 | 3rd Annual Contract Manufacturing in Pharma and Biotech Conference
16th - 18th November 2009, BSG House, London, UK
Background InfoKey Speakers
• Sanjit Lamba, President, Eisai India
• Laurent Pinchard, Director – EU Operations (API), Glenmark Generics
• Nick Hutchinson, Technology Transfer Lead, Lonza Biologics
• Daniel Smith, Commercial Scientifi c Development Manager, Cobra Biomanufacturing
• Debra Nevin, Global CMC and QA Director, Plethora Solutions
• Maarten van Geffen, Senior Director CM&C, Movetis
• Paul Smith, Validation Program Manager (Europe), PerkinElmer LAS
• Rebecca Vangenechten, Consultant - Business and Project Development Life Sciences - USA, Siemens AG
• Tarek Abdel-Gawad, Production Manager, Avecia Biologics
• Bruce Vernon, Director, VYVO BioSolutions 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. (Source: visiongain) Visiongain’s 3rd Annual Contract Manufacturing in Pharma & Biotech 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
• Outsourcing APIs to India: a cheaper way
• 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:
• CMC
• Contract Management
• R & D
• Contracts & Outsourcing
• Biologics
• Operations
• API and Technical Development
• Strategic Alliances
• Formulations Development
• Planning & Logistics
• Drug dosage form
• Procurement & Purchasing
• QbD/PAT
• Business Process Excellence
• Pharmaceutical Science & Process Development
• Sales & Marketing
• Bioprocess Research
• Regulatory Affairs / Compliance
• Manufacturing Science and Technology
• Quality Assurance WorkshopPre-Conference Interactive Workshop, Monday 16th November 2009 Outsourcing early stage development activities Led by: Dr. Rod Baker
Managing Director
Bioedge Pharma Consultancy Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 17:00 Workshop
Timing includes lunch and refreshment breaks About the workshop: Many biotech companies, especially start ups, have no choice for outsourcing early stage development activities as they have no internal manufacturing capabilities. In addition, such companies are unlikely to have staff experienced in selecting and managing outsourced activities. As manufacturing and other early stage development activities are key to success for any project and time to first in man studies it is essential to select the right contractor and avoid the many pitfalls with outsourcing. Furthermore, larger companies are tending to outsource more early stage development activities and this may be an activity that is not familiar to the internal staff involved. The course will highlight the many factors that should be taken into account prior to selection of a contractor and how best to manage them once the work has commenced. Workshop agenda: Overview
• Industry trends in outsourcing
• Growth of service offerings by contractors
• What can be outsourced and when How to select a contractor
• Defining your needs
• Writing a request for proposal
• Identifying suitable contractors
• The ‘one-stop shop integrated approach’ vs ‘horses for courses’
• Short listing possible contractors
• Final selection Contract negotiation and other documentation
• Main contract
• Technical agreement
• Quality agreement
• Documentation generated during the contracted work
• Final reports Management of contractors
• Internal systems for outsourcing
• Who should manage the contractor
• How to manage
• Completion and review
• Building a database of contractors Case studies
• Some real examples of outsourced work and arising problems
• Please bring along your own examples
About your workshop leader: Dr Rod Baker
Dr Rod Baker is a highly experienced drug development manager with specialist knowledge in CMC. In 2008, he founded Bioedge Pharma Consultancy Limited, a company offering drug development services to the biotech, pharmaceutical and drug delivery industries. Bioedge works with a wide range of companies at all stages of development and one key aspect of the services offered is reviewing, selecting and managing contractors for clients. Rod is a physical chemist by training and has over thirty years industrial experience working for a wide range of companies across different industries including agrochemicals, animal health and human healthcare. In the latter field, he worked for Stiefel Laboratories as Pharmaceutical Formulation Manager, British Biotech as Head of Pharmaceutical Technology, Avidex Limited as Head of Development & Director of Operations. Prior to forming Bioedge, he was the Vice President of Development & Operations for MediGene Limited with responsibilities including outsourcing as well as in-house work in the CMC area.
For further information, please visit: www.bioedge.co.uk
Who should attend? The workshop is designed for the professionals involved in or responsible for the outsourcing of development activities, in particular, manufacturing although the review and decision making process for contactor selection applies to many different areas of development. Whether you are new to outsourcing, have limited experience or are already well versed with the outsourcing process, the workshop will have something to offer you. This one-day workshop is aimed at providing valuable insights to outsourcing across disciplines for individuals from pharmaceutical, biotech, drug delivery and venture capitalist companies having responsibilities in manufacturing, API characterisation, salt screening, pre-formulation and formulation, analytical, toxicology, clinical development, quality assurance, regulatory affairs, operations and project management.
Day 1Day One, Tuesday 17th November, 2009 09:30 Registration and refreshments 10:00 Opening address from the chair 10:10 Globalisation of the contract manufacturing market - a shift from the west to east
• Analysing key trends in the global PCM industry
• Understanding the emergence of competition from East European, Indian and Chinese CMOs
• Which regions and segments offer the greatest growth opportunities?
• The competitive edge of emerging markets over USA and EU Sanjit Lamba
President
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 outsourcing services
• Importance of good manufacturing practice (GMP) compliance
• What are the legal liabilities and regulatory considerations in manufacture outsourcing
• Examine the vital role of compliance with FDA provisions Bruce Vernon
Director
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
Movetis 15:10 Designing major pharmaceutical drug dosage forms
• Understanding of the biopharmaceutical factors that influence formulation, manufacture and stability of medicines
• How to develop practical skills and competencies necessary to prepare medicines on a small scale
• What are the issues related to design, manufacture and performance of drug dosage forms
• How to work within the good manufacturing practice (GMP) guidelines 15:50 Afternoon refreshments 16:10 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 16:50 Think globally, outsource locally
• Does the “one-size-fits-all” approach to outsourcing work?
• When and how to outsource?
• How to develop local strategies to outsource manufacturing? 17:30 Closing remarks from the chair 17:40 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting Day 2Day Two, Wednesday 18th November, 2009 09:30 Registration and refreshments 10:00 Opening address from the chair 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 Biostorage – A critical and strategic component of the worldwide drug development process
• Understanding the complexities of Biostorage
• How to build and evaluate cold chain processes
• How to ensure efficient storage of biological products 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 14:30 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: maninder.paul@visiongainglobal.com 16:50 Challenges in contract manufacturing – a CMO’s perspective
• Quality and compliance
• Supply Chain
• Operational excellence
• Overcoming the price war 17:30 Chair’s closing remarks 17:40 End of conference PartnersMedia Partners: PharmiWeb.com
PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com BIOTECHNOLOGY EUROPE
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the main goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com Future Pharmaceuticals
Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries' top issues and the solutions top-tier vendors can provide. For further information, please visit www.futurepharmaus.com Brochure
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