Next generation sequencing (NGS) has the potential to disrupt not only the accepted process of drug development but also the hurdles a drug manufacturer would be expected to face in securing formulary approval and a possible premium price for the new compound.
Maimon Research can assist companies developing platforms for genetic profiling and the linking of mutations to drug candidates for personalized interventions in developing an evidence base that meets standards for formulary listing.
Against a background of what may be described one of creative destruction, where adoption of NGS in personalized medicine sets in train a mechanism of incessant product and process review, companies developing and marketing NGS platforms run the risk of their platform being seen as a commodity; a platform that is seen as no different from others and which does nothing more than provide a crosswalk of mutations to drug products.
To achieve a sustainable market position a platform should be evidence based in its claims; providing a framework that supports continued product development through feedback from treating physicians. Maimon Research has strategies in place that can provide this support.
At the same time feedback on the clinical outcomes and cost-effectiveness of platform choices in targeted populations within disease areas has significant implications for the continued revision of treatment guidelines and their adoption of NGS as integral parts of the treatment pathway.
There are, however, a number of unresolved issues which have to be addressed. These include not only the choice of NGS platform, but recognizing barriers to integrating evidence to support NGS-based therapy choices in treatment guidelines, the implications of NGS for drug development and the modification or rejection of current trial structures, the integration of comorbid disease states and the standards that formulary committees should adopt to evaluate NGS claims. Maimon Research can advise on these issues.