Clinical Trial Design for Commercial Success

Maximum Purchase:
1 unit
Publication Date:
June 2015
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Clinical Trial Design for Commercial Success offers expert insights on how to best position drugs for success through strategic innovative design of clinical trials.

Clinical trials make up, on average, nearly 60 percent of the total development costs for a new drug, and marketplace success is by no means guaranteed. In this challenging environment, complacency in trial design and execution carries a heavy cost.

From launch to patent expiry, Clinical Trial Design for Commercial Success offers key insights on building clinical trials that give new drugs every advantage in the marketplace.

Top Benefits

  • Learn how strategic design of clinical trials can drive the commercial success of new therapies
  • Understand how to ‘design-in’ value creation so your clinical trial delivers data that influences payers and prescribers
  • Learn how to keep your clinical trials on track for commercial success from day one

Answers to Critical Questions

  • How can companies meet the need to deliver returns over the short- and long-term through the design and implementation of clinical trials?
  • Where and when does the process of designing clinical trials for commercial success start? Who are the key stakeholders that need be involved?
  • To what extent should commercial factors like pricing, branding, positioning and risk-benefit be factored into clinical development?
  • How do alternative trial designs and the generation of real-world data contribute to commercial success?

Experts Interviewed

  • Manolo Beelke, Senior Medical Director, Worldwide Clinical Trials
  • Cecil Nick, Vice President, Biotechnology, Parexel Consulting
  • Bob Swann, hHad of US P&MA, Heron Commercialization (Parexel)
  • Rick Sax, Senior Vice President, Clinical Design & Reporting Services, Quintiles
  • Dr Michael Kirchengast, Senior Vice President, Scientific Affairs, PRA Health Sciences
  • Leo James, Associate Director, Medical Affairs - Clinical Trials, Astellas Pharma
  • Dr Domenico Merante, Senior Director Clinical Development, Daiichi Sankyo, UK


Table of Contents

  • Research Objective and Methodology
  • New models for commercial success
    • Success in the post-blockbuster era
    • Choosing a commercial model
    • The therapy area counts
      … and the stage of development
    • Addressing unmet need
    • Industry is behind the curve
    • Cost-effective trials
  • The right compound for success
    • Determining commercial viability
  • A herd mentality in R&D?
  • Planning for commercial success
  • Integrated asset development
    • Ensure you have a solid evidence plan
  • Accommodating divergent stakeholder needs
  • The cross-functional team
  • Breaking down internal silos
  • Incentives for success
  • Value of external input into trial design
    • Addressing payer needs
  • Talking to everyone about trial design
    • Where to look for clinical-trial input
    • Cultivating key opinion leaders
  • Learning from patients
    • Patient input and corporate branding
  • Commercial endpoints and populations
  • Patient-relevant outcomes
  • Benefit versus risk
  • Comparative effectiveness
  • Patient segmentation
  • Commercially oriented trial designs
    • Adaptive Trials
  • Conclusions


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