1Avoca Quality Consortium - Members Meeting - Agenda - Oct.7, 2014

Theme 1: Consortium Member experiences with utilization, adaptation, implementation, and socialization of Consortium best-practice guidelines and tools – Case Studies

Theme 2: 2014 Initiatives – Progress and execution status

Theme 3: Strategies and Focus for 2015

8:30 - 9:00Registration and Continental Breakfast

9:00 - 10:00Welcome and Overview of the Day, Brief Introduction of Attendees, Sharing of Consortium Tenets, Refresher of Consortium Initiatives, and Review of Pulse Survey Results

Patricia Leuchten, CEO, The Avoca GroupSteve Whittaker, Executive Director, Avoca Quality ConsortiumDemo: Debbie Briffa, Senior Project Manager, The Avoca Group

10:00 - 12:45Case Studies (Break Included)

During the Executive Meeting on May 7, 2014, Consortium Executive Sponsors suggested that it would be beneficial to learn from early adopter AQC Members’ experiences as they have implemented Consortium tools and initiatives.

10:00 - 10:30 Session 1a: Case Study 1 – Seattle Genetics; Use of the AQC Quality Agreement Template

Marta Fields, Senior Director, Clinical Operations, Seattle Genetics

Seattle Genetics is a biotechnology company located in the Pacific Northwest. With limited presence outside the US, CROs are used to support global clinical trials. The outsourcing is primarily functional, although recently Seattle Genetics has begun to fully outsource some studies. A Quality

FALL 2014: CONSORTIUM MEMBERS’ MEETING AGENDA Date: October 7, 2014

Philadelphia Marriott Downtown

2Avoca Quality Consortium - Members Meeting - Agenda - Oct.7, 2014

Agreement that would cover either scenario was desired. The modular approach of the Avoca Quality Agreement toolkit enabled Seattle Genetics to construct a workable Quality Agreement tailored to our specific needs within a very compressed timeline. Since our preferred partner, PRA, is also a Member of the Consortium, they were comfortable with the template language and minimal rework was required.

10:30 - 11:00 Break

11:00 - 11:45 Session 1b: Case Study 2 – inVentiv Health Clinical and Grünenthal GmbH; Development of Quality Agreement between CRO and Sponsor using the Avoca Quality Agreement Module

Fiona Blurton, MRQA, Senior Auditor, Quality Governance, inVentiv Health Clinical UK LtdJoseph Fortunato, Senior Vice President, Corporate Quality Assurance, inVentiv Health Clinical

Ever since the Avoca Quality Consortium completed work in melding together best practices from a myriad of expert sources, inVentiv Health Clinical was very eager to put into practice the Quality Agreement Module with a key Sponsor. This presentation and interactive discussion will discuss inVentiv’s experience in utilizing this module in the joint development of an effective, right-first-time, Quality Agreement. The discussion will include insight into the use of the Avoca tools and templates, along with helpful examples of lessons learned between inVentiv and the Sponsor in producing this final Quality Agreement.

11:45 - 12:15 Session 1c: Case Study 3 – Quality Oversight Best-Practice Tools by Amgen

Anne Merritt, Director of Global Supplier Governance and Clinical Pricing, Amgen

A specific technical issue at a central lab, which impacted multiple studies across a large Phase III program, will be outlined. This case study will describe how Amgen’s processes and tools were able to both detect and manage the issue to resolution. Lessons learned will also be shared, including how this type of issue would be specifically communicated and escalated within Amgen.

12:15 - 12:45 Session 1d: Case Study 4 – Use of Quality Metrics

Mark Penniston, Senior Vice President, Clinical Analytics, Theorem Clinical Research

Management by metrics is a challenge for any organization. As a service provider performing similar tasks on multiple platforms and systems, defining the data flow and appropriate metadata for centralized analysis proves to be a greater challenge. Theorem Clinical Research has embarked on the consolidation of information streams to generate a performance score card based upon Metrics Champion Consortium published standards. This presentation will describe the challenges and methodology to consolidate those items, the report services produced for the high level review, and a planned approach for utilization of the Avoca Quality Consortium metrics taxonomy.

12:45 - 1:45 Networking Lunch

3Avoca Quality Consortium - Members Meeting - Agenda - Oct.7, 2014

1:45 - 2:30 Post-lunch Challenge Questions

Table Moderators, The Avoca Group

Each participant will be asked to move to another table and pair up with someone they do not know. They will select a card from a “deck” at each table and take 5 minutes to discuss the topic on Side 1 of the card. Then they will flip the card over and fill in the blank(s) for the item on Side 2 of the card. Participants will provide brief read-outs of their partnered discussions.

2:30 - 3:30Session 2: Transforming Supplier Prequalification for the Future - Technical Service Providers Initiative Deliverables and Next Steps

2:30 - 2:45Janis Hall, Senior Consultant, The Avoca Group

A short presentation will be provided sharing the progress to date for Phase 0 and Phase 1 of the Consortium Prequalification Initiative. Significant accomplishments have been achieved by The Avoca Quality Consortium staff members in partnership with the Prequalification Advisory Board in establishing Core and Niche Industry Standards, and in developing associated tools (RFI templates, Score Cards, and Visit Check Lists for the selected specialty service areas: Central Laboratories, IRT (IVRS/IWRS), Medical Imaging, Biomarker Labs, and ECG Services.

2:45 - 3:30Table Moderators, The Avoca Group

An interactive working session at group tables will focus on reviewing Prequalification Packages (Full Set of Standards and Tools): Each table will be provided a matching set of tools and standards for a technical service (core, central lab, IRT, imaging or ECG). Members will look at the materials as a “prequalification assessment” package and provide feedback on the strengths and weaknesses of any of the materials and identify gaps. They will discuss how the new Industry Standards will benefit industry and their organizations. A debrief session will share their ideas and plans.

3:30 - 3:50 Break

3:50 - 4:15 Session 3: Additional Project News and Updates

3:50 - 4:05Diligent Project

Patricia Leuchten, CEO, The Avoca Group Dennis Salotti, Vice President, Operations, The Avoca Group

The Avoca Group has been developing concepts for an expanded Prequalification service being named “Diligent”. This session will briefly share the vision, concepts, principles, and considerations for this strategic initiative.

4Avoca Quality Consortium - Members Meeting - Agenda - Oct.7, 2014

4:05 - 4:15Quality Metrics and Benchmarking Initiative

Steve Whittaker, Executive Director, Avoca Quality Consortium Background information will be presented regarding Avoca Quality Consortium Quality Metrics and perspectives, based on additional research and investigation. An update will be provided on the metrics database and plans to engage the Executive Forum on October 23 regarding next steps.

4:15 - 4:55Session 4: Strategies and Focus for 2015

Moderators: Patricia Leuchten, CEO, The Avoca Group Steve Whittaker, Executive Director, Avoca Quality Consortium

Review of potential 2015 initiatives based on pulse survey and 2014 Consortium Assessment results

Theme 1: Leveraging the Power of the Consortium for Implementation, Knowledge Transfer and Learning, The Consortium Community

Theme 2: Innovation and Transformation: Protocol Quality through Patient Engagement, QbD Principles, and Root Cause Solutions

4:55 - 5:00 Close of Event