ERICA DEUSO Lean Deployment Coordinator, JANSSEN PHARMACEUTICALS FEATURED TOPICS

g Apply and maintain Lean, Six Sigma, Kaizen and QbD tactics for pharmaceutical, biotechnology and medical device industries

g Utilize A3 problem-solving techniques to drive continuous operational improvements

g Form valuable relationships with external vendors and internal experts to improve efficiency

g Learn to measure the success and progress of Lean, Six Sigma, Kaizen and QbD practices through metrics and analytics

g Implement 5S and initiate a cultural change across global and R&D organizations

Continuous Process Improvement Strategies for Meaningful Metrics to Enhance Development in Clinical and R&D Settings

CONFERENCE CO-CHAIRS

Earn a YELLOW BELT certification through an interactive training course

Complete an advanced training course on STATISTICAL PROCESS CONTROL

OR

GET CERTIFIED

8th Annual

Lean, Six Sigma, Kaizen and QbD Life Science Summit

Jennifer Campbell, Sr. Scientist, PPDM, Preclinical Outsourcing, MERCK

Ajay Dedhia, Principal Consultant, Master Black Belt, BRISTOL-MYERS SQUIBB

Kit Erlebach, Head of R&D Continuous Improvement, FUJIFILM DIOSYNTH BIOTECHNOLOGIES

Magnus Evertson, CPI Functional Lead, Development US, BOEHRINGER INGELHEIM

Atul Goyal, Master Black Belt Consultant, Trainer, PFIZER

Bernie Klemmer, MBA, PMP, CSSBB, Associate Director, cLEAN® Business Process Improvement, NOVO NORDISK

Ashley Martucci, Sr. Scientist,

PPDM GLP BA, MERCK

Sascha Pioske, Senior Operations

Engineer, STRYKER

Heike Roeder, Director, Head Global

Training, SOP and Process

Improvement, UCB PHARMA

Mamta Trivedi, Director of Supply

Chain Synchronization (Operations),

Master Black Belt, REGENERON

PHARMACEUTICALS

Hillary M. Wilson, Cross-Functional

Business Process and Project

Management, BOEHRINGER

INGELHEIM

SPOTLIGHT SPEAKERS

BEN LOCWIN Head of T&D, Global Head of Center of Excellence, Master Black Belt, LONZA BIOPHARMACEUTICALS

NEW FOR 2015

Two OUT OF INDUSTRY Master Black Belt keynote speakers from Fresenius Medical Services and Greene, Tweed & Co.

An engaging session on utilizing Quality by Design principles throughout Clinical and R&D organizations

An interactive session on developing a systematic method to Lean culture led by a medical device professional

19+ sessions devoted to Clinical and R&D continuous improvement strategies

March 12-13, 2015 Hyatt at The Bellevue – Philadelphia, PA

TO REGISTER Call +1 866-207-6528 or Visit www.exlevents.com/lean

Lean, Six Sigma, Kaizen and QbD

Sponsorship and Exhibiting OpportunitiesDo 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 Sean Blank, Sales Manager, at 917-258-5154 or sblank@exlpharma.com.

Dear Colleague,Lean, Six Sigma, Kaizen and Quality by Design (QbD) practices have become the cornerstone of continuous process improvement within the Life Science industry, specifically for R&D and Clinical Operations organizations.

While job titles, backgrounds and day-to-day activities vary between different companies and regions, Lean, Six Sigma, Kaizen and QbD professionals are vital in developing continuous improvement methods and ultimately cutting costs, reducing waste and human error, and speeding up drug development time while preserving quality and value.

The 8th Lean, Six Sigma, Kaizen and QbD Life Science Summit, taking place March 12-13, 2015 in Philadelphia, PA, is the premier educational platform for Pharmaceutical, Medical Device and Biotechnology companies to explore new and relevant tactics, hear case studies, and discover ways to strategically sustain Lean, Six Sigma, Kaizen and QbD methodologies for process improvement.

This year’s conference will feature two tracks within the Lean, Six Sigma, Kaizen and QbD scope: Clinical Operations and Research & Development.

Designed for Clinical Operations and Research professionals, the Clinical Operations Track offers best practices to optimize Lean, Six Sigma, Kaizen, QbD and Process Improvement projects within their organization while learning from other front-runners in the industry. Participants will gain critical knowledge on how to conduct their clinical trials more efficiently and effectively.

The Research & Development Track is tailored specifically to R&D professionals and their extended deployment of Lean, Six Sigma, Kaizen and Process Improvement strategies. This track will focus on applying and sustaining these tools in a research setting for continuous improvement. Participants will learn strategies and best practices from industry leaders on topics such as waste removal in labs, 5S organization, implementing change management and utilizing new technologies.

You asked for content specifically addressing the topics below. We are thrilled to provide you with unique case studies, panels and interactive sessions on:

• Utilizing Statistical Process Control

• Applying QbD principles throughout Clinical and R&D organizations

• Developing a systematic method to Lean culture in the medical device industry

• Sustaining continuous improvement practices during mergers, acquisitions or while partnering with external vendors

• Measuring the success of Lean, Six Sigma, Kaizen and QbD initiatives through meaningful metrics and analytics

Join Lean, Six Sigma, Kaizen and QbD Life Science professionals to discuss best practices for continuous, long-term process improvement.

I look forward to seeing you in Philadelphia!

Sincerely, Charleen Famiglietti Charleen FamigliettiConference Production Director cfamiglietti@exlpharma.comExL Events

WHO SHOULD ATTENDThis conference is designed for professionals from Pharmaceutical, Biotech, Medical Device and Clinical Research organizations with responsibilities in the following areas:

g Lean Deployment

g Kaizen Events

g Process Improvement

g Continuous Improvement

g Operational Excellence

g Business Development

g Standard Operating Procedures

g Change/Design Management

g Clinical Quality Assurance/Control

g Strategic Business Development/Operations

g Project/Study Management/Project Planning

g Clinical Trial Process Improvement/

Enhancement

g Clinical Compliance

g Metrics and Benchmarking Development

g Quality Operations

g Clinical Safety

g System and Process Management

g Compliance Management

g Business Analysis

Pharma

Medical Device

Consulting

BioTech

Solution Providers

2014 SUMMIT AUDIENCE PROFILE

60%

24%

7%5%

4%

VENUE

Hyatt at The Bellevue200 South Broad St.Philadelphia, PA 19102

Room Reservations: If you require overnight accommodations, please contact the hotel to book your room.

ExL Events has reserved a block of rooms at a discounted rate for conference participants. We encourage

conference participants to make reservations by February 18, 2015.

To make reservations guests can call 1-888-421-1442 and request the negotiated rate for ExL’s March

Meeting. Please book your room early as rooms available at this rate are limited.

7:30 Registration Opens & Continental Breakfast for Training Course Participants8:30 PRE-CONFERENCE TRAINING

YELLOW BELT CERTIFICATION This training course provides an overview of what Lean Six Sigma is and how it works. Attendees will:

» Identify the benefits of Lean Six Sigma » See the process view of business » Establish the voice of the customer » Learn the DMAIC improvement strategy » Determine key business metrics » Develop a process for selecting improvement projects » Understand the tools and techniques of Lean Six Sigma

Workshop Led By: Edward Kashmere, President & Founder, Senior Consultant, Lean Six Sigma Master Black Belt, ALLIANCEMAX

WHO SHOULD ATTEND?

Executives and all professionals who are interested in learning what Lean Six Sigma is about and want to see how to implement it successfully in their organization while obtaining a yellow belt certificate.

PRE-CONFERENCE TRAINING STATISTICAL PROCESS CONTROL IN LEAN SIX SIGMA This training course outlines the assumptions behind SPC, shows why and where to use it within a Lean Six Sigma program, and illustrates how to implement the control charts in practice. Attendees will:

» Learn how to establish an SPC program in your organization » Identify places within your LSS program to benefit from SPC » View your processes as statistical in nature » Realize that all processes vary randomly » See how different types of variation lead to different types of action » Learn about the different types of control charts » Be able to interpret control charts correctly

Workshop Led By: Mark Gershon, Project Management and Six Sigma Consultant and Trainer, Six Sigma Master Black Belt, WORLD CLASS TRAINING INSTITUTE

WHO SHOULD ATTEND?

Executives, Sponsors, Black Belts and Green Belts whose organizations are managing any repetitive processes, whether in administration, research service or manufacturing.

12:30 Lunch for Workshop Attendees & Main Conference Registration Begins

1:30 CO-CHAIRPERSON’S WELCOME & OPENING REMARKS Erica Deuso, Lean Deployment Coordinator, JANSSEN PHARMACEUTICALS Ben Locwin, Head of T&D, Global Head of Center of Excellence, LONZA BIOPHARMACEUTICALS

1:45 PANEL DISCUSSION: SUSTAIN LEAN INITIATIVES FOR LONG-TERM PROCESS IMPROVEMENT

» Discuss key success factors for sustaining Lean initiatives » Measure and manage performance for Lean initiatives » Drive a cultural change within your organization to make Lean Six

Sigma practices more accessible and gratifying to Clinical and R&D professionals for continuous process improvement

» Initiate process improvement tactics from a Change Management perspective

Panelists: Paul Nelson, Executive Director, Supply Chain, AUXILIUM PHARMACEUTICALS Heike Roeder, Director, Head of Global Training, SOP and Process Improvement, UCB Bernie Klemmer, MBA, PMP, CSSBB, Associate Director, cLEAN® Business Process Improvement, NOVO NORDISK Erika Zavod, M.S., Operational Lead for Immunology & Head of Procedures GCO, TEVA PHARMACEUTICALS

2:30 HOW TO UTILIZE THE DEFINE, MEASURE, ANALYZE, DESIGN,VERIFY (DMADV) MODEL FOR TRANSACTIONAL PROCESSES

» Analyze real-world applications of the DMADV model » Compare the DMADV model to the Define, Measure, Analyze, Improve

and Control (DMAIC) model and learn best practices to identify the appropriate model for your project

» Understand and develop transactional processes Magnus Evertson, CPI Functional Lead, Development Global, Lean Six Sigma Black Belt, BOEHRINGER INGELHEIM Kimberly Buckland, Lean Six Sigma Black Belt, BOEHRINGER INGELHEIM

3:15 Networking Break

3:45 OUTSIDE INDUSTRY KEYNOTES OUT-OF-THE-BOX PERSPECTIVES ON APPLYING LEAN SIX SIGMA UTILIZATION OF LEAN SIX SIGMA AT FRESENIUS MEDICAL CENTER

» Examine the organization’s Lean strategies and successful implementations from a clinical perspective

» Understand their approach to creating a Lean clinical environment, which resulted in a simplified patient admission process, and an RX & Spectra laboratory partnership

Catherine Quinn, Master Black Belt, Certified Project Manager, FRESENIUS MEDICAL SERVICES

ENTERPRISE EXECUTION EXCELLENCE THROUGH FOCUSING ON PRINCIPLES AND CORE ELEMENTS TO ACHIEVE A CULTURE OF INNOVATION AND CONTINUOUS IMPROVEMENT

» Analyze Enterprise Excellence as a key enabling strategy to achieve a vision

» Illustrate how a focus on tools, systems and results alone fails to create the desired culture

» Build organizational competency through the use of tools and systems to attain the desired culture

James J. Mikulski, Global Lean Six Sigma Master Black Belt, GREENE, TWEED & CO.

4:45 FORM VALUABLE RELATIONSHIPS DURING MERGERS AND ACQUISITIONS TO OPTIMIZE LEAN SIX SIGMA PROJECTS

» Utilize and maintain Lean Six Sigma practices while collaborating with non Lean Six Sigma contractors

» Identify culturally compatible vendors for your Lean Six Sigma projects or Kaizen events

» Form valuable relationships with external vendors and internal experts to improve company efficiency

Heike Roeder, Director, Head of Global Training, SOP and Process Improvement, UCB

5:30 Conclusion of Day One

THURSDAY, MARCH 12, 2015 | PLENARY SESSIONS

THURSDAY, MARCH 12, 2015 | TRAININGS

OU

T O

F IN

DU

STR

Y SE

SSIO

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TO REGISTER Call +1 866-207-6528 or Visit www.exlevents.com/lean

8:00 Continental Breakfast for Conference Participants

9:00 CHAIRPERSON’S WELCOME & OPENING REMARKSErica Deuso, Lean Deployment Coordinator, JANSSEN PHARMACEUTICALS

Ben Locwin, Head of T&D, Global Head of Center of Excellence, LONZA BIOPHARMACEUTICALS

9:15 A SYSTEMATIC METHOD TO DEVELOPING A LEAN CULTURE » Utilize Lean tools to function together seamlessly with leadership engagement » Align and reach all members of an organization to expose obstacles that prevent objectives from being met » Gain valuable insight and a blueprint for creating one’s own continuous improvement system through an interactive discussion

Sascha Pioske, Senior Operations Engineer, STRYKER

RESEARCH & DEVELOPMENT TRACK CLINICAL OPERATIONS IMPROVEMENT TRACK

10:00 ENABLE INNOVATIVE SCIENCE AND ROUTINE SYSTEMS — APPLY AND MONITOR BEST PRACTICES

» Explore a detailed, data-driven review of the development process that led to a twin-track approach for improving lab basic projects

» Establish best practice approaches that enable scientists to innovate » Monitor and support projects » Adapt Lean Six Sigma tools to solve specific problems

Kit Erlebach, Head of Technical Operations, Lean Six Sigma Black Belt, FUJIFILM DIOSYNTH BIOTECHNOLOGIES

DRIVE CONTINUOUS OPERATIONAL IMPROVEMENTS UTILIZING THE A3 PROBLEM-SOLVING TECHNIQUE

» Understand the elements of basic problem solving » Improve outcomes through focus, data and teamwork » Incorporate change management principles to ensure sustainability

Bernie Klemmer, MBA, PMP, CSSBB, Associate Director, cLEAN® Business Process Improvement, NOVO NORDISK

10:45 IMPLEMENT VALUE STREAM MANAGEMENT AS A TOOL FOR PROCESS IMPROVEMENT IN R&D

» Define and map out a value stream for drug development to provide a clear and focused path to long-term process optimization

» Organize and break down a value stream project into meaningful components

» Learn to measure a value stream’s performance through metrics and analytics

» Establish governance oversight and ownership of a value stream project Ajay Dedhia, Principal Consultant, Master Black Belt, BRISTOL-MYERS SQUIBB

DEPLOY A LEAN SIX SIGMA PROCESS IMPROVEMENT PORTFOLIO ACROSS A GLOBAL ORGANIZATION

» Align key stakeholders in multiple countries » Utilize the “fit-for-purpose” approach when applying Lean and Six

Sigma tools » Define meaningful measures » Establish a culture of continuous improvement while straddling

different national culturesHillary M. Wilson, Cross-Functional Business Process and Project Management, BOEHRINGER INGELHEIM

11:30 CASE STUDY WORK SMARTER, NOT HARDER: IMPLEMENT 5S ACROSS GLOBAL AND R&D

» Discuss the case for a change in lab organization and process improvement (the burning platform)

» See Pilot to Global rollout and how the implantation of 5S grew from one lab to 1,000+ labs

» Summarize impact and cultural change within a reasearch environment Jennifer Campbell, Sr. Scientist, PPDM Preclinical Outsourcing, MERCK Ashley Martucci, Sr. Scientist, PPDM GLP BA, MERCK

CASE STUDY: MARKETING CHANNEL SPEND OPTIMIZATION

» Identify waste in channel spend » Resolve channel conflicts » Analyze channel spend versus sales impact

Atul Goyal, Master Black Belt Consultant, Trainer, PFIZER

12:15 Luncheon

1:15 CASE STUDY: HOW NOT TO IMPLEMENT A LEAN R&D PROCESS BY LEARNING FROM OUR MISTAKES

» See how their team conducted Lean R&D implantation in a development lab » Explore multiple issues that arose in planning, implementation and the

continuation of the Lean process » Examine routine reflection and understand how results led to vast

improvements in the current Lean R&D processErica Deuso, Lean Deployment Coordinator, JANSSEN PHARMACEUTICALS R&D

DRIVE OPERATIONAL EXCELLENCE THROUGH AN END-TO-END SIX SIGMA APPROACH

» Engage in an interactive session on utilizing Six Sigma in a clinical operations setting

» Create adequate and detailed SOPs while applying Lean strategiesMamta Trivedi, Director of Supply Chain Synchronization (Operations), Master Black Belt, REGENERON PHARMACEUTICALS

2:00 FACE CHALLENGES WITH QBD IN PRODUCT LIFE CYCLE » Develop a systematic approach for Quality Risk Management (QRM) and

FMEA while dealing with FDA guidelines » Learn a flexible and effective process for quantitatively dissecting risks

during all stages of product development Adnan Sabir, QA-CMC Manager, KOWA PHARMACEUTICALS

IMPROVED OUTCOMES THROUGH A QUALITY BY DESIGN (QBD) PROCESS

» Introduce QbD principles into a clinical setting » Enable QbD in data management » Apply Lean, Six Sigma and other process improvement

methodologies via QbD » Learn why quality becomes better as a result

Ben Locwin, Head of T&D, Global Head of Center of Excellence, LONZA BIOPHARMACEUTICALS

FRIDAY, MARCH 13, 2015 | TRACKS

FRIDAY, MARCH 13, 2015 | TRACKS

“PRESENTERS WERE VERY KNOWLEDGEABLE AND TIED IN REAL-WORLD EXPERIENCE TO MAKE IT INTERESTING.” -MANAGER, R&D QA AND COMPLIANCE, SHIRE

“GREAT PRESENTATIONS! VERY APPLICABLE TO MY EXPERIENCE.” -SCIENTIST, MERCK

RESEARCH & DEVELOPMENT TRACK CLINICAL OPERATIONS IMPROVEMENT TRACK

2:45 Networking Break

3:15 HOW LEARNING CAN DRIVE BOTTOM-LINE AND SUSTAINABLE IMPACT

» Review examples of how learning and development at one big pharma company served as a key element of an operational transformation that yielded more than $400 million in cost savings — representing 25% of total operating costs — over a two-year period

» Illustrate how another global pharma company leveraged learning and capability-building to reduce human error on the shop floor and drive the cultural change needed to sustain those improvements over time

Wendy Koubal, Former Head of Learning, Development & KM, MERCK MANUFACTURING

CASE STUDY: IMPLEMENT CLINICAL KAIZEN EVENTS TO YOUR PROCESS IMPROVEMENT PLAN

» Conducted Kaizen events for electronic site reference files and safety electronic document submissions to sites

» Collaborated with other departments to improve efficienciesMariana Sacchi, Associate Director, Clinical Site Monitoring & Data Management, BRISTOL-MYERS SQUIBB

4:00 Chairperson’s Closing Remarks

4:15 Conclusion of Day Two

Terms & ConditionsBy registering for an ExL Events, Inc. (“ExL Pharma”) event, you agree to the following set of terms and conditions listed below:Registration Fee: The fee includes the conference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments.Payment: Make checks payable to ExL Events, Inc. and write code C551 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full prior to the commencement of the conference. Any discount applied cannot be combined with any other offer‚ and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. Group discounts available to individuals must be registered simultaneously and employed by the same organization.

Cancellation and Refund PolicyIf you need to cancel your registration for an upcoming ExL event, please note the following policies derived from the Start Date of the event:• Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid

for 12 months from the voucher issue date.• Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date.If you cancel at any time after receiving the conference documentation, the voucher issued will be $395 less.To receive a refund or voucher, please fax your request to 888-221-6750.Substitution Charges: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference.

ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare, hotel or any other costs incurred by registrants. ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date, content, speakers or venue.

*The opinions of ExL speakers do not necessarily reflect those of the companies they represent, nor ExL Events, Inc.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made.

EARLY BIRD PRICING Register by January 30, 2015 CONFERENCE + 1 TRAINING: $2,295CONFERENCE ONLY: $1,795

STANDARD PRICING Register After January 30, 2015 CONFERENCE + 1 TRAINING: $2,495CONFERENCE ONLY: $1,995

ONSITE PRICING CONFERENCE + 1 TRAINING: $2,595CONFERENCE ONLY: $2,095 GROUP DISCOUNT PROGRAMSOffers cannot be combined, early bird rates do not apply. To find out more on how you can take advantage of these group discounts, call 866–207–6528. 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 four 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 each registration. To find out more on how you can take advantage of these group discounts, please call 866-207-6528.

WAYS TO REGISTERExL Events, Inc.494 8th Ave, Fourth FloorNew York, NY 10001

www.exlevents.com/lean

registration@exlpharma.com

866–207–6528

888–221–6750

PRICING

Media Partners

Sponsorship and Exhibiting OpportunitiesDo 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 Sean Blank, Sales Manager, at 917-258-5154 or sblank@exlpharma.com.