John Jameson Email & Phone Number

Minneapolis, Mn, Us

Research Triangle Park, North Carolina, Us

• Regulatory Strategy Lead for 4 gene therapy programs (2 neuromuscular, 1 CNS, 1 cardiovascular), including design and execution of regulatory strategy for US and EU/UK/Canada• Lead for preparation of US and EU gene therapy regulatory submissions and interactions, resulting in 1 successful CTA, multiple substantial amendments, IND lifecycle submissions, 1 EU ODD, 1 US ODD, and 1 RPDD granted to-date• In Vitro Diagnostics and Companion Diagnostics Strategy lead for AskBio programs, with emphasis on immunogenicity testing methods, resulting in successful Q-submission interaction to FDA/CDRH• Regulatory strategy lead for RIMS implementation and TPP/QTPP development

• Supervised Regulatory Strategy and Medical Writing team (2 direct reports and multiple vendors, contractors, and consultants), and member of R&D Leadership/Governance Team• Assessed and approved non-promotional external communications on the Medical, Legal, Regulatory, Clinical Review Committee (MLR), including data on file/unpublished data, press releases, corporate decks, publications, and R&D materials related to all programs• Program Head for the first FDA-cleared gene therapy IND to treat a rare fatal lysosomal storage disease (LSD) indication, encompassing cross-functional oversight, guidance and problem-solving for Program Development Team to drive efficient development and commercialization, resulting in successful dosing of low- and high-dose cohorts, multiple milestone readouts during COVID-19 pandemic, 1 FDA Type C meeting, and 2 Scientific Advisory Board meetings• Regulatory Strategy Lead for 2 LSD programs, including design and execution of regulatory strategy for US and EU in accordance with relevant regulatory requirements and guidelines• Oversaw, managed, and led preparation of US and EU gene therapy regulatory submissions, resulting in 2 Rare Pediatric Disease Designations (RPDD), 2 Fast Track Designations, 2 INDs, and multiple successful protocol amendments for 2 adaptive phase 1/2/3 trials• Collaborate with cross-functional teams (nonclinical, CMC, clinical) to ensure seamless integration of components in all submissions• Led interactions and negotiations with health authorities to clarify and solidify product development strategy and resolve issues, including removal of an IND clinical hold in 2020, and 3 FDA meetings in 2021 to discuss comparability package and later-stage clinical development plan.• Performed regulatory intelligence activities including monitoring regulation changes, regulatory guidance, and competitive trends, as well as representing the organization on strategic initiatives, advisory boards, and KOL meetings

Dublin, Oh, Us

• Provided strategic vision and innovative scientific and regulatory leadership to ensure successful advanced therapy product development, including preparation of development plans, design of nonclinical studies (pharmacology/POC, toxicology/safety, hybrid), authoring of study reports and regulatory submissions (3 ODD, 1 RPDD, 3 INTERACTs, 3 pre-INDs, 8 INDs, 1 End-of-Phase meeting), and representation of sponsors at FDA meetings• Led cross-functional teams (regulatory, nonclinical, CMC, clinical) and integrated as a core member of sponsor development teams for small (virtual/startup) to mid-size biotechnology companies• Applied knowledge to drive sponsor decision making, based on expertise with gene therapies/gene editing (AAV, lentiviral vectors, CRISPR/Cas, single gene and multiplex) and cell therapies (engineered cells, CAR-T, NK cells, tissue engineered products)• Conducted regulatory science projects on advanced therapies, resulting in 1 conference presentation on nonclinical dose extrapolation, 1 industry webinar, and 1 white paper on accelerating cell and gene therapy development• Represented organization on strategic initiatives including Alliance for Regenerative Medicine INTERACT Task Force, Cell and Gene Congressional Fly-in, and Standards Coordinating Body Cell and Gene Therapy Working Groups

Silver Spring, Md, Us

• Conducted pharmacology/toxicology reviews of cell and gene therapy products (AAV, lentiviral vectors, CAR-T, Tregs, other cell therapies), combination products (fibrin sealant + delivery device, cells + scaffold products, cells + delivery device), and plasma protein products for safety and effectiveness/activity, in accordance with U.S. laws and regulations (>10 INTERACTs, >15 pre-INDs, >25 INDs, 2 IDEs, 2 pre-BLAs, 1 BLA)• Reviewed expedited requests (multiple Breakthrough, RMAT, and FastTrack requests), and 1 special protocol assessment (SPA)• Provided written and oral communications to interdisciplinary review teams and sponsors including internal review memos, INTERACT comments, pre-IND comments, and FDA/Sponsor meetings (written responses, teleconferences, and face-to-face meetings)• Led cross-cutting Regenerative Medicine Seminar Series between CBER, CDRH, and CVM to discuss emerging research, as well as its impact on FDA's mission and regulatory science• Collaborated with multi-center working groups related to bone fracture healing products, cartilage replacement/repair products, pharmacology/toxicology regulatory science, and alternatives to animals

Silver Spring, Md, Us

• Conducted regulatory reviews of premarket submissions (3 pre-submissions, 5 510(k)s) for orthopedic devices including bone void fillers, joint fixation devices, and spine fusion devices• Collaborated with CDRH/CDER staff on development of 2 FDA Guidance Documents related to products intended to treat osteoporosis and resorbable bone void filler products• Collaborated with CDRH staff and external stakeholders on ASTM standard entitled Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model (ASTM F3207-17)

Rochester, Minnesota, Us

• Led project to develop a preclinical X-ray phase contrast imaging system for characterization of complex soft tissue lesions• Performed particle-based Monte Carlo simulations to model X-ray phase contrast imaging of physiologically relevant lesions, yielding a short paper and podium presentation at an international engineering conference• Initiated extensive literature searches and reviews of online databases to establish a rigorous catalog of soft tissue properties including accurate compositions, geometries, and material properties• Conducted research independently and collaboratively with 4 interdisciplinary team members, with key roles as a subject matter expert and point of contact for tissue modeling and device design considerations

Berkeley, Ca, Us

• Designed and executed mechanical testing and micro-CT imaging studies on 57 human bone samples from 38 donors, leading to improved understanding of structure-function relationships in brittle bone disease, as well as numerous journal/conference papers and 2 book chapters• Initiated industrial collaboration to analyze micro-damage accumulation in human and murine bone tested with an investigational indentation device, resulting in improved testing protocol for customers, as well as 2 scientific meeting presentations and selection of scientific journal cover art• Developed programming tools for efficient image processing, data analysis, and visualization of results• Managed research projects on interdisciplinary team of 12 collaborators from 2 lab divisions and 4 research centers• Mentored new beamline users on experimental setup, data processing, and instrument troubleshooting

Milwaukee, Wi, Us

• Designed and executed characterization experiments on bone samples recovered during routine surgical procedures, leading to a successful 5-year, $4.6 million grant from the U.S. Dept. of Education• Created and maintained a detailed database of patient demographics and experimental results for 52 research subjects• Promoted safe and ethical laboratory procedures by co-authoring human subjects research protocols and consent/assent forms for IRB and IACUC review• Planned and instructed assistive device workshop for 5 graduate students conducting independent research projects, resulting in the development of a new undergraduate laboratory experience• Analyzed kinematic data from upper and lower extremity motion analysis of baseball pitching for the Milwaukee Brewers

Charlottesville, Va, Us

• Developed polymeric bone scaffolds with tailored microstructural and mechanical properties by varying polymer processing variables• Characterized polymeric scaffolds using electron microscopy, porosimetry, and mechanical testing, leading to the identification of relationships among porosity and material properties• Investigated biocompatibility by analyzing mineral deposition onto polymeric scaffolds and electrospun fibers

Doctor Of Philosophy - Phd, Biomedical Engineering

Bachelor Of Science - Bs, Biomedical Engineering