How to Effectively Communicate with FDA and EMA Regulators – In a Virtual Meeting Environment

Virginia Cox, JD - Senior Consultant and Lead, 3D Communications

Virginia Cox has spent more than 25 years in healthcare communications, including at the highest levels of government. She brings a unique blend of strategic communications skills, health policy background, and firsthand FDA regulatory experience to all her clients.

Virginia helps clients embrace any communications challenge – no matter how complex and complicated – and turn it into an opportunity to deliver a compelling story. Her years of experience at the FDA and US Department of Health and Human Services (DHHS), combined with her background in law, enable her to approach any healthcare communications challenge with a critical eye and sound advice. Since joining 3D Communications, she has helped clients prepare for more than 50 FDA Advisory Panel meetings and submissions, as well as numerous CHMP meetings.

Prior to rejoining 3D Communications, Virginia was the highest-ranking communications officer at the US FDA. As associate commissioner for the Office of External Affairs, she provided strategic leadership and communications oversight to a wide range of agency activities. She also served as a special assistant to the secretary of the US DHHS, and as the FDA commissioner’s director of outreach and strategic initiatives. Before working at the FDA, Virginia worked at 3D Communications and the Consumer Healthcare Products Association, where she was senior vice president for communications and strategic initiatives. She received an undergraduate degree from the University of California, Los Angeles and a law degree from Georgetown Law, and is a member of the Maryland Bar Association.

Adam George, PharmD - Senior Consultant and Lead, 3D Communications

Adam George is a seasoned regulatory affairs professional with broad expertise that leverages his prior experience as an FDA Office of New Drugs clinical reviewer to bring a dynamic approach to clients. He specializes in interactions with current and former US regulatory authorities; expedited development programs for rare, serious, and life-threatening diseases; 505(b)(2) new drug applications; and biosimilars.

Adam is known for his creative, analytical, and detail-focused approach to scientific and regulatory communications. He works closely with clients and key opinion leaders to create cohesive and convincing scientific messages supported by credible data presentations.

Before joining 3D Communications, Adam was a regulatory affairs therapeutic area head for oncology, respiratory drugs and biologics at Teva Pharmaceuticals. Prior to joining Teva, he spent more than six years at the FDA as a clinical reviewer in the Division of Hematology Products (DHP), Office of Hematology Oncology Products, and as a senior regulatory reviewer in the Office of Prescription Drug Promotion (OPDP).

As a clinical reviewer in DHP, he was responsible for the clinical review of NDAs, BLAs, and INDs for drugs to treat hematologic malignancies. He has reviewed and recommended products to be discussed at the Oncologic Drugs Advisory Committee, as well as reviewed and recommended products for fast-track designation, priority review, and breakthrough therapy designation. At OPDP, he was responsible for the review of promotional materials for hematology-oncology products and anti-infective agents. He holds a PharmD from Temple University.

Jim DiBiasi, 3D Founding Partner & Communications Lead, 3D Communications

Jim DiBiasi has provided strategic and tactical communications counseling and coaching to top executives, scientists, and doctors in the pharmaceutical, biotech, and medical device industries. With experience guiding more than 100 companies through high-stakes regulatory interactions, Jim is known for his ability to lead diverse teams and help them achieve their goals at decisive communications opportunities.

Jim’s unique approach focuses on both the individual client and the client’s audience. He coaches clients on the need to get into the audience’s head to effectively communicate, so speakers can use audience insights to inform how they develop and deliver clear, engaging, and impactful messages. He also uses 3D Communications’ proprietary process, practical tools, and purpose-built technology to help clients analyze their audience and prepare for challenging communications in more effective ways. Jim is dedicated to bringing out the best in each client – addressing challenges, seizing opportunities, and maximizing their unique talents and skills in every communication.

Jim has always been an entrepreneur who enjoys solving complex problems with creative solutions. With a strong background in business, finance, and accounting, he began his career with Ernst & Young in Philadelphia. He became a CPA, and initially was focused on finance in the independent energy sector, where he was involved in more than a billion dollars in non-recourse debt financing. Moving beyond finance and into operations and communications, he has been responsible for marketing, public relations, contract management, and legislative lobbying – and served as a media spokesperson for a Fortune 500 company. Before 3D, Jim owned a company that developed, financed, oversaw construction, and operated independently owned power plants. He earned an undergraduate degree in accounting from Villanova University.