This program will spotlight some clinical, CMC and regulatory considerations for the successful registration and approval of new indications for autologous CAR T cell therapies. As the industry strives to make these therapies available to additional patient populations, engagement and alignment with global Health Authorities remains paramount.
Topics to be discussed include:
- The need to consider the potential for incoming patient heterogeneity in the starting material when designing cell therapy clinical trials.
- Balancing a patient-centric design with ease of clinical trial interpretability
- How manufacturing a cell therapy product for individual patients can complicate the interpretation of clinical trial results.
- How differences in disease pathophysiology or previous treatments among patient populations might influence the product's quality profile as defined by the critical quality attributes.
- The need to develop a manufacturing process which can accommodate variation in incoming starting material and produce a drug product with a consistent product quality profile.
The panel of experts, including Clinical, CMC and Regulatory professionals from BMS’ Cell Therapy Organization will share their firsthand experiences navigating these complex issues. The event will culminate with a panel discussion featuring senior leaders in the field, followed by a networking session.
The event will kick off with Clinical, CMC, and Regulatory professionals from BMS’s Cell Therapy Organization sharing their experiences, followed by a panel discussion and end with a short networking session.
Bristol Myers Squibb will be hosting the event space.
Registration Fees & Deadlines
Member $25 | Nonmember $35
Learning Objectives
Understand some of the regulatory expectations/challenges in developing and gaining regulatory approvals of new indications/lines of therapy for cell therapy products.
Who Should Attend?
This program will benefit early, mid-career, and senior subject matter experts (SMEs) and regulatory professionals in CMC, Clinical and Regulatory teams working in the development, registration and postapproval lifecycle management of cell therapy products. Regulatory CMC, Regulatory Affairs, CMC development and Clinical Development professionals
Panelist/Presenters
Agnes Yeboah, Ph.D.
Head of Regulatory CMC Cell Therapy, Bristol Myers Squibb
Wendy Corbett, Ph.D.
Head of Cell Therapy Regulatory Affairs, Bristol Myers Squibb
Eric Bleickardt, M.D.
Head of Late Clinical Development Cell Therapy, Bristol Myers Squibb
Candice McCoy, M.D.
Clinical Development Program Lead Cell Therapy, Bristol Myers Squibb
Yogita Bahl, Ph.D.
Senior Director, Global Regulatory Affairs, CMC Cell Therapy, Bristol Myers Squibb
Matthew Campagna, M.Sc.
Associate Director, Global Regulatory Affairs, CMC Cell Therapy, Bristol Myers Squibb
Location
Bristol Myers Squibb
556 Morris Ave
Summit, NJ 07901
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org