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Our strength is our experienced team. When you hire us, you get seasoned executives, each with more than 20 years of pertinent experience. Our team is complimented by a scientific and regulatory advisory board comprised of MDs and PhDs, all of whom have extensive FDA or Advisory Committee experience. | |
 Cindy DiBiasi Cindy DiBiasi has built a reputation as a leading health care communications consultant, working with top executives at some of the world’s largest companies. Her approach is rooted in the belief that even the most daunting communications challenges provide opportunities for companies and executives to define themselves and convey important information to regulatory and government officials, customers, colleagues, shareholders, and the public. Cindy has guided clients through numerous FDA meetings and advisory committee hearings in a variety of indications, including cardiovascular disease, obesity, and infectious diseases. Her consulting, writing, and coaching work with large pharmaceutical, medical device and biotech firms also includes preparing clients for high-stakes public presentations, quarterly earnings calls, and media interviews. Cindy was formerly a broadcast reporter in the United States and Europe, and spent years as the health and science reporter at WUSA-TV, the CBS affiliate in Washington, DC, where as part of her beat she covered the FDA. |
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 Jim DiBiasi Jim DiBiasi has been a business executive, lobbyist, marketer, public relations and crisis communications professional, and communications consultant and trainer to some of the top scientists and executives at Fortune 100 Companies. Jim has prepared clients for numerous advisory committee hearings and FDA meetings in indications ranging from acute bacterial sinusitis to weight loss, as well as handling controversial topics such as pediatric, over-the-counter cough and cold medications. A gifted communicator who served as media spokesperson for a Fortune 200 company, Jim has crafted scores of presentations and provided speaker and media training and tactical counsel for clients in the public, private, and non-profit sectors. He also prepared hundreds of key opinion leaders for major presentations at international symposia in a wide variety of indications, including breast and colon cancer, cardiovascular disease, diabetes, pain management, and asthma. |
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 Penny Daniels Penny Daniels is a strategic communications consultant and coach to executives and scientists at top healthcare organizations, recognized for her ability to distill essential messages from complex data, write clear, engaging scientific presentations, and empower clients to communicate effectively in high-stakes, high-pressure environments. Penny has steered scientists and executives through numerous regulatory communications, from pre-IND and IDE communication with the FDA, to challenging advisory committee meetings for drugs and devices in indications ranging from heart disease to cancer, schizophrenia, GI disease, asthma, pneumonia, and more. Penny also coaches executives, key opinion leaders, and celebrity spokespeople for pharmaceutical companies during product launches, competitive challenges and communications crises. A former national TV news anchor and reporter, Penny is an experienced writer, video producer, and media trainer who helps clients develop and deliver messages to a increasingly skeptical press. |
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 Kell Cannon Kell Cannon brings more than 20 years of U.S. and global pharmaceutical marketing, development and lifecycle experience managing products spanning more than 20 different therapeutic areas. He has held leadership positions at Roche, Novartis, Ciba and Merck in life cycle management, marketing, managed care, pricing and sales. His responsibilities included clinical trial strategy, label negotiations, brand positioning, and advocacy development. With increasing FDA scrutiny, label planning and clinical data interpretation become increasingly important for regulatory planning and long-term brand success. With his diverse experience, Kell has proactively planned for label inclusion that helped competitive differentiation and share growth; and helped reverse a negative regulatory opinion. His proactive clinical and regulatory involvement have helped expedite product access and competitive reimbursement. Kell has an MBA and a BS in Microbiology. |
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 Bert Regeer Bert Regeer, MD, has a 20-year proven track record in clinical development strategy. His expertise is in proactively planning long-term development programs, protocol design, endpoint selection, trial implementation, patient recruitment, trial/site logistics, CRO management, clinical study reports, NDA development, clinical document preparations and medical publications. In his role as a senior medical executive at Roche and Bristol Myers Squibb, Bert initiated clinical studies and solved clinical and label gaps that drove later product share. At those companies he served as an international medical leader, medical director, and product manager. His expertise spans both small molecules and biologics in the areas of oncology, cardiology, infectious diseases, and supportive care. Bert obtained his medical degree from Rijksuniversiteit Leiden, The Netherlands. |
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 Marie-Claude Stockl Marie-Claude Stockl approaches public business presentations, FDA advisory committee preparation, and crisis management issues with the same strategic thinking that made her a successful senior public affairs officer reporting to chairmen and presidents of Fortune 100 companies for twenty years. Her grasp of larger issues is well complemented by her attention to the changing needs of internal and external audiences including stake holders, advocacy groups, and key opinion leaders. She herself has given thousands of print and broadcast interviews and has vast experience coaching celebrities, corporate executives and investigators for media interviews, presentations, and world congresses. A native of France, with a Masters' Degree from the University of Paris, Marie-Claude is often called upon to facilitate international meetings. |
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 Jerry Michaels Jerry brings his dual expertise in psychology and communications to help healthcare clients strategically prepare for high-stakes meetings and media interviews. He has prepared pharmaceutical executives, scientists, and Key Opinion Leaders for FDA meetings, Board of Director and analyst meetings, public presentations, and media interviews. With a Masters degree in Psychology from New York University, Jerry has created and conducted programs on case-based learning, healthcare professional and patient communication, effective product launches, and crisis communications. He has also conducted research on addictions and phobias which has led to appearances on national TV shows including The CBS Evening News and ABC’s Good Morning America. Jerry has been a keynote speaker at numerous healthcare association conferences, including the American Cancer Society, the American Diabetes Association, and The American College of Cardiology. He has taught the Psychology of Communication courses in NYU's Graduate School, and has conducted seminars on Crisis Communication for the Wharton School of Business. |
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3D Communications Scientific and Regulatory Advisory Board (back to top) Eric Brass, MD, PhD, Board Chair and Director of the Center for Clinical Pharmacology at Harbor-UCLA Medical Center and Professor of Medicine at the David Geffen School of Medicine at UCLA. Dr. Brass has been a Chair and voting member on numerous FDA advisory committees since 1995 and continues to serve as a periodic consultant to the FDA. Gregory Burkhart, MD is a regulatory consultant who was a former team leader and epidemiologist at the FDA. Dr. Burkhart has significant FDA and industry experience in both pre-marketing and post-marketing drug development. Bruce Burlington, MD is an infectious disease internist and currently serves as the industry representative on the FDA’s Drug Safety and Risk Management Advisory Committee. Dr. Burlington held senior management positions at the FDA and in the pharmaceutical industry. He now advises companies on drug development, risk management strategies, and preparation for key FDA meetings. Louis R. Cantilena, Jr., MD, PhD is the Professor of Medicine and Director of the Division of Clinical William Hiatt, MD is Chief of Vascular Medicine and professor for cardiovascular research in the Department of Medicine at the University of Colorado, Denver School of Medicine, and president of the Colorado Prevention Center, a university-affiliated, non-profit cardiovascular and clinical trials research organization. Dr Hiatt is the immediate past chairman of the FDA’s Cardiovascular and Renal Drug Advisory Committee. Heidi M. Jolson, MD, MPH is an independent consultant to the pharmaceutical industry, specializing in clinical drug development and regulatory strategy. She previously worked at the FDA, serving in a number of capacities from Director of the Division of Antiviral Drug Products to Deputy Director of the Division of Reproductive and Urologic Drug Products. She was also a primary medical reviewer at the FDA, reviewing clinical trial protocols, new drug applications, and post-marketing safety. Paul Waymack, MD, ScD is a regulatory consultant and previously worked as an FDA Medical reviewer and special consulting reviewer, responsible for assessing New Drug Applications and Investigational Drug Applications. Janet Wittes, PhD is the President of Statistics Collaborative, Inc., which provides statistical collaboration for clinical trials and epidemiology to industry, government and non-profit researchers. Dr. Wittes has served on numerous FDA advisory committees. She was formerly the Chief of the Biostatistics Research Branch of the National Heart, Lung, and Blood Institute at the National Institutes of Health. (back to top) | |