Tuesday, December 14, 2021 at 1pm EST | 10am PST | 7pm CET | 6pm GMT Decentralized clinical trials have forced the industry to rethink their approach to study startup and associated regulations. Forthcoming, ICH E6 (R3) provides stakeholders tools to move from the customary habits of fixed checklists to a fit-for-purpose approach, that can be implemented now allowing for proactive planning and ultimately great adoption of innovative trial designs.
Decentralized clinical trials (DCTs) hold the promise to reduce site and patient burdens and enhance the experience of participating in drug development by offering a more patient-focused approach.
In traditional studies, site study startup takes on average 6 - 8 months to complete according to the Tufts Center for the Study of Drug Development (CSDD) – and this timeline is getting longer – this is unsustainable. DCTs have forced the industry to rethink their approach to study startup and associated regulations.
ICH E6 (R1) led to regulatory driven “one size fits all” SOPs for study design and startup in traditional trials. Forthcoming, ICH E6 (R3) provides stakeholders tools to move from the customary habits of fixed checklists to a fit-for-purpose approach. These can be implemented now, allowing for proactive planning and ultimately greater adoption of innovative trial designs.
Key Learning Objectives:
Who Should Attend:
Pam Tenaerts, MD
Chief Scientific Officer
Dr. Pam Tenaertsis on a mission to improve evidence generation in medicine, she believes we need new models to facilitate and scale the evidence generation system for health by creating re-usable, responsible and more effective ways to understand and treat disease.
Dr. Tenaerts will direct research at Medable to help identify, implement, and make ubiquitous responsible decentralized trial strategies. Dr. Tenaerts brings more than 30 years of experience in clinical trials, as a researcher and academic, in medical device research operations, a hospital-based site administrator, and physician, most recently serving as executive director of the Clinical Trials Transformation Initiative (CTTI) at Duke University. She sits on the board of the Society of Clinical trials, the Scientific Leadership Council of the Digital Medicine Society, participates on the Good Clinical Trial Collaborative, and is a member of the National Academies of Science and Medicine: Forum on drug discovery, development, and translation.
She received her MD from the Catholic University in Leuven and her MBA from the University of South Florida.
Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Advisor and Founder, Clinical Innovation Partners
Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). During that time, Craig designed and launched multiple industry firsts -- from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants.
He currently serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, and, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Craig is an Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health + Technology.
Craig has received the red jacket 'hall of fame' recognition among the PharmaVOICE most inspiring people in the life sciences. He has been recognized among Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, the Medicine Maker Power List and the AlleyWatch Who's Who in eHealth. He studied Music at Brandeis University and earned a Master of Public Health from Columbia.
Founder and CEO, WCG Avoca
Chief Change Officer, WCG
Patricia Leuchten is Founder of WCG Avoca and Chief Change Officer at WCG. She has more than 30 years of experience in the pharmaceutical industry and is a leading authority on global clinical outsourcing, strategic alliances and driving change in clinical trial execution through collaboration.
In 1999, she founded The Avoca Group, a consulting and research firm focused on the elevation of quality in clinical trial execution. The Avoca Group has played an important role in the industry as the first consulting firm to track trends in clinical research and clinical outsourcing and to measure the health of relationships between sponsors and CROs. In 2011, Patricia launched the Avoca Quality Consortium a member-based, pre-competitive collaborative comprised of clinical operations, quality, and outsourcing professionals from pharma, biotech, CROs, and clinical service providers. Since its inception, the rapidly growing Avoca Quality Consortium is transforming clinical development by driving efficiency, improving quality, and mitigating risk in clinical trial execution.
Patricia is a frequent speaker and writer on topics surrounding clinical outsourcing, industry partnerships, innovation, and quality management in the pharmaceutical industry. She has a dual role leading WCG Avoca and serving as Chief Change Officer, supporting WCG’s mission to drive efficiency and quality, at scale, in clinical trial execution.
Risk Based Approach Ltd
Andy is one of the world’s leading experts on the implementation of risk management and Quality by Design in clinical development. He has provided ICH E6 R2 and ICH E8 consulting to over 40 companies/groups across five continents. Andy has extensive experience in computing, statistics, data management, RDE/RDC, system design, and Risk Based Approach in both CSV and clinical trials.
Andy has 46 years of experience in the pharmaceutical industry and the U.K.’s NHS, and was a founding committee member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency.His most notable publications, include the paper with Dr. Alistair Ross on GP Audit. Throughout the 80’s and 90’s this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal.
Director, Industry Strategy
Oracle Health Sciences
Elvin is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies, including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a master of science in industrial engineering from Aalborg Universitet.
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