Boon Meow Hoe holds a Bachelor’s degree in Pharmacy from the National University of Singapore.
After graduation, he served in the commercial pharmaceutical manufacturing industry for 15 years.
He is an active Senior GMP Auditor conducting both local and overseas GMP audits since year 2001. He is also the Deputy Director of Overseas Audit Unit, Audit Branch, Audit & Licensing Division at the Health Products Regulation Group of the Singapore Health Sciences Authority (HSA).
Outside of Singapore, he was an elected Pharmaceutical Inspection Co-operation Scheme (PIC/S) Chairman cum Member of the PIC/S Executive Bureau for year 2018 to 2019. He continues to serve as the official HSA Representative in the PIC/S Committee of Officials.
Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action recommendations relating to inspections and manufacturing site acceptability, and promoting sound regulatory policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.
Kai Yee is an Executive Coach specializing in team and leadership development. He is the founder of Teambiosis, a company dedicated to cultivating great leaders and high-performance teams. Additionally, he serves on the faculty of an international coach training school where he trains and mentors coaches.
With over three decades of experience in the biopharmaceutical industry, Kai Yee has held senior positions in manufacturing, HR, and culture change.
He is a Professional Certified Coach accredited by the International Coaching Federation and possesses an Advanced Certification in Team Coaching. He also holds an honours degree in Chemical Engineering and an MBA.
Driven by a passion for innovation, she accumulated 17 years of experience at GSK across Research, Development and Manufacturing in scientific roles to introduce advanced technologies and innovations that help deliver quality medicines faster and more effectively to patients.
In 2017, she led the Singapore Advanced Manufacturing Technologies team to initiate Digital Twin, Advanced Analytics and Process Intensification solutions and co-led the Digital, Data and Analytics transformation of its Small Molecule API manufacturing site.
Currently, as Program Manager in Global Innovation & Manufacturing Technologies, she is a dynamic innovator who incubates and amplifies internal and external capabilities by unlocking the untapped potential of people, process, science and technology.
She strongly believes in knowledge sharing and digital transformation, and has thus recently embarked to lead an enterprise project to digitise our Tech Transfer activities for GSK’s CMC organisation.
Kai Yin is an Associate Principal Scientist at MSD International GmbH for the Asia Pacific Region. With over 15 years of Biopharmaceutical experience, she specializes in monoclonal antibodies and vaccine platforms. Previously, she held leadership roles in the Quality organization at manufacturing sites before transitioning to the field of CMC regulatory. Kai Yin holds a Bachelor Degree in Applied Chemistry from the National University of Singapore. She is passionate about staying updated on technological advancements in the biopharmaceutical industry and aims to contribute to the integration of these innovations into future regulatory and quality frameworks.
Dr. Peter Qiu is the External Advocacy Lead China at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.
Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.
Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.
Ben Stevens is a Director of CMC Policy and Advocacy at GSK and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam where he led the clinical regulatory CMC development of Vutrisiran prefilled syringe in over 30 countries, and the initial US NDA and EU MAA submissions, including one of the earliest Notified Body assessments under the newly implemented EU MDR. Before Ben joined Alnylam, he was a Principal Consultant at PAREXEL and an acting Branch Chief in the Office of New Drug Products (ONDP) at the FDA. At FDA, Ben worked closely with several key policy groups (OPPQ, ORP), partnered with CDRH on matters related to combination product review, and was a government liaison to USP. Before FDA, Ben spent seven years in medicinal chemistry R&D at Pfizer and Merck. Ben has broad regulatory CMC experience in small molecules, peptides, oligonucleotides, botanicals, and combination products. At GSK, Ben leads CMC policy and advocacy for several priority areas, including biologics, CGT, oligonucleotides, and advanced manufacturing. Ben represents GSK in numerous external trade and association working groups (e.g., PhRMA, BIO, IQ, EFPIA, NIIMBL, ISPE, PDA, Biophorum), where he has led and supported policy positions and interactions with global regulators. He received a Ph. D. in Chemistry from the University of Pittsburgh, a M.P.H. from the Johns Hopkins Bloomberg School of Public Health, and is a co-author of over 30 publications and patents.
Edward C. Tidswell, BSc, PhD - Dr. Tidswell is Executive Director within the Microbiological Quality and Sterility Assurance organization of Merck with ownership over sterility assurance and microbiology quality and compliance issues across all sterile and non-sterile products and manufacturing. His prior appointments include senior global R&D, and quality leadership roles across diverse drug, device and biologics portfolios for the likes of Baxter Healthcare, Eli Lilly and Evans Vaccines. Dr Tidswell actively publishes and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacturing (ORCID: 0000-0003-0069-1967). Currently a member of the PDA Journal’s Editorial Board. Since June 2010 Dr. Tidswell is honored to serve and is currently Vice Chair on the USP’s Expert Committee for Microbiology.
Wallace I. Torres is the VP Site Operations for Amgen Singapore Manufacturing (ASM). He is responsible for the Biologics and Synthetics manufacturing operations in Amgen Singapore.
Wallace is a Senior executive with experience in achieving Quality, Strategic and business growth objectives internationally and within changing environments. Extensive experience on pharmaceutical quality and manufacturing operations with more than 30 years of experience, Wallace worked for 25 years at Hoffmann La Roche in several positions in the QC/QA, Manufacturing, Strategy, and Supply Chain areas. In 2013 he joined Amgen with responsibilities ranging from Quality director to VP of Manufacturing.
His experience includes responsibilities as Manufacturing Site Head, Global Head of Risk Management, Global Quality Manager, and QA/QC Head at Contract Manufacturing facilities. During the years, he also held several leadership positions in Switzerland, USA, Mexico, Brazil, and Singapore.
He holds a Bachelor degree in Biology from the University of Puerto Rico, a Master in management from the University of Phoenix, a Master in Advance Management Practices from the University of South Australia, and a PhD in International Business Management from the Swiss Business School.