DOI:
VOLUME 1 – MARCH ISSUE 1.
Pascal St-Laurent* and François-Xavier Lacasse
Di-Solution Conseil Inc.
ABSTRACT
Drug development is an applied science that should be using a holistic approach. Indeed, several different sciences are involved and could be divided in preclinical sciences, or basic research, and then development research that starts once a safety assessment candidate has been selected and decided to be pushed for clinical development. A lot of departments are involved in the development of a new molecular entity, and it is fair game to see all of them pulling the blanket on their side, claiming that if they were not there, nothing would happen and no drug would reach the market. Of course, this speech may be applied when working in a big pharma, since a list of drug products generate several billions of dollars. However, one must be candid to recognize that this same speech cannot be applied to startups or generics, which, most of the time, have only one product (because of financial constraints) and they do not have the choice to promote it and make it work. Most of the start-ups are made up of several brilliant scientists thinking that science will be better that any regulatory requirements whereas government agencies do not worry about how “wow” the science is since some chemical, safety and efficacy studies will have to be carried out to demonstrate that the drug product can submitted and launched. Large pharmas show a more conservative approach and will go through all the steps that are needed to demonstrate the safety and efficacy of the drug product therefore avoiding surprises without relying on “rocket science”. They are more proponents of the KISS method. Authors of this short communication present more than 50 years of experience in drug development and had to chance to work in different companies ranging from start-ups to large pharma. It will then be illustrated that reinventing the wheel is not the best way “to get a short track for submission” and that it is possible to move slowly but surely by following a proven recipe.
Keywords:
.
