4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA

Director Christopher Gallo was a speaker during module 1, “Identifying and Comprehending Pre-Commercialization Concerns Relative to Small Molecules and Biologics,” at the 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA on October 8, 2024 hosted by American Conference Institute.

Session Overview

The current pre-commercialization landscape:

• Reviewing the types of products that pharmaceutical, biotechnology and biopharmaceutical companies seeking to develop now
• Identifying impediments – through patent or regulatory restraint –  which prevent these companies from pursuing the development of the desired product
  • FDA hurdles that may not clear even if all patent and other IP hurdles are met
• Techniques for analyzing the value the product adds to the company’s portfolio, and methods for proving value
• Assessing the competition and analyzing potential therapeutic interchange considerations

Considerations in light of Health Care Reform:

• Understanding how the introduction of follow-on biologics and biosimilars has changed the commercial landscape
• Examining the role of the Center for Medicare and Medicaid Services (CMS) in the approval process and its impact on R&D
  • The connection between CMS approval and commercial viability via government payor systems and rebates
  • Comparative effectiveness