2nd Annual Clinical Site Feasibility, Selection, and Startup, March 2011, Philadelphia

Presents

Prices Increase After January 14th

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

SPEAKING FACULTY:Heather Almonte, Associate Director, Clinical Operations, OCTAPHARMA

John Burnett, Consultant, Clinical Program Manager, ELAN PHARMACEUTICALS

Chris Conklin, Global Trial Optimization, MERCK & CO

Christina DiArchangelo, CEO, ARMONIA CLINICAL RESEARCH, LLC

Daniela Franschman, Manager, Global Trial Optimization, MERCK & CO

Sheila Gilbride-Wilson, Vice President, Clinical Operations, VERTEX PHARMACEUTICALS

Lani Hashimoto, Director, Strategic Development, MMG

Joseph Kim, Director, Clinical Operations, SHIRE PHARMACEUTICALS

Lisa LaLuna, Senior Vice President Corporate Development & Implementation, ePHARMASOLUTIONS

Mitch Melendez, Director, Clinical Research Learning and Development, CELGENE

Fidela Moreno, MD, Vice President, Global Development Operations, ALLERGAN

Shae Owens, Regulatory Affairs Coordinator, KOOTENAI CANCER CENTER

Raymond Panas, PhD, Director of International Clinical Development, SUCAMPO PHARMACEUTICALS

Ross Pettit, Vice President, Clinical Operations, AMAG PHARMACEUTICALS

Frank Plonski, Assistant Director, Therapeutic Strategies Unit, SANOFI-AVENTIS

Joe Popowicz, Associate Director, Clinical Operations, ORTHOVITA

Richard Robinson, Assistant Director, Diabetes and Metabolism Group, SANOFI-AVENTIS

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

2nd Annual

Clinical Site Feasibility, Selection, and StartupClinical Site Feasibility, Selection, and Startup

2nd Annual

Optimizing Trial Performance and Reducing Pharmaceutical Costs Through Effective Identification and Activation of Sites and Enhancing Stakeholder CommunicationMarch 1-2, 2011Crowne Plaza Philadelphia DowntownPhiladelphia, PA

FEATURED PRESENTATIONS AND CASE STUDIES:

March 1-2, 2011Crowne Plaza Philadelphia DowntownPhiladelphia, PA

Allergan Case Study: Patient Recruitment Planning

Country Feasibility and Global Site Selection

Sanofi-Aventis Case Study: Working with Medical Affairs

Sanofi-Aventis Case Study: Site Scorecards

Sponsored By:

Determining If Your Trial Can Be Run Within a Particular Country and Strategies for Selecting the Trial Countries and SitesRoss Pettit, Vice President, Clinical Operations, AMAG PHARMACEUTICALSRaymond Panas, PhD, Director of International Clinical Development, SUCAMPO PHARMACEUTICALS

Successful Strategies for Implementing Patient Recruitment, Retention, and Contingency PlansFidela Moreno, MD, Vice President, Global Development Operations, ALLERGANMiriam Verduzco, Director, Patient Recruitment and Site Management Services, ALLERGAN

Successful Strategies for Working with Medical Affairs/Regional Medical Liaisons to Gain More In Depth Feedback From SitesFrank Plonski, Assistant Director, Therapeutic Strategies Unit, SANOFI-AVENTIS

Successful Strategies Utilizing Site Scorecards to Optimize Site PerformanceRichard Robinson, Assistant Director, Diabetes and Metabolism Group, SANOFI-AVENTIS

Who Should Attend:

This Summit is specifically designed for C-Level Executives, Department Heads, Vice Presidents, Directors, and Managers at Pharmaceutical, Biotechnology, and Medical Device companies from the following departments:

Clinical Operations

Clinical Research/Development

Trial Optimization

Site Selection

Protocol Feasibility

Investigator Recruitment

Patient Enrollment/Recruitment

Site Monitoring/Management

Clinical Data Analyst/Informatics Analyst

Clinical Quality Assurance

Clinical Project/Study Managers

CRA’s

Regulatory Affairs

Medical Affairs

This conference is also of interest to Senior Level Representatives from Sites and Representatives responsible for Feasibility, Site Selection, Trial Optimization, and Patient Recruitment at CRO’s.

Sponsorship and Exhibiting OpportunitiesDo you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. ExL will work closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, contact Eric Morrin, Business Development Manager, by calling 212-400-6228 or by emailing [email protected].

Dear Colleague:

ExL Pharma is proud to introduce its 2nd Clinical Site Feasibility, Selection, and Startup Conference. This conference centers on the areas of site feasibility, identification and selection, and startup and activation. The overarching themes of global trials and improving stakeholder communication are incorporated throughout the agenda. This re-focused agenda allows for in depth presentations that address the issues those in the industry struggle with daily.

This conference is an excellent opportunity for enhanced networking and interaction with both senior level representatives from sponsor companies and sites and for high level discussions on the issues.

Please join us in March in Philadelphia for this exciting meeting!

Sincerely,

Melissa Colella

Melissa ColellaConference [email protected]

Kristen HunterTeam Leader, Event ProductionExL Pharma

HOTEL INFOCrowne Plaza Philadelphia Downtown 1800 Market Street

Philadelphia, PA 19103

Tel: 215.561.7500

Room Reservations: If you require overnight accommodations, please contact the Crowne Plaza Philadelphia Downtown at 215-561-7500 to book your room. ExL has reserved a block of rooms at a discounted rate for conference participants. Please mention ExL Pharma and the conference name to take advantage of the discount. You must book your room by February 7, 2011to be eligible for the discounted rate. Please book your room early, as the rooms available at this rate are limited.


1:15 Protocol Feasibility Determining if Your Protocol is Doable Early On to Avoid Delays at Trial Inception

LakishaRodwell,GlobalTrialOptimizationSpecialist,MERCK&CO

DanielaFranschman,Manager,GlobalTrialOptimization,MERCK&CO • How do you go about setting up a network of investigators to weigh in on your protocols well before investigator meetings • Strategies for getting investigator feedback • Determining if your protocol needs simplification

2:00 Site and Investigator Selection Internal and External Data Sources and Metrics Used to Identify and Prioritize Sites and Investigators and How These Methods Translate into Results

JohnBurnett,Consultant,ClinicalProgramManager,ELANPHARMACEUTICALS • Metrics that are being used most to identify sites and investigators • Prioritizing sites based on past performance • Where is this data coming from? • How do the metrics on site performance relate ultimately to how a site performs today? • Sharing these metrics on site selection with your sites

3:15 Country Feasibility and Global Site Selection Determining If Your Trial Can Be Run Within a Particular Country and Strategies for Selecting the Trial Countries and Sites

RossPettit,VicePresident,ClinicalOperations,AMAGPHARMACEUTICALS

RaymondPanas,PhD,DirectorofInternationalClinicalDevelopment,SUCAMPO PHARMACEUTICALS

• Determining if your protocol is doable in a particular country • What parameters determine which country is best to run your trial in? • Determining what mix of countries are needed • How do you assess site performance internationally? • Choosing the right CRO(s) to run a global trial

4:15 ROUNDTABLES: Unique Considerations for Working with Sites in Specific Regions and Global Patient Recruitment Planning Each roundtable addresses the following topics specific to the selected region:

• Cultural considerations with regard to patient recruitment in the relevant region • Regulatory and legal considerations • Informed consent and the language that should be used • Ethical issues in emerging countries

Roundtable moderators include:RossPettit,VicePresident,ClinicalOperations,AMAGPHARMACEUTICALSFidelaMoreno,MD,VicePresident,GlobalDevelopmentOperations,ALLERGANJosephKim,Director,ClinicalOperations,SHIREPHARMACEUTICALSRaymondPanas,PhD,DirectorofInternationalClinicalDevelopment,SUCAMPOPHARMACEUTICALS

12:00 Registration Opens for Main Conference

1:00 Chairperson’s Day One Welcome and Opening Remarks


Latin AmericaEastern Europe

Western EuropeSouth Africa

ChinaIndia

Select the preferred region to discuss in an intimate setting:

Main Conference Begins

Agenda Day One – Tuesday, March 1, 2011

8:00 Registration Opens & Continental Breakfast for Workshop Participants

9:00 Pre-Conference Workshop

10:30 Networking & Refreshment Break

12:00 Lunch for Workshop Attendees

Site Contracts A Step-By-Step Approach to Minimizing Delays Associated with Site Contracts To Speed Activation

ChristinaDiArchangelo,CEO,ARMONIACLINICALRESEARCH,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”


Agenda Day Two – Wednesday, March 2, 2011

9:00 Recruitment Feasibility Using Early Site Visits to Quantify the Site Selection and Assess if a Potential Site Can Enroll the Number of Patients Needed

JoePopowicz,AssociateDirector,ClinicalOperations,ORTHOVITA

• Tips to quantify site selection criteria during early visits

• Best practices to maximizing your study’s enrollment

• Employing contingency planning to reduce study delays

• Strategies for dealing with site performance during study conduct

1:30 Site Training Effectively Implementing Site Compliance Training to Streamline Site Activation and Eliminate Delays

MitchMelendez,Director,ClinicalResearchLearningandDevelopment,CELGENE

• What gap exists between the training sites currently receive and FDA expectations

• Properly training sites TODAY to be in compliance with FDA/ICH guidelines

• Successfully implementing virtual training programs

8:00 Continental Breakfast

8:30 Chairperson’s Recap of Day One

8:40 Key Points Addressed From Day One Roundtable Discussions


Main Conference Continues

11:00 Site Questionnaires Streamlining and Improving the Use of the Site Feasibility Questionnaire From Both a Site and Sponsor Perspective to Optimize its Effectiveness

Sponsor: ChrisConklin,GlobalTrialOptimization,MERCK&CO Site: ShaeOwens,RegulatoryAffairsCoordinator, KOOTENAICANCERCENTER

• What do feasibility questionnaires really tell us and are they effective?

• Steps sites can take to reduce the burden of work associated with the questionnaires

• How sponsors can standardize and simplify questionnaires

3:00 CLOSING PANEL DISCUSSION Top Reasons for Trial Startup Delays and How to Avoid Them

HeatherAlmonte,AssociateDirector,ClinicalOperations,OCTAPHARMA MiriamVerduzco,Director,PatientRecruitmentandSiteManagementServices,ALLERGAN SheilaGilbride-Wilson,VicePresident,ClinicalOperations,VERTEXPHARMACEUTICALS

• What are the most common mistakes that result in delays at study startup that sponsors make?

• Concrete strategies for addressing these mistakes

• How can sponsors work to ensure these mistakes are avoided?

• Technologies to speed the trial activation process

11:45 Sanofi-Aventis Case Study: Working with Medical Affairs Successful Strategies for Working with Medical Affairs/Regional Medical Liaisons to Gain More In Depth Feedback From Sites

FrankPlonski,AssistantDirector,TherapeuticStrategiesUnit,SANOFI-AVENTIS

• Best Practices for working with Medical Liaisons to gather feedback on country feasibility

• Working with Medical Liaisons/CRA’s to identify and recommend sites

• Working with Medical Affairs to get site feedback on future pipeline programs

• Lessons learned going forward


9:45 Allergan Case Study: Patient Recruitment Planning Successful Strategies for Implementing Patient Recruitment, Retention, and Contingency Plans

FidelaMoreno,MD,VicePresident,GlobalDevelopmentOperations,ALLERGAN MiriamVerduzco,Director,PatientRecruitmentandSiteManagementServices, ALLERGAN

• Best practices for implementing patient recruitment, retention, and contingency plans

• When should recruitment, retention, and contingency plans be implemented?

• Metrics and lessons learned from this program

12:30 Lunch

4:00 Conference Concludes

2:15 Sanofi-Aventis Case Study: Site Scorecards Successful Strategies Utilizing Site Scorecards to Optimize Site Performance

RichardRobinson,AssistantDirector,DiabetesandMetabolismGroup, SANOFI-AVENTIS

• 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

• Feedback received from sites

Five Ways to Register:

Fax: 888-221-6750

Mail: ExL Events, Inc. 555 8th Ave, Ste 310 New York, NY 10018

Phone: 866-207-6528

Online: www.exlpharma.com

Email: [email protected]

Registration Fees for Attending ExL’s 2nd Clinical Feasibility, Selection, and Startup Conference:

EARLY BIRD PRICINGRegister by Friday, January 14th to Take Advantage of Early Bird Pricing:

Site RateConference + Workshop $1495Conference Only $1195

Corporate RateConference + Workshop $1995Conference Only $1695

STANDARD PRICINGRegister After January 14th:

Site RateConference + Workshop $1695Conference Only $1395

Corporate RateConference + Workshop $2195Conference Only $1895

ONSITE PRICINGSite RateConference + Workshop $1795Conference Only $1495

Corporate RateConference + Workshop $2295

Conference Only $1995

Group Discount ProgramSave 25% per person when Registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time) this is a sav-ings 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 866-207-6528.

Make checks payable to ExL Events, Inc. and write code P807 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.

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 fax your request to 888-221-6750. There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within five business days of the conference.

Important: Discount offers may not be combined. Discounts only apply to standard rate.

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.*

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, Melissa Colella at [email protected]

Media Partners

Prices Increase After January 14th

To Register:ExL Events, Inc.555 8th Avenue, Suite 310New York, NY 10018

866-207-6528

888-221-6750

[email protected]

www.exlpharma.com/siteselection

Yes! Register me for the conference:Please contact me: I’m interested in marketing opportunities at this event I wish to receive email updates on ExL Pharma’s upcoming events

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555 8th Avenue, Suite 310New York, NY 10018Priority Code: P808DM

Questions? Comments?Contact Melissa Colella at 212-400-6239 or [email protected]

Speaking Faculty Includes Representation From:

MERCK & CO

VERTEX PHARMACEUTICALS

SHIRE PHARMACEUTICALS

SANOFI-AVENTIS

ELAN PHARMACEUTICALS

CELGENE

ALLERGAN

SUCAMPO PHARMACEUTICALS

OCTAPHARMA

ORTHOVITA

AMAG PHARMACEUTICALS

Presents

Optimizing Trial Performance and Reducing Pharmaceutical Costs Through Effective Identification and Activation of Sites and Enhancing Stakeholder CommunicationMarch 1-2, 2011Crowne Plaze Philadelphia DowntownPhiladelphia, PA

Clinical Site Feasibility, Selection, and Startup

2nd Annual

Clinical Site Feasibility, Selection, and Startup

2nd Annual

Optimizing Trial Performance and Reducing Pharmaceutical Costs Through Effective Identification and Activation of Sites and Enhancing Stakeholder CommunicationMarch 1-2, 2011Crowne Plaze Philadelphia DowntownPhiladelphia, PA

Featured Presentations: Allergan Case Study: Successful Strategies for Implementing Patient Recruitment, Retention, and Contingency Plans Fidela Moreno, MD, Vice President, Global Development Operations, ALLERGANMiriam Verduzco, Director, Patient Recruitment and Site Management Services, ALLERGAN

Sanofi-Aventis Case Study: Successful Strategies for Working with Medical Affairs/Regional Medical Liaisons to Gain More In Depth Feedback From SitesFrank Plonski, Assistant Director, Therapeutic Strategies Unit, SANOFI-AVENTIS

2nd Annual Clinical Site Feasibility, Selection, and Startup, March 2011, Philadelphia

Documents

Transcript of 2nd Annual Clinical Site Feasibility, Selection, and Startup, March 2011, Philadelphia