exl pharma's 12th investigator initiated trials conference brochure

6
12TH INVESTIGATOR INITIATED TRIALS New IIT Content includes Aggregate Spend, M&A, Emerging Markets, Publication Planning and more! SEPTEMBER 27-28, 2010 HYATT REGENCY SAN FRANCISCO Airport - BURLINGAME, CA The ORIGINAL is still the Best! Join us and share Best Practices with organizations including: Abbott Allergan AstraZeneca Celgene Centocor IISRA Johnson & Johnson Merck Millennium Pfizer Vertex Pharmaceuticals 7 th MSL Best Practices Register Today and Gain Access to Presentations from Both Events! CO-LOCATED { PROUDLY PRESENTS Prices Increase After AUGUST 13th To Register Call 866-207-6528 or Visit Us at www.exlpharma.com/events/12th-investigator-initiated-trials SPONSORS & EXHIBITORS: ASSOCIATION PARTNERS: Sunshine Act Pub Planning IP Us Vs. Ex-Us Training Emerging Markets Contracting Mergers & Acquisitions Grants Systems Process Transparency Compliance FMV Safety Reporting Aggregate Spend

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NEW IIT CONTENT INCLUDES AGGREGATE SPEND, M&A, EMERGING MARKETS, PUBLICATION PLANNING AND MORE! JOIN US AND LEARN BEST PRACTICES WITH OUR SPEAKING FACULTY INCLUDING PARTICIPATION FROM THE FOLLOWING ORGANIZATIONS: * Abbott Laboratories * Allergan * Astrazeneca * Celgene * Centocor * IISRA * Johnson & Johnson * Merck * Millenium * Pfizer * Vertex Pharmaceuticals

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Page 1: ExL Pharma's 12th Investigator Initiated Trials Conference Brochure

12th InvestIgator InItIated trIals

New IIT Content includes Aggregate Spend, M&A, Emerging Markets, Publication Planning and more!

September 27-28, 2010Hyatt regency San FranciSco airport - burlingame, ca

The original is still the best!

Join us and share Best Practices with

organizations including:

abbott

allergan

astraZeneca

celgene

centocor

iiSra

Johnson & Johnson

merck

millennium

pfizer

Vertex pharmaceuticals

7th MSL Best PracticesRegister Today and Gain Access to Presentations from Both Events!

Co-LoCated{

PROUDLY PRESENTS

Prices Increase After

August 13th

To Register Call 866-207-6528 or Visit Us at www.exlpharma.com/events/12th-investigator-initiated-trials

SPONSORS & EXHIBITORS:

ASSOcIATION PARTNERS:

Sunshine Act

Pub Planning

IP

Us Vs. Ex-Us Training

Emerging Markets

Contracting

Mergers & Acquisitions

Grants Systems ProcessTransparencyCompliance

FMV

Safety Reporting

Aggregate Spend

Page 2: ExL Pharma's 12th Investigator Initiated Trials Conference Brochure

SponSorSHip and exHibiting opportunitieSdo you want to spread the word about your or-ganization’s solutions and services to potential clients who will be attending this event? take ad-vantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. exl will work closely with you to customize a package that will suit all of your needs. to learn more about these opportunities, contact lucas carrasco, busi-ness development, by calling 212-400-6231 or by emailing [email protected].

WHO WILL BE IN ATTENDANCE?• InvestigatorInitiated/SponsoredTrials• InvestigatorResearch• MedicalAffairs/FieldMedicalAffairs• MSLManagers/FieldMSLs• ClinicalResearchAssociates• PhaseIV• Legal&RegulatoryAffairs• ClinicalandResearchInvestigators• SiteManagement• Post-MarketStudies• ClinicalAffairs• ClinicalDataAnalysts

“this was an excellent meeting. it covered a broad range of important issues. Speakers are very knowledgeable and very approachable,” Randy Leeder, Clinical Project Manager, Leo PharMa

“excellent, as usual,” Lindsay Tollen, Senior Manager, CePhaLon

“great topics - important issues,” Muriel Siadak, associate Medical Director, SeattLe GenetiCS

“great! exceeded expectations. new data/material; well done presentations, excellent value drive conference!” Patrician Westergren, Product Mgr, iiSr, MeDnet SoLutionS

“yes – no improvements needed,” Coleen Myers, Clinical research Manager, CePhaLon

“great presenter and covered exactly what i was looking for!” Rina Patel, Medical affairs Manager, aLLerGan

“clear, concise info w/good value-added recommendations,” Therica Miller, Manager Clinical trials office, nevada Cancer institute

“yes! great presentations and workshops! good discussions,” Teresa Pena, aD Scientific exchange, uCB

“thoughtful, interactive constantly touching back to mission, goals, value argument,” Laura Williams, Principal Grant and Contract administrator, uMn

rave reviews from exl’s 11th investigator-initiated trials:

HOTEL INFORMATION

to regiSter call 866-207-6528 or ViSit www.exlpHarma.com

Hyatt Regency San FRanciSco airport1333BayshoreHighway,Burlingame,California,USA94010Tel:+16503471234  Fax:+16506962669

reward yourself with a stay at the Four diamond Hyatt regency San Francisco airport hotel. experience our ideal location on San Francisco bay – just 15 minutes from the excitement of downtown San Francisco or the technology corridor of Silicon Valley and only seven minutes from San Francisco international airport, you’ll enjoy easy access to all the sanfrancisco airport attractions surrounding our luxury hotel.

reSerVationS: please make reservations before September 5th

Page 3: ExL Pharma's 12th Investigator Initiated Trials Conference Brochure

Pre-Co

nfer

enCe

Wo

rk

sho

Pday one, monday, September 27, 20108:00 registration and Continental Breakfast for WorkshoP PartiCiPants

12:00 lunCh for WorkshoP attendees

10:30 netWorking and refreshment Break

• ComplianceFocus · Implementingefficienttrackingsystems · Keycompliancechallenges · Identifyingandmitigatingrisks · AddressingHCPinteractionsconcerningpaymentsWendy Tsuei, Sr. Program Manager, Corporate Compliance, AllergAn

• ManagingMasterSpendData · IdentifyingdatasourcesanddataflowassociatedwithIITs · Managementprocessesfordata · Analyzingandreportingsystems · Implementingprocessimprovements · EnsuringdataintegrityAhmad Chaudhri, Director, Business Analytics, AllergAn

PRE-cONfERENcE WORkSHOP9:00 examining the compliance, execution and data management challenges of tracking aggregate Spend Legal Overview of Sunshine Act

Allocated Time for Questions, Answers and Scenarios for maximum participant involvement

to regiSter call 866-207-6528 or ViSit www.exlpHarma.com

12:00 registration oPens for main ConferenCe

1:00 chairperson’s welcome Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTrAZeneCA & eXeCUTIVe DIreCTOr, IISrA

HOW M&A AffEcTS IIT PROgRAMS ANd TRIAlS

1:15 adopting and implementing processes while maintaining the integrity of trials obtained through mergers and acquisitions Alex Kostek, Global Investigator Initiated Research Group Leader, PFIZer Deborah Cassel, Associate Director, Global Center for Scientific Affairs, Merck Investigator Studies Program (MISP), MerCK • Processoverviewofcompliantlyandefficientlytakingonnew IITsasaresultofmergersandacquisitions • DeterminingwhichIITsshouldbeadoptedandwhichcan contractuallybeletgo • Guidanceonplanningandexecutingintegrationplansin differentscenarios

ONlINE IIT APPROvAl SuBMISSION PROcESS

2:15 case report - on-line automation of iit grants management: System design to global implementation Anton ehrhardt, PhD, Sr. Medical Director, MIllenIUM: THe TAKeDA OnCOlOgY COMPAnY • Advantagesandchallengesofbuildingacompletelycustom system • IntegrationwithexistinginfrastructuretosupportAggregate SpendReporting&TransparencyInitiatives • Whyyoushouldconsiderdoingthistoo

3:15 netWorking and refreshment Break

3:45 understanding the role of publication planning Valérie Philippon, PhD, Director, Publications, VerTeX PHArMACeUTICAlS •PublicationPlanningOverview •IncorporatingthePublicationClauseintheIITAgreement •MaximizingtheValueofPublications •DifferencesbetweenIITandClinicalPublicationReview

IISRA uPdATE & ROuNdTABlES

4:30 investigator initiated Sponsored research association update Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTrAZeneCA & eXeCUTIVe DIreCTOr, IISrA IISRAvaluesyourinput.Yourfeedbackhassignificantly contributedtothedevelopmentofStandardsandBest PracticeGuidelineandpositionstatements.

•Membershipandorganizationalmilestones •StandardsandBestPracticeCommitteeDeliverables •Membershipcommitteeandrelatedsubcommittees

ROuNdTABlES dIScuSSION

5:00 cocktail reception roundtable discussion. Sessions on topics including: •AggregateSpend •IISRABreakout •GlobalIITs •PublicationPlanning •SafetyReporting •GrantManagementSystems

Attendees will have additional topic roundtables to choose from focusing on MSL-related topics

6:00 Close of day one

main ConferenCe oPens

Page 4: ExL Pharma's 12th Investigator Initiated Trials Conference Brochure

to regiSter call 866-207-6528 or ViSit www.exlpHarma.com

8:00 Continental Breakfast for ConferenCe PartiCiPants

8:50 chairperson’s day one recap Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTrAZeneCA & eXeCUTIVe DIreCTOr, IISrA

kEy PERfORMANcE INdIcATORS

9:00 How to terminate an iit and maintain relationships with investigators Ashwaq Hermes, PharmD Sr. Clinical Science ManagerGlobal Pharmaceutical Research & Development, ABBOTT

Afterseveralmonthsofhardworkgeneratingadequateinterest,completingtheproposal,theprotocol,consentform,IRBapproval,CRFsandcontracts,theprojectofficiallystarts!Monthslater,itisnotprogressing!Whataretheoptions?

• Whatarethecausesofthelackofprogress?Aretheyfixable? •Whatiftheyarenot?Howdoyouterminatetheproject? •Howdoyouterminatetheprojectwhilepreservingyour relationshipwiththeinvestigator(s)?

kEyS TO SuccESSful IIT PROgRAMS

9:45 walking the compliance tightrope – do you Have a Funambulist on your Staff? Joseph Bray, Product Lead, UBC: envision

Compliance today is a hot button discussion on everyone’sagenda. What is an acceptable risk for one company is toxic toanother.Whataretherules?Whogetstointerpretthem?IsyourSOP compliant in today’s world? How do we bring globalIIT programs together under one set of working practices?What constitutes influence? Small or large: biotech, Pharma,or device company, we all have a lot of the same questions.   Inthis session we will attempt to look at both sides of the manydecisions each company must make when developing acompliantIITprogram.

• Initialsubmission–Who’sideaisit? • Reviewcommitteeinvitations–Doesmyopinioncount? • Multisiteorcoopstudies–Mycontractiswithwho? • Payments–Howdoyoumeasurestudyprogress? • Arewethereyet?–Whatisyourdefinitionofdone? • Whocareshowtheydoitoverthere?–Youdo,it’saglobal program

10:30 netWorking and refreshment Break

cOMPETITIvE gRANT PROgRAM

11:00 implementing competitive grants programs in place of iir Submissions Alison Curtin, Associate Director, Global IIR Primary Care, PFIZer

A product team or disease area may choose to implement acompetitivegrantprograminadditiontoorinplaceofacceptingindividual IIR submissions. This type of program typically hasa defined set of research criteria,   which is broadly publicizedto an appropriate investigator group through one of severalpossible routes (ie professional journal or website).  Submittedapplications are then are reviewed and approved by an externaladvisorycommittee,inlieuofaformalinternalreview. Thistype

ofprogramhasitsbenefits,butalsoitschallenges. Iwilldiscusstheseandhighlightsomekeypointsthat,basedonmyexperience,should be taken into account when setting up a competitiveprogram. Theseinclude:

• HealthcareProfessionalpayments • Programsetup • Internalreviewcommittee’srole • Reviewprocessandmeeting • Postmeetingactivities

PuBlIcATION Of IITS

11:45 How the Sunshine act has impacted iit programs and investigator interactions Dennis Decktor, PhD, MBA, Senior Director, Medical Affairs, CenTOCOr OrTHO-BIOTeCH

12:30 lunCh

INTERNATIONAl IITS

1:30 iit contracting Strategies Annette S. Meints, RN, MS, PMP, Clinical Research Manager II, GPRD, ABBOTT

Thissessionwillprovideanoverview,strategiesandrelevantcaseexamplestodrawfrom. Thefollowingitemswillbeincludedinthediscussion: · Contractstructure,formatandkeycomponents· IntellectualProperty–Whosedataisit?· Publicationrights· Confidentialityconcerns· Indemnification· Maximizingcomplianceandmitigatingdelays

INTERNATIONAl IITS

2:15 effective Strategies for managing investigator initiated trials in emerging markets Kevin Douglass, Associate Director/Investigator Initiated Research (IIR) Manager, Emerging Markets, PFIZer

• HowdoestheprocessdifferfromUSIITs? • Managingmultipleemergingmarketsites • Dealingwithdifferencesinculturewhilenotcompromising theintegrityoftheIIT

3:00 ChairPerson’s Closing remarks; ConferenCe adjourns

day two, tueSday, September 28, 2010main ConferenCe

Page 5: ExL Pharma's 12th Investigator Initiated Trials Conference Brochure

Group Discount proGram

Save 25% per person when Registering Four* Foreverythreesimultaneousregistrationsfromyourcompany,youwillreceiveafourthcomplimentaryregistrationtotheprogram(mustregister4atonetime)thisisasavingsof25%perperson.

Save 15% per person when Registering Three* Canonlysendthree?Youcanstillsave15%offofeveryregistration.

Tofindoutmoreonhowyoucantakeadvantageofthesegroupdiscounts,pleasecall212-400-6240866-207-6528.

*Alldiscountsaretakenoffofthestandardpricing,discountoffersmaynotbecombined

MakecheckspayabletoExL Events, Inc. and write code P1605 on your check. YoumayalsouseVisa,MasterCard,DiscoverorAmericanExpress.Paymentsmustbereceivedinfullpriortothecommencementoftheconference.Cancellations:Ifyouneedtocancelyourregistrationforanupcom-ingExLconference,pleasenotethefollowingpoliciesderivedfromtheStartDateoftheevent:• Four weeks or more:Afullrefund(minusa$95processingfee),oravouchertoanotherExLeventvalidfortwoyearsfromthevoucherissuedate.• Four weeks or Less:AvouchertoanotherExLeventvalidfortwoyearsfromthevoucherissuedate.•Toreceivearefundorvoucher,pleasefaxyourrequestto888-221-6750.• There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague oc-curring within five business days of the conference.Please Note:Speakersandagendaaresubjecttochangewithoutnotice.Intheeventofaspeakercancellation,everyefforttofindasuitablereplacementwillbemade.

*TheopinionsofthisfacultydonotnecessarilyreflectthoseofthecompaniestheyrepresentorExLEvents,Inc.*

Questions? comments?Doyouhaveaquestionorcommentsthatyouwouldliketobeaddressedatthisevent?Wouldyouliketogetinvolvedasaspeakerordiscussionleader?Please email Conference Director, Ethan Denkensohn at [email protected]

Five Ways to reGister:

Fax: 888-221-6750Mail: exl events, Inc. 555 8th Ave, Ste 310 new York, nY 10018Phone: 866-207-6528Online: www.exlpharma.com email: [email protected]

reGistration Fees For attenDinG exL’s 12th InvestIgator InItIated trIals:

eaRLy BiRD PRicingRegister by Friday August 13th to Take Advantage of Early Bird Pricing: Conference + Workshop $1995Conference Only $1695

StanDaRD PRicingRegister After August 13th:Conference + Workshop $2195Conference Only $1895

onSite PRicingConference + Workshop $2295Conference Only $1995 reg

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Page 6: ExL Pharma's 12th Investigator Initiated Trials Conference Brochure

12th InvestIgator

InItIated trIals

New IIT Content includes Aggregate Spend, M

&A, Em

erging Markets, Publication Planning and m

ore!

September 27-28, 2010

Hyatt regency San FranciSco airport - burlingame, ca

The original is still the best!

Join us and share Best Practices w

ith organizations

including:

abbott

allergan

astraZeneca

celgene

centocor

iiSra

Johnson & Johnson

merck

millennium

pfizer

Vertex pharmaceuticals

7th M

SL Best P

ractices

Register Tod

ay and

Gain

Access to

P

resentation

s from B

oth E

vents!

Co

-LoC

ate

d{

PROUDLY PRESENTS

Prices Increase After

August 13th

To Register Call 866-207-6528 or Visit Us at ww

w.exlpharm

a.com/events/12th-investigator-initiated-trials

SPONSORS & EXHIBITORS:

ASSOcIATION PARTNERS:

Sunshine Act

Pub Planning

IP

Us Vs. Ex-Us Training

Emerging Markets

Contracting

Mergers & Acquisitions

Grants SystemsProcess

TransparencyCompliance

FMV

Safety Reporting

Aggregate Spend

Card Number Exp. Date:

Name on Card

Signature

TO R E G I S T E R

Yes! Register me for the Conference & Workshop:

Register me for Conference Only

Please contact me: I’m interested in marketing opportunities at this event

I wish to receive email updates on ExL Pharma’s upcoming events

Name Title

Company

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Address

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Email

Telephone Fax

ExL Events, Inc.555 8th Avenue, Suite 310New York, NY 10018

888-221-6750866-207-6528

www.exlpharma.com

[email protected]

555 8th Avenue, Suite 310New York, NY 10018

PLEASE MENTION PRIORITY CODE: P121