145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi

Let's Combinate - Combining Drugs and Devices

On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses:

01:18 Understanding Regulatory Policy

03:18 Ryan's Career Journey

05:08 Challenges in Regulatory Harmonization

06:54 Legislative Frameworks and Regulatory Differences Globally

11:10 FDA's Role and Recent Legislation (User Fee reauthorization and the Food and Drug Omnibus Reform Act)

15:51 International Harmonization Efforts

22:36 Combination Products and Policy Work

30:10 The Importance of Advocacy and Education

35:22 Closing Thoughts and Personal Insights

Ryan's Article: https://ispe.org/pharmaceutical-engineering/ispeak/chinas-regulatory-framework-combination-products-ongoing

Ryan Hoshi is Director of Regulatory Policy & Intelligence and serves as the global policy topic lead for digital health, artificial intelligence, medical devices, combination products, personalized medicine, clinical pharmacology, and cell and gene therapies. Prior to AbbVie, Ryan served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) in the Office of the Center Director and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Ryan also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices and drug-eluting stents. Ryan earned his bachelor’s degree in Bioengineering from the University of California, Berkeley, his doctorate and master’s degrees in Biomedical Engineering from Northwestern University, and his MBA from Georgetown University, McDonough School of Business.