13th investigator initiated trials, april 2011, basking ridge, nj

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April 14-15, 2011 Dolce Basking Ridge | Basking Ridge | New Jersey 13 th INVESTIGATOR INITIATED TRIALS Pharmaceutical, 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 Forum Register 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 ORIGINAL is still the best ! Join us and share best practices with organizations including: CONTRACT NEGOTIATIONS Identifying Key Elements within a Contract and Strategies for Expediting Negotiations Carrie 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 Services Karen 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 Readiness Kevin Douglass, Associate Director/Investigator Initiated Research (IIR) Manager, Emerging Markets, PFIZER BENCHMARKING IITS Adding Value to IIT Programs Using Benchmarking Data to Effectively Track Performance Patric Nelson, MPH, MBA, Associate Director, Medical Affairs, AMYLIN

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Pharmaceutical, Medical Device, and Biotechnology Professionals Gaining a Robust Understanding for Managing and Implementing, Local and Global IITs

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Page 1: 13th Investigator Initiated Trials, April 2011, Basking Ridge, NJ

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

Page 2: 13th Investigator Initiated Trials, April 2011, Basking Ridge, NJ

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.

Page 3: 13th Investigator Initiated Trials, April 2011, Basking Ridge, NJ

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

Page 4: 13th Investigator Initiated Trials, April 2011, Basking Ridge, NJ

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

Page 5: 13th Investigator Initiated Trials, April 2011, Basking Ridge, NJ

EARLY BIRD PRICINGRegister by Friday, February 25, 2011 to Take Advantage of Early-Bird Pricing:Conference + Workshop $1995Conference Only $1695

STANDARD PRICING Register After Friday,February 25, 2011: Conference + Workshop $2195Conference Only $1895

ONSITE PRICINGConference + Workshop $2295Conference Only $1995

Group Discount Program: Save 25% Per Person when Registering Four 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.

Save 15% per person when Registering Three Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call 866-207-6528.

IMPORTANT! Offers may not be combined. Discount only applies to standard rate. Make checks payable to ExL Events, Inc. and write code P1706 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full, two weeks prior to the commencement of the conference.

Conference registrations may be transferred to other colleagues in the event you are unable to attend. Please notify ExL Pharma, [email protected], prior to the event with the name and contact information of the replacement attendee. There will be an administrative charge of $300 to substitute, exchange, and/or replace attendance badge with a colleague occurring within five business days of the conference.

Cancellations: If you need to cancel your registration for an upcoming ExL conference, please note the following policies derived from the Start Date of the event:Four weeks or more: A full refund (minus a $95 processing fee), or a voucher to another ExL event valid for two years from the voucher issue date.Four weeks or Less: A voucher to another ExL event valid for two years from the voucher issue date.*ExL Pharma’s liability is limited to the conference registration fee in the event of a cancellation

To receive a refund or voucher, please fax your request to 888-221-6750.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replacement will be made.*The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.*

Sponsorship and Exhibiting Opportunities

Do you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. ExL Pharma will work closely with you to customize a package that will suit all of your needs. To learn more about these

opportunities, please contact:

Steve DeckerBusiness Development Manager

212-400-6234, [email protected]

Five Ways to RegisterFax: 888-221-6750Mail: ExL Events, Inc. 555 8th Ave, Ste 310 New York, NY 10018Phone: 866-207-6528Online: www.exlpharma.comEmail: [email protected]

MEDIA PARTNERS

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Page 6: 13th Investigator Initiated Trials, April 2011, Basking Ridge, NJ

13th INVESTIGATOR

INITIATED TRIALS

Register by February 25, 2011

to Receive our Discounted Rate!

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

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888-221-6750

[email protected]

www.exlpharma.com

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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:

Proudly Presents: