1. 1. 12013 Initiativesfor ProactiveQualityManagement
2. 2. 2 Accelerating the development of best practices andindustry standards for proactive quality management Bringing together quality, outsourcing, and operationalprofessionals from member pharma, biotech, and CROs Developing a new paradigm in the industrys approach toquality management and partnering to ensure high qualityand risk mitigation Led by The Avoca GroupThe Avoca Quality Consortium
3. 3. 3 Focus: Helping sponsors and CROs achieve success in thearea of clinical outsourcing Practice Areas: Consulting, Survey Research, Training Founded in 1999 in Princeton, NJAvoca provides their pharma, biotech, and CRO clients withthe strategy and tools to build, measure, manage, andthereby improve partnering relationships.The Avoca GroupAvoca History & Overview
4. 4. 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 lettersLed to the launch of a comprehensive industryassessment on quality practices in early 2011.This ultimately led to the formation of theAvoca Quality Consortium.State of the IndustryChanges have put pressure on the management of quality
5. 5. 5 The work of the Avoca Quality Consortium is in helpingcompanies optimize their approaches to proactive qualitymanagement with an emphasis on bringing sponsors andCROs into greater alignment. Our vision is for the QualityConsortium to serve as a catalyst for:The acceleration of best practices and industry standards forproactive quality management The initial focus was on the development of a QualityAgreement template and short list of Quality Metrics. Bothwere delivered to Consortium Members in July 2012.Avoca Quality ConsortiumFocus of Consortium
6. 6. 6Avoca Research & Leading Practices Avoca Research: Industry-widesurvey and opportunity tobenchmark individual Consortiumcompanies against larger sample Leading Practices: Development ofguidelines, tools, approaches,standards and templates focusedon proactive quality managementAvoca Research and the development of Leading Practices are the twopillars of the Avoca Quality Consortium that providethe foundation for our work.
7. 7. 7 Objective research: Providing insights to individual companies and settingQuality Consortium priorities Leading practices: Optimizing approaches to proactive qualitymanagement Collaboration: Pharma companies, biotech companies and CROsworking together to achieve common goals Engagement: Member involvement at the Executive as well as functionallevel; engagement with regulatory authorities to strive for mutualunderstanding and acknowledgement Implementation: Operationalizing approaches to proactive qualitymanagement Transparency: Sharing of information with other groups, organizations andindustry consortia to ensure no duplication of efforts Innovation: Focusing the Consortiums future priorities on out-of-the-boxapproaches; leading the way for industry breakthroughsConsortium Core Tenets
8. 8. 8ConsortiumMembership
9. 9. 99Avoca Quality ConsortiumPharma/Biotech Industry Participation to Date**Roche and Alexion Pharmaceuticals are also Consortium Members
10. 10. 1010Avoca Quality ConsortiumCRO Industry Participation to Date
11. 11. 11 Access to all Consortium documents via a password protected web portalincluding the Quality Agreement template and Quality Metrics documents(delivered to Members in 2012) Avoca Research Reports, the Consortium Assessment aggregate reportand a benchmarking report focused on quality practices tailoredspecifically for your company 2013 Guidelines for Proactive Quality Management; definition of terms;processes, approaches, roles, skills, structures, and tools for effectiveoversight Assessment results focused on Prequalification Visits and Routine Audits ofclinical suppliers Participation (for two attendees) at the May 2013 Quality Summit and FallWorking Sessions; company participation in the Consortium WebExMeetingsQuality Consortium MemberSummary of Benefits
12. 12. 12 Increased collaboration between pharma/biotech and CROsresulting in:Improved quality and greater predictabilitySimplification of processes; reduced duplicationReduced costMitigation of riskExchange of informationImproved relationshipsGreater respect for each others obligationsInnovative and efficient solutionsQuality Consortium MemberSummary of Benefits (continued)
13. 13. 13Plans and FocusAreas for 2013
14. 14. 142013 Focus Helping our Membersachieve the right balancebetween meeting timelines,ensuring cost containment,and achieving the highestlevel of quality
15. 15. 152013 Core ActivitiesFinalization and Refinement of 2012 Deliverables Continue research to finalize quality metrics Further enhancement of quality agreement based on memberexperiences2013 Consortium Research and Leading Practices Continued focus on proactive quality management and effectiveoversight of outsourced projects Provision of core concepts, guidelines, and practical tools Opportunity for collaboration through consortium meetingsForward-looking High Priority Initiatives Identification of areas for innovations building on existing work andfuture Consortium initiatives
16. 16. 16 Guidelines and tools for Proactive Quality Management and effectiveoversight Analysis of individual companys approaches to proactive qualitymanagement and effective oversight while keeping company-specificinformation confidential Research results that outlines industry approaches to prequalification offull-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 QualityAgreement template Assessments of technology enablers and strategies for operationalizingapproaches for proactive quality management Peer networking and sharing of best practices with consortium members atbi-annual Quality Summit2013 Deliverables
17. 17. 172013Avoca QualitySummit
18. 18. 18This conference focuses around the theme of Ensuring the RightBalance between Time, Cost, and Quality in this ChangingRegulatory Environment. Avoca data not presented in other publicforums will provide the basis for the Summit. May 8th meeting is a closed meeting for Members only May 9th is open to the industry2013 Quality Consortium SummitEvent Co-Chairs: Jeffrey Kasher, PhDVice President, Clinical Trial:Materials, Implementation, andTransformationEli Lilly and Company Christopher J. HiltonVice President, Development &Clinical Alliance ManagementPfizer Development Operations
19. 19. 19 Risk Assessment and Risk Management in OutsourcedClinical Trials The 2013 Avoca Report with a focus on stateof the industry and best practice approaches Two-part session on creating a culture of quality andchange management strategies for ensuring success Strategies for Ensuring Effective Oversight Industry "Call to Action": top areas and industry initiativesthat could make a significant impact in terms of achievinggreater efficiency while ensuring high quality2013 Quality Consortium SummitSummit Key Topic Areas
20. 20. 20Summit Sponsor:Supporting Sponsors:2013 Summit Sponsor Companies
21. 21. 21The Avoca Group, Inc.179 Nassau StreetSuite 3APrinceton, NJ 08542609-252-9020For information regarding new membershipfor Avocas Quality Consortium,please contact Danya BurakoffDanya.Burakoff@TheAvocaGroup.comFor existing members,please contact Caryn LaermerCaryn.Laermer@TheAvocaGroup.com