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ExL Pharma's 12th Investigator Initiated Trials Conference Brochure


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* Abbott Laboratories
* Allergan
* Astrazeneca
* Celgene
* Centocor
* Johnson & Johnson
* Merck
* Millenium
* Pfizer
* Vertex Pharmaceuticals

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ExL Pharma's 12th Investigator Initiated Trials Conference Brochure

  1. 1. Prices Increase After August 13th PROUDLY PRESENTS original The InvestIgator 12th is still the best! Join us and share Best Practices with InItIated trIals organizations New IIT Content includes Aggregate Spend, M&A, including: Emerging Markets, Publication Planning and more! abbott September 27-28, 2010 allergan Hyatt regency San FranciSco airport - burlingame, ca { astraZeneca 7th MSL Best Practices celgene Co-LoCated Register Today and Gain Access to Presentations from Both Events! centocor Safety Reporting Sunshine Act iiSra Johnson & Johnson Us Vs. Ex-Us Training merck FMV Aggregate Spend Contracting millennium Emerging Markets Pub Planning Compliance Transparency pfizer Vertex pharmaceuticals Mergers & Acquisitions IP Grants Systems Process SPONSORS & ASSOcIATION EXHIBITORS: PARTNERS: To Register Call 866-207-6528 or Visit Us at
  2. 2. WHO WILL BE IN SponSorSHip ATTENDANCE? and exHibiting • Investigator Initiated/Sponsored Trials opportunitieS • Investigator Research do you want to spread the word about your or- • Medical Affairs/Field Medical Affairs ganization’s solutions and services to potential • MSL Managers/Field MSLs clients who will be attending this event? take ad- • Clinical Research Associates vantage of the opportunity to exhibit, present an • Phase IV educational session, host a networking event, or distribute promotional items to attendees. exl • Legal & Regulatory Affairs will work closely with you to customize a package • Clinical and Research Investigators that will suit all of your needs. to learn more about • Site Management these opportunities, contact lucas carrasco, busi- • Post-Market Studies ness development, by calling 212-400-6231 or by • Clinical Affairs emailing • Clinical Data Analysts rave reviews from exl’s 11th investigator-initiated trials: “this was an excellent meeting. it covered a broad range “great presenter and covered exactly what i was looking of important issues. Speakers are very knowledgeable and for!” Rina Patel, Medical affairs Manager, aLLerGan very approachable,” “clear, concise info w/good value-added Randy Leeder, Clinical Project Manager, Leo PharMa recommendations,” “excellent, as usual,” Lindsay Tollen, Senior Manager, CePhaLon Therica Miller, Manager Clinical trials office, nevada Cancer institute “great topics - important issues,” “yes! great presentations and workshops! good Muriel Siadak, associate Medical Director, SeattLe GenetiCS discussions,” Teresa Pena, aD Scientific exchange, uCB “great! exceeded expectations. new data/material; well “thoughtful, interactive constantly touching back to done presentations, excellent value drive conference!” mission, goals, value argument,” Patrician Westergren, Product Mgr, iiSr, MeDnet SoLutionS Laura Williams, Principal Grant and Contract administrator, uMn “yes – no improvements needed,” Coleen Myers, Clinical research Manager, CePhaLon HOTEL INFORMATION Hyatt Regency reward yourself with a stay at the Four diamond Hyatt regency San San FRanciSco Francisco airport hotel. experience our ideal location on San Francisco airport bay – just 15 minutes from the excitement of downtown San Francisco 1333 Bayshore Highway, or the technology corridor of Silicon Valley and only seven minutes from San Francisco international airport, you’ll enjoy easy access to all the Burlingame, California, sanfrancisco airport attractions surrounding our luxury hotel. USA 94010 Tel: +1 650 347 1234    Fax: +1 650 696 2669 reSerVationS: please make reservations before September 5th to regiSter call 866-207-6528 or ViSit
  3. 3. day one, monday, September 27, 2010 8:00 registration and Continental Breakfast for WorkshoP PartiCiPants WorkshoP Pre-ConferenCe PRE-cONfERENcE WORkSHOP 9:00 examining the compliance, execution and data management challenges of tracking aggregate Spend Legal Overview of Sunshine Act • Compliance Focus • Managing Master Spend Data · Implementing efficient tracking systems · Identifying data sources and data flow associated with IITs · Key compliance challenges · Management processes for data · Identifying and mitigating risks · Analyzing and reporting systems · Addressing HCP interactions concerning payments · Implementing process improvements Wendy Tsuei, Sr. Program Manager, Corporate Compliance, AllergAn · Ensuring data integrity Ahmad Chaudhri, Director, Business Analytics, AllergAn Allocated Time for Questions, Answers and Scenarios for maximum participant involvement 10:30 netWorking and refreshment Break 12:00 lunCh for WorkshoP attendees main ConferenCe oPens 12:00 registration oPens for main ConferenCe 3:45 understanding the role of publication planning Valérie Philippon, PhD, Director, Publications, VerTeX PHArMACeUTICAlS 1:00 chairperson’s welcome • Publication Planning Overview Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, • Incorporating the Publication Clause in the IIT Agreement ASTrAZeneCA & eXeCUTIVe DIreCTOr, IISrA • Maximizing the Value of Publications • Differences between IIT and Clinical Publication Review HOW M&A AffEcTS IIT PROgRAMS ANd TRIAlS IISRA uPdATE & ROuNdTABlES 1:15 adopting and implementing processes while maintaining the integrity of trials obtained through 4:30 investigator initiated Sponsored research mergers and acquisitions association update Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, Alex Kostek, Global Investigator Initiated Research Group Leader, PFIZer ASTrAZeneCA & eXeCUTIVe DIreCTOr, IISrA Deborah Cassel, Associate Director, Global Center for Scientific Affairs, IISRA values your input. Your feedback has significantly Merck Investigator Studies Program (MISP), MerCK contributed to the development of Standards and Best • Process overview of compliantly and efficiently taking on new Practice Guideline and position statements. IITs as a result of mergers and acquisitions • Determining which IITs should be adopted and which can • Membership and organizational milestones contractually be let go • Standards and Best Practice Committee Deliverables • Guidance on planning and executing integration plans in • Membership committee and related subcommittees different scenarios ONlINE IIT APPROvAl SuBMISSION PROcESS ROuNdTABlES dIScuSSION 2:15 case report - on-line automation of iit grants 5:00 cocktail reception management: System design to global implementation roundtable discussion. Sessions on topics including: Anton ehrhardt, PhD, Sr. Medical Director, • Aggregate Spend MIllenIUM: THe TAKeDA OnCOlOgY COMPAnY • IISRA Breakout • Advantages and challenges of building a completely custom • Global IITs system • Publication Planning • Integration with existing infrastructure to support Aggregate • Safety Reporting Spend Reporting & Transparency Initiatives • Grant Management Systems • Why you should consider doing this too Attendees will have additional topic roundtables to choose from focusing on MSL-related topics 3:15 netWorking and refreshment Break 6:00 Close of day one to regiSter call 866-207-6528 or ViSit
  4. 4. day two, tueSday, September 28, 2010 main ConferenCe 8:00 Continental Breakfast for ConferenCe of program has its benefits, but also its challenges.  I will discuss PartiCiPants these and highlight some key points that, based on my experience, should be taken into account when setting up a competitive 8:50 chairperson’s day one recap program.  These include: Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, • Healthcare Professional payments ASTrAZeneCA & eXeCUTIVe DIreCTOr, IISrA • Program set up • Internal review committee’s role • Review process and meeting kEy PERfORMANcE INdIcATORS • Post meeting activities 9:00 How to terminate an iit and maintain relationships PuBlIcATION Of IITS with investigators Ashwaq Hermes, PharmD Sr. Clinical Science ManagerGlobal 11:45 How the Sunshine act has impacted iit programs and Pharmaceutical Research & Development, ABBOTT After several months of hard work generating adequate interest, investigator interactions completing the proposal, the protocol, consent form, IRB approval, Dennis Decktor, PhD, MBA, Senior Director, Medical Affairs, CRFs and contracts, the project officially starts! Months later, it is CenTOCOr OrTHO-BIOTeCH not progressing! What are the options? • What are the causes of the lack of progress? Are they fixable? • What if they are not? How do you terminate the project? 12:30 lunCh • How do you terminate the project while preserving your relationship with the investigator(s)? INTERNATIONAl IITS 1:30 iit contracting Strategies kEyS TO SuccESSful IIT PROgRAMS Annette S. Meints, RN, MS, PMP, Clinical Research Manager II, 9:45 walking the compliance tightrope – do you Have a GPRD, ABBOTT This session will provide an overview, strategies and relevant case Funambulist on your Staff? examples to draw from.  The following items will be included in Joseph Bray, Product Lead, UBC: envision the discussion:   Compliance today is a hot button discussion on everyone’s ·  Contract structure, format and key components agenda. What is an acceptable risk for one company is toxic to ·  Intellectual Property – Whose data is it? another. What are the rules? Who gets to interpret them? Is your ·  Publication rights SOP compliant in today’s world? How do we bring global ·  Confidentiality concerns IIT programs together under one set of working practices? ·  Indemnification What constitutes influence? Small or large: biotech, Pharma, ·  Maximizing compliance and mitigating delays or device company, we all have a lot of the same questions.   In this session we will attempt to look at both sides of the many decisions each company must make when developing a INTERNATIONAl IITS compliant IIT program. • Initial submission – Who’s idea is it? • Review committee invitations – Does my opinion count? 2:15 effective Strategies for managing investigator initiated • Multisite or coop studies – My contract is with who? trials in emerging markets • Payments – How do you measure study progress? Kevin Douglass, Associate Director/Investigator Initiated Research (IIR) • Are we there yet? – What is your definition of done? Manager, Emerging Markets, PFIZer • Who cares how they do it over there? – You do, it’s a global • How does the process differ from US IITs? program • Managing multiple emerging market sites • Dealing with differences in culture while not compromising the integrity of the IIT 10:30 netWorking and refreshment Break cOMPETITIvE gRANT PROgRAM 3:00 ChairPerson’s Closing remarks; ConferenCe adjourns 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 a competitive grant program in addition to or in place of accepting individual IIR submissions. This type of program typically has a defined set of research criteria,   which is broadly publicized to an appropriate investigator group through one of several possible routes (ie professional journal or website).  Submitted applications are then are reviewed and approved by an external advisory committee, in lieu of a formal internal review.  This type to regiSter call 866-207-6528 or ViSit
  5. 5. media Partners Group Discount proGram Five Ways to reGister: Save 25% per person when Registering Four* Fax: 888-221-6750 For every three simultaneous registrations from your company, you Mail: exl events, Inc. will receive a fourth complimentary registration to the program (must register 4 at one time) this is a savings of 25% per person. 555 8th Ave, Ste 310 new York, nY 10018 registration information Save 15% per person when Registering Three* Phone: 866-207-6528 Can only send three? You can still save 15% off of every registration. Online: email: To find out more on how you can take advantage of these group discounts, please call 212-400-6240 866-207-6528. *All discounts are taken off of the standard pricing, discount offers may not be combined reGistration Fees For attenDinG exL’s 12th InvestIgator InItIated Make checks payable to ExL Events, Inc. and write code P1605 trIals: 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. eaRLy BiRD PRicing Cancellations: If you need to cancel your registration for an upcom- Register by Friday August 13th to Take Advantage ing ExL conference, please note the following policies derived from of Early Bird Pricing: the Start Date of the event: • Four weeks or more: A full refund (minus a $95 processing fee), or Conference + Workshop $1995 a voucher to another ExL event valid for two years from the voucher Conference Only $1695 issue date. • Four weeks or Less: A voucher to another ExL event valid for two years from the voucher issue date. StanDaRD PRicing • To receive a refund or voucher, please fax your request to 888-221- Register After August 13th: 6750. Conference + Workshop $2195 • There will be an administrative charge of $300 to substitute, Conference Only $1895 exchange and/or replace attendance badges with a colleague oc- curring within five business days of the conference. Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a onSite PRicing suitable replacement will be made. Conference + Workshop $2295 *The opinions of this faculty do not necessarily reflect those of the Conference Only $1995 companies they represent or ExL Events, Inc.* Questions? comments? Do you have a question or comments that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please email Conference Director, Ethan Denkensohn at
  6. 6. Prices Increase After August 13th PROUDLY PRESENTS Exp. Date: PLEASE MENTION PRIORITY CODE: P121 original The 12th InvestIgator 555 8th Avenue, Suite 310 InItIated trIals is still the best! New York, NY 10018 Join us and share Best Practices with organizations including: New IIT Content includes Aggregate Spend, M&A, Emerging Markets, Publication Planning and more! abbott September 27-28, 2010 allergan Hyatt regency San FranciSco airport - burlingame, ca Name on Card Card Number astraZeneca { Signature celgene 7th MSL Best Practices Co-LoCated Register Today and Gain Access to centocor Presentations from Both Events! iiSra Please contact me: I’m interested in marketing opportunities at this event Johnson & Johnson Safety Reporting Sunshine Act Us Vs. Ex-Us Training I wish to receive email updates on ExL Pharma’s upcoming events merck Zip Yes! Register me for the Conference & Workshop: millennium Aggregate Spend Contracting 888-221-6750 pfizer Vertex pharmaceuticals FMV State Emerging Markets Title Fax Pub Planning Compliance Transparency Register me for Conference Only Mergers & Acquisitions IP Grants Systems Process New York, NY 10018 TO R E G I S T E R 555 8th Avenue, ExL Events, Inc. 866-207-6528 Suite 310 SPONSORS & ASSOcIATION EXHIBITORS: PARTNERS: Telephone Company Address Name Email Dept. City To Register Call 866-207-6528 or Visit Us at