DIA Regulatory Intelligence Working Group Monthly Meeting
Time: 9 November 2021 12 Noon Eastern Time (US and Canada)
Topic: Diversity in Clinical Research is now a business imperative – why the Regulatory lens is essential
Undertaking clinical research with a diversity lens has been a topic not often discussed. Since the pandemic, there has been a spotlight on this area, including FDA’s publication of the final guidance on clinical trial diversity and the need for a diversity plan early in clinical development. The presenters will share their experiences, offering practical strategies and an in-depth look at FDA’s current thinking on diversity in the Oncology space.
The Presenters
Aman Khera, Vice President, Global Head of Regulatory Strategy, Worldwide Clinical Trials
Aman Khera, a recent PharmaVOICE100 honoree, has earned her nickname: Rebel Regulator, she does not stay in her regulatory lane, an innovative drug and device development leader with over twenty-four years' experience in Global Regulatory Affairs in the Pharma/Biotech industry. For years, she pushed back against the perceived role regulatory teams should play and continues to lobby to make it a strategic role within companies and the industry. By pushing the boundaries of where the regulator’s seat is, she has become a change agent throughout the industry. And her push to give regulatory teams a seat at the table from the beginning has resulted in fewer late-stage surprises, smoother trials and optimal outcomes for the development of new therapies.
Another frontier that she is conquering is diversity and inclusion. In her
view, justice, equity, diversity and inclusion go beyond issues of fairness;
they are necessary parts of sound business and scientific practices, she is a committed champion for the industry.
With a deep foundation in regulatory affairs and the life sciences industry,
Aman also looks into how strategy and innovation are intersecting within
healthcare. She has taken a deep interest in how technological innovations will continue to disrupt the industry, but also how regulations, ethics and compliance will continue to have a loud voice at healthcare table while innovative transformations are occurring. She is a Data Privacy and Blockchain geek and continues to scan the horizon of regulatory and life sciences transformations across the globe.
Linda Bowen, Head of Regulatory Policy and Intelligence/Interim Head of EU and Rest of World (ROW) Regulatory Affairs, Seagen Inc.
Linda has 38 years of industry experience, 28 years of that focused on regulatory strategy, intelligence and policy experience. She has been an Assistant Professor in the Temple University, Masters in Regulatory Affairs and Quality Assurance (RAQA) Program for more than 20 years.
Her professional society work includes being DIA’s Chair of the Regulatory Affairs Community and founder of its Regulatory Intelligence Working Group (2006). Linda won the 2019 Americas Inspire Award and the 2012 Volunteer of the Year Award. Linda is also active in the Regulatory Affairs Professional Society (RAPS) as a two-term Board member, Past Chair of the NJNY Chapter, and Chair of the 2018-2019 Convergence meeting.
She won the 2020 RAPS Founder’s Award and is a member of the 2011 Class of RAPS Fellows.
Linda is a frequent author and speaker on regulatory strategy, policy and intelligence topics, and contributor to FDA policy initiatives, including work as a technical negotiator representing industry on two user fees (OMUFA and BsUFA III)
RARegIntell WG is inviting you to a scheduled Zoom meeting.
Time: Nov 9, 2021 12:00 PM Eastern Time (US and Canada)
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