Centralization of Technical Service Provider Prequalification: The Avoca Diligent Central RFI Program

Transcription

1 Centralization of Technical Service Provider Prequalification: The Avoca Diligent Central RFI Program This session is being recorded June White, Bristol-Myers Squibb James McSweeney, ICON Dennis Salotti, The Avoca Group Janis Hall, The Avoca Group 23August2016

2 Webinar Speakers June White MBA, Associate Director, Central Clinical Services, R&D Operations, Bristol-Myers Squibb James McSweeney, PhD, MBA, Vice President and Global Head for Proposals and Business Information, ICON plc Dennis Salotti MBA, Vice President of Operations, The Avoca Group Janis Hall MBA, Senior Consultant, The Avoca Group 2

3 The Avoca Group Avoca Quality Consortium (AQC) Integrated Research & Consulting Diligent Platform (NEW) Pharma Industry Focus: Clinical Research/Clinical Outsourcing The Avoca Group pillars: Integrated Research and Consulting, the Avoca Quality Consortium, and the new Diligent Platform Avoca development of Diligent Platform to support Industry with centralized approaches to prequalification of technical service providers 3

4 Avoca Quality Consortium (AQC) The AQC brings together quality, outsourcing and operational professionals from Member companies to accelerate the development of leading practices and industry standards for proactive quality management and risk mitigationin clinical research. Avoca Research Avoca Quality Consortium Industry Leading Practice >60 Member Companies (Sponsors, CROs, Clinical Service Providers) Avoca Research: Gathering of quantitative and qualitative data from Members; provision of aggregate data and individual benchmarking reports. Leading Practices: Development of guidelines, tools, approaches, standards and templates focused on proactive quality management. Collaboration Proactive Approaches 4

5 2016 AQC Members: Pharma and Biotech 5

6 2016 AQC Members: CROs and Associate Members Longboat 6

7 Executive Summary: Provider Prequalification The Avoca Quality Consortium (AQC) Members expressed interest (2012) in research and development of centralized approaches to Provider Prequalification to minimize risk, lower costs, and reduce inefficiency and duplication of effort Avoca delivers Avoca Research Report: Prequalification/Routine Audits of Providers and data to industry (2013) AQC Prequalification Advisory Board delivers Prequalification Industry Standards and Tools ( ) for Core and 7 Technical Service requirements Diligent Centralized PrequalificationPlatform operationalized ( ) Central RFI Repository (crfi) 2016 launch- Through collection and central storage of completed RFIs requesters will have rapid access to RFI information to enable baseline provider evaluation without changes to their internal prequalification process Centralized Prequalification Audits (cpqa) Piloting- AQC Member s interest in other centralization options triggers creation of a shared platform for centralized prequalification audits Benefits: Efficiency, Flexibility, Quality, Lower Risk, Lower Cost, Shortened time to onboard providers 7

8 Avoca Quality Consortium and 2012 Industry Research Focus on Prequalification Visits and Routine Audits- 30 page report to industry 8

9 Prequalification: Essential, yet Dysfunctional Prequalification is an area of dysfunction in the industry; it is inefficient, inconsistent and its relationship to quality outcomes is not well understood The volume of provider qualification and requalification audits continues to trend upward, fueled by increased outsourcing, increased innovation and growth in the pipeline of medicines in development Providers and Sponsors suffer negative cost and resource implications due to duplicative efforts, and realize an opportunity cost in the absence of a better model Avoca research indicates Sponsors, CROs and Providers are interested in improving the current state Results of the Avoca Quality Consortium s assessment of Prequalification visits and routine systems audits; MAY 2013

10 AQC Pulse Check Survey on Prequalification (2013) Survey Question: The Avoca Quality Consortium is considering the potential to establish a mechanism to share information regarding the prequalification of ancillary providers as part of an initiative to reduce costs, introduce efficiencies and mitigate risk in the prequalification of these providers. Would you support this initiative? 11% Yes No 89% 10 N=38 AQC Companies (Sponsors and CROs)

11 The Vision for the Future Transformation in the way the industry prequalifies their technical providers to improve quality and efficiency in clinical trials. Standardize Standardization Industry Standards and Tools Centralize Centralization: Collect and centrally store completed RFIs and audit reports Optimization: Build upon central sharing using data analytics Optimize 11

12 Prequalification Advisory Board Companies: Amgen Astellas Baxalta Baxter BMS Chiltern Daiichi Sankyo Endocyte ICON INC Lilly Advisory Board Member Company Representation Merck Nektar Novartis PPD Premier Purdue Quintiles Sanofi Seattle Genetics Takeda Theorem 12 Participation by 22 Advisory Board Member Companies (15 Biopharm, 7 CROs)

13 AQC Prequalification Initiative Eight standardized Prequalification Packages*: Core Requirements Central Laboratories IxRS Services Central ECG Services Medical Imaging Services Biomarker Laboratories Bioanalytical Laboratories Clinical Outcome Assessment Providers 13 *Each includes a set of Industry Standards, RFI template, Score Card, and Visit Check List

14 AQC Prequalification Initiative and Diligent Prequalification Platform AQC Focus: Prequalification Standards and Tools Diligent Focus: Centralization of Prequalification Activities AQC Prequalification Standards Prequalification Tools Updates to PQ Standards as Regulations Change Central RFI Repository* Diligent Centralized Prequalification Audits Data Repository and Data Analytics 14

15 2016 Launch- Diligent Centralized RFIs Status* Achieving the Vision Building the Diligent Repository 42 Completed RFIs 14 Participating Providers Pipeline of Additional Potential Provider Participants 36 additional Providers at various stages of discussion or execution Potential to add up to 95 additional completed RFIs Distribution of Completed RFIs to Requesting Companies 12 companies submitted requests for completed RFIs 128 RFIs requested 31 RFIs sent out 15 *as of 19Aug2016

16 Diligent Participating Providers and Completed RFIs Companies/Services Core Central BioAnalytical BioMarker IxRS/ Lab Lab Lab IRT Imaging ECG COA Total RFIs Almac Banook- Cardiabase ** ** ** 0 Agreement pending* Agreement pending* Bracket ** ** 0 Cancer Genetics ** 1 1 Covance Clinical Reference Lab (CRL) Eurofins 1 1 ** ** 2 Exco Intouch ** ** 0 FlowMetric ** ** 0 icardiac ** ** ** 0 ICON Intrinsic Imaging IXICO Kayentis ** ** 0 New York Genome Center Pacific Biomarkers ** ** 0 PPD Precision for Medicine ** ** 0 Q2 Solutions Worldwide Clinical Trials WriteResult ** ** 0 YPrime Total RFIs * RFIs received, agreement pending ** 10 additional agreements signed leading to 23 incoming Pipeline of 36 companies at various stages of review (potential for >75 more RFIs) 16 Strong pipeline of additional participating providers

17 Industry Perspective: (Sponsor and Provider): June White at Bristol-Myers Squibb James McSweeneyat ICON plc 17

18 Industry Perspective: Sponsor and Provider Challenges Meeting expectations What are the regulators expecting of sponsors? What are senior leaders expecting of their staff/ teams? (Sponsor side and Provider side) What are sponsors expecting of providers? What are we doing? How have we been doing it? What was working well? What was not working so well? Resource challenges How do we operate in a cost cutting environment and do more with less? How do we improve productivity and remain headcount neutral environment (or cut back on resources?)? Balancing priorities Where do we prioritize our limited resources? Should our operational resources focus on implementing clinical trials? How much can we expect them to divert focus to assess providers/respond to RFI requests? 18

19 Industry Perspective: Sponsor and Provider Challenges Assessor s expertise Do sponsors have technical expertise for all service areas? Are sponsors able to stay current with evolving and new technologies (technical and regulatory knowledge)? Do providers find that some sponsor s assessors don t have sufficient knowledge of the technical requirements? Critical Competencies vs. Core Competencies Where do Sponsors WANT to build and maintain expertise? Where can/should Sponsors rely on using external sources of expertise? What can Providers do to support need for and supply external expertise? Pre-competitive collaboration Can challenges be met by leveraging industry leading practices? Where can we partner to share and learn leading practices? Where can we partner with others to avoid duplication of effort? Is risk aversion preventing adoption of new approaches? 19

20 Sponsor Perspective: Bristol-Myers Squibb Sponsor Organizational Challenges and Needs One sponsor representative: My challenges A group of one for oversight of all Scientific/analysing Laboratory Service Providers (>20 Preferred Laboratory Service Providers) Changing technologies (especially biomarkers) Increasing expectations for supporting development programs Managing time; Managing risk Establishing and maintaining positive provider relationships Supporting internal teams to navigate provider performance and quality challenges 20

21 Sponsor Perspective: Bristol-Myers Squibb Sponsor Organizational Challenges and Needs Core Competency/Critical Capability/Non-Core Competency Core competency- research and drug development, launch, life cycle support Critical capability critical as supporting function to core competency; total compliance with FDA/HA regulations; critical function to maintain leading edge Non-core competencies potential to use available expertise outside BMS i.e. typical outsourcing model Large Sponsor company units/functions Shared responsibility for scientific lab selection Scientific community Clinical team Operations Quality Assurance Regulatory Procurement/Finance Outsourcing/Alliance Management Emphasis depends on goal or organization 21

22 Provider Perspective: ICON plc Provider Organizational Challenges and Needs One provider representative: My challenges Volume and range of requests for information Volume >1000 requests per year Network across each business unit to get access to expert input Traditional CRO (Trial set up, execution, data analysis and reporting) Central, Biomarker and Bioanalytical Laboratory IxRS, Medical Imaging and ecoa Services Variability of requests for information Types of Requests request for basic capability and demographic information Highly structured comprehensive (>20 page) questionnaires. Purpose of requests Simple information needs to consider for a study Application for strategic alliance partnerships Requests cover many of the same topics, but often in slightly different ways - limited opportunity for efficiencies to recycle RFI responses 22

23 Provider Perspective: ICON plc Provider Organizational Challenges and Needs Provider Challenges-Billable vs. Non-Billable resources Individuals assigned to respond to RFI requests are not billable (SG&A) Time to respond to requests is cost of doing business (expense hits bottom line) Imperative to drive efficiencies RFIs may require input/support by internal experts (i.e. billable staff) (impacts revenue- hits the top line) Internal Senior Management pressure to reduce expenses (SG&A) maximize leveraging billable staff Client expectations and Provider VALUE Clients want providers (outsourcing) to be a cost efficient strategic option Clients expect providers to be experts in maximizing efficiencies Providers (and Sponsors) want to reduce the time and cost of clinical research 23

24 Sponsor Perspective: Bristol-Myers Squibb Sponsor Meeting these Challenges Membership in the Avoca Quality Consortium (AQC) Collaboration with 60+ other companies facing the same challenges. Networking and learning from each other Member representation on Prequalification Advisory Board BMS representative invited to join Advisory Board Attended meetings; built awareness of source of industry standards Access to leading practice tools and industry experts on Advisory Board Evaluation of Diligent Central RFI Program Working internally to evaluate and adopt where appropriate Evaluate AQC standards for Core requirements vs. BMS requirements 24

25 Sponsor Perspective: Bristol-Myers Squibb Sponsor Meeting these Challenges Early adopter of the Avoca Diligent Program Used Avoca Introductory Message for outreach (first set of 4 providers) Sent Diligent Core RFI (for core requirements) and Biomarker Lab RFI Sent BMS custom internal capability questionnaire Avoca-held WebEx meetings with 3 of these companies Outreach expanded to 4 more providers Avoca held one WebEx meeting with 1 company Avoca met at DIA with 2 companies on BMS list BMS added 2 more providers via Diligent agreement 25

26 Provider Perspective: ICON plc Provider Meeting these Challenges Membership in the Avoca Quality Consortium (AQC) in 2013 Collaboration with 60+ other companies facing the same challenges. Networking and learning from each other Member representation on Prequalification Advisory Board ICON representative invited to join Advisory Board Attended meetings contributed to development of industry standards ICON invited by Sponsor to participate in Diligent Big Pharma Co. asked ICON to participate in Diligent Big Pharma Co. sent out Diligent RFIs for central lab category refresh ICON signs Diligent Participation Agreement ICON completes Core RFI (core requirements) and Central Lab RFI ICON approves Diligent release of Core and Central Lab RFIs to Big Pharma Co. 26

27 Sponsor Perspective: Bristol-Myers Squibb Sponsor Feedback on Diligent Process Outcome: Feedback on Diligent Process Quality of Diligent RFI templates (alignment to BMS needs/expectations) First outreach was quick and easy (prepopulated template) Addressing questions from providers (BMS vs. Avoca involvement) Diligent Agreement challenges (version 1) Diligent Agreement revision (to address challenges) Outcome: Response from BMS Providers Receipt of completed RFIs Timing of receipt Quality of provider information within RFIs 27

28 Provider Perspective: ICON plc Provider Feedback on Diligent Process ICON experience Initial exposure Internal evaluation Decision-making on participation Responded to be a part of Big Pharma category refresh ICON expanded participation for other services Biomarker Lab Bioanalytical Lab IxRS Services Imaging Services COA/eCOA Services 28

29 Sponsor Perspective: Bristol-Myers Squibb Sponsor Value Proposition and Plans for the Future Value Proposition of Diligent for Sponsors Access to very comprehensive RFI templates Avoca support with outreach Avoca support with provider questions (WebEx sessions, follow up, etc.) Time saved; more efficient Utilizing existing tools vs. using my time Leveraging Diligent Sharing approach with others at BMS Possibilities for expansion for other services outside specialty labs Continued participation in Avoca Quality Consortium for shared best practices Continued participation in Prequalification Advisory Board 29 It just makes sense

30 Provider Perspective: ICON plc Provider Value Proposition and Plans for the Future Value Proposition of Diligent for ICON Reduces the number of requests that require customized ICON responses ICON participation demonstrates to industry a commitment to quality ICON participation may result in increased exposure to 60+ AQC Member Companies ICON minimizes non-billable time spent on repetitive questions found in RFIs ICON can shift focus of sponsor discussions to protocol and therapeutic area/indication specific needs, and demonstrate true value-add expertise Expectation that it will drives efficiency, lower cost, reduce time for onboarding Leveraging Diligent If an AQC Sponsor Company asks ICON to respond to a RFI, ICON will direct them to the completed Diligent RFIs If non-aqc sponsors send in RFI requests, ICON can ask those sponsors to consider requesting Diligent completed RFIs (based on AQC Industry Standards) 30 It just makes sense

31 Diligent: Future Vision and Opportunities Dennis Salotti VP of Operations The Avoca Group 31

32 Our Shared Reality 32 Adapted from: Protocol Complexity as a Factor in Clinical Compliance Risk, Marta Fields, Seattle Genetics

33 33 Our Shared Reality

34 A Sharing Economy Outside of our industry, various shared approaches to economic or social pressures have emerged. Finding Things Learning About Things Getting Things Done 34

35 Our Shared Reality 35 Adapted from: Protocol Complexity as a Factor in Clinical Compliance Risk, Marta Fields, Seattle Genetics

36 A Sharing Economy Within our industry, encouraging examples exist and continue to emerge. 36

37 Diligent: A Vision for Optimizing Prequalification Collaboration among all Stakeholders Transformation in the prequalification process for technical providers for improved quality and efficiency. 37

38 Thank you Contact Avoca at: (609) Nassau Street, Suite 3A Princeton, NJ