Protocol Quality: Challenges and Opportunities for Patient Centricity in Protocol Design and Execution

Jennifer Byrne, CEO, PMG Research, Inc.

Jennifer Byrne is Chief Executive Officer of PMG Research, Inc. (PMG) and serves on its Board of Directors. In this role, Jennifer is responsible for driving the company’s growth as a leader of one of the largest wholly owned and operated Integrated Site Networks in the U.S. PMG Research delivers a standardized clinical research infrastructure to large physician practices and mid-market organized systems of care with a commitment to deliver improved care, decreased costs, and improved patient satisfaction through clinical trial participation as a care option. Jennifer spends much of her time with health care providers learning more about the challenges they face in connecting the right patients to the right trials. This understanding leads to better solutions for both the health care system and the Pharma and CRO clients of PMG.

Jennifer has concentrated her career in the clinical research site sector for over 25 years. During her long-term tenure at PMG she and her team have completed over 7,200 Phase I-IV clinical trials which have included over 100,000 research volunteers. Jennifer was recognized as a CenterWatch Top 25 Innovator and currently serves as an Advisory Board member to CISCRP and the Wake Forest Institute of Regenerative Medicine, and Board member of the Hospice Foundation and The Greater Gift Initiative. Jennifer earned her bachelor of science in Nutrition at Texas A&M University.

JoAnn Muir, Head of Clinical QA Vendor Oversight, Novartis Pharmaceutical

JoAnn Muir is the Head of Clinical QA Vendor Oversight at Novartis Pharmaceutical. She received her degree in Community Health from New Jersey City University and is a licensed Respiratory Therapist. JoAnn has worked at Novartis for twelve years in various roles in the development organization running clinical trials and has experience supporting key process improvement initiatives. Currently she is overseeing the Vendor Group in Clinical Quality Assurance. Prior to joining Novartis, JoAnn spent ten years managing an investigative research site performing Pharmaceutical trials. She also worked in the critical care setting in the hospital as a Respiratory Therapist.

Kenneth Getz, Director and Associate Professor, Tufts CSDD

Kenneth A. Getz is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. He is also the Director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine where he conducts research programs on drug development management strategies and tactics, outsourcing, global investigative site and patient recruitment practices and policies. Ken is also the founder and owner of CenterWatch, a leading publisher in the clinical trials industry and an owner and board member of the Metrics Champion Consortium, LLC.

A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken has published extensively in peer-review journals, books and in the trade press. He is the author of two nationally recognized books for patients and their advocates entitled Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials and The Gift of Participation, and the recipient of several awards for innovation and scholarship. Ken has held a number of board appointments in the private and public sectors including serving on the Institute of Medicine’s Clinical Research Roundtable, the DIA Foundation, the Consortium to Examine Clinical Research Ethics, and the Clinical Trials Transformation Initiative. He is on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science, writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials and has twice been nominated for a Distinguished Faculty award at Tufts University.

Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Prior to founding CenterWatch in 1994, Ken worked for over seven years in management consulting where he assisted bioPharmaceutical companies develop and implement business strategies to improve clinical development performance.

Tomasz Sablinski, M.D., Ph.D., Founder, Transparency Life Sciences

Dr. Sablinski is CEO of Transparency Life Sciences (TLS), which he founded in 2010 as the world’s first drug development company based on open innovation. TLS is leveraging the information technology and knowledge networking revolutions to transform drug development. Dr. Sablinski brings more than 15 years of experience in the design and execution of global clinical trials to TLS, as well as over 30 years as a medical practitioner and researcher. He held positions of increasing responsibility managing clinical research activities at Novartis, including directing units in the US, Europe, and Japan. Dr. Sablinski completed his tenure at Novartis as Vice President, US Clinical Development and Medical Affairs Therapeutic Area Head. Earlier in his career, Dr. Sablinski practiced transplant surgery and conducted pioneering work in immunosuppressive drug development at Harvard Medical School, where he was also an Instructor. Before moving to the US, Dr. Sablinski was a transplant and general surgeon in Warsaw, Poland, and a Senior Lecturer at Warsaw Medical School. He is a co-author of more than 50 peer-reviewed publications. Dr. Sablinski received MD and PhD degrees from the Academy of Medicine in Warsaw and completed a fellowship at Harvard Medical School. In addition to his role at TLS, Dr. Sablinski is currently Managing Director and Head of Development at the private equity drug development firm Auven Therapeutics.

Jeremy Gilbert, VP, Life Science Ventures, Patients Like Me

Jeremy Gilbert leads product strategy and development efforts at PatientsLikeMe. Prior to joining the company, he was an Engagement Manager at McKinsey & Company’s health care practice, where he led strategy and execution projects for Fortune 500 clients. Jeremy has co-founded four technology startups and has invented and launched notable products in e-commerce, mobile, and discovery bioinformatics.

Denise Calaprice-Whitty, Ph.D., Senior Consultant, The Avoca Group, Inc.

Dr. Denise Calaprice-Whitty has extensive experience in directing clinical research programs in a variety of settings, including academia, a CRO, a large global Pharmaceutical company, and a small biotechnology company. After receiving her Bachelor’s Degree in Biology from Harvard University and her M.S. and Ph.D. from Princeton, Dr. Calaprice-Whitty entered the world of clinical research as an NIH fellow at Columbia University’s College of Physicians and Surgeons. She subsequently joined Quintiles as a Clinical Research Project and Program Director, where she directed full- service international research programs, including studies in Phases I through IV, and including NDA and IND preparation, submission, and support. As Senior Director of Clinical Research at Altana Pharma, Dr. Calaprice-Whitty developed the infrastructure
of the U.S. clinical research department and contributed to infrastructure development internationally, including training of personnel, SOP and guideline development, and KOL relationship development, while simultaneously overseeing the performance of both outsourced and sponsor-performed international clinical trials. As Director of Clinical Sciences at Regeneron Pharmaceuticals, Dr. Calaprice-Whitty played a similar role, overseeing programs in Phases I through III.

As a consultant for the last 11 years, Dr. Calaprice-Whitty has provided support to Pharmaceutical companies, clinical service providers, university investigators, and government agencies engaged in clinical research, with a focus on the areas of partnering strategies, relationship management, metric development, protocol quality, and business data analysis. She also oversees the annual Avoca Industry Survey and Avoca Quality Consortium Survey research programs, and has recently been engaged by the MCC to work on the development of quality metrics.