John Carpenter, Ph.D.
John Carpenter is Professor of Pharmaceutical Sciences at the University of Colorado School of Pharmacy and a Co-Founder and Co-Director of the University of Colorado Center for Pharmaceutical Biotechnology.
His research interests include mechanisms for protein degradation and stabilization in pharmaceutical formulations, during bioprocessing and in delivery systems. John has worked for several years to define rational strategies for stabilizing proteins and vaccines during freeze-drying and storage in the dried solid.
He has published more than 300 peer-reviewed papers and is an inventor on more than 30 issued patents. He is Editor for Reviews and Commentaries for the Journal of Pharmaceutical Sciences and serves on the Editorial Advisory Boards for Pharmaceutical Research, The AAPS Journal, Journal of Pharmaceutical Sciences, Current Pharmaceutical Biotechnology, Molecular Pharmaceutics and BioPharm International. He has received several teaching awards and The Ebert Prize.
John is a Fellow of the American Association for Advancement of Science and the American Association of Pharmaceutical Scientists (AAPS) and has received the AAPS Research Achievement Award in Biotechnology. He also is the Organizer for the Colorado Protein Stability Conferences.
Vijay Jethwa, Ph.D.
Vijay Jethwa is a senior consultant at Biologics Consulting. He has over twenty five years of industry experience in the development, validation and routine performance of potency assays, cell-based bioassays and immunoassays for diagnostics, PK/PD studies, drug substance and drug product characterization, lot release and stability, as well as immunogenicity assessments.
Jethwa started up the new GMP Bioanalytical Laboratories at the Merck Vaccines Facility in Durham, NC. His group developed and transferred analytical methods for the characterization and release of live virus vaccines. Prior to joining Merck, he was at Biogen Idec for over twelve years in various capacities, including leading all CMC activities related to biosimilar development and serving as the site head of the cGMP Bioassay, Microbiology and Virology QC Laboratories. He established GLP testing laboratories at Biogen, including laboratory design, equipment sourcing and validation, supporting antibody and PK/PD testing for various GLP/GCP studies.
Jethwa prepared and presented Quality sections for Regulatory advice meetings and has authored, reviewed and approved sections of several regulatory submissions (IND, IMPD, BLA, etc.).
Robert Schiff, Ph.D.
Robert Schiff is Founder and CEO of Schiff & Company, Inc., a regulatory affairs, compliance and clinical research organization established in 1982.
Prior to founding Schiff & Company, Robert served with a number of companies, including the Warner Lambert Company as Group Vice President, Diagnostics Research and Development; Hoffmann-La Roche, Inc. as Director, Department of Diagnostic Research and Product Development; the J. T. Baker Chemical Company (Richardson-Vicks) as Director of Research & Development, Diagnostics Division; the Hyland Division Travenol Laboratories (Baxter) as Manager, Serology Research; and as an Assistant Professor in the Department of Anatomy at Tufts University Schools of Medicine and Dental Medicine.
Robert has authored over fifty publications and holds several patents on medical products. He serves on the boards of several companies, is a member of the Editorial Board of the Regulatory Affairs Professional Society, is a Fellow of the Regulatory Affairs Professional Society and is listed in Marquis’ Who’s Who in America, Who’s Who in the World, Who’s Who in the East, Who’s Who in Science & Engineering, and American Men of Science.
He received his BSc. from the City College of New York, M.Sc. from Iowa State University and Ph.D. from the University of California at Davis. He was a member of the Graduate Business faculty at Farleigh Dickinson University, and he also lectures on International Business and Compliance with FDA rules and regulations.
Benjamin Del Tito, Ph.D.
Benjamin Del Tito is currently a consultant to Vaxart and a Senior Affiliate Consultant at Biologics Consulting.
He has more than twenty years of experience in both large pharmaceutical and small to mid-sized biotechnology companies, specializing in a range of products from protein therapeutics to vaccines to diagnostics. His career has focused on the areas of analytical development, quality control, pre-clinical assay development and validation, quality assurance and regulatory affairs. He is knowledgeable in global drug development (Phase I-IV); IND, IMPD, NDA and BLA submissions; regulatory interactions; and regulatory inspections for both the US and Europe. Benjamin has extensive experience in building teams of development and quality professionals for phases of drug development, including early development, clinical manufacturing, licensure and commercial manufacturing.
Benjamin was employed from October 2005 to XXX at Auxilium Pharmaceuticals, where he oversaw the Quality Control, Quality Assurance and Regulatory Affairs departments. Prior to Auxilium, he served as Vice-President, Analytical and QC Operations at Neose Technologies, Inc. Beroe that he served as Senior Director, QC Operations at MedImmune Vaccines, Inc.
Benjamin earned his B.A. in Biology from Millersville University, an MSc. in Biochemistry from Western Kentucky University and a Ph.D in Molecular Biology from Lehigh University. He is an Adjunct Faculty member at Georgia State University in Atlanta, GA.
James Robinson, MD
James (Jim) Robinson is the principal and founder of James Robison Biologics Consulting since 2015. He holds a master’s degree in Chemical Engineering from Lehigh University.
From 2016 to 2021, he was the Vice-Chair of the Scientific Advisory Board for Coalition for Epidemic Preparedness Innovations (CEPI), where he directed guidance for development of a COVID vaccine. From 2010 to 2015, he served as Vice President, Global Technical Operations, Vaccines, Biological and Sterile Products for Merck & Co., Inc., where he oversaw improvements to the company’s manufacturing operations in order to increase supply performance and capacity realization for the vaccine, biologics, and sterile products franchises.
From 2007 to 2010, he was Vice President, Technical and Quality Operations at Novavax, Inc., managing a 40-person biotechnology team focused on recombinant virus-like particle vaccines. The prior 20 years were spent in various positions with Sanofi Pasteur, including, from 1998 to 2006, as Vice President, Industrial Operations. Robinson has been granted various international patents, serves on a number of Scientific Advisory Boards and Councils and is the author of an array of publications covering vaccines and biologics manufacturing.