The FDA guidance on clinical trials during COVID-19 advised sponsors to evaluate alternative methods for safety assessments to protect patients, where necessary and feasible.
Sponsors had already started to explore the benefits of decentralised and hybrid trials and the current conditions have heightened the need to consider this approach to reduce patient burden and increase retention to minimise disruption.
Join our experts to hear more about this approach and the value it brings to patients and sponsors.
Topics covered include:
- The benefits of In-home visits
- Patient populations and study type considerations
- The scope of services and tests feasible in the home setting
- Best practice in planning and execution
- Regulatory guidance and steps required to integrate this option into studies
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Senior Director, Clinical Operations, Alnylam Pharmaceuticals
Donna Mackey has over 25 years of clinical research experience and has spent the last 15+ years focused on developing treatments for patients with rare medical conditions. She is currently Senior Director of Clinical Operations at Alnylam Pharmaceuticals where she is responsible for clinical oversight of several rare disease programs utilizing a new class of therapies based on RNA interference. Previously she was with Synageva BioPharma and Genzyme Corporation as the Therapeutic Clinical Leader for lysosomal storage disease programs well as a Global Team Leader. Prior to joining Genzyme, Donna was with Quintiles and directed the local Cardiovascular Therapeutics group. She is a graduate of McGill University with a degree in Physiology and has also received a Master of Science degree in Management.
Nicki M. Norris
CEO, Symphony Clinical Research, Part of ICON plc
Nicki brings more than thirty years of experience in healthcare, healthcare services and clinical research organizations. Prior to joining Symphony in 2009, Nicki led the College of American Pathologists (CAP), a laboratory accreditation company and professional society. She was the Chief Operating Officer for the Institute for Transfusion Medicine (ITxM), a blood collection and processing organization. Prior to this she was General Manager for Everest Healthcare Services organization, a high-growth dialysis services company. Nicki was at Baxter Healthcare Corporation for 20 years, where she held several positions of increasing responsibility crossing multiple functional areas and business units, including product management, new product development, marketing, operations, strategic planning, financial management, sales management, R&D and employee benefits.
Nicki has a BS in Finance and an MBA from the University of Illinois at Urbana-Champaign. She also successfully sat for the CPA exam after completing the Professional Accounting Program at Northwestern University.
Vice President, Global Regulatory Affairs and Consulting, ICON plc
David provides operational oversight and strategic planning for ICON’s Global Regulatory Affairs services group. He has over 30 years of experience in Regulatory Affairs, including over a decade in the clinical research services industry and nearly two decades at the US FDA. David’s experience covers all phases of product development, from discovery and translational development through to marketing application preparation and post-marketing product life-cycle management. Much of David’s experience has emphasised products for serious and life-threatening disease indications, accelerated development strategies in international trials, and the use of expedited programs in product review. He has multiple publications and presentations regarding product review, the development of new regulations, and the communication of risk to special populations. David has dual Baccalaureates in Biology and Psychology, and a PhD in Neuroscience.