University of Wisconsin–Madison

Drug Development Challenges: Join the Discussion

Making 2018 a Breakthrough Year

As pharmacy professionals, we know that drug development is a lengthy and complex process with no guarantee of success. Despite 25 years of scientific advances that have led to improved safety, today’s drug candidates have a lower chance at success than those in the 1970s.

While it’s more difficult than ever to bring a new drug to market, it’s also much more expensive. The Tufts Center for the Study of Drug Development (CSDD) puts the lifecycle cost of a market-approved drug at $2.9 billion. Development costs have skyrocketed, and efforts to rein in R&D expenses have been offset by costs associated with the increasing complexity of trials and greater comparative testing requirements.

The tremendous cost of drug development also includes expensive project failures. Despite improvements in screening and discovery techniques, the industry sees only a 10-12% rate of success on drug approvals. There are still frequent issues with formulation, lack of translation from animal to human subjects, the lack of suitable biomarkers, and you could probably add a reason or two from your own experiences.

The goal of drug development is to create a product that improves health outcomes, but each project has a unique set of challenges. Small molecule and biologic projects each offer their own sets of difficulties. Some projects experience immediate challenges while others see issues manifest in clinical trials after great expense and years of effort. We would like to know what challenges YOU encounter in YOUR own projects.

At DPPD, our mission is to build the capacity of pharmacy professionals to address challenges like these through programs like our Applied Drug Development certificate. But as much as we aim to teach, we also aspire to learn from you to keep us closely aligned with the needs and challenges of our industry colleagues. A conversation about drug development challenges is one way to do that. What challenges do you face in your projects? How are you attempting to mitigate these challenges? Have you learned from past mistakes?

We would like to hear about your unique drug development challenges and how we can work together to address them. Share your stories with us and your peers on the DPPD LinkedIn Page or the DPPD Facebook Page and let’s keep learning together!

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