Pharma Reform

During the discovery process, Pharma researchers explore molecular systems searching for and testing biological pathways and targets they might be able to turn on or off in an effort to mitigate disease symptoms or to avoid side effects and adverse reactions.  Drug discovery is becoming increasingly challenging, especially to find those elusive innovative new products the market is demanding.  To find those truly unique compounds, Pharma will have to delve even deeper into the biology and pathophysiology of disease.  This is fertile ground for Pharma companies to exploit by developing complimentary diagnostics to go along with their new treatments.  Developing these diagnostics could become a significant competitive advantage, a market embraced marketing tool, and may eventually be a necessity for commercial success in the not too distant future.

Here are some of the reasons why and how a Pharma company might consider developing diagnostics to go along with their new treatments:

The healthcare provider need for better diagnostics:

1. To more definitively identify diseases and their underlying cause
2. Disease identification rather than indirect diagnosis from lab data interpretation
3. Rapid, easy, “bedside” or office practice testing rather than time consuming, remote laboratory testing
4. To identify high risk patients who should be considered for preventive treatment

The market needs for better diagnostics

1. Desire to know which patients are more likely to respond to which treatments.
2. Desire to know which patients are more likely to experience side effects or adverse reactions
3. Tests to determine whether or not a treatment is actually working (having the desired affect)
4. Better treatment specific diagnostics could lead to less wasteful prescribing and avoid costly hospitalizations related to adverse effects

Regulatory considerations

1. Treatment specific diagnostics may provide a quicker path to proof of concept
2. Treatment specific diagnostics may be able to better establish drug superiority to alternative therapeutic options
3. May provide  stronger, more definitive  clinical support for efficacy and safety

Pharma companies looking to take advantage of this opportunity will need to:

1. Increase their research expertise to include diagnostics development expertise
2. Build corporate expectation that new treatment discoveries will come with a need for diagnostics to support the product
3. Expand discovery research to include looking for diagnostic possibilities
4. Include diagnostic companies, research tools and services companies, and other general life science companies in their business development licensing and partnering plans.

Diagnostics development to compliment drug discovery may be one of the most important strategic decisions a pharma company can make to increase their R & D productivity and stay aligned with the evolving new healthcare market.

mike@pharmareform.com