Tony Windebank

TONY WINDEBANK

“Moving emerging tissue engineering applications into the clinic”

Biography

Dr. Windebank received his B.A. and M.A. degrees in Biochemistry and M.D. degree from Oxford University followed by training at Oxford University, Mayo Clinic College of Medicine and Washington University in St. Louis.  He was Dean of Mayo Graduate School from 1992 to 1998 and of Mayo Medical School from 1998 until 2005.  Since 2005 he has been a leader in the the Center for Clinical and Translational Sciences and the Center for Regenerative Medicine.

Dr. Windebank is a neurologist who specializes in the treatment of patients with diseases of the peripheral nervous system and spinal cord.  He has been involved in the design or conduct of more than 50 clinical trials and clinical studies.  His research includes tissue engineering to promote regeneration after peripheral nerve or spinal cord injury.

Dr. Windebank has published more than 600 scholarly articles, abstracts and chapters including more than 260 full-length publications in peer-reviewed journals.

Abstract

Dr. Windebank’s presentation will give a brief overview and introduction to new regulatory pathways being introduced by the FDA to facilitate moving tissue engineering products into first in human clinical trials.  These include the Early Feasibility process and Fast track, Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations.  Dr. Gerson will present a more detailed review of this area later in the week.  The presentation will cover specific examples of tissue engineered or combination products (cells, biologics, drugs and materials) that are being introduced to the clinic through these pathways.  Examples will include products that use 3-D printing and other manufacturing techniques.  Examples will illustrate how products for urologic, laryngeal, endocrine and neurologic diseases are being delivered to patients.  For most of these disorders there previously were no therapeutic solutions. The importance to the field of managing and emphasizing realistic expectations for patients will also be discussed.