Companion Diagnostics - Streamlining drug development and advancing personalized medicine -





April 2013

Personalized healthcare encompasses tailored diagnostics, treatment and management of illnesses and diseases.  Although the concept has been around for many years, it is only with the advent of companion diagnostics that personalized healthcare has started to gain ground.  Companion diagnostics can be used in screening, monitoring, diagnosing and treating patients and can allow for stratification of patients to maximize efficacy and minimize risk

Companion diagnostics can allow for a specific patient population to be identified which will ensure those patients who are most likely to respond are recruited for clinical trials and receive the therapy once the product is launched.  Companion diagnostics can help to rationalize treatment decisions, with specifics such as accurate dosing, risks of adverse events and diagnostics being made possible through these tests.  Through the use of companion diagnostics, the right treatment can be delivered to the right patient at the right time, delivering greater value and optimizing healthcare resource utilization

Oncology has been the most active arena for companion diagnostics but, as research has advanced and new diagnostics developed, applications in other therapy areas are being discovered and established

The report, “Companion Diagnostics – Streamlining Drug Development and Advancing Personalized Medicine” was written to support both the biopharmaceutical and diagnostic industries better understand the current challenges involved in developing products with a companion diagnostic, as well as the opportunities that will exist in the future.  Recent success stories are identified and analyzed, and insights are provided throughout the study to support pharmaceutical & diagnostic strategic planning needs.

 

 Key Reasons to Purchase 

  • This report provides an overview of advantages offered by companion diagnostics from early clinical development through to product launch and ongoing use in the patient population
  • Understand what personalized medicine and companion diagnostics are and how these are expected to change the face of disease management
  • Enables you to understand some of the key challenges faced during the development of companion diagnostics and recommendations on how to overcome them
  • Provides an in-depth analysis of key case studies highlighting the successful application of companion diagnostics and how this has impacted company activities
  • Gain insight into which pharmaceutical companies are leading the way in the development and application of companion diagnostics while assessing the key partnerships in place with diagnostics companies driving this sector forward
Table of Contents 

 

 Executive summary 

 Methodology  

 Personalized medicine and companion diagnostics  

– Personalized medicine overview  

– What are biomarkers?  

– What are companion diagnostics?  

  Advantages of companion diagnostics  

 – A more targeted patient population  

 – Focused drug development  

 – Rationalized treatment decisions  

 – Pharmacoeconomic advantages  

  Challenges in the development of companion  diagnostics  

 – Logistical challenges   

– Strategic business challenges 
  
– Financial risks 

– Regulatory challenges  

 Case studies  

– Roche – leading the way with companion diagnostics  

 – Biogen Idec – a diagnostic to mitigate risk  

 – Xalkori – a sign of things to come?  

    A look to the future  

 – Companion diagnostics – a prerequisite to  approval?  

 – A world beyond oncology  

 – Companies leading the way  

  Appendix  

 Total Report Size – 58 slides; fully sourced