StrataGraft® Biomanufacturing From Discovery to Phase III Clinical Trial
B. Lynn Allen-Hoffmann, PhD
Professor, Department of Pathology
And Professor of Surgery
University of Wisconsin School of Medicine and Public Health
Senior Vice President, Regenerative Medicine
Stratatech Corporation, a Subsidiary of Mallinckrodt
Lynn Allen-Hoffmann, PhD – Professor, Department of Pathology and Department of Surgery, University of Wisconsin-Madison, Senior Vice President, Regenerative Medicine, Stratatech Corporation a Subsidiary of Mallinckrodt. Dr. Allen-Hoffmann received her bachelor’s degree from the University of Illinois and received her Ph.D. from Cornell University in Ithaca, New York. Dr. Allen-Hoffmann was a Damon-Runyon Walter-Winchell Postdoctoral Fellow at the Dana-Farber Cancer Institute at Harvard Medical School where she studied human keratinocyte growth and differentiation. She is a tenured, full Professor in the Departments of Pathology and Laboratory Medicine and Surgery at the UW School of Medicine and Public Health. She is internationally recognized for her innovative research and clinical development of human skin replacements including the world’s first genetically-enhanced human skin replacements. The NIKS cells, discovered in her U.W. laboratory, are a consistent source of genetically uniform, non-tumorigenic, pathogen free human keratinocytes amenable to genetic manipulation. As a result of the discovery in her laboratory, Dr. Allen-Hoffmann founded Stratatech Corporation to deliver cell-based therapies to patients with complex skin loss. She has received numerous state and national awards and is the first woman at the UW to start a biotechnology company. Dr. Allen-Hoffmann has contributed to numerous peer-reviewed publications and patents. Dr. Allen-Hoffmann’s basic and clinical research has received continuous research support, including grants from the NIH, NIST, AFIRM, BARDA, and DOD. Recently Stratatech Corporation has been one of the top 10 companies to receive SBIR and STTR funding in the United States. In 2015, BARDA released a solicitation through Project BioShield for the late stage clinical development and use of cell-based therapies for skin replacement caused by thermal burns in the event of a mass casualty event resulting from the detonation of an improvised nuclear device. Stratatech was the only academic or private sector organization in the United States to successfully compete for a BioShield award. The $247 million Project BioShield award will enable the NIKS technology to be used prior to FDA approval through the FDA’s Pre-Emergency Use Authorization mechanism. Stratatech received a 2016 Tibbitts Award which was accepted by Dr. Allen-Hoffmann at a White House ceremony. Stratatech Corporation was acquired by Mallinckrodt Specialty Pharmaceuticals on August 31, 2016.