Who We Are

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, diabetes, 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. 

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.

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 an increasingly skeptical press.

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 lifecycle 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; he has also 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.

Christen M. Anderson, MD, PhD                                      

Christy is a physician-scientist with more than 25 years of experience in biotechnology, academic medicine, drug development, and regulatory issues. She has led successful drug discovery and development teams at Gensia, MitoKor, Amylin, and Arena Pharmaceuticals. As a biotechnology executive, Christy oversaw clinical development, NDA and advisory committee meeting preparation.   She now assists pharmaceutical and biotechnology companies with clinical development strategy, regulatory submission strategy and implementation, advisory committee preparation, and post-approval activities. 

Christy’s expertise is in obesity, diabetes, cardiovascular disease, and CNS diseases. She received an MD and a PhD in biochemistry from the University of Texas Southwestern Medical School.  Christy completed a fellowship in Endocrinology and Metabolism at the University of California San Diego and is a Fellow of Tthe Obesity Society.

Bert Regeer, MD

Bert Regeer 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.

Rachael Carlisle Roehrig, PhD

Rachael Roehrig utilizes her scientific, regulatory, and technical writing skills to prepare clients and lead teams for successful FDA advisory committee meetings.   Before joining 3D, Rachael had extensive experience with the FDA, working as the director of technical & scientific affairs at the Consumer Healthcare Products Association (CHPA).  Rachael focused on regulatory and quality issues for the over-the-counter pharmaceutical industry, and acted as CHPA’s liaison to the FDA,  building and managing relationships with the Office of Compliance and Office of Regulatory Affairs.  She also represented the World Self Medication Industry, helping to develop the International Conference on Harmonization (ICH) quality guidelines.

Rachael is the Chair-Elect for the Product Quality Research Institute, and also serves on numerous scientific advisory councils and committees, including the United States Pharmacopeia's Council of the Convention.  Rachael was a physical chemistry instructor at Stevenson University in Baltimore, developing curriculums and teaching students on thermodynamics and quantum chemistry.  She received her doctorate in chemistry from The Johns Hopkins University where she studied photophysical inorganic chemistry applied to molecular cardiobiology.

Susan Resnick, PhD

Susan Resnick has more than 20 years experience in clinical research working with a variety of Class II and III medical devices, including implantable devices and technology for surgical procedures.  Susan is a proven leader with extensive knowledge in regulatory strategy, clinical trial design, biostatistics, post-market product surveillance, medical writing, and interactively working with the Food and Drug Administration to obtain product approvals.  Before joining 3D Communications, Susan held a variety of clinical research leadership positions at Guidant (Boston Scientific) and Medtronic Corporations. Susan has published over 35 manuscripts in peer review medical journals prior to joining industry.  She has had the opportunity to develop excellent working relationships with physician and health care professionals in the collaborative development of clinical evidence.  Susan is skilled at the creation of effective presentations and has experience coaching speakers in improving presentation skills. Susan received her Bachelor’s Degree from University of Michigan and her Master of Public Health and PhD in Epidemiology from the University of Minnesota.

Mimi Pappas

Mimi Pappas brings more than 15 years experience in healthcare communications to 3D clients, with an expertise in stakeholder engagement and education. Mimi has created and executed public health education campaigns in partnership with medical professional societies, consumer advocates, and government agencies. Her work includes campaigns and outreach with organizations ranging from the American Pharmacists Association and AARP, to the National Alliance for Hispanic Health and The Partnership for a Drug Free America. Mimi most recently served as the director of communications and outreach at the Consumer Healthcare Products Association (CHPA), the trade group representing over-the-counter (OTC) medicine manufacturers. At CHPA, she had a leading role in developing a public-private partnership with the Centers for Disease Control and Prevention and a host of third-party organizations on the safe storage of medicines. Mimi frequently presented on issues related to safe medicine use and the abuse of medications, and helped prepare others for their public communications activities. She also spearheaded communications activities in support of numerous FDA submissions and advisory committee meeting presentations. Mimi is a graduate of the University of Pennsylvania.

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.

Jerry Michaels

Jerry Michaels 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.

Eileen Crowley

Eileen Crowley brings more than 15 years experience as a communications and advocacy specialist to clients in the pharmaceutical, medical device and public health arenas. During her career Eileen has worked with executives, researchers and product teams to deliver clear and concise scientific messages for Advisory Committee meetings with the FDA, CHMP and Health Canada, and partnered with global thought leaders, health agency and ministry representatives to develop positioning and programming for the appropriate use of prescription medications. Eileen has guided advocacy relations with professional and patient third parties that have supported clients’ products throughout their lifecycle, including Advisory Committee meetings and grassroots disease education programs.  She has also convened roundtables with healthcare professionals, advocacy groups and patients to develop dialogue tools and white papers, and coordinated scientific advisory boards with managed care organizations regarding workplace wellness.   Eileen is a graduate of St. John’s University and holds a Master’s of Science in Clinical Nutrition from New York University.

Jim Kelley

Jim Kelley helps clients prepare for successful FDA advisory committee meetings through a combination of strategic, tactical, and technical expertise. Jim draws from 22 years of experience in the FDA-regulated areas of commercial operations, clinical development, and communications. Through this experience he provides clients with integrated support from content development to meeting-day execution.  As a technology thought leader in the pharmaceutical industry, Jim has created clinical data-collection tools, including international patient registries and REMS for pharmaceutical companies and clinical research organizations, as well as file-management resources for 3D clients.  Jim also leads the 3D Productions team of graphic designers, PowerPoint^TM professionals, and audio and visual experts to ensure flawless planning and execution. Before joining 3D, Jim held leadership positions at GlaxoWellcome, Pharmedica Communications, Presentation Strategies / RPM, and CISYS LifeSciences.

Scott Franklin

Scott Franklin brings more than 18 years of experience in production, graphic design, and multimedia systems integration within the pharmaceutical arena.  As VP of Operations for 3D Productions, Scott is responsible for the strategic production of mock rehearsals and final meetings. In addition to overseeing equipment and technology integration, Scott also directs the team training on the ACCORD^TM document management systems, PinPoint^TM slide recall software and Q&A processes.

Mike Hilton

Mike Hilton has worked on more than a dozen advisory committee projects, creating, editing, and managing thousands of core and backup slides. Mike also oversees the team of additional 3D Productions PowerPoint^TM experts who are called in to support slide efforts during crunch periods. In addition to his PowerPoint^TM duties, Mike takes the lead for on-site preparation and logistics for both the mock rehearsals and actual advisory committee meetings, coordinating activities with meeting managers and travel agents.

Mark Blecher

Mark Blecher is an experienced project manager, production specialist and has a particular expertise in clinical slide development.  Mark brings more than 5 years of experience to the pharmaceutical arena and has worked on over a 28 FDA advisory committee meetings for drugs, devices and biologics across all therapeutic areas.  He has also managed more than 50 mock rehearsals and actual advisory committee meetings.   As a project manager Mark provides leadership in slide development, Q&A preparation, organization and ensures that all files are ready to be illustrated within seconds.  As a leader of the 3D Productions Mark helps manage the successful integration of technology into each project.  Mark also manages all of 3Ds ACCORDTMPortals as well as directs team trainings on the ACCORDTMdocument management systems.  He also manages 3Ds onsite Q&A Systems and helps each client successfully utilize the PinPointTMslide recall software as he guides them through the Q&A processes.

Catherine Carlisle

Catherine has worked as a writer, lecturer, and academic researcher at Penn State University and the State University at Albany.  She has conducted and presented academic research in history and political science to panels of professors nationally, as well as in small classroom settings – and has taught classes at both the university and high school level. She has also worked as a political speech writer for both county and state officials.Catherine brings to 3D an ability to identify, synthesize, and articulate important information from complex research, as well as superior organizational skills to help her manage multi-faceted projects.  Catherine holds a Master’s degree from the State University at Albany, where she has also completed her doctoral coursework.  She holds an additional degree in Baking and Pastry Arts from the Institute of Culinary Education, where she pursued a passion in both nutrition and design. Catherine is a member of the National Society of Collegiate Scholars, and of the International Golden Key Honor Society.

Natalie Vargas

Natalie Vargas is a seasoned project manager, writer, and slide expert, who has worked on dozens of FDA advisory committee meetings for drugs, devices, and biologics across all therapeutic areas.  Natalie possesses excellent, problem-solving, communications, and organizational skills. In addition to her advisory committee work, Natalie has designed document management and medical information systems, and has experience in developing clinical trial protocols, writing white papers, and device brochures.  Prior to getting involved in advisory committee work, Natalie taught Environmental Science and Chemistry to high school students in Morristown, NJ. This experience has helped her translate complex scientific issues into simple-to-understand messages, a key element in developing effective medical and scientific presentations. Natalie holds a Bachelor’s of Applied Science in Bioengineering from the University of Pennsylvania. She will receive her MPH in health systems and policy, and MBA in marketing in 2012. Natalie is an executive board member of the New Jersey chapter of the National Society of Hispanic MBAs.
 

Michelle Costantino

Michelle combines her expertise in clinical trials and academia with public communications and training to make scientific data relevant to both clinical and lay audiences. Michelle has worked in all phases of the research process from recruitment strategies and patient assessment, to educational training programs and data presentation. Michelle has coordinated federally-funded randomized controlled trials, and supervised research staff within the Department of Psychiatry at the University of Pittsburgh Medical Center (UPMC).  She has also established partnerships with community organizations and developed and delivered educational training programs to medical practices.  Michelle’s work in psychiatric research ranges from pediatrics and geriatrics, to primary care and women’s behavioral health.  She holds a Master’s degree in Health Administration from the University of Pittsburgh Graduate School of Public Health.

Cari Newton

Cari Newton has more than 25 years experience in marketing and business development. Having spent time on the client, agency and supplier sides of business, she brings a unique perspective in developing strategic partnership relationships for 3D Communications and 3D Productions. She has managed multi-million dollar retail advertising programs, initiated large-scale promotional programs for the Miller Brewing Company Southeast Region, and was integral in the development of the Clinical Study Services division in support of large pharma for Presentation Strategies/RPM during her 11 years with that firm.

Loren Edwards

Loren Edwards is Lead of the 3D KOLLEAD^TM Database Intelligence Team. KOLLEAD^TM is the database 3D uses to store biographical information as well as FDA meeting attendance, transcript, and voting information for all past and present committee members. The information is then used to produce 3D’s ADCOM RADAR® and MATCH.MOCK® reports which help to profile committee members, predict committee member behavior, direct slide development, as well as find experienced consultants for Mock Adcom Meetings. Loren manages KOLLEAD^TM team members as well as the ongoing maintenance and development of the database, while concordantly managing demands for deliverables based on upcoming FDA meetings, pitches, etc. She tracks FDA meeting announcements and the posting of meeting materials in order to ensure 3D’s KOLLEAD^TM Database stays current and up to date with all FDA Adcom Meeting information available. With a background in psychology and prior experience in Medicare accreditation, she is no stranger to research, the medical field, and regulatory approval processes. Loren has worked on over 20 advisory committee projects and profiled over a dozen FDA Advisory Committees.

Cory Bashaw

Cory Bashaw is part of 3D’s KOLLEAD^TM Database team. He is responsible for profiling advisory committee members for addition to the database as well as maintaining current information on all existing members already present within KOLLEAD^TM. Cory also assists on KOLLEAD^TM deliverables, including but not limited to RADAR and Match.Mock reports.

Katie Clark

Katie Clark is part of 3D’s KOLLEAD™ Database team.  She is responsible for pulling transcripts from FDA meetings and uploading them into the database as well as adding new committee members and keeping current information on existing members within KOLLEAD™.  Katie received her B.A. in Communications in 2006 and has since gained several years of experience maintaining a variety of databases.

Tedd Weigele

Tedd Weigele has 3 years production experience working on live-event audio, video, lighting, and set design.  He has also been contracted with several major sporting networks, including ESPN, Fox Sports, and TSN.  Tedd’s expertise has given him the opportunity to work with audio-visual crews on a wide variety of live events, such as FDA Advisory Committee and Mock Panel meetings, National Hockey League games, college bowl and basketball games and big name concert acts. Prior to coming on board with 3D Communications Tedd’s career was focused on customer service management.

Jack Villott

Jack Villott comes to 3D Communications with more than 25 years of experience in digital media design and design experience in the pharmaceutical arena. Jack’s  extensive knowledge in the latest video, post-production, and online tools allow 3D to offer clients a variety of video and online training tools for both internal teams and external outreach.   Jack is also responsible for the design, editing and maintaining of TalkRight, 3D’s  online video training series.