Our consultancy service offers an insight into the biomarker strategies currently applied within large Pharma.
We can help formulate tailored translational biomarker strategies for your specific programs and advise on best practices for implementation with key outcomes including early identification of clear Go / No-Go decision points and increased confidence of a positive outcome in the clinic.
Our consultancy service covers the following areas:
- Assistance with generation of a tailored Biomarker Strategy Plan (BSP) for your research programs. As with current practices in large Pharma, a BSP documents the key strategies associated with a program and further acts as a management tool in the implementation, coordination, tracking and review of such strategies from early pre-clinical through to proof of concept.
- Peer review of biomarker data or a current biomarker study plan / strategy. Through our extensive experience of implementing biomarker plans and reviewing biomarker study data, we can peer review your current plans / data to ensure best interpretation, define clear decision making and improve future planning.
- Guidance on the inclusion / presentation of biomarker data within IP data packages required during out-licensing discussions with large Pharma. Large Pharma now expect a robust biomarker strategy and/or data as part of an IP package to support a licensing deal (see our blog on this subject). OracleBio can help advise on the presentation of biomarker strategies and/or data within such documents in a format that aligns with current practices within large Pharma.
Please contact us to find out how we can help add value to your Programs.