Stage Gate Partners was founded by Lee Techner, DPM and Amy Rachfal, PhD in 2014, synergizing over 40 years of collective scientific, clinical, and industry experience resulting in capabilities spanning a broad range of research and development initiatives and therapeutic areas including 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. 

Stage Gate Partners provides value to its clients by developing effective strategies for smart, thoughtful drug development that incorporate a broad understanding of the regulatory, clinical, and competitive landscape.

Stage Gate Partners provides consulting services supporting preparation and execution of strategies across all phases of clinical drug development, medical affairs, lifecycle management, and business development initiatives.

 

Recent Work by Stage Gate Partners spans the following : 

  • 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 assessment, evaluation, and recommendation

  • 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

Selected praise for Stage Gate Partners

  • “Stage Gate has been pivotal in getting [Sponsor] ready for Phase 3. Thank you very much for all of your efforts!”

  • “….we can’t thank you enough for the great job you have done. You definitely have saved us a lot of time and money. …. it’s really exceptionally great to work with you”

  • "The White paper was excellent"

  • “What an effort to put this [fast track request] together! Great job! ……It’s a powerful document”

  • “Today I received the FDA designation letter for Fast Track! All the congrats go to you two and thanks for preparing a convincing document!”

  • “This is the highest quality document we have ever received from a vendor”

  • "Really great job organizing such little background support into a good argument....[Sponsor] should be very happy"

  • "I have to say that also this time the document was of very high quality......Great job!!"

  • “Thank You to everyone for all of the great work that was put into this over the last year and half. It has been a long journey but an exercise that needed to be done!”

  • “Thank you for the meeting today. It was very instructive, and the framework was comprehensive, well-organized, and persuasive.”

Stage Gate Partners Collaborations

In addition to our experience, Stage Gate Partners has long-standing relationships and collaborations with experts and organizations in complimentary areas that we bring in as needed to enhance our ability to provide comprehensive, meaningful, and on-target deliverables including biostatistics, regulatory, non-clinical, CMC, clinical and operations services and support, medical writing, health economics and outcomes, drug safety, key medical experts, clinical research organizations, and translational research.