfe, launched by Mumbai-based Lupin Digital Health is an evidence-based, heart care DTx that offers medication reminders, exercise, and diet regimens, online and in-person modules and expert interventions through dedicated health coaches and care managers for cardiac patients. By leveraging guidelines and protocols designed by prestigious medical societies such as the American College of Cardiology, Lyfe provides holistic heart care programmes aimed at reducing heart attack risk and improving health vitals among cardiac patients. The efficacy of the heart care DTx has been clinically proven through an ongoing research study with more than 90% of subjects adhering to the recommended diet, medications, and exercise and 83.3 per cent patients maintaining their vitals in the normal range. Challenges and Recommendations Though AI-based medical imaging and screening solutions offer an invaluable diagnostic tool to healthcare professionals, they have their share of limitations. Difficulty faced by clinicians in interpreting the decision-making process of the AI algorithms coupled with the lack of access to a large number of curated datasets for the training of the models has hampered the wide-scale adoption of the tools in cardiac care. Through the implementation of explainable modelling or post-hoc explanations, the internal functioning of the algorithms can be provided to clinicians to improve their trust levels. Market participants can partner with government agencies to get access to substantial curated imaging data sets that are technically and demographically diverse. Furthermore, there is a vast shortage of AI-trained professionals in India a country that otherwise produces thousands of IT professionals every year which is hampering the rapid development of medical imaging and screening algorithms. To mitigate this issue the companies can partner with
Despite the innovations happening in the DTx space, the lack of a proper regulatory pathway for the approval of DTx is a prominent challenge faced by companies that have hampered the development of these products in India. To overcome this issue, the Central Drugs Standard Control Organisation (CDSCO) can develop alternative regulatory approaches wherein DTx products approved by CDSCO’s reference regulatory agencies (US FDA, Health Canada, and EU Notified Bodies) should be provided abridged evaluation route or expedited review route which can help in facilitating accelerated regulatory approval for them. 40 CARDIOVASCULAR DISEASE BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com universities in India to introduce AI-based offline and online courses that would allow upskilling workforces to address the talent crunch. The use of wearables in India for health monitoring has grown significantly in recent years, however, they face challenges related to maintaining patient data privacy and data security. The lack of clear understanding among the patients regarding the privacy of their critical health information and what measures are adopted to protect their data stored on the cloud from unauthorised access due to security breaches can hamper the adoption of the wearables. The enactment of the Digital Personal Data Protection (DPDP) Bill, 2023 successfully passed through the Indian parliament and received final assent from the President of India in August 2023 is a step in the right direction as obtaining explicit consent from the individuals before collecting or utilising their health data and display of notice regarding the purpose of the processing of the information is made mandatory for the wearable and digital health players which can address patients’ data privacy concerns. Going forward the government can also add additional sections to the current DPDP bill on similar lines to that of the US Health Insurance Portability and Accountability Act (HIPAA) which provides individuals the right to see their health data and request or change the information if it is incomplete or inaccurate. Additionally, the wearable and digital health players can also focus on the implementation of robust security measures such as consistently updating security protocols, encrypting patient data and deploying stringent controls to ensure patient health data is protected on the cloud from unauthorized access, theft or misuse. Despite the innovations happening in the DTx space, the lack of a proper regulatory pathway for the approval of DTx is a prominent challenge faced by companies that have hampered the development of these products in India. To overcome this issue, the Central Drugs Standard Control Organisation (CDSCO) can develop alternative regulatory approaches wherein DTx products approved by CDSCO’s reference regulatory agencies (US FDA, Health Canada, and EU Notified Bodies) should be provided abridged evaluation route or expedited review route which can help in facilitating accelerated regulatory approval for them. Outlook Considering the enormous patient population suffering from CVDs in India and the current gaps regarding the precise understanding of these conditions, the medical device industry in India needs to boost technology development to address these challenges. The industry can step up partnerships with leading local and foreign universities leveraging their research to improve the companies’ expertise in cardiac care. Furthermore, the industry can also adopt breakthrough innovations used in developed countries including voice-based technologies and AI-based chatbots for detecting and predicting cardiovascular events in individuals. Finally, the companies should also work with the Government of India to identify any regulatory roadblocks that hinder the ease of doing research and business related to cardiac care medical devices and subsequently address them to accelerate the development of these products. The development and deployment of these cutting-edge technologies, backed by requisite government policy support and direction, will help in bolstering the fight against CVDs and thus improving the quality of life.
BIOPHARMA RESILIENCE 41 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com Biopharma’s Evolution and Future Resilience in Asia As the world emerges from the COVID-19 crisis, the global biopharma industry remains under spotlight. Recent advancements in the sector such as mRNA-based vaccines, use of artificial intelligence (AI) in drug discovery, exploration of cell and gene therapies, have the potential to reshape lives, offering hope in the face of looming threats such as pandemics and antimicrobial resistance. Based on five pillars - supply chain resilience, talent pool, R&D ecosystem, manufacturing agility, and government policy and regulation, Cytiva has unveiled the findings of the 2023 Global Biopharma Resilience Index, to help us identify the gaps in the industry now, and how to mitigate current challenges for a stronger future within Asia Pacific and Southeast Asia. The rapid deployment of mRNA vaccines in response to COVID-19 catalysed a new era in vaccinology and reignited interest in nucleic acid therapies. Artificial intelligence (AI)-enabled research is accelerating therapeutic development, with the opportunity to radically improve patient outcomes. Breakthroughs in cell and gene therapies (CGTs) have the potential to treat genetic diseases. Despite these breakthroughs and opportunities, however, sustained high growth is not a certainty for the industry. The emergency funding boost of 2020 and 2021 has fallen away, with financing for small and mid-size biotech firms in novel therapeutics pulling back in 2021. The funding landscape remains challenging in 2023 as cost of capital, economic insecurity, talent shortages, regulatory challenges, and disruption all continue to affect the sector. To assess the strength of the global industry in these turbulent times, Cytiva created the Global Biopharma Resilience Index. Introduced in 2021, the index scores and ranks countries on five factors: Supply chain resilience; Talent pool; R&D ecosystem; Manufacturing agility; Government policy and regulation. According to the 2023 index, based on data from a survey of 1250 pharma and biopharma executives across 22 countries, performance across three of the five pillars i.e. talent pool, R&D ecosystem, and government policy and regulation, has weakened. The pillar that has suffered most over the past two years is the R&D ecosystem, which fell from 6.54 in 2021 to 5.22 in 2023. Revealing more details of the 2023 Global Biopharma Resilience Index, Prem Mandalapu, Commercial General Manager, ASEAN, Cytiva highlights, “Seven countries across Asia Pacific (APAC) participated in the Biopharma Resilience Index this year. They are Singapore, Japan, South Korea, Australia, China, India, and Thailand. Across APAC and in Southeast Asia, the resilience varies starkly. The global average score is 6.28 points, while the average APAC score is 5.96 points.” “In APAC, Singapore, Japan, South Korea, and Australia’s scores are the strongest. In Southeast Asia, Singapore has the highest score, and stands out as the only Asian country among the top 5 globally, due to strong performance across most pillars, including talent and R&D ecosystem. Thailand has the lowest score in Asia Pacific for now, as it works to bolster its life science industry,” he adds. How effective is delivery of biopharma talent? The data from the 2023 report shows that overall talent pool resilience fell to 5.60 from 6.27 in 2021, the steepest decline seen across all the pillars. Consistent with global and APAC results, Thailand’s talent resilience has declined from 5.90 in 2021 to 4.60 this year. This is because about half of Thai executives say it is a moderate to very substantial challenge to hire talent across digital, R&D and GMPcapable manufacturing amid a surge in demand for these skills. Addressing this concern, Dr Kitipong Uaesoontrachoon, Chief Scientific Officer, Genepeutic Bio, Thailand says, “Talent is a crucial factor for driving innovation from R&D to commercialisation, and Thailand is keen on transitioning into a knowledge-based economy. However, there is a lack of effective programmes to
42 BIOPHARMA RESILIENCE BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com help healthcare professionals update their knowledge and advance healthcare technology. To address this gap, two strategies can be pursued: first, encouraging experts from different backgrounds to educate local professionals, and second, fostering connections with overseas experience.” On the other hand, Singapore has fared better when it comes to talent with a score of about 6.31. This is in part due to less challenge in hiring talent across digital R&D and GMP manufacturing. Highlighting how companies like Cytiva can help bridge the talent gap between the industry and academia in Asia, Dennis Chau, General Manager, Commercial Discovery, Cytiva says, “To address the talent gap, we have established two key facilities in Southeast Asia. The Cytiva Experience Learning Lab in Singapore has conducted more than 70 trainings with academic and research institutes on the latest bioprocessing and production techniques. At our Nanyang Polytechnic Centre of Excellence, we have conducted about 30 trainings since we launched to students as well as industry. Across Asia Pacific, Cytiva has established the Fast Trak Education and Training Programme for process development in Korea, China, and India. Both centres in Korea and China have the capability to train more than 300 people every year. In India, our collaboration with the Bangalore Bioinnovation Center has led to the establishment of a bio-incubation hub, further enhancing the talent pool for biomanufacturing capabilities.” While multiple initiatives are being taken by the industry and academia across Asia, momentum needs to be built to strengthen this pillar in the coming years. How to nurture R&D ecosystem in Asia? According to the index, R&D ecosystem is APAC’s weakest pillar this year, scoring 5.12 vs the global average of 5.22. It is striking that this comes after a period of intensive industry collaboration during the COVID-19 pandemic. Sharing his thoughts on this observation, Prof. Tan Yong Zi, Assistant Professor, Department of Biological Sciences, National University of Singapore (NUS) says, “Fostering an innovation culture involves facilitating technology transfer from academia to commercial applications and promoting collaborations among academia, industry, and startups. Encouraging researchers and startups to partner with established biotech firms can ignite innovation. Governments can contribute by offering research grants, tax incentives, funding programmes, and regulatory support in the biotech and biopharma sectors. Regulatory agencies must balance safety and innovation by simplifying approval processes for new therapies and treatments.” “Thailand should focus on investment, collaboration, regulatory support, and education to nurture its R&D ecosystem and encourage innovation from academia and startups,” points out Dr Kitipong Uaesoontrachoon. Time to boost the resilience Government policy and regulation also emerged as a weak pillar in this year’s resilience Index. The best way to strengthen this aspect would be for the industry to work in closer collaboration with both government policymakers and regulatory-agency leadership to ensure regulatory processes are adapted to suit emerging technologies and therapies. Policy initiatives on fostering innovation should be designed to translate into clear regulatory guidelines. International and domestic regulations must be much more closely aligned. For instance, Switzerland, the highest performing country in the Global Biopharma Resilience Index 2023, is particularly strong in this regard. Likewise, strong areas among developing countries such as India’s efficient supply chain and China’s manufacturing agility should be studied by other developing countries for ways in which they could emulate these successes and thereby accelerate their own progress. Ayesha Siddiqui
GigXR join hands with NUS Medicine to offer a new gastrointestinal module US-based GigXR, Inc., a global provider of holographic healthcare training, has announced its partnership with the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine), to introduce a new gastrointestinal module for the award-winning HoloScenarios application. Created to better prepare medical and nursing students in diagnosing and treating acute gastrointestinal diseases, HoloScenarios: Gastrointestinal delivers robust clinical simulations that are evidence-based and present hyperrealistic holographic simulated patients and medical equipment to be used in any physical learning environment, accessed anywhere in the world. HoloScenarios: Gastrointestinal uses mixed reality (MR) to simulate the entire patient journey, while including branching logic to catalyse variance in learning experiences. From taking basic medical history to performing invasive testing and emergency procedures, the new module empowers learners to master vital medical decision making and manual skills as they would see them in real-life clinical scenarios and patient care. Australia’s Deakin University inks MoU with Indian Institute of Technology to boost research ecosystem In a significant expansion of its strategic engagement initiatives currently undertaken ‘in India, with India, for India’, Deakin University, a globally renowned Australian University, has signed a Memorandum of Understanding (MoU) with the Indian Institute of Technology (IIT), Gandhinagar. The signing of the MoU is of crucial importance for enhancing collaborative efforts between partner institutions and gives Deakin an opportunity to provide targeted efforts for boosting education and research outcomes in the region. A highlight of the proposed alliance is the amplification of innovation and excellence in research outcomes through a multi-pronged strategy involving – joint doctoral programmes, exploring bilateral funding opportunities and knowledge exchange through joint grant proposals, conference, and workshops. This extends to general academic collaborations including the exchange of educational resource materials and publications that are of mutual interest to both institutions. The Hong Kong Polytechnic University (PolyU) and the Hefei Luyang government in China have reached an agreement to jointly establish the PolyU-Hefei Technology and Innovation Research Institute, with the aim of fostering in-depth and effective collaboration in industry, academia and research and cultivating talents. The establishment of the Research Institute contributes to enhancing and facilitating research development, academic exchange, nurturing of talent and knowledge transfer in various fields, including biomedical and sensing precision technology, and aerospace information. By leveraging the research and academic excellence of PolyU, these collaborations support the development of a top-notch innovation platform in Hefei. Hefei is one of the national core areas for comprehensive technological innovation development. It has the first batch of national laboratories and is one of the cities with the most large-scale scientific facilities in Mainland China. The cooperation will also focus on creating a sustainable incubator for startups, driving innovation in emerging industries, developing key core technologies, and promoting their application based on the needs of Hefei’s economic development. PolyU, Hefei Luyang establish innovation research institute ACADEMICS NEWS 43 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
Hong Kong-based startup Cellomics, a leader in liquid biopsy technology for cancer screening and precision diagnosis, has announced the appointment of Andy A. Liu as the new Group Chief Executive Officer (CEO) of the company. With over 25 years of healthcare experience, Liu brings a wealth of knowledge and expertise to the company, including exceptional commercial operations experience within pharmaceuticals, medical devices, healthcare services as well as big data and AI analytic industries. Liu has held several executive leadership positions, previously serving as the President of Basebit Technologies, CEO of CW Data (Wuxi Apptec JV), and President of Asia Pacific and China for IQVIA. He has also previously worked at Merck and UCB Pharma in both the United States and Asia. Cellomics ropes in Andy A. Liu as new Group CEO Daiichi Sankyo Europe GmbH, the European headquarter organisation of the Japanese pharmaceutical company Daiichi Sankyo Co. has announced the appointment of its new Managing Director (MD) Masahiro Kato. Kato succeeds Dr Jan Van Ruymbeke, who successfully led the European organisation over the last 11 years and who will retire by the end of March 2024. During his tenure the European organisation’s revenues and profit tripled. Kato returns to Europe from Japan, having spent several years already in the European headquarter organisation from 2003 to 2010. His 35 years at Daiichi Sankyo spans roles in Finance, Accounting and most recently Sustainability Promotion, an increasingly important area for Daiichi Sankyo. One of Kato’s main priorities will be facilitating and driving Europe’s role in globalisation initiatives of Daiichi Sankyo while further supporting the organisation’s sustainable growth across therapeutic areas. He will also be a strong advocate for the patients Daiichi Sankyo Europe seeks to impact, in the spirit of Daiichi Sankyo’s purpose which is to contribute to the enrichment of quality of life around the world. Masahiro Kato steps in as MD of Daiichi Sankyo Europe Australia-based Bridgewest Perth Pharma, a global pharmaceutical supply and manufacturing company, has announced that Cyrus K. Mirsaidi is taking the worldwide helm as the Chief Executive Officer (CEO), including its pharmaceutical supplier division, LumaCina, and its Contract Development and Manufacturing Organisation (CDMO) division, NovaCina. Mirsaidi has an accomplished leadership track record. As CEO of BioDuroSundia, he led the company growth from: 500 employees to 2,000+ employees and from 3 sites to 10 global sites, including multiple tuck-in acquisitions and a major merger. Mirsaidi continued as Board Advisor at BioDuroSundia, following his role as President and CEO. Prior, he was President and CEO at Molecular Response, a translational oncology CRO, also funded by Bridgewest Group, where he successfully expanded and exited that business in 2015. He has served as Chairman and Managing Partner at BioSelective Capital Investments, as Advisor to private equity firm Advent International and Board Member at Sanguine Biosciences. Mirsaidi also holds current appointments within Bridgewest Investment Group, that include the Investment Committee at Bridgewest Ventures New Zealand, and member of the Board of Directors at BioOra, LLC. Cyrus K. Mirsaidi steps in as Global CEO of Bridgewest Perth Pharma 44 PEOPLE NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
Arunish Chawla, IAS, previously serving as Officer on Special Duty, Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers has taken over the charge of Secretary, Department of Pharmaceuticals, effective November 1, 2023. Chawla has worked as Additional Chief Secretary, Planning and Development, with additional charge of Secretary, Bihar State Planning Board, Patna/ Project Director, Bihar Disaster Rehabilitation and Reconstruction Society, Patna; and Additional Chief Secretary, Urban Development and Housing and MD, Patna Metro Rail Corporation. He has also worked as a Senior Economist in the Institute of Capacity Development of the International Monetary Fund (IMF), Washington DC, US for a period of two years in 2020. S Aparna, a 1988-batch IAS officer of Gujarat cadre, was previously working as Secretary, DoP, from October 1, 2020. Aparna had then replaced Dr PD Vaghela who superannuated on September 30, 2020. Arunish Chawla steps in as Secretary, Department of Pharmaceuticals The Farrer Park Company in Singapore has announced the appointment of Kelly Yang as the Chief Executive Officer (CEO) of Farrer Park Hospital (FPH). Kelly will succeed Dr Timothy Low, the outgoing CEO, who is leaving to pursue other healthcare ventures and has been a driving force behind extensive innovation efforts at the hospital. Incoming CEO Kelly will continue to build on FPH’s culture of innovation and focus on the ethos of FPH and its vision and mission of comfort, fairness, and value. Kelly is a seasoned healthcare executive with two decades of in-depth industry experience locally and internationally. She has built an excellent reputation in managing various hospital projects and functions, including strategy development, planning and operations, clinical services, service delivery, quality matrix implementation, and talent acquisition for established and greenfield hospital groups. She is well acquainted with the American medical centre healthcare operation model. She has spearheaded projects with renowned medical institutions, including the Cleveland Clinic–LuYe Healthcare joint project and Columbia Heart Centre. She was also CEO of the UCLAR&F Hospital in Guangzhou and successfully delivered three independent hospital projects in Shanghai and Guangzhou. West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, has appointed Nilesh Shah to serve as Vice President (VP) and General Manager (GM) of Emerging Markets, based in Singapore. Overseeing the Asia Pacific and South America regions, Shah will be responsible for growing West’s presence and leadership in these markets. Shah joins West with a 25-year tenure in the medical devices industry, holding leadership roles at large corporations such as Johnson & Johnson, GE Healthcare, Fortive and Draeger. He cultivated his career from the United States, and later extended his international footprint to Italy, Germany, and Singapore, where he recently led the global commercial business for Advanced Sterilization Products-Fortive. 2023 marks West’s 100-year milestone of innovation and the critical role it continues to play in healthcare and the patient experience. Headquartered in the US, West in its fiscal year 2022 generated $2.89 billion in net sales. West Pharma appoints Nilesh Shah as VP and GM of Emerging Markets Farrer Park Hospital names Kelly Yang as CEO PEOPLE NEWS 45 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
The Hong Kong Polytechnic University (PolyU) has achieved another breakthrough in rehabilitation device development. The Mobile Ankle-foot Exoneuromusculoskeleton is the first-of-its-kind multimodal robot for anklefoot rehabilitation specifically designed for stroke patients with hemiplegia, which helps improve the motor function of their lower limb and walking ability. Powered by Internet of Things (IoT) technology, the device enables telerehabilitation for remote management of patients’ rehabilitation progress and allows them to undertake self-help rehabilitation exercises at home. Therapists can remotely monitor the rehabilitation progress of multiple patients. The device can not only correct foot drop and foot inversion effectively, but also improve the gait of stroke patients. Additionally, it can help improve balance while walking and contribute to rehabilitative neuroplasticity in the long term. The research team is collaborating with several local and Mainland hospitals and rehabilitation clinics to conduct clinical studies on the Mobile Ankle-foot Exoneuromusculoskeleton. Hong Kong designs multimodal robot for post-stroke ankle, foot tele-rehabilitation 46 R&D NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com Australia-based Griffith University’s Institute for Glycomics has received a $5 million philanthropic donation from the International Leducq Foundation to further the development of a vaccine to prevent Strep A infection and rheumatic heart disease in a world-first expanded clinical trial. As part of the research programme, and in collaboration with researchers at the Murdoch Children’s Research Institute, volunteers will be vaccinated and then given a deliberate Strep A infection to test the vaccine. The research will lead to Phase II studies where hundreds of volunteers will be vaccinated and followed to test the efficacy of the vaccine in a real-world setting. There is currently no vaccine available for rheumatic heart disease and Strep A, and natural immunity takes years to develop. Strep A is responsible for rheumatic heart disease and many cases of deadly invasive disease and toxic shock. World-first trial by Australia to test efficacy of Strep A and rheumatic heart disease vaccine Korea develops metal-enhanced fluorescence probes for influenza A virus detection In recent years, fluorescence-based lateral flow immunoassay (LFI) has gained popularity as a diagnostic tool for viral detection. It is a rapid virus detection platform which uses molecules that glow under special lighting conditions in the presence of a viral load. However, the performance of this detection platform is limited due to several issues related to detection sensitivity. In a recent study, a team of researchers from the Department of Chemistry at the Gwangju Institute of Science and Technology, South Korea has demonstrated that these fluorescence-based LFIs, when enhanced by gold nanorod (GNR)-based probes, could accurately and rapidly detect an influenza virus protein, without the need for complex diagnostic laboratory equipment. According to the researchers, the findings of this research can not only transform rapid testing in healthcare, but its scope can be also extended to other forms of biomolecule diagnostics, with the ultimate goal of improving people’s quality of life.
A microscopic discovery will not only enable scientists to understand the microbial world around us but could also provide a new way to control CRISPR-Cas biotechnologies. An international team of researchers from the University of Otago in New Zealand and the University of Copenhagen, Denmark has published a study revealing new ways viruses suppress the CRISPR-Cas immune systems of bacteria. This finding could teach us about microbial dynamics in the environment, be used to make gene editing safer, and lead to more efficient alternatives to antibiotics. A major interest in CRISPR-Cas lies in its programmable nature to precisely edit genomes – the Nobel Prize in Chemistry was recently awarded for this technology. Interestingly, anti-CRISPRs can be used as a safety switch to turn off or tune this technology. New Zealand uncovers new way viruses fight back against bacteria Diabetic patients, whose natural wound-healing capabilities are compromised, often develop chronic wounds that are slow to heal. Such non-healing wounds could cause serious infections resulting in painful outcomes such as limb amputation. To address this global healthcare challenge, a team of researchers from the National University of Singapore (NUS) have engineered an innovative magnetic wound-healing gel that promises to accelerate the healing of diabetic wounds, reduce the rates of recurrence, and in turn, lower the incidents of limb amputations. Each treatment involves the application of a bandage pre-loaded with a hydrogel containing skin cells for healing and magnetic particles. To maximise therapeutic results, a wireless external magnetic device is used to activate skin cells and accelerate the wound healing process. The ideal duration of magnetic stimulation is about one to two hours. Lab tests showed the treatment coupled with magnetic stimulation healed diabetic wounds about three times faster than current conventional approaches. Furthermore, while the research has focused on healing diabetic foot ulcers, the technology has potential for treating a wide range of complex wounds such as burns. Singapore offers innovative magnetic gel to heal diabetic wounds faster Researchers from the Indian Institute of Technology (IIT) Mandi, the Institute for Stem Cell Science and Regenerative Medicine (inStem) in Bengaluru, have discovered the biochemical processes that enable the eggs of the dengue-causing mosquito to survive harsh conditions and rejuvenate when favourable conditions return. This research marks a significant stride in our battle against mosquitoborne diseases, offering hope for more effective vector control measures. The collaborative team reared Aedes aegypti mosquitoes, studying their eggs through a series of innovative experiments. By subjecting the eggs to dehydration and subsequent rehydration, they discovered that the developing larvae undergo specific metabolic changes required for survival. The implications of this research are far-reaching. Understanding these survival mechanisms provides a foundation for innovative mosquito control strategies. By disrupting the desiccation tolerance of mosquito eggs, researchers anticipate a significant reduction in mosquito populations and disease transmission. The understanding gained from this work could potentially prevent the resurgence of mosquitoes following monsoon rains, a period traditionally associated with increased disease transmission risks. New research unveils innovative mosquito control strategies in India R&D NEWS 47 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
US-based Parse Biosciences, a leading provider of accessible and scalable single cell sequencing solutions, has announced an agreement with India-based Spinco Biotech to further extend its reach in Asia. This is Parse’s latest expansion in the Asia Pacific (APAC) region following an agreement last year with Research Instruments to distribute its products in Southeast Asia. The company’s agreement with Spinco Biotech will give researchers in India full access to its single cell portfolio, including Evercode Whole Transcriptome, Evercode TCR, Evercode Cell Fixation, Evercode Nuclei Fixation, Gene Capture, CRISPR Detect, and the Parse Biosciences data analysis solution. The agreement is a continuation of Parse’s ongoing introduction of its products in key international markets, which are also currently available in North America, Europe, Australia, South Korea, Singapore, Israel, and New Zealand. With technology developed at The University of Washington by co-founders Alex Rosenberg and Charles Roco, Parse has raised over $50 million in capital and is now used by over 1,000 customers across the world. Parse Biosciences extends Asia reach with India’s Spinco Biotech partnership Germany-headquartered manufacturer of laboratory instruments and consumables, Eppendorf has launched Mastercycler X40 for daily lab routines that will not only be reliable and efficient but elevated. The new product offers proven reliability and the highquality thermal cycler is now available for every lab. Reproducible nucleic acid amplification and reliable temperature homogeneity are a must for the Mastercycler X40 PCR cycler. Combined with the intuitive touch-screen user interface and ergonomic one-hand operation, the new Mastercycler X40 raises the standard in PCR. 0.1 mL, 0.2 mL tubes or tube strips and any type of 96-well PCR plate can be used. The SafeLid securely protects the samples from evaporation. The 12-column gradient facilitates optimisation of different temperature steps in the PCR protocol. With its borosilicate glass being the gold standard for storing lifesaving medications for more than a century, German firm Schott is now taking the next step by introducing improved glass tubing to the global pharma market. FIOLAX Pro is a new type I borosilicate glass, designed to meet three major trends in the industry: increasingly complex pharmaceuticals, sustainable products and circular economy, and digitalisation. FIOLAX Pro has superior chemical quality, such as an improved Extractables & Leachables (E&L) profile and hydrolytic resistance and is completely free of heavy metals. The company plans to produce the new FIOLAX Pro with green energy and significantly reduce the Product Carbon Footprint (PCF). Schott just recently received funding from the German Federal Ministry for Economic Affairs and Climate Action to build the first climate-friendly glass melting tank. The pilot tank will be constructed at the company’s site in Bavaria, Germany, and produce the pharmaceutical glass largely without causing greenhouse gas emissions. Eppendorf unveils Mastercycler X40 for daily lab routine work Schott introduces improved glass tubing for global pharma market 48 SUPPLIER NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com
Qiagen launches new QIAcuity digital PCR kits & updated software Qiagen has announced the launch of new kits for use on its QIAcuity systems and a major new software update designed to expand the portfolio of applications for use of digital PCR technology in areas like cell and gene therapies, DNA and RNA quantification, as well as food and pharmaceuticals safety. The QIAcuity Mycoplasma Quant Kit offers researchers an accurate and precise way to detect mycoplasma contaminants in all steps of research and manufacturing of cell and gene therapies. While the QIAcuity OneStep Advanced EG Kit allows researchers the highly sensitive quantification of RNA or RNA alongside DNA in one reaction. The kit uses intercalating dye technology that makes procedures easier to design and more costefficient than those used in fluorescent-probe-based PCR. Additionally, Qiagen is launching the QIAcuity Software 2.5 update. It is designed to help researchers determine two key features of digital PCR analyses. Using the functionality of a temperature gradient, the software will allow them to determine the precise temperature at which their experiment should run, saving the need to put the sample through an external thermocycler during the development of tests to target specific genetic building blocks. American company Thermo Fisher Scientific Inc. and Sweden-headquartered Olink Holding AB have announced that their respective boards of directors have approved Thermo Fisher’s proposal to acquire Olink for $26 per common share in cash, representing $26 per American Depositary Share (ADS) in cash. The transaction values Olink at approximately $3.1 billion which includes net cash of approximately $143 million. Olink is on track to deliver over $200 million of revenue in 2024 and, as part of Thermo Fisher, is expected to grow mid-teens organically. Upon completion of the acquisition, Olink will become part of Thermo Fisher’s Life Sciences Solutions segment. Olink offers leading solutions for advanced proteomics discovery and development, enabling biopharmaceutical companies and leading academic researchers to gain an understanding of disease at the protein level rapidly and efficiently. Olink’s proprietary technology, Proximity Extension Assay (PEA), provides high throughput protein analysis for the very large installed base of qPCR and next-generation sequencing readout systems in the market. Thermo Fisher buys Olink to enhance capabilities in highgrowth proteomics market Waters accelerates oligonucleotide bioanalysis with launch of OligoWorks SPE workflow and kits SUPPLIER NEWS 49 BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com US-headquartered Waters Corporation has announced the launch of OligoWorks SPE (solid phase extraction) kits and components to improve sample preparation for LC-MS-based bioanalytical quantitation of therapeutic oligonucleotides. Pharma and biopharma companies developing oligonucleotide therapeutics and the Contract Research Organisations (CROs) that support them can now realise up to a 2x increase over competing products in oligonucleotide recovery from biofluids. The kits deliver greater reproducibility and LC-MS sensitivity, enabling lower limits of quantitation and reducing the need for repeat experiments. The pipeline for oligonucleotide therapeutics is rapidly expanding with 13 FDA approved oligonucleotide therapeutics, and 500+ in the pipeline. While potent, these highly modified oligonucleotides are challenging to precisely quantify during dosing, metabolism, and tissue distribution studies.
Adding Value to Valued Senior Citizens Life expectancy, across the world, has increased in the past few decades. Most people, today, can expect to live well into their sixties and beyond. Every country in the world is experiencing growth in both the size and proportion of senior in the population. According to the World Health Organization (WHO) 2022 report, the pace of population ageing is much faster than in the past. In 2020, the number of people aged 60 years and older outnumbered children younger than five years. Between 2015 and 2050, the proportion of the world’s population over 60 years will nearly double from 12 to 22 per cent. By 2030, 1 in 6 people in the world will be aged 60 years or over. At this time the share of the population aged 60 years and over will increase from 1 billion in 2020 to 1.4 billion. By 2050, the world’s population of people aged 60 years and older will double (2.1 billion). The number of persons aged 80 years or older is expected to triple between 2020 and 2050 to reach 426 million. While this shift in distribution of a country’s population towards older ages – known as population ageing – started in high-income countries (for example in Japan, 30 per cent of the population is already over 60 years old), it is now low- and middle-income countries (LMICs) that are experiencing the greatest change. By 2050, two-thirds of the world’s population over 60 years will live in LMICs. The population in WHO South-East Asia Region that includes India, Korea and Thailand is ageing rapidly. While the proportion of people aged 60 or above was 9.8 per cent in 2017, it will be increased to 13.7 per cent and 20.3 per cent by 2030 and by 2050, respectively. Similarly, the Western Pacific Region of WHO that includes China and Australia has one of the largest and fastest growing older populations in the world. There are over 700 million people aged 65 and over in the world and more than 240 million of them reside in the Western Pacific Region. This number is expected to double by 2050. China has one of the fastest growing ageing populations in the world. By 2019, there were 254 million older people aged 60 and over, and 176 million older people aged 65 and over. By 2040, an estimated 402 million people (28 per cent of the total population) will be over the age of 60, due to longer life expectancy and declining fertility rates. China has been exploring innovative approaches to improving access to integrated care, including the establishment of an internetbased medical information platform. This huge demographic shift presents many new challenges and opportunities for public health and socioeconomic development – in particular, the development of an integrated system that caters to the health and social needs of older people, with equal access to healthcare regardless of geographical area. With a rapidly ageing population, there is a vital need to create age-friendly cities and communities where older people can thrive and continue to make meaningful contributions to society. Responding to the issue of ageing, WHO and UN partners have launched the first UN Decade of Healthy Ageing progress report, on November 22, which charts efforts to improve the lives of older people since 2020, capturing the impact of major challenges such as COVID-19, during which over 80 per cent of deaths were among over 60-yearolds. The report also highlights activities in support of healthy ageing in nearly 50 countries. In addition, WHO, in collaboration with Age and Ageing, the journal of the British Geriatrics Society, has released a Special Issue on Measurements of Healthy Ageing on October 30. The Special Issue is showcasing the work of international professionals and experts from over 40 academic institutions to identify the best available tools to measure what truly matters to older people – their intrinsic capacity and functional ability. By understanding and addressing the unique needs and abilities of older people, societies can progress towards a world where everyone ages with dignity and fulfillment. Narayan Kulkarni Editor [email protected] 50 LET’S TALK HEALTH BIOSPECTRUM | DECEMBER 2023 | www.biospectrumasia.com