Michael J. Grace, Ph.D.

Michael J. Grace, Ph.D.

Business Unit Lead - CMC

Dr. Michael Grace joined Biologics Consulting in June 2020 as Head of the CMC Business Unit. Dr. Grace has over 30 years CMC experience as a Senior Executive encompassing CMC from analytical development and drug substance/product development, to drug substance and product manufacturing, fill-finish, QC testing and release, packaging and labelling, and supply management and distribution. As a Senior Executive in the BioPharma industry, he has had responsibility for both Development Operations and Technical Operations/Manufacturing and experience in working capacity and capability from all-internal to pure-play external as well as hybrid internal/external models. His CMC experience ranges from pre-clinical/Phase 1-entry programs through Phase 3 registration and licensing programs. He has both supervisory and hands-on experience with Module 3 dossier writing, compilation and review, and has had numerous successful interactions with FDA, EMA, and other ROW RHAs, that have resulted in helping to place nine commercial products (interferon, fusion-proteins, IO mAbs, and therapeutic peptides) on the market.

As Vice President of Technical Operations & Manufacturing at Advaxis Inc., Dr. Grace led a rapid Phase 3 analytical and process development program, followed by validation and technical transfer to an EU CDMO for the MAA registration submission for an IO vaccine product. He also led the de novo establishment of an internal cGMP facility for Phase 1 manufacture of patient-specific IO vaccines. He lead and supervised the Module 3 activities for the MAA as well as several initial and updated INDs and IMPDs.

Prior to Advaxis, Dr. Grace lead Analytical Development/Technical Operations at NPS Pharmaceuticals. His leadership and subject matter expertise helped resolve drug product process and manufacturing issues that resulted in the successful FDA approval of Natpara (rhPTH (1-84)). He lead and supervised Module 3 activities for the Natpara BLA and MAA, Natpara INDs and IMPDs, and worked with FDA and EMA to address review questions and RFIs. He also lead the analytical and process review for the commercial transfer of Gattex (teduglitide) from Takeda to NPS Pharmaceuticals.

As an Executive Director in Biologics Process & Product Development at Bristol-Myers Squibb, Dr. Grace lead Phase 3 CMC bioanalytical development and validations for Orencia (abatacept) and Orencia SC, Nulojix (belatacept), and Yervoy (ipilimumab), as well as Phase 2 bioanalytical development for Opdivo (nivolumab). Dr. Grace lead the BLA, sBLA, and MAA Module 3 analytical sections authoring, compilation and review activities, and was responsible for pre- and post-approval world-wide RHA interactions for Orencia, Nulojix and Yervoy.

Dr. Grace began his career at Schering-Plough Corporation where he started as a bench-scientist leading a bioassay development laboratory. At Schering-Plough, he had increasing responsibilities in technical and managerial scope within bioanalytical and biophysical development in Biotechnology Development at the Schering Plough Research Institute.


Education

Dr. Grace received his Ph.D. in Biochemistry from the University of Nebraska, in the laboratory of Dr. Naba Gupta while working on mammalian protein synthesis. He received his B.S. in Chemistry cum laude, from the University of Nebraska.