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WATCH THE RECORDING

Session 5: FDA Regulatory Pathways and Requirements

Date and Time: March 5, 2021 Time: 7:00 am – 8:30 am

Course Description: 
This session will provide an overview of regulatory approval and commercialization issues impacting companies developing medical devices, drugs and biologic products.

Educational Objectives:
Attendees should be able to identify which regulatory pathways are likely to apply to their products, meaning that they will be able to more accurately predict the level of funding, research, commercialization strategies they will need to bring their product to market. In addition, attendees who are considering turning their products into companies will be given a better understanding of how to approach some common legal issues.

Topics Include:

Key Issues in Regulation of Drugs:

NDAs and ANDAs 

Evidentiary Standards for Approval

Regulations through the Product Life Cycle

Key Issues in the Regulation of Devices:

Key Issues in the Regulation of Biologic Products:

Key issues in the Regulation of Life Science Companies:

 

Continuing Education Credit: VCU Health designates this live activity for a maximum of 1 AMA PRA Category 1 Credits™. VCU Health also designates this activity for a maximum of 1 ANCC contact hours. Physicians and nurses should claim only the credit commensurate with the extent of their participation in the activity.

Schedule (tentative)

7:00 a.m. Welcome Address L. Franklin Bost, MBA
7:05 a.m.Review of ProcessL. Franklin Bost, MBA
7:10 a.m.SpeakerThomas Miller, Esq
8:00 a.m.Q&AL. Franklin Bost, MBA
8:20 a.m.Closing StatementsL. Franklin Bost, MBA

Speakers and Bios

Thomas (“Tommy”) Miller, Esq [View Image]

Thomas ("Tommy") Miller, Esq

Senior Counsel, Nixon Gwilt Law

Thomas (“Tommy”) Miller, Esq., is Senior Counsel and Life Science Practice Lead at Nixon Gwilt Law and is licensed in Virginia, Washington, D.C., and Maryland. Tommy has almost exclusively served the healthcare life science industries during his career, representing healthcare providers and suppliers, health tech companies, pharmaceutical companies, and biotech clients. His deep knowledge of issues impacting these highly regulated businesses allows him to provide practical business and legal advice in the areas of licensure and certification, payment and reimbursement, commercial transactions, legal and regulatory compliance, fraud and abuse, and patient privacy.

In law school, Tommy was a Law Clerk at the Centers for Medicare and Medicaid Services (CMS), Office of Hearings.  There, he assisted with the adjudication of administrative appeals related to Part C and D drug plan application denials.  After graduating from law school, Tommy spent a brief time as a creditor’s rights and Bankruptcy attorney and later joined a Richmond-based health law firm where he represented large and small healthcare clients, including physician practices, health systems, long-term care providers, and community hospitals.

Tommy has counseled pharma and device companies on key initiatives in the development and commercialization of new and existing drug and device products.  During his time in-house, Tommy advised on a broad range of matters including managed care and market access, drug marketing and advertising, specialty distribution, patient and consumer privacy, patient safety, and best compliance practices in the areas of physician engagement, aggregate spend (Sunshine Act), and third-party educational programs and grants.

Tommy has also spent time assisting a Top 25 pharmaceutical client to maintain smooth operations through a significant merger. With that client, Tommy provided general transactional advice and worked primarily on managed care strategy and contracting, including drafting and negotiating innovative value-based rebate agreements with some of the country’s largest insurance payers and pharmacy benefit managers.

Tommy graduated cum laude from both the University of Baltimore School of Law and Virginia Polytechnic Institute and State University. He is a member of the Virginia State Bar and has co-authored, published, and presented on a variety of topics. Tommy serves the Virginia State Bar, Health Law Section, as a member of the Board of Governors.  He lives with his family in the Richmond metro area and is a member of the Richmond Symphony Chorus.

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VCU College of Engineering
601 West Main Street
Richmond, Virginia 23220
United States

Virginia Commonwealth University
Email: IEM@vcu.edu
Phone: (804) 828-0349
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Last Modified: 03/31/2021
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