2nd Annual Vaccine Manufacturing Conference

Dr. Andreas Neubert has more than 25 years experience in vaccine development and manufacturing. He worked about 10 years on R&D projects for different viral vaccines.
He received extensive training on Vaccine Manufacturing, Gene Technology including Current Good Manufacturing Practice for Biological and Biotechnology derived Pharmaceutical Products. Dr. Neubert is a Veterinary Virologist by training. He is Vice President for Vaccines within the company, and responsible for the production of vaccines for human and veterinary use. He has gathered extensive experience in research and development of viral vaccines, including several successful approved products. He has also good knowledge of vaccines technologies, quality control and analytical characterisation of vaccines according to European and FDA cGMP regulations. His technical skills were proven when he supervised the design and construction of several new production facilities at IDT. Andreas Neubert was invited to study Veterinary Medicine at the Veterinary Academy in Moscow, Russia, and received his doctorate in veterinary virology from the University Leipzig, Germany, in 1991. He is appointed guest lecturer at University Halle/Saale for GMP in Pharmaceutical Biotechnology. He is author or co-author of over 20 scientific publications and meeting abstracts.

Dr. McPherson is Director of Quality Control at Protein Sciences Corporation in Meriden, CT, USA. He joined Protein Sciences in 2005 as Scientist and Project Manager in the Process Development where he was manager of an NIH funded SARS vaccine project. Dr. McPherson became Director of Quality Control in 2007. He has a PhD in Molecular Biology from Vanderbilt University. Prior to joining Protein Sciences Dr. McPherson was an Instructor at the University of Connecticut Health Center following postdoctoral fellowships at Brown University and the University of Connecticut Health Center.

David is an Associate Director at ERA Consulting (UK) Ltd. ERA is one of the longest established and most experienced consulting groups serving the biopharmaceutical industry.

David specialises in quality (CMC) aspects of biological products, particularly vaccines. His responsibilities include compilation of marketing authorisation applications, investigational medicinal product dossiers, scientific advice procedures, orphan drug applications, gap analyses and regulatory strategy planning as well as general consulting on biological processes and European regulatory affairs.

Before joining ERA David gained thirteen years of experience in research including six years working in biological process development, scale-up and technology transfer in the biopharmaceutical industry.

David has experience of a large range of biotech processes including conventional and recombinant vaccines (viral and bacterial), bacterial expression systems, yeast expression systems, cell culture systems and DNA vaccines.

David completed a PhD and Postdoc in Molecular Microbiology at the School of Pharmaceutical Sciences, University of Nottingham, before moving to the biotech industry. He spent three years at Phico Therapeutics Ltd developing a commercial process for production of recombinant bacteriophages then moved to Schering-Plough where he worked on development and scale up of production processes for vaccines. He joined ERA consulting in early 2008.

I studied for my PhD at the Institute for Animal Health at Compton from 1998-2002 as a molecular virologist working on the development of a defective RNA-based recombination system to introduce targeted mutations into infectious bronchitis coronavirus.

Held post-doctoral positions for five years firstly at the Institute of Animal health (2002-2003) then the University of Leeds (2003-2006) working on variety of molecular virology projects primarily how coronaviruses interact with the host at a cellular level to manipulate various cellular structures and functions such as the cell cycle and nucleolus structure.

I joined the Health Protection Agency at Porton Down in 2006 as a senior virologist initially working on Respiratory Syncytial virus antiviral studies before becoming the team leader a commercial diagnostics R&D group working on the development of variety of novel influenza diagnostic assays. Currently, I’m the team leader of the Influenza animal model group established at Porton to conduct both in vivo and in vitro influenza academic and commercial studies.

National Institute for Biological Standards and Control
Blanche Lane, South Mimms, Potters Bar
Herts EN6 3QG
United Kingdom
Tel +44 1707 641309
Fax +44 1707 641366
Email John.Wood@nibsc.hpa.org.uk

Dr. John Wood is a Principal Scientist in the Division of Virology at the Health Protection Agency National Institute for Biological Standards and Control (NIBSC) in the UK. His work contributes to influenza vaccine strain selection by the WHO and the EU, which includes the serological testing of vaccine trials; the preparation and distribution of influenza viruses to vaccine manufacturers; the coordination of the EU vaccine strain selection process; and the official batch release testing of influenza vaccines.
He is also involved in the development and evaluation of vaccines against pandemic and potential pandemic viruses. This work includes the development of safe and productive vaccine viruses from highly pathogenic viruses and newly isolated H1N1 pandemic viruses, as well as testing the protective efficacy of candidate pandemic vaccines and the standardisation of serological tests for H1N1pdm and H5N1 vaccines. A description of the influenza work at NIBSC can be found at the Influenza Resource Centre website http://www.nibsc.ac.uk/flu_site/index.html . Dr. Wood sits on the WHO advisory panel on influenza vaccine composition and is a member of the International Health Regulations Roster of Experts and the OIE Expert Surveillance Panel on equine influenza vaccines. He has also been a member of WHO expert groups on immune correlates of protection; development of influenza vaccines with broad spectrum immunity; biosafety of large scale production of pandemic influenza vaccines and regulatory preparedness for human pandemic influenza vaccines. Dr Wood is currently vice-chair of the International Society of Influenza and other Respiratory Viruses (ISIRV).

Dr. Posner joined Charles River as Director of Regulatory Compliance at the Malvern, Pa site in October, 2006. Prior to Charles River, Dr. Posner spent over 10 years in research, laboratory and quality operational roles at Merck & Co. Inc. Dr. Posner has been involved with analytical release assays, method validation and implementation of capital projects for sterile products and vaccines. As the site head of compliance, Dr. Posner oversees product release, external auditing, validation, and document management activities.

Ferruccio Messi is President & CEO of Cell Culture Technologies LLC, the company he founded in 1992 – just a few weeks after obtaining his PhD degree in biotechnology at the ETH Zurich. Cell Culture Technologies started its activities in the development and production of serum- and protein-free minimal media for Chinese Hamster Ovary cells, and soon entered into Technology Transfer Agreements with a number of well-known biopharmaceutical companies in Switzerland, Germany, France, Netherlands, and United States. In the late 90’s the company amplified its activities to focus on the development of minimal culture media for several mammalian cell lines including hybridomas, myeloma cell lines, kidney cell lines, and immortalised cells of human origin. While such studies were performed in collaboration with several academic research institutions, he has been responsible for the development of all media formulations at Cell Culture Technologies. In 2003, the company entered into a technical collaboration with the European Collection of Animal Cell Cultures (ECACC), Porton Down, UK. Such collaboration resulted in the creation of a remarkable collection of mammalian cell lines adapted to proliferation in protein- and peptide-free minimal culture media.
Cell Culture Technologies currently focus on the industrial application of such media and collaborates with a number of biopharmaceutical companies and vaccine manufacturers worldwide.

Graham has an MSc in Biophysics from King’s and an MBA.

Working first in “big Pharma” then as a partner in the Pharmaceutical & Biotechnology Practice of PA Consulting, he returned to industry as:
• VP, Strategic Product Management, SmithKline Beecham
• Head of Executive Decision Support, GSK R&D; and most recently
• VP of Strategy & Business Development, GE Healthcare Biosciences.

Having helped set up ImmunoBiology and joining its Board back in 2000, he was appointed its CEO at the beginning of 2006.

Jacco Heldens studied at Wageningen University. After he got his PhD in Virology he started working for Solvay (Animal Health). In 2001 he started with Intervet Schering Plough Animal Health as Project Leader. In 2005 he started with Nobilon International (Human Health) as Head Virological R&D.

Katalin Abraham is Director, Influenza Vaccines, US American Regulatory Affairs (USRA), GlaxoSmithKline where she is responsible for the US regulatory strategy for GSK’s adjuvanted pandemic influenza vaccines, both the egg-based and cell culture-based programs. She has also represented GSK USRA at external policy organizations, including PhRMA TSE/BSE Subcommittee and USP Full-Length Vaccine Monographs Project Team.

Prior to joining GSK in January 2007, she was at Merck & Co., Inc. for eighteen years, holding positions of increasing responsibility in the vaccine division, including those in analytical, quality control and regulatory, supporting live virus vaccines and other cell culture-based products. She has experience working with regulatory and release authorities world-wide, participated in WHO and ICH efforts supporting cell substrates and virus vaccines and consulted for small pharma and other organizations. Her last position at Merck was as Associate Director, Regulatory Compliance Management in Vaccine and Biologics Research, responsible for the overall conduct of clinical assays and early vaccine development activities. Before Merck, while at Centocor, Inc., she held positions in monoclonal antibody research and development, the last as Manager, Cell Biology Services, responsible for early development activities through small scale manufacturing. Her career started at Children’s Hospital of Philadelphia in research in infectious diseases and in cancer. Following graduation with a B.S. from the University of Pennsylvania in 1976, she attended St. Thomas’ Hospital Medical School, University of London as a postgraduate student in medical virology.

Education
• MEng Chemical Engineering w/ Biochemical Engineering University of Birmingham, UK
• Ph.D in Biochemical Engineering University of Birmingham, UK
o Thesis title: Expansion of bovine superficial chondrocytes and human mesenchymal stem cells for tissue engineering

Kenneth Lee studied in Birmingham university during both his undergraduate and postgraduate.
Whilst at Birmingham, Kenneth gained experience in various academic and industrial laboratories including Loughborough University, Keele University, and Smith&Nephew, York.
Kenneth Lee started working at The Automation Partnership, a leader in the design and production of automated cell culture since 1989, in 2009 as a Product Development Engineer and Product Specialist in various projects, notably for a new micro-scale bioreactor platform; more information on this system will be given at the presentation.

Kenneth has experience in both process design, including industrial bioreactor design, and practical cell biology and cell culture. His experience in both these areas allows him to appreciate problems such as scalability of bioreactor system as well as the practicalities of performing routine cell culture and cell physiology.
He has experience with multiple mammalian cell lines, including CHO, HEK293, and NS0, microbial lines, including E.coli, B.subtilis, and P.fluoresces, and insect lines, such as SF21.

Stephen joined Stabilitech in 2009, bringing over 14 years of complex biological development and vaccine manufacturing experience into the company. He enjoys converting early research ideas into regulatory compliant products for patients. He has developed and validated commercial manufacturing processes for recombinant biologicals and cell-based medicines, including international cold chain and clinical supply. Commercial/academic multi-disciplinary programmes to predict the effects of manufacturing stress upon product efficacy have been of recent interest, including companion biomarker identification. Prior to joining Stabilitech, he played a key role in the whole cell immunotherapy vaccine programme at Onyvax, and also worked on the hepatitis immunotherapy delivery platform at Medeva. His PhD and early academic research at St Bart's Hospital Medical School and Imperial College London focused on recombinant vaccine design and mucosal protection using attenuated bacterial delivery systems.