Do You Know Your New Molecular Entity (NME)? by Françis Xavier Lacasse, France Guay in Drug Designing & Intellectual Properties International Journal (DDIPIJ) in Lupine Publishers
During the last decades, life science startup companies have relatively
rapidly increased their presence in the pharmaceutical landscape.
Pharmaceutical development has evolved because technology (analytical
and process development) and clinical development (hybrid design in
phase 1, including patients in phase 1B) have evolved in parallel
allowing in certain cases to decrease the time to regulatory filings
(IND, CTA, NDA, NDA 505 (b)(2),..), which seemed attractive for startup
companies. However, new molecular entities have become more complex
since polypeptides, proteins, and monoclonal antibodies drug products
take more and more place in many therapeutic areas (more than 50% in the
50 best seller drugs) along with the more conventional small molecules.
But it is not the end of small molecules; research institutes, startup
companies are still busy working hard to develop more powerful small
molecules, since the physiopathology has also evolved and helped finding
some new targets to enhance their efficacy and decrease their lack of
selectivity. Startup companies are mostly driven by high level
scientists and few of them are familiar with the drug development
process, including its early phases. Scientists do know their NMEs from a
scientific point of view however, much less and, sometimes, not at all
in terms of potential drug product candidates.
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