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NITI Aayog report calls for PPP model for drug development to address pandemic situations
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Our Bureau, New Delhi
October 05 , 2024
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A public-private partnership (PPP) model with organisations from both the public and private sectors is required to develop drugs for priority pathogens through repurposing of approved drugs or identification of novel compounds to address pandemic situations, according to a report by NITI Aayog.
A report submitted recently by an expert group constituted by NITI Aayog to prepare a framework for action for emergency response and preparedness to address future pandemic, said that a focused National Mission on Therapeutics and novel drug development should be launched and the Council of Scientific and Industrial Research (CSIR) could lead with the National Institute of Pharmaceutical Education and Research (NIPER) and other laboratories in PPP model with industry.
"A PPP model involving public and private organisations would be important. Companies with experience in antivirals/drug discovery should be involved. Manufacturers of drugs that are being repurposed should be encouraged to participate. Where Intellectual Property (IP) may not allow compounds to be repurposed, discussions with manufacturers should be initiated early," recommends the study.
The study notes that during Covid, the country faced a situation where, while several therapies and drugs were available for treatment, the required drugs were not available
as repurposed, or new drug development for specific disease targets is still in a nascent stage.
Over the years, while capacities have been built for infrastructure, international partnerships etc., what needs to be added is a coordinated effort to take initial discovery research leads/hits to product development through the value chain right up to manufacture and licensure/market authorisation involving various stakeholders.
"This effort can now be given the required momentum by bringing together the public and private sectors, researchers, manufacturers etc. to meet a targeted goal of developing drugs for priority pathogens A Mission on Therapeutics for priority pathogens needs to be launched urgently," it said.
The drug discovery efforts can be undertaken against viruses of pandemic potential through two major approaches - repurposing approved drugs and identification of novel compounds.
"Each approach has its advantages and disadvantages. Whichever approach one chooses, compounds must be characterized and taken up to phase 1 clinical trials to establish the safety of compounds. This way, compounds are primed and ready for a phase 2 study should the need arise. In the event of a pandemic, a limited phase 2 in patients should be planned and discussed with the Regulator to establish the efficacious dose range and safety considerations," it added.
Over 19,000 FDA-approved drugs have a full clinical package and dosing information, which does not have to go through phase I studies unless the doses predicted for human use fall outside the approved range. The approved drug library should be purchased and screened against a panel of viruses in whole-cell screening assays and with the criteria for hit selection defined, such compounds should be evaluated for pharmacokinetics by the oral and intravenous route in the efficacy species and then tested in vivo in the appropriate model, following which the compound should be further moved through the development process, it added.
For identification of novel compounds, there are two options, it says. The first would be to screen a library of compounds for activity against a panel of viruses. Such compounds should be evaluated for in vitro ADME, followed by pharmacokinetic studies. Compounds with PK profiles suitable for oral dosing should be tested for toxicity in the in vivo models and in rodent and non-rodent species for toxicity, following all requirements for NCE development as per NDCT 2019 rules. Studies should be undertaken to understand the mechanism of action, says the report.
The second approach would be to conduct an in-silico screen against specific viral targets, such as RNA polymerase, helicase, etc., selecting compounds that show affinity for essential viral proteins for more than one class of viruses. Such compounds should be tested for antiviral activity and target-specific activity. Medicinal chemistry and structure guided/AI guided drug design should be used to optimize the compounds. As with the other approaches, pharmacokinetic profiles, efficacy in vivo and toxicity studies should be undertaken for the best compounds. Toxicity studies should be undertaken as per NDCT 2019 rules.
Capacities need to be built for naïve human antibody library, a library of antiviral and antimicrobial compounds, animal models and computer simulations for testing drug efficacy and safety, and robust artificial intelligence (AI)-based platforms to quickly predict the protein structure that could be used to design drug molecules and vaccine candidates, it added.
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