1
2013 Initiatives for Proactive
Quality Management
2
●Accelerating the development of best practices and industry standards for proactive quality management
●Bringing together quality, outsourcing, and operational professionals from member pharma, biotech, and CROs
●Developing a new paradigm in the industry’s approach to quality management and partnering to ensure high quality and risk mitigation
●Led by The Avoca Group
The Avoca Quality Consortium
3
●Focus: Helping sponsors and CROs achieve success in the area of clinical outsourcing
●Practice Areas: Consulting, Survey Research, Training●Founded in 1999 in Princeton, NJ
Avoca provides their pharma, biotech, and CRO clients with the strategy and tools to build,
measure, manage, and thereby improve partnering relationships.
The Avoca Group
Avoca History & Overview
4
●Increase in clinical outsourcing●Consolidation of spend with fewer clinical service
providers●Globalization of clinical trials●Greater protocol complexity●Industry focus on efficiencies and cost savings●Increase in the number of high-profile FDA warning
letters
Led to the launch of a comprehensive industry assessment on quality practices in early 2011. This ultimately led to the formation of the Avoca Quality Consortium.
State of the Industry
Changes have put pressure on the management of quality
5
●The work of the Avoca Quality Consortium is in helping companies optimize their approaches to proactive quality management with an emphasis on bringing sponsors and CROs into greater alignment. Our vision is for the Quality Consortium to serve as a catalyst for:
╸ The acceleration of best practices and industry standards for proactive quality management
●The initial focus was on the development of a Quality Agreement template and short list of Quality Metrics. Both were delivered to Consortium Members in July 2012.
Avoca Quality Consortium
Focus of Consortium
6
Avoca Research & Leading Practices
●Avoca Research: Industry-wide survey and opportunity to benchmark individual Consortium companies against larger sample
●Leading Practices: Development of guidelines, tools, approaches, standards and templates focused on proactive quality management
Avoca Research and the development of Leading Practices are the two pillars of the Avoca Quality Consortium that
provide the foundation for our work.
7
● Objective research: Providing insights to individual companies and setting Quality Consortium priorities
● Leading practices: Optimizing approaches to proactive quality management
● Collaboration: Pharma companies, biotech companies and CROs working together to achieve common goals
● Engagement: Member involvement at the Executive as well as functional level; engagement with regulatory authorities to strive for mutual understanding and acknowledgement
● Implementation: Operationalizing approaches to proactive quality management
● Transparency: Sharing of information with other groups, organizations and industry consortia to ensure no duplication of efforts
● Innovation: Focusing the Consortium’s future priorities on “out-of-the-box” approaches; leading the way for industry breakthroughs
Consortium Core Tenets
8
Consortium Membership
9 9
Avoca Quality Consortium Pharma/Biotech Industry Participation to Date
**Roche and Alexion Pharmaceuticals are also Consortium Members
10 10
Avoca Quality ConsortiumCRO Industry Participation to Date
11
● Access to all Consortium documents via a password protected web portal including the Quality Agreement template and Quality Metrics documents (delivered to Members in 2012)
● Avoca Research Reports, the Consortium Assessment aggregate report and a benchmarking report focused on quality practices tailored specifically for your company
● 2013 Guidelines for Proactive Quality Management; definition of terms; processes, approaches, roles, skills, structures, and tools for effective oversight
● Assessment results focused on Prequalification Visits and Routine Audits of clinical suppliers
● Participation (for two attendees) at the May 2013 Quality Summit and Fall Working Sessions; company participation in the Consortium WebEx Meetings
Quality Consortium Member
Summary of Benefits
12
●Increased collaboration between pharma/biotech and CROs resulting in:
╸ Improved quality and greater predictability
╸ Simplification of processes; reduced duplication
╸ Reduced cost
╸ Mitigation of risk
╸ Exchange of information
╸ Improved relationships
╸ Greater respect for each other’s obligations
╸ Innovative and efficient solutions
Quality Consortium Member
Summary of Benefits (continued)
13
Plans and Focus Areas for 2013
14
2013 Focus
●Helping our Members achieve the right balance between meeting timelines, ensuring cost containment, and achieving the highest level of quality
15
2013 Core Activities
Finalization and Refinement of 2012 Deliverables● Continue research to finalize quality metrics
● Further enhancement of quality agreement based on member experiences
2013 Consortium Research and Leading Practices● Continued focus on proactive quality management and effective
oversight of outsourced projects
● Provision of core concepts, guidelines, and practical tools
● Opportunity for collaboration through consortium meetings
Forward-looking High Priority Initiatives● Identification of areas for innovations building on existing work
and future Consortium initiatives
16
● Guidelines and tools for Proactive Quality Management and effective oversight
● Analysis of individual company’s approaches to proactive quality management and effective oversight while keeping company-specific information confidential
● Research results that outlines industry approaches to prequalification of full-service CROs and niche providers
● Complete assessment on approaches to assessing and managing risk; aggregate report and individual benchmarking report
● Refined work in the area of Quality Metrics and the joint Quality Agreement template
● Assessments of technology enablers and strategies for operationalizing approaches for proactive quality management
● Peer networking and sharing of best practices with consortium members at bi-annual Quality Summit
2013 Deliverables
17
2013 Avoca Quality
Summit
18
This conference focuses around the theme of Ensuring the Right Balance between Time, Cost, and Quality in this
Changing Regulatory Environment. Avoca data not presented in other public forums will provide the basis for the
Summit.
●May 8th meeting is a closed meeting for Members only
●May 9th is open to the industry
2013 Quality Consortium Summit
Event Co-Chairs:
●Jeffrey Kasher, PhDVice President, Clinical Trial: Materials, Implementation, and Transformation
Eli Lilly and Company
●Christopher J. HiltonVice President, Development & Clinical Alliance Management
Pfizer Development Operations
19
●Risk Assessment and Risk Management in Outsourced Clinical Trials – The 2013 Avoca Report with a focus on state of the industry and best practice approaches
●Two-part session on creating a culture of quality and change management strategies for ensuring success
●Strategies for Ensuring Effective Oversight●Industry "Call to Action": top areas and industry
initiatives that could make a significant impact in terms of achieving greater efficiency while ensuring high quality
2013 Quality Consortium Summit
Summit Key Topic Areas
20
Summit Sponsor:
Supporting Sponsors:
2013 Summit Sponsor Companies
21
The Avoca Group, Inc.179 Nassau Street
Suite 3APrinceton, NJ 08542
609-252-9020
For information regarding new membership for Avoca’s Quality Consortium, please contact Danya Burakoff
For existing members, please contact Caryn Laermer
Recommended
