Executive Track: Molecule to Milestone: IND-Enabling Strategy for Pharma Leaders

Executive Education Speaker(s)

• 

  Richard Thakor, Ph.D.

  Associate Professor of Finance
  University of Minnesota, Carlson School of Management
  Minneapolis, Minnesota
• 

  Sanjeev Thohan, PhD

  CEO
  SARx Consulting
  LA JOLLA, California

Moderator(s)

• 

  Robert Poe, MBA (he/him/his)

  President and CEO
  Olon USA, Ohio

Turning a promising idea into a first-in-human trial takes more than good data, it takes a smart plan. This session will lay out a practical roadmap for IND-enabling programs, giving you the tools to navigate timelines, costs, risks, and the decision points that can make or break a program.

We’ll break down what goes into each section of an IND, compare regulatory pathways (505(b)(1), 505(b)(2), ANDA), and highlight the typical milestones along the way. You’ll hear strategies for spotting and managing technical, regulatory, and financial risks, plus how to assemble the right cross-functional team early - CMC, tox, bioanalytical, regulatory, and more.

Finally, we’ll pull back the curtain on the business side of preclinical studies: what’s high-risk, what’s high-cost, and how to position your program for long-term success. Whether you’re new to IND development or looking to sharpen your strategy, this session will help you see the bigger picture and avoid costly missteps.