Pharmacogenomics: Changes in Drug Development

Pharmacogenomics is the study of how genes affect a person’s response to drugs.  As the field grows, it holds many implications for the future of drug development.  Pharmaceutical companies are now rethinking the drug development process and coming up with new approaches to the discovery, development, and marketing of drugs.  The growth of pharmacogenomics may also force the FDA to rethink its regulatory guidelines, particularly as companies change the way they develop new drugs.

Will Pharmacogenomics Impact FDA Guidelines?

One of the primary issues facing pharmacogenomics in drug development is the outdated drug template being used by pharmaceutical companies.  The traditional way of thinking about drug development is by using three separate phases.  Each of these phases shows different regulations that a product must meet before it can move onto the next phase.  The problem with this template is that it does not account for the genetic variability of subjects who are receiving medication.  With new gains in pharmacogenomics, however, this variability will need to factor into the development process. Introducing pharmacogenomics will increase the number of viable drug targets and decrease risks associated with development.  Because there are new factors involved in drug development, the old way of conceptualizing drug development may no longer apply.  

According to Kate Merton, Head of Commercial Development at Navigate BioPharma, the FDA will need to change its regulatory guidelines to reflect the changing landscape in drug development.  This may mean weighing in on the early research process and identifying targets and patient populations. The FDA will also have to account for new genomic technologies being used by companies to develop their drugs.  

Finding the Target Population

As information pertaining to population and genetics becomes more readily available, companies will more easily identify the causes of certain diseases.  It will also be much easier for pharmaceutical companies to find target populations that will be receptive to the drug they are developing. For example, a company may determine that its drug will not work in 45% of the target population.  This will allow the company to focus instead on the group that the drug will work in. Narrowing down the target population through genomic technologies will allow pharmaceutical companies to save their resources and develop the right drug for the right group at the very beginning.

How Is Pharmacogenomics Incorporated?

Incorporating pharmacogenomics into the drug development process begins with looking at population and disease area.  Disease areas including oncology, cardiovascular, and diabetes have been well-developed and researched. This makes it a good starting place for companies to look for correlations between genes and drug response, and may point them in the right direction.

As pharmacogenomics continues to change the shape of drug development, the FDA may reconsider its regulatory guidelines surrounding drug development.  Pharmaceutical companies should stay informed about changing regulations and consult with a lawyer with a background in FDA regulatory law to ensure compliance.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Podcasts or on Apple Podcasts.

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