Jacob Richards, PhD

Operate as regulatory project lead for new products through the whole pre-market product life-cycle from pre-submission/consultations to marketing submission/registrations (510(k), PMA, CE Mark, etc.). Responsible for creating the global regulatory strategy for new products for over 60 countries, including the United States. RA lead for Abbott’s SARS-CoV-2 IgG EUA Assay Authorized by the FDA on April 26, 2020.

Operate as a lead reviewer of multi-function teams of scientists, physicians, statisticians, and policymakers to review medical devices in the Center for Devices and Radiological Health (CDRH). Led the review of over 70 medical device submissions, including original PMAs, PMA supplements, and reports; original IDEs, supplements, and reports; traditional and special 510ks; 513(g)s; pre-submissions and pre-submission supplements. SME to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for over 60 companion diagnostic submissions, including pre-INDS, INDS, NDAs, and BLAs. The 2017 CDRH customer service award was received for outstanding interactions with the medical device industry. I led, organized, and budgeted a yearly training retreat for over forty employees, which resulted in an incentive award for exemplary service. Co-led cross-FDA team on generating a new policy for medical devices combined with cell-based therapeutics. Generate standard operating procedures (SOPs) for the review of medical device submissions, general administrative compliance, and quality assurance.

Designed, executed, and supervised clinical molecular, genomic, and immunological assays on the laboratory’s FDA-regulated cancer immunotherapy trials. Assisted in developing medical device performance data for the group's IND and pre-IND submissions to CBER and CDER. Implemented a new immune phenotyping statistical method, which saved ten thousand dollars per trial. Met with laboratory and potential pharmaceutical research partners to design various molecular, genomic, and immunological assays for FDA-regulated clinical trials. Authored six scientific publications. Created scientific protocols involving the complete genomic analysis process – from isolation to sequencing and analysis.

Ph.D. Student in the Interdisciplinary Program in Biomedical Sciences. Concentration - Biochemistry and Molecular Biology. Mentor - Dr. Michelle Gumz Formulated, tested, evaluated, and supervised molecular biology, protein biochemical, and physiological in vitro and in vivo studies, including PCR and IHC. Reviewed scientific literature, analyzed large data sets, and presented data at local, regional, and national conferences. Drafted and edited presentations, grants, and peer-reviewed publications. Received independent funding through the award of both an intramural and an extramural grant. Supervised and mentored fifteen undergraduate and graduate students.