Michael Grace Email & Phone Number

Responsible for business development and administration of CMC Business Unit consulting

Responsible for all product External and Internal Manufacturing, Analytical and Process Development, and Site Engineering.• Member Executive Committee (MC) with Board of Directors for Advaxis.• Successful Ph.3 technical transfer, validation and established commercial manufacturing and testing for RaligizeTM (axalimogene filolisbac) in Europe.• Established GMP manufacturing on-site at Advaxis Princeton Manufacturing Facility and initiated Ph.1 manufacturing for patient-specific NEO Lm based immunotherapy.• Established 3rd party CMO capability.

Head of Process Development and Analytical Development departments within Advaxis Manufacturing, Technical Operations.• Successful re-development of Lm process (DS and DP) and platform validation for clinical and commercial manufacturing.• Successful development and validation of platform analytical methods for development and QC testing.• Submitted IND Amendments and IMPDs for axalimogene filolisbac new process and analytics.• Submitted IND for patient specific NEO Lm based immunotherapy.

Responsible for Analytical Development and Cross-functional leadership with QC, QA, Technical Services (Process), Pharmaceutical & Device Development, Manufacturing and Regulatory Affairs.• Natparaeghe (rhPTH (1-84))- Resolved analytical and manufacturing/process drug product issues to untrack US BLA submission and secure approval. Lead CMC team for EMA MAA submission and lead for EMA Rapporteur & Co-Rapporteur interactions. CMC Lead for Natpara Global Registrations Team.• Gattexelge (teduglutide)- Completed successful approval of US NDA submission with minimal PMCs and integrated the Takeda sale of the Revestivenecha franchise in Europe into NPS Pharmaceuticals.• Revised and updated QC and Analytical Development SOP framework; Established Critical Reagents Control Management, Global Contract Laboratory Strategy, and Specifications Development, Review and Approval processes.

Lead of CMC bioanalytical clinical development for non-GMP and GMP activities from pre-FIH through product registration across 4 multi-site/multi-state facilities.• CMC integration lead for analytics with the Medarex, Ambrx and Zymogenetics acquisitions.

Cross-functional CMC Lead for Nulojixelge (belatacept) with leadership responsibility across all CMC as well as with the integrated Commercial/Clinical/Quality/Regulatory Drug Development Team.• Mentor and advisor for CMC Leads for Yervoyeghe (ipilimumab).• Yervoyeghe (ipilimumab), Nulojixelge (belatacept), Orencia eje (abatacept) & Orencia SC[]}, CMC Analytics leader for BLA, sBLA and MAA registrational CMC analytics, including BLA/MAA authoring, FDA and EMEA pre- and post-approval interactions and subsequent follow-up measures.• Established and led an integrated department for Analytical Development, Quality Control, and In-process Analytics development for Biologics R&D programs.• Established a successful GMP-hardened R&D QC department for clinical operations.

Lead of CMC bioanalytical activities from pre-FIH through product registration (Characterization, Method Development, Qualification, and Validation, Method Technical Transfer, Clinical Release Testing and Re-assay, In-process Testing, IND and LTSS Stability Testing).

Responsible for managing an Early Development group involved in developing biophysical and biological assays to support CMC and Clinical/Pre-clinical bioassay, in-process testing (HPLC and MS) and Microscopy support (FESEM and Confocal).• Director of the Flow Cytometery and Laser Scanning Microscopy laboratories within the group.• Lead cGMP remediation teams for Laboratory Controls and Facilities and Equipment under Consent Decree (2000 – 2005).

Ph.D., Biochemistry

B.S., Chemistry