Lee M. Techner, DPM, FACFAS (ret)
Principal and Chief Consultant
Clinical, Clinical Development, and Clinical-Regulatory Strategy
Former surgeon with over 25 years of experience in clinical/clinical-regulatory integrated drug development across all phases (nonclinical through Phase 4) in Pharma leadership roles (Clinical Development, Medical Affairs, Drug Safety and Pharmacovigilance) and as an independent consultant
Experience across a broad range of therapeutic areas, US and non-US regulatory interactions
Developed effective strategies and tactics for smart, thoughtful drug development across a broad range of therapeutic areas and stages of development that incorporate a broad understanding of the clinical, regulatory, and competitive landscape
Led development programs through to market, led cross-functional development teams in developing and implementing strategy and tactics for label expansion, been the primary speaker and respondent at FDA Advisory Committee meetings, and the clinical lead in 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