What impact will new initiatives and regulations from the FDA have on drug and device companies? Join Triangle Business Journal and a panel of experts as we explore this topic.
VP of Clinical Development at PRA Health Sciences
Brandon is a drug developer with deep oncology and immunology experience. He has run global clinical development programs in the biotech and CRO sector. In his current role as VP, Clinical Development at PRA Health Sciences, he serves as Chief of Staff within the core CRO, Product Registration. Prior to PRA, Brandon led and owned primary responsibility for clinical development at Heat Biologics, a cell therapy immuno-oncology start-up company. He also led global oncology programs at INC Research at office locations both in the US and in Europe. Brandon began his career as a Clinical Research Coordinator at the University of Virginia in the Carter Immunology Center, and the Asthma and Allergic Disease Division.
Chairman and Chief Executive Officer of Clarkston Consulting
Tom Finegan, Chairman and Chief Executive Officer of Clarkston Consulting, has defined the firms vision since co-founding the company over 25 years ago. Along with the other co-founders, Tom believes consulting firms that genuinely care about driving measurable business results for clients and create a rewarding and stimulating environment for professionals will thrive in the crowded consulting marketplace. Tom is responsible for managing the company, formulating long-term strategies, and driving growth.
Named a finalist in Ernst & Youngs Entrepreneur of the Year, a 40 under 40 Leader, and other industry awards, Tom is recognized in the industry as an entrepreneurial strategist able to bring new innovative ideas to large and emerging companies alike. As a proven leader and a recognized expert in transformational strategy development, Tom still serves as an adviser and advocate for global life sciences and consumer products companies.
Tom also serves as chairman of Rural Sourcing, Inc. and FoodLogiQ, LLC and is a managing member of Clarkston Merchant Partners and Enlight Research. He is a board member for the National Association of Corporate Directors (NACD) Research Triangle Chapter and a past executive member of the board for the Council for Entrepreneurial Development (CED).
David Shoemaker PhD
Senior Vice President, R&D, Rho
Dr. David Shoemaker has more than 25 years of experience in research and pharmaceutical development. He has extensive experience in the preparation and filing of all types of regulatory submissions including primary responsibility for four BLAs and three NDAs. He has managed or contributed to more than two dozen NDAs, BLAs, and MAAs. Dr. Shoemaker has moderated dozens of regulatory authority meetings for all stages of development. His primary areas of expertise include clinical study design and regulatory strategy for development of novel drug and biological products.
Jennifer Henderson Reporter, Triangle Business Journal
On average, it costs billions of dollars and takes more than a decade to get a new drug to market. Well be discussing how new initiatives and regulations from the U.S. Food and Drug Administration may impact the regulatory process for local drug and device companies moving forward.
Expert panelists and TBJ moderators, Jennifer Henderson and Marc DeRoberts, will lead the panel discussion to include Q&A from the audience.
North Carolina Biotechnology Center
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