Meet the Team
Stephen Dewhurst, PhD
Executive Director
Upstate Stem Cell cGMP Facility
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Dr. Dewhurst 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 layout of 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 directs the UR's NIH-funded Center for AIDS Research, in addition to his own research. He is also a former member of the NIH Recombinant Advisory Committee (RAC), and a current NIH study section member. He has been recognized for his mentoring achievements through several awards from the UR, and currently directs several NIH-funded training programs at both the pre- and post-doctoral level. Finally, he is the past President of a UR startup vaccine company (Codevax) and a named inventor on multiple patents.
Luisa Caetano-Davies, PhD
Principal Scientist / Facility Manager
Upstate Stem Cell cGMP Facility
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Luisa is an experienced Scientist in Biochemical Engineering, Toxicology and Cell Biology. Luisa provides scientific and strategic input for projects, to ensure that the research and development efforts are aligned with the overall manufacturing strategy. Her work includes process development, analytical characterization, quality assurance through the documentation of processes and procedures, validation of equipment and analytical methods, and process scale-up for the manufacture of clinical grade products. She has extensive experience in tissue culture, generating, maintaining, differentiating and characterizing embryonic (ESC) and induced pluripotent stem cells (iPSCs). She has additional experience with animal colony management, chromatography, CRISPR, proteomics, confocal microscopy, flow cytometry and ICC. Luisa is also instructor of MBI 406: Biomanufacturing, MS in TEAM-BMTD.
Karen Harrington
Associate Scientist /Analytical Development
Upstate Stem Cell cGMP Facility
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Karen has 15 years of experience in cell culture and in vitro cell-based assays. She was instrumental in developing a therapy for macular degeneration using stem cell-derived human retinal pigment epithelium at the USCGF. Before working at the USCGF, she worked for 9 years at Bausch and Lomb in Nonclinical Safety and Preclinical Pharmacology, and as a Laboratory Technician at the University of Rochester in the Environmental Medicine department. Karen’s current responsibilities at the USCGF include collaboration with contract research clients in technology transfer, cell culture process development, analytical methods development, and qualification as well as manufacturing of GMP clinical trial materials and QC release testing.
Elaine Hart, MS
Associate Scientist /Analytical Development
Upstate Stem Cell cGMP Facility
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Elaine has been working in cGMP preclinical process development for cell based therapeutics since 2013, and in mammalian cell biology for over a decade. She specializes in process characterization and assay development to ensure identity and purity of progenitor cells derived from ESC for use in clinical trials. Elaine is proficient in flow cytometry and has developed and optimized the transfer of multicolor flow cytometry methods across platforms for the BD FACSAria, LSRII, AccuriC6 and BC Cytoflex S cytometers. Prior achievements in assay development include the generation of an unique ELISA protocol for hybridoma screening for novel monoclonal antibodies, development of a recombinant virus panel using bacterial artificial chromosome directed viral mutagenesis, and large scale viral preparations. Elaine has extensive experience with primary tissue derived in vitro culture, including immunoseparation (MACS), compliment depletion, and the propagation of T-lymphocytes and neural progenitor cells from murine and human tissues. She received her Bachelor of Science Degree in Molecular Biology from Portland State University, and her Master of Science Degree in Immunology from the University of Rochester.
Mike Tiberio
Technician
Upstate Stem Cell cGMP Facility
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Mike has been working in research for 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:
Sharyl Zaccaglino
Director, Research Quality and Compliance
Upstate Stem Cell cGMP Facility
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As the Research Quality and Compliance Director at the University of Rochester Medical Center, Sharyl provides strategic direction and leadership regarding interpretation and application of FDA regulatory requirements such as Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP). Sharyl is responsible for quality assurance in the Upstate Stem Cell cGMP Facility (USCGF), overseeing the quality system and ensuring the safety and purity of clinical trial material. Sharyl has extensive experience in quality and compliance in the biotechnology and medical device industries, building robust quality processes and maintaining sustained compliance.
Contact:
Luisa Caetano-Davies
Facility Manager
Upstate Stem Cell cGMP Facility
585.276.6208
E-mail
updated by LCD, Oct 2017