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Innovations and Advances in Large-scale Biopharmaceutical Manufacturing
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This OnDemand webcast was originally broadcast on:

Date: July 12, 2012

Time: 02:00 PM EDT

Duration: 90-minutes


Description:

This webinar will review the advances in biopharmaceutical manufacturing that have taken place over the past ten years, and will relate the current trends in innovation to aspects such as biosimilars, outsourcing, and budget shifts. We will review the impact of these current changes on the future of biomanufacturing. We will cover the newest technologies, shared best practices, and how companies view biopharmaceutical manufacturing now and in the future. Topics addressed will be single use, flexible factory options, hiring and productivity trends, globalization, and outsourcing. You will learn ways that companies today are making their biopharmaceutical manufacturing suites more efficient and productive today.


Speakers:

Eric S. Langer

President & Managing Partner, BioPlan Associates, Inc.


Eric Langer has over 20 years experience in biotechnology and life sciences international marketing, management, market assessment, and publishing. He has held senior management 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 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. He has developed numerous courses, classes and seminar programs, including Marketing in a Regulated Environment, Marketing Technical Products, and TechniManagement™. In 1989 he co-founded BioPlan Associates, Inc. a biotechnology and life sciences marketing company that provides information, market research, pricing, and market analysis to biotechnology and healthcare organizations. He has launched and managed marketing programs for product lines ranging from $500k to $500 million. His company works with both large and small clients at commerical biotechs, non-profit organizations, and governments in assessing and evaluating markets, and marketing strategies and tactics.


Abhinav Shukla, Ph.D.
Vice President, Process Development, KBI Biopharma, Inc.


Dr. Shukla has over 15 years of experience in process development for biopharmaceuticals spanning early development to commercial launch. He has led process development activities at a variety of companies ranging from small biotechnology to large pharmaceutical organizations. Most recently he was Director, Manufacturing Sciences and Technology at Bristol-Myers Squibb leading an organization that successfully commercialized Yervoy™ and Nulojix™ and provided post-commercial process support for Orencia™ in addition to other late-stage programs. Prior to BMS, Abhinav worked in the process development organization at Amgen Inc. where he was instrumental in establishing the organization wide platform process approach for monoclonal antibodies and Fc fusion proteins and aiding the progression of several biopharmaceuticals at various stages of development. Abhinav has a Ph.D. in Chemical and Biochemical Engineering from Rensselaer Polytechnic Institute. He has over 30 publications in scientific journals in the process development area, has edited a book on Process-Scale Bioseparations for the Biopharmaceutical Industry and serves on the editorial boards of Biotechnology and Applied Biochemistry and Bioprocess International.


Parrish Galliher
Chief Technical Officer, Xcellerex


Mr. Galliher earned his BA in Biology at Boston University (1975) and his MS in Biochemical Engineering at MIT (1981). Mr. Galliher joined Biogen, Inc. in 1981 where he was responsible for design, commissioning and management of Biogen's first biomanufacturing facilities for both E.coli and mammalian cell manufacturing. As Director of Process Engineering, he led the team responsible for startup, initial validation and commissioning of Biogen's Avonex® manufacturing facility, later licensed by the FDA in 1996. Mr. Galliher joined Alpha-Beta Technology (ABT) in 1994 as Director of Manufacturing Development and led the technology transfer, startup, validation, and commissioning of ABT's 55,000 sq ft. biopharmaceutical manufacturing plant in Smithfield, RI at which he became Vice President of Operations and General Manager in 1997. Mr. Galliher joined LeukoSite, Inc. in 1999 as Vice President of Biologics Manufacturing and continued in that role after Millennium Pharmaceuticals acquired leukoSite. At Millennium, Mr. Galliher led teh CMC Team that contributed to FDA and EU licensure of CAMPATH® monoclonal antibody in 2001. He also led the Biologics Manufacturing Productivity Improvement Program which enabled high speed development of Millennium's monoclonal antibodies for clinical trials. In December 2002, Mr. Galliher became Founder, President and CEO of Xcellerex, an advanced technology contract biomanufacturing and disposable manufacturing systems company. In December 2004, Mr. Galliher transitioned to Founder and Chief Technology Officer of Xcellerex, Inc. As Principal Investigator, Mr. Galliher has led Xcellerex's $19m US Gov't DOD contract for the "Acclerated Manufacture of Pharmaceuticals Program" (AMP), awarded in 2007 and continued through completion of Phase 2 Live Fire Test in 2009. Mr. Galliher is co-inventor on numerous patents in the field of biomanufacturing.

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