The Impact of COVID-19 on Early Clinical Development – What the New Landscape Will Look Like

With the emergence of SARS-CoV-2, we all have ‘lost our innocence’ by learning that an unexpected, novel infectious agent has a dramatic and, for today’s generations, unprecedented impact on lives, society, economy and as a consequence, on the domain of clinical drug development. Clearly, the world ‘post-COVID-19’ will be different from the world where we came from, but what impact can we expect, and what changes may last?

 This webinar will start exploring clinical drug development in the setting of SARS-CoV-2 being a new entity to deal with, by addressing the questions:

• What is known about SARS-CoV-2, its epidemiology and how it compares to earlier coronaviruses? What is known about COVID-19, the unexpected variation in its clinical presentation, in adults and in children, and the short- and long-term effects?
• How can active infection with SARS-CoV-2 be reliably measured and how can previous infection be proved by measuring immune response? How can we find our way in a myriad of tests that are becoming available in a rapid response setting, with limited, if any, regulatory oversight?
• Now that SARS-CoV-2 is amongst us, how should groups proceed with early clinical development programs, including first-in-human studies, whilst minimizing risk to study participants, maximizing informative value of the study and in compliance with all rules and regulations?
• COVID-19 has pressure tested clinical drug developers and regulators, and has brought about ad-hoc changes in regulatory approaches. What COVID-19 imposed regulatory changes can be expected to be long-lasting and here to stay? Will there be a silver lining to this dramatic event, leading to changes that will expedite access of patients to new treatments, not only in COVID-19, but in unrelated indications as well?

The points above will be addressed in this upcoming concise, one hour webinar. Attendees will be most welcome to submit questions for an included Q&A session.

Speakers

Radboud van Trigt, PhD, Director of Bioanalytical Science – Biomarkers, PRA Health Sciences

Radboud van Trigt started his career in bioanalysis in the early 2000s as a study director for small molecule LC-MS/MS analysis at a CRO. A couple of years later, he joined Astellas, a large pharmaceutical company, as a bioanalytical scientist. Over the years, he got involved in other types of analytical studies supporting drug development including large molecule PK using LBAs, qPCR, flow cytometry, microbiology and biomarkers. van Trigt gained a lot of experience in validation of assays and sample analysis in clinical trials of all phases. Currently, van Trigt is a science director for biomarkers at PRA Health Sciences and in that role responsible for the global biomarker science and strategy for the bioanalytical laboratories.

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Gregory P. Licholai, MD, MBA, Yale School of Management, Chief Medical Officer, PRA Health Sciences

Greg Licholai teaches at Yale School of Management and is Co-Director of the Center for Digital Health. He is Chief Medical and Information Officer at PRA Health Sciences, a leading pharmaceutical service, healthcare data and contract research provider. Previously, he was President of rare disease at Moderna Therapeutics; President and Chief Medical Officer at Castle Creek Pharmaceuticals and was a partner at McKinsey & Co. where he ran the healthcare data service line. He was also a senior executive at Proteostasis, Amicus Therapeutics and Medtronic Neurological as well as venture investor for Domain Associates. He was co-founder of Immunome Therapeutics. Licholai has degrees from Harvard Business School, Yale School of Medicine, Columbia University and Boston College. He trained at the Brigham and Women’s, Children’s and Massachusetts General Hospitals. He serves on multiple company and non-profit boards including advisor to the Clinical Trials Transformation Initiative (CTTI), a public private partnership co-founded by Duke University and the Food and Drug Administration (FDA). He writes about innovation in healthcare for Forbes.

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Arwa Shurrab, Senior Director, Regulatory Strategy, PRA Health Sciences

Arwa Shurrab comes to PRA with over 25 years of industry experience working with both large and small biotechnology companies. Prior to joining PRA, Shurrab served as a regulatory lead overseeing US and global activities. Shurrab has a demonstrated history licensing Biologics in more than 70 countries. She has extensive experience in INDs, BLAs, MAAs and post-marketing regulatory activities. Her area of expertise include Hematology, CMC and regulatory strategy development.

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