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
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 www.exlpharma.com/events/12th-investigator-initiated-trials
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 lcarrasco@exlpharma.com.
• 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 www.exlpHarma.com
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 www.exlpHarma.com
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 www.exlpHarma.com
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: www.exlpharma.com
email: registration@exlpharma.com 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
edenkensohn@exlpharma.com
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
register@exlpharma.com
I wish to receive email updates on ExL Pharma’s upcoming events
merck
www.exlpharma.com
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 www.exlpharma.com/events/12th-investigator-initiated-trials