Understanding FDA Guidance Development and Implementation —Delivered by Asian Women Scientists for FDA (AWS4FDA)

Speaker:

Florence Houn, MD MPH FACP

Former Director, Office of Drug Evaluation III, CDER, FDA

Moderator/Panelist:

Jingyu (Julia) Luan, PhD, RAC, Former Statistical Team Leader and Acting Deputy Division Director, CDER, FDA

Panelists:

Jinjie Hu, PhD, Former Senior IVD and CMC Reviewer, CBER, FDA

Audrey Jia, PhD, Former Senior CMC Reviewer, CDER, FDA

Sharon Liang, MD PhD RAC, Former Device Team Leader, CDRH, FDA

Jing Zhang, MD PhD, Former Clinical Team Leader, CDER, FDA

Speaker: Florence Houn, MD MPH FACP

Owner-manager, Florence Houn MD MPH LLC

Former Director, Office of Drug Evaluation III, CDER, FDA

Former VP for Global Regulatory Science at Bristol-Myers Squibb/Celgene

Former senior official in FDA CDER, CDRH and CBER

DHHS Secretary’s Award for Distinguished Service

DHHS Career Achievement Award

FDA Distinguished Alumni Award

 

Moderator/Panelist: Jingyu (Julia) Luan, PhD RAC

Global Regulatory Affairs Director, AstraZeneca

Former Statistical Team Leader and Acting Deputy Division Director, CDER, FDA

FDA CDER Excellence in Mentoring Award

FDA CDER Leadership Excellence Award Board Member,

Vice president, Chinese Biopharmaceutical Association (CBA)

Board Member, Committee Co-chair, FDA Alumni Association (FDAAA)

Panelist: Jinjie Hu, PhD

President and Principle Consultant of Axteria BioMed Consulting (ABC)

Chief Regulatory Officer at Laboratory of Advance Medicine

Former Senior IVD and CMC Reviewer, CBER, FDA

Former senior consultant at Biologics Consulting Group (BCG)

Scientific advisor, dossier reviewer and manufacturer facility inspector for the In Vitro Diagnostic Pre-Qualification Program at WHO

Chair for the International Network Committee of the FDA Alumni Association (FDAAA)

Panelist: Audrey Jia, PhD

Principal Consultant, DataRevive USA LLC

Former Senior CMC Reviewer, CDER, FDA

20 years of combined experience in biologic drug development and regulatory review

Helped many companies filed US INDs/BLAs successfully

Expert in biopharmaceutical companies working on monoclonal antibody engineering, humanization, affinity maturation, expression, and purification

Expert in IND/BLA filing, cGMP pre-approval inspections (PAIs)

Panelist: Sharon Liang, MD PhD RAC

Senior Regulatory Affairs Director, GRAIL, Inc.

Former Senior Lead Reviewer and Team Leader, CDRH, FDA

MDIC RWE Working Group member for COVID-19 IVD tests FDA Steering

Committee member and Lead for Precision Medicine Initiative (PMI) Bioinformatics Working Group

FDA Commissioner’s Special Citation Award

FDA Outstanding Service Award

Panelist: Jing Zhang, MD PhD

CMO, Axter Therapeutics

Executive Director, CNS, R&D, AbbVie/Allergan Director, CNS, R&D, Janssen (J&J)

Former Clinical Team Leader, CDER, FDA

More than 10 years drug regulatory experience

Five years industry drug development experience

Expert in CNS new drug development