Speaker - ISPE Biotech September 2021 - Session: Cell and Gene Therapy Products, ATMPs, Projects, Commercial Manufacturing. Presentation: "Individualized neoantigen-specific therapies: Unique CMC Challenges and a Novel Regulatory Framework".Co-Author, “A Need for a Novel Regulatory Framework for Individualized Neoantigen-specific Therapies” - BioInsights: Cell and Gene Therapy, June 2022

Technical (CMC) Regulatory Team member supporting original IND, IND Amendment, Annual Reports, and Health Authority Q&A submissions for iNeST; providing regulatory strategy/tactics to support the Biospecimens, Genomics, and Bioinformatics (GB2) workflows used in neoepitope selection processes for Individualized NeoAntigen Specific Immunotherapies (iNeST)Technical Regulatory Lead for individualized neoantigen T-cell therapy, providing regulatory strategy/tactics for the overall programSME and SPOC for key regulatory guidance, proposed regulations, whitepapers, and industry practices related to biospecimens, genomics, and bioinformatics/AI/machine learning; responsible for disseminating and contextualizing via timely knowledge sharing practices to the GB2 Technical Team and manufacturing partnersCo-Lead with technical SMEs for research, creation, and implementation of Pre-Determined Change Control Plans (PCCPs) for genomics and bioinformatics unit operationsLead for research, creation, and implementation of a bespoke Development History Summary for each iNeST program (similar to a medical device/IVD Design History File) to capture and trace the development history and manufacturing changes of GB2 processesCo-Lead for research, creation, and implementation of a bespoke PQS/QMS to govern GB2 processes which are considered part of the end-to-end GMP manufacturing process for iNeST productsLead Author of internal whitepaper - Novel Regulatory Framework for iNeST Therapies (May 2021), detailing unique strategy for PCCPs for genomics and bioinformatics workflowsSpeaker - DIA Europe March 2021 - Session: Examples of Artificial Intelligence and Machine Learning in development, Leveraging Smart Health. Presentation: "Individualized neoantigen-specific therapies: enabling scientific and technical advances in target selection while ensuring quality and patient safety"Promoted from Associate Director to Director (2021).

Lead author for PMA Modules 1 (Manufacturing) and 2 (Software) for novel IVD assay for non-invasive prenatal testing (NIPT) whole genome screening (WGS)RA Core Team Lead for 4+ development programs spanning software, IVD assay, and gene sequencing instrumentsSite Regulatory Lead for on-market Class I/II IVD manufacturing (San Diego, CA): MDR, Recall, Post-Market Surveillance, AuditsAd/Promo review for regulatory labeling requirementsChange Management SME and SPOCCollaboratively authored, revised, and implemented several departmental procedures

Site Regulatory Lead for Class I/II Medical Device manufacturing (Grand Island, NY): MDR, Recall, Post-Market Surveillance, AuditsRA Core Team member for 7+ development programs spanning cell/gene therapy portfolio (cell culture media, quantitative assays)Authored/revised and compiled Drug Master Files (Type II) in eCTD format for cell/gene therapy productsProcess Improvement Champion for Regulatory AffairsChange Management SMEAd/Promo review for regulatory labeling requirementsTrained 100+ sales reps on Regulatory and cGMP requirementsCollaboratively authored, revised, and implemented several departmental procedures

Versatile CMC regulatory affairs program director for multiple biologics spanning oncology, immunology, and Alzheimer’s DiseaseAuthored post-market BLA Amendments, US Annual Report, and APQR for Kadcyla® (oncology biologic) in eCTD formatProject manager for Kadcyla change management and regulatory assessmentFacilitated critical Quality and Supply Chain customer interactions in a highly complex supply chain; attended Change Control Board meetings weeklyCMC Regulatory team member for multiple late-stage clinical biologics, coordinating change management and regulatory assessmentSME for US Biologics Development CMC change management, multi-product regulatory assessment, and IND AmendmentsCollaboratively authored, revised, and implemented several departmental proceduresKey contributor to global product registration process improvement working groupPromoted from Program Manager to Associate Program Director (2015)