The importance of clinical research is in the forefront around the world with COVID-19 as companies race to develop vaccines and antivirals to address the disease. Regulatory agency guidance has presented the industry with a unique opportunity to shift the direction of research to address the myriad of diseases that still need treatments and cures. With protection of health care professionals and clinical trial subjects being paramount, the process and procedures of how we conduct successful clinical trials going forward must be immediately addressed – and for studies currently underway it is even more critical.
The emerging questions are “What is the regulatory guidance regarding how we should proceed with current and proposed clinical studies” and more importantly “Do we have the technology to do so” to keep studies on track and maintain our timelines. We say, ‘yes’!
Regulatory agencies have begun to issue their initial guidance on operational issues regarding clinical trial conduct and how sponsors can maintain the momentum of their ongoing studies.
A panel of CATO SMS experts will review the key issues contained in the emerging Agency Guidance and offer thoughts on what changes and options for sponsors may be seen in the coming months.
Original Air Date: Thursday, April 30, 2020
Time: 10am EST / 7am PST
Duration: 1 Hour
Lynda Sutton has over 40 years’ experience in the drug development industry. She has led teams from Pre-IND to Marketing approval for a variety of products including biologics, drugs and drug/device combination products. As Chief Regulatory Officer, she currently serves as the FDA agent for multiple Sponsors for IND and post-marketing products including two with Breakthrough Therapy Designation. She oversees the preparation of regulatory submissions, and ensures that regulatory requirements for the approval and launch of new products are satisfied.
Dr. Lee has more than 20 years’ regulatory experience specializing in gene therapy, cell therapy, and biologics within the rare disease and oncology arenas. He has been involved in the design and execution of preclinical studies, Phase 1, Phase 2, and Phase 3 clinical studies. He has also participated in the preparation and successful submission of various INDs, BLAs and NDAs.
Angela Rhodes has over 12 years’ experience in drug development, 10 years inspecting research sites as a FDA consumer safety officer and 2 years as a clinical research site manager. She has extensive knowledge of FDA regulations, Good Clinical Practice, and Good Manufacturing Practice for drugs, devices, and biologics. She has been responsible for biomedical regulatory actions, preparation Form FDA 483 letters, and seizures throughout FDA-regulated industries. As CRM she is responsible for directing, planning and execution of clinical trials.