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3D Communications Expands Value Communications for Market Access Services with the Addition of Liz Sherer

Washington, DC3D Communications LLC today announced the expansion of its global Value Communications for Market Access services adding Liz Scherer, a seasoned communications executive. Liz brings to 3D experience across multiple aspects of the pharma development process – from R&D and Regulatory to Marketing and Commercialization.

“Bringing Liz onto the 3D team enhances our Value Communications for Market Access program across multiple touchpoints,” said Cindy DiBiasi, 3D Communications Co-founder. “Her ability to start with the end goal in mind, coupled with a thorough, cross-functional understanding of how to leverage and optimize content, help clients achieve their market access goals.

As a communications specialist, Liz has a strong reputation for aligning communications across multiple organizational silos and throughout a product’s life cycle. Her work across varied therapeutic areas will also enhance 3D’s signature FDA and EMA Regulatory and Scientific Services. Additionally, Liz’s previous experience leading business development for two digital communications consultancies, and her work as a health reporter will support the messaging and content development work for 3D’s pharmaceutical and health technology clients. Visit Liz’s Blog.

3D Communications has established itself as a global leader in healthcare communications and in helping companies navigate the U.S. regulatory approval process. 3D’s Value Communications for Market Access Services builds upon the company’s more than 15 years of experience in life sciences.

 

About 3D

 3D Communications is a strategic communications firm that prepares pharmaceutical and device companies for high-stakes regulatory, payer, and other stakeholder interactions. 3D offers a comprehensive and integrated approach to defining, supporting, and articulating value throughout all stages of product development.

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Former FDA Executive Jamie Page Joins 3D Communications FDA Regulatory and Advisory Committee Preparation Team

Washington, DC3D Communications LLC announced today the continued expansion of its FDA Regulatory and Advisory Committee preparation services with the hiring of former FDA reviewer and project manager Jamie Waterhouse Page.

Jamie Page worked at the Food & Drug Administration (FDA) for seven years in the Center for Devices and Radiological Health (CDRH). At CDRH, she held positions as Lead Reviewer and Project Manager, working in the Division of Cardiovascular Devices and Neurological and Physical Medicine Devices.  Jamie was also a Designated Federal Officer responsible for coordinating Advisory Committee meetings and was involved in Q-Submissions, Pre-IDE, Early Feasibility Study, Expedited Access Program, and Appeals meetings between the FDA and Industry.

“Jamie’s recent in-the-trenches experience with FDA interactions and meetings at every stage of product development will provide valuable insight to our clients,” said Jim DiBiasi, 3D Communications Co-Founder.  “In addition, her work with FDA Advisory Committee meetings will make her an integral part of 3D’s Advisory Committee team.”

Jamie also brings industry experience to her new role at 3D.  Before joining FDA, Jamie worked in industry as a Field Clinical Engineer at a start-up medical device company, responsible for device programming and technical support during implantation and follow-up visits with patients enrolled in clinical trials. Visit Jamie’s blog.

Over the last 15 years, 3D Communications has established itself as a global leader in healthcare communications specializing in helping companies navigate the U.S. regulatory approval process.

About 3D

 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 teams on delivery; and executing realistic mock rehearsals.  We have also developed proprietary processes and technology tools to support these meetings. 3D has written The FDA Clinical Submission Survival Manual, and The FDA Advisory Committee Survival Manual: A Step-by-Step Guild to Preparing for a Successful Meeting. For more information, visit www.3dcommunications.us.

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3D Communications Contributes to New Edition of RAPS’ Essential Regulatory Affairs Text Book

Fundamentals of US Regulatory Affairs, Tenth Edition now available

Rockville, MD, USA—The Regulatory Affairs Professionals Society (RAPS) has just published the updated 10th tenth edition of its popular text, Fundamentals of US Regulatory Affairs, the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices, biologics and other healthcare products intended for the US market. The book is comprised of 44 chapters by 53 regulatory experts.

Among the book’s authors are Jim DiBiasi, Cindy DiBiasi and Kell Cannon of 3D Communications who    authored two chapters in the book: Chapter 4: FDA Communications and Meetings, and Chapter 5: Preparing for FDA Advisory Committee Meetings.  Fundamentals of US Regulatory Affairs covers US regulatory requirements across healthcare product lines, including pharmaceuticals, medical devices, biologics, and other product classifications.

Fundamentals of US Regulatory Affairs is a ‘must-have’ for every regulatory professional,” said Jim DiBiasi, partner at 3D Communications. “The chapters authored by 3D Communications provide insightful and practical tips for pharmaceutical, biotech, and device companies that are preparing to interact with the FDA.”

The tenth edition of US Fundamentals has been updated to address current regulatory requirements from the Food and Drug Administration (FDA). This edition includes more details on pre-clinical and clinical trials and Good Clinical Practices, breaking these subjects down by product lines. It also includes new chapters on Biosimilars and supply chain.

The first edition of US Fundamentals was introduced two decades ago and has undergone regular revisions over the years, reflecting changing regulations and new technologies. Since its introduction, it has sold more than 30,000 copies. US Fundamentals is relied upon by regulatory and legal professionals, professors, students, career-changers and FDA staffers as a valued reference, academic textbook and Regulatory Affairs Certification (RAC) study tool.

The list price for the full 10th edition is $395, while RAPS members get $100 off that price. It is available in both print and e-book versions. For more information or to order Fundamentals of US Regulatory Affairs, visit RAPS.org/fundamentals.

 About 3D Communications

3D Communications is a strategic communications firm that works with top executives and their teams across scientific, healthcare, technology, education, financial, and business sectors to develop and deliver successful messages and presentations. For more information, visit www.3Dcommunications.us  3D has also written The FDA Clinical Submission Survival Manual. ©3D Communications (2010), and The FDA Advisory Committee Survival Manual: A Step-by-Step Guild to Preparing for a Successful Meeting. ©3D Communications (2008). 

Available at: www.3dcommunications.us/FDAsurvivalguide.html.

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