Joerg is the Senior Vice President of Product Supply Biotech, Berkeley Site Head at Bayer Healthcare. A recognized leader in the field of biomanufacturing and a Bayer veteran, Mr. Heidrich has dedicated more than 20 years of his professional career to the management of various manufacturing operations within the global Bayer Group. He currently heads the Global Biotechnology Product Supply organization overseeing the manufacturing and distribution of Bayer’s $3 billion-plus biotechnology product portfolio. His career at Bayer began as a project leader back in 1986. Mr. Heidrich’s leadership and knowledge in the areas of engineering and product development brought him to manufacturing sites in Germany, Switzerland, and Mexico, where he supervised pharmaceutical production and administration of Bayer de México. In 2001, Mr. Heidrich moved to Berkeley, California and served as the Head of Production for Bayer HealthCare until 2005, when he assumed the role as Vice President of Product Supply for Kogenate®.

Wolfgang has over 22 years of industry experience [7 years at Biogen & Biogen-Idec] related to the development of biopharmaceuticals [protein-based] and cells as products [biotech approaches for hu-hepatocytes and hu-dermis & -epidermis cells]. Long-term experience with CC-based vaccine development and production. Since the merger between Biogen & Idec responsible for all biologics process development, spanning over cell culture, protein biochemistry, protein formulation, analytical development. Major activities also encompassing methods & strategy harmonization between the two legacy companies, and “horizontal integration efforts” between BPD-MS/MFG and research-BPD. Head of manufacturing alliances during my years with Boehringer-Ingelheim, before that, head of cell technology and GMP pilot plant operation, head of several inter-company projects [CMO]. Co-leader and organizer of various cell culture related organizations [international / national, as are ESACT, DECHEMA, CC Engineering] Over 70 publications, 4 patents and numerous presentations at international forums.

Associate Director, PROP Operational Excellence Fadel has an extensive background in the strategy and execution of process improvement initiatives. He began his Lean Six Sigma experience in the semiconductor industry where he pioneered process improvement principles in the high volume, high product mix manufacturing environment. Over the past seven years, Fadel has been working in the biotech industry at Amgen and Genentech. As an innovator, Fadel transformed the biotech culture by ensuring the successful deployment of Lean Six Sigma mindset. Fadel’s background combines skills in leadership, quality, operations, manufacturing and technical management.

Mr. Marshall has served as our Senior Vice President, Operations since December 2008. He previously served as Vice President, Operations from December 2006 to December 2008. Prior to joining Amylin, Mr. Marshall was Vice President of Corporate Manufacturing at Amgen Inc. From 2002 to 2005, Mr. Marshall served as Vice President of Global Manufacturing for Recombinant Proteins at the Bioscience Division of Baxter International, where he was responsible for five facilities with a VOS of over $1.3 Billion. From 1999 to 2002, he was Site Head of the Baxter International Thousand Oaks facility, where he supported increased sales through expansion of the facility into a Quad-Suite and Formulation, Fill and Finishing operation. He joined Creative BioMolecules in 1992, first as Head of Process Development and Clinical Manufacturing and then as Head of Operations, where he managed two manufacturing sites responsible for the production and commercial supply of the OP-1 implant device. From 1988 to 1992, Mr. Marshall held various management positions with Welgen Manufacturing Partnership (now Amgen, Rhode Island), Repligen Corporation, and Damon Biotech. He serves as a board member for Medicago, Inc., and is a member of ISPE and ASCB.

Judy K. Glynn is currently a Senior Principal Scientist in the Global Biologics unit at Pfizer Inc, and has been employed in the biotechnology area for 18 years. At Pfizer, her responsibilities include downstream process development and technical transfer of both microbial and mammalian based products (with a focus on antibodies) from early development through to commercialization. Prior to Pfizer, Judy worked for Centocor and Chiron Corp., performing downstream development, technical transfer, and early clinical manufacturing.

Dr Gottschalk is Group Vice President, Purification Technologies, with a global responsibility for bioseparation products at Sartorius Stedim Biotech. He worked in different capacities for Bayer Health Care from 1991-2004 and became head of the GMP protein purification facility in Wuppertal (Germany). He was responsible for the production of monoclonal antibodies and other recombinant proteins using various expression systems. He is member of BioPharm International’s editorial advisory board and has written one book, five book chapters and many other publications in the areas of biotechnology and somatic gene therapy. In academia Dr. Gottschalk is Head Lecturer at the University of Duisburg–Essen (Germany) and also lectures at the Ecole Polytechnique Fédérale de Lausanne EPFL (Lausanne, Switzerland). Dr. Gottschalk is board member of the VBU Association of German Biotech Companies.

Ran Zheng is Executive Director, Plant Manager at Amgen Inc., where she is responsible for Amgen’s clinical bulk manufacturing of pipeline product candidates. In this role, Ran has successfully increased manufacturing capacity, improved production capabilities, and reduced operational cost through technology investment and operational excellence. She also serves as a member of the Bulk Council at Amgen, a governance body for strategic application of technology to achieve excellence in Amgen’s bulk manufacturing network. Prior to her current role, Ran held various technical and leadership positions with increasing responsibilities in Process Development, Process Engineering and Quality Control at Amgen and other companies including Genzyme and Diosynth Biotechnology. Ran has over 15 years experience in the development and manufacturing of biopharmaceuticals, such as monoclonal antibodies, therapeutic proteins and enzymes. Her technical expertise includes process development and scale-up, process characterization, technology transfer, validation and process analytical technology.

Laura Bush is the Editor in Chief of BioPharm International, where she provides expert-related technical and regulatory insights that are currently affecting the biopharmaceutical sector. Before joining BioPharm in November 2005, Ms. Bush spent almost three years as managing editor of Pharmaceutical Technology, another leading publication highlighting pharmaceutical industry trends. Her combination of experience in pharmaceutical publishing, alongside a project management role for the Asia Pacific Latin America region within a division of Pfizer (previously Pharmacia Corporation), has contributed to Laura’s established reputation within the biotech community. In addition, she has also facilitated sessions at various high-level conferences on a global scale. A graduate of McGill University in Montreal, Canada, Ms. Bush spent the first part of her career as a technical translator for an international law firm in Madrid, Spain.

Rohin Mhatre has over 15 years of experience in the biotech industry of which 12 have been with Biogen Idec where he is Senior Director Biopharmaceutical Development. His group is involved in product characterization and supports process and formulation development from the pre-clinical stages to commercialization of the product. Rohin is also currently heading the Quality by Design initiative within Biogen Idec.

Jeff Cisneros has worked for almost 14 years at Genentech Inc. in South San Francisco, California. His work experience includes Aseptic Filling, Seed Train, Clinical Development, Quality Assurance, Lot Release, large-scale production and purification, and Operational Excellence. He earned his first belt in Six Sigma in 2004, and since 2007 has worked full time in Operational Excellence. He led the cross-site 5S program at Genentech, led the development of the OpEx training strategy for Genentech’s Manufacturing unit, and for 2 years was the lead instructor for OE training. He also led the development of a Genentech Belt Certification Program through the pilot phase with 30 participants, and mentors and coaches project leaders.

Rob Carter joined Novartis in 2006 as Site Head for the Vacaville site in California manufacturing microbial biopharmaceuticals. Prior to Novartis, Rob spent 20 years with Baxter Healthcare where he worked in various manufacturing roles including engineering, production, quality and validation for large volume parenterals and plasma fractionation operations. Originally from Canada, Rob has a degree in Mechanical Engineering from the University of Waterloo.

Amit Banerjee is a Research Fellow in BioTherapeutics Pharmaceutical Sciences, Pfizer Inc., in St. Louis. He received his B.Sc (Hons) and MS in Chemistry from Jadavpur University (Calcutta; India) graduating top of his class for both undergraduate and master program. Amit earned his Ph.D degree in Biochemistry from Brown University (Providence, RI, USA) in 1982. He was a post-doctoral fellow at the University of Pennsylvania (Philadelphia, USA) from 1981-1985, under the guidance of Prof Barry Cooperman. In 1986, Amit was hired by Prof Alan MacDiarmid (Nobel Prize recipient in 2000) to help start-up a small biotech company BioSynR, (Philadelphia, Pa, USA). He joined Bristol Myers Squibb (New Jersey, USA) in 1987 and spend eleven years with the company, where he was a member of the bioprocess research group, developing manufacturing technologies for compounds as Pravachol and Taxol. In 1998, he joined Searle/Monsanto (St. Louis, Mo, USA) as Section Head of the fermentation group and after the merger with Pharmacia in 2001, he held the position of Director of Fermentation and Downstream Processing. His group made significant contribution for developing manufacturing process for the pegylated protein therapeutic Somavert. Amit specializes in bioprocess development, technology transfer and manufacture of proteins, monoclonal antibodies and oligonucleotides. Amit has published over 42 publications in peer review journals and has been awarded thirteen patents.

William, is widely recognized in USA as the ‘father of the Generic drug industry’, initiated and negotiated the Drug Price Competition and Patent Restoration Act (“Hatch-Waxman”) in USA. He was instrumental in the passage of the U.S. “Orphan Drug Act”. He headed a team that created the New York Green Book, which became the FDA’s “Orange Book.” His hearings led to the repeal of anti-substitution laws that had effectively prevented use of generic medicines for two decades in USA. A generic drug manufacturer, a founder of the generic trade association and its chairman/president for over a decade. He was vice chairman and CEO of solid dosage manufacturing for Schein Pharmaceutical. He has also helped design New York State’s program to provide low cost medicines for senior citizens. Mr Haddad is a long time Chairman/CEO of the Generic Pharmaceutical Industry Association. In 2002, Mr. Haddad helped to organize the world’s AIDS drugs manufacturers into an association; currently Mr. Haddad serves as its “facilitator.” The U.S. Congress appointed him to the Prescription Drug Review Commission. He created the “memorandum of understanding” between the former Soviet Union and the U.S. He was appointed to serve on a U.S. team working with China on pharmaceutical issues. He was CEO of Schein’s manufacturing operations in Danbury, Conn. and Carmel, New York. Bill formed the United States Research and Development Corp. and later its subsidiary, Biogenerics, Inc.

At KGI, Professor Croughan teaches eight graduate courses on biotechnology development and manufacturing for students earning a Masters in Bioscience (MBS), a unique professional science degree for those who want a career in leadership at the interface of business, engineering, and biology. He also serves as faculty advisor on collaborative projects with industry (Team Masters Projects). His laboratory classes and research range from monoclonal antibody production and purification, to fermented beverages, to biodiesel production from algae. Prior to joining KGI, Dr. Croughan spent 8 years consulting industry-wide on biopharmaceutical process development and manufacturing issues. He still consults with many firms part-time, and has had over 45 clients to date. Prior to consulting, Dr. Croughan worked at Genentech for ten years. He led the development of the first licensed, high-density, fed-batch cell culture process, a breakthrough platform technology now used by Genentech and throughout the industry for production of high-dose therapeutic antibodies and other proteins.

Justin O. Neway, Ph.D., Executive Vice President and Chief Science Officer for Aegis Analytical Corporation, has over 25 years of experience in biotechnology and pharmaceutical process development and manufacturing, and in the application of software solutions to operational issues and quality compliance in biotechnology and pharmaceutical manufacturing. For 15 years prior to founding Aegis in 1996, Dr. Neway was with Wyeth Biosciences (Genetics Institute), Novartis Pharmaceuticals (Cetus), and Baxter Hemoglobin Therapeutics (Somatogen), where he held increasingly responsible positions including Technical Manager, Principal Scientist, Project Leader for the CMC section of the IL-2 PLA, Department Director, and Director of Process Sciences. During this time, Dr. Neway became intimately familiar with the practical difficulties of accessing process development and manufacturing data in separate databases and paper records, and the significant paybacks achievable from connecting to that data for on-demand access by end users, and the benefits of practical investigational analysis to understand and control the sources of process variability and to prepare and support CMC filings for the FDA and other regulatory bodies. He has published refereed papers in scientific journals as well as other papers, editorials, op-ed pieces and interviews in trade publications. He has also presented technical papers and chaired technical conferences in the field of pharmaceutical manufacturing, data analysis and quality compliance.

Lisa Crossley has extensive biopharmaceutical manufacturing and new product development experience. Most recently, she directed the global manufacturing efforts for two therapeutic lead candidates for a publicly-traded biopharmaceutical company (Dyax Corp, Cambridge, MA). She is also an experienced venture capitalist and provided consulting services for several of North America’s largest Life Sciences Venture Capital companies Dr. Crossley currently sits on the Board of Directors for Viron Inc., a venture-backed biopharmaceutical company based in London, Ontario, and is the co-Chair of the Toronto Chapter of CATA-WIT (Canadian Advanced Technology Alliance - Women in Technology). Dr. Crossley holds a BSc in Anatomy & Cell Biology from McGill University and a BScE and PhD in Chemical Engineering from Queen’s University. She is a licensed Professional Engineer in the province of Ontario.

Dr. Johnston is Principal of Bioproduction Group and an established expert in the field of biopharmaceutical operations and economics. Dr. Johnston takes an active role in furthering education in biopharmaceutical operations. He is currently the Executive Co-director of the University of California at Berkeley’s Center for Biopharmaceutical Operations and an Adjunct Professor at the Keck Graduate Institute in Clairemont, California.

David N. Bell, M.Sc., Ph.D., Chief Scientific Officer and Vice President of Drug Development. David’s primary responsibility at Therapure has been the development of a pipeline of new protein and cell culture based product candidates for the treatment of anemia, cancer and infectious diseases. He also leads the team offering development services for new product entries. Prior to joining the company in 1994, he was Group Leader of Cancer Biology at BioChem Therapeutic, Inc. and before this, Laboratory Director of the BioVentures Division of FAA in Worcester, Massachussetts, USA. He received his Ph.D. from the Department of Medicine of McGill University in 1988 and completed a postdoctoral fellowship at the McGill Cancer Centre.

Dr Stefan Steigmiller is Senior Project Manger PAT and joined Bayer Technology Services in 2005. Together with his team, he is responsible for PAT projects in the pharmaceutical and biotech industry. Dr. Steigmiller has a broad range of global experience in Online Analytics, Quality by Design, Process Automation and Optimization projects especially in biopharmaceutical industry.

Edward Graham-Brown Mr. Graham-Brown is Vice President of Strategic Marketing for Millipore Corporation’s Bioprocess Division. In that capacity, he is responsible for marketing communications, business intelligence, long-range planning, knowledge management, M&A pipeline development, business development, pricing and the coordination and execution of division-wide projects. Prior to joining Millipore, Mr. Graham-Brown was head of Bioprocess Marketing at GE Healthcare Protein Separations. He received his BPharm degree from Kings College, London, and an MBA from McGill University, Montreal. He is a member of the UK Royal Pharmaceutical Society.