Strategic Advisors and Consultants
Michael Blaber, PhD
Professor of Biomedical Sciences
College of Medicine
Florida State University
Dr. Blaber graduated with a B.A. in Biochemistry/Molecular Biology from the University of California at Santa Barbara in 1980. After graduation, Blaber was recruited by Genentech Inc. to work as a research assistant in their Protein Chemistry group. Genentech was one of the first biotech startup companies, and Blaber was the 120th employee. After five exciting years studying the properties of recombinant human plasminogen activators, Blaber left Genentech and entered the Ph.D. program in the Department of Biological Chemistry, in the College of Medicine at UC Irvine (in the laboratory of Dr. Ralph A. Bradshaw). During this time Blaber studied structure/function relationships of murine glandular kallikreins, and was supported by an undergraduate NIH fellowship and an Earl C. Anthony dissertation fellowship. After graduating, Blaber was a Postdoctoral Fellow in the laboratory of Dr. Brian Matthews, Howard Hughes Medical Institute, University of Oregon. During this time, Blaber was supported by an NIH Postdoctoral Fellowship to study the structure and stability relationships of T4 lysozyme mutants. After completing his Postdoctoral work, Blaber joined the Department of Chemistry at FSU as an assistant professor, receiving a University Teaching Award in 1999. Blaber earned tenure, and promotion to associate professor in 2000. In fall 2005 Blaber joined the Department of Biomedical Sciences in the College of Medicine at FSU. In 2007 Blaber was promoted to Professor. In 2009 Blaber received the E.K. Frey/E. Werle Gold Medal for research in the area of kallikrein-related peptidases. In 2009-2010 a total of five patents were issued related to work on Fibroblast Growth Factor1 mutants from the Blaber lab.
Judy F. Gordon, DVM
President, ClinReg Consulting Services
Dr. Gordon is President of ClinReg Consulting Services, a clinical and regulatory consulting practice, and has taken multiple NDAs and PMAs through the FDA review process. She has been involved in conducting clinical trials and obtaining FDA approval for a broad range of drugs, biologics and devices including the first intravitreal sustained release drug delivery system (Vitrasert), intravitreal drugs/biologics for AMD and DME, drug delivery systems for glaucoma and KCS, femtosecond lasers for LASIK and cataract surgery, phakic and accommodating phakic IOLs, excimer lasers. In addition, she has provided clinical and regulatory services in a wide range of other specialty areas. Dr. Gordon has been active in chairing several industry-FDA working groups on guidance documents and has served as the industry representative to FDA’s Ophthalmic Devices Advisory Panel and the Dispute Mediation Panel
Adriana E. Manzi, PhD
Co-founder, Atheln, Inc.
Dr. Manzi has worked on biologics R&D for nearly 30 years and has been consulting since 2006. In 2010, she co-founded Atheln, a life science consulting group offering an integrated approach to strategy and execution for product development and commercialization. The team has over 60 industry seasoned experts with 20-35 years’ experience each, covering all technical and commercial disciplines and has contributed to over 65 projects for more than 60 clients. As a consultant, Adriana has led CMC programs for many virtual companies developing biologics, including biosimilars and cell therapies. Prior to consulting, Adriana was Sr. Director of Research and Global Corporate Lead of Biotechnology Analytics for Baxter Healthcare Corporation, Director of Analytical Development / Quality Control at Nextran Inc., and Cytel Corporation as well as Director of the Glycobiology Core Facility and Assistant Professor at the University of California San Diego (UCSD). Adriana is an expert on structural analysis of complex biomolecules as well as the chemistry and biology of carbohydrates. She has taught glycobiology for UCSD, SDSU, IBC, FDA and NIST as well as chemistry at the University of Buenos Aires. Dr. Manzi has published 28 original research articles and 20 book chapters. She is a member of the Advisory Board of Bioprocess International and Patheon. Adriana received a PhD in Organic Chemistry from the University of Buenos Aires and conducted postdoctoral research in biochemistry and glycobiology at the UCSD Cancer Center.