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3D Communications Expands FDA and EMA Regulatory and Scientific Services

Wednesday, November 16, 2016 Corporate News J E 4
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Announces Two New Senior Hires Focused on Clinical Trial Design, Statistical Analyses, and Regulatory Submissions in the US and Europe

WASHINGTON, Nov. 16, 2016 /PRNewswire/ -- 3D Communications LLC announced today the expansion of its global healthcare regulatory services with the hiring of two senior science executives focused on clinical trial design, statistical analysis, and regulatory submissions. Peggy Berry, a former FDA official, regulatory affairs executive and drug development consultant, and Todd Gross, PhD, a biostatistician and clinical development specialist, have joined 3D Communications. They will be leading high-level programs for bio-pharm and device companies advancing innovative medicines and devices in the United States and Europe.

"Bringing Peggy and Todd onto the 3D team enhances our ability to serve the clinical development needs of global life sciences companies," said Jim DiBiasi, 3D Communications co-founder. "With these two additions, we are extending 3D's signature services. We are now partnering with clients earlier in the development timeline with clinical, pre-submission and regulatory consulting services – and expanding those services in global markets including the EU and Asia."

A regulatory specialist since her days at the FDA's Office of Drug Evaluation, Peggy Berry has built a strong reputation inside and outside industry for her deep understanding of all phases of clinical development – from phase 1 through commercialization. Peggy has worked across multiple therapeutic areas, including pulmonary, cardiovascular, neurology and oncology; and across the globe, preparing for regulatory meetings in the US, Canada, the EU, Australia, Japan and the Middle East. A member of the Regulatory Affairs Professional Society, Peggy has earned her Regulatory Affairs Certification and is an ACRP Certified Clinical Research Associate.

Todd Gross has led clinical development, biostatistics, clinical data management and programming departments for pharmaceutical and medical device manufacturers.  He has proven success with FDA, EU and Asia-Pacific regulatory processes for more than twenty NDA, IND, PMA, IDE and 510(k) applications, and has presented at numerous successful FDA advisory panels. A thought leader in statistical analysis for clinical trials, Todd has co-authored more than two dozen publications and presents frequently at industry-sponsored conferences.

For more than 15 years, 3D Communications has been supporting life sciences companies through the U.S. regulatory approval process. With Berry and Gross, the firm's specialized team extends its ability to serve the global needs of sponsors.

About 3D3D 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 teams on delivery; and executing realistic mock rehearsals. 3D's experienced team has developed proprietary processes to support these meetings. 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. For more information, visit www.3dcommunications.us. Follow us on Twitter @3D_Comm (@3D_Comm)

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/3d-communications-expands-fda-and-ema-regulatory-and-scientific-services-300364002.html

SOURCE 3D Communications

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