Boston Hilton Logan Airport, Logan Airport
17-20 October 2005
Pre-conference briefing - 17th October 2005
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08.15 Registration and coffee
09.00 Chairman’s opening remarks
Bill Helming, Director Lifesciences,
PRTM
BIODEFENSE MARKET
09.15 Introduction to the biodefense market Current Situation
Major changes and future direction Bill Helming, Director Lifesciences,
PRTM
09.45 Biodefense government perspective Strategic perspective: capabilities sought, the place of each counter measure/vaccine in the government’s portfolio
Co-existence of government and commercial markets Tom Fuerst,
Office of Public Health Emergency Prepardness
10.15 Morning coffee 11.00 Public-private partnerships in biodefense and public health research Strategic goals and objectives for public health agencies
Research funding mechanisms
Technology areas of interest
Keys to successful partnerships Jaap Goudsmith, Chief Scientific Officer,
Crucell NV
11.30 Legal and contractual challenges in biodefense Contract forms for incentive mechanisms
Liability/indemnity concerns
How BioShield II will change the landscape John Clerici, Partner,
McKenna Long & Aldridge LLP
12.00 Lunch
REGULATION AND ASSESMENT
13.30 Clinical aspects of safety trial design in biodefense vaccines Clinical Development of Biodefense Vaccines
Animal Rule Regulation
Design of Phase 1 and 2 Vaccine Studies
Julia Barrett, Senior Clinical Consultant,
Biologicals Consulting Group
14.00 Adapting commercial best practices for biodefense initiatives Adoption of commercial practices to improve TTM, confidence in outcomes
Decision-making for effective and efficient programs-tolerance/management of risk
Setting actionable top-down guidance for agencies
Efficient use of public funding: mechanisms of funding Chan Harjivan,
PRTM
14.30 Panel session: strategies for the future What is the industry doing?
Networking opportunities
When to make the decision to buy Tom Fuerst,
Office of Public Health Emergency Prepardness
John Clerici, Partner,
McKenna Long & Aldridge LLP
Mark Dertzbaugh, Chief Business plans and programs,
USAMRID
Jaap Goudsmith, Chief Scientific Officer,
Crucell NV
15.15 Afternoon tea
RESEARCH AND DEVELOPMENT IN BIODEFENSE
15.45 Trends in biodefense research, from a government laboratory perspective What are some of the changes impacting the biodefense research community?
How can research be better aligned to meet national needs?
What are some of the opportunities and challenges involved in partnering with a federal research laboratory?
What are the opportunities for technology transfer? Mark Dertzbaugh, Chief Business plans and programs,
USAMRID
16.15 Product development Capability assessment and scale up options
When and how to hand off from government to industry
Pipeline management Ed Acuri, COO,
Emergent Biosystems
16.45 Chairman’s closing remarks
17.00 Pre-congress registration and welcome cocktail reception
19.00 Close of registration
Conference day one - 18th October 2005
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08.00 Registration and coffee
08.45 Chairman’s opening remarks
Jim Weston, Vice President, Corporate and Regulatory Strategy and Managing Director,
Cato Research
INDUSTRY OVERVIEW
09.00 Where is the industry going over the next ten years? Maturation of biologicals
Obtaining excellence through collaborations
The impact of biogenerics Jan Paul Zonnenberg, Lead biopharmaceuticals operations partner,
PRTM
BIOPHARMACEUTICAL OPERATIONS AS A COMPETITIVE ADVANTAGE
09.30 Biopharmaceutical operations industry trends & objectives Current industry trends and impact on operations
Objectives/role of biopharmaceutical operations Peter Watler, Senior Director Manufacturing,
VaxGen
10.00 Case study: commercialisation and new product introduction Integration strategies with R&D and marketing to drive true competitive advantage
Critical commercialisation techniques
Impact of different licensing strategies Stephen Farrand, Vice President, Biotechnology Development,
Schering Plough Research Institute
Morning coffee
11.30 Panel Session: biopharmaceutical operations – manufacturing strategies for the future The future of fermentation/formulation/packaging networks
Creating the ideal manufacturing facility
Investing in, or divesting capacity to meet longer term demands Confirmed:
Maurice Greene, Vice president quality operations,
Schering Plough Corp
Confirmed:
Ben Machielse, Senior Vice President,
MedImmune
Confirmed:
Roland Heinrich, Senior Director, Strategic Operations Planning,
Wyeth Biopharma
Confirmed:
Timothy Moore, Vice President, SSF Manufacturing,
Genentech, Inc
12.15 Case Study: partnering and contract manufacturing Partnering in biopharma operations to create a competitive advantage
Differences/trends in sourcing strategies for fermentation, formulation, packaging, and distribution
Key differences vs. small molecule Ben Machielse, Senior Vice President,
MedImmune
Wolfram Carius, Managing Director Biopharmaceuticals,
Boehringer Ingelheim
12.45 Lunch 14.15 Case study: manufacturing facilities Issues encountered in development of facilities
Design and construction
Validation of facilities Roger Lias, Vice president business development and sales,
Cytovance Biologicals
14.45 Speed networking Meet…move on…. meet…. move on…meet!
Exchange business cards with fellow conference delegates, speakers and moderators
The best 1 hour networking session you’ve ever experienced
15.45 Afternoon tea
REGULATORY CHALLENGES
16.15 Comparability and product variance Comparability protocol development
Issues and concerns from regulatory agencies
Precautions for minimising process change induced comparability difficulties Klaus Neurohr, Head of Quality and Regulatory Affairs,
Avecia Biotechnology
16.45 Importing clinical trial materials into the EU Trials and tribulations of importing clinical trial materials into Europe a year and a half after implementation of the clinical trial directive
Application of EU GMP's to U.S. investigational product manufacturers
Obtaining manufacturer's authorisation/selection and use of qualified persons
Technical and regulatory release of investigational products Jim Weston, Vice President, Corporate and Regulatory Strategy and Managing Director,
Cato Research
17.15 Close of day one followed by networking boat cruise
Conference day two - 19th October 2005
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08.00 Registration and coffee
08.45 Chairman’s opening remarks
Avinoam Kadouri, Former Process Development Director, Manufacturing,
Laboratoires Serono S.A.
DEVELOPMENTS IN PROCESS EQUIPMENT
09.00 Process equipment scalability: critical success factors from development to production scale Equipment scalability from development to process scale
Performance analysis and verification
Process optimisation in small scale and conversion into process scale Maik Jornitz, Group Vice President, Global Product Management, Bioprocess,
Sartorius
09.30 Case study: disposable technologies for aseptic filling The use of pre-sterile disposable components in biopharmaceutical manufacturing operations
The need to create a solid application-based validation strategy
Characterisation, implementation and validation Bob Smith-McCollum, Marketing Manager,
Stedim
10.00 Flexible continuous perfusion process for recombinant protein production High density perfusion process
In house medium production
Flexibility due to single use packaging of media and harvest Bernd Schroder, Head of upstream processing,
Miltenyo Biotec
10.30 Morning coffee
BIOSIMILARS AND BIOGENERICS
11.30 Making equivalent bio generics in the absence of approval processes Obtaining an understanding of how process changes can affect the structure and biological activity
Limited clinical case studies comparing the product to the reference product
Demonstration of equivalence through pharmacokinetic, pharmacodynamic and clinical studies Inger Mollerup, Vice President, Pharmaceutical Development,
Novo Nordisk
12.00 Follow-on biologics: is Europe still ahead? The new framework for similar biological medicinal products in Europe
Proposed EC guidelines for similar biological medicinal products
Latest developments in the EC
Developments in the US
Human growth hormone and other products approved as drugs under the federal food, drug, and cosmetic Act
Products approved under the public health service act Richard Kingham, Partner,
Covington & Burling
12.30 Lunch
14.00 Immunogenicity issues in demonstrating comparability for biosimilar products Factors contributing to the immunogenecity of therapeutic proteins
Potential effects when a therapeutic protein is immunogenic
Clinical example of immunogenecity John Ferbas, Clinical Immunology,
Amgen
14.30 Panel session: are the obstacles faced in entering the market worth it? Is the investment required prohibitive?
Is there too much competition?
Is the industry moving quickly enough to drive this market forward? Inger Mollerup, Vice President, Pharmaceutical Development,
Novo Nordisk
Richard Kingham, Partner,
Covington & Burling
John Ferbas, Clinical Immunology,
Amgen
15.15 Afternoon tea
PROCESS DEVELOPMENT STRATEGIES
16.00 Technology platforms for antibody production Reducing time to clinic
Decreasing development costs and deferring capital at risk
Utilising platform approaches for early stage molecules
Sustainability of traditional platforms David Robinson, Executive Director Bioprocess research and development,
Merck
16.30 Managing launch risk through supply chain simulation Identifying uncertainties in the launch process
Prioritising risks
Developing a risk mitigation strategy
Utilising supply chain modeling in the risk mitigation process Todd Applebaum, Vice President, Operatins Practice,
Maxiom
17.00 Novel chromatography approaches and miniaturised process development for antibodies and recombinant proteins Looking beyond protein A affinity chromatography for antibody purification
Review of alternate methods and sorbents
Application of mixed-mode ligands for capture of antibodies and other proteins
Miniaturised "on-chip" chromatography process development approach John Jenco, Senior Staff Scientist/Chromotragraphy Applications Manager,
PALL Lifesciences
17.30 Close of day two followed by cocktail reception sponsored by Scottish Development International
Conference day three - 20th October 2005
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08.00 Registration and coffee
08.45 Chairman's opening remarks
Daniel Tuse, Vice President, Business Development,
Large Scale Biology Corporation
THREATS AND OPPORTUNITIES IN PLANT BASED PHARMACEUTICAL MANUFACTURING
09.00 The role of plants in pharmaceutical biomanufacturing World-wide need for biologics and their impact on human health
Impact of cost on availability of biologics in industrialised and developing nations
How plant-based manufacturing could meet medical needs not met by conventional manufacturing practices Charles Artzen, Co-director center for infectious disease and vaccinology,
Arizona State University
09.30 Industry’s view of plant-based systems Plants: not ready for prime time?
Why plant systems won’t displace conventional manufacturing
Why all pharma should seriously consider plant systems: threats and opportunities Roland Heinrich, Senior Director, Strategic Operations Planning,
Wyeth Biopharma
10.00 Morning coffee
PLANT BASED MANUFACTURING: KEY TOPICS IMPACTING THE INDUSTRY
11.00 PMP: transgenic vs. transient expression PMP platforms
Transgenic vs. transient expression: pros and cons of each
State of development of plant-based manufacturing platforms Louis Vezina, Vice president Research and development,
Medicago
11.30 Regulatory issues within PMP Regulatory compliance issues with plant systems
Product safety and plant-specific issues
USDA and FDA regulatory approaches Steve Garger, Executive Vice President Biomanufacturing,
LSBC
INDUSTRY’S VIEW OF THE POTENTIAL ROLE OF PLANTS IN BIOMANUFACTURING
12.00 Products: the “sweet-spot” for plant-based manufacturing What can plant systems do better than traditional microbial or animal cell culture?
Comparison of capabilities and cost drivers associated with production in plants vs. microbial and mammalian cells: Economic advantages of each platform
What breakthroughs are necessary for plant systems to become “mainstream”?
At what point should biotech and pharma companies consider using plant-based production systems in their product development pipeline? Ulrich Steiner, Business Development Manager, Plant Made Pharmaceuticals,
Bayer HealthCare
12.30 Lunch
14.00 Panel session: What must PMP companies demonstrate to drive significant alliances and partnerships with pharma/biotech? Industry turn-ons and turn-offs
Partnering drivers and barriers
The road ahead: Preferred business structures and timing Ulrich Steiner, Business Development Manager, Plant Made Pharmaceuticals,
Bayer HealthCare
Charles Artzen, Co-director center for infectious disease and vaccinology,
Arizona State University
Roland Heinrich, Senior Director, Strategic Operations Planning,
Wyeth Biopharma
Louis Vezina, Vice president Research and development,
Medicago
Steve Garger, Executive Vice President Biomanufacturing,
LSBC
15.00 Afternoon tea
STEM CELL THERAPIES
15.30 What is the therapeutic potential of human stem cells? What are the latest developments in human stem cells?
What are the future expectations of the commericalisation of stem cells?
Development from bench to clinic to product Stephen Minger, Director, Stem Cell Biology Laboratory,
King’s College, London
16.00 Regenerative medicine bioprocessing: mass production of cell and tissue engineering therapies Rule 1 - the process is the product
FDA and current good tissue practice (cGTP)
Mass production or mass customisation
Automation: the only way forward!
Chris Mason, Regenerative Medicine bioproessing group,
University College London
16.30 Close of conference
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