Managing CMOs to Deliver Your Product to Your Quality & Time Requirement

1. REGISTER BY FeBruary 25
AND SAVE $400!
CMo Quality oversight
& risk ManageMent
Managing CMOs to Deliver Your Product to Your Quality & Time Requirements
April 28th – 29th, 2011, Omni Parker House Hotel, Boston MA
Featured Presentations: sPeaking FaCulty
regulatory Perspective on Quality assurance within the evolving dhan amaria, Director, Quality Assurance,
Contract Manufacturing relationship NEKTAR THERAPEUTICS
sandra roque, Director, Manufacturing QA, NOVEN PHARMACEUTICALS rhonda Fendelet, Director, External Supply
Integration Quality – PDMS, JANSSEN SUPPLY CHAIN
applying a risk Management system to the Contracting Process rolf hartmann, Procurement Director,
to sustain the highest level of Quality from a CMo/sponsor GLAXOSMITHKLINE
relationship Juanita hawkins, Vice President, Global
Caroline o’Brien, Associate Director QA Sourcing, Pharmaceutical Quality Assurance and Compliance, CELGENE
Development, ASTRAZENECA Jeff huth, Ph.d., Leader, Quality & Compliance,
JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH &
how overall Product lifecycle and Product Phases including DEVELOPMENT
Commercialization Can Factor into the Contract Manufacturing denise Mcdade, Senior Director, Quality
relationship Assurance, AMYLIN PHARMACEUTICALS
Jeff huth, Ph.d., Leader, Quality & Compliance, robert o’hagan, Director Quality Operations,
JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH & DEVELOPMENT ABBOTT BIORESEARCH CENTER
Caroline o’Brien, Associate Director QA
Sourcing, Pharmaceutical Development, ASTRAZENECA
Featured Panel disCussion: sandra roque, Director, Manufacturing QA,
NOVEN PHARMACEUTICALS
global Considerations and Business differences when Contracting Prashant savle, Ph.d., Director, Sourcing,
an off-shore CMo Partner: how Close are We to a harmonized Global Procurement, MERCK SHARPE & DOHME
standard of gMP? Michael semo, Global Sourcing Manager, Virtual
Panelists: CMC Team, ELI LILLY & COMPANY
Prashant savle, Ph.d., Director, Sourcing, Global Procurement,
MERCK SHARPE & DOHME g. sean Williams C.P.M., sCor-P,
Associate Dir, Global Facilities Procurement,
Michael semo, Global Sourcing Manager, Virtual CMC Team, BRISTOL-MYERS SQUIBB
ELI LILLY & COMPANY
Janice B Wilson, Phd, Vice President
dhan amaria, Director, Quality Assurance, NEKTAR THERAPEUTICS Corporate Quality Assurance, ELAN PHARMACEUTICALS
To R e gister Call 866-207-6528 or visit www.exlpharma.com/ c m o

2. Dear Colleague, This Summit is specifically
designed for C-Levels, Department
There is industry agreement that a substantial investment must be made to Heads, Vice Presidents, Directors
support the life-cycle of a pharmaceutical product from the developmental stage and Managers at pharmaceutical,
to commercial production. There is also definitive data that shows in addition to biotechnology and medical device
the FDA, regulatory bodies worldwide are becoming more and more conservative companies from the following
with the candidates they approve for commercial access. departments:
Within the contract manufacturing relationship, pharmaceutical companies are
taking the necessary steps to adjust to this changing industry trend, providing  Contract manufacturing
increased resources to ensure control and consistency in the manufacturing of
 manufacturing Operations
their products to avoid unnecessary delays including regulatory action.
 Regulatory Affairs
Join us April 28th - 29th where presentations dedicated to the successful CMO  Regulatory Compliance
partnership dynamic will be shared, including best practices in management such  Validation
as quality oversight, risk management, and ensuring time requirements are met.  Compliance
The FDA has made it clear that if your name is on the label, you are responsible
 Quality Assurance
for what’s inside the package.
 Quality Operations
Look forward to seeing you in Boston!  Quality Development
 Outsourcing
Sincerely,  Sourcing
 Supply Chain
 Operational Excellence
Matthew Millman
Senior Conference Director
mmillman@exlpharma.com
Sponsorship and
Exhibit Opportunities
OmNI PARkER
HOuSE HOTEl Do you want to spread the word
about your organization’s solutions
60 School Street and services to potential clients who
Boston, MA 02108 attend this event? Take advantage of
P:617-227-8600 the opportunity to exhibit, present an
educational session, host a networking
event, or distribute promotional items to
attendees. ExL works closely with you
As you pass through the sculpted bronze doors of this luxury Boston hotel, you to customize a package that suits all of
will be enveloped by the timeless beauty that has made the Omni Parker House your needs.
a landmark since 1855. Experience the perfect blend of modern amenities and
historic charm at America’s oldest continuously-operating hotel. Walk to Beacon To learn more about these opportunities,
Hill, Faneuil Hall Marketplace, Quincy Market, the Financial District, shopping and contact Eric Morrin, Business
more. Just 2.5 miles (10-15 minutes) from Logan International Airport. Development Manager by calling
212-400-6228 or by emailing
room reservations: If you require overnight accommodations, please contact the hotel
and state that you are with ExL’s CMO Quality Oversight & Risk Management Conference for emorrin@exlpharma.com.
information on our discounted room rates. We encourage conference participants to make
reservations by Wednesday, April 6th with our designated venue as our discounted room
rates are limited.
To R e g i ster Call 866-207-6528 or visit www.exlpharma.com/c m o

3. day one – aPril 28th, 2011
Pre-ConFerenCe WorkshoP
8:00 Registration Opens and Continental Breakfast
is Served for Workshop Attendees
9:00 selecting a CMo Partner
How Including Quality Early in the Selection Process can Ensure a
Stronger Overall Partnership
Led By: Janice B Wilson, PhD, Vice President Corporate Quality Assurance,
ELAN PHARMACEUTICALS
• Including quality in the selection process
- Transparency and accessibility of a potential partners’ quality history
- What quality factors to look for from a partner
- What issues can kill the deal?
• Designing quality agreements with clear criteria that define the responsibilities of an
outsourced partner
- Identifying the important deliverables that need to be included in the Quality Agreement
- Customizing a Quality Agreement that fits a specific project aspect
- Determining which types of agreements to use – technical versus quality? What is the difference?
- Modifying a Quality Agreement to reflect existing regulations and industry standards
*There will be a 30-minute coffee and networking break during the workshop
12:00 Lunch for Workshop Attendees / Registration
Opens for Main Conference
Main ConFerenCe
3:00 networking & refreshment Break
1:15 Chairperson’s Welcome and Opening Remarks
3:30 Case study: integrated Facilities
1:30 keynote talk: CMo Management outsourcing
ManageMent strategy
Thinking with the End in Mind: Driving a Streamlined Global
Integrated Facilities Management Outsourcing Deal from Concept
Aligning Your Corporate Philosophy and Your CMO Outsourcing to Implementation
Strategy to Achieve Business Objectives G. Sean Williams C.P.M., SCOR-P Associate Dir, Global Facilities
Juanita Hawkins, Vice President, Global Quality Assurance and Procurement, BRISTOL-MYERS SQUIBB
Compliance, CELGENE • Evaluating the pros and cons to understand whether an IFM program fits into your
• Gaining internal buy-in and understanding the risk related to strategy company’s strategic planning
• Critical decision making for internal, external or hybrid manufacturing allocation • Building the appropriate quality and performance measurements in the negotiation
• Clarity for expectations, delegating work versus responsibility, and control to prevent post implementation margin erosion
• Key drivers of Service Provider downselecting outside of cost
2:15 regulatory Perspective 4:15 Communication
The Roadmap for Successful Communication within a Partnership that
Regulatory Perspective on Quality Assurance within the
Drives Quality Oversight Success
Evolving Contract Manufacturing Relationship
Rhonda Fendelet, Director, External Supply Integration Quality – PDMS,
Sandra Roque, Director, Manufacturing QA, NOVEN PHARMACEUTICALS
JANSSEN SUPPLY CHAIN
• Agency concerns over business procedures
• The governance model and deployment of Communication Plan
• Expectations for both sponsors and contract sites during inspections and GMP
• Clarifying roles & responsibilities within the relationship to avoid dysfunction
assessments
• Using metrics and feedback as the key performance indicators for success
• Best practices to ensure that sponsors, contract manufacturers and regulatory
agencies are all on the same page
• Upcoming anticipated guidance for selection of a contract facility and
conducting audits 5:00 Close of day one
To R e g i ster Call 866-207-6528 or visit www.exlpharma.com/c m o

4. day tWo – aPril 29th, 2011
international Considerations
Main ConFerenCe 11:45
PANEL DISCUSSION: Global Considerations and Business Differences
when Contracting an Off-Shore CMO Partner: How Close are We to
9:00 Chairperson’s Day Two Welcome and a Harmonized Standard of GMP?
Opening Remarks Panelists Include:
Dhan Amaria, Director, Quality Assurance, NEKTAR THERAPEUTICS
Prashant S Savle, Ph.D., Director, Sourcing, Global Procurement,
9:05 lifecycle Considerations MERCK SHARPE & DOHME
Michael Semo, Global Sourcing Manager, Virtual CMC Team,
How Overall Product Lifecycle and Product Phases Including ELI LILLY & COMPANY
Commercialization Can Factor into the Contract Manufacturing • What are the differences between a domestic partner and an international
Relationship one, if any?
Jeff Huth, Ph.D., Leader, Quality & Compliance, • What cultural considerations should be made prior to commencement of the
JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH & DEVELOPMENT partnership and how do these affect the level of communication and expectations?
Contract Manufacturing Organizations face an evolutionary dilemma in trying to • How does risk acceptability vary between a sponsor and a contract partner?
establish their business plan strategy and technical capabilities every day. While clearly
there is a capital investment consideration in this regard, there are also key technical,
operational, and regulatory considerations. 12:30 lunch
This Session will Examine:
• Elements associated with pharmaceutical product life-cycle as they relate to the
technical, operational, and regulatory issues 1:30 Metrics
• Discussion on the significance of the partnerships required to successfully manage Using KPIs and Operational Excellence to Ensure Quality in an
the evolutionary pharmaceutical product life-cycle Outsourced Supply Chain
• How ICH guidance concepts (in particular, ICH Q10) can provide a platform to not Denise McDade, Senior Director, Quality Assurance,
only manage the relationship, but to enhance it. AMYLIN PHARMACEUTICALS
• Setting quality oversight standards that drive the level of performance
measurement and data collection
• Building a corporate culture that can create a strategy to meet the standards
9:45 risk Management necessary for quality excellence
Applying a Risk Management System to Vendor Assurance and Supplier • Adopting risk-shared principles that extend accountability to a project-wide scope
Management in Development
Caroline O’Brien, Associate Director QA Sourcing, Pharmaceutical 2:15 aPi development
Development, ASTRAZENECA Keys for Successful Contract Manufacturing of Biological API’s to
• Clearly and thoroughly translating risk factors for materials, processes and suppliers Support Clinical and Commercial Material
• Understanding of Supply Chain and application of risk managed supplier auditing Robert O’Hagan, Director Quality Operations,
• Development and maintenance of the holistic approach to Supplier Management ABBOTT BIORESEARCH CENTER
• CMO Selection Considerations
• Successful Business Model for CMO through product lifecycle
10:30 networking & refreshment Break • Quality Agreements and Regulatory Considerations
3:00 Closing Panel disCussion:
11:00 spotlight session: outsourcing and Decommissions, Facing Problems, and Accepting that the Partnership
Quality in latin america is Faulty – What Should be Done to Minimize the Failure
Considerations when Contracting a CMO Partner in Latin America: Featuring Conference Presenters
Regional Benefits & Constraints • What are the initial steps to be taken once a partnership is disconnected?
Rolf Hartmann, Procurement Director, GLAXOSMITHKLINE • How to calculate the financial implications from the missteps that have occurred?
• Examining cost differences between CMOs in Latin America and other Regions • Determine what the consequences are and if they can be fixed?
• Ensuring quality standards and regulatory requirements are met and kept when • What are the public and reputational damage that has been done?
working with an international CMO
• Latin America regional snap-shot: contracting in traditional versus
non-traditional countries 3:45 Close of Conference
To R e g i ster Call 866-207-6528 or visit www.exlpharma.com/c m o

5. Five Ways to register RegistRation Fees FoR attending
exl’s CMo Quality oversight &
PHOnE: 866-207-6528 risk ManageMent ConFeRenCe:
EMAIL: register@exlpharma.com
OnLInE: www.exlpharma.com Best value
REgISTER By FRIDAy, FEBRuARy 25TH AnD SAvE $400!
FAx: 888-221-6750
COnFEREnCE + WORkSHOP | $1795
MAIL: ExL Events, Inc.
COnFEREnCE OnLy | $1495
555 8th Ave, Ste 310
new york, ny 10018
early-Bird PriCing
REgISTER By FRIDAy, MARCH 25TH
TO TAkE ADvAnTAgE OF EARLy-BIRD PRICIng:
Group Discount proGram: COnFEREnCE + WORkSHOP | $1995
COnFEREnCE OnLy | $1695
save 25% Per Person When registering Four
For every three simultaneous registrations from your
company, you will receive a fourth complimentary standard PriCing
registration to the program (must register 4 at one REgISTER AFTER MARCH 25TH:
time). this is a savings of 25% per person.
COnFEREnCE + WORkSHOP | $2195
save 15% Per Person When registering three COnFEREnCE OnLy | $1895
Can only send three? You can still save 15% off of
every registration. to find out more on how you can visit WWW.exlPharMa.CoM/CMo
take advantage of these group discounts, please call
TO VIEw OuR VAluE JuSTIfICATION DOCumENT!
866-207-6528.
Make checks payable to exl events, inc. and write code
mEDIA PARTNERS
P742 on your check. You may also use Visa, MasterCard,
discover or american express. Payments must be received in
full 2 weeks prior to the conference.
Cancellations: if you need to cancel your registration for an
upcoming exL conference, please note the following policies
derived from the start date of the event:
• Four weeks or more: a full refund (minus a $95
processing fee), or a voucher to another exL event valid
for two years from the voucher issue date
Four weeks or less: a voucher to another exL event
valid for two years from the voucher issue date.
• to receive a refund or voucher, please fax your request to
888-221-6750.
• there will be an administrative charge of $300 to
substitute, exchange and/or replace attendance badges
with a colleague occurring within five business days of
the conference.
Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation,
every effort to find a suitable replacement will be made. ExL Pharma’s liability is limited to the conference registration
fee in the event of a cancellation
*The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.*
QuESTIONS? COmmENTS?
do you have a question or comments that you would
like to be addressed at this event? Would you like to get
involved as a speaker or discussion leader?
Please email Conference director, Matt Millman at
mmillman@exlpharma.com

6. Fax: Telephone:
Email:
Zip: State: City:
Address:
Dept.:
Company:
Title: Name:
PLEASE MENTION PRIORITY CODE: P742  I wish to receive email updates on ExL Pharma’s upcoming events
New York, NY 10018  I’m interested in marketing opportunities at this event
555 8th Avenue, Suite 310 Please contact me:
Yes! Register me for the conference only 
Signature:
Yes! Register me for the conference and workshop: 
Name on Card:
www.exlpharma.com/cmo
Exp. Date: Card Number:
registration@exlpharma.com
New York, NY 10018
MasterCard  Visa  Discover Amex Card Type: 888-221-6750
555 8th Avenue, Suite 310
Make checks payable to ExL Events, Inc.
866-207-6528 ExL Events, Inc.
 Check Credit Card Method of Payment:
Registration Form:
REGISTER BY FeBruary 25
AND SAVE $400!
CMo Quality oversight
& risk ManageMent
Managing CMOs to Deliver Your Product to Your Quality & Time Requirements
April 28th – 29th, 2011, Omni Parker House Hotel, Boston MA
Featured Presentations: sPeaking FaCulty
FroM these CoMPanies
Regulatory Perspective on Quality Assurance How Overall Product lifecycle and Product Phases
within the Evolving Contract manufacturing Including Commercialization Can factor into the NEKTAR THERAPEUTICS NOVEN
Relationship Contract manufacturing Relationship PHARMACEUTICALS
MERCK
ELI LILLY & COMPANY
Applying a Risk management System to the Global Considerations and Business Differences GLAXOSMITHKLINE
Contracting Process to Sustain the Highest level of when Contracting an Off-Shore CmO Partner: How BRISTOL-MYERS SQUIBB
CELGENE
Quality from a CmO/Sponsor Relationship Close are we to a Harmonized Standard of GmP? ELAN
ASTRAZENECA PHARMACEUTICALS
To R e gister Call 866-207-6528 or visit www.exlpharma.com/ c m o