CBI’s Expanded Access Programs
New Models for Stakeholder Collaboration, Program Design, Supply Equity and Access for Investigation Drugs
Recent legislation, introduced just before the New Year, stands to dramatically reform the requirements of pharmaceutical and biotech manufacturers to offer compassionate use and expanded access programs. For companies whose drug is granted “Breakthrough,” “Fast Track” or “Qualified Infectious Disease Product”designation, it is critical that they understand the sweeping implications and to prepare now! Never has this meeting been more timely or critical.
The CURE Act is in the U.S. House of Representatives and intends to require that these drugs have a publicly available corporate expanded access policy for the compassionate use of the drug. This includes, but not limited to, designated point person, robust procedures, specific criteria for enrollment and policies for denials. Expect too the formation of an “Expanded Access Task Force” and upcoming formalization of the FDA’s May 2013 guidance, as the focus on Expanded Access Programs is mounting with the CURE Act.
Interactive Sessions, Case Studies, Expert Panel Discussions and More:
- FDA’s Current Thinking on Expanded Access Programs for Investigational & Pre-Launch Drugs
- U.S. Considerations from a Patient and Policy Perspective
- EU Challenges and Country-specific Nationalized Regulations
- Strategies for Ethical, Compliant and Successful Managed Access Programs
- Patient and Physician Collaboration Models
- Payment and Reimbursement Policy for Expanded Access Programs
- Questioning Equity in Compassionate Use
- Sustainable Strategies for Forecasting and Establishing Supply
- Social Media—The New Channel Patients are Leveraging for Early Access
CBI’s Expanded Access Programs is a tailored, two-day meeting for those considering or currently working on the design and execution of a variety of access management programs, including but not limited to: Expanded Access Programs, Early Access Programs, Compassionate Use Programs, Named Patient Programs and Managed Access Programs. Share best practices and lessons learned around providing investigational, pre-launch or end-of-lifecycle drugs to patients for treatment purposes.
Who Should Attend
You will benefit from attending this event if you are a part of the multi-discipline collaboration at a pharmaceutical or biotech company considering or currently running any type of special access management program. You may represent one of the following function areas:
- Market Access
- Pharmacovigilance
- Safety
- Legal
- Medical Affairs
- Regulatory Affairs
- Clinical Affairs
- Managed Markets
This Congress will also benefit CROs, sourcing and logistics vendors and those who provide consulting services on the design or management of access management programs.
