• Over twenty years’ experience in pharmaceutical clinical drug development and drug development consulting
– 15 years in clinical practice (Fellow, American College of Foot and Ankle Surgeons - retired)
• Prior to consulting in drug development, Lee served as
– Medical Director and therapeutic area head at a large global clinical research organization
– In various roles at pharmaceutical companies including Medical lead for multiple development programs, VP of Medical Affairs and Drug Safety and Pharmacovigilance, and VP of Clinical Research
• 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 indication evaluation and assessment, TPP and CDP development, innovative, strategic clinical program and trial design,
surrogate endpoints and accelerated development programs, strategy and execution of critical FDA documents and meetings (including FDA
Advisory Committee meetings), expedited programs and orphan drug designation request strategy, representation and moderation of
advisory panels and data and safety monitoring boards, drug launches, medical affairs strategy, life cycle management, clinical/scientific
strategy supporting business development and partnering activities, portfolio review and assessment, and asset repositioning evaluation
Dr. Lee Techner is a Principal and the Chief Consultant (Clinical, Clinical Development, and Clinical-Regulatory Strategy) at Stage Gate Partners, LLC a consulting firm that establishes effective collaborations with the pharmaceutical industry to provide consulting services supporting preparation and execution of strategies across all phases of clinical drug development, medical affairs, lifecycle management, and business development initiatives across a broad range of therapeutic areas including pain (acute and chronic), gastrointestinal (e.g., postoperative ileus, opioid induced constipation, inflammatory bowel disease, enteral feeding intolerance, gastroparesis, NAFLD, NASH), endocrinology, central nervous system (e.g., neurogenic orthostatic hypotension), musculoskeletal disorders (e.g., osteoarthritis), oncology, and cardiovascular disease.
Dr. Techner received his Doctor of Podiatric Medicine from the California College of Podiatric Medicine followed by a residency in reconstructive foot and ankle surgery at the Veteran’s Administration and Stanford Medical Centers in Palo Alto, California. During his clinical practice career he achieved Board Certification in foot and ankle surgery by the American Board of Podiatric Surgery and Fellow status in the American College of Foot and Ankle Surgeons. After 15 years of clinical practice and research (the majority as an associate within a large general orthopedic surgery practice), Dr. Techner transitioned into the pharmaceutical industry as a Medical Director and the Head of the Arthritis, Musculoskeletal Disorder, and Pain Management therapeutic area of a large, global Clinical Research Organization (CRO), Omnicare Clinical Research.
Subsequent to his tenure at the CRO, Dr. Techner transitioned to a small pharmaceutical company, Adolor Corporation, where within the course of his 11 years there was the medical lead for all alvimopan (a peripherally acting mu opioid receptor antagonist) development programs and co-lead on all other development programs in acute or chronic pain (eg., delta and kappa opioid agonists, cannabinoids). Dr. Techner was the lead presenter and respondent at the alvimopan GI Division Advisory Committee Meeting. Following FDA market approval for alvimopan (ENTEREG) Dr. Techner led and advanced the development of the Medical Affairs department as well as the Drug Safety and Pharmacovigilance team as the Vice President Medical Affairs and Drug Safety and Pharmacovigilance. He was responsible for initiating and driving development of the first validated Patient-reported Outcomes instrument for opioid-induced constipation, provided strategy and oversight for several large health outcomes studies, and worked with multiple academic institutions to build out Adolor’s collaborative research initiatives.
Following Cubist’s acquisition of Adolor in December 2011, Dr. Techner served as a Vice President, Clinical Research for Cubist Pharmaceuticals in Lexington, Massachusetts. Towards the end of his tenure with Cubist he was also the interim Head of Global Pharmacovigilance and Medical Risk Management focused on leading the group and providing strategic input for a re-organization. In his primary role at Cubist as Vice President, Clinical Research, Dr. Techner provided strategic leadership to postoperative ileus (ENTEREG) and opioid-induced constipation (bevenopran) programs and served as the clinical lead for the Drug Discovery group (e.g., disease and target identification, translational science and medicine planning, clinical development strategy) and Business Development (e.g., strategy, due diligence) across multiple therapeutic areas. While at Cubist he successfully led the cross-functional development team to an expanded indication for ENTEREG. Most recently, Dr. Techner was the Cubist clinical lead, primary speaker and respondent, and the company clinical representative for a Multi-Sponsor collaboration supporting the June 2014 FDA Anesthetic and Analgesic Advisory Committee Meeting discussing the potential cardiovascular risk associated with peripherally acting mu opioid receptor antagonists in the treatment of opioid-induced constipation in patients with chronic pain.
Ultimately, Dr. Techner, along with Dr. Amy Rachfal, founded Stage Gate Partners, LCC in 2014 in order to provide consulting services to the pharmaceutical industry using their 40 years of collective scientific, clinical, and industry experience across a broad range of research and development initiatives and therapeutic areas. Since their founding, Stage Gate Partners has provided the following services to a wide range of clients.
Collaboration with early-stage VC-backed biopharmaceutical companies on clinical-regulatory development strategy to support funding, translational plan, first-intent indication selection, target product profiles, clinical development plans, and/or regulatory interactions
Indication evaluation and assessment
Clinical and regulatory development program strategy and design (drugs, single and fixed-combination products, OTC products, medical devices) including clinical development plans and target product profiles
Development program gap analysis (clinical/clinical-regulatory)
Program and issue evaluation and problem solving
Clinical trial design including strategic endpoint development (including patient–reported outcome measures) supporting differentiated labels, adaptive features in phase 2 and 3 trials, and safety evaluation plans for specific adverse events of interest
Gain regulatory acceptance of novel surrogate endpoints to be used within Accelerated Approval development programs and/or to support potential disease modifying therapies
Strategic planning and development of meeting objectives, questions, and briefing dossiers supporting regulatory (FDA, EMA, Health Canada) interactions
Representation at FDA meetings
Expedited program and orphan drug request strategy and document development
Representation on Data and Safety Monitoring Boards
Participation on Sponsor Drug Development Advisory Panels
Clinical, scientific, and medical affairs strategy supporting business development, investor, and partnering initiatives
Medical affairs and scientific communication strategy
Clinical and regulatory strategy for OTC label expansion
Portfolio review and assessment
Asset repositioning evaluation
Due diligence