De-Risking US Market Entry And Regulatory Planning with Tunnell Consulting
The US healthcare market represents a significant opportunity for medical device and pharmaceutical innovators, but its complex regulatory, reimbursement, and clinical landscape can be challenging to navigate. This comprehensive webinar is designed to provide invaluable insights for companies looking to successfully enter and thrive in the US market.
In this 30-minute webinar Tunnell Consulting will cover considerations for US market entry and how your product may align with US Standard of Care, followed by 15 min of Q&A. Tunnell can also offer one-on-one meetings during BIO 2025 week in Boston.
About Tunnell:
Tunnell Consulting has solved complex problems for life sciences companies for over 60 years. Our expertise ranges from strategy-level decisions made in the Board Room and C-Suite, to operational decisions made on the shop floor. And it covers the full spectrum of technical, operational, quality, compliance and regulatory challenges. We don’t require a long learning curve, which translates into faster payback and a greater return on your investment. Our functional expertise crosses the life science ecosystem – Pre-Clinical/Clinical, Regulatory, Quality Assurance, CMC/Manufacturing, Supply Chain, OPEX from early-stage drug development to commercialization.
Melissa Allensworth - Principal and Leader of Tunnell's early stage practice
Melissa has extensive experience in clinical development from pre-clinical/translational medicine to Phase 1-3 drug development and has been instrumental in facilitating virtual biotech models for early-stage clients. Her consulting services include protocol development and trial design, regulatory services (FDA, EMA and NMPA for pIND/IND submission), translational medicine, pharmacovigilance/safety, clinical operations, data management, and more. Utilizing a virtual biotech model, she has collaborated with early-stage clients to bring novel/first-in-human (FIH) assets to patients globally. Melissa’s therapeutic experience includes Hematology/Oncology (blood and solid tumors) with modalities such as Small Molecules, Cell Therapies (CAR-T), Gene Therapies (AAV and Lenti), Immuno-Oncology, and Precision Medicine. She has also worked with leading experts in NASH/Liver Fibrosis and CNS therapies.
Scott Myers - Principal
Scott brings a wealth of experience to Tunnell with over 30 years spent in Quality, Operations, functional managerial and wide business leadership in the emerging pharmaceutical, biotech and cell and gene therapy sectors. He is adept at identifying and controlling risks associated with the development and commercialization of new products and is known for his expertise in the interpretation and execution of domestic and international cGMP requirements. Focused on making his clients successful, he has mastered the art of relationship building and ensuring high quality results from both himself and the teams he onboards and indirect teams he mentors and coaches. Before joining Tunnell, Scott held roles of increasing levels of responsibility at Boehringer Ingelheim, most recently as Executive Director, Compliance and Quality Oversight, where he was the leader for Compliance and Environmental, Health & Safety (EHS) teams and was the program leader for the consent decree program. Previously, he was Executive Director, Launch, where his team ensured high quality, timely and cost-effective product launches for the US and Global markets. His experiences in Quality Assurance, Quality Control and Manufacturing and his wide industry network brings numerous benefits to his clients’ business with a positive impact on their culture, leadership development and standardization of processes.