An Overview of FDA Covid-19 Guidance
Delivered by Asian Women Scientists for FDA (AWS4FDA)
Presentation Title: An Overview of the FDA Guidance to Industry on the Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
Oct 5, 2020, Monday 20:00 (EST)/17:00 (PST)
Registration: bit.ly/35NPB42
Speaker: Florence Houn, MD MPH FACP, Owner-manager, Florence Houn MD MPH LLC; Former Director, Office of Drug Evaluation III, CDER, FDA
Dr. Houn
Abstract:
This webinar will review the content of the “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” (March 2020,updated July 2020) to ensure participants understand the FDA recommendations for industry. Afterwards, a panel of experts will share their advice in response to participants’ questions.
In the US, on January 31, 2020, the US Department of Health and Human Services declared a public health emergency (PHE) in response to COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2. To control COVID-19, measures have been implemented to reduce spread of the virus such as shutdowns and reduced in-person contact. Both the pandemic and PHE actions have impacted the conduct of clinical trials for medical products. To assist continued drug development, the Food and Drug Administration (FDA) issued its guidance to industry, investigators, and institutional review boards. The webinar will focus on the guidance’s general considerations to assist the pharmaceutical industry in assuring safety of trial participants, maintaining compliance with good clinical practice and minimizing risk to trial integrity during the COVID-19 PHE.
Guidance: https://www.fda.gov/media/136238/download
Moderator/Panelist: Jingyu (Julia) Luan, PhD RAC, Regulatory Affairs Director, AstraZeneca; Former Statistical Team Leader, CDER, FDA
Dr. Luan
Panelists:
Jinjie Hu, PhD, President and Principle Consultant of Axteria BioMed Consulting; Former Senior IVD and CMC Reviewer, CBER, FDA
Dr. Hu
Audrey Jia, PhD, Founder and Managing Director, DataRevive USA LLC; Former Senior CMC Reviewer, CDER, FDA
Dr. Jia
Sharon Liang, MD PhD RAC, Senior Regulatory Affairs Director, GRAIL, Inc.; Former Device Team Lead, CDRH, FDA
Dr. Liang
Jing Zhang, MD PhD, Executive Director, AbbVie; Former Clinical Team Leader, CDER, FDA
Dr. Zhang
Florence Houn, MD, MPH, FACP Bio:
Dr. Florence Houn is a consultant to industry and health authorities regarding drug development programs and regulatory capacity building. She was previously the VP for Global Regulatory Science at Bristol-Myers Squibb/Celgene from 2016-2020 and VP, Global Regulatory Policy, Intelligence and Strategy at Celgene from 2008-2015. Prior to this, she served 15 years in the US Food and Drug Administration (US FDA) as Division Director, Deputy Office Director and Office Director in CDRH, CBER, and CDER respectively. In recognition of her contributions to public health, Dr. Houn received the US Department of Health and Human Services’ (DHHS) Secretary’s Award for Distinguished Service in 1998 and DHHS Career Achievement Award in January 2009. In 2014, she received the FDA Distinguished Alumni Award from Commissioner Margaret Hamburg for contributions to global regulatory capacity building. Prior to joining government, she served four years in the National Health Service Corps in a manpower health shortage area in Baltimore.
Dr. Houn was the founding co-chair of the FDA Alumni Association’s (FDAAA) International Network (FDAAAIN) and was a member of the FDAAA Board of Directors 2012-2018. She is a member of the Centers for Medicare and Medicaid Services (CMS) Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), January 2017 to now. She served on the PDUFA V negotiating team representing the Biotechnology Industry Organization (BIO) with FDA in 2010-2011. She serves on the Asia Pacific Economic Cooperation (APEC) Harmonization Center’s Advisory Board (2013 to now), Pharmaceutical Education and Research Institute, Inc. curriculum committee (PERI) (2019-now) and is on the Board of Directors for the International Partnership for Microbicides (IPMglobal.org) (2016-now).
Dr. Houn received her Bachelor of Arts degree, with honors, from Harvard University and her medical degree from the Albert Einstein College of Medicine. She completed her Cancer Prevention and Control Fellowship at the National Cancer Institute and obtained her MPH from the Johns Hopkins School of Hygiene and Public Health. She attended the Johns Hopkins Breast and Ovarian Surveillance Service as an Instructor in Oncology.
The webinar is generously sponsored by Nanjing Leads Biolabs Co., Ltd (南京维立志博生物科技有限公司)
南京维立志博生物科技有限公司(http://www.leadsbiolabs.com/)是一家创新驱动的临床阶段生物制药公司，致力于具有自主知识产权的治疗肿瘤和其他重大疾病的抗体新药研发，拥有多个单克隆和双特异性抗体项目组成的研发管线，特别聚焦新型的肿瘤免疫治疗抗体。公司将不断开拓创新，为广大患者提供安全、有效、可及、可负担的抗体新药，满足尚未满足的医药需求。
Nanjing Leads Biolabs Co., Ltd. is an innovation-driven clinical-stage biopharmaceutical company, committed to the R&D of therapeutic antibody drugs for cancer and other major diseases with multiple novel monoclonals and bispecific antibodies in its rich pipeline, especially focusing on the immune-oncology antibody drugs. The company will strive for innovation providing safe, effective, accessible, and affordable new drugs for patients to meet unmet medical needs.