Conference on 4th Annual Contract Manufacturing

Conference on 4th Annual Contract Manufacturing
Driving contract manufacturing through cost-effective outsourcing
13th – 14th December 2010, BSG Conference Centre, London, UK

Key Speakers

Martin P Grosvenor, Drug Delivery Manager, AstraZeneca,
Anthony Pettigrew, Analytical Development Manager, Novozymes,
Olivia Darmuzey, QbD Expert Pharmaceutical Operations, Novartis,
Mitch Rogers, Business Development Manager, Centre for Emergency Preparedness and Response, Health Protection Agency,
Prof. Elaine Martin OBE, Professor of Industrial Statistics, Biopharmaceutical and Bioprocessing, Technology Centre, Newcastle University,
Paul Smith, Validation Program Manager (Europe), PerkinElmer Life and Analytical Sciences,
Karen MacGregor, Product Development Director, Catalent,

The global demand for contract manufacturing services and affordable outsourcing solutions is increasingly driving the pharmaceutical companies to upgrade their technology and manufacturing capacity. In recent times, investments in implementation of PAT and QbD applications, to ensure high quality and timely supply, have become the prime focus of pharmaceutical and biotech industry. As the competition from off-patent products, in-licensing and mergers and acquisitions grows, Asia is expected to become one of the largest cost-effective outsourcing markets in the next five years.

4th Annual Contract Manufacturing will provide tactical approaches and case studies to improve PAT and QbD practices for a successful contract manufacturing model. Delegates will learn regulatory and planning processes, best manufacturing practices, and strategies to maximise partnership with CMOs.

Our conference is a valuable opportunity to discuss, gain insights and network with thought leaders and key professionals from the industry.

Key themes and discussions include:

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Deliver successful external manufacturing supply chain and planning
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Learn trends, challenges and opportunities for manufacturing in Asia
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Maximise opportunities as a consequence of FDA, PAT and QbD initiatives
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Evaluate outsourcing needs your business:
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Implement strategies for successful analytical technology transfer
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Analyse critical issues affecting technology transfer & scale-up to QC
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Understand QbD principles and continuous improvement in manufacturing
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Capitalise on the benefits of applying QbD approach in biologics contract manufacturing
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Formulate strategies to choose a right CMO partner
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Integrate lean product development in a pharma CMO set-up
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Understand the legal challenges and pitfalls for contract negotiation

Conference Introduction

Learn, discuss and gain insights on:

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Deliver successful external manufacturing supply chain and planning.
*
Learn trends, challenges and opportunities for manufacturing in Asia.
*
Maximise opportunities as a consequence of FDA, PAT and QbD initiatives.
*
Evaluate outsourcing needs your business.
*
Implement strategies for successful analytical technology transfer.
*
Analyse critical issues affecting technology transfer & scale-up to QC.
*
Understand QbD principles and continuous improvement in manufacturing.
*
Capitalise on the benefi ts of applying QbD approach in biologics contract manufacturing.
*
Formulate strategies to choose a right CMO partner.
*
Integrate lean product development in a pharma CMO set-up.
*
Understand the legal challenges and pitfalls for contract negotiation.

Who will be there?

Directors, Heads of Department, Team Leaders and Scientists of:

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Research and Development.
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PAT.
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QbD.
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CMC.
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Process Development & Optimisation.
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Process Science/ Analytics.
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Manufacturing.
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Contracts & Outsourcing.
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Formulation.
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Quality Assurance/Quality Control.
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Operations.
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Strategic Alliances.
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Compliance.
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Regulatory Affairs.
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Legal/ Patents.

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

Day 1
4th Annual Contract Manufacturing
Monday 13th December 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Applying QbD for the development and manufacture of new products

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Achieving QbD objectives
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QbD and continuous improvement in manufacturing
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Design space and control strategy
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The use of MVDA models to ensure quality compliance in routine production

Olivia Darmuzey
QbD Expert - PharmOps CH, Novartis Pharma

10:20 Identifying and exploiting opportunities from Process Analytical Technology (PAT)

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Exploiting on-line process analytical measurements to gain insight into process performance
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Making maximum use of a limited number of data sets in the CMO environment
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Techniques to interpret data from instrumentation to assess on-line process quality
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Skills required to maximise the benefits of PAT

Prof Elaine Martin OBE
Professor of Industrial Statistics, Biopharmaceutical and Bioprocessing Technology Centre, Newcastle University
Prof Gary Montague
Professor of Bioprocess Control, Biopharmaceutical and Bioprocessing Technology Centre, Newcastle University

11:00 Morning refreshments

11:20 Continuous manufacturing for oral solid dosage tablet making PAT application

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PAT as the key enabler to achieve QbD by means of ‘Model Predictive Control’ and ‘Real Time Product Release’
How to deal with tracking and tracing when going from a batch to a continuous process?
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Benefits of continuous processes in commercial manufacturing and late stage product development

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

12:00 GMP Critical Utilities from A to Z

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Design of pharmaceutical water and steam systems
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Quality control during erection
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Commissioning
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Qualification (IQ & OQ)
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Validation (PQ)
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Daily operation and sampling
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Change control
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Re-qualification

Henrik Goldschmidt
Proceskonsulent, GPE Consult

12:40 Networking lunch

13.40 The role of the analytical laboratory in technology transfer

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Common problems,
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Transfer strategy,
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Planning the transfer
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Case studies and learning.

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

14:20 From test tube to tank

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Critical issues affecting technology transfer & scale-up
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Addressing issues surrounding high containment manufacturing
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cGMP production: Therapeutic products of prokaryote fermentation

Mitch Rogers
Business Development Manager, Health Protection Agency

15:00 Afternoon refreshments

15:20 Validation, stability and method transfer activities to QC and contract manufacturers

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Develop and validate new analytical test methodologies
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Strategy and design for methods and complex investigations
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Identifying quality or safety issues

Anthony Pettigrew,
Analytical Development Manager, Novozymes

16:00 Risk mitigation strategies and IP challenges

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Discussing the rules and regulations that apply specifically to the UK
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Using UK regulations in the evaluation process
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IP barriers and challenges

16:40 Closing remarks from the chair.

Day 2
4th Annual Contract Manufacturing
Tuesday 14th December 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Is outsourcing manufacture right for your business?

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Defining the strategic direction of the pharma company
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Risks and benefits of outsourcing
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Impact of outsourcing on marketplace and pharma company
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Manufacture of commodity products
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Manufacture of products using proprietary technologies
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Assessing value benefits in cost, time and quality

Martin P Grosvenor,
Drug Delivery Manager. AstraZeneca

10:20 Contract manufactures: Quality is more than an audit

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Traditional procurement quality
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Customer: Supplier approach isn’t effective
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Relationship management
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Understanding each other

Nigel Cryer
Interim Head, Global Quality Manufacturing & Supply Chain, Norgine,

11:00 Morning refreshments

11:20 Custom manufacturing: Sourcing APIs in emerging markets

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What are the commercial implications of increasing globalisation of the API contract manufacturing market?
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API supplier identification and negotiations
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Market evolution: Regulatory compliances, new patent laws, decreasing number of NCEs

Laurent Pinchard
Director – EU Operations (API), Glenmark Generics

12:00 Emerging markets: CMO outsourcing

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Understanding the influence of global regulatory culture on establishing outsourcing projects
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Indentifying lucrative opportunities and establishing strategic alliances in emerging markets to minimise costs
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Legal and intellectual property challenges in negotiating contracts and managing relationships.

12:40 Networking lunch

13:40 CMO management throughout the lifecycle

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Establish and improve relationship management practices with strategically important CMOs
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The process: Plan, select, negotiate, implement and manage
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Governance plan
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Expected deliverables

Nelson M Lugo
Sr. Director, Contract Manufacturing, Amylin Pharmaceuticals

14:20 Achieving product traceability with pharmaceutical packaging

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Cost effective and integrated processing for packaging
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Operational challenges in working with 3rd party contract manufacturers
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Pack design/process & reproducibility

15:00 Afternoon refreshments

15:20 Globalisation in manufacturing: In-house production vs Outsourcing
Our expert panel will discuss and debate on the need for outsourcing, indentifying opportunities and operational challenges to work with third party contractors
Panel members will be drawn from the speakers who take part on day one or day two.

16:00 Lean product development in a pharma CMO set-up

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Evaluation of the economic, financial and technical needs to drive a lean mentality within product development
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How to achieve, optimise & continually support an integrated approach for implementing lean product development?
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Review of case studies as to the benefits realised from both CMOs and pharmaceutical companies using a lean approach

Karen MacGregor
Product Development Director, Catalent

16:40 Chair’s closing remarks

16:50 End of conference.


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