Faculty – 2017 Trial Protocol Optimization and Design Congress

Ashish Atreja, M.D., MPH
Assistant Professor and Chief Innovation Officer, Medicine, ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI, NY

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Dr. Atreja is a healthcare executive with board certificationin internal medicine, gastroenterologyandclinical informatics. As Chief InnovationOfficer, Medicine, he leads the Sinai AppLab (http://www.applab.nyc) that is one of the firstcollaborative hub within academic medical center to build and test disruptivemhealth technologies. As an intrapreneur, Dr. Atreja has won innovation awards at Cleveland Clinic and Mount Sinai, successfully licensed technologies from academic centers and advises startups, accelerators and Fortune 500 companies in digital medicine.He was first gastroenterologist to get board certified in informatics and one of the first to develop virtual pager and messaging application. Dr. Atreja serves as Scientific Founder for Mount Sinai Spinoff, Rx.Healththat brings first enterprise-wide app curation, prescription and engagement platform to risk sharing hospitals and payers in an affordable and scalable manner.Recently, Dr. Atreja established non-profitNetwork of Digital Medicine (NODE.Health) to connect innovation centers worldwide and share best practices for digital medicine innovation and implementationbetween industry, payers and health systems. Dr.Atreja is a member of many professional organizations, has published 70academicpapers, presented more than 200 abstractsand has been a keynote speaker globallyon topics related to digital medicineevidenceand health system transformation.Dr. Atreja was nominated among the Top 40 HealthCareTransformers in 2017

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

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Rob DiCicco is currently the Vice President of Clinical Innovation and Digital Platforms at GlaxoSmithKline. He is also the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate BioPharma. Rob has more than 25 years of experience in clinical development in a variety of leadership positions in CRO, mid-sized and large pharmaceutical companies. He received his Doctorate of Pharmacy degree from the University of the Sciences of Philadelphia.

Madeline Geday
Associate Director, Patient and Stakeholder Engagement Lead, Global Operations, MERCK

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Madeline is an Associate Director for the Global Trial Optimization Group within GO (Global Operations) at Merck and Co., Inc. She serves as Patient and Stakeholder Engagement Lead for her organization. Madeline is responsible for optimizing clinical trial feasibility and execution through integrated data-driven expert analysis and recommendations while promoting its engagement, development, and opportunities for innovation in recruitment and retention.

Madeline joined Merck in 2004. She began her work as a Medical Program Clinical Specialist working on several insomnia programs in clinical neuroscience with a focus on patient recruitment. Madeline joined Global Trial Optimization in 2006 where she has spearheaded dozens of patient recruitment initiatives, served as Therapeutic Area lead for Neuroscience, Ophthalmology, Hematology and Multiple Myeloma as well as Process Owner and Subject Matter Expert for the department. While at Merck, she has helped launch the Clinical Trials Microsite of merck.com; has lead several voices of the patient projects; and has served as an industry expert in the field of recruitment and retention. Most recently, she has been appointed to lead the initiative for Patient and Stakeholder Engagement within the Global Clinical Trial Organization with the intent of capturing the voice of the patient into operational aspects clinical trial design, feasibility, and recruitment and retention. She also works on several collaborative projects surrounding Diversity in Clinical Trials. Trained in Health Literacy principles, she has used her knowledge and expertise to champion changes to patient-facing materials to ensure health literacy for clinical trial participants and their families.

Prior to Merck, Madeline held positions in Business Development, Education, and in Clinical Research as a CRA Associate.

Madeline received her B.S. in Psychology and Health/Exercise Physiology from Ursinus College in Collegeville, Pennsylvania and is pursuing graduate coursework in Marketing from Temple University.

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.

Dr. Jeff Kingsley

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Dr. Jeff Kingsley received his Bachelor of Science degree from the University of Scranton in 1995 with concentrations in biology, chemistry, history, and cultural anthropology, and his Master of Science degree in 1997 in biochemistry. His medical degree was received from the Philadelphia College of Osteopathic Medicine in 2001 and his MBA was received from Emory University’s Goizueta Business School in 2011.

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

Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and 15 wholly owned and integrated clinical research offices in multiple cities in two states. The family of companies conduct phase Ib 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 is the past 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. Dr. Kingsley obtained his CPI in 2009 and his FACRP in 2017.

He enjoys each day with his wife Christine and four beautiful children.Dr. Jeff Kingsley can be reached at 706-536-6619 and JKingsley@IACTHealth.com

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 Lead, PFIZER

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Sheri Kuss has over 25 years of clinical research experience in the industry working at pharmaceutical, medical device, CRO and biotechnology companies. Sheri’s vast range of expertise has developed from her roles within clinical trial monitoring, clinical trial management, operations, clinical quality assurance, compliance, training and continuous improvement. Sheri has a proven track record of establishing and delivering inspection readiness and regulatory compliance training tools and programs as a direct result of her experiences hosting and preparing for regulatory agency inspections. In the area of operational excellence, she demonstrated success in leading business process teams and improving upon existing quality management systems through continuous improvement initiatives. Sheri’s Sponsor and CRO experiences give her a unique quality insight and a practical approach to the risks and operational compliance issues related to the conduct of clinical trials and quality management systems.

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
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
Senior Manager Clinical Programs, ABBOTT VASCULAR

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Kunal is a Senior Manager, Clinical Research at Abbott Vascular and also the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. His goal is to help you accelerate your clinical research career and be a more effective leader. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. You can find him on LinkedIn at https://www.linkedin.com/in/kunalsampat and through the Clinical Trial Podcast at clinicaltrialpodcast.com.

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, CPI

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Dr. William Smith is the Founder, President, and Principal Investigator of VRG and NOCCR, the AMR centers in Knoxville, TN and New Orleans, LA. He is also one of the original founders of AMR. Dr. Smith is board certified in Internal Medicine, Critical Care Medicine, Nephrology, and Cardiology. He has been involved in more than 1,700 clinical trials over the past 35 years. He is a frequent lecturer and author and publishes extensively.

Luke Stewart
Director of Product Management, SAAMA TECHNOLOGIES

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In his role as Director of Product Management at Saama, Luke drives the vision and strategy for Saama’s Life Sciences solutions and Fluid Analytics for Life Sciences data management offering. He has a passion for creating user-centered, analytic solutions and excited to be doing so in the life sciences space. While at Cisco, he helped drive a pre-revenue internal startup to over 3,500 customers in three years. Prior to Cisco, Luke co-founded a startup and worked at NASA. He has his MBA from Stanford Graduate School of Business and a BA in Math and Computer Science from Duke University.

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

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Dr. Westrick is currently Adjunct Faculty, University of Wisconsin-Madison where she teaches Project Management and Leadership in the Master’s program in Biotechnology, as well as consults on clinical trials for the School of Medicine and Public Health. She also is Team Lead for the ACRES SASI initiative which is developing global standards for Phase I, First-in-Human studies. Dr. Westrick has spent over 30 years conducting and managing Clinical Pharmacology trials at Pharma companies, CROs and stand-alone sites. She was formerly Vice President and Site Head, U.S. Phase I, for Quintiles in Overland Park, KS. Dr. Westrick was Executive Director, Operations, Global Clinical Pharmacology and Exploratory Development at Astellas and Global Vice President of Clinical Pharmacology and Early Clinical Development at Covance. Dr. Westrick holds a BS in Chemistry, and Masters and Doctoral degrees in Pharmacology and Toxicology from Purdue University, where she serves on the Dean’s Industrial Advisory Council for the College of Pharmacy. Dr. Westrick was honored as a Distinguished Alumna by the College of Pharmacy in 2013.

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.