One of the things I enjoy most about the Why Summits conferences is the opportunity to talk with people from across the drug discovery spectrum and learn about both their challenges and how they dealt with them.
There has always been a Great Divide between the discovery and development arms of drug discovery organisations, driven in part by different types of work, different ways of conceiving of a project, and even a different language to describe the work. On the research side of the divide we speak about a project in terms of targets, and compounds and a pipeline; and gradually as things progress, the terms we use morph into programs, assets and a portfolio. The differences in vocabulary mark a change of hands, as much as a change of mindset.
The Why Summits conference marked one of these rare opportunities to talk with people from both sides of the Divide and share ideas and learnings and to learn more about the differences and similarities between the two sides.
To give you some idea of the nature of the Divide, let’s take a look at the landscape on either side.
On the development side, projects are planned by Project Managers. They often have formal PMI certification and experience in CMC, Clinical Trial Management and more. This is a full-time endeavour and involves managing timelines, resources and budgets. This type of planning has a more Waterfall-like approach.
On the discovery side of the Divide, projects are planned by biologists, and chemists. The projects themselves are often iterative in nature, and more suited to an agile form of project management. For the project leads, project management and planning is a part-time function that is often added to their existing workload and involves setting goals (basically scientific questions that must be answered), and identifying the tasks and assays that must be performed in order to answer those questions.
Unifying R&D
Twenty years ago, we spoke about it in terms of “throwing a project over the wall” to the development team. And even though that expression is still in use to some extent, there’s a general recognition that there’s a very real risk in that transition point between the two parts of the organisation. The biggest risk is that the candidate being handed over fails to meet basic developability criteria, and as a result more companies are making an effort to create a more unified process that integrates the two sides of the house, and improves coordination, communication and planning between them.
To that end, drug discovery companies have begun using Target Product Profiles (TPPs) earlier in the drug discovery process to help mitigate risk and to create a common vision of the new medicine that the company is pursuing. The TPP is an FDA recommended document that describes the characteristics of the ideal medicine that the company is trying to create. The TPP represents a common vision of that new medicine that is informed by various groups within the company.
A TPP can be an all inclusive document that includes information about the commercial or regulatory landscape, mechanism of action, patient population and more. In Pipeline’s Planning module our TPP template contains these fields and more. Some organisations create separate TPPs such as a CMC TPP or a commercial TPP. In any case, it’s important to remember that the TPP is not a static document but one that evolves over time as we learn more about the nature of the target space, the indication, the compounds, etc.
The Pipeline Planning Module
In Pipeline’s Planning module every type of plan can be templated. Our default TPP template can be used as a starting point for your own planning efforts.
The template TPPs serve multiple purposes in an organisation beyond simply defining an ideal medicine. They provide an organisation with a common vision of what that ideal medication should look like, and serve as a vehicle for aligning the organisation around that vision.
If you’d like to learn more about how Pipeline supports Research Project Management, contact us for a demo at info@aspenbiosciences.com.