Stephen Tyrpak
VP of North America, Partner, Principal Consultant
PQE Group
Stephen is a healthcare executive and commercialization expert with over 16 years’ experience working with pharmaceutical, medical device, and combination products, supporting companies in the US and around the globe in various areas requiring his expertise. Stephen has spent years corroborating with an array of different specialties including but limited to Regulatory Affairs and Strategy, Non-clinical and clinical studies and GXP compliance. He acts as US agent for global Pharmaceutical and Medical Device companies and provides support in the preparation and possible remediation required as a result of Regulatory Inspections. He has assisted startup companies from around the globe in raising over $180 million in commercial seed funding and over $12 million in US state and federal grants often used to bring novel therapies to market. He is recognized as a commercialization expert, senior Business Advisor, and is an invited speaker and panel expert in the areas of regulatory affairs, MVI, GXP compliance, startup business strategy and fundraising. He is also sought after for his knowledge regarding quality culture and quality maturity in the life sciences. He is a peer reviewed published author, keynote speaker, and sits as the Chair of D’Youville Universities’ Founders Board for their School of Medicine, on The University at Buffalo’s CBLS & CAT Industrial Advisory Board (WNY). He was recognized as one of WNY’s 30 under 30.
