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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.

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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.

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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

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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

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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