- Ethnographic Research and REMS
-Guest Blog by Andrea J. Simon, PhD.- In the past year, pressures to integrate observational or ethnographic research (which really are one and the same) in pharmaceutical and biotech industries are increasing as the value of this research is becoming better understood. In particular, Phase IV research involving the management and use of a drug protocol [...]
Our Team
The foundation of ParagonRx, and your success, is our team of experienced professionals with over 100 years of pharmaceutical, care management, adult education, clinical and other diverse disciplines: engineering, science, drug safety, healthcare, pharmacy, training, project management and health informatics.
Working together over the past eight years, we have developed a culture of proactivity, responsiveness, delivery and value creation that is unrivaled. Most of our clients choose to work with us over and over again. Find out why!
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Jeffrey Fetterman brings a mix of corporate and entrepreneurial leadership to his role as President and CEO of ParagonRx. His corporate background includes directing cardiovascular marketing, clinical education, and strategic planning at DuPont Pharmaceuticals and serving as COO for DuPont Consumer Health. As an entrepreneur, he co-founded Empower Health and later ParagonRx. Jeff has been in the pharmaceuticals industry for more than 20 years, with chemical engineering degree from Lehigh and an MBA from the University of Pittsburgh.
Gary Slatko, MD, MBA, as Chief Medical Officer, leads all aspects of risk management consulting services for ParagonRx, including strategy, design, documentation, negotiation, implementation and assessment. A pioneer in pharmaceutical risk management, he co-authored two books on the subject, established an evidence-based framework REMS program design and has led the development of over 20 RiskMAPs and REMS programs. Applying his 23 years of industry experience to failure analysis and ethnographic clinician observation yields comprehensive programs that are robust, practical, measurable and support appropriate medication use, such that interests of regulators, practitioners, patients and shareholders are all served.
Prior to co-founding ParagonRx in 2001, Gary held executive pharmaceutical positions at GlaxoSmithKline, AstraZeneca, DuPont Merck and Bristol-Meyers Squibb. He obtained his M.D. degree from the University of Miami, his M.B.A. degree from West Chester University and his B.A. degree from Emory University, and is Board Certified in Internal Medicine.
Billy Holden, after undergraduate studies, obtained a Master’s degree in Epidemiology from Columbia University as well and completed his doctorate in Epidemiology at Yale University. After spending some time teaching in the UK, he became the head of research for a pharmaceutical industry consulting firm in New York City, where he spent seven years. He worked for SmithKline Beecham as an epidemiologist and subsequently moved to Aventis as Director of Global Epidemiology, where he spent four years. He then became the Global Head of Epidemiology at Novartis, followed by head of Epidemiology and Risk Management for sanofi pasteur, the vaccine division of sanofi aventis. Most recently, Billy was the head of Epidemiology and Risk Management at Vertex Pharmaceuticals in Cambridge. His numerous publications include articles on the development of quantitative benefit-risk analysis methods as well as comparative studies of leflunomide and other DMARDs. He has presented on numerous occasions to FDA, EMEA, and other drug regulatory agencies. He has been the co-chair of the Scientific Program Committee of the International Society for Pharmacoepidemiology (ISPE) and has received many awards and recognitions for his work.
Kim Bullano, BS, PharmD is Clinical Services Director at ParagonRx. In her role, she brings her 15 years of clinical expertise and technical experience in the design and development of Process of Care® programs and Risk Evaluation and Mitigation Strategies (REMS) documentation. Prior to joining ParagonRx, she served nine years in the pharmaceutical industry in Medical Information and Medical Science Liaison positions. Kim earned her pharmacy degree from the University of Montreal, her doctorate degree from the Philadelphia College of Pharmacy and Science, and completed a post-doctorate residency at Thomas Jefferson University Hospital in Philadelphia, PA.
Donna Dalton, RN joined ParagonRx with more than 20 years of diverse experience in the pharmaceutical and medical device industry. She has demonstrated commercial success in a variety of positions including Sr. Brand Manager, Manager of Medical Relations, Sales Training Manager, and Clinical Marketing Manager. She also has a strong clinical background in patient education and as a board certified Wound Ostomy and Continence Nurse. Donna’s combination of both commercial and clinical experience allows her to have an in depth understanding of our clients business needs. In addition to her nursing degree, she holds a bachelor’s degree in healthcare management.
Marc DeLuca designed and continues to refine the proprietary software implementation of Failure Mode and Effects Analysis (RxFMEA®) at Paragon. Marc supported himself as an independent consultant while attending the University of Delaware, where he earned a BS in biochemistry and performed research at its Marine Biochemistry and Histology Laboratories.
Blaise Hollot brings more than twenty years of pharmaceutical experience to ParagonRx. His blend of sales, marketing, and medical liaison experience allows for thoughtful insights into the process of care. This provides a solid basis for the disciplined approach and analysis of the client's business. Blaise earned his chemical engineering degree from West Virginia University and is pursuing advanced epidemiology education at the University of Pittsburgh.
Karen Lenoir drives customer service at ParagonRx relying on nearly 20 years of experience in the pharmaceutical industry. Karen leads operations for ParagonRx, and as Client Services Director she is responsible for project and resource management as well as partner company relationships. She previously served DuPont Pharmaceuticals as a budget administrator and marketing information specialist and worked as a managed healthcare coordinator at ICI Pharmaceuticals. She holds a BA in organizational dynamics from Immaculata University.
Regina L. Ruben, Ph.D. is a drug safety expert with over 20 years of pharmaceutical industry experience, including 15 years in pharmacovigilance. At ParagonRx, Regina specializes in designing and implementing risk management programs; developing pharmacovigilance procedures and corrective action plans; and recommending improvements to drug safety organizational structure, processes, and systems. She was on the faculty at Hahnemann Medical College & Hospital and held positions of increasing responsibility at the DuPont Pharmaceuticals Company, AstraZeneca, and Cephalon. Regina received her Ph.D. in tumor immunology and anatomy from the Ohio State University College of Medicine and did postdoctoral research in viral transformation and cell senescence at the University of Illinois College of Medicine (Chicago).
Victoria Tait specializes in business operations for ParagonRx, overseeing legal matters, finances, and operational functions for the company. With over twenty years of experience, she previously held the position of corporate secretary, executive assistant and legal secretary for Atlantic Aviation. She worked for years as a legal secretary with Morris, Nichols, Arsht & Tunnell and other law firms. Vicki holds an associate of arts degree from Goldey Beacom College.