Pharma Bioequivalence Strategies:Performance Metrics, Processes & Trends             Best Practices, LLC        Strategic ...
ContentsI.   Executive Summary        Research Overview        Benchmark Participants        Key Findings & ObservationsII...
Generic Bioequivalence Benchmarking: Project OverviewBest Practices, LLC conducted this benchmarking research to provide c...
Benchmark Class: Companies Participating in StudyTwenty executives at 18 leading generic pharmaceutical manufacturing comp...
For Majority, < 1/4 of BE Studies Go to Less-Regulated Markets A majority of the Generic companies in the study currently ...
Increased Use Expected of CROs in Less-Regulated RegionsA majority of participants expect to increase their use of CROs in...
Generic Companies Average 3.27 BE Studies per Application On average, participating Generic companies conduct 3.27 bioequi...
Generics’ Cost per Volunteer per Period Averages $1,110The estimated current cost of a clinical stay ranges from $110 to $...
Pilot Study Results Often Yield Design, Speed & Cost SavingsFor most companies, key benefits of using pilot studies in bio...
More than Two-Thirds Have Dedicated CQA GroupsSixty-eight percent of the participating companies have dedicated Clinical Q...
About Best Practices, LLCBest Practices, LLC is a research and consulting firm that conducts work based on thesimple, yet ...
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Pharma Bioequivalence Strategies Performance Metrics, Processes & Trends Report Summary

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The generics industry is under constant pressure to introduce new products into the marketplace quickly while keeping costs down and quality high. Best Practices ®, LLC developed this study to identify effective strategies and processes for managing the critical bioequivalence studies central to generics development, while effectively managing quality, speed and cost. In addition, the study also looks at recent trends in outsourcing and geographical locations for BE studies. Further, the study provides metrics, executive insights, lessons learned and best practices.

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Pharma Bioequivalence Strategies Performance Metrics, Processes & Trends Report Summary

  1. 1. Pharma Bioequivalence Strategies:Performance Metrics, Processes & Trends Best Practices, LLC Strategic Benchmarking Research Copyright © Best Practices®, LLC
  2. 2. ContentsI. Executive Summary Research Overview Benchmark Participants Key Findings & ObservationsII. Outsourcing & Geographic TrendsIII. Volume & Cost MetricsIV. Bioequivalence Practices & ProcessesV. Clinical Quality Assurance Strategy, Structure & PerformanceVI. Best Practices & Lessons Learned Copyright © Best Practices®, LLC
  3. 3. Generic Bioequivalence Benchmarking: Project OverviewBest Practices, LLC conducted this benchmarking research to provide comparativecost, quality and productivity metrics and best practices that Generics manufacturerscan use in evaluating the performance of their bioequivalence testing programs. Study Objective & Methodology Key Study Topics This benchmarking study aims to identify Outsourcing Activities & Trends key cost, quality and productivity metrics for Use of CROs in Less-Regulated Regions the process of conducting bioequivalence studies required to bring a new generic drug Bioequivalence Volume & Cost Metrics to market. Bioequivalence Practices & Processes In addition to metrics, the study includes Use of Pilot Studies, Power & E-Submission executive insights, lessons learned and best practices for productivity in the Clinical Quality Assurance Function Dedicated CQA Prevalence bioequivalence study process. & Structure Qualitative and quantitative data for this Best Practices study were collected through an online Pitfalls & Lessons Learned survey instrument. 3 Copyright © Best Practices®, LLC
  4. 4. Benchmark Class: Companies Participating in StudyTwenty executives at 18 leading generic pharmaceutical manufacturing companiesparticipated in this benchmarking study. Apotex, Clinigene, Dr. Reddy’s, GeneraMedix, Lupin, Merck, Naari, Perrigo, Ranbaxy, ratiopharm, Roxane, sanofi-aventis, Sun Pharmaceutical, Teva, Wockhardt, Zars, Zentiva, Zydus Cadila. 4 Copyright © Best Practices®, LLC
  5. 5. For Majority, < 1/4 of BE Studies Go to Less-Regulated Markets A majority of the Generic companies in the study currently outsource fewer than one-quarter of their bioequivalence studies to CROs in less-regulated markets (such as India), while one-third outsource most studies to those regions. Q. Approximately what percentage of your companys BE studies are outsourced to CROs in less-regulated markets (such as India or Eastern Europe)? % BE Studies Outsourced to CROs in Less-Regulated Markets 76-100% of studies 22% 1-25% of studies 51-75% of studies 11% 56% 11% 26-50% of studies (n=18) % Respondents 5 Copyright © Best Practices®, LLC
  6. 6. Increased Use Expected of CROs in Less-Regulated RegionsA majority of participants expect to increase their use of CROs in less-regulated regionsduring the next two years. 65% expect to move more BE studies to India. Although 50%plan more activity in Eastern Europe, it is the only benchmarked region where somecompanies expect to decrease BE outsourcing. Q. Please indicate whether you expect your company to change its level of use of CROs in less- regulated regions within the next 24 months. (Indicate direction of expected change.) Future CRO Use in Selected Locations Level of Use Will Increase No Change Expected Level of Use Will Decrease 67% 65% % of Respondents 50% 50% 50% Other Areas for Increased Volume of BE Studies 38% 33% 35% • US (3) • Canada • Mexico 13% • Romania • South Africa Russia China Eastern Europe India (n = 17 8 6 6) 6 Copyright © Best Practices®, LLC
  7. 7. Generic Companies Average 3.27 BE Studies per Application On average, participating Generic companies conduct 3.27 bioequivalence studies (including both pilot and pivotal work) for each submitted ANDA. The median number of studies is three. Q. Please estimate the average number of bioequivalence studies (including pilot and pivotal) that your company conducts for each generic drug application (ANDA) it submits to the FDA. Number of Studies per Application 7 # of Studies 4 3.27 3 2 2 Mean Max 75th Median 25th Min Percentile Percentile (n=18) 7 Copyright © Best Practices®, LLC
  8. 8. Generics’ Cost per Volunteer per Period Averages $1,110The estimated current cost of a clinical stay ranges from $110 to $3,200 across the benchmark class.Although the two lowest responses came from Generic companies in India and the highest few from NorthAmerican companies, some Indian companies have higher costs than some North American companies. Q. Please estimate your current average cost per volunteer per period (cost of clinical stay). (Include meals, lodging, stipend, travel and other individual volunteer costs.) Cost per Volunteer per Period $3,200 $1,750 USD ($) $1,110 $500 $400 $110 Mean Max 75th Median 25th Min Percentile Percentile (n=15) 8 Copyright © Best Practices®, LLC
  9. 9. Pilot Study Results Often Yield Design, Speed & Cost SavingsFor most companies, key benefits of using pilot studies in bioequivalence testing areimproved design of pivotal studies and faster screening of experimental formulations.Saving time and/or money are additional benefits of using pilots. Q. If you use pilot studies in the bioequivalence process, what benefits have you realized as a result? Pilot Study Benefits Better design for pivotal studies 95% Faster screening of experimental 79% formulation Saved money 47% Saved time 37% (n=19) % of Respondents 9 Copyright © Best Practices®, LLC
  10. 10. More than Two-Thirds Have Dedicated CQA GroupsSixty-eight percent of the participating companies have dedicated Clinical QualityAssurance groups. Q. Do you have a group dedicated to clinical quality assurance (CQA) within your company? Generic Companies with Dedicated CQA Groups No, 32% Yes, 68% (n=19) % of Respondents 10 Copyright © Best Practices®, LLC
  11. 11. 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 best@best-in-class.com www3.best-in-class.com 11 Copyright © Best Practices®, LLC

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