Resources
Educational Materials
Slide decks covering key topics in pharmaceutical regulation and drug development policy.
Introduction to Expanded Access
Overview of FDA's expanded access (compassionate use) program, including eligibility criteria, application processes, and key considerations for patients and sponsors.
Introduction to FDA's Expedited Programs
Guide to FDA's four expedited pathways: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review. Covers eligibility, benefits, and strategic considerations.
Introduction to U.S. Pharmaceutical Laws and Regulations
Overview of the U.S. regulatory framework for pharmaceuticals, including the FDA's role, drug approval process, and key legislation shaping the industry.
Conference Organization
- Rethinking Strategy & Innovation in Biopharmaceutical and Healthcare Industries, SMS2025 [registration]
- Strategy and Innovation in Biopharmaceutical Industry, AOM2022 [abstract]
- Science and Firm Strategy, AOM2021 [abstract]
- Where do Ecosystems Come From? The Origins of Ecosystem Structure and Performance, AOM2021 [abstract]
