Our Experts

Experts

Jeffrey Fetterman, President

Jeffrey Fetterman, as President of ParagonRx, has solidified the company's status as a leader in the field of REMS (Risk Evaluation and Mitigation Strategies) and benefit-risk management for pharmaceutical, biotech, and medical device industries. He draws upon his engineering experience to give clients a unique set of tools that help to keep them on trend within the ever-changing regulatory environment.

As coauthor of two pharmaceutical risk management books and consultant for numerous risk management programs, he is a proven pioneer in applying risk management principles to the pharmaceutical industry. Having led the pre-startup safety assessment of the only nuclear reactor to be reactivated following deactivation, Jeff is familiar with the cross-industry implications of risk management techniques.

Prior to cofounding ParagonRx, Jeff cofounded Empower Health, a business that integrated care management tools and services to improve clinical health outcomes of people with chronic illness. Fetterman has extensive pharmaceutical industry experience, having led marketing, medical education, strategic planning, and business development organizations at DuPont Pharmaceuticals and DuPont Consumer Health

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He is an Adjunct Instructor in the Lehigh University Healthcare Systems Engineering Program that applies industrial systems improvement methods to the complex healthcare system. He is also a board member for First State Innovation which fosters entrepreneurial businesses in Delaware. He holds a BS in Chemical Engineering from Lehigh University and an MBA from Katz School of Business at University of Pittsburgh.

Stephen Sun MD, MPH, Chief Medical Officer

Dr. Stephen Sun is the Chief Medical Officer at ParagonRx. Dr. Sun earned his Bachelors of Science in Chemistry, Food, and Nutrition from Rutgers University, his medical degree from UMDNJ-New Jersey Medical School, and his Masters in Public Health from the Johns Hopkins Bloomberg School of Public Health. While training in general surgery at Beth Israel Medical Center in New York City, he dedicated his off-hours to developing a medical internet start-up. He eventually left residency to work full-time on his medical knowledge company, Medtower, which delivered relevant late-breaking news to research scientists in the life sciences.

Dr. Sun then transitioned to work for the pharmaceutical industry, first at Organon in Drug Safety and Medical Knowledge Management. He next joined Alpharma as Director of Drug Safety for all US generic and branded drugs. He was soon promoted to Senior Director of Medical Affairs, where he oversaw Phase I, II and IV clinical studies, risk management plans, pharmacovigilance, medical education, scientific publications, government affairs, health outcomes, and supported sales and marketing teams as well as working with medical science liaisons.

After King Pharmaceuticals', Dr. Sun moved on to further expand his industry experience in over-the-counter medications at Reckitt-Benckiser. With an interest in public health, Dr. Sun joined the FDA as a Medical Officer. He has served in the CDER Division of Risk Management and most recently in the Controlled Substances Staff. Highlights of his tenure at the FDA include the TIRF class REMS, the abuse potential assessment decision tree, the proposed standardization of abuse-related adverse event MedDRA terms, and the development of a surveillance system using mobile technology called Realtime Application for Portable Interactive Devices (RAPID).

He now joins ParagonRx (Parent: InVentiv Health) as Chief Medical Officer to provide science-based, systems-level expertise on the management of risks throughout the various stages of product development and launch.

Kim Bullano, BS, PharmD, Senior Director, Clinical Consulting
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) programs. Prior to bringing her vast pharmaceutical knowledge to 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, Director, Clinical Consulting
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, MHSEng, Associate Director, Clinical Consulting
Marc DeLuca has spent over a decade at ParagonRx working with various risk management methodologies such as Failure Mode and Effects Analysis (FMEA), Root Cause Analysis (RCA), Hazard Analysis and Critical Control Points (HACCP), and Probabilistic Risk Assessment (PRA). Marc uses these evidence based tools as well as his broad knowledge of the industry to partake in a range of activities involving project management, risk assessment, process development, program implementation, and evaluation of risk minimization programs. Marc has designed the first pharmaceutical Failure Mode and Effects Analysis (RxFMEA®) database. He now maintains and manages this database for ParagonRx. This allows ParagonRx to transcend from a paper-based system to a highly efficient method of assessing and documenting potential failures in the medication use process. Marc received his BS in Biochemistry at the University of Delaware and is currently pursuing a Masters Degree in Health Systems Engineering from Lehigh University.
Kevin Fetterman, Associate Director, Business Development
Kevin Fetterman is responsible for collaborating with our partner companies at inVentiv Health to create innovative, comprehensive services for our clients. This complete package helps clients manage the full life cycle of their products. Kevin began his career at ParagonRx as a summer intern in 2003 and returned to the company full time in 2006, when he was named Marketing Manager. Kevin holds a BS from the University of Delaware.
Karen Lenoir, Senior Director, Client Services
Karen Lenoir has been a part of the ParagonRx team for over a decade. As Client Services Director, Karen's chief responsibility is providing operational oversight and account management on all ParagonRx's projects. She also helps maintain customer satisfaction by ensuring that each engagement is aligned with client objectives, including reaching targeted goals and meeting budget requirements. Karen also leads all REMS assessment projects for the company. Her 20 years of experience in the pharmaceutical industry include posistions in managed care, marketing, and business development. She holds a BA in organizational dynamics from Immaculata University.
Regina L. Ruben, PhD, Director, Clinical Consulting
Regina L. Ruben, PhD is a seasoned drug safety expert with over 20 years of pharmaceutical industry experience, including 15 years in pharmacovigilance. At ParagonRx, Regina parlays that expertise into designing, implementing, and supporting risk management programs; applying pharmacovigilance requirements to the development of procedures and corrective action plans; recommending improvements to drug safety organizational structure, processes, and systems; and preparing risk management documents for regulatory submission. 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, Business Manager
Victoria Tait oversees legal matters, finances, and operational functions for ParagonRx. With over twenty years of experience, including holding past positions of corporate secretary, executive assistant and legal secretary for Atlantic Aviation, she provides ParagonRx with a breadth of financial as well as legal expertise. Vicki holds an associate of arts degree from Goldey Beacom College.
James Wang, Senior Manager, Client Services
James Wang joined ParagonRx in 2011. He plays an integral role in implementing the evidence-based processes to support our clients safe use initiatives such as RxFMEA®. In addition, James is instrumental in preparing and communicating the current trends in REMS both year-end and on a monthly basis. Before joining ParagonRx, James worked in the hospitality industry where he thrived in guest relations, operations management, and service-staff management. James holds a BA from the University of Delaware.
Jenna Sisler, Marketing Coordinator
Jenna Sisler utilizes her creativity as the Marketing Coordinator for ParagonRx. Her organizational skills and an understanding of messaging drive all marketing activities including direct marketing camaigns, event planning, and managing the website and social media outlets. She is responsible for handling logistics for the monthly FoREMS & More Webinars, which focus on trends in the pharmaceutical risk management arena today. Jenna began her career at ParagonRx shortly after graduating with a BS degree from the University of Delaware in 2011.
Kris Srinivasan, MD, MBA, MHSEng, Director, Clinical Consulting

Kris Srinivasan, MD, MBA, M.Eng.HSE is the Clinical Consulting Director at ParagonRx and his role is to provide strategic plans for both the regulatory and commercial needs of clients. As a physician and engineer by training, with years of experience working in many different types of healthcare systems, Kris provides clinical innovations and analytics to the unique, systematic approach ParagonRx has for guiding risk management strategies in the pharmaceutical industry. Kris founded Gold Standard Solutions, LLC, which provides quality improvement and clinical practice optimization solutions to various types of medical practices. He has successfully optimized over a dozen medical facilities to ensure positive patient outcomes by maximizing practice efficiency and ensuring continuous quality improvements. Kris’s experiences in the healthcare industry are now being used in the pharmaceutical industry to ensure medication safe use for positive patient outcomes and optimizing regulatory and commercial strategies.

Kris completed his medical training in New York City and received a degree in medicine from the American University of Antigua School of Medicine. He concurrently earned a Master’s in Business Administration from Davenport University and most recently graduated with a Master’s degree in Healthcare Systems Engineering from Lehigh University.

Ning Wang, PhD, MBA, Director, Clinical Consulting
Ning Wang, PhD, MBA is the Clinical Services Director at ParagonRx. In her role, Ning brings a combination of her extensive scientific research and business experience to drive the safe use of medications. Prior to joining ParagonRx, she was on the faculty at Cincinnati Children’s Hospital where she worked closely with physicians, clinical research coordinators, and research scientists to study the genetics underlying human complex diseases and how the genetic variations impact patient’s response to treatment. Ning received her Ph.D. in Bioinformatics from Institute of Biophysics, Chinese Academy of Sciences in Beijing, China, and an MBA from Thunderbird School of Global Management in Phoenix, Arizona.
Tony Reynolds, Head of International Sales and Strategic Alliances
Anthony (Tony) Reynolds is Head of International Sales and Strategic Alliances at ParagonRx. Born and educated in South Africa, Tony’s chief responsibilities include building alliances both inside and external to inVentiv Health companies in order to expand the mission of risk management, RxFMEA® and safe use of medicines throughout the product life cycle. Tony comes to the business from a background in Dental Pharmaceuticals, Dental Radiology and Orthopedic CBCT Imaging where he carried out similar if not identical roles. Tony also has experience with consulting assignments in the medical and pharmaceutical arena.