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CONFERENCE

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5th Annual Contract Manufacturing

Examining the best outsourcing practices, new technological developments and the latest regulatory issues

7th - 8th December 2011, Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, UK

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Background Info
Day 1
Day 2
Partners
Past Papers
Venue Info
Speakers

Silver Sponsor

Associate Sponsors

Media Partners

Background Info

Key Speakers
• Dr. Dieter Roethlisberger, Outsourcing Manager & Senior Scientist, F. Hoffmann La-Roche
• Peter Murray, Quality Director, External Supply Strategy, GlaxoSmithKline
• Martin P Grosvenor, Drug Delivery Manager, AstraZeneca
• Andrea Calenne, Sr. Manager, Contract Manufacturing, Biogen Idec
• Dr. Holger Bartos, Director Strategic Marketing, Boehringer Ingelheim Pharma GmbH & Co.KG
• Gaelle Gibbs, QA Manager, MAX Products and Strategic Vendors, UCB Pharma
• Sohail Chohan, Manufacturing Outsourcing Manager, ERA Consulting
• Dr. Nigel Allison, Process Development Specialist, Health Protection Agency
• Philip Pratten, VP Manufacturing Services, Elan Pharmaceuticals
• Professor Nigel Titchener-Hooker, Head of Department and Director Biochemical Engineering, University College London
• Paul Ranson, Partner, Fasken Martineau LLP
• Jo Pisani, Consultant, PricewaterhouseCoopers
• Jan-Gunnar Gustafsson, Consultant, Bio Evaluation BO AB
• Alan Harris, Partner, Alacrity Pharma Associates
• Dr. Steve Musgrave, Founding Partner, Unicorn Biologics
• Glenn Killingworth, Senior Director Business Development, Europe, Asymchem

The importance and role of contract manufacturing has changed over the years from solely providing efficiencies in cost, capacity and time-to-market, or a specific expertise not available in-house to unique, innovative, and state-of-the-art processes and production technology to the pharmaceutical industry.

As more and more pharmaceutical companies are willing to outsource, the contract manufacturing market continues to grow and is expected to reach $61.51bn in 2015 and $94.70bn by 2025¹.

Visiongain's Contract Manufacturing conference has grown from strength to strength in last couple of years and now in its 5th year, the conference will address every aspect of outsourcing process from selecting an outsourcing partner to tech-transfer through to regulatory frameworks, latest FDA contract manufacturing legislation, recent patent and safety issues.

At this 2 day event the attendees will learn, debate, discuss and network through panels discussions and presentations.

Whether you are a service provider or a pharmaceutical company by attending this conference you will:
• Assess future outsourcing trends and manufacturing strategies with changing CMO industry structure
• Hear about emerging business models
• Determine the essential criteria for CMO selection and effective relationship management
• Learn key success factors for establishing successful CMO partnerships with analysis of the multi-step sourcing process for CMOs
• Gain insight on future growth potential, regulatory frameworks, recent patent and safety issues
• Identify the latest FDA contract manufacturing legislation
• Evaluate the major risks and challenges of contract manufacturing projects by gaining insights into the potential downsides
• Investigate about costs :importance of tech-transfer/scale-up
• Discover the outsourcing potential of India and China
• Maximise opportunities as a consequence of PAT and QbD initiatives
• Deliver successful external manufacturing supply chain and planning
• Build new relationships with other key players in pharmaceutical and contract manufacturing industry

¹ Visiongain's report : Pharmaceutical contract manufacturing :industry and market prospects 2010-2025

Who will be there?
VPs Directors, Heads, and Managers in:
Directors, Heads of Department, Team Leaders and Scientists of:
• Research and Development
• PAT
• QbD
• CMC
• Process Development & Optimisation
• Process Science/ Analytics
• Manufacturing
• Contracts & Outsourcing
• Formulation
• Quality Assurance/Quality Control
• Operations
• Strategic Alliances
• Compliance
• Regulatory Affairs
• Legal/ Patents
Pharmaceutical and Biotechnological Companies
Contract Manufacturing Organisations (CMOs)
Drug Regulators, Intellectual Property/Law Firms
Academia, Government Bodies, Regulatory Affairs

Venue:

Thistle City Barbican
Central Street, Clerkenwell
London
EC1V 8DS
Phone: 0871 376 9004 / +44 845 305 8304
Fax: 0871 376 9104 / +44 845 305 8343
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html

Day 1

Day 1, Wednesday 7th December 2011

09:00 Registration and refreshments

09:30 Opening address from the Chair

Howard Tranter
Business Development Manager
HPA Business Development

09:40 Supplying the future: how to develop effective contract manufacturing relationships
• An update on the trends impacting the pharma and life sciences industries
• A review of current outsourcing trends
• An outline of new business models for success

Jo Pisani
Consultant
PWC

10:20 Optimal information flow and communication structure when outsourcing clinical manufacturing of biotechnological drug products
• Main communication structures and their dilemma
• Information flow and how to avoid communication gaps
• How to avoid data graveyards by using shared workspaces
• Integration of non compatible data in overview tools
• Milestone and payment tracking

Dr. Dieter Roethlisberger
Outsourcing Manager & Senior Scientist
F. Hoffmann La-Roche

11:00 Morning refreshments

11:20 Experience, expertise and enthusiasm - key success factors in winning and keeping the deal
• This talk will outline why these three key elements are most important in not only winning the deal but also maintaining your CMO supplier contracts
• Experience – critical for a company handing over their drug commercial manufacture. Without a track-record in manufacturing product, it is near on impossible to gain a company’s trust. (cite example of EDT’s experience in solid oral manufacture, this experience which is more evident in established markets of Europe and US is also an important factor)
• Expertise – as well as experience, having the right expertise to solve the problem at hand, tech transfer skills paramount for seamless movement into full scale production, also regulatory expertise very important, particularly for smaller pharma clients
• Enthusiasm – essential for getting through when problems do inevitably arise, always looking at ways to improve the service to the client (OE initiatives), essential in building relationship with clients
• Many other factors that are a given such as good quality record, GMP facilities, competitive pricing, health and safety record etc, but the 3E’s are most important

Philip Pratten
VP Manufacturing Services
Elan Pharmaceuticals

12:00 Using the principles of QbD for outsourced late phase process validation

Sohail Chohan
Manufacturing Outsourcing Manager
ERA Consulting

12:40 Networking lunch

13:40 Methods for rapid process characterisation in the successful translation of process technologies
• Case studies of methods developed to allow fast process characterisation
• Tools for effective scale up
• Examples drawn from industry collaborations

Professor Nigel Titchener-Hooker
Head of Department and Director, Biochemical Engineering
University College London

14:20 Identifying and managing risks of contract manufacturing
• Understanding the concept of ‘risk’
• Key risks applicable to contract manufacturing
• Managing and modelling risks

Peter Murray
Quality Director, External Supply Strategy
GlaxoSmithKline

15:00 Afternoon refreshments

15:20 To outsource or not - is it a solution for you?
• Defining the strategic direction of the pharma company
• Risks and benefits of outsourcing
• Impact of outsourcing on marketplace and pharma company
• Manufacture of commodity products
• Manufacture of products using proprietary technologies
• Assessing value benefits in cost, time and quality

Martin P. Grosvenor
Drug Delivery Manager
Astrazeneca

16:00 Challenges of outsourcing biopharmaceutical manufacturing
• Unique features of biopharmaceuticals
• Key considerations in outsourcing biological medicines manufacture

Dr Steve Musgrave
Founding Partner
Unicorn Biologics

16:40 Closing remarks from the Chair

16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2

Day 2, Thursday 8th December 2011

09:00 Registration and refreshments

09:30 Opening address from the Chair

Jan-Gunnar Gustafsson
Consultant
Bio Evaluation BO AB

09:40 Timing API process route changes for optimum value
• The importance of choosing the best route and process to an API
• Dividing when, if at all, to change – chemistry involved, regulatory aspects, costs and speed of manufacture
• Differences in approach between small and large pharma when it comes to route change
• The role of CROs
• Why changing early development makes sound scientific and economic sense

Alan Harris
Partner
Alacrity Pharma Associates

10:20 Contract manufacturing: sharing the risk
• Setting up the assignment covering:
- Deliverables
- Economical
- Regulatory
• Small biotech vs. big CMO
• How to create a win-win deal

Jan-Gunnar Gustafsson
Consultant
Bio Evaluation BO AB

11:00 Morning refreshments

11:20 Evolution in contract manufacturing organisation management and risk management
• Changes in contract manufacturing organisation management and regulatory requirements
• Complexity in product supply chains
• Contract manufacturing organisation and risk management
• Proactive risk management of new business development opportunities
• Adaptation of the industry to the new risks with focus on patient safety and regulatory requirements

Gaelle Gibbs
QA Manager MAX Products and Strategic Vendors
UCB

12:00 Risk mitigation – Contribution of a CMO
• Reliability
• Quality
• Speed and Flexibility
• Innovative Technologies
• Strategic Partnerships/Integration

Dr. Holger Bartos
Director Strategic Marketing
Boehringer Ingelheim Pharma GmbH & Co.KG

12:30 Networking lunch

13:40 Contractual arrangements
• Technology transfer
• IP rights
• Liability issues

Paul Ranson
Partner
Fasken Martineau LLP

14:20 “One-stop-shop”
• A Platitude, often attempted but as yet it is not a reality – Asymchem’s Integrated CMO Service Platform

Glenn Killingworth
Senior Director Business Development, Europe
Asymchem

15:00 Afternoon refreshments

15:20 Process technology transfer between the US and the UK – a case history
• Technology transfer at the HPA
• Transfer of a vaccine manufacturing process from the US to the UK for late stage process development
• Process verification at small-scale
• Scale-up and process improvement
• Post-development transfer of a “GMP-ready” process to a US CMO

Dr Nigel Allison
Process Development Specialist
Health Protection Agency

16:00 Closing remarks from the Chair

16:10 End of Conference

Partners

Silver Sponsors:

Boehringer Ingelheim
Boehringer Ingelheim is your global contract developer and manufacturer delivering excellence, committed to your success with a flexible strategy covering the entire process chain from cell line development to fill and finish.
As one of the leading companies for the contract manufacturing of biopharmaceuticals, Boehringer Ingelheim offers the entire production technology chain in development and production at its facilities in Biberach (Germany), Vienna (Austria) and Fremont (USA).
All types of services from mammalian cell line or microbial strain development to final drug production can be delivered within a one-stop-shop concept.
For further information, please visit www.biopharma-cmo.com

Associate Sponsors:

Kemwell
Kemwell operates manufacturing facilities in Sweden and India and employing over 1000 people worldwide. Kemwell is a 100% family-owned company, with a focus on long term strategies rather than short term goals. Kemwell is a provider of contract manufacturing and development services for the pharmaceutical- and biotech industry globally.
We are one of the largest formulations contract manufacturers in India and serving blue-chip multinational pharmaceutical companies such as Bayer, GSK, J&J, Pfizer and Novartis.
Kemwell is your ideal strategic partner in areas such as Formulation Development, Analytical Support, Clinical Batch Production, EU Gateway Release, Commercial-Scale Manufacturing, Packaging, Distribution World Wide and One-Stop Shop Solutions. For further information, please visit www.kemwellbiopharma.com

Media 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

InPharm
InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

International Pharmaceutical Industry (IPI)
"Supporting the Industry through Communication"
IPI was established to fill in the void for effective marketing and communication between all stakeholders in the life sciences sector globally. Clients use us due to the extensive knowledge and reach we have built up over the years with our Editor, Editorial Advisory board and market research. We give you links into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. In addition to our extensive reach in the Americas & Europe, we have established a strong presence in the Middle East, Latin America, Eastern Europe, Asia and Africa which are becoming increasingly important to the way the industry is moving forwards in areas of Research and Development, Trials, manufacturing and Technology Transfer. For further information, please visit www.ipimedia.com

Pharmatching.com
Pharmatching.com is an efficient, targeted and easy-to-use-"Web2.0"-tool for finding the right partners in the pharmaceutical industry worldwide. It saves time and costs in all (out)sourcing and business development processes, as it fascilitates and accelerates the searching process for appropriate business partners significantly.
Pharmatching.com is particularly advantageous for projects where a special service is (immediately) required or to offer capacities which are currently available. It is useful for services in all categories and stages of drug development including contract manufacturing, contract research, laboratory investigations, contractual testing, non-clinical and clinical research, active pharmaceutical ingredients, consulting, marketing, registration, in- and outlicensing etc. For further information, please visit www.pharmatching.com

Enquiries

If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 5th Annual Contract Manufacturing Conference, please contact:
Piyush Patel, +44 (0)20 7549 9961
piyush.patel@visiongainglobal.com

Past Papers

Speaker presentations are free to paying delegates. If you are unable to attend the event, the presentations are published two weeks after the event and are available to purchase.

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Venue Info

Thistle City Barbican
Central Street, Clerkenwell
London, EC1V 8DS
Phone: 0871 376 9004 / +44 845 305 8304
Fax: 0871 376 9104 / +44 845 305 8343
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html

Click here for Google maps.

Transport links:

London Underground
You can access this venue via the Northern Line (black), Metropolitan (purple), Circle (Yellow) and Hammersmith & City (Pink) line.

From Old Street Tube station (10 mins walk)
Take exit 8 out of Old Street station and walk up city road until you reach Moorfields Eye Hospital. Turn left after the hospital down Cayton Street and cross over Bath Street into Lever Street opposite. The Thistle City Barbican is 350 yards up this road on the right hand side.

From Barbican Tube station (10 mins walk)
Turn left out of Barbican station down Goswell Road. Turn right on to Old Street and take the first left up Central Street. Walk up this road and you will see The Thistle City Barbican to your right.

Heathrow Airport to the Thistle Barbican
Take the Heathrow express to Paddington national rail Station. Walk to Paddington underground station and take the Circle line (yellow) or Hammersmith & City line (pink) towards Kings cross St Pancras or Baker Street. Alight at Barbican and follow the above directions.

Gatwick Airport to the Thistle Barbican
Take the First Capital connect service towards Bedford Rail Station. Alight at London Bridge, walk to London Bridge underground station and take the northern line (black) towards Edgware or High Barnet. Alight at Old Street and follow the above directions.

Accommodation:

The Thistle City Barbican
Central Street
Clerkenwell
London
EC1V 8DS
Phone: 0871 376 9004 / +44 845 305 8304
Fax: 0871 376 9104 / +44 845 305 8343
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/location/index.html

Discounted room rates - How to book:
Guests to make their own reservations, by calling:
UK Telephone Number: 0871 977 0218
International Telephone Number: +44845 073 7154
E-mailing: groupsadmin.citybarbican@thistle.co.uk
Reference Number: VISY071211
Guests should quote the booking reference when making their booking in order to guarantee they receive the group rate.
Guests to provide credit card details on booking in order to guarantee their accommodation
The above sleeping rooms will be held until Thursday 1st December 2011. After this date reservations will only be taken on a space and rate availability basis.

Travelodge - London City Road Hotel
7-12 City Road
London
EC1Y 1AE
Tel: 0871 984 6333
Fax: 0207 628 2503
http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340

Jury's Inn Islington
60 Pentonville Road
Islington
London
N1 9LA
Tel: +44 (0) 207 282 5500
http://londonhotels.jurysinns.com/jurysinn_islington

London City Holiday Inn Express
275 Old Street
London
EC1V 9LN
Tel: +44 (0) 207 300 4300
http://www.hiexpress.com/hotels/gb/en/london/lonct/hoteldetail

For further information contact details:

Sarah Nicoise
Conference Co-ordinator
Tel: +44 (0) 20 7549 9988
Fax: +44 (0) 20 7549 9930
Email: sarah.nicoise@visiongainglobal.com

Carrie Lancaster
Conference Manager
Tel: +44 (0)20 7549 9978
Fax: +44 (0) 20 7549 9930
Email: Carrie.Lancaster@visiongainglobal.com

Sara Peerun
Commercial Director
Tel: +44 (0) 207 336 6100
Fax: +44 (0) 207 549 9930
Email: sara.peerun@visiongainglobal.com

Speakers

Andrea Calenne

Sr. Manager, Contract Manufacturing

Biogen Idec
Dr. Nigel Allison

Process Development Specialist

Health Protection Agency
Jan-Gunnar Gustafsson

Consultant

Bio-consulting
Martin P Grosvenor

Drug Delivery Manager

AstraZeneca
Philip Pratten

VP Manufacturing Services

Elan Pharmaceuticals

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