RESEARCH TRIANGLE PARK, N.C. – BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the company has appointed regulatory expert and former deputy center director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), Amy McKee, M.D., to its board of directors.
Dr. McKee currently serves as vice president of regulatory consulting services for Parexel, a leading global clinical research organization. Prior to joining Parexel in 2019, Dr. McKee spent more than a decade at the FDA in leadership roles of increasing responsibility. While there, she applied flexible, evidence-based regulatory approaches to assess novel drugs for serious unmet needs.
Dr. McKee served as a primary reviewer of new drug applications (NDAs) and biologics license applications (BLAs) across multiple divisions and served as both the acting deputy director and supervisory associate director of the Office of Hematology and Oncology products where she managed four separate divisions performing NDA and BLA reviews. From January 2018 through February 2019, Dr. McKee was the deputy center director for the OCE, which helps expedite development of innovative medical products for oncologic and hematologic malignancies and supports an integrated approach to their clinical evaluation.
“At the FDA, we were frequently considering complex drug development programs without regulatory precedent as we worked to advance safe and effective new medicines to patients. I am excited to bring this experience to BioCryst as the company advances BCX9930 into pivotal trials in PNH and other complement-mediated diseases. This R&D team is prolific—they continue to produce new molecules for additional rare diseases and demonstrate innovative thinking in their development programs,” Dr. McKee said.
“Amy’s strategic regulatory perspective and substantial FDA experience, especially related to novel approaches to drug development programs to meet serious and unmet needs, represent an exciting addition to the BioCryst board,” said Robert Ingram, chairman of BioCryst.
Dr. McKee received a B.A. in Russian and East European studies from Middlebury College and received her M.D. from Tulane University School of Medicine. She was a clinical fellow at the National Cancer Institute/Johns Hopkins University in the pediatric hematology/oncology fellowship program and is board certified in pediatric hematology/oncology by the American Board of Pediatrics. Dr. McKee has authored more than 30 peer-reviewed articles.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO® (berotralstat) is approved in the United States, the European Union, Japan, the United Arab Emirates and the United Kingdom. BioCryst has several ongoing development programs including BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva, and galidesivir, a potential treatment for Marburg virus disease and Yellow Fever. RAPIVAB® (peramivir injection) has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company’s website at www.biocryst.com.
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