Dr. Nicole Paulk is an Assistant Adjunct Professor and K01 Fellow in Viral Gene Therapy at UCSF in San Francisco.Dr. Paulk has a BS in Medical Microbiology, a PhD in Viral Gene Therapy and Regenerative Hepatology from OHSU with Dr. Markus Grompe, and completed her Postdoctoral Fellowship in Human Gene Therapy with Dr. Mark Kay at Stanford University. She is a pioneer in the development of next-generation AAV gene delivery platforms and has engineered payloads for gene repair and gene transfer for numerous rare diseases, utilized directed evolution to evolve capsid serotypes with novel tropisms, and has applied comparative proteomic approaches to interrogate challenges in vector manufacturing. Dr. Paulk’s translational research lab at UCSF now develops solutions for the biggest problems in gene therapy: cost, delivery and efficacy, with a focus on treatments for rare diseases and cancer.
Bill Whitford is Strategic Solutions Leader, BioProcess, GE Healthcare in Logan, UT with over 20 years experience in biotechnology product and process development. He joined the company as a team leader in R&D developing products supporting biomass expansion, protein expression and virus secretion. Bill has published over 300 articles, book chapters and patents in biotechnology. He now enjoys such industry activities as serving on the editorial advisory board for BioProcess International.
Christine Le Bec joined Genethon in 1997 as a scientist and currently heads the CMC
Analytical Department. She is responsible for the analytical activities in the characterization
and release testing of gene therapy products at early stage development, stability studies,
and interface with CMO for method transfer and validation, analytical/QC testing. She also
assists in the response to CMC questions from regulatory agencies query. She has a strong
expertise in the development and qualification of analytical methods based on biochemical,
biophysical and cell based assays to assess identity, potency, impurity profile, and safety.
Before joining Genethon, she obtained her PhD in Bio-Organic Chemistry from Université
Pierre et Marie Curie (Paris VI) in 1993. She worked as a postdoctoral researcher at Thomas
Jefferson University (Philadelphia, US) and then at Institut Pasteur (Paris, France) in the field
of synthesis, structural analysis and in vitro evaluation of antisense DNA as therapeutic
agents for cancer and AIDS.
Jim DeKloe serves as the director and founder of the Industrial Biotechnology program at Solano College
in the North San Francisco Bay area. This program emphasizes biomanufacturing by training students in the skills
required to work in companies that have located in the biotech manufacturing cluster in Vacaville, CA (located half
way between San Francisco and Sacramento). This program has served as the model for biomanufacturing
programs all around the country. On sabbatical he worked in the manufacturing department of biotech pioneer
Genentech Inc. He also served as a consultant to help biotech giant Amgen redesign the training programs for their
biomanufacturing technicians and for their quality assurance associates. In 2000, the Association of Community
College Trustees chose Jim as the Distinguished Faculty Member of the Pacific Region which includes the Western
United States and Canada, Hawaii Alaska and Guam. In 2011 Solano College faculty chose Jim as the
Distinguished Faculty Member of the Year. In 2016, he and his colleague Ed Re were finalists for an Award of
Excellence of the American Association of Community Colleges. In 2015 Jim led the successful effort that resulted
in the approval for Solano College to offer a Baccalaureate Degree in Biomanufacturing; that made Solano College
one of only fifteen community colleges approved to offer a Baccalaureate degree for the first time in California
history. The Bachelors degree started in Fall 2017 and the first cohort graduated in May 2019. This was coincident
with the opening of the new $ 34 million building that contains four biomanufacturing suites to train students in
Haruki is a molecular cell biologist specializing in protein folding and intracellular trafficking of therapeutically important proteins. His main interests are: (1) elucidating cargo-specific biosynthetic mechanisms for broad classes of proteins—both drug targets and biotherapeutics; (2) determining the fate of proteins in intracellular and extracellular space after the synthesis; (3) membrane protein topogenesis; (4) target characterization & validation; (5) difficult-to-express antigen design & expression; (6) mAb folding and secretion. After receiving a Ph.D. in Molecular Cell Biology from the University of Michigan, Haruki undertook a postdoctoral training at the National Institutes of Health, Bethesda. His first pharma experience came from the Assay Development group in Bayer’s Kyoto Research Center where he developed biochemical and cell-based HTS assays by gene-to-assay approach. For the last 14+ years in Amgen, Haruki works closely with disease area scientists, antibody discovery technologists, and bioassay experts to advance early exploratory projects from target validation to biologics lead selection.