The Università Campus Bio-Medico di Roma opens its 25th Academic Year with the Minister of Health Beatrice Lorenzin, the President of the Lazio Region Nicola Zingaretti and the President of the Conference of Rectors Giancarlo Manfredi. In the speech by the pharmacologist and dean of the Departmental Faculty of Medicine and Surgery, Giorgio Minotti, some possible future scenarios of international pharmacology
Rome, 22 November 2017 Failure to transfer the EMA to Milan it was decided by bad luck and the cumbersomeness of an elective mechanism that leaves to chance such important decisions for industrial development and for access to medicines by hundreds of millions of patients. But it won't be a matter of good or bad luck to seize the therapeutic opportunities and related industries offered by the approximately 7 drugs in clinical trials worldwide, which with increasingly personalized therapies open up new treatment perspectives. A spring of research and development in the pharmaceutical sector, favored by the transition from old to new models of innovation, which however has seen the costs of drugs rise. In many ways, therefore, a 'perfect storm' is brewing between patient hopes and risk of financial unsustainability. In summary, this is the picture drawn by the professor Giorgio Minotti, Pharmacologist and Dean of the Departmental Faculty of Medicine and Surgery of theUniversità Campus Bio-Medico di Roma (UCBM) in the Prolusion "Pharmacology of the crisis", delivered on 22 November on the occasion of the inauguration of the 2017-18 Academic Year of the University, the twenty-fifth of UCBM.
"However, the horizon of pharmaceutical innovation is less frowning than what the numbers would suggest, because the financial sustainability of the new therapies – explains Minotti – will be at least partially counterbalanced by prescriptive appropriateness and optimization of the cost-results ratio. Thanks to genetics, the personalization of therapies allows, and will increasingly allow, to reduce healthcare costs generated by side effects or lack of therapeutic effect. We then go towards the medicine of the right drug to the right patient at the right time". Basic, according to the Professor, will be adequate training of doctors in the optimal use of the new therapeutic weapons".
Un virtuous example how this can happen transforming a crisis into new opportunities, comes from the case of a anti-leukemic drug. "Approved by the American FDA - the Professor recalls - it is first withdrawn from the market after a peak in vascular adverse events and then reintroduced in view of its life-saving effect. In Italy, a courageous program of training and information for doctors, conducted by the manufacturer in collaboration with experts from the university world, including UCBM, has allowed us to better understand the drug profile and allow one safe and prolonged administration, more than in the rest of the world, including the United States where the drug was patented".
What is certain is that there will be an increasing need for appropriateness to guarantee the sustainability of the new drugs on the way. A good seven thousand in clinical development (1.813 in oncology, 1.329 in neurology, 1.257 against infectious diseases, 1.211 immunological, 599 cardiovascular, 511 for behavioral disorders, 475 for metabolic diseases, 159 against HIV.
"A turning point that starts from afar, from the breaking point of the year 2000, when – explains Minotti – moving from a closed drug development system to an open one, where several industries, but also Universities, public and private Research Centers, Biotechs, collaborate on a model of open innovation". "A system that also involves patients and their quality of life requests, and which has led to a significant decrease in drug development failures".
To decree the success of the turning point are the numbers illustrated in the Prolusion: with the transition to the open system early stage clinical trial failures have decreased 50 to about 30%, to decrease further in the more advanced stages. A success that made it possible to reinvest in research and development and bring the molecules of potential interest from 6 in 2001 to almost 15 in 2017. A real record of investment in research, which in the pharmaceutical sector have reached the 18,3% of the entire turnover, more than any other production sector, which for computers and electronics does not reach 12%.
"Data – concludes Professor Minotti – which show how from crises we can emerge victorious by opening up to opportunities instead of falling back on outdated models. A lesson that the drug industry has treasured, but which applies to everything else, from politics to the economy and, why not, even for our unfortunate football".
