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Bio: Meena Datta is global co-leader of the Sidley’s Healthcare practice and member of the global Life Sciences team, manages key strategic matters for life sciences and healthcare companies throughout the world. Meena specializes in all areas of health care regulatory law for pharmaceutical and medical device manufacturers, including the government pricing, Anti-Kickback Statute and state pricing transparency laws, the Sunshine Act, health care reform, and HIPAA and data privacy and security. Her particular areas of focus include patient support programs, market access, and government pricing. She routinely works with General Counsels, Compliance Officers, and their departments to develop and implement effective compliance programs. Meena serves as outside counsel to a wide range of healthcare clients, including emerging and established biopharmaceutical, medtech, and big data companies.

Bio: Craig is an experienced health care executive, having served as corporate vice president and general counsel for Novo Nordisk, and senior vice president, general counsel and secretary for Daiichi Sankyo. As a practicing corporate and health care lawyer for almost 30 years, he advises clients on legal, compliance, policy and regulatory matters relating to health care products and businesses along the full spectrum—from discovery through commercialization. Well versed in the processes and the inner workings of the Food & Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), he advises on clinical studies, inspections and recalls, drug safety programs and negotiates product labeling with the FDA. He advises clients on promotional and medical communications under FDA regulations, guidance and enforcement practices, and First Amendment litigation precedent, including print ads, direct-to-consumer television ads, websites and applications.

Craig Bleifer, Partner, Akin Gump

Meena Datta, Partner, Sidley Austin 

Keren Bisnauth, Associate Vice President of Legal & Regulatory, RLDatix Life Sciences 

Bio: Keren Bisnauth is Associate Vice President of Legal & Regulatory with RLDatix Life Sciences (formerly Porzio Life Sciences). Ms. Bisnauth collaborates on creating new products and services and managing existing offerings from the company.  Keren guides pharmaceutical, medical device, and biotechnology companies on compliance-related issues, including global transparency and aggregate spend, industry standards regarding interactions with healthcare professionals, federal and state fraud and abuse laws, and FDA promotional regulations. Keren also has significant experience working on transactional matters, concentrating on corporate mergers, acquisitions, and general contract areas.

Jake DeBoever, Vice President Chief Compliance Officer, Dermavant Sciences

Bio: Since 2021, Jake DeBoever has brought significant compliance and corporate experience to the Dermavant team. His previous roles as Vice President and Chief Compliance Officer at Galderma and Vice President of Compliance and Ethics at McKesson helped build his extensive knowledge of healthcare, prescription drugs, medical devices, drug distribution, litigation, antitrust, and more. He graduated with a bachelor’s in public policy from Hamilton College and a JD from Washington University School of Law in St. Louis.