• Over fifteen years’ experience in pharmaceutical clinical drug development and drug development consulting
– Training as PhD scientist and molecular biologist
• Prior to consulting in drug development, Amy served as
– An adjunct professor
– Scientific Director at a Medical and Regulatory Communications Agency
– In various roles in pharmaceutical companies including Director of Medical Communications (Clinical Research & Development and
Medical Affairs), Director of Global Medical Affairs Strategy, and Director of Scientific Communications Medical lead for multiple
development programs
• 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
• Expertise in indication evaluation and assessment, target product profile 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, drug launches, medical affairs and scientific communication strategy, life cycle management, clinical/scientific
strategy supporting business development, investor, and partnering activities, portfolio review and assessment, and asset repositioning
evaluation
Dr. Amy Rachfal is a Principal and Chief Consultant (Clinical Development, Clinical-Regulatory Strategy, and Scientific Communications) 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. Rachfal received her MS in Molecular Genetics and PhD in Molecular, Cellular, and Developmental Biology from The Ohio State University followed by a postdoctoral fellowship assessing the role of connective tissue growth factor in fibrosis at Children’s Hospital in Columbus, Ohio. After serving as adjunct faculty at a State Community College, Dr. Rachfal transitioned into Scientific Communications, first serving as a scientific writer, then Director at ProEd Communications. Dr. Rachfal led teams of scientists, writers, and managers to serve a wide variety of clients, across a broad range of therapeutic areas and in varied stages of clinical development from early to post-marketed. During her time at ProEd Communications, Dr. Rachfal served as the scientific strategic partner with Adolor Corporation and developed and executed strategic communications strategy plans including acting as the scientific director supporting Adolor’s FDA Advisory Committee Meeting which lead to the approval of alvimopan (ENTEREG), a peripherally acting mu opioid receptor antagonist, in 2008.
Dr. Rachfal then moved from a client service role to the pharmaceutical industry itself by joining Adolor. There she straddled multiple functions within the company including Clinical Research and Development and Medical Affairs. Within her role in Clinical Research and Development, Dr. Rachfal contributed to strategy related to clinical protocols (endpoints, key thought leaders to engage, early data dissemination planning) and regulatory interactions for a variety of compounds across the pain, gastrointestinal, and surgical therapeutic areas as well as managed medical writing resources and staff. Within her role in Medical Affairs, she developed and executed strategic communication plans for products across all stages of development and cultivated relationships with thought leaders to ensure plans were strategically and clinically sound. Dr. Rachfal provided strategic and tactical support to several large health outcomes studies, worked with multiple academic institutions in support of collaborative research projects, as well as guided institutions in the evaluation and communication of drug use evaluations. Dr. Rachfal presented clinical data both internally and externally and was the point for ensuring the scientific competitive landscape was known and its strategic implications understood by key stakeholders within the company (Medical Affairs, Clinical Research and Development, Commercial, and Business Development). Dr. Rachfal also developed scientific materials to train the medical science liaisons in addition to providing support for scientific training of field sales. Towards the culmination of her career at Adolor, Dr. Rachfal also managed medical drug information and developed strategy for Continuing Medical Education (CME) and acted as the primary interface with providers of these educational programs.
Following Cubist’s acquisition of Adolor in December 2011, Dr. Rachfal served as Director of Global Medical Affairs Strategy where she provided strategic oversight for implementation of global medical affairs initiatives including publication strategy, supportive research strategy, thought leader engagement, and global alliances for alvimopan (ENTEREG; for the acceleration of upper and lower GI recovery after surgery), bevenopran (for opioid-induced constipation), daptomycin (CUBICIN, for complicated skin and skin structure infection, bacteremia, and infectious endocarditis), and tedizolid (SIVEXTRO; for acute skin and skin structure infections). Dr. Rachfal was a key team member and driver in preparing the strategy and supporting documents that lead to an expanded indication for ENTEREG. In addition, Dr. Rachfal supported the development of the strategic approach to Cubist’s participation in the multi-Sponsor 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. Furthermore, Dr. Rachfal was instrumental in contributing to the successful launch of SIVEXTRO within an abbreviated timeline. Toward the end of her tenure with Cubist, Dr. Rachfal transitioned to the role of Director of Scientific Communications to build out, strengthen, and manage the group. In this role, she provided oversight, lead, and managed a team of global medical publications, communications, and medical education professionals to maintain an overarching view of portfolio communication strategy and execution.
Ultimately, Dr. Rachfal, along with Dr. Lee Techner, 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