Starting with the End in Mind

Starting with the end in mind is the SPARK NS core philosophy, guiding our mission to bring neuroscience discoveries from the lab to patients.

Traditional diagram showing drug development stages
Traditional diagram showing drug development stages

You’ve probably seen that diagram used to show the process of therapeutic development: discovery, preclinical studies then to clinical trials to approval to commercialization. It looks neat and linear. But it’s misleading. In reality drug development is complex and expensive, with an unacceptably high failure rate. Only about 10-15% of therapeutics that enter clinical trials ever make it to market, typically after years of preclinical refinement and validation. Getting there takes a long time and isn’t cheap. Estimates are that it takes 12 years or more and costs $1-2 billion.

That’s because far from being straightforward and predictable, the drug development process is dynamic and iterative, a constant interplay between many disciplines: basic science, clinical trials, regulatory strategies, manufacturing, and more. Each of these disciplines must independently succeed and ultimately synchronize to make it past the finish line.

A powerful strategy to address these challenges is to take into consideration the steps that routinely fail later in the process when ideas are first conceived. At SPARK NS, we call this starting with the end in mind.

Opher Kornfeld, PhD, Director of Translational Research and Development of SPARK NS
Opher Kornfeld, PhD, Director of Translational Research and Development of SPARK NS

Starting with the end in mind means that from the moment we consider the therapeutic application of an idea, we begin building a profile of the final product known as a Target Product Profile. Creating one requires asking product-defining questions:

  • Why would a patient want to take this drug over other options?
  • What specific, unmet clinical need does it address?
  • How will it compare to existing therapies?
  • Why would a prescriber choose it, and will payers cover it?
  • What does a Phase 3 clinical trial for this therapy look like?
  • Do we have the right tools to identify the patient most likely to benefit from the therapy and measure the efficacy of it in the clinic?

The answers to these questions allow us to shape our ideas and approach early in ways that maximize our potential to make an impact in the clinic.

Starting with the end in mind is fundamental to how SPARK NS advances promising academic discoveries in neuroscience to the clinic. The strategy is so central to the SPARK NS approach, and in our view to successful drug development, that we can't do it justice in a single article. With this article setting the stage, the News + Insights section of our website will revisit the topic frequently from different angles.

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