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

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

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

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

  • Prices Increase After January 14th Presents 2nd Annual ndClinical SiteFeasibility, Selection, and StartupOptimizing Trial Performance and Reducing PharmaceuticalCosts Through Effective Identification and Activation of Sitesand Enhancing Stakeholder CommunicationMarch 1-2, 2011Crowne Plaza Philadelphia DowntownPhiladelphia, PA SPEAKING FACULTY: Heather Almonte, Associate Director, Clinical Operations, OCTAPHARMA John Burnett, Consultant, Clinical ProgramFEATURED PRESENTATIONS AND CASE STUDIES: Manager, ELAN PHARMACEUTICALS Chris Conklin, Global Trial Optimization, MERCK & COAllergan Case Study: Patient Recruitment Planning Christina DiArchangelo, CEO, ARMONIASuccessful Strategies for Implementing Patient Recruitment, CLINICAL RESEARCH, LLCRetention, and Contingency Plans Daniela Franschman, Manager, Global TrialFidela Moreno, MD, Vice President, Global Development Operations, ALLERGAN Optimization, MERCK & COMiriam 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 MMGDetermining 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 PHARMACEUTICALSRoss Pettit, Vice President, Clinical Operations, AMAG PHARMACEUTICALS Lisa LaLuna, Senior Vice President Corporate Development & Implementation, ePHARMASOLUTIONSRaymond Panas, PhD, Director of International Clinical Development,SUCAMPO PHARMACEUTICALS Mitch Melendez, Director, Clinical Research Learning and Development, CELGENESanofi-Aventis Case Study: Working with Medical Affairs Fidela Moreno, MD, Vice President, Global Development Operations, ALLERGANSuccessful Strategies for Working with Medical Affairs/Regional Shae Owens, Regulatory Affairs Coordinator,Medical Liaisons to Gain More In Depth Feedback From Sites KOOTENAI CANCER CENTERFrank 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, TherapeuticSuccessful Strategies Utilizing Site Scorecards to Optimize Site Performance Strategies Unit, SANOFI-AVENTISRichard 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-AVENTISSponsored 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
  • 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 Managersof site feasibility, identification and selection, and startup and activation. at Pharmaceutical, Biotechnology, andThe overarching themes of global trials and improving stakeholder Medical Device companies from the following departments:communication are incorporated throughout the agenda. This re-focusedagenda allows for in depth presentations that address the issues those in Clinical Operationsthe industry struggle with daily. Clinical Research/Development Trial OptimizationThis conference is an excellent opportunity for enhanced networking and Site Selectioninteraction with both senior level representatives from sponsor companies Protocol Feasibilityand sites and for high level discussions on the issues. Investigator Recruitment Patient Enrollment/RecruitmentPlease join us in March in Philadelphia for this exciting meeting! Site Monitoring/ManagementSincerely, Clinical Data Analyst/Informatics AnalystMelissa Colella Clinical Quality Assurance Clinical Project/Study ManagersMelissa Colella CRA’sConference Producermcolella@exlpharma.com Regulatory Affairs Medical Affairs This conference is also of interest to SeniorKristen Hunter Level Representatives from Sites andTeam Leader, Event Production Representatives responsible for Feasibility,ExL Pharma Site Selection, Trial Optimization, and Patient Recruitment at CRO’s.HOTEL INFO Sponsorship and Exhibiting OpportunitiesCrowne PlazaPhiladelphia Downtown Do you want to spread the word about your organization’s solutions and services to potential1800 Market Street clients who will be attending this event? TakePhiladelphia, PA 19103 advantage of the opportunity to exhibit, presentTel: 215.561.7500 an educational session, host a networking event, or distribute promotional items to attendees. ExLRoom Reservations: will work closely with you to customize a packageIf you require overnight accommodations, please contact the Crowne Plaza Philadelphia Downtown that will suit all of your needs. To learn moreat 215-561-7500 to book your room. ExL has reserved a block of rooms at a discounted rate for about these opportunities, contact Ericconference 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 emailingthe 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
  • Agenda Day One – Tuesday, March 1, 20118:00 Registration Opens & Continental Breakfast for Workshop Participants9:00 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 Break12:00 Lunch for Workshop AttendeesMain Conference Begins 3:15 Country Feasibility and Global Site Selection Determining If Your Trial Can Be Run Within12:00 Registration Opens for Main Conference a Particular Country and Strategies for Selecting the Trial Countries and Sites1:00 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 PHARMACEUTICALS1:15 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
  • Agenda Day Two – Wednesday, March 2, 2011Main Conference Continues8:00 Continental Breakfast 11:45 Sanofi-Aventis Case Study: Working8:30 Chairperson’s Recap of Day One with Medical Affairs Successful Strategies for Working with Medical Affairs/Regional Medical Liaisons to Gain More8:40 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 feasibility9:00 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 expectations9:45 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 scorecard10:30 Networking & Refreshment Break • Feedback received from sites11:00 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
  • Five Waysto 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 beRegister 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, pleaseSite 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 aConference + 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 requestCorporate 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 colleagueConference 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 RateConference + Workshop $1695Conference Only $1395 Media PartnersCorporate RateConference + Workshop $2195Conference Only $1895ONSITE PRICINGSite RateConference + Workshop $1795Conference Only $1495Corporate RateConference + 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
  • To Register: ExL Events, Inc. 866-207-6528 Method of Payment: Check Credit Card 555 8th Avenue, Suite 310 Make checks payable to ExL Events, Inc. 888-221-6750 New York, NY 10018 Card Type: MasterCard Visa Discover Amex registration@exlpharma.com Card Number: Exp. Date: www.exlpharma.com/siteselection Name on Card:Yes! Register me for the conference:Please contact me: Signature: I’m interested in marketing opportunities at this event I wish to receive email updates on ExL Pharma’s upcoming events 555 8th Avenue, Suite 310 New York, NY 10018Name: Title: Priority Code: P808DMCompany:Dept.:Address:City: State: Zip:Email:Telephone: Fax:Questions? Comments?Contact Melissa Colella at 212-400-6239 or mcolella@exlpharma.com Prices Increase After January 14th Speaking Faculty Includes Representation From: Presents 2nd Annual nd MERCK & COClinical Site VERTEX PHARMACEUTICALS SHIRE PHARMACEUTICALSFeasibility, Selection, and StartupOptimizing Trial Performance and Reducing PharmaceuticalOptimizing 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 ALLERGANFeatured Presentations: SUCAMPO PHARMACEUTICALSAllergan Case Study: Successful Strategies for Implementing Patient Recruitment,Retention, and Contingency Plans OCTAPHARMAFidela Moreno, MD, Vice President, Global Development Operations, ALLERGANMiriam Verduzco, Director, Patient Recruitment and Site Management Services, ALLERGAN ORTHOVITASanofi-Aventis Case Study: Successful Strategies for Working with MedicalAffairs/Regional Medical Liaisons to Gain More In Depth Feedback From Sites AMAG PHARMACEUTICALSFrank Plonski, Assistant Director, Therapeutic Strategies Unit, SANOFI-AVENTIS