Pharmaceutical and biotech companies are being influenced by the financial and operational benefits of outsourcing further aspects of their manufacturing processes. As a result of this, it is important for a company to mitigate risks, while maximizing profit and production. For our 10th Contract Manufacturing for Pharmaceuticals and Biotech conference, we have gathered many high-level industry experts together to provide insights and unique solutions for the most common challenges faced within the industry today.

1. The MUST ATTEND Contract
Manufacturing event of the year!
10th
Contract Manufacturing
for Pharmaceuticals and Biotech
TM
Mitigating Risks, Ensuring Compliance, and Improving Efficiency May 10-12, 2010
for Domestic and International Outsourced Manufacturing San Francisco, CA
Key topics include:
• Assessing Risk Management of the Quality System of Your • Analyzing the CMO Market: Tools for Choosing a
CMO Preferred CMO
• Roche/Genentech's Risk-Based Approach to CMO • A Regulatory Approach for Contract Manufacturing
Management • Understanding the Essential Elements for Successful
• Mitigating the Risks When Outsourcing Pharmaceutical Technology Transfer
Manufacturing • Using CMOs as a Resource to Tap into a New Product
• Working with an Overseas CMO to Gain FDA Inspection Market
and Approved Status
Register by 3/26/2010 and pay only $2,199
all access (saving $698) for the all access pass
Learn from Leading Innovators Including:
Jim Browne, Director, Contract Manufacturing, Europe, GlaxoSmithKline
Prasad Gogineni, Associate Director, Pharmaceutical Technology, Watson Laboratories
Paul Kanan, Vice President, Operations, Agensys, Inc.
Earl Sullivan, Chief Executive Officer, Landela Pharmaceutical, Inc.
Tim Sirichoke, Head of Commercial Operations, Novartis
Paul Hingst, Senior Manager, Contract Manufacturing, Amgen
Franco Pasquale, Senior Manager, Roche Contract Manufacturing
Operating Unit
Nicole S. Ferrari, Engineering and Contract Manufacturing Manager,
Bausch & Lomb Pharmaceuticals
Rebecca Tholmer, Manager, Quality Systems, Baxter Healthcare
Alex Badal, Director, Global Strategic Sourcing Supply, Valeant
Pharmaceuticals
Doris St. John, Manager Supplier Quality GPS, Johnson & Johnson
Jim Damon, Regional Director, External Manufacturing, Johnson &
Johnson Consumer Healthcare
Sponsored by: Media
Partner:
www.PharmaContractManufacturing.com

2. 10th Who will attend?
Contract Manufacturing Vice Presidents / Directors / Heads from
Pharmaceutical, Biotech, Animal Health,
Contract Manufacturing Organizations,
Consultants and Service Providers working in
for Pharmaceuticals and Biotech TM
the following:
• Manufacturing and Operations
• Outsourcing
Dear Colleagues, • Supply Chain
The pharmaceutical and biotech
• Contract Manufacturing and Transfers
industry has been increasingly influ
and operational benefits of outsourc enced by the financial • Engineering
ing further aspects of their manufac
achieve faster time to market on drug turing processes to
products. As a result of this, it is impo • Operational Excellence
company to mitigate risks, while maxi rtant for a
mizing profit and production. • Strategic Process Optimization
For the 10th Contract Manufacturin • Release Coordination
g for Pharmaceuticals and Biot
have gathered many high-level indu ech conference, IQPC
stry experts together to provide insig • Compliance and Validation
solutions for the most common chall hts and novel unique
enges faced within the industry toda
organizations efficient, economically-v y to help assist your • Process Development
iable and compliant manufacturin
g supply chain.
By attending this conference, you
• Quality Assurance / Quality Control
will hear industry-specific case stud
addressing: ies and examples • Procurement
• The
current shape of the contract man
• Key
ufacturing industry
requirements for an effective man
• Max
agement system
imizing innovation: Addressing the
• In-Ho
use vs. outsource: How to decide
importance to small biotech’s and
and then how you can generate savin
start-ups Past Attendee Profile
maintaining quality and efficiency gs whilst Job Title Breakdown from our Previous
• Susta
ining a mutually beneficial operation Contract Manufacturing for
• And
al relationship with your CMO
many more sessions including over Pharmaceuticals and Biotech Conference
4+ hours of scheduled networking,
interactive panel discussions and a insightful
series of interactive workshops.
Benefit from industry participation
from Roche, GlaxoSmithKline, Nova
Johnson, Baxter Healthcare, Valea rtis, Amgen, Johnson &
nt Pharmaceuticals, Watson Laborator
pharmaceutical and biotech industry ies and many more
experts.
Engage in dynamic conversation with
your industry peers at our multiple
and work closely with many Cont networking sessions,
ract Manufacturing industry experts.
yourself and a team of key people Be sure to register
for this important event today!
We look forward to seeing you in
San Francisco in May! ■ 16% Quality Assurance
Best Regards, ■ 10% Engineer/Engineering Manager
P Highly interactive
.S. ■ 10% Director
■ 10% Supply Head
and informative pre- ■ 7% Executive
confer ence workshops! ■ 7% Business Development
Simon Curtis
Conference Director Se e page 5 for details ■ 7% Operational Head
PharmaIQ
■ 3% Professor
■ 3% Capital Markets Manager
■ 3% Clinical Supplies
■ 3% Regulatory Manager
Comments from IQPC’s Past Contract Manufacturing for ■ 3% CEO
Pharmaceuticals Conferences: ■ 3% Business Manager
“Interesting participants and concrete business options.” – CEO, Labiana ■ 3% R&D Direct
Pharmaceuticals
“Nice blend of topics – not much, if any, repetition.” – Director, Pharmaceutical
Operations, Arena Pharmaceuticals
“Great speakers!” – Site Assessment Officer/Compliance Coodinator, Health Canada For Registration Information and to
“Good opportunity to hear from all sides (sponsors, CMO’s, consultants).” –
Download the Complete Brochure
Vice President, Supply Chain, Impax Laboratories Visit our website at
www.PharmaContractManufacturing.com
“Very experienced speakers.” – Manager, CMQA, Solvay Pharmaceuticals or Call 1-800-882-8684
“Good selection of speakers, who cover a wide spectrum of experiences; in- For sponsorship opportunities, please
depth information provided to audience.” – Director, API Development, Intermune contact Mario Matulich at 212-885-2719
or at sponsorship@iqpc.com
2 REGISTER ONLINE AT www.PharmaContractManufacturing.com OR CALL US AT 1-800-882-8684

3. Main Conference Day 1 Tuesday,
May 11, 2010
7.45 Registration and Coffee • Process chemistry and route scouting: When a CMO has a good idea
• Quality: Who's in charge; harmonizing SOPs
• Contracts and reports: Understanding and reaching customer
8.30 Welcome Address
and Chairpersons’ Opening Remarks expectations
Justin D. Noll, Senior Vice President,
8.45 Opening Keynote: Industry Overview - The current Plant Manager, Cherokee Pharmaceuticals LLC
shape of the Contract Manufacturing Industry
• Discussing the direction the contract manufacturing market is heading 12.30 Networking Lunch
• Changing environment & dynamics of contract manufacturing
opportunities and commercialisation 1.30 Sustaining a Mutually Beneficial Operational
• Evaluating in-house vs external manufacturing options Relationship with Your CMO
• Examining the emergence & challenges of domestic and overseas • Managing risk with CMO – Developing an aligned approach to
outsourced manufacturing benefit both parties
• Considering manufacturing opportunities for small biotechs and • Addressing the importance of Process Development and Change
start-ups Control in contract manufacturing
• Discussing new strategies and creative partnerships for improving • Handling strategies by inventory projections
• Choosing a Contractor – A multidirectional audit approach to arrive
success
Jim Browne, Director, Contract Manufacturing, Europe, at the CMO best fit for your needs.
• Inspecting supplies – Who is supplying to your CMO?
GlaxoSmithKline
Tim Sirichoke, Head of Commercial Operations, Novartis
Effective CMO Sourcing and Relationship Management
Operational Benefits of Post-CMO Collaboration
9.30 Panel Discussion: Analyzing the CMO Market: Tools
for Choosing a Preferred CMO 2.15 Using Your CMO as a Resource to Tap into a New
• Understanding the scientific background and capabilities of tentative Innovative Product Market
CMOs • Gaining the competitive edge on manufactured products through
• Addressing a CMO's experience developing a biologic product from CMO-utilized tools and technologies
• Identifying novel product design and re-launch technologies from
early clinical stages through regulatory review and commercialization
• Assessing a CMO's necessary facility, equipment and personnel your CMO
• Unveiling novel product revamping technologies for post patent-
infrastructure for successful commercialization of a biologic drug
product expired products
• Examining the importance of quality agreements • Optimizing your marketed product pipeline with innovative drug
• Assessing the potential of a CMOís global reach with regards to delivery and manufacturing capabilities from your CMO
• Extending product lifecycle through new product launches
manufacture, supply channels, quality/regulatory requirements
• Compiling a data set in order to rank and risk assess potential CMOs Adam Sabouni, Ph.D., President & CEO, PharmaArtz, Inc.
Jim Browne, Director, Contract Manufacturing, Europe,
GlaxoSmithKline 3.00 Afternoon Networking Break
Paul Kanan, Vice President, Operations, Agensys, Inc.
Alex Badal, Director, Global Strategic Sourcing Supply, Valeant 3.45 Due Diligence within the Selection Process of
Pharmaceuticals Your CMO
Adam Sabouni, Ph.D., President & CEO, PharmaArtz, Inc. • Reviewing the internal J&J due diligence process for CMO selection
• Examining key points critical for future success
• Managing risk with CMO – Developing an aligned approach to
10.15 Morning Networking Break
benefit both parties
• Maximizing product lifecycle with an aligned approach with a “like-
11.00 Creating a Sourcing Strategy within Your
minded” CM
Organization • Developing the future due diligence relationship for a CMO from
• Strategizing opportunities to increase a large biotech's ability to
both a business and compliance angle
create a suitable sourcing strategy
• Recognizing late product lifecycle: Outsourcing to maintain product
Jim Damon, Regional Director, External Manufacturing, Johnson &
Johnson Consumer Healthcare
market performance, while saving costs
• Maximizing product lifecycle with an aligned approach with a ìlike-
mindedî contract manufacturer 4.30 Maximizing Innovation: Addressing the Importance
• Maximizing product lifecycle through an aligned approach with a to Small Biotech’s And Start-Ups
“likeminded’ contract manufacturer finding/locating/attracting a
• Identifying successful strategies in order to go about
suitable CMO finding/locating/attracting a suitable CMO
• Unearthing the breakdown of manufacturing costs: How to locate
Paul Hingst, Senior Manager, Contract Manufacturing, Amgen
cost-saving solutions and techniques within your outsourcing supply
11.45 Successfully Organizing and Adapting Your Internal chain
• Locating the correct CMO geared to working with small-scale/ start-
Structure to Effectively Handle a CMO
up companies
As big pharma sheds its in-house manufacturing sites, more and more • Discussing the importance on focusing on your pilot projects from
companies are turning to Custom Manufacturing Organizations
start to finish
(CMOs). A successful collaboration involves harmonizing many • Discussing case study examples
different activities. This panel discussion will discuss a number of the
Michael Ramsay, Contract Managing Expert, Biopharmassist, Inc
key drivers for success in a relation with a CMO.
• Successful selection of a CMO: What to look for in a partner
• Technology transfer: The elements for speed, accuracy and success 5.15 Chairpersons’ Closing Remarks and End of Day One
3 Sponsored by:

4. Main Conference Day 2 Wednesday,
May 12, 2010
7.45 Registration and Coffee 12.30 Networking Lunch
8.30 Welcome Address and Regulatory Compliance and Compatibility
Chairpersons’ Opening Remarks
1.30 A Regulatory Approach for Contract Manufacturing
Risk Management and Mitigation • Addressing the impact of the FDA draft guidelines on
manufacturing process
8.45 Mitigating the Risks When Outsourcing • QBD initiatives: How does your organization compare on trend
Pharmaceutical Manufacturing monitoring data
• Discussing Q9 – Design process
• Understanding the range of Quality and Business risks you may need
• Examining Q10 – Commercial
to manage
• Developing with partner a common understanding of which party is • Becoming compliant as the key to continuous improvement
• Developing a robust risk mitigation strategy to prevent negative
managing which risk
• Displaying the importance of constant risk management rather than consequences of non-compliance by the CMO
just an initial assessment Prasad Gogineni, Associate Director, Pharmaceutical Technology,
• Examining best practice risk management strategies and the Watson Laboratories
practicalities of managing risk
• Evaluating lessons learnt and how that knowledge has and can be 2.15 Working with an Overseas CMO to Gain FDA
applied to future projects Inspection and Approved Status
Rebecca Tholmer, Manager, Quality Systems, Baxter Bioscience • Discussing due diligence with foreign CMOs to determine best
candidates for success
9.30 Understanding the Essential Elements for Successful • Examining common obstacles to overcome within the transfer or
Technology Transfer development process and getting to FDA approvable status
• Outlining contract types and deal points when helping a foreign
• Establishing the project plan: site readiness, suppliers, raw material
inventories, and risk assessment CMO gain an FDA inspection
• Monitoring the project plan: milestones, anticipate slippage early, • Displaying a specific Case study of Italian CMO
back-up plans/strategy Earl Sullivan, Chief Executive Officer, Landela Pharmaceutical, Inc.
• Understanding the latest compliance requirements and performing a
gap assessment with the initial product validation 3.00 Afternoon Networking Break
• Managing the financials (considering approval and delivery timelines
for capital expenditures i.e. new processing equipment) Multiple Project and Cost-Effective Strategies
Nicole S. Ferrari, Engineering and Contract Manufacturing Manager,
Bausch & Lomb Pharmaceuticals 3.30 Panel Discussion: In-House Vs. Outsource: How to
Decide and Then How You Can Generate Savings
10.15 Morning Networking Break Whilst Maintaining Quality and Efficiency
• Outlining the key factors considered when looking to outsource:
11.00 Roche/Genentech's Risk-Based Approach to CMO • Economics, technological capabilities and in-house capacity
Management • Reviewing the decision-making process and timelines involved
• Preliminary evaluation of contract manufacturers: How do you cover
• Discussing how Roche and Genentech's reliance on contract
manufacturing has dramatically increased over the past 10 years all the bases?
• Examining why the company put into place a Contract Management • Parameters that lead you to make a decision on your manufacturing
Operational unit with a goal to manage a global network of CMOs operations
• Displaying how both Roche and Genentech's outsourced clinical and • How do you handle the relationship and generate savings in
commercial products external supply chains within the current economic climate?
• Relying on the management of risk throughout the CMO lifecycle; Jim Browne, Director, Contract Manufacturing, Europe,
from selection to decommissioning, CMO risk profiles serve as the GlaxoSmithKline
basis for decision-making Doris St. John, Manager Supplier Quality GPSG, Johnson &
• Evaluating a flexible approach depending on the product Johnson
development phase, the CMO performance history and the scope of Prasad Gogineni, Associate Director, Pharmaceutical Technology,
CMO activities Watson Laboratories
Franco Pasquale, Senior Manager, Roche Contract Manufacturing
Operating Unit 4.15 Execution of Multiple Outsourcing Projects
• Designing a framework for your organization when considering
11.45 Assessing Risk Management of the Quality System of multiple projects with a CMO at one time
Your CMO • Successfully managing several small and medium size projects
• Utilizing a risk-based auditing approach simultaneously
• Realizing warning signs from outsourced projects and providing
• Using a monitoring plan for your suppliers in lieu of an audit
• Evaluating ongoing quality performance of your suppliers mitigation plans
• Importance of Quality Agreements • Prioritizing projects in terms of importance and delivery date
• Discussing qualification of suppliers from a quality standpoint Ralph L. Dillon, Director, Compliance Surety Associates
• Key areas for supplier audits
Doris St. John, Manager Supplier Quality GPSG, Johnson & 5.00 End of Conference & Chairpersons’ Closing Remarks
Johnson
4 REGISTER ONLINE AT www.PharmaContractManufacturing.com OR CALL US AT 1-800-882-8684

5. Pre-Conference Workshops Monday,
May 10, 2010
Workshop A 11.00am – 2.00pm (Registration at 10.30am, Lunch Included)
Simplifying Outsourcing Decisions and Project Execution with Cloud Computing and SaaS (Software-as-a-
Service) Solutions
This workshop will evaluate functionality and TCO of traditional What you will learn:
procurement systems ranging from enterprise systems to desktop software • Displaying solutions through procurement systems
used for emailed RFPs with an emphasis on cloud computing and SaaS • Evaluating systems used for emailed RFPs with an emphasis on cloud
solutions used by industry-leading organizations including Genentech and computing and SaaS solutions
Amylin. This will discuss security considerations in the adoption of these • Discussing security considerations in the adoption of these systems
systems and in the transfer of data from legacy systems. • Examining the transfer of data from legacy systems
Intended Audience Benefits of attending:
Any person involved in screening vendors using RFPs or executing projects Most companies outsource, whether it's product development to CMOs, IT services
with external partners for services and products including: or HR, to conserve resources and focus on core competencies. Very often, the cost
1. Capital equipment purchases of the outsourcing process is underestimated if calculated at all. Most companies
2. Construction projects do not realize that there are cost-effective solutions that are accessible to them
3. CMO projects regardless of size- SAP and Oracle are no longer the only options.
4. HR services
Your Workshop Leader:
5. IT services
Premila Anand, Managing Director, SourceSolution
6. Sales and marketing services
Workshop B 2.30pm – 5.30pm (Registration at 2.00pm, Coffee Served)
Using a CMO Model as the Fastest and most Cost Effective Path from Development Though Marketed Product
Optimizing manufacturing operations externally can be a challenging Benefits of attending:
responsibility. This workshop will address and analyze the CMO model as • Financial leaders will be interested in this workshop as a means to use scarce
an option for developing and manufacturing your product in the most capital more effectively by shortening the investment to return cycle and
cost-effective manner, without jeopardizing quality. reducing risk
• Technical staff will be interested in this workshop as a means to extend
What will be covered: scarce talent resources and achieve their business objectives more quickly
• CMO dosage development
• Relevant for HR & training professionals as a means to train qualified
• CMO qualification batches and market launch product
• Concurrent capital project development at NDA holder
people more effectively before the initiation of a new production line
• Tech transfers, training, and rapid precise start-up deployment
Your Workshop Leader:
• Regulatory agency considerations (FDA EMEA etc.)
Ralph L. Dillon, Director, Compliance Surety Associates
• NDA management strategic and financial advantages
Registration Information
Sponsorship and Pricing Register and Pay Register and Pay Standard
Exhibition Opportunities By 3/26/2010 By 4/16/2010 Price
Conference Only $1,199 (save $600) $1,599 (save $200) $1,799
Sponsorships and Exhibits are excellent opportunities for
your company to showcase its products and services to All Access $2,199 (save $698) $2,599 (save $298) $2,799 (save $98)
high-level, targeted decision makers attending10th
Contract Manufacturing for Pharmaceuticals and Biotech. Workshops $549 each $549 each $549 each
Pharma IQ and the International Quality & Productivity
Center (IQPC) help companies like yours achieve sales, * All prices include lunches, refreshment and detailed conference For IQPC’s Cancellation, Postponement and Substitution Policy,
marketing and branding objectives by setting aside a materials. Contact us at 1-800-882-8684 for special dietary please visit www.iqpc.com/cancellation
limited number of event sponsorships and exhibit spaces – requirements. MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC
all of which are custom-tailored to help your company * Discount cannot be combined
Details for making payment via EFT or wire transfer:
create a platform to maximize its exposure at the event. Team Discounts JPMorgan Chase
Contact Customer Service at 1-800-882-8684 for the following Penton Learning Systems LLC dba IQPC: 957-097239
discounts: ABA/Routing #: 021000021
Visit us on the web and see what other exciting and TEAM: Only one discount may be applied per registrant. Reference: Please include the name of the attendee(s) and the event
information-packed conferences are being offered by NON-PROFIT, GOVERNMENT, ACADEMIA: Call for more information. number: 10854.005
the International Quality and Productivity Center! To PAYMENT INFORMATION: Special Dietary Needs: If you have a dietary restriction, please contact
find out more about upcoming Pharma IQ events, A $99 processing charge will be assessed to all registrations not Customer Service at 1-800-882-8684 to discuss your specific needs.
contact Mario Matulich at (212) 885-2719 or via accompanied by credit card payment at the time of registration
©2010 IQPC. All Rights Reserved. The format, design, content and
email at sponsorship@iqpc.com. Payment Policy: Payment is due in full at the time of registration. arrangement of this brochure constitute a trademark of IQPC.
Your registration will not be confirmed until payment is received and Unauthorized reproduction will be actionable under the Lanham Act
may be subject to cancellation. and common law principles.
About Our Sponsor:
Cherokee Pharmaceuticals
Website: www.cherokee-pharma.com
Cherokee Pharmaceuticals is a custom manufacturer located in the heart of rural Pennsylvania. Formerly a dedicated production facility for Merck,
Cherokee offers route scouting, optimization and scale-up of complex, multi-step chemistry from phase one through commercial supply. Complete
analytical support including method development and validation are also provided. Cherokee has a background with all major chemistries and has
unparalleled experience in working with anti-infectives, including anti-viral compounds, and oncology products in an FDA regulated environment
5 REGISTER ONLINE AT www.PharmaContractManufacturing.com OR CALL US AT 1-800-882-8684

6. International Quality & Productivity Center
REGISTRATION CARD 535 5th Avenue, 8th Floor
YES! Please register me for New York, NY 10017
10th
Contract Manufacturing
for Pharmaceuticals and Biotech
TM
❑ Conference only (11-12 May 2010) ❑ Workshop(s) Only ❑ A ❑ B
❑ All Access (10-12 May 2010) (10-12 May 2010)
See Page 5 for pricing details.
Your customer registration code is:
When registering, please provide the code above.
Name__________________________________ Job Title ________________________
Organization____________________________________________________________
Approving Manager______________________________________________________
Address_______________________________________________________________
City__________________________________State______________Zip___________
Phone________________________________Fax_______________________________
E-mail__________________________________________________________________ 5 EASY WAYS TO REGISTER:
❑ Please keep me informed via email about this and other related events. 1 Web: www.PharmaContractManufacturing.com
❑ Check enclosed for $_________ (Payable to IQPC) 2 Call: 1-800-882-8684 or 1-646-378-6026
❑ Charge my __Amex __Visa __Mastercard __Diners Club 3 Email: info@iqpc.com
Card #__________________________________Exp. Date___/___CVM Code_____ 4 Fax: 1-646-378-6025
Details for making payment via EFT or wire transfer can be found on 5 Mail: IQPC
preceding page. 535 5th Avenue, 8th Floor,
❑ I cannot attend, but please keep me informed of all future events. New York, NY 10017
10854.005/D/KR
The MUST ATTEND Contract
Manufacturing event of the year!
10th
Contract Manufacturing
for Pharmaceuticals and Biotech
TM
Mitigating Risks, Ensuring Compliance, and Improving Efficiency May 10-12, 2010
for Domestic and International Outsourced Manufacturing San Francisco, CA
Key areas this conference will be focusing on include:
• Assessing Risk Management of the Quality System of Your CMO • Analyzing the CMO Market: Tools for Choosing a Preferred CMO
• Roche/Genentech's Risk-Based Approach to CMO Management • A Regulatory Approach for Contract Manufacturing
• Mitigating the Risks When Outsourcing Pharmaceutical Manufacturing • Understanding the Essential Elements for Successful Technology
• Working with an Overseas CMO to Gain FDA Inspection and Approved Transfer
Status • Using CMOs as a Resource to Tap into a New Product Market
Sponsored by: Media Partner:
Register Today! Call 1-800-882-8684
visit www.PharmaContractManufacturing.com