Vice-President, Regulatory Affairs
Asher Biotherapeutics, Inc.
Dr. Cross currently serves as Vice President of Regulatory Affairs at Asher Bio, overseeing Regulatory, Quality and Drug Safety. He brings nearly 20 years of biopharmaceutical experience drawn from industry, academia, and the FDA. Prior to Asher Bio, Jamie was founder of Cross BioStrategies LLC, where he assisted companies with product development strategies, filings, and provided regulatory leadership. Prior to consulting, Jamie served as Executive Director of Regulatory Affairs at Halozyme Therapeutics, leading product strategy for oncology assets in global late-stage development. Earlier, at Forty Seven Inc., he served as the company's firsst Head of Regulatory Affairs and supported the clinical program expansion of magrolimab while also managing CMC QA and medical writing functions. He started his industry career at Genentech in Drug Safety and then oncology Regulatory Affairs, where he led BLA/sBLAs for Rituxan and Tecentriq. Prior to industry, he worked at the FDA for five years in project management supporting both IND/NDA reviews and the development of new policies and guidance. Dr. Cross earned his PhD in health outcomes research from the University of Washington, MS in Immunology from the University of California at Davis, and Bachelors degree in Biology and French from Tufts University.
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Tuesday, September 13, 2022
9:45 AM – 11:00 AM MST