CRO Bioequivalence Strategies Performance Metrics, Processes & Trends Report Summary


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Generics manufacturers are on a constant lookout to improve efficiency and reduce costs when conducting the required bioequivalence studies for their new products. Thus, they often turn to contract research organizations (CROs) to conduct these critical studies. This not only helps to reduce costs, but it also produces efficient clinical trial results. However, CROs are under constant pressure to reduce costs to survive in the competitive CRO sector while maintaining the high quality work needed to conduct the complex activities required for bioequivalence studies.

Best Practices ®, LLC developed this report to help enhance CRO bioequivalent study processes in spite of these hurdles. Specifically, this study aims to identify key cost, quality and productivity metrics for the process of conducting bioequivalence studies required to bring a new generic drug to market. In addition to metrics, the study includes executive insights, lessons learned and best practices for productivity in the bioequivalence study process.

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CRO Bioequivalence Strategies Performance Metrics, Processes & Trends Report Summary

  1. 1. CRO Bioequivalence Strategies:Performance Metrics, Processes & Trends Best Practices, LLC Strategic Benchmarking Research Copyright © Best Practices®, LLC
  2. 2. Contents:I. Executive Summary Research Overview Benchmark Participants Key Findings & ObservationsII. Geographic TrendsIII. Bioequivalence Practices & ProcessesIV. Sponsor Relationships & SupportV. Volume & Cost MetricsVI. Best Practices & Lessons Learned Copyright © Best Practices®, LLC
  3. 3. CRO Bioequivalence Benchmarking: Project OverviewBest Practices, LLC conducted this benchmarking research to provide comparative datathat Contract Research Organizations (CROs) can use in evaluating the performance oftheir bioequivalence testing programs. Study Objective & Methodology Key Study Topics This benchmarking study aims to identify Geographic Trends key cost, quality and productivity metrics for the process of conducting Volume & Cost Metrics bioequivalence studies required to bring a new generic drug to market. Bioequivalence Practices In addition to metrics, the study includes & Processes executive insights, lessons learned and Sponsor Relationships best practices for productivity in the & Support bioequivalence study process. Best Practices Qualitative and quantitative data for this study were collected through an online Lessons Learned survey instrument. 3 Copyright © Best Practices®, LLC
  4. 4. Benchmark Class: Companies Participating in StudyTwenty-seven executives and managers from 26 different Contract ResearchOrganizations (CROs) participated in this benchmarking study. Abridge Clinical Research Abridge, Actimus, Algorithme, Alticure, Anapharm, Assign, bioRASI, Celerion, Chiltern, CNS, CRBio, Fortis, FP Clinical, Info Kinetics, Kronos, Medpace, Micro Therapeutic Research, Norwich, Novum, PharmaMedica, PPD, Q-Pharm, Quartesian, Terapia, Veeda, Vimta 4 Copyright © Best Practices®, LLC
  5. 5. Majority Use Less-Regulated Regions for Some BE TestingMore than half the survey respondents currently conduct bioequivalence studies in India,compared with 4% to 22% hosting studies in other less-regulated regions, such asEastern Europe, Russia and China. Q. Please indicate whether your company currently conducts bioequivalence studies in any of the following less-regulated regions? (check all regions that apply) Current Study Locations 57% % of Respondents 22% 13% 13% 4% India Eastern Other less- Russia China Europe regulated (excluding regions Russia) (n=23) 5 Copyright © Best Practices®, LLC
  6. 6. Key Sponsor Support Activities Help Improve CRO AbilitiesEarly delivery of test product and Certificates of Analysis is the sponsor support servicethat CROs find most effective in improving their ability to work with sponsors. In all,100% of participants rate that service either highly effective (74%) or effective (26%). Q. Which of the following activities/services that sponsors may provide are effective in improving your ability to work with the sponsors providing them? Effectiveness of Sponsor Support Activities & Services Total Highly effective Somewhat effective Effective (n=27) Early delivery of test product & 74% 26% Certificates of Analysis 100% (n=26) Quality assurance inspections 54% 38% 92% (n=25) Providing a template for final reports 52% 40% 92% (n=25) Protocol preparation 48% 40% 88% (n=25) Rigid dosing schedules 48% 36% 84% % of Respondents 6 Copyright © Best Practices®, LLC
  7. 7. Majority of CRO Customers Do Not Conduct On-Site MonitoringAbout one-third of benchmark participants support a Generic customer base where morethan half the companies conduct on-site monitoring visits. For nearly half the CROs,fewer than 25% of Generic clients conduct on-site bioequivalence monitoring. Q. Please estimate the percentage of generic companies that you work with that conduct on-site monitoring visits for their bioequivalence studies. Prevalence of Generics Companies Conducting On-Site Monitoring 76-100% of sponsors monitor on-site 11% 51-75% of sponsors 22% 1-25% of sponsors monitor on-site 48% monitor on-site 26-50% of sponsors monitor on-site 19% (n=27) % of Respondents 7 Copyright © Best Practices®, LLC
  8. 8. Top Future Challenge for CROs Is Price ErosionPrice erosion, increased competition, regulatory changes and Generics industrymergers are the key concerns for CROs working with Generics companies. Severeprice pressure is the greatest challenge noted by the benchmark class. Q. In your opinion, what are the greatest challenges that CROs will face related to working with the generics industry over the next two years? “Increased number of CROs in lower cost jurisdictions dilute talent pool; low cost “Reduction in study price will be jurisdictions drive down cost of services in Price extremely challenging for the North American economies to the point CRO to generate profit.” where quality is at risk or CRO has to give Erosion up playing in that space.” “FDA considering “Most generic more stringent companies are CRO bioequivalence looking at opening up their own Future criteria for generic product in response Bioequivalence ed Re as ion gu to American public CRO. The business re t Ch lator will be decreasing Inc peti ang y es (or innovative m company lobbying) for CROs.” Co concerns.” “Mergers and acquisitions within the generic market is reducing the number of generic players and the domestic client base.” 8 Copyright © Best Practices®, LLC
  9. 9. CROs Most Often Average Two BE Studies per ApplicationNearly half the CROs in the benchmark class average two bioequivalence studies(including pilot and pivotal) per generic drug application to the FDA. Eighty percentof respondents average either one, two or three BE studies per application. Q. On average, how many bioequivalence studies (including pilot and pivotal) do you conduct in support of a single generic drug application to the FDA? Number of Studies per Application 45% % Responses 20% 15% 15% 5% One Two Three Four >Four (n=19) # of Studies per Application 9 Copyright © Best Practices®, LLC
  10. 10. About Best Practices, LLCBest Practices, LLC is a research and consulting firm that conducts work based on thesimple, yet profound principle that organizations can chart a course to superioreconomic performance by studying the best business practices, operating tactics andwinning strategies of world-class companies. Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 919-403-0251 10 Copyright © Best Practices®, LLC