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Speakers 
Dr Sylvio Bengio,
Scientific Communications Manager,
PALL BioSepra
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Mr Thomas Bols,
Director Government Affairs, Europe,
Amgen
Thomas is Amgen’s Director Government Affairs Europe and a member of the Amgen European Leadership Team. He joined Amgen in January 2003 from Fleishman-Hillard/GPC International, a worldwide government and public relations consulting firm, where he was Executive Director Health Care & Pharmaceuticals. Previously, he has been working for management consultancies, industry federations and the EU Institutions. Thomas is a member of EuropaBio’s healthcare board working group and Chairman of the Association’s Task Force on Biosimilar Medicinal Products. Thomas studied Political Sciences at the University of Amsterdam and holds a postgraduate degree in European Law. A Dutch citizen, born in 1964, he is married and has 2 children.
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Mr John M. Clerici,
Partner,
McKenna Long & Aldridge LLP
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 Dr Pieter De Geus,
Vice President, R&D,
DSM Pharmaceutical Products
Dr. de Geus (48) obtained his PhD in Biochemistry in 1986 from the University of Utrecht, the Netherlands, on the subject of engineering of (phospho)lipid-degrading enzymes. He then held several research management positions in the areas of recombinant protein production and engineering at Plant Genetic Systems (Belgium), Unilever Research, Gist-Brocades and DSM (the Netherlands). In this period he worked on industrial development and (fermentative) production of enzymes, antibodies and secondary metabolites for applications in the agro-, consumer goods and pharmaceutical businesses. In 1997 he moved into the bio-pharmaceutical field when appointed site director of the contract manufacturing organization of DSM Biologics in Groningen (The Netherlands). There he managed the transition of the company from a development services company into a cGMP contract manufacturing company, with its first commercial product being approved by FDA mid 2004. Dr. de Geus recently became Vice President R&D for the DSM Pharmaceutical Products (DPP) business group, head-quartered in Parsippany, NJ (USA).
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 Dr Brendan Fish,
Director, Bioprocess Sciences,
Cambridge Antibody Technology
(1998-Present) Cambridge Antibody Technology. Joined CAT as Head of Downstream Processing in November 1998 and was promoted to Director in October 2001. Assumed responsibility for all of Bioprocess Sciencen in sping 2004. Currently in control of all aspects of the development of purification methodologies, formulation and delivery solutions and biochemical and biophysical characterisation of all CAT’s products in relation to their use in commercial pharmaceutical processes. This includes process design and optimisation, formulation and stability studies, comparability and product characterisation, scale-up, process cost modelling, process integration and technology transfer to GMP Production for clinical trial supply.
(1991-1998) Delta Biotechnology Limited. Consulting Scientist. Played a key role in the development of Delta’s biotechnology-based products providing expert opinion and strategies for QA, QC, Production, Marketing, Operations, Regulatory Affairs and Engineering on all aspects of Process Development.
(1989-1991) University of Toronto in Canada. Post-doctoral fellowship working in the School of Nutritional Sciences, studying the anti-nutritional effects of lectins in the diet.
Also held posts as a Reseach Assistant and a Medical Laboratory Scientific Officer.
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 Ms. Sandra Fox,
President,
HighTech Business Decisions
Ms. Fox has a Master of Business Administration degree from the University of California at Berkeley, Haas School of Business, and is a Phi Beta Kappa graduate in the life sciences at UC Berkeley. She has conducted and managed market research projects for business-to-business biotechnology, pharmaceutical drug discovery, and biopharmaceutical manufacturing products and services since 1988. Ms. Fox has written numerous articles for 'Genetic Engineering News' regarding biomanufacturing and drug discovery technologies, given presentations on biotechnology markets at industry conferences, and helped more than 150 clients increase sales, fine-tune their business strategies, and make successful decisions regarding high tech markets. She manages and coordinates an outstanding team of analysts to research the markets for biotechnology and drug discovery and products and services.
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 Dr. Frank Hanakam,
VP Process Development,
Micromet AG
Dr. Frank Hanakam is Vice President, Process Development at Micromet AG, Munich, where he leads a group of 20 people.He joined Micromet in 1996 where he started to establish a functional unit for the development of cell lines and production processes of antibodies andrecombinant derivatives for use as immuno-therapeutics. Over the past eight years Dr. Hanakam was furthermore in charge of multiple outsourcingactivities and collaborations with EU- & US-based companies, in the contextof process development, supply and release of clinical trial material, involvingtech-transfers and subsequent process scale-up into the kg-range.In 2002 he received his MBA from the Open University Business School, Milton Keynes, UK.
Prior to joining Micromet he did postdoctoral studies on fluorescence correlation spectrometry at the Max-Planck Institute of Biochemistry,Martinsried, Germany, in collaboration with Evotec, Hamburg, Germany. He received his Ph.D. in cell biology in 1995 from the University of Tuebingen, Germany, with work on functional protein characterization performed at theMax-Planck Institute of Biochemistry.
Dr. Hanakam, biologist by training, earned his MS degree in 1991 from the University of Tuebingen with practical work on antibodies and rt-PA performed at Boehringer Ingelheim, Biberach, Germany.
Dr. Hanakam has more than 13 years of experience in cell culture, protein purification and characterization.
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 Dr Philipp Hess,
President and Founder,
Philipp Hess Associates
Philipp N. Hess is Founder and Managing Partner at PHA – Philipp Hess Associates.
Founded in 1994, PHA provides project and consulting services entirely dedicated to the global biopharmaceutical manufacturing sector with projects in Europe, USA, Latin America, and Far East.
Since 1999 PHA is a member of PMSA – Pharmaceutical and Medical Services Associates, Zürich, a strategic marketing and consulting organization with members in 5 European countries and the USA.
From 1988 to 1993 Philipp Hess worked in various positions at Centocor’s Therapeutics Division in The Netherlands and the USA; positions included Head of Logistics and Head of Project Management. He was deeply involved in the manufacturing development of successful monoclonal antibodies such as ReoPro and Remicade and less successful ones like Myoscint and the “textbook failure” Centoxin.
Philipp Hess holds a Doctor’s degree in biotechnology from the Department of Biotechnology at the Swiss Federal Institute of Technology, Zürich, Switzerland and a Master’s degree in chemistry from the Technical University of Munich.
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Dr R. Barry Holtz,
Principal,
Holtz BioPharm Consulting
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Dr Amer Jaber,
Vice President Lifecycle Management, Global Product Development,
Serono International S.A
Dr. A. Jaber has held several positions with responsibilities of process and product improvement, within the Serono Organization. In his different roles, He has led the implementation of several activities related to Serono’s blockbuster Rebif (process re-engineering, product improvement). More recently, Dr. A. Jaber is leading several lifecycle management programs, with significant dedication to innovative approaches to critical aspects such as immunogenicity and injection tolerability.
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Dr Feroz Jameel,
Prinicpal Scientist Drug Product and Process Development,
Amgen Inc
Feroz Jameel, Ph.D, is a Principal Scientist in Drug Product Process Development at Amgen Inc, Thousand oaks, CA. He received his undergraduate degree in Pharmacy from Kakatiya University, Master’s degree in Pharmaceutics from University of Delhi and Ph.D in Pharmaceutics from University of Connecticut. He performed his postdoctoral work with professor M.J Pikal where he was involved in the formulation and process design for freeze drying of various proteins, antibiotics and conventional small molecules. Some of this work led to granting of patent and served as basis for further development of protein formulations and lyophilization cycles of biopharmaceuticals. He received several awards including AAPS and PDA’s Fred Simon’s award. He has chaired several symposia on the development of biological products. In his current role at Amgen he is involved in the development, optimization, scale-up and transfer to manufacturing of formulation, filling and lyophilization processes for biopharmaceutical products.
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 Mr Reg Joseph,
Business Area Manager,
Invitrogen
Mr. Joseph is a Business Area Manager with Invitrogen where he has held positions in corporate development and acquisition integration. His expertise includes technology commercialization, licensing and intellectual property management, and new business creation.
Mr. Joseph completed his Bachelors of Science (physiology & pharmacology) at the University of Saskatchewan in Canada and assisted with research on islet cell transplantation with the Alberta Heritage Medical Foundation at the University of Alberta. After completing his MBA (finance) he began his career with the licensing office at the University of Alberta focusing on the medical biotechnology portfolio. Mr. Joseph then moved on to the Protein Engineering Networks Centers of Excellence (Canada), where he managed large federally funded multi-institutional research projects with the nation’s leading protein scientists. He commercialized the resulting IP via licensing and new start-up creation. After spending two years in management positions with academic start-up companies, he joined Invitrogen in 2002. Mr. Joseph is currently developing and implementing strategy for Invitrogen’s bioproduction division with an emphasis on designing novel products and services targeted to the early stage process development market to enhance Invitrogen’s PD Direct™ family of offerings.
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Dr Avinoam Kadouri,
Chief Executive Officer,
Rainbow Biotechnologies
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 Dr Niamh Kinsella,
Assoicate Director of Regulatory Affairs,
ERA Consulting
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Dr Otfried Kistner,
Senior Director Virology / Viral Vaccines,
Baxter AG
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Dr Roland G. Lageveen,
CEO,
IQ Corporation
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 Dr Christian Leist,
Head of Bioprocess and Technology Development,
Novartis Pharma AG
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Mr Gregory Levine,
Parnter,
Arnold and Porter LLP
Greg Levine is a partner in Arnold & Porter LLP’s Pharmaceutical and Medical Device group. His practice focuses on providing regulatory and compliance counseling to U.S. and multinational pharmaceutical, biotechnology, cosmetics, and medical device companies. Mr. Levine has advised clients in regulatory and compliance matters covering all aspects of the product life cycle. He also has assisted clients in responding to government investigations and enforcement actions and helped clients negotiate and draft consent decrees and other settlements with the FDA, the U.S. Department of Justice, and state Attorneys General. In addition, he has prepared expert witnesses and helped negotiate, draft, and implement settlements in major product liability litigation cases involving pharmaceuticals and medical devices.
Prior to joining Arnold & Porter LLP, Mr. Levine was a legislative staff member in the U.S. House of Representatives and a member of a White House task force on health care reform. Mr. Levine received his J.D. magna cum laude from the Georgetown University Law Center in 1996 and an A.B. magna cum laude from Brown University in 1990.
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Dr Trevor Marks,
Business Development Manager,
Health Protection Agency Porton Down
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Dr Shai Meretzki,
Founder and Chief Technology Officer,
Pluristem
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 Dr Peter F. Moesta,
Divisional Vice President, Biologicas Manufacturing, Global Pharmaceutical Operations,
Abbott Laboratories
Dr. Peter F. Moesta, Divisional Vice President, Biologics Manufacturing, Abbott Laboratories, is responsible for Abbott’s world wide biologics manufacturing. He assumed his current position in 2003, after joining Abbott through its acquisition of BASF’s pharmaceutical business in 2001. Dr. Moesta joined BASF in 1984, and held various positions in research and manufacturing at BASF both in Germany and the US. Dr. Moesta received a Ph.D. in biochemistry from the University of Freiburg and held a post-doctoral position at the University of California before joining BASF. He is the recipient of various internal and academic awards and scholarships.
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Dr Steve Peppers,
Principal Scientist,
Invitrogen
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Mr Bernd Schroder,
Head of Upstream Processing,
Miltenyi Biotech
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 Andrew Sinclair,
Co-Founder, Managing Director, UK,
Biopharm Services
Andrew Sinclair founded BioPharm Services in December 1998 to develop a technology based services business focused on all aspects of biopharmaceuticals manufacturing. The company has developed software tools and databases for economic analysis and optimisation of bioprocesses and manufacturing operations. It also has developed unique insights into the market biomanufacturing market dynamics. Biopharm Services is six years old it has 12 employees based both in the UK and the US. Andrew Sinclair has over 20 years experience within the biopharmaceutical sector working for manufacturing operations (Lonza, Eli Lilly, GlaxoSmithKline) and contractors (Kvaerner, Jacobs engineering). He has been responsible for design, building and operation of biomanufacturing facilities. Prior to setting up Biopharm Services Andrew was the Director of Engineering and Logistics and Lonza Biologics.
Recent publications include.
In Print Paper ‘A Risk-Based Tool to Access Uncertainty in the Production of Therapeutics using Cell Culture’. Lim, A. C: Washbrook, J.; Sinclair, A.; Fish, B.; Francis, R.; Titchener-Hooker, N. J.; Farid, S. Biotechnol. Prog.
2004 Chapter ‘Worldwide Therapeutic Production Capacity’ Advances in Large Scale BioManufacturing and Scale-Up Production, ASM Press
2004 Paper ‘Biomanufacturing for the 21st Century – Designing a Concept Facility Based on Single Use Disposables’, Andrew Sinclair (Biopharm Services) Miriam Monge (Stedim), BioProcess International
2003 Paper ‘Capacity Availability: Impact on Commercialisation Strategies’, SCREENING - Trends in Drug Discovery, GIT Verlag, May 2003
2002 Paper ‘Quantitative Economic Evaluation of Single Use Disposables in Bioprocessing’, Andrew Sinclair (Biopharm Services) Miriam Monge (Stedim), Pharmaceutical Engineering
2001 Patent “Methods and apparatus for simulating industrial processes”, Sinclair P.A., UK Patent Application GB 2 362 484 A, (43) Date of A Publication 21.11.2001
2001 Paper ‘Biomanufacturing capacity: Current and future requirements’ vol. 8, 1 43-50 Journal of Commercial Biotechnology
2000. "Financial Model for Production of Monoclonal Antibodies Using Transgenic Chickens" Sinclair A, Ransohoff T, Latham P. IBC Symposium, ‘Cost of Goods and Process Modeling’. November 2000
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 Dr Linda Somerville,
Technical Manager,
SAFC Biosciences
I joined SAFC Biosciences (a division of the Sigma-Aldrich group) in December 2005 as Technical Manager. I work closely with the Tactical Marketing Department in the USA and the European Sales and Marketing Team to manage key Business Development Projects. I provide technical assistance and advice in cell culture related projects to the European Business Development Managers and to our customers. I also support the European Business Development Managers through joint visits, presentations and workshops.
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 Professor Beate Stern,
Department of Biomedicine,
University of Bergen
Beate Stern, PhD, is Associate Professor at the Department of Biomedicine, University of Bergen, Norway, and Chief Scientific Officer at UniTargetingResearch AS (www.unitargeting.com), Bergen, Norway, a biotech R&D spin-off company of which she is a co-founder. Her expertise is in molecular biology, cell biology and bioinformatics and her fields of current research interest are DNA mobility and mRNA/protein localisation. Former professional activities include science journalism and former affiliations include the Max Planck Institute of Biochemistry, Martinsried, Germany.
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 Dr Richard Turner,
Director of Regulatory Affairs,
ERA Consulting
Dr Richard Turner is the Director of Regulatory Affairs at ERA Consulting (UK) Ltd., the UK arm of the ERA Consulting Group. Dr Turner obtained a BSc in Applied Biology from Thames Polytechnic London in 1986. In 1990 he received his PhD in Microbial Biochemistry from the University of East Anglia where he studied the structural and functional properties of proteins from microbial respiratory pathways using magnetic circular dichroism, electron paramagnetic resonance and nuclear magnetic resonance spectroscopies. Between 1991 and 1997, Dr Turner was a research scientist in the Process Development Department of Delta Biotechnology Ltd., Nottingham. Leading a team of scientists Dr Turner developed downstream processes and analytical tests for the manufacture of recombinant human serum albumin. In 1997 he was employed as a Pharmaceutical Assessor for the UK Medicines Control Agency (now the Medicines and Healthcare Products Agency). As an Assessor in the Biological and Biotechnology Unit of the Agency.
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Dr Ir Peter van der Meijden,
Section manager USP-MPF,
Diosynth Biotechnology
P. van der Meijden (January 11, 1953 in Rotterdam, The Netherlands)
MSc in Chemical Technology - Biochemistry at the Technical University Delft (1979).
PhD in Microbiology at the University of Nijmegen (1984).
Professional:
Research Scientist at Department of Microbiology, Organon, 1984 - 1992.
Section Manager at the Cell Culture Department, Diosynth, 1992 – 1999.
Section Manager of the Microbiology Department, Diosynth, 1994 -
Project Manager of the Diosource Upstream Processing Facility under construction, 1999 – 2005
Dr Ir Peter van der Meijden has 22 years of experience in the production of API’s using fermentation and mammalian cell culture processes at Organon and Diosynth in the Netherlands after he studied at the technical University of Delft and did its PhD on the methanol conversion by methanogenic at the Universtity in Nijmegen, the Netherlands. At Organon/Diosynth he was involved in process development and production of the recFSH with CHO cells, the development of a process for the production of rec Insuline and the development of various biotransformation processes for steroids.
In the last 6 years he was responsible for the design and realisation of Diosynth/Organon’s large scale upstream production facility for therapeutic proteins.
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Dr Meenu Wadhwa,
Leader,Cytokine and Growth Factor Group,Division Of Immunology and Endocrinology,
NIBSC
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Mr Frank Wolpers,
Industrial Sales Director Europe,
Hyclone
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 Diederik Zijderveld,
Director,
Netherlands Genomics Initiative (NGI)
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