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Session 9A2: Investigational Products: Access, Medical Information, and Communications Channels
Session Chair(s)
Ivy Chang, PharmD
Director, Medical Information, Dompe US, United States
The number of pharmaceutical companies with active pipelines is steadily increasing every year. While the pipeline is rich, the probability of success from Phase I to approval in the US remain about 10% overall. As manufacturers race to get drugs to market faster, does access to investigational products increase? How do investigators and patients learn about clinical trials? Payers need to know about new products for their planning purposes. How do manufacturers inform payers about the status of their pipeline products? During this session the faculty will share their views and experiences on these topics.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss the state and federal right-to-try legislations and their potential impact on pharmaceutical industry’s business process of product development programs
- Describe challenges and best practices to address access to investigational products
- Apply the AMCP Dossier 4.0 guidance for preparing and submitting a dossier before FDA approval/clearance or product launch
Speaker(s)
Ivy Chang, PharmD
Director, Medical Information, Dompe US, United States
Speaker
Patricia J. Zettler, JD
Associate Professor, Georgia State University College of Law, United States
The Right To Try Movement - What Do The State Laws and Federal Bills Mean?
Judy Lee, PhD
Sr. Trial Information Specialist, Genentech, A Member of the Roche Group, United States
Pre-Approval Access - Challenges and Best
Iris Tam, PharmD
Founder & Principal Consultant, Iris Tam, LLC, United States
AMCP Dossier for Investigational Products (v4.0)
Christine Sunwoo, PharmD, MPH
Senior Manager, Strategic Medical Communications and Innovation, Celgene Corporation, United States
Multichannel Medical Communications: Beyond the Standard Response
Panel Discussion
, All Session Speakers, United States
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