13th investigator initiated trials, april 2011, basking ridge, nj
DESCRIPTION
Pharmaceutical, Medical Device, and Biotechnology Professionals Gaining a Robust Understanding for Managing and Implementing, Local and Global IITsTRANSCRIPT
April 14-15, 2011Dolce Basking Ridge | Basking Ridge | New Jersey
13th INVESTIGATOR
INITIATED TRIALSPharmaceutical, Medical Device, and Biotechnology
Professionals Gaining a Robust Understanding for Managing and Implementing, Local and Global IITs
Proudly Presents:
Tri-Located with ExL Pharma’s
8th Annual MSL Best Practices Conference, and Medical Affairs Executive ForumRegister Today and Gain Access to Presentations from all Three Events!
{
Sponsors:
Register by February 25, 2011
to Receive our Discounted Rate!
To Register Call 866-207-6528 or visit us at www.exlpharma.com/iit
ACTELION
AMYLIN
ASTRAZENECA
COVIDIEN
EISAI
IISRA
NOVARTIS
NOVO NORDISK
PFIZER
SIGMA-TAU PHARMACEUTICALS
SUNEVA MEDICAL
TALECRIS BIOTHERAPEUTICS
– The –ORIGINALis still the best !
Join us and share best practices with
organizations including:
CONTRACT NEGOTIATIONS Identifying Key Elements within a Contract and Strategies for Expediting NegotiationsCarrie Kissick Rabbitt, JD, Senior Attorney, NOVO NORDISK
IISRA UPDATE ON FAIR MARKET VALUE Investigator Initiated Sponsored Research Association Update on Best Practices to Efficiently Determine FMV For Investigator’s Time and ServicesKaren Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTRAZENECA, & Executive Director, IISRA
INTERNATIONAL IITS Managing Compliance in Emerging Markets IITs to Optimize Research Quality , Patient Safety, and Inspection ReadinessKevin Douglass, Associate Director/Investigator Initiated Research (IIR) Manager, Emerging Markets, PFIZER
BENCHMARKING IITS Adding Value to IIT Programs Using Benchmarking Data to Effectively Track PerformancePatric Nelson, MPH, MBA, Associate Director, Medical Affairs, AMYLIN
Dear Colleague,ExL Pharma’s 13th Investigator Initiated Trials conference offers professionals from pharmaceutical, medical device, and biotechnology companies a complete understanding of the issues and strategies for managing and implementing, successful and compliant, local and global IITs. ExL Pharma is the proud host of the longest running IIT event and original conference in this field, delivering new educational sessions, never heard before case studies, prominent speakers, loyal attendees (with over 80% from pharmaceutical, medical device, and biotechnology companies), and tremendous networking opportunities to help build relationships through memorable and relevant shared experiences. In addition, attendees also have the unique opportunity to hear best practices for determining fair market value from the Investigators Initiated Sponsored Research Association (IISRA).
The 13th IIT event is being co-located with two other ExL Pharma events, the 8th MSL Best Practices conference and the new Medical Affairs Executive Forum. These three events share networking breaks, continental breakfast, and lunch, which allow for increased networking opportunities filled with senior level medical affairs professionals and MSLs. This is a must attend event for everyone involved in investigator initiated trials looking to advance their knowledge and learn new strategies, while interacting with other IIT professionals.
We look forward to greeting you in April!
Sincerely,
Mary Ruggiero Kristen HunterConference Director Team Leader, [email protected] ExL Pharma
Who Should Attend?This conference is designed for representatives from pharmaceutical, biotechnology, and medical device companies with responsibilities in the following departments:
Investigator Initiated Trials, Research, and Studies Medical Affairs MSLs Medical Communications Research Grants Clinical Project Manager Clinical Affairs Manager Compliance, Legal and Regulatory Affairs Program/Project Management Contract Administrators Clinical Research Investigators Clinical Data Analysts
This event is also of interest to:
Consultants Solution Providers for Data & Lifecycle Management Law Firms Contract Research Organizations
Dolce Basking Ridge300 North Maple Avenue Basking Ridge, NJ 07920 USATel: (800) 953-8033Fax: (908) 953-3105
Dolce basking ridge is less than an hour west of Manhattan from Interstate 287, 78 and 80. Newark Liberty Airport is a 30-minute drive, while LaGuardia and JFK Airports are just an hour away.
Shuttle Information: Dolce Basking Ridge offers complimentary shuttle service within a 6 mile radius which would include to Basking Ridge Train Station.Airport Information: Newark International Airport is 30 minutes away.
ROOM RESERVATIONS:If you require overnight accommodations, please contact the hotel and state that you are with ExL Pharma’s IIT conference by Wednesday, March 23, 2011. We encourage conference participants to make reservations with our designated venue to take advantage of ExL Pharma’s discounted room rate.
Dolce Basking Ridge combines a retreat-like setting with over 20,000 square feet of IACC approved function space. The award-winning Dolce Basking Ridge is the Tri-state region’s setting of choice for business and pleasure. A recent multi-million dollar redesign has updated our accommodations, restaurant and lobby to have the chic and contemporary feel of New York City while maintaining the quiet seclusion of Basking Ridge.
Day One – Thursday, April 14th
9:00 IIT 101: BUILDING A SUCCESSFUL INVESTIGATOR INITIATED TRIAL PROGRAM
PRE-CONFERENCE WORKSHOP
• KeypointstoconsiderwhendevelopingacompliantIITprogram• Determiningthecostoftheinvestment,anddevelopingtimemanagementskills• Learninghowtofindnewinvestigators• UnderstandingthereviewprocessofanIITandhowtonetworkreviewcommitteesforIITproposals• Choosingtherightinvestigatortoresearchtherighttopicformaximumresults• Balancingyourcompany’sroleinandoversightoftheresearch• Issuinggrantsandproposals,andhowtoreviewthematerialbeforesubmission• Understandingavarietyofstepstoconsidertohelpmitigateriskagainstviolationofapplicablelaws:
–EstablishingproperintentandfostercompliancewithFDAregulations–Ensuringthattheinvestigatorisincontrolofthestudy–Determiningfairmarketvalue–AvoidinginfluenceofsalesforceintheIITprocess–LimitinginvolvementinIITstudiesafterapproval–Promotingtransparencyanddisclosure
• Understandingtheroleofpublicationsinasuccessfulinvestigatorinitiatedtrialprogram:–Briefoverviewofhowwegotwherewearetoday–Understandingofthecurrentenvironment–Transparency,disclosures,conflictofinterest(COI),authorship,authorpayments,acknowledgments,useofmedicalwritersand“ghostwriting”–Waystoensurecompliance:-Policies/guidelines-SOPs-Training-Documentationofpublicationactivities-Regularaudits-GPP2
-Certificateprogram-CMPP–Understandingthedifferencebetweencompany-sponsoredpublicationsandinvestigatorinitiatedpublications
Moderator:Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTRAZENECA & Executive Director, IISRA
Speakers:Marc Massanari, PharmD, Global Medical Affairs, Health Economics & Outcomes Research, NOVARTISDeborah St. James, Scientific Communications and Publication Planning, TALECRIS BIOTHERAPEUTICS
10:30 Networking and Refreshment Break
12:00 Luncheon for Workshop Attendees
12:00 Registration for Main Conference
8:00 Registration and Continental Breakfast For Workshop Participants
Main Conference Begins 1:00 CHAIRPERSON’S WELCOME & OPENING REMARKS Alexander Kostek, Global Investigator Initiated Research Group Leader, PFIZER
1:15 SELECTING AN IIT Establishing a Governance Model for the Review and Selection of an IIT and Communicating these Decisions to the Investigator
• BuildingacommitteeboardtoreviewandselectinvestigatorsandproposedIITs• Selectingboardmembers,definingindividualroles,andmanagingtheboardstime• LearningkeycriteriaforevaluatinginvestigatorsandproposedIITstomakethebestselection• EstablishingascorecardforreviewingIITproposals• Communicatingthecommittee’sdecisiontotheinvestigatorandclarifyingexpectations
Marianne Parnell, Manager, Medical Affairs, SIGMA-TAU PHARMACEUTICALS
2:00 CONTRACT NEGOTIATIONS Identifying Key Elements within a Contract and Strategies for Expediting Negotiations
• DevelopingthecontractingprocesswithanIITandselectingkeyissuesandtopicstobeincludedinanIITcontractualagreement
• Definingresponsibilitybetweenthesponsorandinvestigatorinthefollowingareas:-PaymentStructure-IntellectualProperty-StudyData-Indemnification
• EffectivelynegotiatingcontractstoensuretheoverallsuccessofanIIT• Establishingtipsforacceleratingthecontractnegotiations
Carrie Kissick Rabbitt, JD, Senior Attorney, NOVO NORDISK
2:45 IIT REGULATORY ENVIRONMENT Understanding the Varying Interpretations on the Rules and Requirements Governing IITs and How to Effectively Achieve Compliance
• UpdatesonthechangingregulationofIITsandthedifferentinterpretationsandtechniquestoensureoverallcompliance
• Whatresourcesarerequiredtofulfillacorporateintegrityagreement(CIA)andwhataretheconsequencesandimpactofanon-compliantCIA?
• WhatpreventiveprogramscancompaniesputinplacewhentheyarenotunderCIAs?• ExplanationofthetypesofagreementswhenworkinginIITs,includingMTA,CTA,andPSA
Renata J. Matsson, PhD, JD, Director, Compliance R&D, EISAI
3:30 Networking & Refreshment Break
4:00 CORPORATE INTEGRITY AGREEMENTS Developing a Corporate Integrity Agreement (CIA) As it Relates and Impacts IITs
• ThisdiscussionhighlightskeyareasofIITsupportthatshouldbeconsideredaspotentialrisksortargetsofaCIA
• LearnbestpracticesaftersubmittingaCIA• OvercomingobstacleswhencomplyingwithCIAcompliancerequirements
Caroline Flotron, Senior Attorney, PFIZER
To Register Call 866-207-6528 or visit us at www.exlpharma.com/iit
-PatientInjury-Confidentiality-PublicationRights
To Register Call 866-207-6528 or visit us at www.exlpharma.com/iit
4:45 IISRA UPDATE ON FAIR MARKET VALUE Investigator Initiated Sponsored Research Association Update on Best Practices to Efficiently Determine FMV For Investigator’s Time and Services
• UnderstandingwhyIISRAguidelinesareusefulwhensupportinganIITandwhatmakestheseFMVguidelinesvalid
• EfficientlydeterminingthefairmarketvalueforsupportinginvestigatorsinvolvedinIITs• Methodstoestablishingastandardvalueforequipmentandmedicalresources
Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTRAZENECA, & Executive Director, IISRA
5:15 ROUNDTABLE DISCUSSIONS Choose from one of the following tables and be part of an intimate
discussion on different IIT topics 1) How M&A Affects IITs:Successfully adopting new IITs after an M&A and determining which IITs can be let go 2) IIT Timeline Management: Lessons learned on keeping timely IITs and how to handle unforeseen delays 3) Financial Support of IIT Publications:Learning if and when the sponsor provides funding for the creation of publications, presentation of publications, and knowing what your company limits are 4) IISRA Breakout:Membership and organizational milestones of IISRA and its development for investigator initiated research standards and best practices 5) Aggregate Spend Requirements: Discussing best practices to ensuring effective and compliant IIT processes within your organization and an update on the Physician Sunshine Act and its affect on your relationship with the IIT 6) Safety Reporting Requirements: Understanding what your reporting obligations are and how these requirements will change with new and pending legislation
6:00 Day One Concludes
8:00 Continental Breakfast
8:50 CHAIRPERSON’S RECAP OF DAY ONE Alexander Kostek, Global Investigator Initiated Research Group Leader, PFIZER
9:00 INTERNATIONAL IITs Managing Compliance in Emerging Markets IITs to Optimize Research Quality, Patient Safety, and Inspection Readiness
• LearningwhatrulesandrequirementsarerelevantwhenapprovingandmanaginganIITinanemergingmarket
• EstablishingresponsibilitiesformanagingIITcompliance• Identifyingcomplianceissuesandsuccessfullyresolvingthem• BalancingcomplianceandefficiencywhenconductinganemergingmarketsIIT
Kevin Douglass, Associate Director/Investigator Initiated Research (IIR) Manager, Emerging Markets, PFIZER
9:45 IIT TRACKING AND PAYMENT SYSTEMS Implementing Software for Tracking IIT Compliance, Obtaining Updated Data, and Streamlining Proposals, and Payments
• AdaptingasoftwaresystemtostreamlineproposalstohelpexpeditethecontractingprocessofanIIT
• LearninghowtotrackIITregistration,requestsubmission,andreviewcurrentIITdatatomaintaintimelinesandmanageexpectations
• SuccessfullymaintainingabudgetandtrackingpaymentsmadetoinvestigatorstoensurecompliancewithexistingrulesgoverningIITs
10:30 Networking & Refreshment Break
11:00 IITs FOR NON-APPROVED PRODUCTS Understanding the Differences and Challenges in Supporting an IIT for a Non-Approved Product and How this Can Increase Access for Treatment Use and Dose-Finding
• UnderstandingthebenefitsofundergoinganIITforanon-approvedproductandthereasonswhycompaniesaregettingmoreinvolvedinthesestudies
• EvaluatingtheresultsofIITsonnon-approvedproductsandhowthisaffectsthesponsoringcompany
• ComplyingwithSAEreportingfromIITsfornon-approvedproducts
Scott Kelley, MD, Vice President, Medical Affairs, COVIDIEN 11:45 BENCHMARKING IITs Adding Value to IIT Programs Using Benchmarking Data to Effectively Track Performance
• IncorporatingbenchmarkingintoIITpreparationsandexecutions• Derivingmeaningfulconclusionsfrombenchmarkingdata• Thebigpicture-lookingbeyondbenchmarkingwhenjustifyinganIITprogram’sROI
Patric Nelson, MPH, MBA, Associate Director, Medical Affairs, AMYLIN
12:30 Luncheon
1:30 IIT INSPECTION AND AUDIT Protecting Yourself from an FDA IIT Audit and Seamlessly Overcoming an Internal Investigator Inspection
• ThechallengesandprocessofpreparingforanFDAinspectionandaudit• BenefitsofusingaconsultingfirmtobecomereadyforGCPauditsandknowingwhat
informationmustbeprovided• Knowingwhatisneededwhenconductinganauditontheinvestigatorandstudysite
Scott Tsurutani, Senior Clinical Program Manager, ACTELION
2:15 THE ROLE OF THE MSL Utilizing the MSL in an IIT and How they Help Enhance Communication with Investigators
• UnderstandingtheroleofMSLsandthesizeoftheirnetwork• HowinvolveddoMSLsgetinIITs• LearningnewcommunicationskillswithMSLstomaintainopencorrespondenceandlearn
updatesonthestatusoftheIITandinvestigator• UnderstandingtherelationshipbetweentheinvestigatorandMSLandjustifyingthevalueofan
MSLinfurtheringmedicalstrategy• ComplianceconsiderationswhenMSLsworkwithIITs
Lisa Misell, PhD, Senior Director, Medical Affairs and Clinical Operations, SUNEVA MEDICAL
3:00 PANEL DISCUSSION SELECTING A CRO TO MANAGE IITs AND DEFINING THEIR FUNCTION AS AN INTEGRAL PART OF THE IIT Building and Improving Partnerships and Alliances with CROs
• WhatarethecriteriausedtoselectaCROandwhoisinvolvedinthedecisionmaking?• DeterminingwhethertouseoneormultipleCROs• Managingoutsourcedrelationships:thechallenges,benefits,andrisk• CreatingandmaintainingpositiveandproductiverelationshipswithCROs• Determiningwhoshouldbenegotiatingwithsites,investigatorsandotherthird-partyvendors
Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTRAZENECA, & Executive Director, IISRA Alexander Kostek, Global Investigator Initiated Research Group Leader, PFIZER Scott Tsurutani, Senior Clinical Program Manager, ACTELION
4:00 Conference Concludes
Day Two – Friday, April 15th
EARLY BIRD PRICINGRegister by Friday, February 25, 2011 to Take Advantage of Early-Bird Pricing:Conference + Workshop $1995Conference Only $1695
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INITIATED TRIALS
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April 14-15, 2011Dolce Basking Ridge | Basking Ridge | New Jersey
Pharmaceutical, Medical Device, and Biotechnology Professionals Gaining a Robust Understanding for Managing and Implementing, Local and Global IITs
Tri-Located with ExL Pharma’s
8th Annual MSL Best Practices Conference, and Medical Affairs Executive ForumRegister Today and Gain Access to Presentations from all Three Events!{
SELECTING AN IIT
CONTRACT NEGOTIATIONS
PUBLICATION RIGHTS
PAYMENT STRUCTURE
CORPORATE INTEGRITY
AGREEMENT
STREAMLINING PROPOSALS
AND PAYMENTS
FAIR MARKET VALUE
PHYSICIAN SUNSHINE ACT
COMPLIANT AE REPORTING
IITS IN EMERGING MARKETS
NON-APPROVED PRODUCT IIT
INSPECTION AND AUDIT
BENCHMARKING
MSL ROLE
SELECTING A CRO
INTELLECTUAL PROPERTY
Register by
March 19th, 2010
To Register call 866-207-6528 Or Visit Us at http://www.exlpharma.com/events/investigator-initiated-trials
Presents
InvesTIgATORInITIATeD TRIAls11th
April 29-30, 2010sheraton national HotelArlington, vA
Register by
March 19 th, 2010
CO-lOCAtEd{
Risk/Benefit Profile
IND or IDE?
CBER Perspective
Fair Market Value Transparency
Safety Reporting
Grant Systems
Metrics
312.2(b)
US vs EU
IT Challenges
MSL Value
Benchmark Progress
IRB Exemptions State Laws and Reporting
Budgets
Technology Platforms
Regulatory Guidance
Sponsors
Informed Consent
– The –ORIGINALis still the best!
Join us and share best practices with
organizations including:
Arnall Golden Gregory
AstraZeneca
Center for Biologics Evaluation and Research
Centocor Ortho-Biotech
Cephalon
Duke Translational Medicine
Genentech
Johnson & Johnson
Merck
Novo Nordisk
Pfizer
University of Minnesota
Publications
to Receive our Discounted Rate
6th Annual MSL Best Practices Conference.Register Today and Gain Access to Presentations from Both Events!
Sponsors:
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