Maritza C. McIntyre, Ph.D. · President, Advanced Therapies Partners, LLC
Dr. McIntyre has 20 years of experience in the development, evaluation and regulation of biological and small molecule products within startup biotech firms, the Food and Drug Administration (FDA), and as a consultant. Dr. McIntyre was a product reviewer and ultimately Branch Chief in the Division of Cellular and Gene Therapies at FDA/CBER, where she was actively involved policy development and liaison activities to stakeholder groups. She has since worked in regulatory affairs and product development at Bavarian Nordic, REGENXBIO, Inc. and NanoCor Therapeutics. She served as Executive Vice President of Regulatory Affairs and Product Development at Bamboo Therapeutics where, as part of the senior management team, she participated in portfolio selection, product development and fundraising that resulted in an initial $50 million finance round and ultimate the sale of the company to Pfizer.
As president of Advanced Therapies Partners LLC, Dr. McIntyre provides strategic regulatory and product development advice to biotech companies, academics, and venture capital firms. She has proven success in defining development strategies for products with complex regulatory challenges including special designations (orphan, RMAT, pediatric orphan drug designation), endpoint selection, accelerated approval, complete response letters and dispute resolution. She has also been involved in the preparation of some of the first BLA and MAA submissions for gene therapy products to FDA and EMA. She has multidisciplinary experience, including chemistry manufacturing and control (CMC), preclinical, and clinical with a wide range of product types, including novel gene and cell therapy products, vaccines, biological products and small molecules at varied stages of product development.
Through her participation in industry associations, including ASGCT and the Standards Coordinating Body she has continued to contribute to gene therapy regulatory policy development.
Dr. McIntyre received a Ph.D. in virology from the University of Chicago and graduated magna cum laude with an Honors B.S. in biology from Wayne State University.Back to Schedule