Time: 9 March 2021 12 Noon Eastern Time (US and Canada)
US Agents Wear Many Hats
“United States Agent” is just one term describing a regulatory affairs professional that serves as a liaison and/or primary contact to FDA staff for a sponsor. This presentation will shed some light on the many terms in circulation, the diverse potential responsibilities, depth of collaboration with FDA and/or sponsor, legal implications and best practices when serving as a US agent.
Three regulatory affairs professionals with direct experience of serving as a US agent will share their insights, responsibilities in that role and case studies of interactions with FDA staff.
We have created a short survey (should take about 3 minutes to complete) and would
appreciate if you could complete it prior to the meeting. We would like to know about your US Agent experiences and to provide input that will help drive discussions during the meeting.
Google Forms Survey
The Presenters:
Sandra Hecker, RAC – Hecker and Associates
A biologist/biochemist by training, Sandy has 40 years of clinical/regulatory experience in small molecule and biologic development. Her career began at NIH, where she was in the press office and on the NIAID IRB. She created the Medical Writing department at Genentech in 1990, then worked for CSOs as manager of regulatory submissions groups where she learned submissions writing best practices. She
later headed regulatory and then drug development groups. Sandy is liaison with
FDA for her clients, prepares her teams for and leads FDA meetings, and advises them through development to the marketing application. She is US Agent for foreign companies filing to FDA where her current focus is oncology. Sandy
loves coaching teams on how best to work with FDA’s drug, biologic, and gene therapy groups, about what FDA expects, and how FDA expectations are different from those in a client’s home region, e.g., the EU's EMA.
Kirsten Messmer, PhD, RAC – Agency IQ
Kirsten Messmer, PhD, RAC is a Senior Research Analyst at POLITICO’s Agency IQ. She was a Principal Regulatory Affairs Specialist in the Regulatory Intelligence, Policy
and Advocacy team at PPD prior to joining the Agency IQ team. Dr. Messmer received her PhD in Neuroscience from University of Sheffield and a Biology Diplom from the Eberhard-Karls University in Tübingen, Germany. She completed post-doctoral research fellowships at the Royal Free Hospital and University College London and the University of Maryland, Baltimore before joining Theradigm to develop stem cell therapies for neurodegenerative diseases. In her position at ERA Consulting, Kirsten was responsible for authoring regulatory intelligence newsletters, consulting on biopharmaceutical product development
and including US Agent services. At PPD, she was part of a specialist team providing regulatory intelligence to clients and within PPD to support efficient, compliant and successful clinical research and drug development. In
her current role, she contributes to the research and development of content for Agency IQ.
Michael Spitz, MS, RAC – Independent Regulatory Consultant
Michael is a Regulatory Affairs professional with over 30 years of experience supporting the development and commercialization of biologics, specialty pharmaceuticals, and combination products, for both high incidence and rare diseases. In addition to his RAC credential, Michael has a BS in Biology, and a MS in Biotechnology from Johns Hopkins University. He has worked both as an employee at a number of companies including Centocor,
AstraZeneca, Shire, Auxilium, and Teva, and as a Regulatory consultant for clients of all sizes. Michael has supported products across a variety of therapeutic areas as a GRL and as TA Regulatory Lead. He has also served as Committee Lead/Regulatory Reviewer of scientific and promotional materials, and as the Lead of an international Regulatory Intelligence function. Michael has presented as invited speaker on a variety of Drug Development and RA topics, and previously served as Development Working Group Lead of the DIA RA Community.
Time: Mar 9, 2021 12:00 PM Eastern Time (US and Canada)
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Meeting ID: 947 7550 1791
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