The document announces the 5th Annual Contract Manufacturing conference to take place on December 7-8, 2011 in London. It will address every aspect of outsourcing from selecting partners to regulatory issues. Key speakers include outsourcing managers from major pharmaceutical companies. Attendees will learn about emerging trends, selection criteria, partnership strategies, and regulatory frameworks. The conference aims to help pharmaceutical companies and contract manufacturers assess outsourcing strategies and opportunities.

1. 5th Annual
Contract Manufacturing
Examining the best outsourcing practices, new technological developments and the latest regulatory issues
7th - 8th December 2011, Visiongain Conference Centre, London, UK BOOK NOW!
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
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-consulting
Alan Harris, Partner, Alacrity Pharma Associates
Dr. Steve Musgrave, Founding Partner, Unicorn Biologics
Driving the Industry Forward | www.futurepharmaus.com
Media Partners
Organised By
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/contractmanufacturing

2. Conference Introduction
5th Annual Contract Manufacturing
7th - 8th December 2011, London, UK
Dear Colleague, Media Partners:
he importance and role of contract manufacturing has changed over the years from
T PharmiWeb.com is the leading industry-sponsored portal for
solely providing efficiencies in cost, capacity and time-to-market, or a specific expertise the pharmaceutical sector. Supported by most of the leading
not available in-house to unique, innovative, and state-of-the-art processes and pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features,
production technology to the pharmaceutical industry. events listings and international jobs to industry professionals across Europe and the US.
s more and more pharmaceutical companies are willing to outsource, the contract
A For further information please email: corporate@pharmiweb.com
manufacturing market continues to grow and is expected to reach $61.51bn in 2015
and $94.70bn by 20251 BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD.
It is based and located in Warsaw, Poland. Biotechnology World
isiongain’s Contract Manufacturing conference has grown from strength to strength
V was founded in 2007 to provide the world’s biotech and pharma information and market
in the last couple of years and now in its 5th year, the conference will address to make it universally accessible and useful for scientific and business processes. Its first
every aspect of the outsourcing process from selecting an outsourcing partner to step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will
tech-transfer through to regulatory frameworks, latest FDA contract manufacturing allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers
legislation, and recent patent and safety issues. companies completed internet public relations, publication and marketing solutions. One of
t this 2 day event the attendees will learn, debate, discuss and network with leaders
A the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector
and key professionals from the industry. in Europe to global biotechnology, pharmaceutical and life science activities.
For further information please visit: www.biotechnology-europe.com
Whether you are a service provider or a pharmaceutical company by Driving the Industry Forward | www.futurepharmaus.com
Future Pharmaceuticals has forged powerful relationships with key
attending this conference you will: industry leaders to provide a platform for successful brand recognition,
• ssess future outsourcing trends and manufacturing strategies with changing CMO
A and for senior decision-makers to have the means to procure and plan implementation
industry structure strategies based on the topics covered. Positioned to be an authoritative resource within top
• ear about emerging business models
H 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
• etermine the essential criteria for CMO selection and effective relationship
D gap between the industries’ top issues and the solutions top-tier vendors can provide.
management
For further information please visit: www.futurepharmaus.com
• earn key success factors for establishing successful CMO partnerships with analysis
L
of the multi-step sourcing process for CMOs InPharm is the online platform for exclusive pharmaceutical
• ain insight on future growth potential, regulatory frameworks, recent patent and
G news, comment, contracts, services, jobs and events and is
safety issues home to InPharmjobs.com, Pharmafile and Pharmafocus.
• dentify the latest FDA contract manufacturing legislation
I For further information please visit: www.inpharm.com
• valuate the major risks and challenges of contract manufacturing projects by
E “Supporting the Industry through Communication”
gaining insights into the potential downsides IPI was established to fill in the void for effective marketing and
• nvestigate about costs :importance of tech-transfer/scale-up
I communication between all stakeholders in the life sciences sector
globally. Clients use us due to the extensive knowledge and reach we have built
• iscover the outsourcing potential of India and China
D up over the years with our Editor, Editorial Advisory board and market research. We
• aximise opportunities as a consequence of PAT and QbD initiatives
M give you links into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. In
• eliver successful external manufacturing supply chain and planning
D 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
• uild new relationships with other key players in pharmaceutical and contract
B becoming increasingly important to the way the industry is moving forwards in areas of
manufacturing industry Research and Development, Trials, manufacturing and Technology Transfer.
I look forward to meeting you at the conference For further information please visit: www.ipimedia.com
Best regards 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
Sumita Sengupta 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
Conference Producer 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
Who will be there?
VPs Directors, Heads, and Managers in:
Directors, Heads of Department, Team Leaders and Scientists of:
• Research and Development Sponsorship and exhibition opportunities
• PAT
This event offers a unique opportunity to meet and do business with some of the key
• QbD
• CMC players in the pharmaceutical and biotech industries. If you have a service or product to
• Process Development & Optimisation
• Process Science/ Analytics
promote, you can do so at this event by:
• Manufacturing
• Hosting a networking drinks reception
• Contracts & Outsourcing
• Formulation • Taking an exhibition space at the conference
• Quality Assurance/ Quality Control
• Advertising in the delegate documentation pack
• Operations
• Strategic Alliances • Providing branded bags, pens, gifts, etc.
• Compliance
• Regulatory Affairs If you would like more information on the range of sponsorship or exhibition possibilities
• Legal/ Patents
for visiongain's 5th Annual Contract Manufacturing Conference, please contact us:
Pharmaceutical and Biotechnological Companies
Contract Manufacturing Organisations (CMOs) Damian Gorman, +44 (0)20 7549 9934
Drug Regulators, Intellectual Property/Law Firms
damian.gorman@visiongainglobal.com
Academia, Government Bodies, Regulatory Affairs
Visiongain’s report: Pharmaceutical contract manufacturing: industry and market prospects 2010-2025
1

3. Day 1
5th Annual Contract Manufacturing
Wednesday 7th December 2011
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the Chair
13:40 Methods for rapid process characterisation in the
successful translation of process technologies
09:40 To outsource or not - is it a solution for you?
• Defining the strategic direction of the pharma company • Case studies of methods developed to allow fast process characterisation
• Risks and benefits of outsourcing • Tools for effective scale up
• Impact of outsourcing on marketplace and pharma company
• Examples drawn from industry collaborations
• Manufacture of commodity products
• Manufacture of products using proprietary technologies Professor Nigel Titchener-Hooker
Head of Department and Director, Biochemical Engineering
• Assessing value benefits in cost, time and quality
University College London
Martin P. Grosvenor
Drug Delivery Manager
Astrazeneca 14:20 Timing API process route changes for optimum value
• The importance of choosing the best route and process to an API
10:20 Optimal information flow and communication
• ividing when, if at all, to change – chemistry involved, regulatory
D
structure when outsourcing clinical manufacturing
aspects, costs and speed of manufacture
of biotechnological drug products
• Main communication structures and their dilemma • ifferences in approach between small and large pharma when
D
it comes to route change
• Information flow and how to avoid communication gaps
• How to avoid data graveyards by using shared workspaces • The role of CROs
• Integration of non compatible data in overview tools • hy changing early development makes sound scientific and
W
• Milestone and payment tracking economic sense
Dr. Dieter Roethlisberger Alan Harris
Outsourcing Manager & Senior Scientist Partner
F. Hoffmann La-Roche Alacrity Pharma Associates
11:00 Morning refreshments
15:00 Afternoon refreshments
11:20 Experience, expertise and enthusiasm - key success
factors in winning and keeping the deal.
• his talk will outline why these three key elements are most important in not
T 15:20 Sponsor Spotlight Session
only winning the deal but also maintaining your CMO supplier contracts
T
ake this unique opportunity to be a part of the conference
• xperience – critical for a company handing over their drug commercial
E theme, network, share ideas and provide an overview of your
manufacture. Without a track-record in manufacturing product, it is near product/services to the audience. For more information please
on impossible to gain a company’s trust. (cite example of EDT’s experience contact damian.gorman@visiongainglobal.com
in solid oral manufacture, this experience which is more evident in
established markets of Europe and US is also an important factor)
• xpertise – as well as experience, having the right expertise to solve the
E
problem at hand, tech transfer skills paramount for seamless movement 16:00 Challenges of outsourcing biopharmaceutical
into full scale production, also regulatory expertise very important, manufacturing
particularly for smaller pharma clients
• Unique features of biopharmaceuticals
• nthusiasm – essential for getting through when problems do inevitably
E
arise, always looking at ways to improve the service to the client (OE • Key considerations in outsourcing biological medicines manufacture
initiatives), essential in building relationship with clients Dr Steve Musgrave
• any other factors that are a given such as good quality record, GMP
M Founding Partner
facilities, competitive pricing, health and safety record etc, but the 3E’s Unicorn Biologics
are most important
Philip Pratten
VP Manufacturing Services 16:40 Closing remarks from the chair
Elan Pharmaceuticals
12:00 Using the principles of QbD for outsourced late
phase process validation 16:50 Networking drinks
Sohail Chohan
Take your discussions further and build new
Manufacturing Outsourcing Manager
relationships in a relaxed and informal setting
Era Consulting
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

4. Day 2
5th Annual Contract Manufacturing
Thursday 8th December 2011
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the Chair 13:40 Contractual arrangements
• Technology transfer
09:40 Identifying and managing risks of
contract manufacturing • IP rights
• Understanding the concept of ‘risk’ • Liability issues
• Key risks applicable to contract manufacturing Paul Ranson
• Managing and modelling risks Partner
Fasken Martineau LLP
Peter Murray
Quality Director, External Supply Strategy
GlaxoSmithKline
14:20 Sponsor Spotlight Session
10:20 Contract manufacturing: sharing the risk T
ake this unique opportunity to be a part of the conference
• Setting up the assignment covering: theme, network, share ideas and provide an overview of your
- Deliverables product/services to the audience. For more information please
contact damian.gorman@visiongainglobal.com
- Economical
- Regulatory
• Small biotech vs. big CMO
• How to create a win-win deal 15:00 Afternoon refreshments
Jan-Gunnar Gustafsson
Consultant
Bio-consulting 15:20 Process technology transfer between the US and
the UK – a case history
11:00 Morning refreshments • Technology transfer at the HPA
• ransfer of a vaccine manufacturing process from the US to the UK for
T
11:20 Evolution in contract manufacturing organisation
CASE STUDY
late stage process development
management and risk management
• Process verification at small-scale
• hanges in contract manufacturing organisation management and
C
regulatory requirements • Scale-up and process improvement
• Complexity in product supply chains • Post-development transfer of a “GMP-ready” process to a US CMO
• Contract manufacturing organisation and risk management
Dr Nigel Allison
• Proactive risk management of new business development opportunities Process Development Specialist
• daptation of the industry to the new risks with focus on patient safety
A Health Protection Agency
and regulatory requirements
Gaelle Gibbs
QA Manager MAX Products and Strategic Vendors 16:00 Supplying the future: how to develop effective
UCB contract manufacturing relationships
• n update on the trends impacting the pharma and life sciences industries
A
12:00 Auditing regulatory compliance within a contract
manufacturing business scenario • review of current outsourcing trends
A
• ntroduction: what is regulatory compliance, Module 3, typical
I • n outline of new business models for success
A
discrepancies and their origin Jo Pisani
• ackground: contractual scenario, regulatory requirements, setting
B Consultant
of boundaries PWC
• reliminary steps: defining an agenda for regulatory compliance audits
P
• udit execution: strategy and prioritisation of schedules
A 16:40 Closing remarks from the chair
• ollow-up: review of a CAPA/Remediation plan related to regulatory gaps
F
• onclusion
C
16:50 End of Conference
Andrea Calenne
Sr. Manager, Contract Manufacturing
Biogen Idec

5. Registration Form
5th Annual Contract Manufacturing
7th - 8th December 2011, London, UK
Angel
Conf. code PP Pentonville Road
5th Annual Contract
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Standard Prices
ty
Manufacturing
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ad
Conference only Fee: £1299 VAT: £259.80 Total: £1558.80 7th - 8th December 2011 Old Street
Location: Visiongain Conference Centre Old Street
Number of bookings: Total cost:
Address:
230 City Road
City Road
London
Promotional Literature Distribution EC1V 2TT
Distribution of your company’s promotional literature to all conference attendees UK
Fee: £999 VAT: £199.80 Total: £1198.80
How to book
Details
Email: Piyush.patel@visiongainglobal.com
Forename: Surname: Web: http://www.visiongain.com/contractmanufacturing
UK Office:
Job Title: Company: Tel: +44 (0) 20 7549 9961
Fax: +44(0) 20 7549 9932
Main Switchboard Number: Visiongain Ltd
230 City Road
London
Address: EC1V 2QY
UK
General information
Venue: Venue: Directions: Visiongain Conference Centre 230 City Road, London, EC1V 2TT. United
Country: Postcode: Kingdom. Closest tube station is Old Street (Northern Line).
Accommodation: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376
Phone: Fax: 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
Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207
Email: 628 2503, http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340
Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain
Signature: Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may
be requested if payment has not been received in full before the event. Visiongain Ltd reserves the
I confirm that I have read and agree to the terms and conditions of booking right to charge interest on unpaid invoices.
Substitutions/name changes or cancellations: There is a 50% liability on all bookings once
Methods of payment made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or
after one month before the start of the event. Should you decide to cancel after this date, the full invoice
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to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK substitutions must be from the same company or organisation and are not transferable between
countries. Please note that discounted delegates places at a visiongain event are non refundable.
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Visiongain Ltd A/C: visiongain Ltd
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Fee: The conference fee includes lunch, refreshments and conference papers provided on the day.
This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly
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