Skip to main content
2025 National Biotechnology Conference Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.

Executive Track

Executive Track: Developability and Due Diligence: How to Assess, Draw, and Sometimes End the Road(map) for New and Unusual Modalities

Monday, May 5, 2025
8:00 AM - 9:30 AM ET
Location: Otis
This session will focus on the technical, scientific, and business process challenges that developers of new and unusual modalities face as they navigate their molecules into the development pipeline. Specific attention will be given to project termination inflection points – what factors determine developability or lack thereof and how does a development team make balanced decisions that incorporate clinical, CMC, and business considerations?

Key topics:
-Uncharted territory – how different is my modality and what are the associated clinical, development, and regulatory challenges?
-Understanding, setting, and abiding by technical, scientific, or business inflection points for the project
-Partnering for success – finding and evaluating the right development partners: what does due diligence mean and what does it look like in your setting?
-Milestones and money – when and how to decide if your organization can go all the way to market or should sell/partner to work with another manufacturer.

Learning Objectives:

  • Understand how to evaluate the scientific, technical, and business factors that drive go/no-go decisions in the development of new or unusual modalities.
  • Hear case studies from leaders who have walked the uncharted territory of new modality development.
  • Learn how to decide if a modality should be developed in house, out licensed, or developed in a partnership.
  • Find out how to plan for and conduct a potential partnering due diligence exercise.
  • Upon completion, participants will be able to understand the major business and financial drivers causing some programs to be funded and others to be terminated or outlicensed.