The Signature Series
Meet the Changemakers: Driving Clinical Research Quality through Collaborative Leadership
Learn about collaborative initiatives to tackle the most pressing challenges facing clinical development. Executive leadership from the organizations driving clinical research quality improvement through process and technology change initiatives will discuss initiatives ranging from investigator qualification and GCP mutual recognition to quality by design, mobile clinical trials, and more.
- Dr. Pamela Tenaerts, MD, MBA, Executive Director, Clinical Trials Transformation Initiative (pictured)
- Patricia Leuchten, President and CEO, The Avoca Group
- Douglas Peddicord, Ph.D., Executive Director, Association of Clinical Research Organizations
- Andy Lee, SVP, Head Global Clinical TrialOperations, Merck and Treasurer, TransCelerate
Saturday, April 28, 8:00-9:00am
Inside NIH: Turning Discovery Into Health
Understand new initiatives underway at the National Institutes of Health (NIH) that could impact your clinical trial operations. NIH officials will highlight initiatives to enhance the accountability and transparency of clinical research and will discuss “All of Us,” an historic effort to gather data from one million or more people living in the U.S. to accelerate research and improve health. Attendees will also gain insider perspectives and practical tips for grant and funding applications, clinical study reporting requirements via ClinicalTrials.gov, and more.
- Jodi Black, Ph.D, Deputy Director of the Office of Extramural Research, National Institutes of Health
- Katherine Blizinsky, Ph.D, Policy Director for All of Us Research Program, National Institutes of Health
- Rebecca J. Williams, Pharm.D., MPH, Assistant Director, ClinicalTrials.gov, National Library of Medicine, National Institutes of Health
Saturday, April 28, 2:15-3:15pm
Advances in Competence and Career Path Standardization Initiatives
Learn about collaborative initiatives to standardize professional competence and career paths in clinical research. Attendees will learn about the Core Competence Framework for Clinical Trial Monitoring and hear a case study on its use in AstraZeneca’s initiative to internalize its monitoring program. Updates on development of the Core Competence Framework for Clinical Research Coordinators will also be shared.
- Doug Schantz, Executive Director, Clinical Operations, AstraZeneca
- Jennifer Byrne, Former CEO of PMG Research & Co-Founder of Greater Gift (pictured)
- Beth Harper, Workforce Innovation Officer, Association of Clinical Research Professionals
Sunday, April 29, 8:00-9:00am
A Career's Journey in Clinical Research Comes Full Circle
Imagine dedicating your career to developing breakthrough therapies for others and one day finding yourself as a study subject. This is reality for Peter and Vicky DiBiaso. After two decades of working in clinical research and championing the value and importance of participation in clinical trials, the DiBiaso’s are now engaged as study volunteers and advocates living with Parkinson’s. Come gain a deeper understanding and broader perspective of clinical research as Peter and Vicky share their candid observations and experiences.
Sunday, April 29, 2:15-3:15pm
State of the Industry
Join Kenneth A. Getz, MBA, Director of Sponsored Research Programs & Research Associate Professor, Tufts Center for the Study of Drug Development, as he examines the forces shaping the current and future state of the clinical research industry. Explore the individual dynamics of technology, process, and workforce on the industry and their effect on each other.
Monday, April 30, 10:45-11:45am