David Kallend, Global Clinical Leader and PD Group Medical Director at Roche is speaking at this years World Drug Safety Congress Europe on De-risking strategies for CV drug development including the use of novel imaging modalities to evaluate pre-clinical and clinical safety findings. We spent a few minutes asking his opinion on the safety data collection and the associated challenges. Here is a sample:
Prof Guido Rasi, the new Executive Director of the EMA, has expressed his support for the idea of staggered approvals (or adaptive licensing) whereby new drugs can make it to the market faster while safety data is being collected. With this in mind, how do you see the role and capabilities of post-marketing monitoring of medicines changing in the near future?
In the CV and metabolic area, and specifically the dyslipidaemia space where outcomes data is often required for approval of new therapies, I am not sure this is realistically possible at present. For many targets surrogate markers of outcome benefit have not yet been validated from a regulatory perspective. Once these surrogate markers of outcomes have been established for new classes of drugs, just as LDL-C and HbA1c have been in the past, this would be an efficient and potentially less expensive way to develop new drugs. Outcomes studies would most likely still be needed to establish efficacy post launch and the long term safety data could be collected in these studies. Post marketing safety data collection would also have to rigorously conducted and analysed in such a scenario.