Roundtable Session: Fielding CMC Questions from the FDA: Improve your Communication Strategy and Responses
Friday, September 8, 2023 01:45 PM - 02:45 PM
337 AB
Moderator
J. Wade Atkins, MS, MT(ASCP) SBB, CQA (ASQ), NIH Clinical Center Department of Transfusion Medicine (DTM), USA
Panelists
Kevin Bosse, PhD, RAC-US, CABP(H), Nationwide Children’s Hospital, USA
Patrick Hanley, PhD, Children's National Hospital, USA
Olive J. Sturtevant, MHP, MT(ASCP)SBB,SLS, CQA(ASQ), Dana Farber Cancer Institute, USA
Session Objectives
J. Wade Atkins, MS, MT(ASCP) SBB, CQA (ASQ), NIH Clinical Center Department of Transfusion Medicine (DTM), USA
Panelists
Kevin Bosse, PhD, RAC-US, CABP(H), Nationwide Children’s Hospital, USA
Patrick Hanley, PhD, Children's National Hospital, USA
Olive J. Sturtevant, MHP, MT(ASCP)SBB,SLS, CQA(ASQ), Dana Farber Cancer Institute, USA
- Discuss common questions from FDA review staff that review IND submissions
- Use the information from this discussion to craft acceptable response to common questions
- Include more information in the initial submission that can reduce the chance of getting common questions from the FDA review staff
Session Objectives
- Better understand the process of responding to agency request for more information post application submission reviews.
- Be more comfortable and confident in discussing how to gather pertinent information from key stakeholders to provide a response that has a high probability of being accepted by the agency.
- Be more skilled for preparing succinct responses that fully answer the posed question or address the concern but does not open the door for more follow up questions.
- What are common requests you see from FDA in response to your submissions? Are there any hot topics that seem to come up each time?
Kevin Bosse PhD, RAC-US, CABP(H)
Director, Office of Research Regulatory Affairs
Nationwide Children’s Hospital
Panelist
Director, Office of Research Regulatory Affairs
Nationwide Children’s Hospital
Panelist
Patrick Hanley PhD
Chief and Director, Cellular Therapy Program; Associate Professor of Pediatrics
Children's National Hospital
Panelist
Chief and Director, Cellular Therapy Program; Associate Professor of Pediatrics
Children's National Hospital
Panelist
Olive J Sturtevant MHP, MT(ASCP)SBB,SLS, CQA(ASQ)
Senior Administrative Director of Connell & O'Reilly Families, Cell Manipulation Core Facility
Dana Farber Cancer Institute
Panelist
Senior Administrative Director of Connell & O'Reilly Families, Cell Manipulation Core Facility
Dana Farber Cancer Institute
Panelist