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3D Communications Expands its Executive Communications and Value Communications Programs with Hiring of Former Industry Executive

Cara Vivarelli-O’Neill brings two decades of pharmaceutical and healthcare industry experience.

Washington, DC3D Communications, LLC announced today the hiring of Cara Vivarelli-O’Neill, MPH, the former Director of Communications for North America for ViiV Healthcare.  A seasoned communications specialist, Cara brings two decades of pharmaceutical and healthcare industry experience across government affairs, community relations, academic and medical affairs, and regulatory affairs.

“Today’s pharmaceutical and device clients are facing complex and controversial issues that cut across traditional company functions and siloed external stakeholder groups,” said Cindy DiBiasi, 3D Communications Co-Founder.  “Cara’s experience within healthcare organizations, and her understanding of the external environment, are the perfect fit for 3D’s holistic approach to Executive Communications, Value Communications for Market Access, and Regulatory Affairs.”

Cara is recognized for her ability to engage important and influential stakeholders, analyze the environment, and frame messaging that reflects how value is perceived in the marketplace.  She also has a proven track record of coaching executives and teams to deliver authentic communications that drive performance and outcomes. Cara also has worked in regulatory affairs across varied therapeutic areas, adding value to 3D’s signature FDA and EMA Regulatory and Scientific Services.

 

About 3D Communications

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. Our Executive Communications coaching help executives develop and articulate authentic, clear and compelling messages on complex and controversial issues. www.3dcommunications.us

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3D Communications Expands Regulatory and Communications Consulting Services

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)

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Chris Miller's Article "Achieving Approval for Abuse-Deterrent Opioids in the era of an Opioid Epidemic" Published in The Pharma Letter

We are proud to announce that today The Pharma Letter published an article written by Chris Miller. It’s entitled:Achieving approval for abuse-deterrent opioids in the era of an opioid epidemic. 

 

In this article, Chris provides his perspective on the regulatory challenges pharmaceutical companies face as they try to get abuse-deterrent opioid products approved. In keeping with the 3D mission of providing solutions for problems – Chris offers companies tips on how to address those challenges.

Read the article here.

 

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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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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