Data sharing and possible way forward
All the data generated by testing the Partner's compounds in LEO Pharma's disease-relevant in vitro bioassay will be reported in full to the Partner. LEO Pharma will only use the generated data to evaluate if a continued collaboration is of interest. The Partner may use the data generated in any way, including for scientific publication. If so, we ask of the Partner to refer to LEO Pharma Open Innovation and also that we are notified about such publication.
Possible way forward
If the results indicate an interesting possibility we will suggest a follow-up profiling, which could include studies to address e.g.:
- Additional in vitro assays profiling
- Drug Metabolism and Pharmacokinetic evaluation
- Compound physical and chemical properties
- Testing for in vivo effect
The details of the follow-up profiling will be handled on a case-to-case basis. There are many factors that jointly affect the decision to progress a project further, e.g.:
- The effect in some assays and not in others
- Effect on viability
- Pharmacological profile
- Previously related projects
- Technological match
- Current patient need focus
Expectations and experience
What we all hope for is of course to detect that your compound has a specific, efficacious and potent bioactivity combined with favorable physical-chemical compound properties and intellectual ownership situation.
In our experience this happens only rarely and we would like to emphasize that it is more likely that the result will not be favorable.
Drug discovery often relies on serendipity or simply numerous iterations – but, of course, there is always a chance that the first step towards the next new innovative patient treatment is actually discovered using the disease-relevant in vitro assays as provided by LEO Pharma Open Innovation. We sure believe so!
If the promising compound does not work
Please do note that lack of biological effect in the Open Innovation assays doesn’t necessarily mean that the compound is concluded to be without value.
It might simply be that it doesn’t fit in the current disease and technology platform, or that the compound targets a pathway that is not present in the simplified disease-relevant in vitro assay.
Case-by-case evaluation and discussion under CDA
Should data look promising, we will return with a suggestion to sign a Confidentiality Disclosure Agreement (CDA) in order to continue with a more detailed follow-up discussion.