NOTE: If your membership is expiring on July 31, 2017, you will not be able to attend this meeting free of charge unless you renew it prior to the meeting. To renew your membership, please follow in the instructions in our FAQs page.
TOPIC: The 21st Century Cures Act – An Overview
TOPIC DESCRIPTION: The 966-page 21st Century Cures Act (Public Law No 114-255) passed both houses of Congress by wide margins in late 2016 and was duly signed by outgoing President Obama in December 2016. The Cures Act has a bit of something for everybody – which in part explains its strong bi-partisan support. It includes funding to address the opioid crisis; an expedited pathway for “breakthrough” medical devices; clarifying FDA authority over medically-related software, patient-focused drug development and use of “real world evidence;” NIH funding, changes to the regulation of combination products; and promotion of access to mental health and substance abuse care to name a few. This presentation will provide an overview of key provisions of the Cures Act with emphasis on those provisions most affecting the development of drugs, biologics and devices, offer some insight into FDA work to implement the Cures Act, and consider the potential impact on the Cures Act of current congressional efforts to reform/repeal/replace the ACA.
SPEAKER: Deborah Elvins
SPEAKER BIOGRAPHY: Deborah Elvins is a managing member of Adkins, Plant, Elvins & Black, focusing her practice on business and legal services for life-sciences companies in the early to mid-stage levels of development. Deborah’s practice includes a wide range of services, from advising boards of directors to negotiating and drafting in- and out-license agreements, manufacturing agreements, CRO and clinical trial agreements and other life sciences-specific transactions to general business advice and transactional work. Before joining APEB, she was vice president of legal affairs for Dendreon Corporation, where she provided legal services and intellectual property and human resources management. Prior to that, she was the managing partner of the Seattle office of Stoel Rives LLP, where she practiced general corporate and business law with an emphasis on non-profit, healthcare and technology businesses. Deborah earned an undergraduate degree in history from the University of Washington and her J.D. from the University of Washington School of Law. She is also a member of the Board of Directors of Foster Care Alumni of America, a nonprofit dedicated to transforming the foster care system.
WHO: Suitable for everybody in life sciences
This meeting includes:
- Coffee and tea
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification