Starting With The End In Mind

Recently I've been writing about Pipeline's new Planning module and some of its new features, including the new Target Product Profile (TPP). Traditionally TPPs are used to help drug development teams define the product (medicine) that they are trying to create. But the role of the TPP appears to be evolving from a largely "development only" tool, to a shared tool used by both discovery and development teams.

For the most part, its purpose is to answer some fundamental questions about that new medicine:

• What indication are we working on?
• How big is the patient population?
• What is the competitive landscape like in the market? Who currently has a drug in this space? Who is conducting clinical trials in the space
• What will differentiate us from those competitors?
• What does the regulatory landscape look like for this product?

As such, you typically don't see a TPP being used on a project until it reaches the Preclinical Testing phase. They're rarely seen in the discovery end of the business.

Recently, we've been conducting a series of informational interviews with Research PMs in both mid-size biotech companies and large pharmaceutical companies to learn more about their processes and to see how TPPs are used. One emergent trend from these conversations is that that project teams are starting to push TPPs earlier into the drug discovery process. This has a number of benefits:

• It reduces the risks that occur when a project is transitioned from the discovery team to the development team. The development team is less likely to receive a drug candidate that fails to meet basic developability criteria.
• By pushing the TPP earlier in the process, the discovery team has a better understanding of factors that may affect the ability of the team to develop the product. This means that during lead optimisation the team can optimise various characteristics of the molecule in a manner that contributes to its developability.
• Both discovery and development team members contribute to the TPP over the course of the project, so what you end up with is a shared vision of that new medicine that the team is working on.

What was perhaps most compelling about this, was that we were hearing the same things from drug discovery companies, regardless of the size of the company. Whether you were managing 300 research programs or 3, the story was the same.

If you'd like to participate in our interviews or learn more about Pipeline and how TPPs and other planning tools can help you improve your drug discovery processes, reach out to me for a demo [email protected]