Creating Added Value in the Preclinical and Clinical Areas through a Culture of Continuous Improvement

1. RegisteR By JanuaRy 21st foR MaxiMuM savings!
6σΣ
The 4th
Proudly
Presents:
[ Lean Sigma & Kaizen for
Pharma R&D Conference ]
Creating Added Value in the Preclinical and Clinical Areas
through a Culture of Continuous Improvement
MaRCh 1st – 2nd, 2011 • hYaTT REgENCY MiaMi • MiaMi, FloRida
Participating FEaTuREd PRESENTaTioNS
Companies establishing a Business Process Management Capability
in Pharmaceutical R&D
ABBOTT Paul Knight, Director, R&D Productivity & Continuous
Improvement, BRISTOL-MYERS SQUIBB
ALCON LABORATORIES accelerating Pre-Clinical Development using Lean six sigma
Martin Hynes, Senior Director, Six Sigma Champion,
BRISTOL-MYERS SQUIBB ELI LILLY & CO.
CENTOCOR examination of a newly Developed enterprise-Wide
Process at Pfizer: “Building Quality-in for the trial
ELI LILLY & CO. Master file Process”
Ivan Walrath, Trial Master File Process Owner, PFIZER
JOHNSON & JOHNSON Linne Svensson, Process Engineer, Continuous
Improvement Specialist, PFIZER
MERCK
PRE-CoNFERENCE WoRkShoP
NOVO NORDISK Mapping Critical Questions in R&D–Creating strategic Direction and
flexible, fast Learning structures to support Clinical Research
PFIZER WoRkshoP LeaDeRs:
Terry Barnhart, Senior Director of Strategy and Continuous Improvement,
PFIZER
Arnoud H.J. Herremans PhD, Behavioral Pharmacologists, Local Unit
Manager, Preclinical Candidate Selection Unit, ABBOTT
To REgiSTER: Call 866-207-6528 or visit us at www.exlpharma.com/4thlean

2. [A History of Success] Who Should Attend:
This Summit is specifically designed
for life science professionals at
pharmaceutical, CRO, and Medical
Device companies from the following
★★ departments:
★
• Clinical Operations
★ • R&D Operations
• Clinical Research
• Continuous Improvement
• Quality Assurance/Control
• Supply Chain
• Clinical Outsourcing – Planning and
February 2008 March 2009 September 2009 March 2010 September 2010 Vendor Management
• Operational Excellence
[Attendee Experience Level] • Strategic Business Development/
Operations
• Project/Study Management/Project
Planning
Associate, 49% • Manufacturing & Supply
Coordinator Level 14% Vice-President, • Clinical Trial Capacity Planning/
Director Level
Management
• Clinical Trial Process Improvement/
37% Enhancement
Senior Manager, • Metrics and Benchmarking
Manager Level
• Performance Management
• Global Strategic Operations/
Development
[Hotel Information] • Strategic Development
• Business Excellence
hyatt Regency Miami • Business Process Development
400 South East Second avenue • Miami, Florida • Process Technology Improvement
Tel: +1 305 358 1234 • Fax: +1 305 358 0529 • Industrial Operations
• Information Technology
Move with the rhythm of the city at our downtown Miami hotel. The striking white towers
of Hyatt Regency Miami overlook Biscayne Bay and connect to the Convention Center
This conference is also of interest to:
providing effortless access to everything from Brickell and Coral Gables to Coconut Grove
and world-famous white sand beaches. Our newly updated Hyatt hotel in downtown • Clinical Research Organizations
Miami offers an outstanding array of amenities – including the city’s largest meeting • Business Process Consultants
space, dramatic bayside or skyline views from spacious guestrooms, and a lively bar and • Quality Improvement and Statistics
restaurant. Discover this exclusive setting among downtown Miami Florida hotels and Software Providers
experience the excellence you’ve come to expect from Hyatt. • Academic Clinical Research
Institutes
Room Reservations: • Six Sigma Project Management
If you require overnight accommodations, please contact the Hyatt Regency Miami at Software Providers
305-358-1234 and mention our discounted room rates. We encourage conference
participants to make reservations by Wednesday, February 3rd with our designated
venue as our discount room rates are limited.
To REgiSTER: Call 866-207-6528 or visit us at www.exlpharma.com/4thlean

3. DAY ONE • Tuesday, March 1, 2011
Pre-Conference Workshop – Mapping Critical Questions Workshop Session
8:00 REGISTRATION OPENS AND CONTINENTAL BREAKFAST IS SERvED
FOR WORKSHOP ATTENDEES
9:00 Mapping Critical Questions in R&D – Creating Strategic Direction and Flexible, Fast
Learning Structures to Support Scientific Quality and Speed from Idea to Launch
WORKSHOP LEADER:
Terry Barnhart, Senior Director of Strategy and Continuous Improvement, PFIZER
Arnoud H.J. Herremans PhD, Behavioral Pharmacologists, Local Unit Manager,
Preclinical Candidate Selection Unit, ABBOTT
Critical question mapping background:
• What is critical question mapping?
• How critical question mapping can be used to support quality, creativity and speed of science in pharmaceutical R&D
• How mapping works to set strategic direction and gain alignment within the scientific team
• How to map critical questions for your business needs
• How to convert critical question maps into fit for purpose value streams
Full contact mapping session:
• The audience will identify several strategic opportunities they’d like to explore
• Selecting an opportunity of interest, each audience member will gather in teams to map along
the walls of the conference room, the critical questions needed to solve that opportunity
Take-Aways:
• Practice a new technique to
◆ Define scientific direction across multiple functions
➤ Identify the right scientific problems and set them in sequence and priority
➤ Define cross-functional dependencies and interactions
◆ Create management strategy and systems for execution
◆ Gain cross-functional alignment on strategy
• Learn how to convert that strategic direction into new R&D (or other) value streams
◆ Define the right experiments to achieve success within cost, time, quality constraints
◆ Create fast, flexible management systems based on learning
◆ Ensure on-time delivery of novel science
12:30 LUNCH FOR WORKSHOP ATTENDEES / REGISTRATION OPENS FOR MAIN CONFERENCE
Main Conference Begins
1:30 Chairperson’s Welcome and Opening Remarks Bob Moroz, Associate Director, Global Clinical Research
Operations, MERCK
Clinical improvement David Rodin, Head of Business Performance Management, Global
Clinical Trial Operations, MERCK
1:35 Using Process Improvement to Improve Study Start-Up in Latin • Identifying process improvement tools and which ones work best for
America and Other Regions a desired function
• Defining waste and solutions for removing it – why it exists and how it
Alister Thomson, Director, Strategic Process Optimization, builds in a clinical process
BRISTOL-MYERS SQUIBB • Applying process improvement to a real clinical process to show how
• Study start-up - similarities & differences with other regions of it removes waste
the world
• Recent experiences in using Lean Sigma projects to improve study Business Process Management
start-ups in Latin America
• Observations on fostering a continuous improvement culture in a 4:45 Establishing a Business Process Management Capability in
multinational clinical development organization
Pharmaceutical R&D
improving Clinical Research Efficiency Paul Knight, Director R&D Productivity Management, BRISTOL-
MYERS SQUIBB
2:15 Increasing Patient Recruitment Success and Regulatory Bristol-Myers Squibb’s R&D organization has added positions to its
Submission Efficiency of a Difficult Trial Using Process Productivity and Continuous Improvement function to enable Business
Process Management. The expanded group will map key cross-
Improvement
functional processes, partner with process owners to provide process
Terry Barnhart, Senior Director of Strategy and Continuous performance metrics and identify continuous improvement opportuni-
Improvement, PFIZER ties, and coordinate the launch of new process optimization projects.
• Critical success factors for optimizing enrollment Topics of this talk include:
• The business case for BPM
3:00 NETWORKING AND REFRESHEMENT BREAK • Strategic and tactical mission
• BPM roles and responsibilities
3:30 Deconstructing a Clinical Process to Identify Applications of
Lean: A Before-and-After Look at a Wasteful and Lean Clinical 5:30 COCKTAIL RECEPTION BEGINS
Operations Framework

4. DAY TWO • Wednesday, March 2, 2011
8:30 Chairperson’s Day Two Welcome and Recap Pre-Clinical improvement
8:35 Examination of a Newly Developed Enterprise-Wide Process at 10:45 Accelerating Pre-Clinical Development Using Lean Six Sigma
Pfizer: “Building Quality-In for the Trial Master File Process” Martin Hynes, Senior Director, Six Sigma Champion,
Ivan Walrath, Trial Master File Process Owner, PFIZER ELI LILLY & CO.
Linne Svensson, Associate Director, Continuous Improvement • Examining Lean Six Sigma’s relationship with the scientific method
Specialist, PFIZER • Differences of Lean Six Sigma in manufacturing and R&D
Global standards for Trial Master Files are evolving as Health Authori- • Examples of pre-clinical lean six sigma projects from a variety of
ties increase their scrutiny of the TMF. A process redesign effort at function will be shared
Pfizer has involved the introduction of several radical concepts in
terms of people, process and systems. 11:30 Applying the Concepts of Lean Product Development to
This talk will examine: Monoclonal Antibody Development
• The establishment of a single point of accountability, called a Process Bella Englebach, Senior Director, Strategic Business
Owner, for Trial Master Files who is responsible for the TMF process Improvement, CENTOCOR
across disciplines or traditional functions like Clinical Operations,
• Using Value Stream Mapping to understand the process from the
Regulatory Affairs, Data Management etc.
Compound Development Team’s experience
• Leveraging a Quality by Design approach, including identification of
• Which principles of lean NPD apply to drug development
critical to quality process elements
• Examples of improvement opportunities
• TMF content requirements/Reference Model and a comprehensive
review of documents generated by clinical trial conduct across func- Level Loading in the Lab: Getting to Flow
tional disciplines which go far beyond ICH E6 requirements
• Effective process performance metrics that provide views into the
Jill Carton, Associate Director, Biologics Research, , CENTOCOR
quality and status of the TMF throughout the study conduct Michael Naso, Associate Director, Biologics Research,
• Innovative approaches of retrieving TMF content from the system CENTOCOR
based on underlying business process rather than document type • Workflow variability in an R&D Discovery laboratory and the effect
on productivity
9:25 Case Study: Successful Application of Lean Principles in a • Re-design using level loading for increased productivity and
Dynamic R&D Regulatory Environment to Streamline the decreased overburdening
6σΣ
Labelling process • Early learnings from implementation in the lab
Shakeel Zaki Dar, Project Manager, Regulatory Affairs, Labelling 1:00 LUNCH
& IT, NOVO NORDISK
Focusing on; 2:00 Case-Study: How Key Performance Indicators Themselves
• Data rather than opinions and gut feelings
Have Matured within the Development of the Novo Nordisk
• How we avoided being de-tracked due to high expertise/deep
knowledge explanations Organisation
• How we used data to design solutions, rather than experts stating Tine Jørgensen, Ph.D., Department Manager, DRU cLEAN®
the solutions Partner, NOVO NORDISK A/S
• How important hand-over and focus can be (solution start drifting • The identification and development of process data and KPI’s
4 weeks after implementation) • The transmission of data and results throughout the organisation
• Defining the key drivers and tool for sustaining the benefits • How KPI’s are being used to drive the strategic direction of R&D
(MAAR charts)
Results 2:45 Reducing Time-to-Market: Focusing on the Critical Path!
• 60% decrease in lead time
John Wilmoth, Manager, Global Operations Excellence,
• 40% increase in throughput
ALCON LABORATORIES , INC.
• Decrease variation in output
• Successful focus on main contributors to long lead time • How reducing time-to-market impacts company profits
• Using Lean and Six Sigma tools to analyze Product Development
10:15 NETWORKING AND REFRESHMENT BREAK processes.
• The power of identifying the critical path in reducing time-to-market
• Moving from sequential to parallel process steps in Product
Development.
3:30 CLOSE OF CONFERENCE
[Sponsorship and Exhibiting Opportunities]
Do you want to spread the word about your organization’s solutions and services to potential clients who attend
this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event,
or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of
your needs. To learn more about these opportunities, contact Steve Decker, Business Development Manager, by
calling 212-400-6234 or by emailing sdecker@exlpharma.com.

5. [Media Partners] 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
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4th Lean Sigma & Kaizen for Pharma R&D Conference: of the event:
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To REgiSTER: Call 866-207-6528 or visit us at www.exlpharma.com/4thlean
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accelerating Pre-Clinical Development using Lean
ALCON LABORATORIES six sigma
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ELI LILLY & CO.
BRISTOL-MYERS SQUIBB
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Mapping Critical Questions in R&D–Creating strategic Direction
NOVO NORDISK
555 8th Ave, Ste 310
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and flexible, fast Learning structures to support Clinical Research
WoRkshoP LeaDeRs:
PFIZER
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Arnoud H.J. Herremans PhD, Behavioral Pharmacologists, Local
Unit Manager, Preclinical Candidate Selection Unit, ABBOTT
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To REgiSTER: Call 866-207-6528 or visit us at www.exlpharma.com/4thlean