MEDICAL AFFAIRS STRATEGIC SUMMIT - ExL Eventsinfo.exlpharma.com/rs/exlpharma/images/C404-brochure.pdf · Medical Science Liaison Best ... overcome regulatory compliance and ... information

September 23–25, 2013 Hyatt Regency Mission Bay Spa and Marina

San Diego, CA

Medical Affairs Executive Forum Medical Science Liaison Best Practices

Investigator-Initiated Trials

CUSTOMIZE YOUR EXPERIENCE ACROSS THREE TRACKS

ATTENDEE BENEFITS

nFull Access to 3 Different Events for Customization of Your Agenda at NO EXTRA COST

n40+ Unique Educational Sessions Spanning the Medical Affairs and Clinical Research Landscape

nPlenary Sessions includes an Executive Panel, Sunshine Act Updates, and Compliant Information Sharing

nChoose from Six Pre-Conference Workshop Sessions

nEight Networking Opportunities includ-ing Meals, Breaks, and Reception

MASS WEST 2013 LEARNING OBJECTIVES

nEnhance your organizations medical and scientific communication through innovative strategies with leading Medical Affairs and Medical Science Liaisons Professionals

nMaximize your Medical Affairs teams impact on a brand through innovative involvement in publication planning, education grants, review boards, advisory boards, and many more

nImprove your MSL teams impact by establishing long term relations with KOL while participating in internal projects

nAlign research and business strategies, overcome regulatory compliance and funding hurdles, while managing global and local IITs

SPONSORS

Communicate Medical and Scientific Information in a Regulated, Compliant-Driven, and Patient-Centered Environment

MEDICAL AFFAIRS STRATEGIC SUMMIT

FOR MORE INFORMATION WEST.EXL-MASS.COM

Dear Colleague,

We’ve come a long way since the inaugural Medical Affairs Executive Forum,

Medical Science Liaison Best Practices, and Investigator-Initiated Trials event

started about ten years ago. Over the years, our conferences have adapted to

the regulatory, compliance, and scientific communication needs of industry.

However, we know that change within a medical affairs department is a

common occurrence. As we continue to navigate this highly regulated and

dynamic environment, it is of the utmost importance to discover new ways to

communicate medical and scientific information through a dynamic medical

affairs team, medical science liaisons, and investigator-initiated trials.

The Medical Affairs Strategic Summit West serves as your educational

platform to learn new ideas and connect with your medical affairs, MSL, and

clinical research peers, while exploring new strategies to improve your team’s

performance through three tracks:

n THE 5TH MEDICAL AFFAIRS EXECUTIVE FORUM focuses on developing

a compliant team that disseminates medical and scientific communication

to all internal and external stakeholders

n THE 13TH MEASURING AND OPTIMIZING MSL PRACTICE explores the

impact of leveraging an MSLs value through key relationships with KOL

and thought leaders while maintaining internal and external responsibilities

n THE 18TH INVESTIGATOR-INITIATED TRIALS SUMMIT examines the need

to align research and business functions while overcoming regulatory

compliance and funding hurdles to successfully manage your global and

local IIT portfolio

As the roles of medical affairs, MSLs, and investigator-initiated trials

continue to evolve, let us be your guide to the very best in innovative ideas

and practices.

Warmest Regards,

Scott Grossman,Senior Conference Director, Medical Affairs Strategic Summit Series

W E L C O M E T O

MASSWEST2013

H OT E L I N F O R M AT I O N

Hyatt Regency Mission Bay Spa and Marina 1441 Quivira Road San Diego, CA 92109

Tomakereservationscall1-888-421-1442

or402-592-6464andrequestthe

negotiatedrateforExL’sMASSWest.

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AT T E N D E E P R O F I L E

Academics, InvestigatorsAssociates

Medical Science Liaisons

Managers

Directors

Vice-Presidents, Senior Directors, Heads

26%

29%18%

21%

6%

Academics, InvestigatorsAssociates

Medical Science Liaisons

Managers

Directors

Vice-Presidents, Senior Directors, Heads

26%

29%18%

21%

6%

2 FOR MORE INFORMATION WEST.EXL-MASS.COM

https://resweb.passkey.com/go/EXLMassWest

https://resweb.passkey.com/go/EXLMassWest

9.00 | WORKSHOP ADeveloping a Compliant Medical and Scientific Communication Plan for Medical Science Liaisons and Medical Affairs Teams

■n Aligning business plans with the need for scientific communications

■n Understanding communication channels and the need to develop different approaches

■n Effectively managing a communication plan to ensure compliance

■n Determining the best plan for your team to support a product entering the market

■n Developing various communication structures for field-based and internal team members

■n Managing and training virtual team members

Archie StonePhD,SeniorMedicalDirector,GlobalMedicalAffairs,CORNERSTONE

9:00 | WORKSHOP BDetermining Fair Market Value for Your Investigator-Initiated Trials while Remaining Compliant with Sunshine

■n Understanding the Submitted Proposal and Pricing Structure

■n Examining physician payments

■n Assessing value of procedures that occur during the trial

■n Periodically reviewing IIT budgets

■n Analyzing the consistency of fair market value

■n Developing a Sunshine Act compliance strategy

John Neal, ChiefExecutiveOfficer,PERFERRED CLINICAL RESEARCH SITES NEWTORK

9:00 | WORKSHOP CUnderstanding the Sunshine Act and its Implications on the Industry

■n Examining the regulations and the escalating demand for transparency

■n Evaluating financial relationships between manufacturers and prescribers

■n Maintaining compliance during clinical trial activities and study result transparency

■n Price transparency and the need to reduce healthcare spending

■n Uncovering novel strategies for social media and Internet exposure while understanding the online impact this has on the industry

Sunita Sethia, PharmD,President,

INTELLIPHARM COMMUNICATIONS

1:30 | WORKSHOP DBuilding Productive Partnerships with Key Opinion Leaders and Bringing Maximum Value to Your Company

■n Understanding the role of the MSL and their function within a life science company

■n Sharpen and broaden the MSL skill set and preserve the success of the position

■n Define and categorize KOLs

■n Learn strategies for building productive, enduring relationships with KOLs

■n Gain a greater appreciation for the impor-tance of preparation

■n Enhance communication internally and externally

■n Maximize medical conference coverag

■n Plan and execute a successful advisory board

■n Discussion around the universal truths of an effective MSL

Jill Dacierno, Consultant,AM/PM STRATEGYJane Musser, Consultant,AM/PM STRATEGY

1:30 | WORKSHOP EUnderstanding the Planning and Execution of Emerging Global Investigator-Initiated Trials

■n Establishing and funding IITs in newly identified emerging markets

■n Determining infrastructure / resource requirements needed

■n Considerations for global policy and process for reviewing proposals

■n Determining requirements for IIT proposals to ensure consistent and efficient review

■n Planning –Communicatingkeyselectionfactors

throughoutanorganization –Reviewing,contracting,anddetermining

fairmarketvalue –Safetyandreportingconsiderations –Determininghowclinicalsuppliesmaybe

optimallydistributed –Allocatingadditionalresourcesneededfor

globaltrials –Regulatoryactivitiesandpublication

concerns

■n Executing –Trackingperformancethroughoutthetrial –Addressingquality,regulatory,andsafety

concerns –Monitoringlegalandregulatoryfunctions

Alexander M. Kostek, PE,Director,GlobalInvestigatorInitiatedResearch(IIR),ExternalMedicalCommunications,PFIZER

1:30 | WORKSHOP FIncorporating Health Economics and Managed Markets Responsibilities into Medical Affairs Functions

■n Integrating HEOR and medical affairs strategies and activities

■n Dissemination of clinical data and health economics information to clinical and payor decision-makers

■n Structural and functional aspects of HEOR and medical affairs organizations to support market access

■n Industry response to CER expectations

■n A systematic approach to assessing risk and opportunities when incorporating HEOR into commercialization

■n Overview of HEOR value-add to medical affairs communication

■n Overview of Managed Care Liaison responsibilities within a Medical Affairs framework

David A. Jencen, Ph.D.,Principal,JENCEN FIELD MEDICAL CONSULTING

MichaelDubroff,SeniorDirectorofHealthOutcomesandPayerSupport,GENENTECH

4:30 DAY ONE CONCLUDES

*Lunch provided for workshop A, B, and C delegates

W O R K S H O P MasterClasses

AGENDA DAY MONDAY, SEPTEMBER 23, 20131

12:00 LUNCHEON FOR AM WORKSHOP ATTENDEES ONLY

FOR MORE INFORMATION WEST.EXL-MASS.COM 3

9:00 KEYNOTE PANEL:

Communicating Medical and Scientific Information in a Heavily-Regulated, Compliant-Driven, and Patient-Centered Environment■n Overview of the impact compliant medical information has on a patient

■n Understanding how the value of a well–executed scientific exchange can benefit your audience

■n Recognizing the value-add your data has on thought leaders

■n Ensuring that all communication remains compliant from all aspects of your organization

■n Altering communication strategies to meet the needs of your audience

■n Fostering robust medical and scientific discussions based on your audience

■n Planning demonstrations, promotional materials, and touch points

■n Addressing current, future, and actual state of a therapeutic area

Gregory Fiore, MD,ChiefMedicalOfficer,THE MEDICINES COMPANY

Jeff Hersh,MD,ChiefMedicalOfficerforHealthcareSystem,GENERAL ELECTRIC HEALTHCARE

Sheila Gujrathi, ChiefMedicalOfficer,RECEPTORS

Krishna Sudhir, MD,DivisionalVicePresident,MedicalAffairsandProductPerformance,ABBOTT VASCULAR

Mark Monane, ChiefMedicalOfficer,CARDIODX

10:00 PANEL DISCUSSION:

Utilize Metrics, Benchmarks, and SOPs to Measure your Medical Affairs and MSL Teams, Team Members, and Core Functions to Demonstrate Internal and External Value

■n Developing benchmarks to understand the impact that scientific communication has on an organization

■n Utilizing corporate goals to develop metrics for each MA function

■n Identifying communication goals from early phases in a products’ development

■n Examining the value that core functions and teams are bringing to an organization

■n Utilizing metrics that justify team performance to demonstrate incre-mental value set

Mason Ross, VicePresident,MedicalAffairs,NORDIONJanet Karlix, Director,MedicalAffairs,ELANKevin Appareti, MBA,GlobalDirector,MSL,PHILLIPS HEALTHCARESheila Komara, SeniorMedicalScienceLiaison,GlobalMedicalAffairs,HOSPIRARamin Farhood, SeniorDirector,GlobalMedicalAffairs,BAXTER

11:00 NETWORKING AND REFRESHMENT BREAK

11:30

Understand the Impact of Sunshine Disclosures on Physician Interactions

■n Perspectives on the final regulations of spending

■n Maintaining compliance on a local, regional, and global level

■n Improving current processes and payment management for clinical trials

■n Managing continued HCP relationships with industry

■n Key operational aspects for managing an aggregate spend system

12.00

Examine the Role of Medical Affairs and MSLs in Clinical Research Functions Including IITs to Enhance the Research Process

■n Increasing successful clinical trial outcomes by incorporating medical affairs team members and MSLs

■n Developing study steering committees

■n Utilizing thought leaders and KOLs to demonstrate trial productivity

■n Value add for MSL involvement in a publication plan for trial data

Stacey Benefiel, PharmD,Director,MedicalScienceLiaisons,Coronary&RenalDenervation,MEDTRONIC

Alexander M. Kostek, PE,Director,GlobalInvestigatorInitiatedResearch(IIR),ExternalMedicalCommunications,PFIZER

Jonas Hylton, PharmD,RegionalDirector,MedicalAffairs,MEDIVATION

David Herman, PhD,MedicalScienceLiaison,QUESTCOR

1:00

LUNCHEON

M A I N C O N F E R E N C E PlenarySessions

8:00 REGISTRATION OPENS AND CONTINENTAL BREAKFAST

8:45 Chairperson’s Welcome and Opening Remarks

V. Miles Rios, Jr., Director,MedicalOperations,MedicalAffairs,VIVUS Chad Schroer, VicePresident,MedicalScienceLiaisons,EMD SERONO Christian Wade, SeniorManager,MedicalAffairsSystemsandOperations,SEATTLE GENETICS

AGENDA DAY TUESDAY, SEPTEMBER 24, 20132


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Chairpersons’ Opening Remarks

V. Miles Rios, Jr., Director,MedicalOperations,MedicalAffairs,VIVUS

Build A Global Medical Affairs Team by Aligning Organizational Needs and Ensure Efficiency in Product Communication, Education, and Medical Marketing■n Exploringtheprogressionofmedicalaffairsanditsimpactonanorganization

■n Definetheneedsofamedicalaffairsteam

■n Understandingdevelopingastrategicplanthatincorporatesmedicalaffairsinvolvementinresearch,evidencegeneration,KOLengagement,andmedicalinformation

■n DevelopinganSOPforyourmedicalaffairsdepartment

■n Definingyourneedstodevelopaproperfoundation

■n Creatingorganizationalbuy-inandallocatingproperresources

Mason Ross, VicePresident,MedicalAffairs,NORDION


Christian Wade, PhD,AssociateDirector,ScientificAlliancesandOperation,MedicalAffairsSystemsandOperations,SEATTLE GENETICS

Understand the Changing Environment of Investigator-Initiated and the Impact on Industry ■n Adaptingtoanenvironmentoflimitedgovernmentfunding

■n IdentifyingthenewroleofCERtrialsandtheIITcapabilities

■n Identifyingthepowerofinfluenceaorganizationhasasthefundingprovider

■n OrganizationbenefitsofIITsandtheimpactthemcanhaveonanorganizationandbrand

Michael Montgomery, ExecutiveMedicalDirector,INCYTE CORPORATION


Chad Schroer, VicePresident,MedicalScienceLiaisonsEMD SERONO

Explore the Growing Functions of a MSL Role and the Impact they Have on Your Organization■n ExaminingkeyfunctionsoftheMSLrolethroughoutinternalandexternalfunctions

■n BuildinganMSLteamthatcanmanagecoreresponsibilitiesandcross-collaborationprojectswithinternalfunctions

■n DiscussingkeycharacteristicsneededforasuccessfulMSL

■n UnderstandingtheadaptationofanMSLthroughoutanorganization

J. Lynn Bass, Director,MedicalScientists,JAZZ PHARMACEUTICALS

DAY TUESDAY, SEPTEMBER 24, 20132mainconference


Medical Affairs Role in Supporting the Advancement of Medicine through an Integrated Educational Grant Program ■n UnderstandinghowagrantprogramcancontinuetheeducationtoHCPsand,inturn,increasepatientcare

■n Overviewofthedisseminationofeducation

■n Budgetingforunrestrictededucation

■n Identifyingneedsofagrantreviewcommunity

Stephen Petersdorf, SeniorMedicalDirector,MedicalAffairs,SEATTLE GENETICS

Key Insights from Senior Leaders: Addressing the Challenges Impacting MA OrganizationsForthesecondyearrunning,CampbellAlliancebroughttogetherMedicalAffairs(MA)leadersfromadiverserangeofpharmaceuticalandbiotechnologycompaniestosharetheirideasaboutthechallengestheyfaceaswellaspotentialsolutions.Thissessionwilldriveaninteractiveaudiencediscussionbasedonthethreekeyareascoveredinthissummit,including:

■n MAglobalandaffiliatemanagementandalignment

■n MA’schangingroleinsupportingmarketaccessandreimbursement

■n ThefutureofKOLmanagement

Jemma Contreras, Director,CAMPBELL ALLIANCE

Maintain a Prosperous IIT Portfolio in an Environment of Budget Constraints■n Adaptingtoshrinkingbudgetsforsponsor-fundedprograms

■n Allocatingresourcesthatalignallbusinessfunctions

■n Overcomingfundingallocationhurdles

■n Identifying,maintaining,andremainingonbudgetforallIITs

Christine Lim, SeniorManager,WorldwideMedicalAffairs,LIFESCAN, A JOHNSON AND JOHNSON COMPANY

MSL Compliant Collaboration with Sales, Marketing, and Clinical Operations to Provide Additional Value ■n Identifyingopportunitiestoenhancesalesforcefunctions

■n LeveragingMSLstoassistincreatingsuccessfulmarketingmaterials

■n Overcomingchallengeswithincorporatingdataintosalesandmarketingfunctions

■n Overcomingcorporatebarrierstoworkwithinternalandfield-basedsalesteams

■n DevelopinganSOPforcollaborationwithclinicaloperationstoassistwithsiteselectionandstudyenrollment

William Sypula, SeniorMedicalScienceLiaison,LEO PHARMACEUTICALS

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Sharing Scientific Information While in the Field■n ReviewchallengesinrapidlyrespondingtoKOLqueriesandpreparingformeetingswhiletravellingandworkingremotely

■n Overviewofhowcompaniesarepromotingaccesstoscientificinformationinacompliantenvironment

■n Howonlinetools,apps,anddevicesarebeingcombinedasintegratedmobileofficeplatformstobetterequipMSLsandstreamlinetheexchangeofinformation

■n Toolsforencouragingcollaborationthatwillexcitebothearlyadoptersandnewusers

■n Successfulstrategiesforlaunchingnewtechnologiesthatwillcaptivateattendeesanddriveusage

Michael Rai, GeneralManagerofQUOSA,ELSEVIER, INC.

CASE STUDY: Develop an Innovative Field Based MSL Team Structure Centered in a Therapeutic Area■n OverviewofastandardMSLstructurethatsupportsclinicaltrialsandscientificdiscussionsaswellassupportfromapayorandaccessperspective

■n Designinganinternalcommunicationplanaroundatherapeuticareaandexploringthevalue-addtheyhavetoanorganizationintheadventofcurrenthealthcarereform

■n Impactthatthisfocusedteamhasonanorganizationandbenefittheyhavewiththoughtleaders,andaccessopportunities

Ralph Rewers, Director,OncologyMSLGroup,BRISTOL MYERS SQUIBB

DAY TUESDAY, SEPTEMBER 24, 20132


MASSWEST2013mainconference5:00 5:45 6:00 7:00

Develope a Medical Communication Strategy through Enhanced Thought-Leader Engagement■n Usingliteraturesurveillancetoidentifyunmetmedicalneeds

■n Reconcilingpublishedliteratureandregulatorydecisionmaking

■n Aligningcommunicationstrategythroughouttheorganization

William Bailey, PharmD,MD,SeniorDirector,MedicalAffairs,DAIICHI SANKYO

Examine the Impact Field MSLs Have on Both a Product and its Life-Cycle■n EngagingwithKOLsforoff-label,on-label,andotheropportunitieswithaproduct

■n ManagingthehighdemandofrequeststoanMSLteam

■n Maintainingcompliancetoallregulationsaroundscientificexchanges

■n Managingoff-labelrequestandsupportingoff-labelbenefits

■n OpportunitiesanMSLteamhasforexpandingalabel

David Sileo, SeniorMedicalScienceLiaison,HOSPIRA

The Unique Aspects of Investigator-Initiated Research■n Investigator-initiatedvsindustrysponsored

■n Whodefinesthequestion

■n Whataretheresponsibilitiesoftheinvestigator

■n Howisthestudyconducted

■n Howisfundingobtained

■n Whataretherewards

L. O. Lutherer, MD,PhDExecutiveDirector,ClinicalResearchInstitute,TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER

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What your colleagues are saying

about the MASS:

“There were many good speakers

and a wide range of topics covered”

DEPARTMENT COORDINATOR, BAXTER

“Great meeting, the group provided

many educational conversation”

SENIOR MANAGER., TEVA PHARMACEUTICALS

“Very dynamic presenter throughout

the day”

MEDICAL AFFAIRS, PROJECT MANAGER, GENZYME

“Perfect meeting! that provided a

great learning environment!”

ASSOCIATE DIRECTOR, BRISTOL-MYERS SQUIBB

“Very dynamic summit, I was able

to take a lot of knowledge back

to my department”

SENIOR DIRECTOR, MEDICAL AFFAIRS, ABBOTT

“One of the best medical affairs

meeting I have attended”

MEDICAL AFFAIRS, LIFESCAN,

A JOHNSON AND JOHNSON COMPANY


AGENDA DAY WEDNESDAY, SEPTEMBER 25, 2013M

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8:00 8:30 8:45 9:30

Build and Empower an Investigator-Sponsored Trial Review Team■n Definingreviewcommitteemembershipandvotingauthority

■n Managingreviewcommittees’meetings

■n Effectivelyintegratingscientific,clinical,andtranslationalresearchprioritieswithinthecorporatestrategy

■n DevelopinganSOPforyourreviewcommittee

■n Continualprocessevaluationandimprovementstrategies

Christian Wade, PhD,AssociateDirector,ScientificAlliancesandOperation,MedicalAffairsSystemsandOperations,SEATTLE GENETICS

Develop and Implement Milestones into your IIT Contracts to Successfully Manage Global Trials■n UnderstandingtheresearchgoaloftheIIT

■n Workingwiththeinvestigatortoalignprogressandbusinessplans

■n Developingmanageabletimelinesforyourtrial

■n Creatingreachablemilestonesthatwillenhancetheprogressofthetrial

Bob Numerof, Director,GlobalMedicalAffairs,BAXTER

3

Incorporate MSLs Involvement in SOP Writing and Guidelines to Improve a Teams Productivity■n IdentifyingthevaluethatoccurswhenanMSLisinvolvedintheSOPwritingprocess

■n OverviewofSOPwritingpracticeincorporatingcompliant,legal,andmedicalcommunication

■n EnsuringthattheSOPincludessuitablecompliantprocesses

David Herman, PhD,MedicalScienceLiaison,QUESTCOR

Leverage the Value of MSLs while Optimizing Opinion Leaders Engagement, Measuring Field Medical Impact, and Enhance Internal Communication■n AdvancingtheroleandscopeoftheMSLinanevolvinglandscape

■n StrategicallyplanningOLengagementstosupportcompanyobjectives

■n UtilizingtechnologytoevaluatethefieldimpactoftheMSL

■n DemonstratingthevalueoftheMSLtocommercialfunctions

Chad Schroer, VicePresident,MedicalScienceLiaisons,EMD SERONO

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Three Things You Should Know About the Reality of KOL Influence■n Castingawidenettogatherasmanykeyopinionleaders(KOLs)aspossibleisanapproachisnolongermeetsbusinessneeds

■n TargetedapproachtoKOLidentificationandinfluencemappingoptimizesspendandyieldsmoreactionabledatafaster.

■n Adoptinganeffectiveandlong-standingapproachtoKOLidentificationandinfluencemapping

PRESENTATION BY:Dave Johnson, VicePresident,ENCUITY RESEARCH

Developing and Launching a High-Performing Field Medical Affairs Team that Provides Value to all Stakeholders■n Understandingthemedicalaffairsrolethroughoutanorganization

■n Determiningtheoptimumstructureforateam

■n Adaptingtonewbusiness,products,andbrandneeds

■n Maintainingcompliancethroughouttheteamsfunctions

■n Lifecyclemanagement

■n Cross-functionalcommunicationstrategiestoenhanceyourteam

■n Implementingtrainingplatformsformedicalandtherapeuticfunctions

Janet Karlix, Director,MedicalAffairs,ELAN

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Align Medical Communication and Medication Information Teams to Disseminate Compliant Medical Information to Avoid FDA Warning Letters■n Developingacommunicationstructurethroughbothteamfunctions

■n Strategicallybuildingandtrainingyourcallcenterrepresentatives

■n Assistinginpromotionalsupporttoyourcommercialteam

■n Understandingbothteamleadership

■n Challengesandsolutionsincrosscommunication

Omid Khodai, OD,RAC,CQA,CQM,SeniorDirectorClinical&MedicalAffairsandMedicalCommunications,BAUSCH + LOMB

Incorporate Scientific Information Sharing into Medical Affairs Responsibilities to Increase Product Awareness ■n Creatingaddedvaluebyincorporatingmedicalaffairsintoaproducts’lifecyclemanagement

■n Aligningcommercialgoalswithscientificsharing

■n Supportingcommercialfunctionsduringalifecyclemilestone

Lisa Stepp, PhD,MBA,Director,ClinicalResearch-OncologyandInflammationTherapeutics,GILEAD SCIENCES

Empower the MSL Involvement Before and During Clinical Trial ■n Identifyingcorefunctionsandthevalue-addthataMSLcanbringtoaclinicaldevelopmentfunctions

■n Supportingearlyphasetrialsthroughkeyrelationshipwithcustomers

■n Developingandleveringrelationshipswithinvestigatorsandsites

■n Managingglobaltrailprocess

■n CommunicatingdatabetweenHEOR,Managedcare,andclinicaldevelopmentteams

Donna Cronin, AssociateDirector,RegionalMedicine,ACORDA

CASE STUDY:

Successfully Build an MSL Team with a Third-Party Agency■n Keyelementstobuildingasuccessfulteam

■n Decisionstoanalyzeforbuildingateaminternallyoroutsourcingone

■n PotentialcostconsiderationsincludingSunshineandaggregatespend

■n Evaluatingthevendorselectionprocess

Gail Rosen Spahn, PharmD,SeniorDirector,MedicalSciences,XENOPORT

Explore the Overview and Evaluation of an IIT Review, Approval, and Oversight■n Understandingthecomponentsofanevaluation

■n Developinganorganizationalstructure

■n Definingthescopeandstrategyoftheprogram

■n Developinganalysisandforecasting

■n Creatingevaluationcriteriaandprovidingfeedbacktoinvestigators

Dennis Decktor, PhD,MBA,SeniorDirector&RheumatologyLead,MedicalAffairsStrategicTrialsTeam,JANSSEN

CASE STUDY:

Strategy for Managing an IIT System through Buyouts and a Changing Regulatory Environment■n UnderstandingtheneedforaIIRstrategymanagingsystem?

■n Mitigatingricksandimprovecompliancewhilecontrollingcosts?

■n Adaptingtodemandsforincreasedtransparency?

■n Incorporationofadditionalprogramsandlegacydatafromacquiredsources?

■n Maintainingsupportforauditrequirementsanddocumentations

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3DAY WEDNESDAY, SEPTEMBER 25, 2013

1:00

Ensure Compliance and Customer Oriented Strategy when Developing a Scientific Communication Plan

■n Preparing your team for scientific interactions with healthcare providers

■n Streamlining exchange-management practices with thought leaders, KOLs, and MSL’s

■n Understanding communication channels and developing different approaches

■n Ensuring that the advisory board is being compliant

■n What can be done about a product from the scientific product with data

■n Communication on label data

Gretchen Fritz, Esq.,SeniorDirector,AssociateGeneralCounsel,CommercialBrands,LegalAffairsDepartment,DAIICHI SANKYO

1:45

Maintain Compliance Throughout all Aspects of Medical and Scientific Communications While Being Prepared for Off-label Requests

■n Developing a plan to strategically review all communication materials through internal stakeholders

■n Preparing for medical and scientific communication and post-event follow up for all conferences

■n Training and preparing MSLs and field medical affairs professionals for scientific communication

■n Working with a medical review committee in order to gain product support

■n Responding to unsolicited requests for off-label information

2:45 PANEL DISCUSSION:

Understand the Value-Add that HCPs and KOLs have on Publications, Steering Committees, Advisory Boards, and Patient Advocacy Groups

■n Identifying the right value-add project that can assist in the success of your products

■n Addressing business functions with product support tools

■n Developing a training platform for healthcare providers

David Sileo, SeniorMedicalScienceLiaison,HOSPIRA

Stephen Petersdorf, SeniorMedicalDirector,MedicalAffairs,SEATTLE GENETICS

Rachel Couchenour, Director,MedicalAffairsCommunications,CHELSEA THERAPEUTICS

3:15

Chairperson’s Closing Remarks

V. Miles Rios, Jr., Director,MedicalOperations,MedicalAffairs,VIVUS

Chad Schroer, VicePresident,MedicalScienceLiaisons,EMD SERONO

Christian Wade, SeniorManager,MedicalAffairsSystemsandOperations,SEATTLE GENETICS

3:30 CONFERENCE CONCLUDES

M A I N C O N F E R E N C E PlenarySessions

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MASSWEST REGISTRATION

Information

FOUR WAYS TO REGISTERPlease Mention Priority Code C404B

ONLINE: west.exl-mass.com

PHONE: 866-207-6528

FAX: 888-221-6750

MAIL: ExL Events, Inc. 494 8th Ave, 4th Floor New York, NY 10001

Group Discount Program

For every three simultaneous registrations |from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time). This is a savings of 25% per person.

Can only send three? You can still save 15% off of every registration.

Want to send more? Contact us about our group pricing. Please call 212-400-6240.

*Discount offers may not be combined*

SPONSORSHIP OPPORTUNITIESDo you want to spread the word about your organization’s expertise and services to the executives who attend this event? Take advantage of this opportunity to exhibit, showcase your subject matter expertise, host a networking event, and/or distribute promotional items to attend-ees. ExL Pharma’s MASS event is the ideal platform to showcase your organization to your target market over three days in one intimate location. ExL’s customized packages will maximize ROI and comple-ment your organizational strategies. For more information on a customized MASS West package to maximize your ROI and complement your organizational strategies please contact Steve Decker at [email protected] or 212-400-6234.

Make checks payable to: ExLEvents, Inc. and write code C404B 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(s).

TERMS & CONDITIONS: By registering for an ExL Events, Inc. (“ExL Pharma”) event, you agree to the following set of terms and conditions listed:REGISTRATION FEE: The fee includes the con-ference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments. PAYMENT: Must be received in full by the confer-ence date. All discounts will be applied to the Conference Only fee (excluding add-ons)‚ cannot be combined with any other offer‚ and must be paid in full at the time of order. Group discounts available to individuals must be registered simultaneously and employed bythe same organization.

COSTS TO ATTEND MASS WEST 2013EARLY BIRD PRICINGBefore August 9th, pricing is as follows:

ALL ACCESS PASS

Conference & Two Half-Day Workshops $2395

Conference & One Workshop $2095

Conference Only $1795

STANDARD PRICINGAfter August 9th, pricing is as follows:

ALL ACCESS PASS

Conference & Two Half-Day Workshops $2595

Conference & One Workshop $2295

Conference Only $1995

SPONSORS

MEDIA PARTNERS


ExL Events, Inc.494 8th Avenue, 4th FloorNew York, NY 10001

CONFERENCE CODE C404B

September 23–25, 2013 Hyatt Regency Mission Bay Spa and Marina

San Diego, CA

Medical Affairs Executive Forum Medical Science Liaison Best Practices

Investigator-Initiated Trials

CUSTOMIZE YOUR EXPERIENCE ACROSS THREE TRACKS

SPONSORS MA

Communicate Medical and Scientific Information in a Regulated, Compliant-Driven, and Patient-Centered Environment

MEDICAL AFFAIRS STRATEGIC SUMMIT

Documents

MEDICAL AFFAIRS STRATEGIC SUMMIT - ExL Eventsinfo.exlpharma.com/rs/exlpharma/images/C404-brochure.pdf · Medical Science Liaison Best ... overcome regulatory compliance and ... information