Hsiao-Ling Hung

President
Taiwanese American Association of Biotechnology
Former SVP Regulatory Affairs, Ambrx Biopharma
Former Senior Director Regulatory Affairs, Bristol Myers Squibb

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Hsiao-Ling is currently an independent consultant providing regulatory strategy services to over 20 biopharmaceutical companies, President of Taiwanese American Association of Biotechnology, and volunteer organizer for Taiwan Innovative Drug Alliance Regulatory Strategy and Clinical Development & Operations Discussion Groups.
Her past professional experience includes Senior VP, RA/QA at Ambrx, a public clinical-stage biotech company that focuses on developing Engineered Precision Biologics, Sr Director in Global Regulatory Sciences at Bristol-Myers Squibb, leading regulatory strategy and managing regulatory staff for the Opdivo portfolio, Director of US and International Regulatory Affairs at Johnson & Johnson in Oncology and Immunology.
Prior to a career in regulatory affairs, Hsiao-Ling was a preclinical scientist for over 20 years, leading the discovery and preclinical research programs of compounds across multiple therapeutic areas.
Hsiao-Ling received a B.S. in Medical Technology from the National Taiwan University and a Ph.D. in Pathology and Molecular Biology from the University of Pennsylvania. 


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Speech title & Synopsis

From Drug Approval Differences by Major Health Authorities to Illustrate Challenges in Harmonization & Reliance: OPDIVO Case Study

Concerted efforts in recent years in benchmarking, harmonization, reliance and convergence by major health agencies, ICH and WHO, have resulted in reducing the time lag of drug approvals among countries.  In this presentation, the speaker uses the vantage point of a former global regulatory leader at Bristol Myers Squibb, to illustrate the challenges faced in indication harmonization and experience in participating in the US FDA Project Orbis, using Opdivo as a case study.
Opdivo is approved worldwide in over 11 cancer types and close to 30 indications. In about 70% of the approved indications, there is global harmonization of the indication languages. In 30% of the approved indications, there are differences in the approved patient populations by the FDA and EMA, even though the assessments were based on the same pivotal study data. The speaker will illustrate the different approaches taken by the HAs to assess efficacy data and arrive at conclusion of the benefit risk profiles. In addition, the speaker led the first BMS participation in the FDA Oncology Center of Excellence Project Orbis. She will share key learnings from this experience.