Jason Condon, Senior CMC Project Manager, Vaccinex, Inc.
Melissa Joseph, CMC Pharma Development Consultant, Chymesis
Paul Mason, Director, Lachman Consultant Services
Jim Miller, President, PharmSource Information Services
Gautam Ranade, Principal Consultant, Pharma Falcon Consulting
Bharat Shah, PEH Clinical Supply Project Manager, Hospira (Pfizer)
Mehran Yazdanian, Sr. Director, Pharmaceutics, Teva
Founder and President, Pharmsource
Jim Miller is the founder and president of PharmSource Information Services. A preeminent expert in bio/pharmaceutical outsourcing, Jim established and presides over the industry’s principal resource for serious consumers of information on contract drug development and manufacturing: PharmSource STRATEGIC ADVANTAGE. He is editor and publisher of Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report. Jim serves as an editorial advisory board member for Advanstar Communication’s Pharmaceutical Technology and BioPharm magazines. He writes regular columns on outsourcing for Pharmaceutical Technology, Contract Services Europe and BioPharm magazines. In addition, Jim chairs the advisory committee of the Pharma & Biopharma Outsourcing Association (PBOA), and is a member of the board of directors of the American Type Culture Collection (ATCC), and serves on its technical committee.
Senior CMC Project Manager, Vaccinex, Inc.
Jason Condon is a senior CMC project manager at Vaccinex, Inc. in Rochester, NY, and an adjunct assistant professor in biomedical engineering at the University of Rochester. He has also held roles in biopharmaceutical manufacturing and process development at Bristol Myers Squibb and Janssen R&D. His expertise in cell culture and cGMP manufacturing has aided him in developing manufacturing processes for monoclonal antibody, cell therapy, and vaccine production throughout his 13-year career in the industry. A significant portion of this work has involved continuous (perfusion) bioreactors and hollow fiber filter cell retention devices. Mr. Condon is currently responsible for the clinical supply chain at Vaccinex and oversees drug substance and drug product manufacturing and testing, as well as the packaging, labeling and distribution of the finished product.
Director, Lachman Consultant Services
Paul Mason, Ph.D. is a director in the science and technology practice at Lachman Consultants who has over 17 years of experience in the pharmaceutical industry. He is a quality control chemist experienced in sterile parenteral, API, and solid oral dosage forms. His experience spans finished dosage form, CMOs, and API (intermediates) manufacture support in both a quality control and analytical development setting. Mr. Mason offers a deep understanding of business strategy relating to drug research, development, quality assurance, quality control, CMC submissions, laboratory design, clinical and pre-clinical quality and analytical development support. In addition, he has provided expert scientific support for the timely resolution of complicated scientific issues raised by FDA application reviewers.