Expanded Access can be leveraged to advance and even accelerate clinical development of treatments for serious or life-threatening conditions.  For example, an appropriately executed Expanded Access program can gather early data that can help plan a label expansion, accelerate a pediatric development plan, or gather real-world data useful for post-approval pricing and reimbursement.  Focusing on strategic considerations for a product development program, this webinar will discuss the following:

  • Regulatory framework and processes for Expanded Access
  • Sponsor support for Individual Patient Expanded Access and Emergency Use
  • Execution of studies under treatment protocols or treatment INDs
  • Therapeutic area considerations
  • Regulatory utility of clinical data generated by Expanded Access programs
  • Myths about Expanded Access

This webinar is for professionals in clinical development, regulatory, medical affairs, clinical operations, and program management in pharma and biotech, working on products to treat serious conditions in areas such as rare disease, oncology, infectious disease, and neurology.

Featured Speakers

Kevin Barber, MS, PhD, RAC, PMP

Vice President, Regulatory Strategy & Submissions
Rho, Inc.

Kevin Barber, VP, Regulatory Strategy & Submissions, has more than 20 years of experience in regulatory affairs and product development, working for both sponsor companies and CROs, across all stages of development from pre-clinical through product launch and post-approval life cycle management. He has lead the preparation and execution of integrated regulatory strategy and clinical development plans for drug, biologic, and medical device products. 

Mark Shapiro, MA, MBA

Partner, Pharma Initiatives Consulting & Chief Operating Officer
xCures, Inc.

Mark Shapiro, COO of xCures and principal investigator for XCELSIOR., has experience as SVP, Operations at a global CRO, where he was responsible for a team of 500 drug development professionals and a portfolio of more than 100 clinical trials. He was also previously a management consultant in the Clinical Development and Medical Affairs consulting practice at Campbell Alliance and managed a pragmatic trials network coordinating center at Duke University.

Date:  Wednesday, October 13, 2021
Time:  1pm ET / 10am PT
Duration:  1 Hour

Register now for this webinar