Our RAC-certified regulatory experts provide objective insights, drive strategic development, and facilitate consensus within US and global product teams.
Our team of MDs and clinicians provides evidence-based guidance throughout a product’s life cycle from early development to postmarketing.
Our team of PhD medical directors understands complex scientific concepts and has the know-how to make them clear and accessible to different audiences.
Our former journalists and communications coaches train presenters at all skill levels to deliver powerful presentations and address the most challenging questions with confidence and poise.
Our network of over 6,000 subject matter experts and former advisory committee members provides the perfect mix of expert presenters and experienced panelists for your regulatory advisory boards, mock panel meetings, and document reviews.
Our energetic, dedicated, and diligent account services staff maintains your projects on message, budget, and quality.
Our creative, digital, and technical team can plot complex data and illustrate novel concepts, making our slides and documents look better and work better for regulatory audiences.
Our team of detail-oriented medical editors keeps your content consistent and accurate through editorial review and a thorough QC process.
Our fabulous event management team is trusted by our advisors and respected by suppliers and vendors in DC and the pharma corridor to provide the most seamless experience for all participants.
Do you need a fresh pair of eyes to vet your approach and strategy? Are you looking to better understand the perspective of the FDA, EMA, or an advisory committee panel?
At ProEd we have assembled a scientific advisory board composed of key experts in their fields to provide our clients with the objective and critical perspective they so frequently seek.
We challenge your thinking and push your team to greater success. You will find that your practices were tougher than the real game. There will be hardly a question asked at the actual meeting that you didn’t face in rehearsals.
Garret A. FitzGerald, MD, FRS
Garret A. FitzGerald, MD, FRS, is chair of the Department of pharmacology, director of the Institute for Translational Medicine and Therapeutics, professor of medicine and pharmacology, McNeil professor in translational medicine and therapeutics, and associate dean for translational research at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Dr. FitzGerald has served on many advisory boards nationally and internationally, including the WHO and the NIH. He is internationally renowned for his work on bioactive lipids. His discoveries have contributed fundamentally to the adoption of low-dose aspirin for cardioprotection. He was the first to predict and then mechanistically elucidate the cardiovascular hazards of NSAIDs. His laboratory was the first to characterize the molecular clock in the cardiovascular system.
Dr. FitzGerald continues to investigate the role of peripheral molecular clocks in cardiovascular biology, metabolism, and aging.
Gregory T. Brophy, PhD
Gregory T. Brophy, PhD, is a regulatory consultant who provides senior-level leadership to small and large companies in regulatory affairs, drug development, regulatory policy, toxicology, strategic planning, and due diligence.
Dr. Brophy earned valuable pharmaceutical company drug development experience over 32 years with Eli Lilly & Co in Indianapolis, Indiana. He previously served there as director of US regulatory affairs, providing significant strategic regulatory and development leadership in support of original approvals and marketed compounds.
Most recently, he was senior director of global regulatory affairs for neuroscience, cardiovascular, urology, and musculoskeletal medicine at Eli Lilly. While there, he was also involved in message development, team training, and Q & A management in preparation for numerous FDA advisory committee meetings.
Dr. Brophy's broad therapeutic area expertise includes psychiatry, neurology, pain, cardiovascular, endocrinology, urology, oncology, and musculoskeletal medicine.
Retired from Eli Lilly, Dr. Brophy brings his experience in establishing positive relationships with FDA divisional and office senior leadership to help teams prepare for health authority meetings, including the preparation of briefing materials and presentations for various FDA and advisory committee meetings.
Tarek M. Mekhail, MD, MSc, FRCSI, FRCSEd
Tarek M. Mekhail, MD, MSc, FRCSI, FRCSEd, is medical director of the thoracic oncology program at the Florida Hospital Cancer Institute, and associate director of clinical research at the Cancer Institute of Florida in Orlando. He is also an associate professor at the University of Central Florida in Orlando.
A board-certified internal medicine, hematology, and medical oncology physician and specialist in thoracic oncology, Dr. Mekhail was previously the director of the lung cancer medical oncology program at the Cleveland Clinic in Cleveland, Ohio.
A national and international clinical investigator, his clinical interests include lung cancer, head and neck cancer, kidney cancer, aerodigestive malignancies, and the development of novel therapeutic agents.
Marlene E. Haffner, MD, MPH
Marlene E. Haffner, MD, MPH, is a regulatory consultant, an adjunct professor in the department of preventive medicine and biometrics, and a clinical professor in the department of medicine at the F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences in Bethesda, Maryland.
Before establishing her own company, Dr. Haffner served as executive director, global regulatory policy and intelligence at Amgen Inc, where she assisted with issues relating to orphan products in development or under approval. A well-known expert in orphan drug development, Dr. Haffner is a sought-after speaker and consultant in that area of regulatory science.
She began her career with the Indian Health Service in Gallup, New Mexico, and served for 36 years in the United States Public Health Service, rising to the rank of rear admiral. She went on to serve as director of the Office of Orphan Products Development (OOPD) of the FDA. In her 20 years as OOPD director, she was responsible for the leadership and management of the FDA orphan products development program, the first such program in the world.
Today, she brings her depth of experience to serve the regulatory and health policy needs of industry and voluntary groups in regulatory affairs relative to the development of new pharmaceutical products, with special knowledge of interactions with the FDA and HHS.
Lee-Jen Wei, PhD
Lee-Jen Wei, PhD, is a professor of biostatistics at the Harvard School of Public Health in Boston, Massachusetts, and a senior statistician at the statistical and data analysis center.
Dr. Wei has served on numerous data safety monitoring boards. This, coupled with his extensive experience in quantitative science and his intimate involvement in designing, monitoring, and analyzing various kinds of studies and assessing postmarketing surveillance data to identify safety signals, adds to his overall expertise.
Additionally, Dr. Wei has invented numerous novel statistical methods, many of which have been included in commonly used statistical packages, such as SAS, S-plus, and R. In particular, his multivariate Cox procedures to handle multiple event times have become quite popular. He and his colleagues have also discovered alternative models to the Cox proportional hazards model for analyzing survival observations.
Kevin Joseph Carroll, PhD, CStat, CSci, Honorary Senior Lecturer
Kevin Joseph Carroll, PhD, CStat, CSci, Honorary Senior Lecturer, is a professional statistician with more than 20 years of drug development experience across all trial phases and multiple therapeutic areas. Currently a statistical consultant, Dr. Carroll is Honorary Senior Lecturer, Medical Statistics, at The University of Sheffield, in Sheffield, United Kingdom.
Most recently, Dr. Carroll held the position of Vice President, Statistics and Chief Statistical Expert with AstraZeneca, where he was accountable for the design, conduct, analysis, and reporting of clinical trial programs. Through this senior leadership role he was involved in shaping the content and strategy of multiple new and supplemental drug applications in the United States and European Union. Additionally, Dr. Carroll has served with Boehringer Ingelheim as an expert statistician for central nervous system research. Uniquely for a statistician in industry, Dr. Carroll was the main presenter and sponsor representative at several FDA Advisory Committees and, further, has experience of several EMA Oral Hearings. His clinical and regulatory experience has spanned cardiovascular and metabolism, oncology, neuroscience, respiratory, inflammation, infection, and gastrointestinal therapeutic areas.
Dr. Carroll offers a wealth of experience in face-to-face interactions with health authorities worldwide, and he is often called upon to share this expertise as a panelist at mock FDA meetings. Dr. Carroll’s research interests include survival analysis, non-inferiority trial design, cardiovascular and other safety outcomes trial design, interim and futility analyses, adaptive design and Bayesian methods, and decision making in drug development. He has multiple first-author publications on statistical and strategic issues in drug development and in 2014 he received his Doctorate by Published Works in "Statistical Issues in Oncologic Clinical Drug Development."
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 runs the communications coaching function at ProEd.
A seasoned and renowned presentation and media trainer and war games facilitator, he has led programs for a wide variety of spokespeople at all levels of an organization and across industries.
Greg has helped prepare more than 40 FDA advisory committee teams.
In the course of this work, he has taught hundreds of presenters and responders to craft overarching message platforms and create compelling stories in support of their products, deliver persuasive advisory committee presentations, and respond to questions with poise and confidence.
Greg believes that the key to success for presenters lies in staying true to their styles and personalities. He will help you leverage your individual strengths, build a presentation that speaks in your voice, and empower you with tools to help you critique and improve your own performance.