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Clinical Trial Design for Commercial Success

  • June 2015
  • -
  • Firstword Pharma
  • -
  • 72 pages




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




About FirstWord Reports

FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. FirstWord offers a range of products and services designed to help your company gain a competitive edge by making key business decisions with speed and confidence



FirstWord Pharma PLUS is a personalised and comprehensive intelligence service delivering up-to-the-minute pharma news, insight, analysis and expert views of importance to your company’s success.
FirstWord Reports deliver timely, need-to-know intelligence about your products, your competitors and your markets. Covering biosimilars, market access, medical affairs, sales & marketing, technology and therapy areas, FirstWord Reports provide expert views and intelligence on the challenges facing pharma today.


Table Of Contents

Clinical Trial Design for Commercial Success
1.Research Objective and Methodology
2.New models for commercial success
2.1.Success in the post-blockbuster era
2.2.Choosing a commercial model
2.3.The therapy area counts
… and the stage of development
2.1.Addressing unmet need
2.2.Industry is behind the curve
2.3. Cost-effective trials
3.The right compound for success
3.1. Determining commercial viability
4. A herd mentality in RandD?
5. Planning for commercial success
6.Integrated asset development
6.1.Ensure you have a solid evidence plan
7.Accommodating divergent stakeholder needs
8.The cross-functional team
9.Breaking down internal silos
10.Incentives for success
11.Value of external input into trial design
11.1 Addressing payer needs
12.Talking to everyone about trial design
12.1. Where to look for clinical-trial input
12.2. Cultivating key opinion leaders
13. Learning from patients
13.1.Patient input and corporate branding
14. Commercial endpoints and populations
15.Patient-relevant outcomes
16.Benefit versus risk
17.Comparative effectiveness
18.Patient segmentation
19.Commercially oriented trial designs
19.1. Adaptive Trials
20.Conclusions

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