BioVentures Consulting Limited can put together a product development plan and regulatory strategy for both biological products and chemical entities. We have taken both biological products and chemical entities from discovery through to marketing authorisation (New Drug Application, Marketing Authorization Application and Biologics License Application respectively), and in both the US and EU. BioVentures Consulting Limited understands the issues involved. We have expertise in reviewing and devising development programmes and will assess potential issues such as:
- discrepancies between the studied patient population and the proposed indications (see cartoon 2 ‘’Just for Fun’’)
- the sufficiency and robustness of the clinical package, particularly the pivotal trial design
- clinical endpoints, biomarkers and adequate demonstrations of efficacy
- dose level selection
BioVentures Consulting Limited can help with predefined clinical endpoints of the statistical analysis plan, including consistency of statistical method between the protocol and report.
Of primary importance too will be to ensure that the data allow a comprehensive evaluation of the safety profile.
BioVentures Consulting Limited will aim to identify development issues which allow an approvable clinical opinion
BioVentures Consulting Limited will aim to identify development issues which allow an approvable clinical opinion. BioVentures Consulting Limited an help compile the target product profile. This may include ensuring the development programme fills an unmet medical need, having a relevant effect in the control of patients with the disease, that the selected primary endpoints are considered relevant and validated, and that the serious adverse events (SAEs) were reported at a similar rate in the study drug as in the placebo treated patients.