Avoca Quality Consortium Summit May 9 Agenda
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  • 1. Page 1 of 5Avoca Quality Summit – Agenda – May 9, 2013      AVOCA QUALITY SUMMITThe Westin Princeton at Forrestal Village201 Village BoulevardPrinceton, NJ 08540AgendaMAY 9th 2013  8:00 AM - 9:00 AMRegistration and Continental Breakfast9:00 AM - 9:10 AMWelcome and OverviewPatricia Leuchten, CEO, The Avoca Group  9:10  AM  -­‐9:40  AM  Introductory Remarks§ Stephen Cutler, Ph.D., Group President, ICON Clinical Research Services§ Christopher J. Hilton, Vice President, Development & Clinical AllianceManagement, Pfizer Development Operations§ Jeffrey Kasher, Ph.D., Vice President, Clinical Trial: Materials, Implementationand Transformation, Eli Lilly and CompanyAn overview of efforts to enhance quality in the industry and the mission for the day.  9:40 AM -9:50 AMSession 1: Ann Meeker-O’Connell, Acting Division Director, Good Clinical PracticeCompliance, US FDA (via Skype)Ann Meeker-OConnell will provide her insights on strategies for ensuring effectiveoversight of outsourced clinical trials.
  • 2. Page 2 of 5Avoca Quality Summit – Agenda – May 9, 2013    9:50 AM -10:50 AMSession 2: Strategies for Ensuring Effective OversightIn this two-part session, interim results from work done to date on creating guidelines forproactive quality management and effective oversight will be presented. This will befollowed by an Executive Roundtable comprised of both sponsor companies and CROswho will discuss approaches for ensuring appropriate levels of oversight and collaboration.Moderator: Steven Whittaker9:50 - 10:05 – Presentation: Avoca Interim Results: Steven Whittaker, Director, AvocaQuality Consortium, The Avoca Group10:05 - 10:50 – Executive Roundtable DiscussionParticipants:§ Mike Collins, Vice President, Global Clinical Operations, AlexionPharmaceuticals§ Stephen Cutler, Ph.D., Group President, ICON Clinical Research Services§ James D. Esinhart, Ph.D., CEO, Chiltern International§ Christopher J. Hilton, Vice President, Development & Clinical AllianceManagement, Pfizer Development Operations§ Jeffrey Kasher, Ph.D., Vice President, Clinical Trial: Materials, Implementationand Transformation, Eli Lilly and Company10:50 AM -11:00 AMBreak11:00 AM -11:10 AMSession 3: Ann Meeker-O’Connell, Acting Division Director, Good Clinical PracticeCompliance, US FDA (via Skype)Ann Meeker-OConnell will provide her insights on risk assessment and risk management ofoutsourced clinical trials.11:10 AM -12:10 PMSession 4: Risk Assessment and Risk Management in Outsourced Clinical TrialsIn this two-part session, attendees will be given an overview of data collected to date byAvoca around the state of the industry and best practices. There will then be an ExecutiveRoundtable discussion between thought leaders from sponsor companies and CROs focusedon identifying best practices.
  • 3. Page 3 of 5Avoca Quality Summit – Agenda – May 9, 2013  Session 4: Risk Assessment and Risk Management in Outsourced Clinical Trials (continued)Moderator: Steven Whittaker11:10 - 11:25 – Highlights from Avoca’s 2013 industry research on Risk Assessment,Risk Management in Outsourced Clinical Trials. Denise Calaprice-Whitty, Ph.D.,Executive Director, Survey Research and Relationship Management Programs, TheAvoca Group11:25 - 12:10 – Executive RoundtableParticipants:§ Merry Chu, Director, Medical Quality, Regional and Third Party Management,Eli Lilly Canada Inc.§ Heather Jorajuria, Global Head, Product Development, Quality Assurance,F. Hoffmann-La Roche, Ltd. and Genentech, Inc.§ Margaret Keegan, Senior Vice President & Global Head, Integrated Processesand Technologies, Quintiles§ Jeffrey A. Kueffer MBA, PMP, Senior Vice President , Global OperationsManagement, INC Research®§ Angelika Tillmann FRQA, Vice President Global Clinical Quality Assurance &Compliance, General Manager Europe, Theorem Clinical Research12:10 PM -1:00 PMLunch1:00 PM -2:00 PMSession 5: Master Class in Leading ChangePeter Bregman, CEO, Bregman Partners, Inc.Peter Bregman will lead an interactive working session on change management, providinginsights into “The How” a company can work to create a culture of quality.2:00 PM -3:00 PMSession 6: Creating a Culture of QualityIn this interactive, two-part session, the attendees will be provided with a sense of what a“culture of quality” involves, an overview of the approaches used to establish this culturewithin organizations and what gaps and opportunities the industry faces. This will beaccomplished through a presentation followed by an Executive Roundtable.2:00 - 2:20 – Presentation: Components that Comprise a Culture of Quality: MargaretDavis, President, Margaret Davis Consulting2:20 - 3:00 – Executive RoundtableModerator: Steven Whittaker
  • 4. Page 4 of 5Avoca Quality Summit – Agenda – May 9, 2013  Session 6: Creating a Culture of Quality (continued)Participants:§ Hazel Collie, Vice President, Head of Global Compound Development Quality& Systems, Grünenthal GmbH§ Margaret Davis, President, Margaret Davis Consulting§ James Dixon, Senior Vice President, Global Quality and Compliance, PPD§ Mitchell Katz, Ph.D., Executive Director, Medical Research Operations, PurduePharma L.P.3:00 PM -4:00 PMSession 8: Crowdsourcing SolutionsFacilitator: Marc Monseau, Managing Partner, Mint CollectiveAttendees will be asked for their help to tackle a key topic covered during the previoussessions. Each attendee will be asked to join one of six groups who will be lead through acrowdsourcing methodology to identify new approaches that could be developed into atangible solution for a dilemma many organizations in the industry face in their efforts toensure quality.4:00 PM -5:00 PMSession 9: Industry “Call to Action”Through a roundtable discussion, industry thought leaders will discuss what has been doneto date and what more has to be accomplished in 2013 and beyond to achieve the goals ofenhancing quality in outsourced clinical trials.Moderators: Marc Monseau, Steven WhittakerParticipants:§ Stephen Cutler, Ph.D., Group President, ICON Clinical Research Services§ Christopher J. Hilton, Vice President, Development & Clinical AllianceManagement, Pfizer Development Operations§ Jeffrey Kasher, Ph.D., Vice President, Clinical Trial: Materials, Implementationand Transformation, Eli Lilly and Company§ Harris Koffer, Pharm.D., President, Research Pharmaceutical Services, Inc.§ Jeffrey P. McMullen, Vice Chairman, inVentiv Health, Inc.§ John G. Potthoff, Ph.D., President and CEO, Theorem Clinical Research
  • 5. Page 5 of 5Avoca Quality Summit – Agenda – May 9, 2013  5:00 PM - 5:15 PMClosePatricia Leuchten, The Avoca GroupMarc Monseau, MDM ConsultingSteven Whittaker, The Avoca GroupAn overview of what was discussed during the day and insights into what the future couldhold.5:15 PM -6:45 PMCocktail Reception