3D Communications Expands Regulatory and Communications Consulting Services
Source: 3D Communications
3D Communications Expands Regulatory and Communications Consulting Services Hires Former FDA and Industry Executives to Prepare Clients for FDA and CHMP Regulatory Submissions and Meetings
Washington, DC – 3D Communications LLC announced today the hires of Marianne Mann, MD and Adam George, PharmD in two new senior level roles — continuing the expansion of the company’s regulatory and communications consulting services for regulatory submissions and FDA and CHMP meetings.
Both hires bring decades of FDA, regulatory, and industry experience in the development of successful clinical drug design and regulatory submissions. Marianne and Adam will serve as Science Leads to deepen 3D Communications ability to work with pharmaceutical and device companies earlier in the submission process and help sponsors to gain approval in the United States and abroad.
“Pharmaceutical and device companies need world-class support when going to regulatory bodies with increasingly complex filings,” said 3D Communications founding partner Jim DiBiasi. “Marianne and Adam are amazing additions to 3D’s already seasoned team.”
A former FDA Medical Expert, Marianne Mann brings more than 25 years of experience as a regulatory and clinical drug expert, including 9 years with the FDA. She’s helped guide successful drug development programs for sponsors and prepared them for FDA Advisory Committee meetings. Along with her specialty in Respiratory Drug Development, Marianne has worked on indications including diabetes, migraines, hormone replacement, contraception, and lipid disorders.
Adam George’s FDA and industry experience provide 3D clients with a broad range of relevant insights. Adam served as a clinical reviewer in hematology and oncology at FDA, providing him with experience in how the FDA reviews submissions, considers applications for Fast Track designation, priority review and breakthrough therapy designation. Adam was a senior regulatory reviewer in the Office of Prescription Drug Promotion, and a therapeutic area head for oncology and respiratory drugs at Teva Pharmaceuticals.
About 3D Communications
3D Communications is preeminent in preparing pharmaceutical, biotech and device companies for regulatory meetings with the FDA, EMA, and other regulatory agencies. Our services include: developing strategy; creating content, including messaging, scripting, slides, Q&A and briefing books; coaching team son delivery; and executing realistic mock rehearsals. We have prepared more than 100 companies for 170 key regulatory interactions, including: FDA advisory committee meetings, EOP2 meetings, and CHMP oral hearings. 3D has authored two books on preparing clinical submissions and FDA advisory committee meetings. Visit www.3dcommunications.us. Follow us on Twitter @3D Comm (@3D_Comm)