The Rise of Asia Pacific: Learning From the Region’s Leaders and Innovators
Organized by: ISCT Asia Regional Executive Committee
Summary of Key Points from ISCT 2024 Vancouver Roundtable session on May 31, 8 am
Moderator:
Steve Oh, PhD - Independent Cell Therapy Leader, Singapore
Panelists:
Camie Chan, MS, PhD - Xellera Therapeutics, Hong Kong
Chae-Ok Yun, MSc, PhD - GeneMedicine, Korea
Gayatri Sharma, MSc, PhD - Cellvec Pte Ltd, Singapore
Shin Kawamata, MD, PhD - Cyto-Facto, Japan
Growth and Opportunities in Asia Pacific
The discussion highlighted the significant growth and vast opportunities in the cell and gene therapy (CGT) sector across the Asia Pacific region. Panelists emphasized that Asia Pacific represents one of the fastest-growing markets for CGT globally, driven by increasing healthcare expenditure, rising prevalence of chronic diseases, and growing investment in biotechnology research and development.
Each panelist provided insights into their respective countries' opportunities. Singapore is positioned as a strategic hub for CGT development and manufacturing, leveraging its advanced infrastructure and supportive regulatory environment. Hong Kong's proximity to China and its established healthcare system were seen as key advantages, particularly in accessing the vast Chinese market. Korea's CGT market was projected to reach $1 billion by 2027, reflecting the country's rapid advancement and strong government support. Japan's focus on supporting the industry through manufacturing initiatives was highlighted, emphasizing its strengths in process development and quality control.
The discussants also touched upon broader regional opportunities, including large and diverse patient populations for clinical trials and strong manufacturing capabilities. Increasing investment from local governments and international pharmaceutical companies, the emergence of biotech startups, and the expansion of research institutions were noted as creating a vibrant ecosystem for innovation.
The growing middle class and aging population in many Asian countries were identified as key factors driving market growth. Overall, the panelists agreed that the Asia Pacific region offers immense potential for the CGT sector, spanning research, clinical development, manufacturing, and commercialization.
Regulatory Challenges and Harmonization
A key theme that emerged during the roundtable was the need for greater regulatory harmonization across different countries in the Asia Pacific region. The panelists acknowledged that while many Asian nations are working to align their regulatory frameworks with global standards such as those set by the FDA and EMA, significant variations in interpretation and implementation remain.
The discussion highlighted the adoption of PIC/S GMP (Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice) standards by several countries in the region, including Singapore and Hong Kong. This was seen as a positive step towards harmonization, particularly in manufacturing practices. However, the panelists noted that interpretation and application of these standards can still vary between countries.
To address ongoing challenges, the panelists proposed several opinions:
- Increased engagement between regulators, developers, and patient groups to foster mutual understanding and collaboration.
- Formation of regional alliances to work collectively with regulators, promoting a more unified approach to CGT regulation.
- Writing a joint opinion white paper on regulatory best suitable practices for CGT in the region.
The panelists agreed that while achieving full harmonization is complex, these initiatives would significantly benefit the CGT field in Asia Pacific, fostering innovation and improving patient outcomes.
Reimbursement and Access Challenges
One of the most significant challenges discussed was the issue of reimbursement and access to CGT products. The high cost of these therapies, often exceeding $500,000 per treatment, poses a major barrier to patient access in most Asian countries. The panelists explored various solutions to this problem, including the development of multi-payer systems that combine contributions from governments, insurance providers, hospitals, and patients. They also discussed the potential of localized manufacturing to reduce costs, as well as innovative funding approaches such as crowdfunding and installment payment options to make treatments more accessible to patients.
Role of CDMOs in the Region
The role of Contract Development and Manufacturing Organizations (CDMOs) in the region was another key topic of discussion. The panelists representing CDMOs outlined how their organizations support the growing CGT industry in Asia well. They emphasized the importance of offering flexible support for startups, providing end-to-end services from vector design to clinical manufacturing, and helping to educate and guide companies through the complex development process. The unique perspective that CDMOs in the region can offer, particularly in understanding the challenges faced by startup companies, was highlighted as a valuable asset to the industry.
Education and Training
Education emerged as a critical theme throughout the roundtable. The panelists agreed on the need for comprehensive education programs to train healthcare professionals, researchers, and regulators on the complexities of CGT development and manufacturing. This was seen as essential not only for advancing the field but also for ensuring the safe and effective implementation of these therapies across diverse healthcare systems in the region.
Conclusion and Future Outlook
In conclusion, the roundtable discussion provided a comprehensive overview of the current state and future potential of the cell and gene therapy industry in Asia Pacific. The panelists highlighted the significant growth and opportunities in the region, while also candidly addressing the challenges that need to be overcome. They agreed that the future of CGT in Asia Pacific is promising, but realizing this potential will require continued collaboration among industry stakeholders, regulators, and healthcare providers. With its rapid growth, large patient populations, and strong manufacturing capabilities, Asia Pacific is positioned to play an increasingly important role in the global CGT landscape. The insights shared during this roundtable provide a valuable roadmap for stakeholders working towards advancing the field in the region, highlighting both the challenges to be addressed and the opportunities to be seized as Asia Pacific continues its rise in the global CGT landscape.
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