Page 1 of 5 Avoca Quality Summit – Agenda – May 9, 2013  

 

 AVOCA QUALITY SUMMIT

The Westin Princeton at Forrestal Village 201 Village Boulevard Princeton, NJ 08540

Agenda

MAY 9th 2013   8:00 AM - 9:00 AM Registration and Continental Breakfast 9:00 AM - 9:10 AM Welcome and Overview Patricia 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 Alliance

Management, Pfizer Development Operations § Jeffrey Kasher, Ph.D., Vice President, Clinical Trial: Materials, Implementation

and Transformation, Eli Lilly and Company

An overview of efforts to enhance quality in the industry and the mission for the day.  9:40 AM -9:50 AM Session 1: Ann Meeker-O’Connell, Acting Division Director, Good Clinical Practice Compliance, US FDA (via Skype) Ann Meeker-O'Connell will provide her insights on strategies for ensuring effective oversight of outsourced clinical trials.

Page 2 of 5 Avoca Quality Summit – Agenda – May 9, 2013  

  9:50 AM -10:50 AM Session 2: Strategies for Ensuring Effective Oversight In this two-part session, interim results from work done to date on creating guidelines for proactive quality management and effective oversight will be presented. This will be followed by an Executive Roundtable comprised of both sponsor companies and CROs who will discuss approaches for ensuring appropriate levels of oversight and collaboration. Moderator: Steven Whittaker

9:50 - 10:05 – Presentation: Avoca Interim Results: Steven Whittaker, Director, Avoca Quality Consortium, The Avoca Group 10:05 - 10:50 – Executive Roundtable Discussion

Participants:

§ Mike Collins, Vice President, Global Clinical Operations, Alexion Pharmaceuticals

§ 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 Alliance

Management, Pfizer Development Operations § Jeffrey Kasher, Ph.D., Vice President, Clinical Trial: Materials, Implementation

and Transformation, Eli Lilly and Company

10:50 AM -11:00 AM Break 11:00 AM -11:10 AM Session 3: Ann Meeker-O’Connell, Acting Division Director, Good Clinical Practice Compliance, US FDA (via Skype) Ann Meeker-O'Connell will provide her insights on risk assessment and risk management of outsourced clinical trials. 11:10 AM -12:10 PM Session 4: Risk Assessment and Risk Management in Outsourced Clinical Trials In this two-part session, attendees will be given an overview of data collected to date by Avoca around the state of the industry and best practices. There will then be an Executive Roundtable discussion between thought leaders from sponsor companies and CROs focused on identifying best practices.

Page 3 of 5 Avoca Quality Summit – Agenda – May 9, 2013  

Session 4: Risk Assessment and Risk Management in Outsourced Clinical Trials (continued) Moderator: Steven Whittaker

11:10 - 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, The Avoca Group 11:25 - 12:10 – Executive Roundtable

Participants:

§ 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 Processes and Technologies, Quintiles

§ Jeffrey A. Kueffer MBA, PMP, Senior Vice President , Global Operations Management, INC Research®

§ Angelika Tillmann FRQA, Vice President Global Clinical Quality Assurance & Compliance, General Manager Europe, Theorem Clinical Research

12:10 PM -1:00 PM Lunch 1:00 PM -2:00 PM Session 5: Master Class in Leading Change Peter Bregman, CEO, Bregman Partners, Inc. Peter Bregman will lead an interactive working session on change management, providing insights into “The How” a company can work to create a culture of quality. 2:00 PM -3:00 PM Session 6: Creating a Culture of Quality In 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 culture within organizations and what gaps and opportunities the industry faces. This will be accomplished through a presentation followed by an Executive Roundtable. 2:00 - 2:20 – Presentation: Components that Comprise a Culture of Quality: Margaret Davis, President, Margaret Davis Consulting 2:20 - 3:00 – Executive Roundtable Moderator: Steven Whittaker

Page 4 of 5 Avoca 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, Purdue

Pharma L.P. 3:00 PM -4:00 PM Session 8: Crowdsourcing Solutions Facilitator: Marc Monseau, Managing Partner, Mint Collective Attendees will be asked for their help to tackle a key topic covered during the previous sessions. Each attendee will be asked to join one of six groups who will be lead through a crowdsourcing methodology to identify new approaches that could be developed into a tangible solution for a dilemma many organizations in the industry face in their efforts to ensure quality. 4:00 PM -5:00 PM Session 9: Industry “Call to Action” Through a roundtable discussion, industry thought leaders will discuss what has been done to date and what more has to be accomplished in 2013 and beyond to achieve the goals of enhancing quality in outsourced clinical trials. Moderators: Marc Monseau, Steven Whittaker Participants:

§ Stephen Cutler, Ph.D., Group President, ICON Clinical Research Services § Christopher J. Hilton, Vice President, Development & Clinical Alliance

Management, Pfizer Development Operations § Jeffrey Kasher, Ph.D., Vice President, Clinical Trial: Materials, Implementation

and 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

Page 5 of 5 Avoca Quality Summit – Agenda – May 9, 2013  

5:00 PM - 5:15 PM Close Patricia Leuchten, The Avoca Group Marc Monseau, MDM Consulting Steven Whittaker, The Avoca Group An overview of what was discussed during the day and insights into what the future could hold. 5:15 PM -6:45 PM Cocktail Reception