Anthony W.

Background

About Anthony W.

Senior Global Regulatory Affairs Executive, focused on software as a medical device (SaMD) and combination products. Leads a global team of regulatory affairs professionals at Pear Therapeutics combined with 25+ years industry and FDA experience. I’ve been at the forefront of the development of FDA emerging technology global regulatory schemes affecting the evolution of regulated combination products (combination of drugs/biologics/medical devices), software as a medical device (SaMD), and human factors. Starting at the FDA during the early days of the formation of these regulations, I eventually rose to a Supervisory Engineer focused primarily on the regulation of combination products and SaMD to lead a team of more than 80 multidisciplinary professionals. • Trained as an engineer at the Naval Academy and with an MBA and MS in Management Information Systems • Combine exceptional leadership and relationship building qualities with rigorous analytical skills. • At both biotech and large biopharma organizations, I have engaged my true passion - to create new teams and processes for the medical device units at these traditional biotech/pharma companies. Industry & Product Experience: Biotech, Pharmaceutical, Medical Device, Software as Medical Device, Combination Products Where I excel: • Creating new regulatory teams • Problem Solving – Expert at defining the problem and finding optimal solutions • Creating robust strategic plans • Outstanding communicator up and down an organization • Implementing cross-functional projects ¬ • Deep understanding of FDA & global device regulatory principles ¬ Differentiators: • Expert Level Knowledge of Regulations and Approval Process relating to Combination Products and Software as a Medical Device (SaMD) • Working under Pressure • My Network – Deep network within the biopharma/medical device industry. Active industry speaker. Well respected with regulators. • Strategy to Execution - Planning, resource allocation, prioritization of activities • Working with Stakeholders – Adept at working with stakeholders who hold the cards and know how to achieve win-win solutions.