How to bridge the ‘Valley of Death’
The SciLifeLab Drug Discovery Model
A number of years ago, the term ‘Valley of Death’ was coined to describe how difficult it was for academic ideas for therapeutic intervention to reach all the way to the patient. The Valley of Death still exists, says Kristian Sandberg, Director of the Drug Discovery and Development Platform at SciLifeLab. But work done there has yielded results. “We believe we make a difference,” he claims. In this chronicle, he talks about the drug discovery model developed and employed at the lab.
In 2004, the former NIH Director Elias Zerhouni minted the phrase Valley of Death to describe why so few of the many academic ideas for therapeutic intervention in disease actually progress all the way to the patient.
There are, in fact, many reasons for this failure, two of which are 1) limited funding to translate basic science into applied science, and 2) academic scientists in biomedical research with entrepreneurial ambitions face a more challenging career ladder than their counterparts with a traditional research focus.
Different viewpoints of science
I would argue that there is a third main reason shaping this Valley of Death: fundamental different viewpoints of science. The focus for the academic science of biomedicine is on disease pathogenesis, fundamental principles of gene and protein function, etc. For applied (industrial) scientists, the focus is on the product – the drug.
One of the main objectives of the Drug Discovery and Development (DDD) platform at SciLifeLab is to make the academic community aware of these different perspectives on science. What data are required to make investors (and research funding agencies) attracted to projects developed in the academic milieu?
Platform in operation for four years
The SciLifeLab DDD platform has now been in operation for four years and is currently supporting 18 major drug discovery programs from different Swedish universities. Seven programs supported by the DDD platform have successfully exited it, either via start-up company ventures, being licensed to pharma, or by entering clinical studies.
We believe that we make a difference by providing a mix of cutting edge wet-lab resources and expert skills. In our drug discovery programs, the academic principal scientist only pays for consumables. The SciLifeLab DDD platform, as a national infrastructure supported by government funds, takes the remaining costs (approximately 90%) in the program.
Key distinctive elements of the SciLifeLab Drug Discovery Model are:
Begin with the goal in mind!
Projects proposed to DDD captures nine different perspectives of ability for drug discovery, namely:
- Scientific validity of the therapeutic approach
- Medical need and differentiation from standard of care
- Safety concerns
- The competitive situation
- A patent and publication strategy
- The feasibility to conduct a phase 2 study
- Competence and ability of the academic research team
- Technical feasibility to develop a drug
- Entrepreneurial behavior
Biannual prioritization!
Principal Investigators receive support for six-month periods, all coordinated by a project leader. Any lack of key component that adversely affects progression will result in the project being stopped or delayed. An unbiased national steering group makes the prioritisation.
Feedback!
Regular project reviews provide continuous feedback to the principal investigator, which results in a steep learning curve in how to become a skilled drug-hunter!
Major improvements can be made
Major improvements can nevertheless still be made to the innovation support systems in Sweden. Investments in the translational science of biomedicine should consider the time required for developing prototype drugs and the timing for these investments.
There are also untapped talents in Swedish academia. The majority of principal investigators supported by SciLifeLab DDD are well over 50 years of age. How can we motivate our young scientists to embark on exploratory research aiming to develop new therapeutic drugs?
Kristian Sandberg is Director of the Drug Discovery and Development platform (DDD), SciLifeLab in Uppsala. He has held scientific and leadership positions at Astra Arcus AB/AstraZeneca and has 20 years’ experience from drug discovery and development projects involving both small molecules and therapeutic antibodies. He joined SciLifeLab in 2015.