4th Lean Sigma & Kaizen for Pharma R&D Conference, March 2011, Miami

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

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4th Lean Sigma & Kaizen for Pharma R&D Conference, March 2011, Miami

  1. 1. RegisteR By JanuaRy 21st foR MaxiMuM savings! 6σΣ The 4thProudlyPresents: [ 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, FloRidaParticipating FEaTuREd PRESENTaTioNSCompanies establishing a Business Process Management Capability in Pharmaceutical R&DABBOTT Paul Knight, Director, R&D Productivity & Continuous Improvement, BRISTOL-MYERS SQUIBBALCON 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 trialELI LILLY & CO. Master file Process” Ivan Walrath, Trial Master File Process Owner, PFIZERJOHNSON & JOHNSON Linne Svensson, Process Engineer, Continuous Improvement Specialist, PFIZERMERCK PRE-CoNFERENCE WoRkShoPNOVO NORDISK Mapping Critical Questions in R&D–Creating strategic Direction and flexible, fast Learning structures to support Clinical ResearchPFIZER 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. 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 Excellencehyatt Regency Miami • Business Process Development400 South East Second avenue • Miami, Florida • Process Technology ImprovementTel: +1 305 358 1234 • Fax: +1 305 358 0529 • Industrial Operations • Information TechnologyMove with the rhythm of the city at our downtown Miami hotel. The striking white towersof 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 Groveand world-famous white sand beaches. Our newly updated Hyatt hotel in downtown • Clinical Research OrganizationsMiami offers an outstanding array of amenities – including the city’s largest meeting • Business Process Consultantsspace, dramatic bayside or skyline views from spacious guestrooms, and a lively bar and • Quality Improvement and Statisticsrestaurant. Discover this exclusive setting among downtown Miami Florida hotels and Software Providersexperience the excellence you’ve come to expect from Hyatt. • Academic Clinical Research InstitutesRoom Reservations: • Six Sigma Project ManagementIf you require overnight accommodations, please contact the Hyatt Regency Miami at Software Providers305-358-1234 and mention our discounted room rates. We encourage conferenceparticipants to make reservations by Wednesday, February 3rd with our designatedvenue as our discount room rates are limited. To REgiSTER: Call 866-207-6528 or visit us at www.exlpharma.com/4thlean
  3. 3. DAY ONE • Tuesday, March 1, 2011 Pre-Conference Workshop – Mapping Critical Questions Workshop Session8:00 REGISTRATION OPENS AND CONTINENTAL BREAKFAST IS SERvED FOR WORKSHOP ATTENDEES9:00 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 science12:30 LUNCH FOR WORKSHOP ATTENDEES / REGISTRATION OPENS FOR MAIN CONFERENCE Main Conference Begins1:30 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, MERCK1:35 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 SQUIBB2:15 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 BPM3:00 NETWORKING AND REFRESHEMENT BREAK • Strategic and tactical mission • BPM roles and responsibilities3:30 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. 4. DAY TWO • Wednesday, March 2, 20118:30 Chairperson’s Day Two Welcome and Recap Pre-Clinical improvement8:35 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 productivity9:25 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 Development10:15 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 attendthis 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 ofyour needs. To learn more about these opportunities, contact Steve Decker, Business Development Manager, bycalling 212-400-6234 or by emailing sdecker@exlpharma.com.
  5. 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 Group Discount Program:[Five Ways to Register] Discounts cannot be combined; Early Bird Rates do not apply Save 25% per person when Registering FourFax: 888-221-6750 For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must registerMail: Exl Events, inc. 4 at one time). This is a savings of 25% per person. 555 8th ave, Ste 310 Save 15% per person when Registering Three New York, NY 10018 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, pleasePhoNE: 866-207-6528 call 866-207-6528.oNliNE: www.exlpharma.com/4thlean Make checks payable to ExL Events, Inc. and write code P739 on your check.You may also use Visa, MasterCard, Discover or American Express.EMail: register@exlpharma.com Payments must be received in full prior to the commencement of the conference.Registration Fees for Attending ExL’s Cancellations: If you need to cancel your registration for an upcoming ExL conference, please note the following policies derived from the Start Date4th Lean Sigma & Kaizen for Pharma R&D Conference: of the event: Four weeks or more: A full refund (minus a $95 processing fee),EARLY BIRD PRICING or a voucher to another ExL event valid for two years from theRegister by Friday, January 21st to voucher issue date.Take Advantage of Early Bird Pricing: Four weeks or Less: A voucher to another ExL event valid for twoConference + Workshop $1995 years from the voucher issue date.Conference Only $1695 To receive a refund or voucher, please fax your request to 888-221-6750. Please Note: Conference registrations may be transferred to other colleaguesSTANDARD PRICING in the event you are unable to attend.There will be an administrative charge ofRegister After January 21st: $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within five business days of any ExL conference.Conference + Workshop $2195 Please notify ExL Pharma, info@exlpharma.com, prior to the event withConference Only $1895 the name and contact information of the replacement attendee.ONSITE PRICING Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitableConference + Workshop $2295 replacement will be made.Conference Only $1995 *The opinions of this faculty do not necessarily reflect those of the companies they represent nor ExL Events, Inc.* To REgiSTER: Call 866-207-6528 or visit us at www.exlpharma.com/4thleanTo RegisTeR Call 866-207-6528 oR visiT us aT www.exlpharma.com/Kolsummit
  6. 6. RegisteR By JanuaRy 21st foR MaxiMuM savings! ❑ Amex 6σΣ 6σΣ The 4th [Pharma R D&Conference Lean Sigma Kaizen for ] ❑ Discover Make checks payable to ExL Events, Inc. Proudly❑ Credit Card & Presents: PLEASE MENTION PRIORITY CODE: P739 ❑ Visa Creating Added Value in the Preclinical and Clinical Areas ❑ MasterCard 555 8th Avenue, Suite 310 through a Culture of Continuous Improvement❑ Check Name on Card New York, NY 10018 MaRCh 1st – 2nd, 2011 • hYaTT REgENCY MiaMi • MiaMi, FloRidaMethod of Payment: FEaTuREd PRESENTaTioNS Participating establishing a Business Process Management Capability Companies Card Type: in Pharmaceutical R&D Card Number Paul Knight, Director, R&D Productivity & Continuous Signature Exp. Date ABBOTT Improvement, BRISTOL-MYERS SQUIBB accelerating Pre-Clinical Development using Lean ALCON LABORATORIES six sigma Martin Hynes, Senior Director, Six Sigma Champion, Email: register@exlpharma.com ELI LILLY & CO. BRISTOL-MYERS SQUIBB examination of a newly Developed enterprise-Wide ❑ I wish to receive email updates on ExL Pharma’s upcoming events CENTOCOR Process at Pfizer: “Building Quality-in for the trial Phone: 866-207-6528 888-221-6750 Master file Process” Ivan Walrath, Trial Master File Process Owner, PFIZER ELI LILLY & CO. ❑ YES! Register me for the Conference and Workshop ❑ I’m interested in marketing opportunities at this event Linne Svensson, Process Engineer, Continuous Improvement Specialist, PFIZER JOHNSON & JOHNSON Zip Online: www.exlpharma.com/4thlean Fax: [Registration Form] MERCK PRE-CoNFERENCE WoRkShoP ❑ Register Me for the Conference Only State Title Mapping Critical Questions in R&D–Creating strategic Direction NOVO NORDISK 555 8th Ave, Ste 310 New York, NY 10018 and flexible, fast Learning structures to support Clinical Research WoRkshoP LeaDeRs: PFIZER Mail: ExL Events, Inc. Terry Barnhart, Senior Director of Strategy and Continuous Improvement, PFIZER Please contact me: Arnoud H.J. Herremans PhD, Behavioral Pharmacologists, Local Unit Manager, Preclinical Candidate Selection Unit, ABBOTT Telephone Company Address Name Email Dept. City To REgiSTER: Call 866-207-6528 or visit us at www.exlpharma.com/4thlean

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