Paul Ray

As a Regulatory Writer with a decade of nonclinical and clinical experience, I have authored and submitted a wide range of regulatory documents to bring novel therapeutics such as gene therapies and CAR T cell drug products to the clinic. I communicate with project teams on deliverable timelines and review responsibilities and work closely with subject matter experts to author and subsequently revise document(s) for submission. I have worked closely with gene therapy teams (3 gene therapy products), supporting nonclinical and clinical development through aiding teams in nonclinical strategy development, authoring scientific advice meeting briefing books for US (INTERACT and pre-Investigational New Drug [IND]) and ex-US (MHRA, ANSM, and EMA) agencies, and clinical study protocols. I have managed junior medical writers to meet submission goals for CAR T cell and gene therapy technical reports and US and ex-US meeting requests briefing packages. I have supported submission of IND applications by authoring Module 2, 4, and 5 documents. Additionally, I have authored deliverables such as research to development packages, integrated and clinical development plans, Orphan Drug Applications, Regenerative Medicine Advanced Therapy Designation applications, and Breakthrough Therapy Designation applications. My background is in toxicology with several years of research experience in the field of epigenetics. My interests lie in novel gene therapies and epigenetic-based products.