Meet the Team
Leadership
Luisa Caetano Davies, PhD
Executive Director, Upstate Cell Therapy cGMP Facility
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Luisa is the Director of the GMP Facility, leading the overall GMP manufacturing operations to support the production of cell-based therapies to be tested for the first time in clinical trials. Her role includes coordination of technology transfer, day-to-day facility operational decision making, the definition of roles and responsibilities for all personnel working in the manufacturing areas as well as the coordination of partner functions, that include Quality Assurance, Facility Operations, Environmental Health and Safety, Finance, UR Flow Core and UR Clinical Microbiology lab. Luisa is responsible for the alignment between product development and manufacturing priorities at the site operations, providing scientific and strategic input for programs with academia and industry, ensuring that the research and development efforts are aligned with the overall manufacturing strategy for clinical trials. Luisa's team building, management, and business development style foster a culture of flexibility, efficiency, effectiveness, and compliance while coaching and leading staff members, promoting collaboration among all team members, partners, and key stakeholders. Luisa provides unique opportunities to train students and leverage their experience by teaching MBI 406: Biomanufacturing course for the Master's program TEAM-BMTD with guest lectures from industry and other cGMP facilities and providing internship opportunities in the GMP Facility.
Steve Dewhurst, PhD
Founding Director and Senior Advisor, Upstate Cell Therapy cGMP Facility
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Steve is Vice Dean for Research at the School of Medicine and Dentistry (SMD), and Associate Vice President for Health Sciences Research at the University of Rochester (UR). He co-designed the USCGF, and was the PI on the NYSTEM grant which funded its construction. He has over 25 years experience as a molecular virologist, working on both RNA and DNA viruses, with emphasis on HIV and influenza viruses; he also has expertise in viral vector systems. He is a former member of the NIH Recombinant Advisory Committee (RAC), and a current NIH study section member. He connects the USCGF with University leadership, and provides input on strategic directions and partnerships involving the facility, including its role in education and training programs at the UR.
Manufacturing Team
Zack Knowlden, PhD
Staff Scientist, Upstate Cell Therapy cGMP Facility
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Zack has an extensive background in immunology having completed his doctorate in the Center for Vaccine Biology and Immunology at the University of Rochester. His previous work focused on cellular immune responses in the context of influenza infection and vaccination, as well as in other models of pulmonary inflammation where he developed expertise in tissue culture, flow cytometry and immunological assays. He is currently involved with GMP process development, production, analysis and documentation management of several ongoing immunotherapy projects at the USCGF.
Brianna Shares, PhD
Staff, Upstate Cell Therapy cGMP Facility
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Brianna joined the USCGF in the summer of 2018 as an intern and became a staff member in April 2019. She is actively pursuing her PhD in Pathology within the musculoskeletal field deciphering stem cell metabolism in bone. During her internship she aided in tech transfer and qualifications of methods within the USCGF. She is adept in culturing and isolating primary cell lines and is proficient in assays such as, IHC, western blot and qPCR. She will provide a key role for technology transfer, GMP process and analytical development, as well as GMP production and testing of cell-based therapies in Torque Therapeutics' clinical trials.
Janice Gerloff
Tech Associate 2, Upstate Cell Therapy cGMP Facility
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Janice joined the USCGF in the summer of 2018. Prior to working in the facility, she gained 15 years of experience here at the University of Rochester in the Environmental Medicine and Neuromuscular departments as well as the Cardiovascular Institute. She is adept in culturing and isolating primary cell lines and is proficient in assays such as, ELISA, Flow-cytometry, ICC, IHC, and qPCR. Her current responsibilities at the USCGF are, assay qualification and validation, as well as playing a role in the manufacturing of products under GMP environment to be tested for the first time in clinical trials.
Michelle Lacagnina
Tech Associate 2, Upstate Cell Therapy cGMP Facility
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Michelle previously worked in research here at the University of Rochester for 18 years in the Biomedical Genetics Department. Her skill sets include cell culturing of stem cells, q-PCR, ICC, DNA isolation, western blotting and cloning. At the USCGF, Michelle is part of the production team playing a role in the manufacturing of cell-based therapies to be tested in clinical trials in autologous or allogeneic transplants. Michelle work also involves process development, documentation of processes and procedures, analytical characterization and assay qualification.
Brooke Burgess
Tech Associate 1, Upstate Cell Therapy cGMP Facility
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Brooke has been working in research with the University of Rochester since 2016. Prior to being with the cGMP facility, she was working with the University of Rochester in the Neuroscience department where she gained experience in assays such as IHC, Western Blots, Cell culture, siRNA transfection, and adenoviral infection as well as gaining experience in the recordkeeping, and organizational skills necessary to maintain stock and reagents for experiments. Currently, Brooke is responsible for stock management, as well as being part of the production team, playing a role in the production of clinical grade products to be tested in clinical trials.
Wade Narrow
Tech Associate 1, Upstate Cell Therapy cGMP Facility
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Wade joined the USCGF in the Spring of 2019 after gaining 23 years of experience at the University of Rochester. He has developed laboratory experience in the areas of viral vector design and growth, cloning, IHC, Western blotting, primary cell line isolation and tissue culture. His current responsibilities at the USCGF involve process development and production of cell-based therapeutics under GMP environmental conditions to be tested in Torque Therapeutics' clinical trials.
Christine Madamba
Technician, Upstate Cell Therapy cGMP Facility
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Christine joined the USCGF in winter of 2019 as part of her TEAM-BMTD practicum and later became a technician in the spring. Prior to being with the cGMP facility, she worked as an assay development intern with Biodesix, Inc. as well as a research assistant at Texas A&M University where she gained experience in DNA isolation and q-PCR. During her internship with USCGF, she aided in the qualification of methods. Her current responsibilities involve process development and production of clinical-grade cell-based therapeutics to be tested in Torque Therapeutics’ clinical trials.
Mike Tiberio
Technician, Upstate Cell Therapy cGMP Facility
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Mike has been working in research for more than 16 years. He is an experienced Research Technician in cGMP and GLP environments. At the USCGF, he works on tissue culture, producing ESC derived products for pre-clinical trials. Mike’s strengths are problem solving, organization and planning. Previously, he worked at Wyeth Vaccine on vaccine formulation and at Finger Lakes Community College providing technical support for 38 other community colleges for their research projects, where he was involved in all aspects of project management, including supporting student’s research. Mike was honored with Employee Excellence awards and a Distinguished service award at Wyeth Vaccines and Finger Lakes Community College, respectively. Additionally, Mike has extensive experience in genotyping, DNA purification and hybridization assays, protein expression and purification, he is proficient with PCR, ELISA and chromatography, among others.
Quality Management Team
Carrie Bowman
Interim Director, Research Quality and Compliance, Upstate Cell Therapy cGMP Facility
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Carrie joined the USCGF as Quality Associate to provide support in the application of, and commitment to, Good Manufacturing Practices (cGMP). Carrie has a strong background in cGMP and ISO compliant environments and biomedical/pharmaceutical manufacturing. Her work with corrective and preventive action (CAPA) and internal auditing programs enable her to drive continuous improvement initiatives at the USCGF to maintain an effective quality system.
Daiva Oluic
Quality Associate 1, Upstate Cell Therapy cGMP Facility
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Daiva Oluic joined the Upstate Stem Cell cGMP Facility (USCGF) as a Quality Associate to provide support in environmental monitoring and release of raw materials and final product. Daiva is a member of the QA/QC team responsible for upholding quality and compliance for the Quality Management System of the USCGF. She is experienced in FDA Regulated cGMP and GLP Environments and pharmaceutical manufacturing. She has a strong background in analytical instrumentation, and in reviewing, analyzing and approving GMP documents such as product testing documentation packets from Stability, Microbiology, Product Development, Finished Products and Raw Materials laboratories.
Finance
Chris Bock
Finance Liaison, Upstate Cell Therapy cGMP Facility
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Chris has been working in accounting and finance for over seven years. He has in-depth experience in auditing, financial planning, budgeting and financial advisement. He has been working with the University of Rochester since 2017, in the School of Medicine and Dentistry (SMD) Dean’s Office Finance Department as a Senior Financial Analyst. He holds an Master’s of Business Administration degree in Accounting Management and a Bachelor’s Degree in Public Accounting. His strengths include being an innate problem-solver, analytical skills and being a team player/leader. Chris acts as a financial liaison to the Dean’s office and is in-charge of the major functions of the financial operations of the Upstate Stem Cell cGMP Facility (USCGF).
Program Manager
Wendy Keck
Program Manager, Upstate Cell Therapy cGMP Facility
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Wendy has worked in various research areas in the University of Rochester for many years. She was recognized for her years of service as a 2018 recipient of the University’s Witmer Award for Distinguished Service. For the last ten of those years, she has worked as a Research Program Manager in the Department of Microbiology and Immunology. In this capacity, she was a member of the committee responsible for building the cGMP Facility and managed the grant budgets and institutional funds available for the project. She was involved in the staffing and other management for the facility’s opening, and has continued to assist with their considerable growth, monitoring their hiring processes, managing any human resource needs, and has been responsible for financial oversight of several grants received. Wendy has recently taken on a new responsibility as project manager for the group.