Friday, November 25, 2011

3 benefits of drug repositioning – and the application of Strategic GPS®

A number of studies have shown that in the last 10 to 15 years, while R&D spending has steadily increased, the number of drugs making it to the market has not followed pace.  That’s why the advantages of drug positioning hold such allure.

The key advantage of the drug repositioning approach is that it reduces the time, cost, and risk compared with de novo development. As well as providing an advantage to companies, it also provides an advantage to patients, because it reduces the overall cost by rescuing the investment in failed drugs and makes safer and more effective drugs available. 
“Drug repositioning is a means of obtaining better health outcomes without the massive investments and long time frames associated with traditional drug development. As such, it is both commercially and socially attractive,” says Steven Flostrand, business development director, at Marco Polo Pharmaceuticals.

Take a closer look at 4 benefits of drug repositioning:

1. Recouping existing investments

Many pharma companies have drug libraries of well-characterized compounds that are gathering dust and losing value as assets, whether it’s through failures in development or a change in therapeutic focus.

2. Saving time and money

Drug repositioning is generally a faster process than de novo development because it can rely on existing data, including efficacy and toxicity studies. Developing an NCE (new chemical entity) can take 10 to 17 years, depending on indication. For a drug repositioning company, the development process from compound identification to launch can be around 3 to 12 years.  What’s more, development of a single compound to enter clinical trials will cost around $10 to $20 million. The cost of identifying a repositioning candidate that already has phase 1 data varies but could be as low as $2 to $3 million.

3. Reducing risk

Drug repositioning is a significantly lower risk than de novo development, certainly from a scientific or clinical perspective. Because it deals with compounds whose safety profiles are already known, it significantly reduces this risk of drug development.

For the improvements to existing marketed drugs, we know what needs to be changed and generally, how to make these improvements. Very few 505[b][2] projects fail due to a science issue — most are due to money or markets.
In classical drug development, everyone is chasing ‘first-in-class,’ which does provide a high reward, but is very high risk. It’s still possible to get a ‘first-in-class’ with drug repositioning, even with an old drug, because it may represent a new mechanism applied to a new indication.
Read more in “Getting The Drug Repositioning Genie Out Of The Bottle” at www.lifescienceleader.com
When working with early-stage technologies, I have used a proven process designed to configure the technologies’ “road map” called Strategic GPS® Navigation Process. This process: 
  • Identifies the key targets 
  • Articulates the current situation (Where we are)
  • Defines the desired objective (Where we want to be)
  • Conveys the over-arching strategy
  • Delineates the milestones 
  • Outlines the key tactics 
  • Bridges the science and the business in a comfortable atmosphere

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