In this second session of the Weill Digital Health Series, our guest experts will present an overview of the regulatory landscape and the challenges related to privacy and data protection. They will also address the future of reimbursement for digital health products.
Bio to come.
Melissa Hudzik is a Senior Counsel in the FDA Regulatory, Health Care, and Consumer Products practice of the Washington, DC office of Wilson Sonsini Goodrich & Rosati. She is also a Certified Professional Coder. Melissa represents health care providers, durable medical equipment manufacturers, and MedTech and life sciences companies in health care regulatory, fraud and abuse, and reimbursement and billing matters. She helps health care companies develop and implement health care compliance programs and regularly counsels clients on internal and external billing audits. Melissa also advises clients in mergers and acquisitions to ensure health care regulatory compliance with the arrangement and pre and post-closing.
Vernessa Pollard is Chair of McDermott Will & Emery’s FDA practice. She provides strategic business and regulatory advice to FDA-regulated companies on complex issues related to the development, manufacture, marketing, post-market safety and compliance for FDA-regulated products, including drugs, medical devices and digital health technology. Vernessa counsels companies on product development and premarket strategy, good manufacturing practice/quality system requirements, advertising/promotion, adverse event reporting, FDA warning letters, FDA inspections, recalls, import detentions, corporate compliance programs and regulatory due diligence in mergers and acquisitions. She is a former Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel and has been recognized in numerous Law and Life Sciences publications, including Chambers USA 2014 to 2020, Healthcare: Pharmaceutical/Medical Products Regulatory (DC) and LMG Life Sciences, Regulatory Attorney of the Year: FDA Medical Devices, 2018. Vernessa received her B.A. in Communications from Howard University and her JD from Temple University School of Law.
Dr. Placanica is Senior Managing Director, Center for Technology Licensing at WCM. In this role, she is responsible for overseeing WCM’s activities in technology management, marketing, licensing, and outreach to support Cornell’s goals in commercializing technologies, promoting start-ups, and building partnerships.
Prior to joining WCM in 2020, Dr. Placanica held the position of Managing Director, Business Development and Licensing at Mount Sinai Innovation Partners. In this role, she was responsible for managing a team of business development professionals focused on identifying, advancing, and partnering therapeutic technologies developed at the Mount Sinai Health System and acted as deal team lead for closing complex intellectual property transactions. Dr. Placanica also was a Licensing Manager in the Office of Technology Development at Memorial Sloan Kettering Cancer Center where she focused on development and commercialization of cell and gene therapy related inventions and previously was a key member of the Cell Biology research group at Athersys, Inc in Cleveland, Ohio.
Dr. Placanica received her Ph.D. in Pharmacology from Weill Cornell Medical College where she studied the biochemical composition of gamma secretase and its role in Alzheimer’s Disease in the laboratory of Dr. Yueming Li at Memorial Sloan Kettering Cancer Center. She holds a B.A. in Biology from Cornell University where she graduated Magna Cum Laude with Distinction.
In 2013, Dr. Placanica became a Certified Licensing Professional.
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