Do You Know Your New Molecular Entity (NME)?
Volume 1 - Issue 1
François Xavier Lacasse1* and France Guay2
-
Author Information
Open or Close
- 1Faculty of Pharmacy, University of Montreal, Canada
- 2President, FG Pharma Inc, Canada
*Corresponding author:
François Xavier Lacasse, Faculty of Pharmacy, University of Montreal, Canada
Received: January 10, 2018; Published: January 24, 2018
DOI: 10.32474/DDIPIJ.2018.01.000101
Full Text
PDF
To view the Full Article Peer-reviewed Article PDF
Abstract
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.
Introduction|
Evolving Regulatory Requirements|
Conclusion|