Do You Know Your New Molecular Entity (NME)?
Journal Title: Drug Designing & Intellectual Properties International Journal - Year 2018, Vol 1, Issue 1
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. From a regulatory standpoint, according to Pharmaceutical Development ICH Q8 Guideline, the aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. It means that irrespective of the development steps and the scale, both the NME and the dosage form should be reliable, reproducible, stable and develop in such a way thatthe changes (scale-up, fine tuning) through development should not require, in a ideal world, bridging studies. A lot of people working in the PR&D area have noticed that this last ICH Q8 was more than a challenge to achieve. It represents one of the reasons why drug development will hurt. Questions are then the following: How it can and will hurt- Where does it start? a) With the NME: although drug development requires a scientific approach, science should be used to meet regulatory requirements. b) The NME needs to be developed into an active pharmaceutical ingredient (API) irrespective of its indication. c) Even though outstanding results were obtained during the proof of concept (POC), a NME is not in itself an API, even less a dosage form.
Authors and Affiliations
Françis Xavier Lacasse, France Guay
Keywords
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- EP ID EP583297
- DOI 10.32474/DDIPIJ.2018.01.000101
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