Paula Katz, Director of Manufacturing Quality Guidance and Policy
FDA, CDER Office of Compliance
Paul Mason, Director, Lachman Consultant Services
Jason Condon, Senior CMC Project Manager, Vaccinex, Inc.
Jim Miller, President, PharmSource Information Services
Robert Marohn, Consultant, ClinLogic
Eric Langer, Managing Partner, BioPlan Associates
Maria Conklin, Associate Director, QC, Karyopharm Therapeutics
Gautam Ranade, Principal Consultant, Pharma Falcon Consulting
Melissa Joseph, CMC Pharma Development Consultant, Chymesis
Bharat Shah, PEH Clinical Supply Project Manager, Hospira (Pfizer)
Mehran Yazdanian, Sr. Director, Pharmaceutics, Teva
Director of Manufacturing Quality Guidance and Policy
FDA, CDER Office of Compliance
Paula R. Katz, J.D., is Director of Manufacturing Quality Guidance and Policy in CDER’s Office of Compliance. She leads an interdisciplinary staff of senior compliance officers and technical experts who focus on CGMP enforcement and drug quality policy issues. Ms. Katz frequently advises Center and Agency leadership regarding manufacturing supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy development and enforcement strategy. Ms. Katz has chaired Agency working groups and directed the development of guidance for industry, regulations, and legislation; managed responses to Congressional oversight and other stakeholder inquiries; and conducted domestic and international inspections, case evaluations, and enforcement actions. She is a frequent presenter at industry and agency meetings, conferences, and training events. Prior to joining FDA in 2009, Ms. Katz was a litigation associate at a large law firm in Washington, D.C., where her practice included regulatory compliance, white-collar crime, and general commercial litigation. Ms. Katz is a graduate of the University of Virginia and the University of Virginia School of Law.
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.
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.
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.
As a consultant, Robert Marohn helps organizations with all aspects of developing and implementing comprehensive quality information technology policy/procedures, frameworks, and Data Integrity plans and programs. He has significant experience auditing for compliance and helping life science organizations with the selection, implementation, and validation of technology. He has worked in the clinical trial and pharmaceutical industry for over twenty-five years developing and managing information solutions, IT quality and compliance approaches, and technology teams. Most recently, he was the Chief Information Officer of Worldwide Clinical Trials for eight years. Prior to this, he was Vice President of IT at Ingenix and a senior validation consultant for Clarkston Consulting, a technology integrator specializing in SAP for the life science industry. Mr. Marohn has consulted with companies such as ALARIS Medical Systems, Berlex Laboratories, Bayer Pharmaceutical (as a technology auditor), Osmonics, Celera Genomics, Serological, and Beirsdorff North America. Mr. Marohn holds a Bachelor of Science as well as a Master of Science in the Management of Technology from Georgia Institute of Technology.
Managing Partner, BioPlan Associates
Eric Langer, President and Managing Partner, BioPlan Associates, has over 20 years experience in biotechnology and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He is an experienced biotechnology strategist, marketing practitioner, publisher, and researcher. He has published, edited and authored numerous books, reports, and major studies on topics including: Advances in Biopharmaceutical Technology in China, Advances in Large-scale Biopharmaceutical Manufacturing, Biopharmaceuticals in the US Market, cell culture reports, media, sera, tissue engineering, stem cells, diagnostic products, blood products, genetics, DNA/PCR purification, blood components, and many others. He lectures extensively on marketing, pricing and channel management topics, and teaches at Johns Hopkins University and American University: Biotechnology Marketing, Marketing Management, Services Marketing, Advertising Strategy, and Bioscience Communication. In 1989 he co-founded BioPlan Associates, Inc. He has launched and managed marketing programs for product lines ranging from $500k to $500 million.
Associate Director, QC, Karyopharm Therapeutics
Maria is Associate Director, QC at Karyopharm Therapeutics, a virtual company, a critical role in the quality unit as manufacturing and testing is completely outsourced to contract organizations. Maria performs quality control (QC) and quality assurance (QA) activities for both the organization and contract service providers. While at Karyopharm, she has also helped develop and implement quality programs, and support all CMC quality activities in preparation of phase 3 and commercialization (NDA filing). Maria has almost 15 years of experience in quality—including managing teams of up to eight people as QC supervisor of raw materials, and over six years in roles developing and optimizing analytical methods.
Founder and Principal Consultant, PharmaFalcon Consulting
Dr. Gautam Ranade is an active consultant to the pharmaceutical industry in the areas of Pharmaceutical R&D outsourcing, dosage form development, novel drug delivery, due diligence, CMC strategy and external alliance management. Previously, Dr. Ranade was a Senior Director, Strategic Sourcing (Pharmaceutical Sciences) in Pfizer Worldwide R&D. He has a Ph.D. in Chemical Engineering and has many years of R&D, technology transfer and supply chain experience in pharmaceutical R&D at Pfizer. In a prior role, he was a Senior Director of Drug Product Manufacturing. He made major contributions to the development and commercialization of many parenteral/oral/topical dosage forms for several Pfizer drugs. He holds 19 U.S. patents and many international patents in the areas of drug delivery and formulation development. He has 20 publications in various scientific journals in the areas of novel dosage forms and drug delivery systems. He was actively involved in outsourcing activities for drug product development. Based on his broad and extensive experience Gautam is uniquely qualified to advise on how best to navigate the complex challenges of outsourcing drug product development.
Supply Chain Expert and Project Manager, Hospira, a Pfizer Company
Bharat Shah is a supply chain expert and project manager in Pfizer’s Hospira PEH Division. He has broad experience in Pharmaceutical R&D with a main focus on managing clinical supplies, project management, API and drug product sourcing and, regulatory CMC. His areas of expertise include: supply chain management; project and resource planning; leadership and mentoring; process development and improvement; regulatory compliance and filings; and outsourcing and vendor management. He has developed outsourcing strategies and implemented best business practices for API and Clinical supplies while at Pfizer as well as managed a global network of CMOs and CROs. Mr. Shah is currently working on Clinical Supply management for LATAM markets at Hospira, a Pfizer company.
Sr. Director of Pharmaceutics, Teva Branded Pharmaceutical Products R&D Inc.
Mehran Yazdanian is the Sr. Director of Pharmaceutics at Teva Branded Pharmaceutical Products R&D Inc. He received his B.S. in biochemistry and M.S. and Ph.D. in pharmaceutics from the University of Wisconsin-Madison. His current responsibilities are concentrated on directing formulation and analytical development activities from early drug discovery support and preformulation to formulation development and manufacturing for clinical programs and commercialization. The focus of his research has been on drug delivery from two perspectives: optimization of biopharmaceutical properties and formulation strategies to enhance oral absorption. Previously he was responsible for the Physical Pharmaceutics section of the Pharmaceutics department at Boehringer Ingelheim Pharmaceuticals Inc. Before that he held a position at Merck Research Laboratories where he worked on formulation development of transdermal and liquid dosage forms for veterinary applications.
Owner and Principle Consultant, Chymesis
Melissa Joseph, Ph.D., has over 20 years of experience in the pharmaceutical industry and is currently owner and principle consultant at Chymesis, LLC. Dr. Joseph has worked and consulted for small, virtual pharmaceutical development companies that rely on vendor relationships for all of their manufacturing and distribution needs. Dr. Joseph has been responsible for establishing and overseeing vendor relationships supporting all aspects of the manufacture of clinical trial material from the synthesis of the drug substance, through to the manufacture, packaging, distribution and regulatory activities required to support clinical trial supplies from Phase 1 to NDA. She has been integral in reformatting Quality Systems in order to ensure compliance with current Good Manufacturing Practices, while at the same time structuring systems and processes in order to optimize vendor relationships. Given her previous employment at contract as well as sponsor firms, Dr. Joseph has a unique understanding of the importance of the vendor relationship from both parties’ perspectives.