Matthew Hewitt Email & Phone Number

Wilmington, Massachusetts, US

Lead various technical, operational, and strategic initiatives across Charles River’s Manufacturing portfolio which includes CDMO, Testing, and Microbial Sterility Solutions. My group includes our global SMEs for CDMO, Testing and Microbial to help clients/partners advance their programs. In addition, I work with the VP of R&D to oversee our Microbial R&D.

Wilmington, Massachusetts, US

• Lead Contributor to CRL’s global cell and gene therapy strategy.
• Work closely with our strategic and corporate development teams on portfolio management and expansion.
• Work in a matrix environment to collaborate with various CGT functions within CRL including cell supply, plasmid manufacturing, vector manufacturing, and cell therapy manufacturing.
• Operational role overseeing a CRL CGT CDMO site which focuses on cell and gene therapy process and analytical development.

Wilmington, Massachusetts, US

London, England, GB

Camden, New Jersey, US

Basel, CH

• Recruited to the senior leadership team leading Clinical Development for Lonza’s Personalized Medicine (PerMed) Business Unit whose mission is to enable cell therapy commercialization via addressing pain-points in.
• Serve as a global cell and gene therapy subject matter expert (SME)/key opinion leader (KOL) as well as lead all plasmid and vector manufacturing activities.
• Lead and/or significantly contributed to multiple regulatory submissions (IND/IMPD/CTA/etc) in various jurisdictions (NA, EU, AIPAC) as well as various regulatory interactions (FDA, Health Canada, EMA, etc).
• Continue to oversee the R&D Innovation group comprised of Biology, Engineering, and Software teams.
• Launched the Personalized Medicine Scientific Advisory Board, which aids in directing current and future Personalized Medicine activities.
• Lead scientific collaboration discussions (academic & industry) in cell therapy. Current publicly announced collaborations include Sheba Medical Center, Stanford University School of Medicine, Parker Institute for.

Basel, CH

• Identified a need to split R&D functions from Process Development (PD). On an interim basis, I led Cocoon platform R&D efforts. The R&D group is a multidisciplinary team across in Biology, Engineering, and Software.
• Develop, prioritize, and implement workplans/timelines for new features increasing the Cocoon's stable of cell therapy manufacturing capabilities.
• Lead decisionmaker for identifying anchor-partners for new feature beta-testing.
• Oversee tech transfer of new features from R&D to Process Development.

Houston, Texas, US

• Recruited to build and lead the Tumor Immunology & Microenvironment (TIME) program with a focus on increasing cell therapy (CAR-T/TCR/etc) efficacy in solid tumors. To address this problem our group developed.
• Oversaw the development of a 3D spheroid assay, co-culturing cancer cells with pro-tumor cell populations (MDSCs/M2 Macrophages/CAFs). This assay allows lead cell therapy candidate testing or combinatorial therapy.
• Development of Bellicum’s rodent NSG and syngeneic solid tumor models to advance lead candidates.
• Assess whether Bellicum's molecular activation switches, primarily iMC (inducible MyD88/CD40 complex) can bias the TME to a pro-inflammatory/anti-tumor environment. We have also developed assays to assess whether GO.
• Work to support/mentor junior colleagues to assist with their career development.
• TIME data is prepared for my direct supervisor, the Chief Technology Officer (CTO) for relevant lab meetings, Executive & BOD meetings, along with conferences relevant to Bellicum's mission.

PA, US

• Recruited to lead a group of 6 research specialists in a GLP BSL-2 lab environment providing immunogenicity assay services for pre-IND/IND-enabling studies and clinical trials (under GCP guidelines 21 CFR 50)..
• Expert in Neutralizing Antibody (NAb) and ELISPOT assays working with isolated lymphocytes (ELISPOT), serum, plasma, vitreous fluid, and CSF from multiple animal species and humans.
• Developed and GLP validated a new NAb assay for multiple AAV serotypes using cellular engineering techniques (process development/assay development) with viral and non-viral vectors expanding the Core's stable of assays.
• Initiate, plan, and execute research projects for internal and external sponsors to tease apart immunological (B-Cell/T-Cell) mechanisms affecting gene therapy efficacy (Flow Cytometry; Luminex Analysis; Intracellular.
• Attend Gene Therapy Program (GTP) Management meetings to assist in decisions driving the Immunology Core and GTP's priorities and milestones.
• Compose and/or contribute to manuscripts resulting from research efforts and attend conferences relevant to the Gene Therapy Program and Immunology Core.

• Promoted to a leadership position within Discovery Biology with similar responsibilities listed under the Scientist position but with increased autonomy.
• Responsibilities required me to independently propose, plan, and execute scientific research that plays a significant role in defining key elements and process steps within Discovery Biology in a matrix team environment.
• Contributed to advancing 3 Galleon lead compounds, GAL-021, GAL-054, & GAL-160, through the research operating plan (ROP) resulting in the submission of completed pre-IND and IND reports and documents with significant.

• Recruited to a Scientist position in Discovery Biology, reporting directly to the Director of Discovery Biology Dr. Francis John Golder, B.V.Sc., Ph.D. Key responsibilities include the development, validation, and.
• Analysis and presentation of data to board of directors and Sleep Apnea Scientific Advisory Board Meetings with key opinion leaders in Sleep Medicine.
• Data preparation and presentation (poster & oral talks) at national and international meetings (American Thoracic Society, Experimental Biology, Society for Neuroscience, Sleep and Breathing, SLEEP).
• Serve as a collating author on pre-IND and IND reports/appendices for pre-clinical Discovery/in vivo Biology.
• Lead initial screening efforts to identify successor compounds which includes working with the Head of Chemistry in prioritizing compounds and supplying data for patent filings.
• Resource to junior staff in biostatistics, use of AD Instruments LabChart software, and research literature discussions of relevant research.

Post-Doctoral Fellowship, Neural Control Of Airway Diseases

Phd, Physiology/Immunology

B.A., Biology (Molecular)