Regulatory Pathways for Phase I SBIR Companies

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Meet the presenter: Dr. Aaron Carrithers

Dr. Aaron Carrithers, MD is a physician entrepreneur that focuses on the creation of user-defined product value through the deployment of clinical innovation.  In doing so, Dr. Carrithers assists biotech start-ups and/or start-up technologies with strategies that will help in the development of potential options for their FDA/Regulatory pathways (510k PMA, De Novo, PMA, PDP, etc) and in turn, support the applicant’s SBIR/STTR Phase I/II/IIB proposals in their POC, feasibility, R&D, and clinical validation studies. 

Dr. Carrithers converges these activities with strategies that will enhance the company’s patent portfolio by adding critical (and clinical) IP. Dr. Carrithers currently serves as Chief Medical Officer for SEQUELA Biotech and Director of Clinical Diagnostics for Lagrange Scientific, LLC.  He is currently in discussions with the FDA (In Vitro Diagnostics and Radiological Health, CDRH) with a product/device that was developed through the SBIR-funding mechanism. Recently, Dr. Carrithers has co-founded a start-up/biotech company from technology licensed from the University of Kentucky, where he is Principal Investigator and CMO. 

Dr. Carrithers earned his B.A. in Biology from Transylvania University in 2012 and his M.D. from the University of Kentucky College of Medicine in 2018.  He completed his postdoctoral work in Translational Medicine and Entrepreneurship in 2020 with SEQUELA while sponsoring a senior level MBA-candidate team out of UofK (which won first place in the Bluegrass Angels Pitch-Deck Contest) and has undergone training in the NIH Commercialization Accelerator Program (via Larta: Commercialization and Regulatory Track).

Today, Dr. Carrithers will lend his training and latest experiences to SBIR/STTR Phase I applicants in early stage development of medical devices and therapeutics to develop early strategies for patient population discovery, associated regulatory and reimbursement pathways, and understanding the need for a well-defined clinical indication that benefits the patient, physician, and healthcare system.