There is a lot of basic research happening in academia that never gets converted to actual usable medicines or devices for the patients. The gap between academia and industry is considered by Seyhan A, as the valley of death; death of ideas that could have turned out to be revolutionary for the patient. Translational research acts as a bridge between basic and clinical research. Lack of information, distance between collaborating parties, time, speed of response, regulatory guidelines or the absence thereof, intellectual property issues could be some reasons why we find it difficult to navigate this valley. Below are a few examples where Pharmawisdom has facilitated this transition.
An international company while reviewing data noticed a few publications from India which they thought could be screened, and if possible, developed into medicines for niche areas, like psoriasis using topical liposomal formulations, nanosuspension of an antimalarial. Since the work had been conducted in Indian universities Pharmawisdom worked with all stakeholders so as to facilitate contracts, transfer of technology and liaising with Indian CROs for possible studies.
Medical device rules 2017 have brought in a lot of clarity about classification of devices and the need for clinical trials before they are launched. Consequently, manufacturers and marketers of medical devices now need to conduct clinical trials before receiving marketing permission for certain categories of devices. Pharmawisdom has been involved in clinical trial planning for first in man safety studies for devices like a walker for paraplegics and a tissue ablator to be used to manage certain types of tumours.