Faculty – 2017 Trial Protocol Optimization and Design Congress

Ashish Atreja
Chief Technology Engagement and Innovation Officer, ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

Sarah Berk

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Sarah Berk is an Associate Director at The Michael J. Fox Foundation (MJFF) where she focuses on the ways in which ecosystem approaches can be used to increase research participation. In this role, Sarah designs and evaluates programs aimed at enhancing site infrastructure, creating community level awareness and breaking down individual level barriers to participation. Prior to joining The Michael J. Fox Foundation, Sarah worked in healthcare policy, domestically and internationally, with a focus on increasing access to care for vulnerable and medically underserved populations. Sarah holds a B.A. in International Relations from American University and an M.P.H. in Sociomedical Sciences from Columbia University.

Robert DiCicco
Vice President, Clinical Innovation and Digital Platforms, GSK

Madeline Geday
Associate Director, Clinical Research, Global Trial Optimization, MERCK

Patrick Hu
Senior Safety Physician, ASTRAZENECA

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Patrick Hu, M.D., was a senior safety physician at AstraZeneca. He was trained in Second Military Medical University in Shanghai, China and New York University, New York. After more than 20 years clinical practice (academic and private), Patrick ventured into pharmaceutical industry around 2015. He has been involved in many worldwide clinical trials with high impact with expertise in safety analysis in clinical trials as well as marketed medicine and medical instrument. He is an internally known scholar who has been an invited speaker/moderator around the world.

Jeff Kingsley
Chief Executive Officer, IACT HEALTH

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Dr. Kingsley has been faculty with the Columbus Regional Health Family Medicine Residency as well as Director of Family Medicine and Urgent Care. He currently holds faculty appointments with the Mercer School of Medicine, Philadelphia College of Osteopathic Medicine Georgia, and Georgia Regents University.

Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and nine wholly owned and integrated clinical research offices throughout Georgia. The family of companies conducts phase I through IV research in nearly every medical specialty; inpatient and outpatient; pharmaceutical, biotechnology, and medical device. He has dedicated his career to clinical research since 2006.

Dr. Kingsley currently serves as Chair of the Board of Trustees for the Association for Clinical Research Professionals, which represents more than 13,000 clinical research professionals internationally. He is the former Treasurer for ACRP and APCR, Past President of ABSAME, sits on three additional Boards, and participates on numerous other local, national, and international committees.

Jim Kremidas

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Jim Kremidas is currently the Executive Director for ACRP, a nonprofit association the represents the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients, including support for investigator sites, academic institutions, sponsors and suppliers. He was the SVP of Patient Recruitment at two large CROs for more than six years, where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company. From 1999 to 2008 he led their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. While in Strategic Sourcing he was responsible for the outsourcing of clinical development projects to strategic suppliers, including CROs, scientific staffing firms and patient recruitment suppliers. Before his assignment in clinical development strategic sourcing, Mr. Kremidas led Lilly’s efforts to select and establish relationships with direct to consumer and professional advertising agencies, as well as to implement standardized processes for the development and implementation of marketing materials.

He is on the advisory board of CISCRP (a nonprofit organization focused on enhancing patient participation in clinical trials) and is also a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the NIH. He is a frequent presenter at industry conferences and his articles/papers have been published in a wide variety of trade journals.

Sheri Kuss
Director, Clinical Quality Management, PFIZER

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Sheri is a biopharmaceutical professional with more than 20 years of clinical research experience in pharmaceutical, device, biotech and CRO companies. Her expertise ranges from clinical operations monitoring and management to quality assurance and compliance, including training and continuous improvement. Sheri has a proven track record of establishing and delivering inspection readiness and regulatory compliance training tools/programs. This was a direct result of hosting and/or preparing for more than 16 preapproval regulatory agency inspections and an FDA warning letter remediation.

Sheri is utilizing her experience to promote implementation of Quality by Design and risk management principles to drive the proactive culture of quality excellence within clinical trials.

Richard Murray
Vice President and Deputy Chief Patient Officer, MERCK

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Dr. Murray joined Merck & Co., Inc. in November 1994, and he was promoted to Vice President, External Medical and Scientific Affairs, in August of 2007. Since June of 2016, he has held the position of Vice President and Deputy Chief Patient Officer at Merck. In that role, he leads a cross-divisional and global effort to increase engagement with patients in all aspects of the firm’s business. Dr. Murray graduated from Clark University (Worcester, Massachusetts) with an A.B. in psychology and an M.A. in chemistry. He graduated from Howard University College of Medicine (Washington, DC) and subsequently was an intern, resident, Chief Medical Resident, and Pulmonary and Critical Care Fellow at the University of Pennsylvania in Philadelphia. He is Board Certified in Internal Medicine and Pulmonary Diseases, and is a Fellow of the American College of Physicians. He currently serves on the Board of the Foundation of the American Thoracic Society, and is also on the Board of The Asthma and Allergy Foundation of America and Project HOPE.

Rosemarie Pincus, Ph.D.
Principal Medical Writing Scientist, Oncology Division, JOHNSON & JOHNSON

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Rosemarie Pincus, Ph.D. has been a Medical Writing Scientist in the Oncology Division of Janssen Research & Development (Johnson & Johnson) for 19 years. During that time, she spent four years in a specialized Protocol and Protocol Amendment writing group and has continued to focus the last eight years of her writing expertise in the protocol area. She has written Phase 1-4 protocols and amendments, actively participates on workstreams for template and guidance updates, participates in the cross-pharma TransCelerate Protocol Initiative, works on minimizing the number of controllable amendments generated, trains cross-functions teams on the use of the protocol template and best practices, and mentors new writers and colleagues about contents of the protocol sections and guidelines for writing and QC’ing a quality protocol. After receiving a Ph.D. in biochemistry, she worked for eight years at universities and hospitals studying the mechanism of multidrug resistance to anti-cancer drugs in tumor cells and clinical tumor samples.

Kunal Sampat, MNA
Senior Manager, Clinical Programs, ABBOTT VASCULAR

Bernadette Siddiqi
Research Programs Officer, MICHAEL J. FOX FOUNDATION

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Bernadette Siddiqi joined The Michael J. Foundation (MJFF) in 2016. As a Programs Officer on the recruitment and retention team, Bernadette consults research teams on developing and implementing strategies to engage individuals with Parkinson’s disease in clinical trials. In addition, the Foundation supports studies to learn more about the barriers to research participation and communicates findings to inform the field. Prior to joining MJFF, Bernadette worked at Penguin Random House to facilitate the translation and international sale of the company’s large collection of books. Bernadette graduated from New York University with a B.A. in History and an M.A. in French Studies.

William Smith, M.D., FACC

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William B. Smith, M.D., FACC, is currently a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care Medicine.

Dr. Smith is the President and Founder of New Orleans Center for Clinical Research and Volunteer Research Group located within the University of Tennessee Medical Center. Dr. Smith has been involved as a Principal Investigator in more than 1,800 clinical research studies involving cardiac disease, renal/hepatic disease, healthy volunteers, diabetes, women’s health, HSDD, obesity, Parkinson’s, Alzheimers, Multiple Sclerosis, smoking cessation and numerous variations of PK trials. Dr. Smith has extensive experience conducting complex trials, including Phase 1/special population trials; First-in-Human; POC; SAD-MAD; and with vaccines, including Smallpox, H5N1, H1N1, Seasonal flu, Dengue Fever, TDAP, Bubonic Plague, Ebola and others.

Kate Vila
Manager, Vendor Contract Specialist, BIOVERATIV

Mary Westrick
Adjunct Faculty (Phase I Clinical Trials Specialty), UNIVERSITY OF WISCONSIN, MADISON

Allan Wilson, M.D., Ph.D.

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Allan Wilson, M.D., Ph.D., was Full Professor and Head of the Section of Addiction Psychiatry at the University of Ottawa for more than 25 years. He co-founded IMC in 2002, and is now fully devoted to the study of medication compliance. Allan has worked as a consultant in the healthcare field for public and private sectors, and his research interests lie in clinical pharmacology, biotechnology and large data systems. He is an internationally known researcher in the field of addiction medicine, and has published more than 100 academic papers in the areas of pharmacology and clinical outcome research.