1. 4th Annual Contract
Manufacturing
Driving contract manufacturing through cost-effective outsourcing
13th – 14th December 2010, BSG Conference Centre, London, UK BOOK NOW!
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
Driving the Industry Forward | www.futurepharmaus.com
Media Partners
Organised By
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/cm

2. Conference Introduction
4th Annual Contract Manufacturing
13th - 14th December 2010, London UK
Media Partners:
Dear Colleague,
PharmiWeb.com is the leading industry-sponsored portal for
he global demand for contract manufacturing services and affordable outsourcing solutions
T the pharmaceutical sector. Supported by most of the leading
is increasingly driving the pharmaceutical companies to upgrade their technology and pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news,
manufacturing capacity. In recent times, investments in implementation of PAT and QbD features, events listings and international jobs to industry professionals across
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-
Europe and the US.
licensing and mergers and acquisitions grows, Asia is expected to become one of the largest For further information please email: corporate@pharmiweb.com
cost-effective outsourcing markets in the next five years.
isiongain’s 4th Annual Contract Manufacturing will provide tactical approaches and case
V BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY
studies to improve PAT and QbD implementation for a successful contract manufacturing WORLD. It is based and located in Warsaw, Poland. Biotechnology
model. Delegates will learn regulatory and planning processes, best manufacturing practices, World was founded in 2007 to provide the world’s biotech and pharma information
and strategies to maximise partnership with CMOs. and market to make it universally accessible and useful for scientific and business
ur conference is a valuable opportunity to discuss, gain insights and network with thought
O processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY
leaders and key professionals from the industry. 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 mains goals of BIOTECHNOLOGY
Learn, discuss and gain insights on: EUROPE is to integrate the Biotech and Pharma Sector in Europe to global
• Deliver successful external manufacturing supply chain and planning biotechnology, pharmaceutical and life science activities.
For further information please visit www.biotechnology-europe.com
• Learn trends, challenges and opportunities for manufacturing in Asia
• Maximise opportunities as a consequence of FDA, PAT and QbD initiatives Future Pharmaceuticals has forged powerful relationships with
Driving the Industry Forward | www.futurepharmaus.com
• Evaluate outsourcing needs your business key industry leaders to provide a platform for successful brand
• Implement strategies for successful analytical technology transfer 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
• Analyse critical issues affecting technology transfer & scale-up to QC authoritative resource within top pharma companies as well as small, specialty,
• Understand QbD principles and continuous improvement in manufacturing and biotech, Future Pharmaceuticals magazine is geared to create a deep
• Capitalise on the benefits of applying QbD approach in biologics contract manufacturing
penetration into a highly targeted and responsive audience, bridging the gap
between the industries’ top issues and the solutions top-tier vendors can provide.
• Formulate strategies to choose a right CMO partner For further information please visit: www.futurepharmaus.com
• Integrate lean product development in a pharma CMO set-up
• Understand the legal challenges and pitfalls for contract negotiation 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
‘Pharma Connections Worldwide® is the leading professional
Maninder Paul business networking website focused in the Pharmaceutical,
Conference Producer Biotechnology and Life Sciences research industry. Our goal is to provide a
conduit for delivery of premiere content coupled with the right clientele in order
to facilitate business development opportunities among industry professionals
responsible for making key decisions in a global marketplace. ‘
Who will be there? For further information please visit www.pharmaconnections.com
Directors, Heads of Department, Team Leaders and Scientists of:
• Research and Development
• PAT
• QbD Sponsorship and exhibition opportunities:
• CMC
This event offers a unique opportunity to meet and do business with some of the
• Process Development & Optimisation
• Process Science/ Analytics key players in the pharmaceutical and biotech industries. If you have a service or
• Manufacturing product to promote, you can do so at this event by:
• Contracts & Outsourcing
• Hosting a networking drinks reception
• Formulation
• Quality Assurance/Quality Control • Taking an exhibition space at the conference
• Operations
• Advertising in the delegate documentation pack
• Strategic Alliances
• Compliance • Providing branded bags, pens, gifts, etc.
• Regulatory Affairs If you would like more information on the range of sponsorship or exhibition
• Legal/ Patents
possibilities for visiongain's 4th Annual Contract Manufacturing Conference,
Pharmaceutical and Biotechnological Companies
please contact us:
Contract Manufacturing Organisations (CMOs)
Ronald Magali, +44 (0)20 7549 9934
Drug Regulators, Intellectual Property/Law Firms
Academia, Government Bodies, Regulatory Affairs ronald.magali@visiongainglobal.com

3. Day 1
4th Annual Contract Manufacturing
Monday 13th December 2010
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the chair
13.40 The role of the analytical laboratory in
09:40 Applying QbD for the development and technology transfer
manufacture of new products • ommon problems
C
 • chieving QbD objectives
A • ransfer strategy
T
 • bD and continuous improvement in manufacturing
Q
• lanning the transfer
P
 • esign space and control strategy
D
 • he use of MVDA models to ensure quality compliance in routine production
T • ase studies and learnings
C
livia Darmuzey
O aul Smith
P
QbD Expert - PharmOps CH Validation Program Manager (Europe)
Novartis Pharma PerkinElmer Life and Analytical Sciences
10:20 Identifying and exploiting opportunities from
Process Analytical Technology (PAT) 14:20 From test tube to tank
 • xploiting on-line process analytical measurements to gain insight into
E • ritical issues affecting technology transfer & scale-up
C
process performance • ddressing issues surrounding high containment manufacturing
A
 • aking maximum use of a limited number of data sets in the CMO
M
environment • GMP production: Therapeutic products of prokaryote fermentation
c
 • echniques to interpret data from instrumentation to assess on-line
T itch Rogers
M
process quality Business Development Manager
 • kills required to maximise the benefits of PAT
S Health Protection Agency
rof Elaine Martin OBE
P
Professor of Industrial Statistics
Biopharmaceutical and Bioprocessing Technology 15:00 Afternoon refreshments
Centre, Newcastle University
rof Gary Montague
P
Professor of Bioprocess Control 15:20 Validation, stability and method transfer
Biopharmaceutical and Bioprocessing Technology activities to QC and contract manufacturers
Centre, Newcastle University • evelop and validate new analytical test methodologies
D
• trategy and design for methods and complex investigations
S
11:00 Morning refreshments
• dentifying quality or safety issues
I
11:20 Continuous manufacturing for oral solid dosage nthony Pettigrew
A
tablet making PAT application Analytical Development Manager
Novozymes
 • AT as the key enabler to achieve QbD by means of ‘Model Predictive
P
Control’ and ‘Real Time Product Release’
• ow to deal with tracking and tracing when going from a batch to a
H
continuous process? 16:00 Risk mitigation strategies and IP challenges
 • enefits of continuous processes in commercial manufacturing and late
B  • iscussing the rules and regulations that apply specifically
D
stage product development to the UK
ebecca Vangenechten
R  • sing UK regulations in the evaluation process
U
Consultant - Business & Project Development Life Sciences, USA
Siemens Industry & Automation  • P barriers and challenges
I
12:00 GMP Critical Utilities from A to Z
16:40 Closing remarks from the chair
 • esign of pharmaceutical water and steam systems
D
 • uality control during erection
Q
 • ommissioning
C
 • ualification (IQ & OQ)
Q
 • alidation (PQ)
V
16:50 Networking drinks
 • aily operation and sampling
D
 • hange control
C Take your discussions further and build new
 • e-qualification
R relationships in a relaxed and informal setting.
enrik Goldschmidt
H
Proceskonsulent
GPE Consult
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2010

4. Day 2
4th Annual Contract Manufacturing
Tuesday 14th December 2010
09:00 Registration and refreshments 13:40 CMO management throughout the lifecycle
• stablish and improve relationship management practices with
E
09:30 Opening address from the chair strategically important CMOs
• he process: Plan, select, negotiate, implement and manage
T
09:40 Is outsourcing manufacture right for your business? • overnance plan
G
• efining the strategic direction of the pharma company
D • xpected deliverables
E
• isks and benefits of outsourcing
R elson M Lugo
N
• mpact of outsourcing on marketplace and pharma company
I Sr. Director, Contract Manufacturing
Amylin Pharmaceuticals
• anufacture of commodity products
M
• anufacture of products using proprietary technologies
M 14:20 Achieving product traceability with
• ssessing value benefits in cost, time and quality
A pharmaceutical packaging
artin P Grosvenor
M • ost effective and integrated processing for packaging
C
Drug Delivery Manager • perational challenges in working with 3rd party
O
AstraZeneca contract manufacturers
• ack design/process & reproducibility
P
10:20 Contract manufactures: Quality is more than
an audit 15:00 Afternoon refreshments
• raditional procurement quality
T
 • ustomer: Supplier approach isn’t effective
C
• elationship management
R
15:20 Globalisation in manufacturing:
 • nderstanding each other
U
In-house production vs Outsourcing
igel Cryer
N
PANEL DISCUSSION
O
ur expert panel will discuss and debate on the need for outsourcing,
Interim Head, Global Quality Manufacturing & Supply Chain indentifying opportunities and operational challenges to work with third
Norgine party contractors
P
anel members will be drawn from the speakers who take part on day
11:00 Morning refreshments one or day two.
I
f you would like to submit a question to the panel, please email it to:
11:20 Custom manufacturing: Sourcing APIs in maninder.paul@visiongainglobal.com
emerging markets
• hat are the commercial implications of increasing globalisation
W
of the API contract manufacturing market?
• PI supplier identification and negotiations
A
16:00 Lean product development in a pharma CMO set-up
• valuation of the economic, financial and technical needs to drive a lean
E
• arket evolution: Regulatory compliances, new patent laws,
M
mentality within product development
decreasing number of NCEs
• ow to achieve, optimise & continually support an integrated approach for
H
aurent Pinchard
L
implementing lean product development?
Director – EU Operations (API)
Glenmark Generics  • eview of case studies as to the benefits realised from both CMOs and
R
pharmaceutical companies using a lean approach
aren MacGregor
K
12:00 Emerging markets: CMO outsourcing
Product Development Director
• nderstanding the influence of global regulatory culture on
U Catalent
establishing outsourcing projects
• ndentifying lucrative opportunities and establishing strategic
I 16:40 Chair’s closing remarks
alliances in emerging markets to minimise costs
• egal and intellectual property challenges in negotiating contracts
L
and managing relationships
16:50 End of conference
12:40 Networking lunch

5. Registration Form
4th Annual Contract Manufacturing
13th - 14th December 2010, London UK
Angel
For multiple bookings Pentonville Road
Photocopy this form Conf. code VG 4th Annual Contract
C
Ci
ty
Ro
Manufacturing
ad
Standard Prices
13th – 14th December 2010
Old Street
Conference only Fee: £1299 VAT: £227.33 Total: £1526.33
Location: SG Conference Centre
B
Old Street
Address:
226-236 City Road
London
City Road
Promotional Literature Distribution
EC1V 2TT
Distribution of your company’s promotional literature to all conference attendees UK
Fee: £999 VAT: £174.83 Total: £1173.83
Details
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Forename: Surname: Email: conferences@visiongainglobal.com
Web: http://www.visiongain.com/cm
Job Title: Company: UK Office:
Tel: +44(0) 20 7336 6100
Main Switchboard Number: Fax: +44(0) 20 7549 9932
Visiongain Ltd
Address: BSG House
226-236 City Road
London
EC1V 2QY
UK
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General information
Venue: Directions: BSG Conference Centre 226 – 236 City Road, London, EC1V 2TT. United
Phone: Fax: Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Travelodge London City
Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503,
Email: http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340
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