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Exploring New Pathways to Approval

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At this month’s PhUSE Single Day Event in Durham the focus was Exploring new pathways to Approval. When I first heard the theme back in the summer, what came to mind was the length of time and cost that it takes to bring a drug to market and the negative impact this has on patients.

Russ Helms, CEO of Rho and d-wise client, opened the event with a passionate plea to “think outside the box” and always innovate ideas forward. Following Russ' presentation, I was able to take the stage and put forward a provocative presentation (based on a 2017 article in Politico written by Dan Diamond) that challenges the current FDA approval process, weighing alternatives and providing both sides of arguments for each option, and laying the foundation for the rest of the days discussions.

The rest of the conference was centered around new initiatives that ideated additional methods beyond Dan Diamond's ideas to optimize the approval process. Several speakers discussed the power of sharing data and introduced a new concept of master protocols – an approach to create an umbrella over many protocols, accelerating drug development and identifying new treatment options more quickly. The last set of speakers explored the use of newer technology and approaches such as virtual trials, digital biomarkers, and the use of new streams of data such as wearable devices to make faster and better decisions.

By the end of the day I had a lot more hope that the industry collectively desires to motivate regulatory agencies to adopt technology and out of the box thinking from Sponsors that provide accelerated approvals. It was exciting to see how these ideas align with the investments and industry collaborations being made to create Aspire, the industry’s first open platform for clinical data and submissions. At the end of the day it was apparent whether you were a CRO, Sponsor, or Consultancy, collectively our goals are all the same. We want to get drugs in the hands of patients faster and save lives.

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