APPROACHES AND TASKS DIVISION FOR ACADEMY - INDUSTRY PARTNERSHIP ON NEW DRUGS DISCOVERY IN BRAZIL

EDUARDO PAGANI, MD, PhD(1)

(1)Clinical Trials Manager from Cristalia

The first word pharmaceutical companies proudly divulges that for every 10,000 new synthetic compounds screened, 250 start pre-clinical studies, 5 arrive to the clinical phases and only one is finally marketed. This "compound killing" approach costs over $800,000,000.00. Many argue that this number is artificially inflated. The real number could lowered to a half, but hardly to a tenth of it. This is still too much for Brazilian sponsors to afford. Brazilian scientists and pharmaceutical companies could and should work together in order to propose a cheaper but trustable approach for new drugs discovery. Toxins allow for a "compound optimization" approach that could avoid exhaustive screening. Accidental poisoning by natural toxins produces clinical manifestations attributable to toxin’s components. Some can be isolated and purified giving birth to drug candidates. The first task is to perform in vitro and in vivo experiments aimed to widen the comprehension on its biological effects. The demonstration of any effect in concentrations below 10-8 M is a strong indicator of specificity. Up to this point, the job was predominantly done by the academy, more tolerant to negative results after long time spending especially if these could be published. But, if a specific biological effect was consistently demonstrated, a putative target should be chosen and validated. It is the time for publication refraining, geting advice on patentability and looking for partnership with a pharmaceutical company. The next tasks are: toxicity and pharmacokinetic assessing. These studies are better performed by specialists. These can be in the academy or in a private institution. The industry can contract and support the service. This information will drive the compound’s optimization. Could the molecule weight be lowered? Could anything be done to improve its bioavailability? What is the best way to write the patent? The industry can provide financial support as well as technical advice on these subjects. It also can perform a preliminary evaluation of marketability. After the formulation establishing by the industry, the clinical trials start. They are usually projected together by the academy and the industry, conducted at the academy and monitored and sponsored by the industry. The submission of the dossier to the health authorities is a bureaucratic and heavily regulated task better performed by the industry. The pharmacovigilance starts after product launching. This is also an industry’s task.