European Process Innovation for Pharmaceutical R&D Summit

ProuDLY PrESEnTS:

Quantify and Improve Creative Processes in Research and Development

3rd

8-9 september, 2011 n Kempinski Hotel Bristol n Berlin

sponsored by:

The only pharma conference in Europe tailored specifically to clinical and pre-clinical process improvements!

register by Friday, 29 July, 2011 to Take Advantage of Early-Bird Pricing

TO rEGISTEr: call 866-207-6528 or visit us at www.exlpharma.com/europrocessinnovation

Also Featuring Presentations By:

Fernanda Yamaguchi Aoki, regional Clinical Support Manager, ASTrAZEnECA BrAZIL

Gyorgy Bathori, Head of the Applied Liposome research Laboratory, nAnoMEDICInE rESEArCH AnD EDuCATIon CEnTEr

Susanne Busta, Associate Director, Site and Data Management, BrISToL-MYErS SQuIBB

Keith Dorricott, Director, Business Improvement, InC rESEArCH, Member of the METrICS CHAMPIon ConSorTIuM Process Improvement Working Group

David Hampton, Vice President, rATH & STronG

Patricia Hayes, Continuous Improvement Leader, r&D, ASTrAZEnECA

Arnoud Herremans, Manager, Preclinical Candidate Selection unit, ABBoTT LABorATorIES

Tine Jorgensen, Department Manager, Dru cLEAn Partner, noVo norDISK

Gemma Satterthwaite, Associate Director, ASTrAZEnECA

Toby Winchester, Materials Management Team Leader

Why you must attend!

n Learn from over a dozen pharma r&D case studies about how Lean improved their r&D and clinical research.

n Benefit from the experience of others — including successes and mistakes.

n “Lean Basics” workshop to bring newcomers up to speed on the material discussed in the main conference. This primer will help you benefit from advanced material.

1

2

3

Three Panel Discussions!

cULTUrE cHANGE PANEL: Integrating Process Innovation into the creative Process of Drug Discovery and DevelopmentMODErATOr: Heike roeder, Director, Global SoP and Training, uCB

PANELISTS: Lotte Juul Foghsgaard, cLEAn Partner, Device r&D, noVo norDISKrobert Bottome, Associate Director, Manufacturing operations, GEnEnTECHJeffrey naglestad, Director, Process Improvement, SAnoFIAdrienne Motion, Senior Director, Continuous Improvement Lead, PFIZEr

MOTIvATION AND MOMENTUM PANEL: Generating Interest and Achieving Success in the control PhaseMODErATOr: nadine De Decker, Director, Strategic Business Improvement, JoHnSon & JoHnSon

PANELISTS: Bob Moroz, Associate Director, Global Clinical Trial operations, MErCKGreg Johnson, Senior Director of Process Solutions, MEDTronICnilesh Tailor, Associate Director, Data operations, BrISToL-MYErS SQuIBB

kNOWLEDGE MANAGEMENT PANEL: Tangible Lessons about Transferring knowledge between People and ProjectsMODErATOr: Jean-Pierre Fonta, Corporate VP Global Product Development unit, MErCK SErono

PANELISTS: Filip Frostemark, Associate Director, Lean and Process Excellence, McnEIL ABnancy Dynes, Consultant, Portfolio Management Systems, ELI LILLYAnders Kanstrup, cLEAn Project Manager, Dru cLEAn office, noVo norDISK

Register by Friday, 29 July, 2011 to Take Advantage of early-Bird Pricing

To RegisTeR: Call 866-207-6528 or visit us at www.exlpharma.com/europrocessinnovation

Hotel InformationkEMPINSkI HOTEL BrISTOL kurfürstendamm 27 • 10719Berlin, Germany room reservations: +49 30 8843 47 20

For your convenience, ExL has reserved a block of rooms at a discounted rate. Please make your reservation by 8 August, 2011.

Nearest airports: Tegel (TXL)—7 km AnD Schönefeld (SXF)—25 km

Meeting space: Gartensaal and Wintergarten located on the ground floor

Who Should Attend?Pharma, Biotech, and Medical Device company Managers, Directors, vice Presidents and Associates of:

n Clinical/r&D operations/research

n Clinical Quality Assurance/Control

n Strategic Business Development/operations

n Project/Study Management/Project Planning

n Clinical Trial Process Improvement/Enhancement

n Clinical Compliance

n Clinical Safety

n Metrics and Benchmarking Development

n Performance Management

n Global Strategic operations

n Data Management

n Business Development/operations

n Strategic Development

n Business Excellence

n operational Excellence

n Business Process Development

n Process Technology Improvement

This conference is also of interest to:

n Clinical research organizations

n Business Process Consultants

n Academic Clinical research Institutes

n Six Sigma Project Management Software Providers

Dear Colleague,

Professionals working in pharmaceutical drug discovery and development are constantly trying to juggle the creativity of research and the uncertainty of clinical results within the framework of corporate deadlines. Without both, the industry will fail to bring new drugs to market in an efficient and timely manner.

The 3rd European Process Innovation for Pharmaceutical r&D Summit brings together project managers, clinical and pre-clinical researchers, and those involved with optimizing the effectiveness of discovery and development. now in its third year, attendees will hear presentations and panel discussions on how leaders from top level companies have transmitted lean and other forms of process innovation into their r&D activities.

A conference is the most efficient way to hear best practices and network with peers in the only two-day process innovation summit focusing on pharmaceutical r&D in Europe. I look forward to seeing you in September!

Sincerely,

Dave HoffmanDave Hoffman Matt MillmanConference Director Division Headdhoffman@exlpharma.com Program Development mmillman@exlpharma.com

Day One – Thursday, 8 September, 2011

MAIN cONFErENcE BEGINS

1:00 cHAIrPErSON’S INTrODUcTION

Nancy Dynes, Consultant, Portfolio Management Systems, ELI LILLY

1:15 cULTUrE cHANGE PANEL: Integrating Process Innovation into the creative Process of Drug Discovery and Development

• How to involve continuous improvement principals in the overall development program without stifling important non-quantifiable value-add tasks

• Making the case for process improvement in a creative process• Communicating Lean principles and procedures across verticals to

foster creativity and cooperation

MoDErator:Heike roeder, Director, Global SoP and training, UCB

PaNELIStS:Lotte Juul Foghsgaard, cLEaN Partner, Device r&D, NoVo NorDISKrobert Bottome, associate Director, Manufacturing operations, GENENtECHJeffrey Naglestad, Director, Process Improvement, SaNoFIadrienne Motion, Senior Director, Continuous Improvement Lead, PFIZEr

2:00 rEDUcING TIME cASE STUDY: The Purple Path to Operational Excellence

• Case study that encompasses the whole of r&D• Breaking down silos with a cross functional versus a functional

perspective• using innovative process improvement methodologies to reduce cycle time

Patricia Hayes, Continuous Improvement Leader, r&D, aStraZENECa

2:45 rEFrESHMENT BrEAk

3:15 cAN YOU TrUST YOUr ASSAY rESULTS? cautionary Tales from Drug Discovery that Show the Power of Six Sigma to Diagnose and Fix Laboratory Data Problems

• using Measurement Systems Analysis to uncover hidden obstacles to lead generation

• Diagnosing the link between ‘activity’ and plate position• Minimizing variability in dispensed volumes using Designed Experiments

toby Winchester, Materials Management team LeaderDavid Hampton, Vice President, ratH & StroNG

4:00 USING LEAN FOr PHArMAcEUTIcAL rESEArcH cASE STUDY: Determining which kPIs are most appropriate for applying Lean to research and development

• What challenges are inherent in identifying areas for improvement in a fluid research situation?

• recognizing the importance of equipment and human interaction as a part of the creative research process

• Extracting measurable KPIs from more nebulous research goals

tine Jorgensen, Department Manager, DrU cLEaN Partner, NoVo NorDISK

4:45 EFFIcIENT crOSS FUNcTIONAL INTErFAcE: Maximizing clinical Operations by communicating Process Improvements between Pre-clinical, commercial, clinical Trial Supply, IT, and Other Departments

• Clinical Development is not an isolated island, well-functioning inter-faces are essential for the success

• Lean Sigma methodology could help to identify and improve interfaces• Case study: Improvement of cycle times for clinical study initiation

through optimized interface management

Heike roeder, Director, Global SoP and training, UCB

5:30 INTEGrATING NEW TEcHNOLOGIES IN THE LAB: Applying Process Excellence Methodologies in a complex r&D Environment

• Examining the use of value stream mapping in r&D to identify, simplify and prioritize improvement activities in the areas of greatest return

• using Kanban to reduce waste and create value ensuring maximum cost savings and efficiency improvements in an innovation-centric environment

• Implementing an electronic lab notebook: designing new processes (and selection of the supporting system) correctly the first time

Nadine De Decker, Director, Strategic Business Improvement, JoHNSoN & JoHNSoN

6:15 END OF DAY ONE

PrE-cONFErENcE WOrkSHOP

8:00 BrEAkFAST AND rEGISTrATION OPENS FOr WOrkSHOP ATTENDEES

9:00 LEAN BASIcS: The Fundamentals of Lean Training Within a Life Science Organization

This workshop will give people with little or no knowledge of Lean the background information they need to benefit from the high end sessions on the agenda• Lean and its role in the growing strategy of process innovation• What are tried-and-true methods of making research processes more efficient?• Q&A session to establish baseline understanding• Sample case study with expanded explanatory session

TAKE AWAYSParticipants will be able to:• Identify Lean Sigma practices, tools, and techniques and how/when they are used to improve processes.• Describe the process for setting up a Lean Sigma Kaizen projects• Select and use lean sigma tools

WorKSHoP FaCILItatorS:Bob Moroz, associate Director, Global Clinical trial operations, MErCKNilesh tailor, associate Director, Data operations, BrIStoL-MYErS SQUIBB

10:30 rEFrESHMENT AND NETWOrkING BrEAk

12:00 LUNcHEON FOr WOrkSHOP PArTIcIPANTS/rEGISTrATION OPENS FOr MAIN cONFErENcE

Day Two – Friday, 9 September, 2011

8:00 rEGISTrATION

8:30 cHAIrMAN’S rEcAP OF DAY ONE

arnoud Herremans, Manager, Preclinical Candidate Selection Unit, aBBott LaBoratorIES

8:40 INNOvATION Q & A SESSION: Process Improvement as a Forum to Encourage creative Initiative

• This is an interactive session structured around audience participation• rewarding people for taking initiative to improve the current process or

put forward an innovative/creative idea• Fostering trust that taking initiative will be positively rewarded irrespec-

tive of the result

arnoud Herremans, Manager, Preclinical Candidate Selection Unit, aBBott LaBoratorIES

9:15 kNOWLEDGE MANAGEMENT PANEL: Tangible Lessons about Transferring knowledge between People and Projects

• Applying lessons/Lean successes across departments – facilitating communication

• Comparing Lean as applied to research, manufacturing, supply chain, and clinical development

MoDErator:Jean-Pierre Fonta, Corporate VP Global Product Development Unit, MErCK SEroNo

PaNELIStS:Filip Frostemark, associate Director, Lean and Process Excellence, McNEIL aBNancy Dynes, Consultant, Portfolio Management Systems, ELI LILLYanders Kanstrup, cLEaN Project Manager, DrU cLEaN office, NoVo NorDISK

10:00 rEFrESHMENT AND NETWOrkING BrEAk

10:30 INFOrMATION FLOW cASE STUDY: The Application of Lean Information Flow in research and Development

• Focus on efficacy and predictive science• Sharing challenges, learning and recommendation for improvements• Emphasizing the importance of efficient communication flow in creative

research and development projects

Gemma Satterthwaite, associate Director, aStraZENECa

11:15 rEDUcING SAFETY AND cOMPLIANcE rISkS IN cLINIcAL TrIALS: A case Study on Using Lean Six Sigma to Pinpoint Process Weaknesses and Identify Lasting Improvements

• Identify the systematic problems behind multiple individual risks• Break the habit of using training and checks as answers to every problem• Engage employees at all levels in improving clinical trial quality

David Hampton, Vice President, ratH & StroNG

12:00 QUALITY ScOrING TOOLS: Using a Systematic Approach to Evaluate Quality, Identify risk, and Influence Behavior to Improve the Drug Development Process

• Case Studies: Experiences with the Protocol Development Quality Evaluation Tool and Site Selection & Site operations Quality Scoring Tool

• Incorporating quality metrics into a new standardized performance metrics benchmarking database

• Challenges of implementing standard, cross-industry metrics

Keith Dorricott, Director, Business Improvement, INC rESEarCH, Member of the MEtrICS CHaMPIoN CoNSortIUM Process Improvement Working Group

12:45 LUNcHEON FOr cONFErENcE ATTENDEES

1:45 IMPrOvEMENTS TO THE STArT UP OF cLINIcAL TrIALS cASE STUDY: Experiences from Europe and Latin America

• Applying Lean Sigma methodology for the improvement of administrative processes and fostering a continuous improvement culture in a global development organization

• using Lean Sigma projects to improve study start up times in various regions of the world

• How improvements towards speed, quality, process flow, and variations need to gind balance and local solutions in multi-country studies

Fernanda Yamaguchi aoki, regional Clinical Support Manager, aStraZENECa BraZIL

Susanne Busta, associate Director, Site and Data Management, BrIStoL-MYErS SQUIBB

2:30 vIrTUAL PHArMAcEUTIcAL FAcTOrY cASE STUDY: How to Handle “Added Failure” in Pharmacological Drug Development

• Viewing “added failure” as a non-value added step caused by long development time and segmented supply chain

• Handling the supply chain within the frame of one organization to reduce development time

• Developing liposomes by concentrating r&D, project management and production within a virtual factory, and outsourcing all other functions

Gyorgy Bathori, Head of the applied Liposome research Laboratory, NaNoMEDICINE rESEarCH aND EDUCatIoN CENtEr

3:15 rEFrESHMENT AND NETWOrkING BrEAk

3:45 rEBOUNDING FrOM FAILUrE cASE STUDY: Understanding customer Needs When the customer is a Health Authority

• Lessons Learned from agency interaction for submission• understanding customer needs and managing Critical to Customer

(CTC) elements.• Institutionalizing lessons learned into routine operations

Jeffrey Naglestad, Director, Process Improvement, SaNoFI-aVENtIS

4:30 MOTIvATION AND MOMENTUM PANEL: Generating Interest and Achieving Success in the control Phase

• Introducing Lean into an organization• Making sure the improvements get integrated into the process after the

Lean project is over• The value of top-down versus bottom-up initiation• Demonstrating value to each specific stakeholder

MoDErator:Nadine De Decker, Director, Strategic Business Improvement, JoHNSoN & JoHNSoN

PaNELIStS:Bob Moroz, associate Director, Global Clinical trial operations, MErCKGreg Johnson, Senior Director of Process Solutions, MEDtroNICNilesh tailor, associate Director, Data operations, BrIStoL-MYErS SQUIBB

5:15 cONFErENcE cONcLUDES

Do you have a question about the event? Would you like to get involved as a speaker or discussion leader at our 3rd European Process Innovation for Pharmaceutical r&D Summit? Please email conference Director, Dave Hoffman at dhoffman@exlpharma.com

Media Partners

To RegisTeR: Call 866-207-6528 or visit us at www.exlpharma.com/europrocessinnovation

Sponsorship and Exhibiting OpportunitiesDo you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to sponsor, underwrite an educational session, host a networking event, or distribute promotional items to attendees. ExL Pharma will work closely with you to customize a package that suits all your needs. To learn more about these opportunities, please contact:

STEvE DEckErBusiness Development Manager212-400-6234 or sdecker@exlpharma.com

Five Ways to RegisterMail: ExL Events, Inc. Phone: 866-207-6528 555 8th Ave, Ste 310 Fax: 888-221-6750 New York, NY 10018 Email: register@exlpharma.comOnline: www.exlpharma.com/europrocessinnovation

Registration Fees for Attending ExL Pharma’s European Process Innovation for Pharmaceutical R&D Summit:EArLY BIrD PrIcING register by Friday, 29 July, 2011to Take Advantage of Early-Bird Pricing:

conference + Workshop €1695conference Only €1495

STANDArD PrIcINGregister After Friday, 29 July, 2011:

conference + Workshop €1995conference Only €1795

ONSITE PrIcING

conference + Workshop €2095conference Only €1895

Group Discount Program: Save 25% Per Person when registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time). This is a savings of 25% per person.

Save 15% Per Person when registering Three Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call 866-207-6528. IMPOrTANT!! Offers may not be combined. Discount only applies to stan-dard rate. Make checks payable to ExL Events, Inc. and write code P914 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full, two weeks prior to the com-mencement of the conference.

Conference registrations may be transferred to other colleagues in the event you are unable to attend. Please notify ExL Pharma, info@exlpharma.com, prior to the event with the name and contact information of the replacement attendee. There will be an administrative charge of $300 to substitute, exchange, and/or replace attendance badge with a colleague occurring within five business days of 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.

In the event of a cancellation or postponement ExL Events, Inc. will not be liable and/or responsible for any individual or group expenses related to said conference.

To receive a refund or voucher, please fax your request to 888-221-6750.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replace-ment will be made.*The opinions of this faculty do not necessarily reflect those of the com-panies they represent or ExL Events, Inc.*

European Process Innovation for Pharmaceutical R&D Summit

ProuDLY PrESEnTS:

Quantify and Improve Creative Processes in Research and Development

3rd

8-9 september, 2011 n Kempinski Hotel Bristol n Berlin

The only pharma conference in Europe tailored specifically to clinical and pre-clinical process improvements!

sponsored by:

TO rEGISTEr: call 866-207-6528 or visit us at www.exlpharma.com/ europrocessinnovation

123

Three Panel Discussions!

cULTUrE cHANGE PANEL: Integrating Process Innovation into the creative Process of Drug Discovery and Development

MOTIvATION AND MOMENTUM PANEL: Generating Interest and Achieving Success in the control Phase

kNOWLEDGE MANAGEMENT PANEL: Tangible Lessons about Transferring knowledge between People and Projects

Registration FormMail: ExL Events, Inc. Phone: 866-207-6528 555 8th Ave, Ste 310 Fax: 888-221-6750 New York, NY 10018 Email: register@exlpharma.comOnline: www.exlpharma.com/europrocessinnovation

❑ YES! register me for the conference and Workshop ❑ register me for the Conference only

Please contact me:❑ I’m interested in marketing opportunities at this event ❑ I wish to receive email updates on ExL Pharma’s upcoming events

name Title

Company

Dept.

Address

City State Zip

Email

Telephone

Method of Payment: ❑ Check ❑ Credit Card Make checks payable to ExL Events, Inc.

card Type: ❑ MasterCard ❑ Visa ❑ Discover ❑ Amex

Card number

Exp. Date name on Card

Signature

555 8th Avenue, Suite 310 new York, nY 10018 PLEASE MEnTIon PrIorITY CoDE: P914