BESTPRACTICES,®LLCCopyright © Best Practices , LLCFixed Dose Combination ProductsBenchmarking Research
BESTPRACTICES,®LLC2Copyright © Best Practices , LLC Project Overview Key Insights Detailed Findings AppendixTable of C...
BESTPRACTICES,®LLC3Copyright © Best Practices , LLCProject Methodology and Study ObjectivesThe economic advisability of de...
BESTPRACTICES,®LLC4Copyright © Best Practices , LLCParticipating CompaniesFifty-one representatives from 34 biopharmaceuti...
BESTPRACTICES,®LLC5Copyright © Best Practices , LLCJob Titles of RespondentsFrom seasoned executives to innovative manager...
BESTPRACTICES,®LLC6Copyright © Best Practices , LLCMost Respondents Currently Active in the FieldAre you currently engaged...
BESTPRACTICES,®LLC7Copyright © Best Practices , LLCMost Recognize FDC as a Lifecycle Management PlayNearly two-thirds of r...
BESTPRACTICES,®LLC8Copyright © Best Practices , LLCFDC Products Raise Issues for Portfolio StrategyPlease rank order the f...
BESTPRACTICES,®LLC9Copyright © Best Practices , LLCBest Practices, LLC6350 Quadrangle Drive, Suite 200Chapel Hill, NC 2751...
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Fixed Dose Combination Products Successful Strategies for Developing and Bringing FDC Products to Market Report Summary

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The pharmaceutical industry's steep patent cliff forces strategy and development executives to uncover opportunities for sustainable growth. One opportunity for growth lies in combination therapies with branded products to extend patent life. Fixed dose combination (FDC) products, which have been around for many years, can have clinical and commercial advantages. For the drug manufacturer, an FDC product can extend the therapeutic advantage and becomes part of lifecycle management. For the patient, FDC products can address unmet medical needs and reduce pill burdens.
Best Practices ®, LLC’s timely study identifies successful strategies and innovative practices for developing and bringing FDC products to market. Through executive insights and advice, the study also addresses the pitfalls and obstacles to avoid in this work.

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Fixed Dose Combination Products Successful Strategies for Developing and Bringing FDC Products to Market Report Summary

  1. 1. BESTPRACTICES,®LLCCopyright © Best Practices , LLCFixed Dose Combination ProductsBenchmarking Research
  2. 2. BESTPRACTICES,®LLC2Copyright © Best Practices , LLC Project Overview Key Insights Detailed Findings AppendixTable of Contents
  3. 3. BESTPRACTICES,®LLC3Copyright © Best Practices , LLCProject Methodology and Study ObjectivesThe economic advisability of developing fixed dose combination products can be difficultto determine owing to the many associated development and commercial challenges. This benchmarking study explores the logic, decisions, and strategiesinvolved in developing and commercializing fixed dose combination(FDC) products Primary research was conducted through an online survey instrument andin-depth interviews Primary research goals To identify successful strategies and innovative practices for developingand bringing FDC products to market To understand the pitfalls and obstacles to avoid in this work
  4. 4. BESTPRACTICES,®LLC4Copyright © Best Practices , LLCParticipating CompaniesFifty-one representatives from 34 biopharmaceutical companies participated in thisprimary research. Eight participating companies are in the top 20 according to 2008global pharma sales.Policlinica Dr. LuisRodriguez Carrasquillo
  5. 5. BESTPRACTICES,®LLC5Copyright © Best Practices , LLCJob Titles of RespondentsFrom seasoned executives to innovative managers, the range of respondent titles reflectsdepth and breadth of perspective in developing and/or commercializing FDC products.Respondents have an average of nearly 10 years of experience in working with FDCs.• Analyst, Business Intelligence• Analyst, Sales• Associate Principal Scientist• Research Administrator• Research Fellow, Pharmaceutical Development• Medical Science Liaison• Associate Manager, Marketing Analytics & BusinessInsights• Associate Manager, Training & Development• Product Manager• Group Product Manager• Senior Product Manager• Manager, Business Development• Manager, Market Research• Manager, Marketing• Manager, Sales & Marketing• Project Leader, Discovery Medicine• Therapy Area Leader• Medical Director• Scientific Director• Unit Director, Clinical Research• Director, Commercial Analysis• Director, Global Marketing• Director, Global Product Strategy• Director, New Product Planning• Director, Oncology Clinical Development• Director, Strategy• Director, US Marketing• Executive Director, Commercial Development & Ops• Executive Director, Managed Markets• Senior Director, Clinical Development• Senior Director, Commercial Development• Senior Director, Pharmaceutical Development Services• Senior Director, Pharmaceutical Sciences• Senior Director, Worldwide Pharmaceutical Sciences• Head, Intellectual Property• Head, International Pricing & Reimbursement• Vice President, Clinical Development• Vice President, Global Business Development• Vice President, New Business Development• Senior Vice President, Clinical Development &Regulatory Affairs
  6. 6. BESTPRACTICES,®LLC6Copyright © Best Practices , LLCMost Respondents Currently Active in the FieldAre you currently engaged in managing activities that involve FDC products or working to develop FDCs?Yes, 84%No, 16%(n=51) % of ResponsesEighty-four percent of respondents currently manage activities that involve FDC products.
  7. 7. BESTPRACTICES,®LLC7Copyright © Best Practices , LLCMost Recognize FDC as a Lifecycle Management PlayNearly two-thirds of respondents say their company pursued FDC development as part ofa lifecycle management strategy geared to extend therapeutic as well as commercialadvantage. One-third say FDC development addressed an unmet medical need.What was the chief reason for pursuing FDC development? (Please check all that apply.)(n=51)33%22%10%61%61%Extend therapeutic advantagePart of lifecycle managementUnmet medical needNew therapy (e.g., to addressmultiple pathways)Other (Please specify)% of ResponsesOther:• Convenient for Patient• Diuretic added• Improve pill burden,competitive advantage• Standard of care are FDC(oral contraceptives)• Synergistic compounds
  8. 8. BESTPRACTICES,®LLC8Copyright © Best Practices , LLCFDC Products Raise Issues for Portfolio StrategyPlease rank order the following areas in terms of the difficulty of bringing this FDC to market(1 = most problematic, 6 = least problematic).% of n Responses per Rankingn =1 – MostProblematic2 3 4 56 – LeastProblematicPortfolio Strategy 37 35% 8% 3% 11% 19% 24%Alliances/Partners 36 19% 14% 25% 17% 14% 11%Marketing/Positioning 41 15% 10% 2% 17% 22% 34%Clinical 38 13% 21% 29% 8% 18% 11%Regulatory 41 7% 10% 29% 29% 12% 12%CMC/Manufacturing 39 5% 36% 10% 13% 21% 15%Portfolio strategy and CMC/manufacturing are the most problematic areas as agreed onby 43 percent and 41 percent of respondents respectively. Most found that Marketing andPositioning is a relatively lesser concern when bringing a combination product to market.
  9. 9. BESTPRACTICES,®LLC9Copyright © Best Practices , LLCBest Practices, LLC6350 Quadrangle Drive, Suite 200Chapel Hill, NC 27517www.best-in-class.com919-767-9226bestpractices@best-in-class.comAbout 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 superior economicperformance by studying the best business practices, operating tactics, and winningstrategies of world-class companies.Link for Report: Successful Strategies for Launching FDC Products

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