NGS, creative destruction, therapy pathways, credibility, evaluation, replication
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. The purpose of this commentary is to consider the role of NGS in this process, one which is characterized as a process of creative destruction, where adoption of NGS in personalized medicine sets in train a mechanism of incessant product and process review. A mechanism driven by continuing modifications and extensions to NGS platforms as our understanding of the role of mutations and mutation load in therapy choice expands. At the same time this mechanism 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 the choice of NGS platform, 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. The overarching theme, however, is the need to invest in a robust and credible evidence base. While we are a long way from achieving this, the focus must be on putting claims for therapy choice forward that are credible, evaluable and replicable.
Langley PC. Creative Destruction: Next Generation Sequencing in Drug Development, Formulary Evaluations and Pricing. Inov Pharm. 2016;7(4): Article 13. http://pubs.lib.umn.edu/innovations/vol7/iss4/13.