Career Development
Stacey Axler (she/her/hers)
Community Manager
AAPS
Brian Bettencourt, PhD
CSO
Torque Bio
Durham, North Carolina
Sanjeev Thohan, PhD
CEO
SARx Consulting
LA JOLLA, California
Learning Objectives:
-Assess & De-risk Scientific Foundations Evaluate a startup’s lead asset or platform for translational readiness by mapping mechanism of action, fit-for-purpose models, and decision-gating data packages that support IND-enabling investment. Identify key derisking experiments that build credibility.
-Design an Integrated Development & Regulatory Strategy Build a roadmap from discovery to IND using a Target Product Profile (TPP), staged go/no-go criteria, and alignment to FDA expectations. Select and manage CRO/CMO partners to generate data suitable for regulatory submission.
-Build the Right Team, Governance & Capital Plan Structure a lean internal team augmented by domain-specific advisors and SAB members to cover scientific, CMC, regulatory, and clinical gaps. Link capital deployment to development milestones to preserve runway and valuation.
-Prepare for Investor & Partnership Engagement Translate data into a defensible value proposition for venture, strategic, or pharma partners. Define timing triggers (data inflection points), partnering scenarios (option-to-license, co-dev, equity-linked), and essential diligence materials to support a first formal partnership discussion.