David O'Donnell Email and Phone Number

• Head of CMC - Responsible for Integrating Analytical & Process Development, Manufacturing, Quality and Regulatory CMC with the business drivers defined by Program Teams and Clinical Operations. Defined requirements, rationale, scope & stakeholders and then driving decisions and tasks to completion. • Managed CMO, CDMO and CTL contracts, scheduling, production, release, storage and stability of plasmids and viral vector drug substances required for production of autologous T cell therapy drug products• Led companies Apheresis task force, to improve and control critical quality attributes of autologous PBMC acquisition• Developed integrated CMC/clinical program timelines for pipeline assets. Routinely presented key decisions to the CEO and Executive Team.• Partnered with Quality and Regulatory teams to update and implement deviation, CAPA, change control and product complaint procedures

• Represented technical operations function on executive team, managing corporate strategy and direction • Responsible for overall management of manufacturing, supply & logistics, and QA/QC teams in U.S. and abroad• Partnered with medical affairs group to perform audits, updates and enact needed CAPA at clinical sites• Coordinated with research and PD teams to qualify and implement front-end process improvement steps• Reorganized international warehousing footprint for costs reduction in line with changing corporate strategy• Organized corporate data diligence room to streamline partnering and outsourcing communications • Upgraded EM programs to minimize turnaround time and reduce costs• Revised COGS and S&OP modeling to reflect process and facilities improvements

• Coordinated with PD, QA, Medical Affairs and commercial team to implement and launch Ovaprime clinical trial• Lead manufacturing team responsible for isolating autologous cellular product for 70 patients involved in phase 1 clinical trials based in Canada and UAE • Streamlined AUGMENT drug product manufacturing process from a 2-day process yielding a fresh product with 4-hour shelf-life to a 1-day process delivering a frozen drug product with a 1-year shelf life• In-housed, and optimized antibody conjugation process to increase process control, and reduce costs of critical process raw material• Led product optimization steering committee in a cross-functional review and assessment of all aspects of AUGMENT therapy following first two years of clinical availability • Partnered with commercial/medical affairs teams to develop comprehensive clinical on-boarding package

• Authored, revised and updated manufacturing SOPs, batch records, work instructions and forms• Developed and implemented manufacturing department training and assessment program• Hired, trained, managed international team of 25 production scientists manufacturing autologous cell therapy products• Established production facilities supporting IVF clinics in 6 international regions• Coordinated with R&D, PD, Clinical and Quality teams to refine manufacturing process and establish in-process controls for AUGMENT and OvaPrime platforms• Collaborated with nursing operations to coordinate tissue procurement, processing and delivery of autologous AUGMENT therapy for more than 300 patients

• Developed and standardized immune assays to monitor and quantify T cell expansion in pre- vs. post vaccination PBMC samples in support of HerpV phase I and II clinical trials• Trained clinical trial sites in blood processing and PBMC isolation• Developed and qualified ELISpot biological potency assay to evaluate autologous T cells responses to HSPPC based Onocophage cancer vaccine candidates• Developed and qualified FACS based T cells activation screening to assay in-vivo biological response to Oncophage cancer vaccines • CMO scientific liaison responsible for transitioning clients’ pre-clinical cell therapy procedures to GMP appropriate batch records and subsequent training and supervision of on-site manufacturing staff

• Evaluated effectiveness of HSPPC70 and HSPPC96 vaccine candidates in combination with standard chemotherapeutic combination therapy in murine cancer models • Evaluated/optimized human dendritic cell line propagation protocols for use as autologous APC for ELISpot/CTL assays• Developed and standardized immune cell FACS panels to evaluate fluctuations in cell populations in response to vaccines and chemotherapy dosing in murine models • Developed mycoplasma testing protocol; implemented monthly screening of all active cell lines in tissue culture facility

• Characterized pre-clinical efficiency of lipid contained chemotherapeutic agent in single or combination therapy across a panel of cancer cell lines, murine cancer models and xenograph tumor models• Evaluated QS-21 adjuvant capacity and modulatory effects on B cell, T cell and dendritic cell populations in combination with other clinically relevant adjuvant regimes