Email: enquiries@bioventurescl.com

Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Success factors for approval

BioVentures Consulting Limited is willing to act as a regulatory sounding board for any part of our client’s development and submissions strategy, and hence advise on the success factors for approval. We can provide consultancy advise by highlighting whether there are any major concerns in the EU dossier which may result in non-approvability, or Refuse-to-File (RTF) issues in the US dossier.

BioVentures Consulting Limited will advise that such consultations take place early in the clinical development programme, well before the pivotal phase III clinical studies are ongoing, so that potential efficacy objections can be addressed and incorporated into the study design. In this context we also usually recommend that clients seek Scientific Advice (whether at the National or European level) and can provide assistance with that.

BioVentures Consulting Limited can... highlight the likely areas of concern

BioVentures Consulting Limited can assess whether our clients have adequately identified the mode of action of their product (pharmacodynamics), the adequacy of the dose-finding programme and whether the benefit/risk profile is favourable. We are able to input on the clinical design to advise on potential clinical efficacy concerns such as sample size, the adequacy of the clinical endpoint, advantages over current therapies, the clinical relevance of the control arm (for both US and EU development programmes), regional differences in the patient selection profile, and whether or not the therapeutic benefit is likely to be demonstrated from a study design perspective.

BioVentures Consulting Limited can also provide expert advise on the Quality (CMC) components throughout the development programme, and highlight the likely areas of concern.

We can review the adequacy of the commercial scale data, the timing of the manufacture of consistency lots against the anticipated filing date, completeness of the data package of both the solvents and the substances used in the manufacture, and the real-time stability data of the drug product. BioVentures Consulting Limited recognises from our direct expertise with working at manufacturing plants that there are frequent changes throughout the manufacturing development programme. We can assess the process differences between the final commercial scale and development scale manufacturing procedures, the different process development stages which may be conducted at different manufacturing sites, the changed conditions and limits of defined critical process parameters, the purification process and the completeness of the validation data relating to manufacturing site transfers, and the extent of the clinical data obtained with commercial scale batches.

BioVentures Consulting Limited is able to review the whole dossier in context and provide guidance for pre-submission preparation, advising on key success factors of the nonclinical, clinical and quality programme together. We recognise that the outcome of the submission in terms of success and approval time depends on the adequacy of the study design (including the indication and the disease stage, the comparator used, where relevant and the methodologies chosen for efficacy assessments; and whether Scientific Advice has been sought). The expertise we can provide on parameters likely to affect the magnitude of the clinical effect, and the robustness of the safety data, and the benefit/risk (which should include a review of other treatment options) is likely to be extremely valuable to clients keen on maximising success factors for approval.

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