Regenerative Medicine for Kidney Patients, Peripheral Artery Disease, and Beyond
Sponsored by: Covance
- Regenerative Medicine
- Kidney Patients
- Bioengineered Blood Vessels
- Peripheral Artery Disease
Date: 20 March
Time: 3PM London/11AM New York
Big Ideas from a Small Biotech: Humacyte's Journey in Paving their Regulatory and Reimbursement Pathway for Bioengineered Blood Vessels
Patients with kidney failure require a life-saving treatment, hemodialysis, but have had very few therapies approved to enhance their care. As an exciting and relatively new area with novel therapies, can regenerative medicine make a difference for these patients?
Join our guided conversation to discuss Humacyte’s development of bioengineered blood vessels for hemodialysis patients, and patients with Peripheral Artery Disease.
You will also hear about issues that span the spectrum of drug development in getting new therapies from bench to bedside. Find out how one company has learned to mitigate common pitfalls in the execution of clinical trials, from slow recruitment rates to distribution challenges to regulatory and reimbursement issues.
The promise of regenerative medicine for vascular medicine may extend to vessels of all sizes, including therapeutic needs for vasculature in the eye and heart. Join us to learn more about this innovative area.
Barbara S. Gillespie, MD, FASN,
Vice President, Covance and Adjunct Professor, University of North Carolina
Barbara S. Gillespie, MD, MMS, FASN, is a board-certified nephrologist who is currently a Vice President at Covance, a global CRO where she is the Therapeutic Head of Nephrology and supports sponsors on renal drug & device development. She is also an Adjunct Professor at the University of North Carolina, Division of Nephrology and Hypertension; and on the Board of Directors at the Kidney Health Initiative, a public-private partnership between the FDA and American Society of Nephrology. Dr. Gillespie completed her residency in internal medicine at the University of North Carolina and her nephrology fellowship at Duke University Medical Center.
Prior to Covance, Dr. Gillespie worked at Quintiles for 11 years, and most recently reported directly to the Chief Medical and Scientific Officer to support issues related to strategy, science, ethics and governance, with a focus on Medical Expertise Integration. She is a past Head of the North American Internal Medicine Medical Teams & was a team leader for 8 physicians reporting to her. As a Global Nephrology Lead she led CKD & ESRD trials from protocol development to trial execution, serving as a consultant to sponsors for Clinical Development Plans, Due Diligence, Regulatory submissions, Commercialization Plans, Health Economics Outcomes Research and Patient Reported Outcomes. Her roles also included Executive Sponsor on a Strategic Partnership and member on a Steering Committee and a Scientific Ad Board.
Dr. Gillespie participates in several Advisory Boards and/or Stakeholder Panels including the FDA/EMA/NKF Workshop on Renal Endpoints (Stakeholder Committee and invited participant for March 2018), NKF CKD Registry (Scientific Ad Board), UNC's PCORI grant on Building Research Capacity in the Dialysis Community (Stakeholder Advisory Panel), and the global Standardized Outcomes for Nephrology (SONG) Initiative.
She is an Associate Medical Director at a small local dialysis unit, a Fellow of the American Society of Nephrology, and received board certification in Internal Medicine in 2004 and in Nephrology in 2006 & 2015.
Jeffrey H. Lawson, MD, PhD,
Chief Medicial Officer, Humacyte and Professor of Surgery, Duke University
Jeffrey H. Lawson, M.D., Ph.D. received his Medical Degree and a Ph.D. in Cell and Molecular Biology from the University of Vermont in Burlington. He then completed a Postdoctoral Fellowship in Biochemistry at the same location and a residency in General and Thoracic Surgery and a Fellowship in Vascular Surgery at Duke University Medical Center in Durham, North Carolina.
Dr. Lawson was formerly Vice Chair, Professor of Surgery and Professor of Pathology at Duke University Medical Center, and also Director of the Vascular Surgery Research Laboratory and Director of Clinical Trials in Vascular Surgery. Dr. Lawson was the Program Director of the General Surgery Research Residency Program and the Medical Director of Department of Surgery Clinical Research Unit.
Dr. Lawson is a physician-scientist, clinically practicing vascular surgery and actively pursuing basic, translational and clinical research. Lawson has had a lifelong interest in the field of blood coagulation and vascular biology and has continuously studied these areas both scientifically and clinically in his laboratory. He has become a recognized leader in the field of vascular translational technology and his Duke-based laboratory has successfully developed a number of molecular, cellular and tissue engineered technologies through translational research studies to first-in-man clinical trials. He is the co-author of over 120 journal articles on the topics of hemostasis, tissue engineering and vascular surgery and lectures on these topics both nationally and internationally. Dr. Lawson’s Duke research laboratory has been funded by grants from the American Heart Association, National Institutes of Health, Department of Defense and various biotechnology companies.
Key Learning Objectives
- Understand Regenerative Medicine in the context of Kidney Failure Patients
- Discuss the progression of an asset from bench, to preclinical then clinical studies
- Address how Humacyte has mitigated challenges in trial design and execution
- Discuss regulatory and reimbursement challenges
- Heads of Clinical development
- Medical Affairs
- Project Management
- Regulatory Specialist
- Medical Directors
- Clinical Operations
- Commercial and Sales