Optimizing Trial Performance and Reducing Pharmaceutical Costs Through Effective Identification and Activation of Sites and Enhancing Stakeholder Communication

1. Prices Increase After
January 14th
Presents
2nd Annual
nd
Clinical Site
Feasibility, Selection, and Startup
Optimizing Trial Performance and Reducing Pharmaceutical
Costs Through Effective Identification and Activation of Sites
and Enhancing Stakeholder Communication
March 1-2, 2011
Crowne Plaza Philadelphia Downtown
Philadelphia, PA SPEAKING FACULTY:
Heather Almonte, Associate Director, Clinical
Operations, OCTAPHARMA
John Burnett, Consultant, Clinical Program
FEATURED PRESENTATIONS AND CASE STUDIES:
Manager, ELAN PHARMACEUTICALS
Chris Conklin, Global Trial Optimization,
MERCK & CO
Allergan Case Study: Patient Recruitment Planning
Christina DiArchangelo, CEO, ARMONIA
Successful Strategies for Implementing Patient Recruitment, CLINICAL RESEARCH, LLC
Retention, and Contingency Plans Daniela Franschman, Manager, Global Trial
Fidela Moreno, MD, Vice President, Global Development Operations, ALLERGAN Optimization, MERCK & CO
Miriam Verduzco, Director, Patient Recruitment and Site Management Services, ALLERGAN Sheila Gilbride-Wilson, Vice President, Clinical
Operations, VERTEX PHARMACEUTICALS
Lani Hashimoto, Director, Strategic Development,
Country Feasibility and Global Site Selection MMG
Determining If Your Trial Can Be Run Within a Particular Country and Joseph Kim, Director, Clinical Operations,
Strategies for Selecting the Trial Countries and Sites SHIRE PHARMACEUTICALS
Ross Pettit, Vice President, Clinical Operations, AMAG PHARMACEUTICALS Lisa LaLuna, Senior Vice President Corporate
Development & Implementation, ePHARMASOLUTIONS
Raymond Panas, PhD, Director of International Clinical Development,
SUCAMPO PHARMACEUTICALS Mitch Melendez, Director, Clinical Research
Learning and Development, CELGENE
Sanofi-Aventis Case Study: Working with Medical Affairs Fidela Moreno, MD, Vice President, Global
Development Operations, ALLERGAN
Successful Strategies for Working with Medical Affairs/Regional Shae Owens, Regulatory Affairs Coordinator,
Medical Liaisons to Gain More In Depth Feedback From Sites KOOTENAI CANCER CENTER
Frank Plonski, Assistant Director, Therapeutic Strategies Unit, SANOFI-AVENTIS Raymond Panas, PhD, Director of International
Clinical Development, SUCAMPO PHARMACEUTICALS
Ross Pettit, Vice President, Clinical Operations,
Sanofi-Aventis Case Study: Site Scorecards AMAG PHARMACEUTICALS
Frank Plonski, Assistant Director, Therapeutic
Successful Strategies Utilizing Site Scorecards to Optimize Site Performance Strategies Unit, SANOFI-AVENTIS
Richard Robinson, Assistant Director, Diabetes and Metabolism Group, SANOFI-AVENTIS Joe Popowicz, Associate Director, Clinical
Operations, ORTHOVITA
Richard Robinson, Assistant Director, Diabetes and
Metabolism Group, SANOFI-AVENTIS
Sponsored By:
Lakisha Rodwell, Global Trial Optimization
Specialist, MERCK & CO
Miriam Verduzco, Director, Patient Recruitment and
Site Management Services, ALLERGAN
Jeffrey Zucker, Senior Director and Global Head,
Patient Recruitment, KENDLE
To Register Call 866-207-6528 or visit www.exlpharma.com/siteselection

2. Dear Colleague:
Who Should Attend:
ExL Pharma is proud to introduce its 2nd Clinical Site Feasibility, This Summit is specifically designed for
C-Level Executives, Department Heads,
Selection, and Startup Conference. This conference centers on the areas Vice Presidents, Directors, and Managers
of site feasibility, identification and selection, and startup and activation. at Pharmaceutical, Biotechnology, and
The overarching themes of global trials and improving stakeholder Medical Device companies from the
following departments:
communication are incorporated throughout the agenda. This re-focused
agenda allows for in depth presentations that address the issues those in Clinical Operations
the industry struggle with daily.
Clinical Research/Development
Trial Optimization
This conference is an excellent opportunity for enhanced networking and
Site Selection
interaction with both senior level representatives from sponsor companies
Protocol Feasibility
and sites and for high level discussions on the issues.
Investigator Recruitment
Patient Enrollment/Recruitment
Please join us in March in Philadelphia for this exciting meeting!
Site Monitoring/Management
Sincerely, Clinical Data Analyst/Informatics Analyst
Melissa Colella Clinical Quality Assurance
Clinical Project/Study Managers
Melissa Colella
CRA’s
Conference Producer
mcolella@exlpharma.com Regulatory Affairs
Medical Affairs
This conference is also of interest to Senior
Kristen Hunter Level Representatives from Sites and
Team Leader, Event Production Representatives responsible for Feasibility,
ExL Pharma
Site Selection, Trial Optimization, and Patient
Recruitment at CRO’s.
HOTEL INFO Sponsorship and
Exhibiting Opportunities
Crowne Plaza
Philadelphia Downtown Do you want to spread the word about your
organization’s solutions and services to potential
1800 Market Street
clients who will be attending this event? Take
Philadelphia, PA 19103
advantage of the opportunity to exhibit, present
Tel: 215.561.7500
an educational session, host a networking event,
or distribute promotional items to attendees. ExL
Room Reservations: will work closely with you to customize a package
If you require overnight accommodations, please contact the Crowne Plaza Philadelphia Downtown that will suit all of your needs. To learn more
at 215-561-7500 to book your room. ExL has reserved a block of rooms at a discounted rate for about these opportunities, contact Eric
conference participants. Please mention ExL Pharma and the conference name to take advantage
Morrin, Business Development Manager,
of the discount. You must book your room by February 7, 2011to be eligible for
by calling 212-400-6228 or by emailing
the discounted rate. Please book your room early, as the rooms available at
emorrin@exlpharma.com.
this rate are limited.
To Register Call 866-207-6528 or visit www.exlpharma.com/siteselection

3. Agenda Day One – Tuesday, March 1, 2011
8:00 Registration Opens & Continental Breakfast for Workshop Participants
9:00 Pre-Conference Workshop
Site Contracts
A Step-By-Step Approach to Minimizing Delays Associated with
Site Contracts To Speed Activation
Christina DiArchangelo, CEO, ARMONIA CLINICAL RESEARCH, LLC
• Concrete strategies for expediting the contract process, including specifics strategies for streamlining the process on the sponsor and site sides
• Sponsor Temptations to avoid throughout the process
Writing the Contract
• When is it appropriate to set up a master clinical study agreement?
• How to appropriately standardizing contract language
Negotiating the Contract
• Tips for increasing site responsiveness
• Contract negotiation Ins and Outs
• Knowing when to “give in”
10:30 Networking & Refreshment Break
12:00 Lunch for Workshop Attendees
Main Conference Begins 3:15 Country Feasibility and
Global Site Selection
Determining If Your Trial Can Be Run Within
12:00 Registration Opens for Main Conference a Particular Country and Strategies for
Selecting the Trial Countries and Sites
1:00 Chairperson’s Day One Welcome and
Opening Remarks Ross Pettit, Vice President, Clinical Operations, AMAG PHARMACEUTICALS
Raymond Panas, PhD, Director of International Clinical Development, SUCAMPO
PHARMACEUTICALS
1:15 Protocol Feasibility • Determining if your protocol is doable in a particular country
Determining if Your Protocol is Doable Early • What parameters determine which country is best to run your trial in?
On to Avoid Delays at Trial Inception • Determining what mix of countries are needed
Lakisha Rodwell, Global Trial Optimization Specialist, MERCK & CO • How do you assess site performance internationally?
• Choosing the right CRO(s) to run a global trial
Daniela Franschman, Manager, Global Trial Optimization, MERCK & CO
• How do you go about setting up a network of investigators to weigh in on your 4:15 ROUNDTABLES:
protocols well before investigator meetings Unique Considerations for Working with Sites in
• Strategies for getting investigator feedback Specific Regions and Global Patient Recruitment
• Determining if your protocol needs simplification Planning Each roundtable addresses the following
topics specific to the selected region:
2:00 Site and Investigator Selection • Cultural considerations with regard to patient recruitment in the relevant region
Internal and External Data Sources and • Regulatory and legal considerations
Metrics Used to Identify and Prioritize Sites • Informed consent and the language that should be used
and Investigators and How These Methods • Ethical issues in emerging countries
Translate into Results
Select the preferred region to discuss in an intimate setting:
John Burnett, Consultant, Clinical Program Manager, ELAN PHARMACEUTICALS Latin America Western Europe China
• Metrics that are being used most to identify sites and investigators
Eastern Europe South Africa India
• Prioritizing sites based on past performance
• Where is this data coming from?
Roundtable moderators include:
• How do the metrics on site performance relate ultimately to how a site performs today?
• Sharing these metrics on site selection with your sites
Ross Pettit, Vice President, Clinical Operations, AMAG PHARMACEUTICALS
Fidela Moreno, MD, Vice President, Global Development Operations, ALLERGAN
Joseph Kim, Director, Clinical Operations, SHIRE PHARMACEUTICALS
Raymond Panas, PhD, Director of International Clinical Development, SUCAMPO
2:45 Networking & Refreshment Break PHARMACEUTICALS
To Register Call 866-207-6528 or visit www.exlpharma.com/siteselection

4. Agenda Day Two – Wednesday, March 2, 2011
Main Conference Continues
8:00 Continental Breakfast 11:45 Sanofi-Aventis Case Study: Working
8:30 Chairperson’s Recap of Day One with Medical Affairs
Successful Strategies for Working with Medical
Affairs/Regional Medical Liaisons to Gain More
8:40 Key Points Addressed From Day One In Depth Feedback From Sites
Roundtable Discussions
Frank Plonski, Assistant Director, Therapeutic Strategies Unit, SANOFI-AVENTIS
• Best Practices for working with Medical Liaisons to gather feedback on country feasibility
9:00 Recruitment Feasibility • Working with Medical Liaisons/CRA’s to identify and recommend sites
Using Early Site Visits to Quantify the Site • Working with Medical Affairs to get site feedback on future pipeline programs
Selection and Assess if a Potential Site Can
• Lessons learned going forward
Enroll the Number of Patients Needed
Joe Popowicz, Associate Director, Clinical Operations, ORTHOVITA
• Tips to quantify site selection criteria during early visits 12:30 Lunch
• Best practices to maximizing your study’s enrollment
• Employing contingency planning to reduce study delays 1:30 Site Training
• Strategies for dealing with site performance during study conduct Effectively Implementing Site Compliance Training
to Streamline Site Activation and Eliminate Delays
Mitch Melendez, Director, Clinical Research Learning and Development, CELGENE
• What gap exists between the training sites currently receive and FDA expectations
9:45 Allergan Case Study: • Properly training sites TODAY to be in compliance with FDA/ICH guidelines
Patient Recruitment Planning
• Successfully implementing virtual training programs
Successful Strategies for Implementing
Patient Recruitment, Retention, and
Contingency Plans 2:15 Sanofi-Aventis Case Study:
Fidela Moreno, MD, Vice President, Global Development Operations, ALLERGAN Site Scorecards
Miriam Verduzco, Director, Patient Recruitment and Site Management Services, Successful Strategies Utilizing Site Scorecards
ALLERGAN to Optimize Site Performance
• Best practices for implementing patient recruitment, retention, and contingency plans Richard Robinson, Assistant Director, Diabetes and Metabolism Group,
• When should recruitment, retention, and contingency plans be implemented? SANOFI-AVENTIS
• Metrics and lessons learned from this program • Best practices for providing feedback to sites through the use of scorecards
• Using scorecards to motivate inactive sites and spark enrollment
• How to create a scorecard and metrics to include on the scorecard
10:30 Networking & Refreshment Break • Feedback received from sites
11:00 Site Questionnaires
Streamlining and Improving the Use of the 3:00 CLOSING PANEL DISCUSSION
Site Feasibility Questionnaire From Both a Top Reasons for Trial Startup Delays and
Site and Sponsor Perspective to Optimize its How to Avoid Them
Effectiveness
Heather Almonte, Associate Director, Clinical Operations, OCTAPHARMA
Sponsor: Chris Conklin, Global Trial Optimization, MERCK & CO Miriam Verduzco, Director, Patient Recruitment and Site Management Services, ALLERGAN
Site: Shae Owens, Regulatory Affairs Coordinator, Sheila Gilbride-Wilson, Vice President, Clinical Operations, VERTEX PHARMACEUTICALS
KOOTENAI CANCER CENTER • What are the most common mistakes that result in delays at study startup that sponsors make?
• What do feasibility questionnaires really tell us and are they effective? • Concrete strategies for addressing these mistakes
• Steps sites can take to reduce the burden of work associated with the questionnaires • How can sponsors work to ensure these mistakes are avoided?
• How sponsors can standardize and simplify questionnaires • Technologies to speed the trial activation process
4:00 Conference Concludes
To Register Call 866-207-6528 or visit www.exlpharma.com/siteselection

5. Five Ways
to Register: Group Discount Program
Fax: 888-221-6750 Save 25% per person when Registering Four
Mail: ExL Events, Inc. For every three simultaneous registrations from your company, you will receive a fourth
555 8th Ave, Ste 310 complimentary registration to the program (must register 4 at one time) this is a sav-
New York, NY 10018
ings of 25% per person.
Phone: 866-207-6528
Online: www.exlpharma.com Save 15% per person when Registering Three
Can only send three? You can still save 15% off of every registration.
Email: registration@exlpharma.com
To find out more on how you can take advantage of these group discounts,
Registration Fees for Attending ExL’s 2nd Clinical Feasibility, please call 866-207-6528.
Selection, and Startup Conference:
Make checks payable to ExL Events, Inc. and write code P807 on your check.
EARLY BIRD PRICING You may also use Visa, MasterCard, Discover or American Express. Payments must be
Register by Friday, January 14th to Take received in full prior to the commencement of the conference.
Advantage of Early Bird Pricing:
Cancellations: If you need to cancel your registration for an upcoming ExL conference, please
Site Rate 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
Conference + Workshop $1495
voucher to another ExL event valid for two years from the voucher issue date.
Conference Only $1195  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 fax your request
Corporate Rate to 888-221-6750.
Conference + Workshop $1995  There will be an administrative charge of $300 to substitute,
exchange and/or replace attendance badges with a colleague
Conference Only $1695 occurring within five business days of the conference.
Important: Discount offers may not be combined. Discounts only apply to standard rate.
STANDARD PRICING
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.
Register After January 14th: *The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.*
Site Rate
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Conference Only $1395 Media Partners
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ONSITE PRICING
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Conference + Workshop $2295 Questions? Comments?
Do you have a question or comments that you would like to be addressed at this event?
Conference Only $1995
Would you like to get involved as a speaker or discussion leader?
Please email Conference Director, Melissa Colella at mcolella@exlpharma.com

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Prices Increase After
January 14th Speaking
Faculty Includes
Representation From:
Presents
2nd Annual
nd
MERCK & CO
Clinical Site VERTEX PHARMACEUTICALS
SHIRE PHARMACEUTICALS
Feasibility, Selection, and Startup
Optimizing Trial Performance and Reducing Pharmaceutical
Optimizing Trial Performance and Reducing Pharmaceutical SANOFI-AVENTIS
Costs Through Effective Identification and Activation of Sites
Costs Through Effective Identification and Activation of Sites ELAN PHARMACEUTICALS
and Enhancing Stakeholder Communication
and Enhancing Stakeholder Communication
March 1-2, 2011 CELGENE
Crowne Plaze Philadelphia Downtown
Philadelphia, PA ALLERGAN
Featured Presentations: SUCAMPO PHARMACEUTICALS
Allergan Case Study: Successful Strategies for Implementing Patient Recruitment,
Retention, and Contingency Plans OCTAPHARMA
Fidela Moreno, MD, Vice President, Global Development Operations, ALLERGAN
Miriam Verduzco, Director, Patient Recruitment and Site Management Services, ALLERGAN
ORTHOVITA
Sanofi-Aventis Case Study: Successful Strategies for Working with Medical
Affairs/Regional Medical Liaisons to Gain More In Depth Feedback From Sites AMAG PHARMACEUTICALS
Frank Plonski, Assistant Director, Therapeutic Strategies Unit, SANOFI-AVENTIS