Join us on 30th November to hear NDAs Laurie Smaldone Alsup, MD, COO/CSO, discuss:
- Insight into the HOW to avoid market delays that impact patients and ultimately reimbursement
- The importance of early planning, pressure testing and preparation for the make or break end game
- How to convince payers that your product brings important value to patients and to the system.
In addition, she will share proven methods to critique and provide strategy through expert panels that pressure test the pivotal trials designs and value documentation. These methods can help align companies internally and efficiently focus investments. Cross functional teams that can benefit from these strategies include regulatory, clinical, outcomes research, marketing, market access, commercial and medical affairs operations.
Ultimately at the end of product development the key product messages must be communicated through the pharmacoeconomic value dossier in seeking reimbursement. We will focus on the importance of internal communication across development and commercial teams, and on how to prepare for payer negotiation training and affiliate alignment.
Dr. Smaldone Alsup will be available to answer questions at the end of the session.
Click here to book your place today.
Dr. Smaldone Alsup has over 25 years of global leadership experience in the pharmaceutical and biotechnology industries in drug development, regulatory strategy and regulatory approvals across all major therapeutic areas. She has led the development and commercialization of drugs for oncology, HIV/AIDS, cardiovascular, metabolics, immunology, infectious diseases, neuroscience, dermatology, inflammatory and immune-based diseases. She has led numerous multidisciplinary teams in over 50 US FDA and European EMA proceedings, including preparations for numerous key FDA meetings, Advisory Committee hearings and EU Scientific Advice and Oral Arguments.