The Emerging ATMP Industry in Thailand: Latest Regulatory and Clinical Developments

When:  Sep 28, 2023 from 09:00 to 11:00 (ICT)

Contact

Elizabeth Lam

elizabeth@isctglobal.org


The Emerging ATMP Industry in Thailand: Latest Regulatory and Clinical Developments

Presented by the ISCT Asia Regional Executive Committee

Part 3 of the ISCT Asia Webinar Series

 

Thailand is strategically poised to establish itself as a prominent medical hub in the Asian region, boasting an exceptional medical infrastructure, skilled healthcare specialists, and a multitude of internationally accredited medical facilities. Consequently, Thailand's medical services have garnered global recognition.


Advanced Therapy Medicinal Products (ATMPs) are promising medical products that will break through the constraints of current standard therapies.  The burgeoning ATMP manufacturing sector in Thailand is facing considerable demand from advanced therapy service sites.  Additionally, technology and manufacturing standards are being established based on FDA guidelines to support sustainable development, and the Thai government has progressive policies and incentives to support this growing sector.  


Key Learning Objectives: 

To provide information about the promotion and development of the ATMP industry in Thailand including:

  • Market authorization
  • Product development (specifically clinical phase)
  • Government support policy for ATMP manufacturing investment 
  • Example from the Thai private sector - successful regulatory approval process


Chair:

 

Chaiyong Koaykul, PhD

Lecturer, Faculty of Medicine, Chulalongkorn University, Thailand
General Manager, Excellence Center for Advanced Therapy Medicinal Products (EC-ATMPs), King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Thailand

Thailand

 










Speakers:

 

Piyanan Boonprasirt, PhD

Pharmacist, Professional Level, ATMPs & Biological Products, Medicines Regulation Division, Thai Food and Drug Administration

Thailand

Regulatory Framework for ATMPs in Thailand 

Piyanan Boonprasirt, she is a Professional Level Pharmacist who works at ATMPs & Biological Product Sub-Unit, Medicines Regulation Division, Thai FDA.
She got a BSc in Pharmaceutical Science (BPharm) from Prince of Songkla University, Thailand, an MSc in Pharmaceutical Biotechnology from the University of Greenwich, and a PhD in Chemical Engineering from the University of Bath, United Kingdom. She has been with the Thai FDA since 2013 responsible for the approval of biological products such as monoclonal antibodies, blood products, vaccines and ATMPs. As the ATMPs regulation focal point, she has got involved in scientific and regulation consultation, human resource capacity building, and developing relevant guidelines for ATMPs.


 

Nusara Satproedprai, PhD

Deputy Director, Medical and Health Division, Eastern Economic Corridor Office of Thailand

Thailand

Thailand's Readiness in Advanced Medical Industry and Investment Opportunities in the Eastern Economic Corridor (EEC) 

 

Nusara studied medical technology at Faculty of Allied Health Sciences at Chulalongkorn University in Bangkok, Thailand and she received Ph.D. in microbiology and immunology with focus on molecular biology from Virginia Commonwealth University where she developed her interests in gene expression analysis, gene signaling and human genetics. After graduation, she joined the Department of Medical Sciences at the Ministry of Public Health, Thailand where she continued her research in development of the novel methods for infectious disease diagnosis using molecular techniques and studied human genetic factors associated with susceptibility to infectious diseases. Nusara is also the founding members of the national strategic project on population genetics entitled “Genomics Thailand” and the committee of the medical technologist council of Thailand. She joins Eastern Economic Corridor Office in 2021 to work on promoting investment in medical industry of Thailand.

Prof. Yingyos Avihingsanon, MD

Deputy Director for Medical and Research Affairs
King Chulalongkorn Memorial Hospital, Thai Red Cross Society

Thailand

Clinical Development Promotion of Advanced Therapy Medicinal Products


Yingyos Avihingsanon graduated with a Medical Degree in 1990 from Chulalongkorn University, Thailand. Then, he completed a diploma from The Thai Board of Internal Medicine (Nephrology) in 1996 and a Master's in Science in 1999. After that, he was a research fellow at Immunobiology Research Center, Harvard Medical School, USA. He received a president's fellowship and young investigator awards from the American Transplant Society in 2000 and 2003, respectively. Moreover, he also obtained a young researcher award from Thailand Research Fund and an ISN fellow poster award from the International Society of Nephrology in 2006 and 2009, respectively. In 2012, he was promoted to Professor at the Faculty of Medicine, Chulalongkorn University. Moreover, he was a director of the University Tech Center (UTC) of Chulalongkorn University and a Chairman of the Training panel of Thailand's Medical Product Consortium under the Thai FDA, Ministry of Public Health. Now, he is a Deputy Director for Medical and Research Affairs, and Chief of the Division of Nephrology, Department of Medicine at King Chulalongkorn Memorial Hospital, the Thai Red Cross Society.

 


Kitipong Uaesoontrachoon, PhD

Chief Scientific Officer, Genepeutic Bio Co., Ltd., Thailand

Thailand

CD19 allogenic CAR T-cells for treatment of pediatric patients with 
Relapsed/Refractory B-cell Malignancies

Dr. Uaesoontrachoon has been involved in the gene therapy field for more than a decade, starting with the neuromuscular diseases. Under his guidance, promising therapies have either entered into various phases of clinical trials or received accelerated approval for use by The Food and Drug Administration (US FDA). He received his PhD in molecular and cellular biology from the University of Melbourne, Australia and post-doctoral training in the laboratories for genetic medicines at Children’s National Medical Center, Washington, DC. He held an Adjunct Professorship in Department of Pharmacology at Dalhousie University, Halifax, Canada, and served as the Principal Director of Research at AGADA Biosciences overseeing their entire pre-clinical trials and clinical testing operations. Currently, he holds a Chief Scientific Officer position at Genepeutic Bio, a CDMO specializing in manufacturing CAR-T cells for treatment of various forms of cancer.