In recent decades, the pharmaceutical industry has experienced increasing difficulty in returning to investments in research and development of new drugs, finding itself in a sort of double constraint: the need to constantly renew the “pipeline” of new products in a context in which development costs have grown exponentially. An indicator of the trend are the costs of placing a new drug on the market, which doubled every 9 years, compared with a higher probability of failure during the trial. Over the years there has been an annual growth of about 3.6% in drug research and development costs, against a growth in sales of no more than 2%.
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It is clear that the international context of pharmacological research is destined to change in all sectors, including cardiology. The “good for all” drug paradigm is evolving towards the new, which envisages a very personalized approach to therapies, the drug “good for everyone”. For this, the industry needs data that come directly from biology and from patients, through the “omics sciences”, such as genomics, proteomics, metabolomics, which respond to the need to efficiently identify molecular targets for new drug therapies advanced, reducing times and costs of production and placing on the market.
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It is a revolution in the drug development process, which has been driven up to the present day by the “Ehrlichian” concept of specificity of the interaction between a drug and a molecular target, through the mechanistic model of the “key” (drug) and of the “lock” (molecular target), which presupposes a reductionist approach to biology. The modern approach of pharmacology must take into account the complexity of biological systems and recognize that a drug targets not a single biological molecule, but a set of molecules, which interact within a more complex biological network. The problem that arises from such a paradigm shift is the management of the enormous amount of biological data.
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at Federico Mereta
And here comes the second factor of change, the digital technologies, a fundamental ally of academic and industrial research. According to Farmindustria, companies in the health sector will take the path of digital innovation: 88% plan to bring it into production and 71% into research. It is a market that, in Italy, according to a study by the Milan Polytechnic, is worth 1.1 billion euros. The reason for such interest is soon said.
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The management of data derived from biology, the so-called big data, through innovative computational processes, such as machine learning and artificial intelligence, capable of predicting drug targets and operating “simulated” clinical studies, accelerates the process of discovery of new targets and / or drug repositioning.
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There follows a positive impact both from the point of view of the “time to market” of a drug, and economic, reducing costs and times. The industry and the world of biological and technological research are called to create new forms of collaboration to favor more effective ways of carrying out research and innovation. Covid-19 has taught that the winning model is an alliance between industry, start-ups, research centers, institutions and intermediate bodies representative of the public interest. It would be essential, I say this thinking of our country, not to disperse this teaching.
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at Federico Mereta
* Scientific Director Monzino Cardiology Center, Irccs, Milan
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