Advanced Therapeutics


    13 January 2016 - 15 January 2016
    09:00am - 05:00pm


    Duke-NUS Medical School; Amphitheatre Level 2

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Advanced Therapeutics


13-15 January 2016

Amphitheatre, Level 2

Duke-NUS Medical School


The Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School held an “Advanced Therapeutics Workshop” from 13 – 15 January 2016, bringing together 93 speakers and participants from international and ASEAN regulatory authorities, government agencies, industry, academia, healthcare providers and research institutions. 



The workshop provided a neutral academic forum for sharing and learning of experiences in the challenging area of regulating advanced therapeutic products, developing a better understanding of relevant regulatory requirements and systems in more advanced jurisdictions, and identifying opportunities for regulatory convergence in this field. 



Participants found the workshop very helpful in gaining a better understanding of the scientific fundamentals of advanced therapeutics, the basis of existing regulatory frameworks, and experiences faced by different regulatory authorities. 



The workshop concluded with an emphasis on early and continued engagement amongst multiple stakeholders as an important step to move forward and strengthen regulatory processes and frameworks, to enhance robustness, flexibility and alignment with the latest scientific perspectives in this field.


Leveraging on the knowledge and expertise of the international experts present at the workshop, a closed-door roundtable was held on the afternoon of 15 January to discuss and identify practical steps to enhance the regulation of advanced therapeutics in Asia. The roundtable participants, including regulators and industry representatives, contributed helpful advice and opinions on identifying priority areas and feasible actions towards capacity building in Asia through a more constructive platform for better collaboration between regulators and key stakeholders. The roundtable discussion and recommendations will be reported in a white paper later in 2016.


Speakers of the event

Asst Prof Raymond Chua

Group Director,
Health Products Regulation Group
Health Sciences Authority

Professor Dario Campana, MD, PhD

Mrs. Lee Kong Chian Chair in Advanced Cellular Therapy Professor,
Department of Paediatrics Yong Loo Lin School of Medicine,
Centre for Translational Medicine
National University of Singapore


Patrick Celis, PhD

Committee Secretariat
Scientific Committee
Support Department Committee for Advanced Therapies,
European Medicines Agency

Willis H. Ennis

Associate Vice President
Biologics Quality Operations Platform
Global Manufacturing Quality Operations,


Donald W. Fink, Jr., PhD

Center for Biologics Evaluation and Research (CBER),
Office of Cellular, Tissue and Gene Therapies,
Division of Cell and Gene Therapy Cell Therapy Branch,
U.S. Food and Drug Administration

Goh Choon Wee

Regulatory Consultant
GMP and Licensing Unit Audits Branch,
Audit & Licensing Division,
Health Products Regulation Group,
Health Sciences Authority


Ian Harris, PhD

Product Development Team Leader
Cell Therapy
Janssen Research & Development, LLC

Srinivasan Kellathur, PhD

Advanced Therapeutic Products Unit
Pre-Marketing Division
Health Products Regulation Group
Health Sciences Authority, Singapore


Tae-Gyun Kim, PhD

Deputy Director
Cell and Gene Therapy Products Division
Korea Ministry of Food and Drug Safety

Yoshiaki Maruyama, PhD

Review Director
Office of Cellular and Tissue-based Products,
Pharmaceuticals and Medical Devices Agency,


Savita Nandal, MD

Head of Medical Oncology
Novartis (Singapore) Pte Ltd

Ong Lee Lee, PhD

Senior Regulatory Specialist
Advanced Therapeutic Products Unit
Pre-Marketing Division
Health Products Regulation Group
Health Sciences Authority, Singapore


Daisaku Sato, PhD

Office of Cellular and Tissue - based Products,
Pharmaceuticals and Medical Devices Agency, Japan

Katherine A. Tsokas, JD

Senior Director, Global Regulatory Affairs,
Johnson & Johnson


A/Prof John Lim

Executive Director, CoRE, Duke- NUS & Deputy Director of Medical Services (Industry & Research Matters), Ministry of Health, Singapore