Amy W. Rachfal, PhD

Principal and Chief Consultant

Clinical Development, Clinical-Regulatory Strategy, and Scientific Communications

  • Former molecular biologist with over 20 years of experience in clinical/clinical-regulatory integrated drug development across all phases (nonclinical through Phase 4) in Agency and Pharma leadership roles (Clinical Research & Development, Medical Affairs) and as an independent consultant

  • Experience across a broad range of therapeutic areas, US and non-US regulatory interactions

  • Developed effective strategy and tactics for smart, thoughtful drug development across a broad range of therapeutic areas and stages of development that incorporates a broad understanding of the clinical, regulatory, and competitive landscape

  • Integral part of cross-functional teams representing Clinical Development and Medical Affairs developing and implementing strategy and tactics for first intent and label expansion programs, Scientific lead for multiple FDA Advisory Committee preparation teams, primary clinical/scientific support at innumerable FDA meetings

  • Expertise in strategic program planning, innovative, strategic clinical program, trial design and endpoint strategy supporting label claims (including patient reported outcomes), optimization of clinical trial design and execution to increase probability of clinical, regulatory, and commercial success, indication evaluation and assessment, target product profile and clinical development plan development, surrogate endpoints and accelerated development programs, FDA engagement strategy, strategy and execution of critical FDA documents and meetings (including FDA Advisory Committee meetings), expedited programs and orphan drug designation request strategy, representation on and moderation of advisory panels, drug launches, medical affairs and scientific communication strategy, competitive intelligence, life cycle management, clinical/scientific strategy supporting business development, investor, and partnering activities, portfolio review and assessment, and asset repositioning evaluation