Moore's Law is the opposite

How to provide humanity with affordable medicines

Dmitry Mungalov, Skolkovo Foundation

Familiar to many physicians and pharmacologists, the "Eroom law" is the direct opposite of Moore's law not only in spelling ("Eroome" is "Moore" on the contrary), but also in content. The "Eroom Law" states that it takes more and more time and money to create new drugs (the cost of development doubles every 9 years).

Graph from the article by Scannell et al. Diagnosing the decline in pharmaceutical R&D efficiency
(Nature Reviews Drug Discovery, 2012) – VM

In the coming years, humanity will have to find an answer to the question of how, without sacrificing safety and lowering strict regulatory standards, to prevent regression in the creation of new drugs.

This global paradigm became the backdrop for the two-day conference "Regulatory Aspects of Drug Development" at Skoltech on June 21. Opening the conference, its moderator, the editor-in-chief of the newspaper "Pharmaceutical Bulletin" German Inozemtsev recalled that one of the main topics of the recent St. Petersburg International Economic Forum was export orientation.

In this sense, the Skolkovo conference thematically quite echoes the SPIEF agenda. How to make a dossier to the regulatory authorities? What kind of research should be carried out and what is mandatory for a drug portfolio? How to conduct a dialogue with the US FDA (Food and Drug Administration, US Food and Drug Administration) and the European EMA (European Medicines Agency)? What are the differences in the registration of medicines in different regulatory authorities? How will medicines be registered in the Eurasian Economic Union if clinical trials are conducted in Russia? These are just some of the questions that the experts gathered in innograd are looking for answers to, among whom there are famous foreigners.

One of them is Karl Peck, associate professor at the University of California, head of the Center for the Theory of drug Development. He spoke about the history and principles of the FDA, created at the beginning of the XX century in order to sort out the chaos that reigned in the American food and drug market. At that time, there were cases when hundreds of people were poisoned with cough syrup, which included opium, insect particles and other exotic ingredients, and other goods sold without a prescription.

From a small laboratory in Washington for a hundred years, the FDA has turned into a powerful structure, employing 12 thousand people and whose budget is measured in billions of dollars. It was with the filing of the FDA (and with considerable opposition from the American medical community) in the 1960s that clinical trials of new drugs became mandatory. We owe the increased safety and effectiveness of medicines to just one letter "S" (in the FDA documents, the word investigation, "research", was replaced by investigations, that is, "research").

Vice-President of Skolkovo, head of the biomedical cluster Kirill Kaem told the audience about the activities of the Foundation. Skolkovo feels great. Yesterday we very successfully passed the Board of Trustees chaired by Prime Minister Dmitry Medvedev. The Fund exceeds all key indicators. Skolkovo – and this is partly due to regulatory issues – is becoming one of the main Russian centers for the protection of intellectual property," stated Mr. Kaem. A significant proportion of international applications for intellectual property objects generated in Russia are processed through the Skolkovo Intellectual Property Center.

"In a global sense, we are experiencing a moment when medicines are becoming more specialized. At the same time, they must be carried out through sufficiently high regulatory barriers. This means that the cost of each highly specialized drug increases and, as a result, the economy will not be able to cover these costs," Kirill Kai outlined the problem. – During one of my visits to the United States, I asked the Nobel laureate David Baltimore how it was possible to force the regulator to lower barriers. The answer was: the more we know about biology, the greater the security of developments should be provided."

On the second day of the conference, a master class for biomedical startups "Development of innovative medicines: from science to registration" will be held.

Portal "Eternal youth" http://vechnayamolodost.ru  22.06.2016