Global Regulatory Policy Lead, New Technologies, Biogen, United States
Lauren Oliva is the Global Regulatory Policy Lead for New Technologies at Biogen. She oversees the development and execution of R&D’s policy roadmap for digital health technologies and gene therapy to enable Biogen’s neuroscience portfolio. She is passionate about patient centric...
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Global Policy Lead, Digital Health, Diagnostics, Oncology, & Combination Product, Amgen, United States
Megan Doyle is an attorney and policy professional with more than 13 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public...
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Co-Founder, Chief Executive Officer, Elektra Labs, United States
Andy Coravos (@andreacoravos) is the CEO/co-founder of Elektra Labs, building a digital medicine platform focusing on digital biomarkers for decentralized clinical trials. She serves as a research collaborator at the Harvard-MIT Center for Regulatory Sciences. Formerly, she served...
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Project Manager, Clinical Trials Transformation Initiative (CTTI), United States
Lindsay Kehoe is a project manager at the Clinical Trials Transformation Initiative (CTTI), currently managing the implementation of CTTI's digital Novel Endpoints project. Prior to joining CTTI, she coordinated genetic and rare disease clinical trials at Children’s National Medical...
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Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
Dr. Papadopoulos serves as the Deputy Director (acting) of the Division of Clinical Outcome Assessment in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The Division provides consultation to CDER’s Review Divisions as well as other FDA Centers on...
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