Stage Gate Partners, LLC was founded by Lee Techner, DPM, FACFAS (ret) and Amy Rachfal, PhD in 2014, synergizing over 40 years of collective scientific, clinical, clinical development, regulatory, and industry experience resulting in capabilities spanning a broad range of research and development initiatives.
Stage Gate Partners is a consulting firm that collaborates with its clients to develop effective strategy for smart, thoughtful integrated drug development that incorporate a broad understanding of the clinical, regulatory, 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 across a broad range of therapeutic areas including pain (acute and chronic), opioid use disorder, opioid overdose, gastrointestinal, NASH/MASH, metabolic/endocrine, renal disease, central nervous system, mental health, musculoskeletal disorders, oncology, pulmonary, infectious disease, and cardiovascular disease.
Since their founding Stage Gate Partners has provided the following services to a wide range of clients across varied therapeutic areas.
Collaboration with VC groups, 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 that incorporate early opportunities for value inflection
Indication evaluation and assessment
Target product profile and supportive clinical development plan development
Strategic program planning
Clinical and regulatory development strategy and plans (single and fixed-combination products, botanical products, OTC products, medical devices) including clinical development plans and target product profiles
Development program gap analysis (clinical, clinical-regulatory)
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
Optimization of clinical trial design and execution to increase probability of clinical, regulatory, and commercial success
Gain regulatory acceptance of novel surrogate endpoints to be used within Accelerated Approval development programs and/or support potential disease modifying therapies
Strategic planning and development of meeting objectives, questions, and briefing dossiers supporting FDA interactions (Pre IND, Type B, Type C, and End-of-Phase 2 meetings, Advisory Committee Preparation)
FDA engagement strategy
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
Representation on and moderation of advisory panels
Clinical, scientific, and medical affairs strategy supporting business development, partnering, and investor initiatives
Acting CMO support
Sponsor medical director support for clinical trials
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
“….your strong commitment and your understanding of [our] circumstances mean a great deal to us. Our drug development program is both important and challenging, and having your proactive, hands-on support gives us great confidence.”
“ [SGP] is indispensable to the success of the study”
“Great responses [from the Agency]! Thank you so much for a great outcome!”
“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.