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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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3D Communications Expands FDA and EMA Regulatory and Scientific Services

Announces Two New Senior Hires Focused on Clinical Trial Design, Statistical Analyses, and Regulatory Submissions in the US and Europe

Washington, DC– 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.

3D Communications and SolemEU Announce a Joint Venture, Expanding Value Communications for Market Access Services in Europe

New Approach to Communicating Value of Drugs and Devices

3D Communications and SolemEU have entered into a joint venture to help pharmaceutical, biotechnology and medical device companies develop and successfully communicate their value proposition to key stakeholders – including payers, physicians, patients and policymakers.

The joint venture expands 3D’s Value Communications for Market Access services throughout Europe, leveraging SolemEU’s network of senior executives experienced in developing and executing pricing, reimbursement, and market access strategies.

“The strategic alliance with SolemEU comes at a critical time for the pharmaceutical and device industries, as the prices of products are increasingly under fire,” said 3D Communications’ founding partner Cindy DiBiasi. “We believe the old way of justifying the price of a drug or device and communicating its value is obsolete. The current environment demands strong communication. We have developed a new approach to ensure a product’s value proposition is based in both economic reality and what stakeholders perceive as valuable.”

The process moves beyond traditional market access approaches. It utilizes a three-dimensional method that assesses how the complex stakeholder environment, local market realities, and the evolution of treatment interact, and ultimately influence, a product’s value proposition.

3D Communications and SolemEU’s Value Communications for Market Access service is built on experience and insights gained from 20 years of working with both small and large healthcare companies, associations and stakeholder groups around the world.

“By combining 3D’s expertise in strategy and effective communications, with SolemEU’s experience in health economics and market access strategies throughout Europe, we will be able to provide clients with a more practical, thoughtful approach to an evolving and challenging global marketplace,” said SolemEU principal Peter Zaudtke.

3D Communications is a strategic communications firm, offering a comprehensive and integrated approach to defining, supporting, and justifying value supported by effective communications. Our integrated suite of communications services ensures message consistency across all levels of an organization and throughout all stages of product development.

SolemEU is an international market entry advisory firm offering strategy development, data generation, stakeholder testing and preparations in Europe for HTA interactions and dossier submission – leading to a credible Value Story and high-value reimbursement.

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The Regulatory Affairs Professional Society (RAPS) Published a Positive Review of 3D Communications’ Book: 'The FDA Clinical Submission Survival Manual'

Meredith Brown-Tuttle, RAC, chair of the RAPS Publication Task Force, recently reviewed 3D Communications FDA Clinical Submission Survival Manual.

In her review, Ms. Brown-Tuttle notes that, “The quality of a regulatory professional’s communication skills can make or break a company. The FDA Clinical Submission Survival Manual contains useful tips and processes to improve FDA communication. It contains specifics on how to plan, develop and test strategy and key messages for a marketing application, with a focus on clinical data.”

“The book could be a good primer for those interested in moving up the ‘ladder,’ especially for those wanting to understand the marketing application planning process and accompanying pitfalls. It also will be useful for those at a senior level who have been through the NDA process, but would appreciate external validation or support for implementing new processes.”

For the full review visit the RAPS site here.

To purchase the book, visit the 3D Bookstore or purchase via the RAPS web site.


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3D Communications Expands Executive Communications Programs and Training, Opens Boston Office

3D Communications announced today that it has opened an office in Boston, Massachusetts and significantly expanded its executive communications training programs to help companies communicate more effectively in increasingly complex and contentious environments. The expansion of communications services, and the opening of the Boston office, will allow 3D to better serve clients in New England and globally.

3D’s Executive Communications Programs and Training will now include: Leadership Communications Coaching, Change Management Communications, and Crisis Communications. These will be in addition to 3D’s current offerings of Messaging, Media Training, and Speaker Training services.

To lead the Boston office, 3D has recruited Executive Communications Consultant and Former 60 Minutes Producer Lee Zeidman to join the team.