Project Portfolio Management in Pharma

Boston22nd & 23rd April 2010

IN THE CHAIR:

Dr. Markus Thunecke | Catenion, Germany Senior Partner

Dr. Carmel Egan | Eli Lilly & Company Vice President - Project ManagementPaul Biondi | Bristol Myers Squibb Vice President - R&D OperationsDr. Orest Hurko| Pfizer Inc. Assistant Vice President Discovery Translational ResearchJames Kirwin | Pfizer Inc. Assistant Vice President - Clinical Resources & Process Development, & Clinical Development OperationsDr. Christopher Beck | Shire Pharmaceuticals Vice President, Program Resources & Decision SupportGeorge Marmo | Bayer Healthcare Director - Regional Program ManagementDr. Thomas Hampe | Amgen Global Project Director - R&D Project ManagementPhil Beccue | Baxter Healthcare Director - Strategy & Portfolio ManagementDr. Jeffrey Handen | Merck & Co. Director, R&D Portfolio ManagementDr. Frank Hermann | Daiichi Sankyo Director - Decision AnalysisDr. Jane Relton | Biogen Idec Associate Director - Program and Alliance Management Dr. Mak Jawadekar | Pfizer Director - Portfolio Management & AnalyticsFlorian Jehle | Catenion, Germany Manager

WHO WILL ATTEND?

Effectively Managing Project Portfolio in Changing Economic & Regulatory Environment

Joseph Scheeren | Bayer Pharmaceuticals Senior Vice President-Head of Global Regulatory Affairs

Dr. Rick Mayes | University of Richmond Associate Professor of Public Policy - Political Science Department University of California, Berkeley Faculty Research & Fellow - Petris Center on Healthcare Markets

Dr. Michele Mercuri | Daiichi Sankyo Vice President - Acting Head of the Dept. of Cardiovascular Medicine, Global Development

Trupti Trivedi |GlaxoSmithKline Pharmaceuticals Vice President - Strategy and Governance, Medicines Development

Michelle Zupancic | Roche Vice President - New Products Planning

Dr. Suzanne K. Brown | Merck & Co. Executive Director - R&D Portfolio Management Resource & Decision Management

Dr. Mak Jawadekar | Pfizer Inc. Director - Portfolio Management & Analytics

Achieving goal of maximized asset base, extending lifecycles, optimal resource allocation, and creating satisfying ROI thru affective prioritization of project portfolio, has become essential in order to maintain a competitive edge and to survive in this challenging period.

• Identify current industry best practices and benchmark your performance against leading pharmaceutical and biotechnology companies

• Asses industry best practices and benchmark your performance against leading pharmaceutical and biotechnology companies

• Convertpromisingproductportfoliosintohighlyprofitablerevenuestreams

• Efficiently manage projects within organization’s pipeline through periods of slow growth

• Maximize revenues in changing economic and regulatory environment

• DelivershareholderconfidenceinpotentialfuturedevelopmentAnd much more...

Vice Presidents, Heads, Directors, Senior Managers and Managers of: Portfolio Management, Project Management, Pharmaceutical Development, Research & Development, Strategic Planning & Decision, Strategy & Portfolio Analysis, Portfolio Selection, Decision Analysis

YOUR EXPERT ADVISORY BOARDYOUR PRESTIGOUS SPEAKER PANEL

8:30 Registration and Coffee

9:00 Opening remarks from the chair

REGULATORY FRAMEWORK & NEW HEALTHCARE INITIATIVES

9:10 KEYNOTE PRESENTATION: Regulatory Framework & New Healthcare Initiatives•Maintainingacompetitiveedgeandsurvivinginthis

challenging period•Reversepaymentsettlement–Intersectionof

contemporary fears & the law of competition •Make-or-Breakfactorinprofitability-Reimbursement

in changing regulatory environment•Adaptingactiveapproachtolongerapprovaltimelines

and increasing access to care

9:40 Payer Landscape Environment•Howtocosteffectivelymanagepayerenvironment•Lowerpayerenvironment&implicationsforProject

Portfolio Management•Identifying&managingglobalpayerlandscape

implications in Project Portfolio Management

10:10 Morning coffee and networking

11:30 CASE STUDY: Impact of Changing Regulatory Environment on Cost of Discovery & Drug DevelopmentThis session is designed to provide our audience with the opportunity to join a HIGHLY-INTERACTIVE brainstorming discussion with your peers. The audience has chance to take part in the discussion by asking questions, sharing experiences and opinions on the topics from the morning session accompanied by speakers from preceding presentations.

GLOBAL TRENDS IN R&D OUTSOURCING AND PARTNERING

12:00 Essential Role of Global Outsourcing of R&D •Outsourcingasameantocontrolcostsandstreamline

operations•Collaborativeapproachtooutsourcedcontract

manufacturing •Enthusiasmforoutsourcingseveralelementsofthe

clinical trial process•Strategicapproach-Outsourcingnoncoreactivities•Tacticalapproach-Addressingshort-termneeds

12:50 Luncheon

14:00 Yet Another Wave in M&A Deals •GrowingdiversifiedprojectportfoliothroughMergers&

Acquisitions •R&Dinnovation,organicgrowth,andinternaldriversas

the key aspect of M&A•Transferoftechnicalknowledge,scalabilityandreducing

time thru M&A deals •PrioritizingtheproductportfolioinM&Aandpost

merger portfolio evaluation

15:00 CASE STUDY: R&D Collaborations to Enhance Portfolio Performance•RisksandinformationsecurityissuesinvolvedinR&D

collaboration•Pros&ConsofResearch&Developmentcollaboration•Whereandhowtoconcentrateourinternalresourcesin

product development •Increasingflexibilityinresourcing,competence

development and technology focus•Managingbusinessprocesses,procedures,risks&

controls to successfully achieve R&D collaboration

16:00 CASE STUDY: Identifying Opportunities for University - Industry R&D Collaborations•Increasedimportanceofadvancedindustrialsocieties

- Partnering with higher educational institutions in ordertocommercializetheresultsofscientificandtechnological research

•Illustratingtheextentofuniversity-industryR&Dcollaborations

•Sponsoringhigh-qualityresearchmodels•Allocatingresourcestofunduniversityprofessors•Obtainingclearaddedvaluebyfundinguniversitieswith

a research consortium Dr. Orest Hurko, Pfizer Inc. (Wyeth)Assistant Vice President Discovery Translational Research

16:30 Afternoon tea & networking

16:50 Maintaining Strong Portfolios and Importance of Alliance Management

•TacklingincreasingcostofR&Danddecliningapprovalrates of new innovative drugs thru alliance management

•Successfullyapproachingpost-dealmanagementchallenges by developing a robust alliance management strategy

•Reviewofbestpracticesinalliancemanagementincluding governance structures, issue management, financialandcontractmanagement,andclientcommunications

•CreatingstrategicalliancesbetweenLargePharmaandSmall Biotech

17:30 Interactive Q & A SessionFeaturing speakers from the afternoon session

18:20 Closing Remarks from the Chair

Speakers and Delegates are Cordially Invited to Attend a Networking Coctail Reception

DAY 1- April 22nd 2010

DAY 2- April 23rd 2010

8:30 Registration and Coffee

9:00 Opening remarks from the chair

INNOVATIVE STRATEGIES AND MODELS FOR R&D PORTFOLIO SUCCESS

9:10 Prioritization of existing pipeline between early stage & late portfolio•Identifyingnewandemergingstrategiestocosteffectively

expand product portfolios•Settingclearstrategicgoalstoaccelerateorhaltindividual

project in the pipeline•Comparingproject’scontributiontostrategicgoalswith

other projects in the portfolio•Assessingtheproject’scontributiontostrategicgoals•Balancinginternalcapabilitiesagainstexternal

opportunitiesDr. Carmel Egan, Eli Lilly & CompanyVicePresident–ProjectManagement

9:40 Morning Coffee and Networking

10:00 Catenion Presentation

10:40 Increasing effectiveness of product lifecycle management by centralizing agendas •AdaptingthePLMtoimproveproductorientedprocessand

overcome the challenges•PharmaceuticalLicensingStrategiesToEnhanceLife-Cycle

Management •ManagingProductLife-CycleInTheChangingPatent

Environment•Increasingprojectportfolio&growingdemandonProcess

R&D for late development activities•Successfullypassingnextmilestonebyestimatingwork

scope at any point along the project’s development lifecycle

11:20 Strengthening Project Portfolio thru Business Development•Meetingtheneedsofthechangingcustomerbaseand

strengthening project portfolio thru BD•Securing&managingmarketintelligence,todevelopa

sophisticated understanding of healthcare markets•Addingvalueonnewtreatmentsbyusingqualitativeand

quantitative marketing data •Newforecastingandvaluationtoolsdeployedtoprovideefficientprojectionstocriticaldecisions

•Assessingpossiblein-licensingopportunities

CONTINUED FOCUS ON RESOURCE ALLOCATION & EXECUTION OF PROJECT PORTFOLIO MANAGEMENT

12:00 Managing Cross-functional Integration Processes•Communicating&Educatinguniformstrategyacross

organizational boundaries•Settingstrategies&monitoringoverallportfoliofor

particular disease areas •Necessityofearlyinteractionbetweencrossfunctional

teams •Assuringcontinuesflowofknowledgeandabilitytoshare

information •Achievingsmoothhandoverfromdrugdiscoveryphasetodevelopment–PracticalExamples

12:40 Improving Decision Quality within BioPharmaceuticals•The“Value-basedDecision-making”coursehasraised

awareness, transferred skills, and provided a common language

•Aweb-basedportfoliotoolhashelpedtostandardizebusiness cases for our investments and focused on drivers of value

•Aparticipatorygamewithdifferentbetsandrealcashpayouts drove home analytical results and achieved consensus among an opinionated leadership team

Phillip C. Beccue, Baxter BioScienceDirector, Strategy and Portfolio Management

13:20 Luncheon

14:20 Ensuring Project Management Tools and Processes Improve Business Decision Making•Howcantheprojectmanagementmethodologysupport

portfolio prioritization and resource allocation decisions? •Whatdoesittaketoensuretheinformationistimelyand

reliable? •Howdoyouminimizethemaintenanceburdenonthe

organization to ensure that the value is worth the effort? ImportanceofunifiedprioritycriteriawithinPPM

Dr. Christopher Beck, Shire PharmaceuticalsVice President, Program Resources and Decision Support

NEW DRUG DISCOVERY & RISK MANGEMENT

15:00 New drug discovery project management solutions and risk budgeting technologies •Maximizingprofitsbycontrollingindividualassetlevelsandfinancialriskswithinportfolio

•Maintainingtherightbalancebetweenprofit&riskaspectsof project portfolio

•Trackingthegapbetweentotalriskofportfolioandactualrisk taken by fund managers

•Allocatingexpectedprofitsandtolerablerisksinnewdrugdiscovery

•ValueandRiskMeasurementofNewDrugDiscovery

15:40 Risk assessment & Risk management in Pharmaceutical Industry•Ensuringqualityofdevelopmentactivitiesbyapplyinga

holistic operational approach to risk assessment•Beyondriskassessmentattheclinicallevel,risk

management processes and risk assessment methods •Assessmenttoolsidentifyinghazardsandevaluatinglatent

affects on project portfolio•Riskassessmentproceduresandtechniquesattheoperationalandscientificlevel

16:20 Closing Remarks from the Chair

16:20 Farewell Coffee and Networking

I would like to thank everyone who has helped with the research and organization of this event, especially the speakers for their support and commitment.

Maros Petres, Project Manager - Lifesciencesmaros.petres@americanleaders.com

Meet Our Comprehensive Speaker Panel

Dr. J. Carmel Egan | Eli Lilly and CompanyVice President, Project Management

Johanna Carmel Egan, Ph.D., was named vice president of project management for Lilly in March 2005. Prior to that, she had been vice president, manufacturing science and technology since 2001. She had been executive director of product development since July 2000. She is a member of the senior management council. Born in Ireland, she received a Bachelor of Science degree in chemistry from University College, Cork, in 1980 and a doctorate in chemistry in 1984 from the University College, Dublin. ShejoinedLillyin1986attheaffiliateinKinsale,Ireland,followingan industrial postdoctoral fellowship in Puerto Rico. In 1990, she transferred to the United States at Clinton Laboratories as group leader of technical services. Egan moved to corporate headquarters in Indianapolis as manager of development projects management in 1992. She was named head of chemical process research in 1995 and the next year was named manager of regulatory affairs: chemistry, manufacturing and control. She was named director, development projects management in 1997. The next year, she became the program team leader for SERM III, and the following year was named product team leader for SERM III. In July 2000, she was named executive director of product development. She was a recipient of the 1999/2000 Chairman’s Ovation Award. SponsoredbySidneyTaurel,chairmanandchiefexecutiveofficer,the award is presented annually to a select number of leaders who demonstrate an exceptional ability to motivate and develop people.

Dr. Christopher Beck | Shire Pharmaceuticals Vice President - Program Resources and Decision Support

Chris Beck has more than twenty years of human capital strategic planning, operations management, and project management experience. His pharmaceutical experience includes establishing AstraMerck’sfirstProjectManagementOfficeandhumanresourceforecasting capability, building and implementing a Global ProjectOfficeforAstraZenecaPharmaceuticals,andcreatingandimplementing a resource and decision management methodology and organization for Merck and Co. Currently at Shire Pharmaceuticals he is responsible for the creation and management of the project and resource capacity planning organization and capability. Beck holds a BS in Information Systems Management from Drexel University and a MBA from Pennsylvania State University. Other education includes the successful completion General Electric’s Information Systems Management Program.

Markus Thunecke | Catenion Senior Partner

Markus Thunecke is a founding Senior Partner of Catenion who lives in Berlin, Germany. Markus started his consulting career in 1997 at Mercer Management Consulting before joining a strategy consulting boutique, Theron, and setting up Catenion in 2003. Markus has helped numerous clients around the globe in the pharmaceutical and medical products industries create competitive advantage. In addition to his work on strategy, Markus specialises in developingleading–edgeanalyticaltoolsandcombiningthemwithorganisational development capabilities. Markus is the developer of a number of Catenion’s proprietary tools for portfolio management and risk assessment. In recent engagements, Markus has helped clients develop and realign their R&D strategies, review their discovery and development portfolios, and create organisational models that foster innovation.Markus is a frequent speaker at conferences on R&D strategy and portfolio management. He holds a PhD in biochemistry from the University of Heidelberg, where he generated transgenic animal models for Alzheimer’s disease. HealsohasthreeyearsofresearchexperiencewithintheCNSfieldatSchering AG.

Phil Beccue | Baxter Healthcare Director of Strategy & Portfolio Management

Phil Beccue is the Director of Strategy and Portfolio Management at Baxter Bioscience. Phil specializes in decision analysis, portfolio optimization, risk analysis, and strategic business support. He helps decision-makers frame decisions, structure their values, and analyze the risks and returns of competing strategies. Phil applies his expertise at Baxter on product strategy decisions, portfolio management, and functional decision-making. He has trained over 600 managers and senior executives on the principles and processes of strategic decision-making.Prior to joining Baxter, Phil was responsible for building the Decision Sciences group at Amgen and played a key role in institutionalizing decision analytic processes. Before joining Amgen he was a consultant with Applied Decision Analysis, where he helped clients in diverse industries solve challenging business problems in strategy, prioritization, and risk analysis. Phil serves as Associate Editor for the Decision Analysis Journal, and received degrees from both Westmont College and Stanford University.

Florian Jehle | CatenionManager

Florian started his consulting career in 2002 at Theron, a strategy consulting boutique. In 2005, he joined Catenion.Florian has worked on multiple projects for European and global pharmaceutical companies. As an interim manager he was responsible fortheEuropeanlaunchpreparationofalate–stageCNScompound.He has led large client teams at a leading global pharmaceutical company during an extensive Strategy and Therapy Area review and a decisionanalysisprojectforseveralclinical–stagecompounds.Hesupportedaglobalcompanyindefiningamarketentrystrategyforthe biopharmaceutical market including a pre-selection of potential partners and licensing candidates. In the medical device industry, he has implemented Catenion’s approach to portfolio management for the prioritisationofearly–stageaswellaslate–stageprojects.Florian holds a degree of wood science and economics from the University of Hamburg, Germany. Prior to his consulting career, he worked for companies in Germany, Singapore and the US