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Products & Services

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

ID: POP-232


Features:

7 Info Graphics

21 Data Graphics

77 Metrics

6 Narratives


Pages: 55


Published: Pre-2014


Delivery Format: Shipped


 

License Options:
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Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.




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919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
Fixed dose combination (FDC) products are becoming increasingly popular as they reduce the number of medications certain patients need to take while suffering from illness. But while pharmaceutical companies are eager to delve into this growing sector, many lack the necessary expertise and experience to work effectively in developing strong new FDC products.

Drawing on the successes and failures of leading pharma companies, this Best Practices, LLC benchmarking study identifies proven strategies for developing and commercializing FDC products. Companies can use the insights and benchmarks contained in this study to better understand the FDC space and develop effective strategies for delivering a profitable FDC product into the marketplace.

Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Biotech; Consulting; Biopharmaceutical


Companies Profiled:
Abbott; Xanodyne Pharmaceuticals; Victory; Valeant; Solvay Pharmaceuticals; Shire; Sanofi-aventis; Sandoz; PLIVA Pharmaceuticals; Pfizer; Patheon; Noven Therapeuticals; Novartis; Merck; GlaxoSmithKline; Genzyme; IMS; Forest Laboratories; Inc; Elixir Pharmaceuticals; Eisai; Daiichi Sankyo; Catalent Pharma Solutions; Boehringer Ingelheim; Bristol-Myers Squibb

Study Snapshot

Primary research was conducted through an online survey instrument and in-depth interviews. Fifty-one representatives from 34 biopharmaceutical companies participated in this primary research. From seasoned executives to innovative managers, the range of respondent titles reflects depth 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. Eighty-four percent of respondents currently manage activities that involve FDC products.

Sample Key Findings

Less than a third of respondents said they partnered with another pharmaceutical company to develop the FDC

  • Most successful FDCs are developed by a single company, using its own assets and resources. Less than a third of respondents said they partnered with another pharmaceutical company to develop the FDC
Table of Contents

Project Overview
  • Key Insights
  • Detailed Findings
  • Appendix

List of Charts & Exhibits

Chief reason for pursuing FDC development
  • Success of the FDC effort so far
  • Important measures used to evaluate success
  • Years from decision to develop through first development activity
  • Years from first development activity through final formulation
  • Years from final formulation through launch
  • Approximate cost of development of FDC product
  • Difficulty areas for bringing FDC product to market
  • % partnering with another pharmaceutical company
  • Reasons for partnering with another company to develop FDC product
  • Time lapsed from initial contact to signed contractual agreement with partner
  • Summary basis of approval for FDC product
  • Application locations for registration of the drug product
  • US filing routes used
  • EU filing routes used
  • Months from filing to approval
  • Differentiating or enabling drug delivery technology used
  • Use of third party vendor for development
  • use of third party vendor to produce launch or material supplies
  • Patent applications and approvals
  • Market exclusivity achieved
  • Preclinical toxicity or safety testing done to support registration
  • Pre-launch marketing challenges
  • Specific reimbursement challenges
  • Strategies, tactics, practices to help accelerate or impede launch progress
  • Lessons learned from executives