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

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ORIGINAL INVESTIGATOR
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Join us and share
best practices with
organizations
including:
Pharmaceutical, Medical Device, and Biotechnology
ACTELION
Professionals Gaining a Robust Understanding for
Managing and Implementing, Local and Global IITs
AMYLIN
April 14-15, 2011
ASTRAZENECA
Dolce Basking Ridge | Basking Ridge | New Jersey
COVIDIEN
EISAI
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!
IISRA
CONTRACT NEGOTIATIONS
Identifying Key Elements within a Contract and Strategies for Expediting Negotiations
NOVARTIS Carrie Kissick Rabbitt, JD, Senior Attorney, NOVO NORDISK
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
PFIZER Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTRAZENECA, & Executive Director, IISRA
SIGMA-TAU INTERNATIONAL IITS
PHARMACEUTICALS 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
SUNEVA MEDICAL
BENCHMARKING IITS
TALECRIS Adding Value to IIT Programs Using Benchmarking Data to Effectively Track Performance
BIOTHERAPEUTICS Patric Nelson, MPH, MBA, Associate Director, Medical Affairs, AMYLIN
Sponsors:
To Register Call 866-207-6528 or visit us at www.exlpharma.com/iit

2. Dear Colleague, Who Should Attend?
ExL Pharma’s 13th Investigator Initiated Trials conference offers professionals from This conference is designed for representatives
pharmaceutical, medical device, and biotechnology companies a complete understanding from pharmaceutical, biotechnology, and
of the issues and strategies for managing and implementing, successful and compliant, local medical device companies with responsibilities
and global IITs. ExL Pharma is the proud host of the longest running IIT event and original
in the following departments:
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
 Investigator Initiated Trials, Research,
biotechnology companies), and tremendous networking opportunities to help build relationships
and Studies
through memorable and relevant shared experiences. In addition, attendees also have the
 Medical Affairs
unique opportunity to hear best practices for determining fair market value from the Investigators
 MSLs
Initiated Sponsored Research Association (IISRA).
 Medical Communications
 Research Grants
The 13th IIT event is being co-located with two other ExL Pharma events, the 8th MSL Best
 Clinical Project Manager
Practices conference and the new Medical Affairs Executive Forum. These three events share
 Clinical Affairs Manager
networking breaks, continental breakfast, and lunch, which allow for increased networking
 Compliance, Legal and Regulatory Affairs
opportunities filled with senior level medical affairs professionals and MSLs. This is a must attend
 Program/Project Management
event for everyone involved in investigator initiated trials looking to advance their knowledge
 Contract Administrators
and learn new strategies, while interacting with other IIT professionals.
 Clinical Research Investigators
 Clinical Data Analysts
We look forward to greeting you in April!
This event is also of interest to:
Sincerely,
 Consultants
 Solution Providers for Data & Lifecycle
Management
 Law Firms
Mary Ruggiero Kristen Hunter
 Contract Research Organizations
Conference Director Team Leader, Production
mruggiero@exlpharma.com ExL Pharma
Dolce Basking Ridge
300 North Maple Avenue
Basking Ridge, NJ 07920 USA
Tel: (800) 953-8033
Fax: (908) 953-3105
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.
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.

3. Day One – Thursday, April 14th PRE-CONFERENCE WORKSHOP
8:00 Registration and Continental Breakfast For Workshop Participants
9:00 IIT 101: BUILDING A SUCCESSFUL INVESTIGATOR INITIATED TRIAL PROGRAM
• Key points to consider when developing a compliant IIT program • Understanding the role of publications in a successful investigator initiated trial program:
• Determining the cost of the investment, and developing time management skills – Brief overview of how we got where we are today
• Learning how to find new investigators – Understanding of the current environment
• Understanding the review process of an IIT and how to network review committees for IIT proposals – Transparency, disclosures, conflict of interest (COI),
• Choosing the right investigator to research the right topic for maximum results authorship, author payments, acknowledgments, use of
• Balancing your company’s role in and oversight of the research medical writers and “ghostwriting”
• Issuing grants and proposals, and how to review the material before submission – Ways to ensure compliance:
• Understanding a variety of steps to consider to help mitigate risk against violation of applicable laws: - Policies/guidelines
– Establishing proper intent and foster compliance with - SOPs
FDA regulations - Training
– Ensuring that the investigator is in control of the study - Documentation of publication activities
– Determining fair market value - Regular audits
– Avoiding influence of sales force in the IIT process - GPP2
– Limiting involvement in IIT studies after approval - Certificate program- CMPP
– Promoting transparency and disclosure – Understanding the difference between company-sponsored
publications and investigator initiated publications
Moderator: Speakers:
Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, Marc Massanari, PharmD, Global Medical Affairs,
ASTRAZENECA & Executive Director, IISRA Health Economics & Outcomes Research, NOVARTIS
Deborah 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
Main Conference Begins
1:00 CHAIRPERSON’S WELCOME & OPENING REMARKS 2:45 IIT REGULATORY ENVIRONMENT
Alexander Kostek, Global Investigator Initiated Research Group Leader, Understanding the Varying Interpretations on the Rules and
PFIZER Requirements Governing IITs and How to Effectively Achieve Compliance
• Updates on the changing regulation of IITs and the different interpretations and techniques to
1:15 SELECTING AN IIT ensure overall compliance
Establishing a Governance Model for the Review and Selection of an IIT • What resources are required to fulfill a corporate integrity agreement (CIA) and what are the
and Communicating these Decisions to the Investigator consequences and impact of a non-compliant CIA?
• Building a committee board to review and select investigators and proposed IITs • What preventive programs can companies put in place when they are not under CIAs?
• Selecting board members, defining individual roles, and managing the boards time • Explanation of the types of agreements when working in IITs, including MTA, CTA, and PSA
• Learning key criteria for evaluating investigators and proposed IITs to make the best selection Renata J. Matsson, PhD, JD, Director, Compliance R&D, EISAI
• Establishing a scorecard for reviewing IIT proposals
• Communicating the committee’s decision to the investigator and clarifying expectations
Marianne Parnell, Manager, Medical Affairs, SIGMA-TAU PHARMACEUTICALS 3:30 Networking & Refreshment Break
2:00 CONTRACT NEGOTIATIONS
4:00 CORPORATE INTEGRITY AGREEMENTS
Identifying Key Elements within a Contract and Strategies for
Developing a Corporate Integrity Agreement (CIA) As it Relates and
Expediting Negotiations
Impacts IITs
• Developing the contracting process with an IIT and selecting key issues and topics to be
• This discussion highlights key areas of IIT support that should be considered as potential
included in an IIT contractual agreement
risks or targets of a CIA
• Defining responsibility between the sponsor and investigator in the following areas:
• Learn best practices after submitting a CIA
- Payment Structure - Patient Injury
• Overcoming obstacles when complying with CIA compliance requirements
- Intellectual Property - Confidentiality
- Study Data - Publication Rights Caroline Flotron, Senior Attorney, PFIZER
- Indemnification
• Effectively negotiating contracts to ensure the overall success of an IIT
• Establishing tips for accelerating the contract negotiations
Carrie Kissick Rabbitt, JD, Senior Attorney, NOVO NORDISK
To Register Call 866-207-6528 or visit us at www.exlpharma.com/iit

4. 4:45 IISRA UPDATE ON FAIR MARKET VALUE 10:30 Networking & Refreshment Break
Investigator Initiated Sponsored Research Association Update on Best
Practices to Efficiently Determine FMV For Investigator’s Time and Services 11:00 IITs FOR NON-APPROVED PRODUCTS
• Understanding why IISRA guidelines are useful when supporting an IIT and what makes these Understanding the Differences and Challenges in Supporting an IIT for a
FMV guidelines valid Non-Approved Product and How this Can Increase Access for Treatment
• Efficiently determining the fair market value for supporting investigators involved in IITs Use and Dose-Finding
• Methods to establishing a standard value for equipment and medical resources • Understanding the benefits of undergoing an IIT for a non-approved product and the reasons
Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTRAZENECA, why companies are getting more involved in these studies
& Executive Director, IISRA • Evaluating the results of IITs on non-approved products and how this affects the sponsoring
company
5:15 ROUNDTABLE DISCUSSIONS • Complying with SAE reporting from IITs for non-approved products
Choose from one of the following tables and be part of an intimate Scott Kelley, MD, Vice President, Medical Affairs, COVIDIEN
discussion on different IIT topics
1) How M&A Affects IITs: Successfully adopting new IITs after an M&A and 11:45 BENCHMARKING IITs
determining which IITs can be let go Adding Value to IIT Programs Using Benchmarking Data to Effectively
2) IIT Timeline Management: Lessons learned on keeping timely IITs and how to Track Performance
handle unforeseen delays • Incorporating benchmarking into IIT preparations and executions
3) Financial Support of IIT Publications: Learning if and when the sponsor • Deriving meaningful conclusions from benchmarking data
provides funding for the creation of publications, presentation of publications, • The big picture- looking beyond benchmarking when justifying an IIT program’s ROI
and knowing what your company limits are
Patric Nelson, MPH, MBA, Associate Director, Medical Affairs, AMYLIN
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 12:30 Luncheon
and compliant IIT processes within your organization and an update on the Physician
Sunshine Act and its affect on your relationship with the IIT 1:30 IIT INSPECTION AND AUDIT
6) Safety Reporting Requirements: Understanding what your reporting Protecting Yourself from an FDA IIT Audit and Seamlessly Overcoming
obligations are and how these requirements will change with new and pending an Internal Investigator Inspection
legislation • The challenges and process of preparing for an FDA inspection and audit
• Benefits of using a consulting firm to become ready for GCP audits and knowing what
6:00 Day One Concludes information must be provided
• Knowing what is needed when conducting an audit on the investigator and study site
Day Two – Friday, April 15th 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
8:00 Continental Breakfast with Investigators
• Understanding the role of MSLs and the size of their network
8:50 CHAIRPERSON’S RECAP OF DAY ONE • How involved do MSLs get in IITs
Alexander Kostek, Global Investigator Initiated Research Group Leader, • Learning new communication skills with MSLs to maintain open correspondence and learn
PFIZER updates on the status of the IIT and investigator
• Understanding the relationship between the investigator and MSL and justifying the value of an
9:00 INTERNATIONAL IITs MSL in furthering medical strategy
Managing Compliance in Emerging Markets IITs to Optimize Research Quality, • Compliance considerations when MSLs work with IITs
Patient Safety, and Inspection Readiness Lisa Misell, PhD, Senior Director, Medical Affairs and Clinical Operations,
• Learning what rules and requirements are relevant when approving and managing an IIT in an SUNEVA MEDICAL
emerging market
• Establishing responsibilities for managing IIT compliance 3:00 PANEL DISCUSSION
• Identifying compliance issues and successfully resolving them SELECTING A CRO TO MANAGE IITs AND DEFINING
• Balancing compliance and efficiency when conducting an emerging markets IIT THEIR FUNCTION AS AN INTEGRAL PART OF THE IIT
Kevin Douglass, Associate Director/Investigator Initiated Research (IIR) Building and Improving Partnerships and Alliances with CROs
Manager, Emerging Markets, PFIZER • What are the criteria used to select a CRO and who is involved in the decision making?
• Determining whether to use one or multiple CROs
9:45 IIT TRACKING AND PAYMENT SYSTEMS • Managing outsourced relationships: the challenges, benefits, and risk
Implementing Software for Tracking IIT Compliance, Obtaining Updated Data, • Creating and maintaining positive and productive relationships with CROs
and Streamlining Proposals, and Payments • Determining who should be negotiating with sites, investigators and other third-party vendors
• Adapting a software system to streamline proposals to help expedite the contracting process of
Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, ASTRAZENECA, &
an IIT
Executive Director, IISRA
• Learning how to track IIT registration, request submission, and review current IIT data to
Alexander Kostek, Global Investigator Initiated Research Group Leader, PFIZER
maintain timelines and manage expectations
Scott Tsurutani, Senior Clinical Program Manager, ACTELION
• Successfully maintaining a budget and tracking payments made to investigators to ensure
compliance with existing rules governing IITs
4:00 Conference Concludes
To Register Call 866-207-6528 or visit us at www.exlpharma.com/iit

5. EARLY BIRD PRICING MEDIA PARTNERS
Register by Friday, February 25, 2011
to Take Advantage of Early-Bird Pricing:
Conference + Workshop $1995
Conference Only $1695
STANDARD PRICING
Register After Friday,February 25, 2011:
Conference + Workshop $2195
Conference Only $1895
ONSITE PRICING
Conference + Workshop $2295
Conference Only $1995
PM 36O
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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.*

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COMPLIANT AE REPORTING
Fair Market Value Transparency Pharmaceutical, Medical Device, and Biotechnology
INTELLECTUAL IRB Exemptions State Laws
312.2(b)
PROPERTY STREAMLININGReporting Professionals Gaining a Robust Understanding for
Risk/Benefit Profile
PROPOSALS
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MSL
Regulatory
PAYMENTS Metrics
AND Budgets Managing and Implementing, Local and Global IITs
Guidance Safety Reporting
ROLE Benchmark Progress
US vs EU
Publications
CBER Perspective
INSPECTION AND AUDIT
IITS IN
April 14-15, 2011
BENCHMARKING
Informed Consent
Grant Systems IT Challenges
EMERGING
MARKETS
Technology Platforms
Dolce Basking Ridge | Basking Ridge | New Jersey
IND or IDE? MSL Value
Sponsors:
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8th Annual MSL Best Practices Conference, and
Tri-Located with Medical Affairs Executive Forum
ExL Pharma’s Register Today and Gain Access to Presentations from all Three Events!
://www.exlpharma.com/events/investigator-initiated-trials
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