Conference on 3rd Annual Contract Manufacturing

Venue: BSG Conference Centre, London, UK

Location: United Kingdom

Event Date/Time: Nov 17, 2009 End Date/Time: Nov 18, 2009
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3rd Annual Contract Manufacturing

The A - Z of choosing the right outsourcing partner

17th - 18th November 2009, BSG House, London, UK

Key Speakers
• Laurent Pinchard, Director – EU Operations (API), Glenmark Generics
• Rebecca Vangenechten, Consultant - Business and Project Development Life Sciences USA, Siemens
• Paul Smith, Validation Program Manager (Europe), PerkinElmer
• Sanjit Lamba, President, Eisai India
• Nick Hutchinson, Technology Transfer Lead, Lonza Biologics
• Maarten van Geffen, Senior Director CM&C, Movetis
• Tarek Abdel-Gawad, Production Manager, Avecia Biologics

The recent surge in contract manufacturing landscape is influencing huge challenges and opportunities in the global pharmaceutical market. The highly competitive nature of the industry has been driving pharma and biotech companies to set up off-shoring alliances with emerging markets to minimise costs and maximise profits. The revenue for world contract manufacturing business in 2007 was approximately $30bn, with a growth rate of 6% from 2006. The revenues are expected to reach $48bn by 2015.

3rd Annual Contract Manufacturing conference will examine the current and emerging trends that are mobilising contract manufacturing companies, and shifting the focus from the west to east. This conference will address various quality, regulatory and development challenges to establish cost-effective and successful outsourcing alliances. As the global outsourcing landscape is changing, this conference will unleash opportunities to sustain a robust growth in the current economy.

Why Attend?

By attending this conference you will gain knowledge on:
• How the globalisation of the contract manufacturing market is shifting focus from the west to east
• Outsourced laboratory compliance and qualification services
• Using PAT to accomplish real time release/continuous manufacturing
• New shifts: from API to FDF, from generic drugs to R&D based companies
• How to think globally and outsource locally
• CMO's and SME's: the route to success of a virtual specialty pharmaceutical company
• Designing major pharmaceutical drug dosage forms
• Biostorage – A critical and strategic component of the worldwide drug development process
• Screening process to identify a suitable outsourcing partner
• Embracing Quality by Design (QbD)
• How to administer packaging engineering and design

Target Audience:
• Pharmaceutical and Biotechnological Companies
• Contract Manufacturing Organisations (CMOs)
• Drug Regulators, Intellectual Property/Law Firms
• Academia, Government Bodies, Regulatory Affairs

Who should attend?
VP, Directors, Managers, Team Leaders, Senior Scientists in:
• Contract Management
• R & D
• Contracts & Outsourcing
• Biologics
• Operations
• API and Technical Development
• Strategic Alliances
• Formulations Development
• Planning & Logistics
• Drug dosage form
• Procurement & Purchasing
• Business Process Excellence
• Pharmaceutical Science & Process Development
• Sales & Marketing
• Bioprocess Research
• Regulatory Affairs / Compliance
• Manufacturing Science and Technology
• Quality Assurance

Day 1

Day One, Tuesday 17th November, 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

Tim Cummins
International Association for Contract and Commercial Management (IACCM)

10:10 Globalisation of the contract manufacturing market - a shift from the west to east
• Analysing key trends in the global PCM industry
• Which regions and segments offer the greatest growth opportunities?
• The competitive edge of emerging markets over USA and EU

Sanjit Lamba
Eisai (India)

10:50 Outsourcing APIs (advanced pharmaceutical ingredients = active substance) to India: a cheaper way?
• Producing in India: cost, IP, manufacturing experience. Forever green?
• Some consequences on the current market evolution: consolidations, new patent laws in India, decreasing number of NCEs
• New shifts: from API to FDF, from generic drugs to R&D based companies

Laurent Pinchard
Director – EU Operations (API)
Glenmark Generics

11:30 Morning refreshments

11:50 To outsource or not - Is it a solution for you?
• Making the decision to outsource – pros and cons
• Screening process to identify a suitable outsourcing partner
• Set of selection criteria is required to evaluate potential suppliers
• Steps to ensure provision of the deliverables

Debra Nevin
Global CMC and QA Director
Plethora Solutions

12:30 EU Requirements for outsourced services (a QP’s perspective)
• Legal and regulatory considerations for outsourced manufacture
• Importance of EU GMP
• API vs. medicinal product
• Issues specific to biologics and ATMPs

Bruce Vernon
VYVO BioSolutions

13:10 Networking lunch

14:30 CMO’s and SME’s: the route to success of a virtual specialty pharmaceutical company
• What is the concept of a virtual pharmaceutical company
• How to outsource all CM&C activities: do’s and dont’s
• Success drivers of a small company vs. established ‘big pharma’
• How to relate with your CMO partners and how not?

Maarten van Geffen
Senior Director CM&C

15:10 Managing the risk of contamination - A proactive approach
• Rapid Hydrogen Peroxide vapour decontamination: science, efficacy and process validation
• A proactive approach to Biodecontamination00
• Case study: Emergency remedial decontamination of a site: impact on process, methodology and outcomes

Dr Richard Lucas
Biopharmaceutical Process Specialist
Bioquell UK

15:30 Afternoon refreshments

15:50 Integration of disposable technologies into process development and clinical trial production
• Use of disposables in the CMO environment
• The journey from development to clinical manufacture
• Novel solutions to novel problems
• Regulatory perspective for disposables
• Future directions for disposables

Daniel Smith
Commercial Scientific Development Manager
Cobra Biomanufacturing

16:40 Manufacturing the impossible: From fundamental research to the patient
• Research: containment, animal Models, biosafety, emerging infectious diseases
• PAT: Eukaryote & prokaryote
• cGMP Production: Therapeutic products of prokaryote fermentation

Mitch Rogers
Business Development Manager, Centre for Emergency Preparedness and Response
Health Protection Agency

17:20 Closing remarks from the chair

17:30 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2

Day Two, Wednesday 18th November, 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

Tim Cummins
International Association for Contract and Commercial Management (IACCM)

10:10 CMOs: A robust growth trend
• What are the key indicators for the growth of CMO business
• Understanding the current market trends and leveraging benefits from it
• What are the commercial implications of increasing globalisation of the API contract manufacturing market

Shiva Khalafpour
Vice President, Europe - Business Development
CMC Biologics

10:50 Challenges of outsourcing biopharmaceutical manufacturing
• Unique features of biopharmaceuticals
• Manufacturing Strategy – in-house or outsource?
• Biopharmaceutical manufacturing capacity constraints
• Emerging opportunities
• Regulatory considerations

Steve Musgrave
Executive Director and co-founder
Unicorn Biologics

11:30 Morning refreshments

11:50 Embracing Quality by Design (QbD)
• Learn on how the FDA is promoting QbD
• Implementing to strengthen the contractor/client relationship
• How to implement Quality by Design to differentiate contractors from competitors
• Using PAT to accomplish real time release/continuous manufacturing

Rebecca Vangenechten
Consultant - Business & Project Development Life Sciences, USA
Siemens Industry & Automation

12:30 Outsourced laboratory compliance and qualification services
• Benefits and advantages of harmonised services
• Meeting regulatory requirements
• Balancing risk and costs through flexibility
• Supporting technology transfer and audits
• A catalyst for change and continuous improvements
• Provisions

Paul Smith
Validation Program Manager (Europe)
PerkinElmer Life and Analytical Sciences

13:10 Networking lunch

14:10 How to optimise the integration of process development and manufacturing into the biopharmaceuticals development value chain
• Integration of the value chains for drug development and biopharmaceuticals production
• Value of early data acquisition
• Development of scalable and affordable manufacturing processes
• Case studies

Dr. Philipp Göpel
Business Development Manager
Richter-Helm BioTec

14:30 Technology transfer is simple in theory, but difficult in practice
• Understanding different types of transfers
• Formalising the technology transfer procedure
• Allowing scope for future continuous improvements

Nick Hutchinson
Technology Transfer Lead
Lonza Biologics

15:10 Contract packaging is ‘not just boxes’
• Choosing the right CMO
• Considerations of pack design/process & reproducibility
• Regulatory considerations – current and future
• Ease of use in the market/patient compliance

David Downey
VP, Commercial Operations
Almac Pharma Services

15:50 Afternoon refreshments

16:10 Leveraging profits through outsourcing in the current economic times
• How to achieve sustained communication and address demand and supply issues to your overseas CMO?
• Understanding the influence of global regulatory culture on establishing outsourcing projects
• Indentifying lucrative opportunities and establishing strategic alliances in emerging markets to minimise costs
Panel members will be drawn from the speakers who take part on day one or day two. If you would like to submit a question to the panel, please email it to:

Panelist: Michelle Scott, Executive Director and co-founder, Unicorn Biologics

16:50 Fitting processes to plant: Balancing flexibility and experience
• Understanding the key manufacturing factors for process design
• Leveraging plant knowledge for efficient manufacture
• Converting learning into continuous improvement

Tarek Abdel-Gawad
Production Manager
Avecia Biologics

17:30 Chair’s closing remarks

17:40 End of conference