final agenda register by plus! the next 20 people that ...pharmacovigilance • discuss the...

CHI’s BioPharma Strategy Series presents…

November 8 - 9, 2010Crowne Plaza Philadelphia Downtown Philadelphia, PA

Post-Approval

DrugSAfetyStrategiesOvercoming Challenges in Supporting the Product’s Best Benefit-risk Balance

5th Annual

Corporate Support Sponsors:

Sponsoring Organization:

Corporate Sponsors:

healthtech.com/phv

Final Agenda register by September 17th and Save up to $200

Cambridge Healthtech Institute 250 First Avenue, Suite 300, Needham, MA 02494 T: 781.972.5400 l Toll-free in the U.S. 888.999.6288 F: 781.972.5425 l www.healthtech.com

Organized by:

Key DeliverAbles:

• HEAR how leading companies are defining and implementing a formal framework of corporate risk management

• ATTAIN strategies to place risk management more in connection with benefits

• EXAMINE the use of quantitative and qualitative methods to better balance benefit-risk

• MASTER global regulatory authorities’ evolving expectations

• UNDERSTAND how to improve clinical trial safety and surveillance

• LISTEN to practical FDAAA and REMS case studies from industry leaders

• LEARN how others are optimizing Electronic Health Records for pro-active pharmacovigilance

• DISCUSS the opportunities and challenges of linking pre-market and post-market data

• INTEGRATE drug safety knowledge longitudinally across a compound’s lifecycle

CO-LOCAteD eventMitigating Safety Risks in

Early Clinical Development:Bridging the Gap between Preclinical and

Clinical Safety to Improve PredictionNovember 8-9, 2010

PLuS! The next 20 people that register by September 17, 2010, will receive a FREE soon to be published book Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk See page 6 for details.*

For suggestions about the meeting:Micah Lieberman Executive Director, ConferencesBioPharma Strategy SeriesCambridge Healthtech Institute (CHI)T: (+1) 541.482.4709E: [email protected]

For exhibit, partnering and sponsorships: Arnold WolfsonBusiness Development ManagerBioPharma Strategy SeriesCambridge Healthtech Institute (CHI)T: (+1) 781.972.5431E: [email protected]

For marketing and media partnerships: James PrudhommeMarketing ManagerCambridge Healthtech Institute (CHI)T: (+1) 781.972.5486E: [email protected]

Distinguished Faculty:• CarmenBozic,M.D.,SeniorVicePresidentandGlobalHead,DrugSafetyandRiskManagement,BiogenIdec,Inc.

• PatrickCaubel,M.D.,Ph.D.,MBA,VicePresident,GlobalHeadPharmacovigilanceandEpidemiology,Sanofi-Aventis

• BartonCobert,M.D.,BLCMDAssociatesLLC;formerGlobalHead,Pharmacovigilance,Schering-PloughResearchInstitute

• PaulCoplan,D.Sc.,MBA,ExecutiveDirector,RiskManagementandEpidemiology,PurduePharmaL.P.

• JamesCross,Ph.D.,IntegratedSafetyRiskManager,Genentech

• KellyD.Davis,M.D.,VicePresident,Safety,Epidemiology,Registries&RiskManagement,UnitedBioSourceCorporation(UBC)

• GretchenDieck,Ph.D.,VicePresident,Safety,EpidemiologyandRiskManagement,UnitedBioSourceCorporation(UBC)

• MichaelForstner,Ph.D.,IntegratedSafetyRiskManager,DrugSafetyRiskManagement,F.Hoffman-LaRoche

• MickFoy,GroupManager,SignalManagementGroup,VigilanceandRiskManagementofMedicines,Medicines&HealthcareProductsRegulatoryAgency(MHRA)

• StephenFurlong,Ph.D.,SafetyScienceLead,USPatientSafety,AstraZeneca

• ElizabethGarrard,Pharm.D.,R.Ph.,ChiefSafetyOfficer,DrugSafetyAlliance,Inc.

• MichaelJ.Klepper,M.D.,formerFounderandPresidentofIntegratedSafetySystems,Inc.

• RobynLim,Ph.D.,ScientificAdvisor,OfficeofLegislativeandRegulatoryModernization,HealthProductsandFoodBranch,HealthCanada

• JohnMcLane,Ph.D.,ChiefOperatingOfficerandVicePresident,Clinical&RegulatoryAffairs,Clinquest

• JamesMilligan,M.D.,SafetyScienceExpert/SafetyPhysician,ClinicalSafety,AstraZeneca

• SteveOsborne,M.D.,ExecutiveDirector,DrugSafetyOversightBoard,CDER,FDA

• SusanEaton,MSPHMT(ASCP),ResearchManager,NorthAmerica,GeneralPracticeResearchDatabase,MedicinesandHealthcareProductRegulatoryAgency

• MaryK.Pendergast,President,PendergastConsulting;formerDeputyCommissionerandSeniorAdvisortotheCommissioner,U.S.FoodandDrugAdministration

• ColetteF.Saccomanno,Ph.D.,MSLIS,IntegratedSafetyRiskManager,F.Hoffman-LaRoche

• PhilSager,M.D.,VicePresident,ClinicalResearch,Head,CV/MetabolicClinicalDevelopment,Gilead

• JohnSeeger,Pharm.D.,DrPH,AdjunctAssistantProfessor,DepartmentofEpidemiology,HarvardSchoolofPublicHealth

• AnjaSlikkerveer,M.D.,ScientificDirectorTranslationalScience,DrugSafetyResearchLaboratories,AstellasPharma

• BillTrombetta,Ph.D.,ProfessorofPharmaceuticalMarketing,PharmaceuticalMarketing,St.Joseph’sUniversity

• AshrafYoussef,M.D.,Ph.D.,AssociateMedicalDirector,Pharmacovigilance,TakedaGlobalR&D

• SeanZhao,M.D.,Ph.D.,ExecutiveMedicalDirector,GlobalSafety,Amgen,Inc.

Lead Sponsoring Publications:

Sponsoring Publication:

Web Partners:

Dear Colleague:

Improving products’ clinical safety will increase the industry’s fundamental value proposition to patients, healthcare providers, payors, and regulators. The program will focus on pharmacovigilance program implementation and specific strategies and approaches to creating true value from a peri- and post-approval drug safety program. The approach of this conference is not to look at safety in the silos of early-phase safety or post-approval safety but to view safety holistically, across the lifecycle, especially at the transition from approval to broader use in the marketplace.

Post-Approval Drug Safety Strategies will tackle many of the pressing issues that executives are facing today. Some of the topics to be covered include:

• Defining and Implementing a Formal Framework of Corporate Risk Management

• Strategies to Place Risk Management More in Connection with Benefits

• Qualitative Strategies Towards Benefits Optimization, Risk Minimization and Uncertainties Management

• Understand Global Regulatory Authorities’ Evolving Expectations

• Fulfilling Post-Marketing Commitments and REMS Required Studies in the Current Regulatory Environment

• Optimizing Electronic Health Records for Pro-Active Pharmacovigilance

• Integrating Drug Safety Knowledge across a Compound’s Lifecycle and across a Company

In addition, once again in 2010 we will be dedicating time to the informal breakout discussion groups wherein attendees and faculty will continue sharing ideas on the topics above.

The BioPharma Strategy Series (BPSS) mission is to assist in improving the overall health of the pharmaceutical industry by producing high-level meetings that bring together R&D leaders to discuss and debate potential solutions to overcoming the most pressing challenges facing their organizations. I hope you can join us on November 8-9, 2010 in Philadelphia, PA to discuss and debate this emerging drug safety paradigm and how innovative drug safety risk assessment, management, and mitigation hold the promise of creating considerable value for the industry.

Very sincerely,

Micah Lieberman

8 Online: healthtech.com/phv *

Email: [email protected] 7 Fax: 781-972-5425 2

Monday, noveMber 8, 2010

8:00 am Registration and Morning Coffee

8:45 Chairperson’s Opening RemarksDaniel Foltz, Director, Health Informatics, Computer Sciences Corporation

CORPORATE RISK MANAGEMENT

8:50 Special Co-Presentation on Integrating Drug Safety Knowledge across a Compound’s Lifecycle and across a Portfolio

Part 1: Corporate Risk ManagementMichael Forstner, M.Sc., Ph.D., Integrated Safety Risk Manager, F. Hoffmann-La Roche, Basel, SwitzerlandIntegrated Safety Risk Management planning involves the coherent and consistent identification, assessment, and improvement of

the management of drug safety risks throughout the lifecycle of a product and across the product portfolio to improve knowledge of products, com-municate that knowledge, and to protect patients. The Integrated Safety Management Plan (ISMP) is a tool for the prospective strategic assessment of safety risks as well as the retrospective collection, handling and archiving of safety assessments, including the documentation of the benefit risk as-sessment of a drug. As such, the ISMP is the single repository of key safety information, serving as a basis for post-approval risk management planning.

Part 2: Data MiningColette F. Saccomanno, Ph.D., MSLIS, Integrated Safety Risk Manager, Hoffmann-La Roche, Nutley, NJData Mining spans the complete product lifecycle. One role of the Integrated Safety Risk Managers is to assist Safety Teams

with accurate and appropriate data mining via the use of integrated business processes that link the various and often disparate data sets that exist across the product lifecycle. An illustration of how Roche is implementing this function will be presented.

Part 3: Comparative Benefit Risk AssessmentJames Cross, MS, Ph.D., Integrated Safety Risk Manager, Genentech, San Francisco, CAThe purpose of Comparative Benefit-Risk Assessment (CBR) is to improve company practices in comparative benefit-risk assessment to ensure that the products we move forward in development and commercialization ulti-mately have benefit-risk tradeoffs acceptable to patients and clinicians. This shall be achieved by improving consistency and transparency in deci-sions regarding tradeoffs by developing and implementing structured ap-proaches to CBR assessment. Illustrations of an cross-functional approach being developed will be highlighted.

10:15 Networking Refreshment Break

BENEFIT-RISK AND A FOCUS ON THE POSITIVE / PROACTIVE RISK COMMUNICATION

10:45 Qualitative Strategies towards Benefits Optimization, Risk Minimization and Uncertainties Management: A Regulator’s PerspectiveRobyn Lim, Ph.D., Scientific Advisor, Office of Legislative and Regulatory Modernization, Health Products and Food Branch,

Health CanadaA benefit-risk-uncertainty management approach, which is holistic and more explicit, is suggested to enhance federal regulatory and downstream deci-sions by: 1) placing potential benefits in context with risks so that deciders can confront inherent trade-offs and examine their risk tolerance; and 2) recognizing associated uncertainties in benefit and risk estimates that can modulate the value assigned to each by health community deciders.

11:15 Using Benefit-Risk Assessment as a Guidepost for Developing Risk Management Plans and REMSPaul Coplan, D.Sc., MBA, Executive Director, Risk Management and Epidemiology, Purdue Pharma L.P.

11:45 The Role of Social Media in Drug Safety Sponsored by and how this Technology can Promote Transparency and Health LiteracyElizabeth Garrard, Pharm.D., R.Ph., Chief Safety Officer, Drug Safety Alliance, Inc.

Patients and healthcare professionals are exponentially seeking information and having conversations on the Internet to gather health information in un-paralleled numbers. They are using social networks, blogs, chat rooms and other social media to take control of their health decision making and share their experiences with other users. This presentation will explore the use of social media by pharma and examine how this technology can promote transparency and health literacy.

12:15 pm Sponsored Luncheon Presentation (Opportunity Available. Contact Arnie Wolfson: 781.972.5431, [email protected]) or Lunch on your Own

BETTER LINKING PRECLINICAL DATA, CLINICAL STUDIES AND POST-APPROVAL DRUG SAFETY

Shared Session with CHI’s Mitigating Safety Risks in Early Clinical Development

1:25 Chairperson’s Opening RemarksStephen Furlong, Ph.D., Safety Science Lead, US Patient Safety, AstraZeneca

1:30 Bridging the Gap between Preclinical Data, Clinical Studies and Post-Approval Drug SafetyPhil Sager, M.D., Vice President, Clinical Research, Head, CV/Metabolic Clinical Development, GileadThis session explores how preclinical testing results can be used

to guide the early clinical development program with respect to the intensi-ty and approaches to early CV safety data collection and analysis. Using the paradigm presented, the early human testing approach can be modulated to most efficiently determine the presence or absence of a safety signal in a manner that maximizes efficiency and is mindful to resource utilization. Furthermore, the preclinical data and the clinical database will significantly impact the post-approval safety database and strategies to further define and mitigate potential safety issues will be discussed.

2:00 Better Integrating Clinical and Preclinical Safety to Achieve Translational Safety

James Milligan, M.D., Safety Science Expert/Safety Physician, Clinical Safety, AstraZeneca

Co-developed by Stephen Furlong, Ph.D., Safety Science Lead, US Patient Safety, AstraZenecaIntegration of clinical and preclinical safety strategy will be dis-cussed from a strategic and operational perspective. Why an orga-

nization must re-evaluate its strategy and organizational structure and how to implement the change (sounds obvious, but easier said than done) are the key points of the discussion

2:30 Breaking Down Pre- & Post-Approval Safety Sponsored by Silos with BPM Ed Chase, Director Life Sciences Framework Solutions, Pegasystems Inc.Presentation abstract: In many organizations, clinical trial safety report-ing and post market surveillance are managed separately, with challenges arising whenever they cross paths. While many barriers arise from where the safety data originates (i.e. EDC/CRFs vs. contact centers), the down-stream requirements are often the same – how to quickly and accurately acquire, analyze and report on safety data in the context of a given product or study? BPM can improve safety practices by harmonizing the man-agement of processes and business rules across your organization while preserving and improving the flow and transparency of both safety and process data.

3:00 Networking Coffee Break



3:30 Lessons Unlearned: Determining Risks from Clinical TrialsMichael J. Klepper, M.D., former Founder and President of Integrated Safety Systems, Inc.; co-author of “Drug Safety Data”The ability to determine risk from clinical trials is limited in a number of ways including limited numbers of subjects exposed and limited

duration of exposures. Nevertheless preemptive measures can and should be taken to maximize the detection of risk. Unfortunately, these steps are often not taken resulting in greater and unnecessary risks to subjects; increased time, costs and expenditure of resources to the company; and potential delays in approval or non-approval of drugs. These issues are universally relevant but remain inadequately addressed. The audience will gain an understanding of the pitfalls in determining risk and a pragmatic approach of how to avoid these pitfalls and maximize risk detection during clinical development.

4:00 Translational Toxicology as Part of Risk Management throughout the Life Cycle of a ProductAnja Slikkerveer, M.D., Scientific Director Translational Science, Drug Safety Research Laboratories, Astellas PharmaFrom the moment of the first study in humans, risk management is imple-mented in drug development. At that time there is only non-clinical data. Gradually, during the development these data become complimented with clinical safety data. It is essential that throughout this period, there is an ade-quate integration of the data sets. More importantly, a greater awareness and understanding needs to be created between non-clinical and clinical safety specialists to make the process work. At Astellas, it is the role of the transla-tional toxicolgist to build the bridges between non-clinical and clinical.

4:30 Break-Out Discussion Groups and Afternoon Session Wrap-Up: Concurrent roundtables are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of issues presented in the afternoon session. Delegates will join a roundtable of interest to them and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

TABLE 1: Improving Pre-Clinical ModelsModerators: Peter Hoffmann, M.D., Ph.D., Executive Director, Preclinical Safety, Novartis Institutes for BioMedical ResearchPierre Lainee, Ph.D., Principal Scientist, Preclinical Safety, AstraZeneca• Useofdiseasemodelsinpreclinicalsafety(e.g.,diabetesmodels)?• Whichmodelsshouldbeintroducedforbetterpredictionoflatestagehuman

cardiovasculartoxicity?• Howtoselect,establishandvalidatenewmodels?• Decisionmakingbasedondataobtainedinexploratorypreclinicalstudies

TABLE 2: Improving Signal Detection and Validation: How do you Maximize your Ability to Detect Important Safety Signals Early in Clinical Development? Moderator: Michael J. Klepper, M.D., former Founder and President of Integrated Safety Systems, Inc.; co-author of “Drug Safety Data”• Whatarethepitfallsinearlyidentificationofimportantsafetysignalsinearly

clinicaldevelopment?• Howdoyoumaximizeidentificationofsafetysignalsinearlyclinical

development?• Whatare“bestdrugsafety/pharmacovigilancepractices”inearlyclinical

development?

TABLE 3: Leveraging Informatics and IT to Improve Safety PredictionModerators: Sandeep Modi, Ph.D., Cheminformatician, Safety & Environmental Assurance Centre, Unilever; former Research Associate, GlaxoSmithKline; Aris Persidis, Ph.D., President, Biovista, Inc.• Howcanwebetteranalyzesafetydataandmanageknowledgeacrossan

organization?• Whatarethetruecostsandbenefits?• WhereisthegreatestROIforsmallandlargecompanieswhenconsidering

tools,technologyandhumanresourcestodedicate?

INTERACTIVE BREAKOUT DISCUSSIONS

TABLE 4: How to Minimize the Risk of Drug-Induced Liver InjuryModerators: Paul Watkins, M.D., Verne S. Caviness Distinguished Professor of Medicine, Professor of Pharmacotherapy, University of North Carolina Chapel Hill; James Dykens, Ph.D., Group Leader, Investigative Cell Toxicity, Drug Safety R&D, Pfizer, Inc.• Willrecentgeneticinsightschangenogodecisionsinclinicaldevelopment?• Whatareappropriateuseofinvestigationalbiomarkers?• Doyouconsideroff-targetmitochondrialimpairmentimportantforthe

etiologyofDILI?Ifso,howareyouaddressingit?

TABLE 5: QT Analysis during Clinical Development and Post-Approval Safety AssessmentModerator: Phil Sager, M.D., former Vice President, Clinical Research, Head, CV/Metabolic Clinical Development, Gilead• TheroleofcarefulQTassessmentduringSADandMADstudies• AutomaticQTanalysis-isthisaviableapproach?Doesitaddvalue?• WhatarethebestapproachestoPhaseIIIwhenthereisaQTsignal

TABLE 6: Overcoming Challenges in Cardiovascular Risk AssessmentModerator: Ihor Gussak, M.D., Ph.D., FACC, Chief Medical Officer and Vice President, NewCardio, Inc.• Automatedversussemi-automatedECGevaluationinearlycardiacsafety

assessment• Newmarkersforcardiac(pro-arrhythmic)toxicityandtheirclinicalvalidation

TABLE 7: Challenges and Opportunities for Outsourcing and Off-shoring Post Approval-Drug SafetyModerator: Gretchen Dieck, Ph.D., Vice President, Safety, Epidemiology and Risk Management, United BioSource Corporation (UBC)• OutsourcingvsOff-shoring-prosandconsfromacost,quality,and

regulatory perspective• Dolowcostcentersremainlowcostoverthelongterm?Aretheylowcost

intheshortterm?• Buildingcorporatehistoricalmemoryresafety-shouldthisbea

consideration?

TOPIC 8: How to Evaluate the Effectiveness of Your Risk Minimization StrategiesModerator: Michael Forstner, M.Sc., Ph.D., Integrated Safety Risk Manager, F. Hoffmann-La Roche, Basel, Switzerland• Howcanwemeasurewhatwemayhavecausednottohappen?• Subjectiveassessments,objectivemeasures,evaluationmodels• Whatcanwelearnfromotherindustries?

TOPIC 9: DSMBs as a Part of a Pro-Active Risk Communication StrategyModerator: Barton Cobert, M.D., FACP, FACG, FFPM, President, BLCMD Associates LLC• IsthereeveraroleforaDSMBinphaseIstudiesforhighlytoxicor

controversial drugs• ForDSMBscoveringmultiplestudies,whatoperationaltoolsareavailableto

helpthecommitteemonitorlargeamountsofdata?• ShouldthestatisticianbefromoutsidethesponsorinallDSMBs?• ShouldtheDSMBeverinteractwiththesponsor’sdrugsafetygroupand/or

theinvestigators?• HowshouldtheDSMBrespondifitfeelsthesponsors’drugsafetygroupis

notadequatelyhandlingsafetydataorpickingupsignals?• ShouldtheDSMBmeetroutinelyinitsclosedsessionswithoutanysponsor

representativespresent?

TABLE 10: The Role of Social Media in Drug Safety and How this Technology May Improve or Hurt CommunicationModerator:ElizabethE.Garrard,Pharm.D.,RPh.,ChiefSafetyOfficer,Drug

SafetyAlliance,Inc.• Whatformsofsocialmediaarebeingusedbyyourcompanywhereyou

work?Ifthemediaisinteractiveandunderthecontrolofthepharmacompanyyouworkfor,doyouactivelylookformentionofAE’s?

• WhatchallengesfacepharmaintheuseofsocialmediaandAEdetection?• Dothebenefitsofincreasedcommunicationoutweightheriskswiththeuse

ofsocialmedia?



TOPIC: DSMBs as a Part of a Pro-Active Risk Communication StrategyModerator: Barton Cobert MD, FACP, FACG, FFPM, President, BLCMD Associates LLC• IsthereeveraroleforaDSMBinphaseIstudiesforhighlytoxicor

controversialdrugs• ForDSMBscoveringmultiplestudies,whatoperationaltoolsare

availabletohelpthecommitteemonitorlargeamountsofdata?• ShouldthestatisticianbefromoutsidethesponsorinallDSMBs?• ShouldtheDSMBeverinteractwiththesponsor’sdrugsafety

groupand/ortheinvestigators?• HowshouldtheDSMBrespondifitfeelsthesponsors’drugsafety

groupisnotadequatelyhandlingsafetydataorpickingupsignals?• ShouldtheDSMBmeetroutinelyinitsclosedsessionswithoutany

sponsorrepresentativespresent?

TOPIC: The Role of Social Media in Drug Safety and How this Technology May Improve or Hurt CommunicationModerator: Elizabeth E. Garrard, PharmD, RPh., Chief Safety Officer, Drug Safety Alliance, Inc.• Whatformsofsocialmediaarebeingusedbyyourcompanywhere

youwork?Ifthemediaisinteractiveandunderthecontrolofthepharmacompanyyouworkfor,doyouactivelylookformentionofAE’s?

• WhatchallengesfacepharmaintheuseofsocialmediaandAEdetection?

• Dothebenefitsofincreasedcommunicationoutweightheriskswiththeuseofsocialmedia?

5:30 Networking Cocktail Reception

6:30 Close of Day

Tuesday, November 9, 2010

8:00 am Morning Coffee or Sponsored Breakfast Presentation(Opportunity Available. Contact Arnie Wolfson: 781.972.5431, [email protected])

8:20 Chairperson’s Opening RemarksElizabeth E. Garrard

UNDERSTANDING GLOBAL REGULATORY AUTHORITIES’ EVOLVING EXPECTATIONS

8:30 FDAAA and REMS: What Have We Learned, What Don’t We KnowMary K. Pendergast, President, Pendergast Consulting; former Deputy Commissioner and Senior Advisor to the Commissioner, U.S. Food and Drug Administration

9:00 REMS: Implications for Strategy and Marketing after the Risk Identification and AssessmentBill Trombetta, Ph.D., Professor of Pharmaceutical Marketing, Pharmaceutical Marketing, St. Joseph’s UniversityAfterriskidentificationandassessment,therearenumerousstrategy

andmarketing issuesthatmakethedrugfirmvulnerabletoregulatory issues.Forexample,howdoyoucompensatesales reps fordecreasingsalesdue tosmallerpatientpopulations;canREMSofferanopportunitytopartnerwithphysi-ciansinsteadofjustdetailingthedrug;andmostimportant:whatistheroleofthe strategy of Demarketing inminimizing regulatory exposure under REMS.ThispresentationaddressesthepracticalissuesthatfollowaftertheclinicalandscienceREMSassessment.Theaudiencewill learnhowtobecomeawareofstrategiesandmarketingtacticsthatcanbeemployedtoenhanceREMSasanopportunitytobecomeastrategicpartnerwithphysiciansinsteadofjustasup-plierofdrugs.

9:30 Preparing for Success in a New Era of Sponsored by Pharmacovigilance and Medical Information Auditing: A Case StudyJohn McLane, Ph.D., Chief Operating Officer and Vice President, Clinical & Regulatory Affairs, Clinquest

ItwasanormalTuesdayat9:41amwhentheunrecognizedvisitorenteredtheofficelobby.Abriefintroductionandtheflashofabadgecatalyzedacompany-widereac-tiontoanunannouncedFDAauditfocusingonthecompany’sPharmacovigilanceandMedical Informationsystems.Fivedaysand280questionsandrequests later, theAuditorleftwithoutissuinga483.AsthefrequencyofPharmacovigilanceandMedicalInformationregulatoryaudits increases,youcanguaranteethattheauthoritieswillcometoyourdoor.Willyoubeprepared?

9:45 Networking Refreshment Break10:30 The Benefits of REMS Planning in Sponsored by

Pre-Approval Studies and the Transition to Post-Approval REMSGretchen Dieck, Ph.D., Vice President, Safety, Epidemiology and Risk Management, United BioSource

Corporation (UBC)• CommonmisconceptionsofREMSplanninginpre-approval• OpportunitiesforREMSdevelopmentandtestinginclinicaldevelopment

planning• Thevaluepre-approvalREMSplanningbringstopost-approvalREMS

implementation

11:00 FDA Drug Safety Oversight Board and its Role inthe Evaluation of, and Communication About, Important Postmarket Drug Safety IssuesSteve Osborne, M.D., Executive Director, Drug Safety Oversight Board, CDER, FDA

ThemannerinwhichFDAevaluatespostmarketdrugsafetyhasevolvedtomeetgreaterexpectationsof thepublicandhealthcareprofessionals. In2005,FDAformedtheDrugSafetyOversightBoardtoprovideadviceandrecommendationstotheDirectoroftheCenterforDrugEvaluationandResearchonthemanage-mentandcommunicationofimportant,oftenemerging,drugsafetyissues.TheBoardisformedwithrepresentativesfromFDAandsixFederalPartneragenciesand ispositioned toprovidekeyadviceand recommendationsonnarrowandbroaddrugsafetytopics.

Very informatiVe and current usable information from pre-clinical to post-marketing perspectives. Senior Medical Director, Post-marketing Safety, Abbott Laboratories

it’s more than i expected! Global Drug Safety Officer, Celgene Corp.



11:30 Break-Out Discussion Groups and Morning Session Wrap-Up: Concurrent roundtables are interactive, guided discussions hosted by a facili-tator or set of co-facilitators to discuss some of the issues presented in the morning session. Delegates will join a roundtable of interest to them and be-come an active part of the discussion at hand. To get the most out of this in-teractive session and format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

TABLE 1: Planning Assessments of Your REMS ProgramModerator: Kelly D. Davis, M.D., Vice President, Safety, Epidemiology, Registries & Risk Management, United BioSource Corporation (UBC)• HowtoDetermineWhetherPatientsandHealthcareProvidersaregettingthe

Message• DevelopingSurveyProtocols• WhattoIncludeinREMSAssessmentReports

TABLE 2: In-licensing Opportunities: What are the Red Flags from a Safety Perspective?Moderator: Ashraf Youssef, M.D., Ph.D., DABT, MBA, Associate Medical Director, Pharmacovigilance, Takeda Global R&D• Weightofevidenceatdifferentstagesofdevelopment:Whatarethemain

areasofconcernforeachstageofdevelopment?• Whataresomegoodexamplesofsuccessfulin-licensingopportunitydespite

redflags?• Wouldyouin-licensethisproduct?Acasestudy

TABLE 3: Data Quality and Compliance in ICSR ReportingModerator: Mick Foy, Group Manager, Signal Management Group, Vigilance and Risk Management of Medicines, Medicines & Healthcare Products Regulatory Agency (MHRA)• Whattocodefromthecasenarratives• Creatingfalsesignalsandmissingimportantsignals• Howtoachievehighqualityagainstcompliancetimelines

TABLE 4: Endpoint Trials as a Risk Management ToolModerator: Stephen Lin, M.D., Head, Diabetes Medical Safety Evaluation, Global Pharmacovigilance & Epidemiology, sanofi -aventis• HowcanEndpointTrialsserveasaRiskManagementTool?And,forwhat

aspects?• WhatarethelimitationsofthesestudiesasaRiskManagementTool?• WhenshouldEndpointTrialsbeconducted,iftheyareusedasaRisk

ManagementTool?

TABLE 5: Design and Execute a Proactive Risk Management Plan to Achieve the Best Benefi t-Risk RatioModerator: John McLane, Ph.D., COO & Vice President, Clinical and Regulatory, Clinquest, Inc.• AnticipateearlyifadrugwilllikelytobeputintoaREMSprogramandat

what level• Evaluateifdiagnosis,testingorfollow-upwillimproveyourassessmentof

benefitriskratio(evenifnotatREMSlevel)• TestyourRMPatPhIIandIII

TABLE 6: Collaborative Research and Surveillance: Can Anyone Really Afford to “Go it Alone”?Moderator: Daniel Foltz, Director, Health Informatics, Computer Sciences Corporation • Influentialstakeholdersarecreatingcollaborativenetworkstoleveragethe

growing body of real world data for both research and surveillance purposes.• Whichcollaborativenetworksappeartobeonesthatwillshapethefuture?

Why?• Whatarethecommonattributesofsuccessfulcollaborativenetworks?• Whatopportunitiesandbarriersexistforbiopharmaceuticalcompaniesas

theseresearchandsurveillancenetworkscontinuetoemergeandevolve?

INTERACTIVE BREAKOUT DISCUSSIONS12:15 pm Sponsored Luncheon Presentation (Opportunity Available. Contact Arnie Wolfson: 781.972.5431, [email protected]) or Lunch on your Own

INTEGRATING DRUG SAFETY KNOWLEDGE

1:40 Chairperson’s Opening Remarks

1:45 Case Study: Stratifying Risk among PopulationsCarmen Bozic, M.D., Senior Vice President and Global Head, Drug Safety and Risk Management, Biogen Idec, Inc.

2:15 Registries and Observational Studies: Analyzing and Incorporating Drug/Condition Information for Overall Population and Subgroups to Demonstrate your Product’s True Value and Risk/Benefi t and Improve Decision MakingSusan Eaton, MSPH MT (ASCP), Research Manager, North

America, General Practice Research Database, Medicines and Healthcare Product Regulatory Agency

2:45 Optimizing Electronic Health Records for Pro-Active PharmacovigilanceMick Foy, Group Manager, Signal Management Group, Vigilance and Risk Management of Medicines, Medicines & Healthcare Products Regulatory Agency (MHRA)

This presentationwill reflect on recent developmentswith the EHR and howthesecanaidADRreporting,signaldetectionandriskmanagementplanning.Thespeaker aims to stimulate debate on the new capabilities offered by electronic health records. Audience will learn about up to date information on new UK initia-tives and some of the pitfalls of e-transmission of such data.

3:15 Drug Safety on a Budget: Cost/Benefi t Analyses andBudgeting for the Drug Safety FunctionBarton Cobert, M.D., BLCMD Associates LLC; former Global Head, Pharmacovigilance, Schering-Plough Research InstituteDrug safety is a critical and vital function necessary to protect the pub-

lic health. Although much is talked about and written regarding what is needed, howtominimizeriskandhowtodoit,littleisavailableonthecost/benefitanaly-ses and budgeting for the drug safety function. This session will examine how to approach the issue and how to prepare a plan to perform excellent drug safety within a reasonable cost structure. The aim is to understand what functions are necessaryandwhatfunctionsare“nicetohave”.Wewillexaminewhichfunc-tions must remain in-house and which ones can feasibly and appropriately be out-sourced from the costing point of view. Finally, we will propose a strategy for companies, vendors and providers to develop the appropriate models for their situations realizing that small, mid-size and large companies all have different needs and interests.

INTERACTIVE PANEL3:45 What is the Best Method to Fulfi ll Post-Marketing Commitments and REMS Required Studies in the Current Regulatory Environment?Panelists:

Sean Zhao, MD., Ph.D., Executive Medical Director, Global Safety, Amgen Inc.

John Seeger, Pharm.D., DrPH, Adjunct Assistant Professor, Department of Epidemiology, Harvard School of Public Health

Paul Coplan, D.Sc., MBA, Executive Director, Risk Management and Epidemiology, Purdue Pharma L.P.

Mary K. Pendergast, President, Pendergast Consulting; former Deputy Commissioner and Senior Advisor to the Commissioner, U.S. Food and Drug Administration

4:15 Closing Comments

4:30 End of Conference

Abbott Laboratories

IT’S MORE THAN I EXPECTED! Global Drug Safety Offi cer, Celgene Corp.



Register by September 17th and Save up to $200Plus! The next 20 people to register by September 17, 2010, will receive a FREE soon to be published book:*

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine RiskBy:

MichaelJ.Klepper,MD,President,MichaelJ.Klepper,MD,LLC, ResearchTrianglePark,NorthCarolina

BartonCobert,MD,FACP,FACG,FFPM,BLCMDAssociatesLLC

Theonlyguideofitskind,DrugSafetyData:HowtoAnalyze,Summarizeand Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment.

Paperback Length: 376 pages

Willpublish:9/13/2010

Register | Book Details & Order Book Only | Website

*This is a special promotion valid from August 9, 2010 – September 17, 2010. Book promotion does not apply to previously registered delegates. The first twenty delegates that register between August 9, 2010 – Septem-ber 17, 2010 will receive a complimentary copy of the book on-site at the conference. If you are not one of the first twenty delegates that registers between August 9, 2010 – September 17, 2010, and would like to purchase the book, click here.

CO-LOCAteD event

Mitigating Safety Risks in Early Clinical

Development:Bridging the Gap

between Preclinical and Clinical Safety to

Improve Prediction

November 8-9, 2010

healthtech.com/ptx



Hotel & travel InformationConference Hotel: Crowne Plaza Philadelphia Downtown1800 Market Street Philadelphia, PA 19103Phone: 215-561-7500Fax: 215-561-2556

Discounted Room Rate: $149 s/dDiscounted Cut-off Date: October 11, 2010

Please visit our website to make your reservations online or call the ho-tel directly to reserve your sleeping accommodations. Identify yourself asaCambridgeHealthtechInstituteconferenceattendeetoreceivethereduced room rate. Reservations made after the cut-off date or after the group room block has been filled (whichever comes first) will be accepted on a space-and-rate-availability basis. Rooms are limited, so please book early.

Your company has a unique opportunity to influence a major gathering of life science executives, primarily from large pharma, who will come together at the Post-Approval Drug Safety Strategies conference, produced as part ofCHI’sBioPharmaStrategySeries.

Brand your company as a thought leader by participating as an active Sponsor. Presenting your solutions or ser-vices directly to our top-tier delegates can significantly impact their buying decisions and help you achieve your sales and business development objectives.

Presentation opportunities include Agenda Presentations, Breakfast and Luncheon Workshops or you may pre-select and gain access to your highest level prospects through an Invitation-only VIP Dinner or function (limited availability).

CHIwillsupportyourSponsorshipandbrandyourcompanywithstrongmarketingprogramsbefore,during,andafter the event. The earlier you secure your Sponsorship, the more opportunity for exposure.

to explore ways for your company to participate, please contact:Arnie Wolfson, Manager of Business Development, BioPharma Strategy Series Phone:(+1)781-972-5431•Email:[email protected]

Sponsorship Information:

Flight Discounts:To receive a 5% or greater discount on all American Airline flights please use one of the following methods: • Call 1-800-433-1790 use Conference code A62N0AG• Go online www.aa.com enter Conference code

A62N0AG in promotion discount box• Contact Wendy Levine, Great International Travel

1-800-336-5248 ext. 137

Car Rental Discounts: SpecialdiscountrentalshavebeenestablishedwithHertzforthis conference. Please use one of the following methods:• CallHERTZ,800-654-3131useourHertzConvention

Number (CV): 04KL0001• Goonlinewww.hertz.comuseourHertzConvention

Number (CV): 04KL0001

PrOfILe By InDuStry SeCtOr

Top Pharma 40%

Biotech 30%

Other 5%

CROs 25%

PrOfILe By JOB funCtIOn

Drug Safety 50%

Pharmacovigilance 25%

Other 3%

Product Marketing & Risk Management 22%

PrOfILe By SenIOrItyCEOs, Vice Presidents, Global Directors 45%

Executive Directors, Sr. Managers, Heads 35%

Other 4%

Manager, Associates, Specialist 16%

Post-Approval

DrugSAfetyStrategies

WHO yOu WILL Meet At

tArget AuDIenCe

Pharmaceutical and biotech Market:

Drug Safety

Clinical Safety

Clinical Affairs

Clinical Operations

Pharmacovigilance

Regulatory Affairs

Clinical Data Management

Medical Affairs

Quality Assurance

REMS

Medical Safety

Safety Risk

Safety Surveillance

QA

GCP

Marketing

Risk Management

Pharmacoepidemiology

Post-Marketing Surveillance

Global compliance

Cro Market:

Business Development

Sales and Marketing

Research & Development

Technology

Clinical Services

Compliance

Strategy



Mail Registration to: Cambridge Healthtech Institute

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* REGISTER 3 - 4th IS FREE Individuals must register for the same conference or conference combination and submit completed registration form together for discount to apply. Please reproduce this registration form as needed.

GROUP DISCOUNTS AVAILABLE! Special rates are available for multiple attendees from the same organization. For more information on group discounts contact David Cunningham at 781-972-5472

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Invoices unpaid two weeks prior to conference will be billed to credit card at full registration rate. Invoices must be paid in full and checksreceivedbythedeadlinedatetoretainregistrationdiscount.Ifyouplantoregisteronsite,pleasecheckwithCHIbeforehandfor space availibility.

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Post-Approval

DrugSAfetyStrategies

Overcoming Challenges in Supporting the Product’s Best Benefit-risk BalanceNovember 8 - 9, 2010Crowne Plaza Philadelphia Downtown Philadelphia, PA

r The latest industry news, commentary and highlights from Bio•IT World

CHI Insight Pharma ReportsA series of diverse reports designed to keep life science profession-als informed of the salient trends in pharmaceutical technology, busi-ness, clinical development, and therapeutic disease markets. For a detailed list of reports, visit InsightPharmaReports.com, or contact Rose LaRaia at [email protected], 781-972-5444.

Barnett Educational ServicesBarnett is a recognized leader in clinical education, training, and reference guides for life science professionals involved in the drug development process. For more information, visit www.barnettinternational.com.

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T: 781-972-5400 or toll-free in the U.S. 888-999-6288F: 781-972-5425 • www.healthtech.com

Eachregistrationincludesallconferencesessions,posters

and exhibits, food functions, and a copy of the conference

proceedings link.

Register 3 - 4th is Free! Individuals must register for the same

conference or conference combination and submit completed

registration forms together for discount to apply. Please

reproduce this registration form as needed.

Group Discounts are Available! Special rates are available

for multiple attendees from the same organization. For more

information on group discounts contact David Cunningham at

781-972-5472

Handicapped Equal Access

InaccordancewiththeADA,CambridgeHealthtechInstitute

is pleased to arrange special accommodations for attendees

with special needs. All requests for such assistance must be

submittedinwritingtoCHIatleast30dayspriortothestart

of the meeting.

Substitution/Cancellation Policy

In the event that you need to cancel a registration, you may:

• Transfer your registration to a colleague within your

organization.

• CredityourregistrationtoanotherCambridgeHealthtech

Institute program.

• Request a refund minus a $100 processing fee per conference.

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NOTE:Cancellationswillonlybeaccepteduptotwoweekspriorto

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Additional Registration Details

register by September 17th and Save up to $200

Register by September 17th and Save up to $200Plus! The next 20 people to register by September 17, 2010, will receive a FREE soon to be published book:* See page 6 for details.*

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine RiskBy: BartonCobert,MD,FACP,FACG,

FFPM,BLCMDAssociatesLLCMichaelJ.Klepper,MD,President,MichaelJ.Klepper,MD,LLC, ResearchTrianglePark,NorthCarolina

final agenda register by plus! the next 20 people that ...pharmacovigilance • discuss the...

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