San Jose

The San Jose SOCRA Chapter presents:

“Single-Patient Expanded Access for Drugs, Biologics, and Devices”

Date: Wednesday, March 19th, 2025

Time: 12-1pm PST

Location: Webinar – Online Only

Speaker: Amy Hummel, MS

About the Speaker:
Amy Hummel joined the Yale Center for Clinical Investigation in 2018 as the Associate Director of IND and IDE Management. Under her leadership her team provides both strategic guidance and operational assistance to Yale investigators whose research requires that they hold an IND (drugs and biologics) or IDE (devices) with the FDA.

Amy holds an undergraduate degree in Biological Sciences from Carnegie Mellon University and a Master’s degree in Quality Assurance and Regulatory Affairs from Temple University. Prior to joining Yale, she worked in the Regulatory Affairs departments for a variety of biopharmaceutical companies, managing assets in such therapeutic areas as women’s health, infectious disease, hematology, autoimmune disease, and inborn errors of metabolism. She has experience guiding programs through all stages of the product lifecycle from preclinical/discovery, through Phase 1-3 clinical trials and marketing application development, to post marketing activities including labeling extensions and advertising and promotional material support.

Speaker’s Affiliations:
• Associate Director, IND/IDE Management, Yale Center for Clinical Investigation, Yale University
Objectives:
• Identify the different types of expanded access
• Discuss the process for obtaining initial FDA approval
• Review the considerations for obtaining initial IRB approval
• Assess the follow-up reporting requirements

SOCRA CEUs available: 1 (for SOCRA members)

Questions: Please contact Allie Mossing (amossing@aligntech.com)

*Please RSVP to receive Conference Call Details: https://events.teams.microsoft.com/event/61ddd25b-25e4-468f-9cd6-e130b8510d08@9ac44c96-980a-481b-ae23-d8f56b82c605

 

Chapter Chairpersons:

Allie Mossing - Chair
Phone: 408 394 0304
email

Spencer Todd - Vice Chair
email