exl pharma's 3rd annual european investigator initiated trials conference, october, london

3rd

European Investigator- Initiated Trials

Register by

17 September, 2010

to Receive our Discounted Rate!

The ORIGINAL is still the best!

Proudly Presents:

Join us and share best practices with

organizations including:

Actelion Pharmaceutics

Biocompatibles

Celgene

Centocor

European Brain Council

GlaxoSmithKline

Johnson & Johnson

Shire Pharmaceuticals

Takeda Oncology

CO-lOCaTED- Medical/Scientific

advisor and Medical Science liasion Best Practices

Conference.

REGISTER TODay anD GaIn aCCESS TO

PRESEnTaTIOnS FROM BOTh

EvEnTS!

Overview of a Successful IIT Implementation Process

28-29 October, 2010 | Ambassadors Bloomsbury, London, UK

To Register: Call +1 212-400-6240 or visit us at www.exlpharma.com/3rdeuroIIT

Sponsored by:

SESSIOn hIGhlIGhTS InCluDE:

OPENING KEYNOTE SPEAKER— THE VALUE OF IITs

Realizing the Benefits of Funding IITs and the Impact on the Product, the Patient, and the Company

Alastair Benbow, MB BS MRCPI FFPM, Interim Executive Director, EUROPEAN BRAIN COUNCIL, Belgium, Former SVP for Pharmacovigilance and VP/European Medical Director,

GLAXOSMITHKLINE, UK

PANEL DISCUSSION—MAXIMIZING THE EFFICIENCY OF IITsIncreasing the Efficiency of IITs through Enhanced Management and Clear Communication

Belinda Carlsen, Clinical Project Manager, HOFFMANN-LA ROCHE, UKOuadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products Division,

BIOCOMPATIBLES, SpainJackie Pullen, Quality Manager, Joint Clinical Trials Office, KINGS HEALTH PARTNERS, UK

EU REGULATORY ENVIRONMENTUnderstanding the EU Rules and Regulations and How to Achieve Compliance for IITs

Fabien Peuvrelle, PharmD, Director, Regulatory Operations Europe, CELGENE R&D, Switzerland

PHASE IV TRIALSOptimizing European Phase IV Trials via Investigator-Initiated or Company-Sponsored

Models that Support Regulation and Reimbursement GoalsMichael L. Lim, PharmD, Scientific Affairs Director, Oncology Centre of Excellence,

GLAXOSMITHKLINE, UK

ven

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ExL Pharma’s 3rd European Investigator-Initiated Trials conference offers educational discussions with expert industry leaders explaining the value and reasons for supporting an IIT, the implementation and process of IITs, and solutions to common problems. This event offers valuable lessons and techniques on safety reporting, an explanation of the EU regulatory environment, and over-coming the sponsorship challenges when conducing IITs in dif-ferent countries. Presentations discuss tools and techniques on maximizing the value of IITs and overcoming the difficulties, while valuable Q&A time and refreshment breaks provide excel-lent networking opportunities! This is the only European IIT conference and ExL Pharma is proud to continue providing infor-mation for pharmaceutical, medical device, and biotechnology companies who are interested in expanding their knowledge and business within IITs.

This is a must attend event and we look forward to welcom-ing you 28-29 October, 2010 at ambassadors Bloomsbury in london, England!

Sincerely,

Mary Ruggiero Kristen HunterConference Director Team Leader, [email protected] ExL Pharma

Who Should attend?Professionals from pharmaceutical,

biotechnology and medical device companies with responsibilities in the following

departments:

• Investigator Initiated/ Sponsored Trials and Research• Medical Affairs/ Medical Directors• Clinical Trials/ Research • Clinical Development/ Operations• Clinical Project Management• Business Development• Medical Education• Director Processes & Compliance• Scientific/Clinical Affairs• Medical Marketing/ Communication• Medical Grants• QP (Qualified Person)• Phase IV

This conference is also of interest to:

• Data Management and Technology Service Providers• Law Firms• Clinical Research Organizations• Consultants

Ambassadors Bloomsbury12 Upper Woburn PlaceLondon, UK WC1H 0HX, United Kingdom020 7693 5400

Ambassadors Blommsbury is a stylish, contemporary hotel, which prides itself on exceptional standards of customer service. New rooms designed for comfort and style. Visionary conference suites. Cutting edge restaurant and bar. Located just five minutes walk from both Euston and King’s Cross St Pancras stations (the Eurostar terminal), Ambassadors Bloomsbury is ideally located for both business trips and short leisure breaks.

Room ReservationsIf you require overnight accommodations, please contact the hotel and state that you are with ExL Pharma’s European Investigator Initiated Trials confer-ence by Thursday, 30th September, 2010. We encourage conference partici-pants to make reservations with our designated venue to take advantage of ExL Pharma’s discounted room rate by the aforementioned date.


Main conference Begins–Day one

13:00 CHAIRPERSON’S WELCOME AND OPENING REMARKS

Ouadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products Division, BIOCOMPATIBLES, Spain

13:15 OPENING KEYNOTE SPEAKER-THE VALUE OF IITs

Realizing the Benefits of Funding IITs and the Impact on the Product, the Patient, and the Company

• Understanding the link between IITs and the achievement of corporate objectives

• Tools needed to support the IIT process and demonstrating this to your management team

• Exploring the financial impact when supporting an IIT • Demonstrating the value of IITs to upper management

Alastair Benbow, MB BS MRCPI FFPM, Interim Executive Director, EUROPEAN BRAIN COUNCIL, Belgium, Former SVP for Pharmacovigilance and VP/European Medical Director, GLAXOSMITHKLINE, UK

14:00 EU REGULATORY ENVIRONMENT

Understanding the EU Rules and Regulations and How to Achieve Compliance for IITs

• Explanation of the current EU regulations and guidelines• Understanding the purpose of the EU Clinical Trial Directive• Discussing multi country compliance “hot” buttons

Fabien Peuvrelle, PharmD, Director, Regulatory Operations Europe, CELGENE R&D, Switzerland

14:45 NETWORKING AND REFRESHMENT BREAK

15:15 PANEL DISCUSSION: MAXIMIZING THE EFFICIENCY OF IITs

Increasing the Efficiency of IITs through Enhanced Management and Clear Communication

• Getting to know your investigator and improving communications• Discovering IIT management trends and establishing which

method works best • Overcoming IIT challenges to ensure proper data reports, results,

and clarifying expectations

MODERATOR: Ouadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products Division, BIOCOMPATIBLES, Spain

SPEAKERS: Belinda Carlsen, Clinical Project Manager, HOFFMANN-LA ROCHE, UKJackie Pullen, Quality Manager, Joint Clinical Trials Office, KINGS HEALTH PARTNERS, UK

16:15 CASE STUDY

Developing an IIT Program: Balancing Patient and Investigator Interests

• Interaction between investigator and company within EU legal frame• Identifying the common ground and why the medical community can

benefit from IITs• Understanding the patients when participating in an IIT and how to

communicate this benefit

Gavin Collins, Director, Medical Affairs, CELGENE CORPORATION, Switzerland

17:00 ROUNDTABLE DISCUSSIONS

Roundtable sessions with attendees from the Medical/Scientific Advisor and Medical Science Liaison Best Practices:

1. Challenges and Solutions when Working on an IIT, and the Impor-tant Participation of CROs

2. Managing a Budget and Time Line for IITs: Lessons learned on successful budgets and time lines, and how to handle unforeseen expenses and delays

3. Overview of Intellectual Property: Explanation and overview of IP and understanding when it is important to include in a contract, how to protect your company and data ownership

4. Enhancing Cross Country IITs and Safety Reporting: Overcom-ing the sponsorship challenges when conducting IITs in different countries and explaining safety reporting obligations needed to satisfy requirements

5. EU Rules and Regulations: Explanation of the different EU rules and guidelines

17:45 CLOSE OF DAY ONE

8:00 REGISTRATION AND BREAKFAST FOR WORKSHOP PARTICIPANTS

9:00 PRE-CONFERENCE WORKSHOP

THE BASIC OVERVIEW AND APPLICATION OF A SUCCESSFUL IIT IMPLEMATION AND EXECUTION• Training sessions on the following areas include:

- Development of an IIT- How to determine the cost of the investment- Time management skills- Balancing your company’s role in and oversight of the research

• Learning how to find new investigators• Choose the right investigator to research the right topic for maximum results• Understanding the review process of an IIT• Issuing grants and proposals, and how to review the material before submission

Rudolf Schopf, MD, FAAD, Professor of Medicine, Dept Dermatology, JOHANNES GUTENBERG UNIVERSITY, GermanyMarc Urich, PhD, Clinical Program Manager, ACTELION PHARMACEUTICALS, Switzerland

10:30 30-Minute Networking & Refreshment Break12:00 Workshop Concludes; Luncheon for Workshop Participants

Day one Thursday, 28 October 2010

“Very good overview of the regulatory environment, and clear examples” —PAC Coordinator, ABBoTT VASCULAR, Belgium

“This program met my expectations and provided a great networking opportunity”

—Publication Manager, FERRINg INT’T PHARMA

SCIENCE CENTRE, Denmark

“Easy listening with great examples” —CTA, THRoMBogENICS, Belgium

“Great presentations!” —Senior Medical Advisor, CSL BEHRINg Ag,

Switzerland

“Very good discussions and presentations! Great to hear how other companies are organized” —Medical Information Manager,

BIoVITRUM AB, Sweden

conference Day two Friday, 29 October 2010

7:00 BREAKFAST FOR CONFERENCE PARTICIPANTS

8:00 CHAIRPERSON’S RECAP OF DAY ONEOuadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products Division, BIOCOMPATIBLES, Spain

8:15 IIT KEY PERFORMANCE INDICATORS

Identifying and Evaluating Key Performance Indicators when Measuring and Tracking the Progress of an IIT

• Understanding what key performance indicators are when supporting an IIT • Identifying what types of tracking methods to use when interpreting data • Measuring IIT performance, and establishing evaluation criteria to

achieve the clinical objective

Michael Montgomery, MD, CPI, President, investigator initiated/sponsored research association (iisra), Director, Worldwide Medical Affairs, Immunology Research, CENTOCOR ORTHO-BIOTECH, USA

9:00 IMPROVED IIT MANAGEMENT TECHNOLOGIES

IIT Management Systems to Support Scalability Globalization, Compliance, and Documentation

• Deciding on the use of technology to coordinate and manage IIT programs from application through grant close out

• Considerations for support of multi-national programs• Audit readiness to support program compliance and transparency

initiatives, including FMV documentation need• Support of program scalability without large personnel investment

Anton Ehrhardt, PhD, Sr. Medical Director, Global Medical Affairs, MILLENNIUM: THE TAKEDA ONCOLOGY COMPANY, USA

9:45 NETWORKING AND REFRESHMENT BREAK

10:15 PHASE IV TRIALS

Optimizing European Phase IV Trials via Investigator-Initiated or Company-Sponsored Models that Support Regulation and Reimbursement Goals

• Understand the pros and cons of investigator-initiated versus company-sponsored Phase IV trials

• Examine budget, resource, and infrastructure necessary for each model, including the role of cooperative groups

• Share case studies illustrating opportunities, perceived risks, and decision-considerations when evolving toward company-sponsored model

Michael L. Lim, PharmD, Scientific Affairs Director, Oncology Centre of Excellence, GLAXOSMITHKLINE, UK

10:45 QUALIFIED PERSON ROLE IN IITs

How to Effectively Use and Plan for a QP and Understanding their Unique Responsibilities and Cost Benefits

• Identifying a Qualified Person (QP) that is not associated with a company• Necessary steps and considerations when using a QP• Selecting a QP and how to make this determination

Martine Tratsaert, Qualified Person, Senior Director, Global Qualified Person Group, JOHNSON & JOHNSON, Belgium

11:30 IISRA UPDATE

Investigator Initiated Sponsored Research Association: Industry-led Initiatives Promoting Standards and Best Practices for Investigator Initiated-Sponsored Research (IISR)

• Introduce Investigator Initiated-Sponsored Research Association (IISRA)• Learn industry lead initiatives for Investigator Initiated-Sponsored Re-

search (IISR) standards/best practices• Discuss the expansion of IISRA to Europe

Ran Frenkel, RPh, CEO, PHARMA FOCUS ISRAEL, Switzerland

11:45 LUNCHEON

12:45 IIT TECHNOLOGY AND DATA PROGRAMS

New Technology Systems to Organize Data, Improve Project Management and Increase Productivity

• Learning how new technology systems can improve IIT data organi-zation and management

• Applying how this information can be shared between both the spon-sor and the provider

• Understanding how a technology system can help keep track of com-plete grants program across multiple products, therapeutic areas, and indications and how this helps facilitate submission, review, ap-proval and financial management

13:30 EXAMINING SOLUTIONS TO COMMON IIT PROBLEMS

Identifying IIT Obstacles and an Explanation of the Answers through Lessons Learned

• How to identify and address an IIT issue before it becomes a problem• Successful solutions to problems that arise before, during, and after

an IIT• Working within a reasonable time frame to ensure company wide

success, and investigator satisfaction

Michael Montgomery, MD, CPI, President, investigator initiated/sponsored research association (iisra), Director, Worldwide Medical Affairs, Immunology Research, CENTOCOR ORTHO-BIOTECH, USA

Marc Urich, PhD, Clinical Program Manager, ACTELION PHARMACEUTICALS, Switzerland

14:15 CLOSE OF CONFERENCE


Reg

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form

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edia

Par

tner

s Sponsorship and Exhibiting Opportunities

Do you want to spread the word about your organization’s solutions and services to poten-tial clients who will be attending this event? Take advantage of the opportunity to exhibit, present an educational session, host a net-working 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 opportu-nities, please contact:

Lucas CarrascoBusiness Development Manager+1 212-400-6231, [email protected]

To RegisTeR Call 866-207-6528 oR visiT us aT www.exlpharma.com/Kolsummit

Four Ways to RegisterMail: ExL Events, Inc. 555 8th Ave, Ste 310 New York, NY 10018

Phone: +1 212-400-6240

Online: www.exlpharma.com

Email: [email protected]

Registration Fees

EARLY BIRD PRICING

Register by Friday, 17th September, 2010: to Take Advantage of Early-Bird Pricing:Conference + Workshop £1,450 Conference Only £1,300

STANDARD PRICINGRegister After Monday, 20th September, 2010: Conference + Workshop £1,600Conference Only £1,450

ONSITE PRICINGConference + Workshop £1,750 Conference Only £1,600

Group Discount Program:

Save 25% Per Person when Registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registra-tion 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 +1 212-400-6240.

IMPORTANT!! Offers may not be combined. Discount only applies to standard rate. Make checks payable to ExL Events, Inc. and write code P1703 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full prior to the commence-ment of the conference.

Conference registrations may be transferred to other col-leagues 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.

To receive a refund or voucher, please email your request to [email protected].

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.*


To RegisTeR Call 866-207-6528 oR visiT us aT www.exlpharma.com/Kolsummit

3rd

Eu

ropean

Investigator- In

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Register by

17 September, 2010

to Receive our D

iscounted Rate!

Sponsored by:

The O

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Proudly Presents:

Join u

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organization

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Actelion Pharm

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Celgene

Centocor

European B

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laxoSmithK

lineJohnson &

JohnsonShire Pharm

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ncology

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Overview

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Registration Form

Mail: ExL Events, Inc. Phone: +1 212 400-6240 555 8th Ave, Ste 310 Email: [email protected] New York, NY 10018 Online: www.exlpharma.com

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