Founded in 1991, ProEd Communications, Inc., is a full-service health science and regulatory communications company with offices in Beachwood, Ohio; Basking Ridge, New Jersey; and New York, New York.
ProEd’s reputation is built on more than 2 decades of experience developing quality communication products aimed at improving patient outcomes. We blend insightful understanding of unmet needs, educational gaps, and scientific information to guide the development of evidence-based data dissemination for a vast array of products, biologics, devices, and nutritionals. ProEd is a nimble, entrepreneurial, and flexible partner with additional depth easily available through the Omnicom Group, our parent company.
ProEd’s tenure is the result of consistently meeting and exceeding each client’s unique data dissemination needs. Every year our people conduct more than 100 meetings (advisory boards, mock FDA meetings), nurture relationships with countless medical experts around the globe, and support the development of over 150 print and digital communications. Our work is performed by a full-time staff of highly skilled professionals, including PharmDs, PhDs, and MDs, who digest data and develop compelling content while serving as liaisons to clients and experts. Our team of regulatory affairs consultants brings an added dimension to data digestion and dissemination. Deliverables are the product of a rigorous content development process that is built around transparency with all stakeholders. The culmination of our efforts is the ultimate value we bring to our clients and their stakeholders through our discerning and efficient approach to the translation of the scientific data, mindful and diligent support of client policies, superior quality-control processes, and a focus on customer service.
The successful translation of complex scientific data into educationally focused content requires a unique blend of collaborative intellectual endeavor and educational expertise. We have been developing data-driven, scientifically accurate content with the goal of improving patient outcomes for more than 20 years for products all along the life cycle for clients large and small around the globe. We employ bench-trained scientists who are able to climb inside the data—preclinical, clinical, and postmarketing—and work with your team to identify your product’s strengths and weaknesses. And we employ professionals with specialized training in educational programming as well as learning styles and health literacy to make certain the content developed is appropriate for the audience for whom it is intended, as well as the channel through which it will be delivered.
Our scientists work with medical experts around the globe, forging relationships that allow for healthy scientific exchange. The result is thoughtful content and educational programming that explores each product’s unique niche or disease state. Our corporate culture recognizes these relationships as business assets. As such, we don’t just maintain these relationships, we recognize their value and cultivate them through scientific rigor, integrity, and staying true to the molecule.
Pharmaceutical and medical device companies around the world face greater scrutiny than ever when seeking to bring new products to market or to expand their indications.
At ProEd, we created the industry’s first dedicated regulatory communications team 20 years ago to help our clients secure regulatory approvals and obtain the optimum labels for their pharmaceuticals, medical devices, and biologic products.
Since then our dedicated team of physicians, pharmacists, scientists, and communications professionals has helped more companies succeed in the regulatory arena than any other communications firm.
We have helped support over 90 FDA advisory committee meetings across 100 submissions with an impressive 80% success rate.
We continue to lead the industry by providing the deepest scientific expertise, the most experienced regulatory strategists, and the most effective communicators. Our services include:
For more information please visit www.ProEdRegulatory.com.
Mary Rofael, MD
A communications counselor and strategist, Mary Rofael, MD, has more than 20 years’ experience leading medical affairs, publications, and regulatory communications programs for innovative pharmaceutical, medical device, and biotechnology companies.
In the course of this work, Dr. Rofael has led the assessment of drug development plans and data for an extensive portfolio of therapies across numerous therapeutic areas and strategic challenges. She has evaluated data packages to identify and address potential clinical and regulatory hurdles, worked with clients to build credible and compelling messages and presentations, and trained client teams to manage issues and handle objections. She is an experienced facilitator with a focus on moderating communication strategy sessions.
Since 1998, Dr. Rofael served in several positions within ProEd. She founded ProEd’s regulatory division and, as Medical Director and Chief Strategic and Regulatory Officer, served as a trusted partner to more than 120 pharmaceutical, biotechnology, and medical device clients as they prepared for FDA Advisory Committee Meetings, EU oral hearings and other critical regulatory interactions. Over 16 years, Dr. Rofael built a team of in-house scientists and regulatory experts, designers and technology specialists, speaker coaches, and program managers who provide full-service support for FDA AdComs and other critical regulatory interactions. As Head of Scientific Services, she provided strategic direction, scientific consulting, and oversight for a division of ProEd that has developed and maintained more than 125 medical publication plans overall, and annually supports the development of more than 350 print and digital projects, including manuscripts, medical abstracts, and posters designed to improve patient outcomes.
Most recently, Dr. Rofael served as Chief Strategic Officer for the Healthcare Consultancy Group (HCG), developing communications strategies and solutions for clients of ProEd and its fellow HCG agencies (Chameleon, Health Science Communications, Hyphen Digital, ProEd Communications, and The Scienomics Group) to address the ever-increasing medical information needs of physicians and patients.
Currently, as President of ProEd Communications Inc., Dr. Rofael directs ProEd’s industry-leading medical affairs, publications, and regulatory communications divisions as well as the firm’s growing market access and development consulting services. She leads teams of MD, PharmD and PhD scientists, client service professionals, designers, and communications coaches to address our clients’ needs across audiences and therapeutic areas.
Scott Roberts, MBA
Executive Vice President, Global Market Access
As the leader of ProEd’s Global Market Access practice, Scott Roberts, MBA, leverages more than 20 years of strategic consulting experience to direct market access and pricing strategies for pharmaceutical, medical device, and biological product companies. Mr. Roberts has developed innovative solutions for high-value, specialized medicines in oncology, immunology, neurology, and rare diseases as well as curative and gene therapies.
Before rejoining ProEd, Mr. Roberts spent 5 years in executive positions with Biogen, where he directed Global Market Access and Pricing Strategy, and led regional teams in Japan, Australia, and emerging markets. Under his direction, Biogen built a world-class market access organization able to align executives and key matrix functions from early asset development through maintenance and lifecycle management. He launched 6 products globally, leading negotiations with the German AMNOG system, Japan’s MHLW, and other challenging national payers worldwide.
Mr. Roberts’ previous experience includes 4 years developing pricing strategies at PriceSPective, and 5 years at leading brand commercialization and marketing programs at ProEd/HCG.
Mr. Roberts has an MBA from Boston University and undergraduate degrees in Engineering and Economics from Brown University.
Senior Vice President, Strategic Communications
Greg Connel leads the communications coaching function at ProEd, where he co-created a specialized training program for FDA advisory committee meetings. Since 2005 he has directed script development and issue management as well as presentation and Q&A training for more than 35 advisory committee teams. With more than 15 years of communications training experience, he has instructed more than 1,000 people to address regulatory authorities, media, colleagues, and other diverse audiences with confidence and poise.
Before joining ProEd, Mr. Connel was senior vice president and partner, general manager, at Fleishman-Hillard International Communications in Cleveland, Ohio, where he directed message and program development, led crisis communications teams, facilitated strategy and war games sessions, and provided local, national, and trade media relations counsel for clients in healthcare and other industries.
A former co-chair of the Fleishman-Hillard media council, Mr. Connel spent nearly a decade as a journalist. He was an Associated Press correspondent, business editor of Ohio’s largest suburban daily newspaper, associate editor of 2 construction industry magazines, and editor of the member newsletter for the National Association of Emergency Medical Technicians.
Mr. Connel received his bachelor of science degrees in journalism and marketing from Bowling Green State University in Bowling Green, Ohio.
Laura L. McCormick, PhD
Senior Vice President, Scientific Services
Before joining ProEd, Laura L. McCormick, PhD, served as a senior research associate in the department of dermatology at Case Western Reserve University in Cleveland, Ohio, where she had previously served as a postdoctoral research associate and fellow. Her research interests there included the study of anti–TGF-β‚ antibody therapy, and gene therapy in a mouse model for scleroderma. Prior research experience, also at Case Western Reserve University, involved the development of bispecific antibody therapy for the treatment of bacterial lung infections in patients with cystic fibrosis.
A graduate of Youngstown State University in Youngstown, Ohio, Dr. McCormick earned a bachelor of science degree in applied science there before going on to complete postgraduate work at Ohio University in Athens, Ohio. Dr. McCormick earned her doctorate in biological sciences there, with a major in molecular and cellular biology. Her primary research area was cellular immunology.
Currently, Dr. McCormick is responsible for crafting high-quality scientific and medical communications, ensuring accuracy and reliability of scientific data, and keeping abreast of the current medical literature concerning products and indications within her purview. Dr. McCormick also provides strategic direction to her clients, ensuring consistent implementation of corporate strategy, and is responsible for establishing and maintaining faculty and client relationships.
Dr. McCormick brings a wealth of scientific knowledge and experience to all of the therapeutic areas we serve on behalf of our clients.
Allen D. McCrodden, MBA
Creative Group Supervisor
Allen D. McCrodden, MBA, has worked in medical communications for the past 7 years. He is a talented artist with a track record of providing fresh, creative solutions and incorporating cutting-edge technologies and digital approaches. His skills include creative direction and multidisciplinary problem-solving resulting in comprehensive design solutions for a wide variety of clients and projects. Mr. McCrodden has extensive experience in all design channels from print to interactive to web to app development, and he manages a team of talented graphic artists with broad and varying skill sets.
Before joining ProEd, Mr. McCrodden served as art director for 7 years at Anthony Thomas Advertising, Inc., in Akron, Ohio. While there he was responsible for the direction and design of advertisements, sales collaterals, logos, websites, and interactive applications for a national client base, as well as the planning and execution of marketing and branding strategies.
Mr. McCrodden earned his bachelor of fine arts degree, with a concentration in graphic design, from the University of Michigan in Ann Arbor, Michigan, and his master of business administration degree from Case Western Reserve University in Cleveland, Ohio.