The Johns Hopkins University

University of Alabama at Birmingham

Goucher College

Head of Clinical Development; Head of R&D (a.i.) Lonza Personalized Medicine

Ori Biotech

Strategic Advisory Board Member

Charles River Laboratories

Vice President, CTO Manufacturing Business Division

Coriell Institute for Medical Research

Member Board Of Trustees

•	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.

Executive Director, Scientific Solutions, Cell & Gene Therapy

Senior Director, Scientific Solutions Cell & Gene Therapy

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.

Lonza

Head of Research and Development (a.i.), Personalized Medicine

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 development and manufacturing. Many pain-points are addressed via the Cocoon, a closed, automated, scalable cell/gene therapy manufacturing platform. I liaise with current and potential collaborators to identify promising cell therapy program collaborations/technologies.   
• 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 Cancer Immunotherapy, and Fred Hutchison Cancer Research Center. Additional industry collaborations with Noga Therapeutics, and Triumvira Immunologics (others in process and confidential). 
• Launched analytics initiative to understand cell therapy products and provide deeper insight to enhance clinical efficacy and process robustness. A collaboration with Isoplexis has been announced with others confidential or in negotiation. 
• Attend and speak (talks, panels, etc) at meetings relevant to Personalized Medicine’s mission.

Director, Head of Clinical Development, Personalized Medicine

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 innovative avenues to increase efficacy via improved tumor access and neutralizing the pro-tumor microevironment (TME). A Research Operating Plan (ROP) was created to promote program structure and focus target discovery efforts. 
• 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 assessment prior to in vivo studies. Additionally, this assay provides a platform to conduct additional mechanistic studies to tease apart each cell population’s contribution in the TME.   
• 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 switch (iMC) activation results in GoCAR-Ts “bypassing” immunosuppressive pathways (PD-1, COX-2, TGF-beta, etc).
• 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. 
• Serve as the primary POC for vendors and evaluating potential new lab equipment for all Bellicum R&D.

Bellicum Pharmaceuticals, Inc.

Principal Scientist/Director, Tumor Immunology & Microenvironment (TIME)

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). Day-to-day responsibilities include managing the GLP lab, assigning projects, and ensuring staff is on track to meet deadlines. I work with  the QA Unit to write, edit, and maintain all GLP SOPs according to FDA guidelines (21 CFR Part 58) and to resolve any outstanding CAPA investigations using RCA. As Associate Director I serve as the primary point of contact (POC) and provide expert advice as to the relevance of data for internal and external sponsors. Included in these responsibilities is writing IND Immunology reports for submission to the FDA/relevant health authority.  I serve as the primary POC with finance to develop assay rates. Additionally I work with the business development and contracts team to compose/negotiate budgets, CDAs, MTAs, and FFS/MSAs for new/current sponsors. 
• 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 Cytokine Staining; NGS). 
• 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.

University of Pennsylvania School of Medicine

Associate Director, Immunology Core, Gene Therapy Program

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 contributions to another 5 lead compounds in various stages of pre-clinical development.

Galleon Pharmaceuticals

Senior Scientist, Discovery Biology

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 implementation of rodent models that mimic Obstructive Sleep Apnea (OSA) in humans to enable screening of lead compounds for efficacy as well as interacting with key opinion leaders (KOLs) in the Sleep Medicine field to increase clinical relevance. Additional responsibilities are the instruction and supervision of junior staff members, including performance, management, and development. Further position expectations are: 
•	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. 
•	Lead member of the Institutional Animal Care and Use Committee (IACUC).  This committee reviews all animal use proposals for research and weighs whether proposals represent a necessary and ethical use of animals.     
•	Key participant in budget preparation and discussion for Discovery Biology.  This includes being the primary contact for vendor and contract research organization (CRO) relationships.

Matthew Hewitt