II All-Russian Scientific Conference “Modern drug toxicology: fundamental and applied aspects”
The II All-Russian Scientific Conference “Modern Drug Toxicology: Fundamental and Applied Aspects” was held on June 13-15, 2017. It was prepared by the Federal Agency for Scientific Organizations of the Russian Academy of Sciences as part of the NIIFiRM named after E.D. Goldberg and the Research Institute of Pharmacology named after VV Zakusov.
Andrei Dmitrievich Durnev, Corresponding Member of the Russian Academy of Sciences, Professor (VV Zakusov Research Institute of Pharmacology) and Prof. Dr. med. Director of Goldberg Research Institute of Pharmacology and Regenerative Medicine of Tomsk National Research Medical Center of Russian Academy of Sciences Vadim V. Zhdanov provided remarks on the conference opening.
They noted the need for the exchange of experience and training of new qualified specialists in the field of preclinical studies of drug safety and the introduction of rules of good laboratory practice. According to experts, the introduction of new methods and knowledge in the field of drug development and harmonization with international experience is also relevant.
Arina I. Selezneva, Deputy Head of the Department of Preclinical Research at FSI “SID&GP”, showed the main trends and developments of personalized medicine in the world, evaluated the possibilities of using methods and knowledge of pharmacogenomics in drug development (presentation). The report aroused interest among the professional community of toxicologists, further discussion led to the identification of directions for the development of personalized medicine methods in the domestic pharmaceutical industry, including as a part of research activities to evaluate the safety of new drugs.
According to one of the latest FDA reporting reports, for the third year in a row, personalized drugs accounted for more than 25% of all new drugs approved in the United States (FDA).
The Personalized Medicine Coalition (PMC FDA) report indicates that out of 22 drugs approved by the FDA in 2016, 6 are personalized drugs: Rubraca (rucaparib), Exondys 51 (eteplirsen), Epclusa (sofosbuvir and velpatasvir), Tecentriq (atezolizumab) , Venclexta (venetoclax), Zepatier (elbasvir and grazoprevir). The half are oncology drugs. This continues the three-year trend, which PMC first documented in 2014, when they reported that 9 out of 41 approved medicines were recognized as personalized.
The approval of new drugs that are based on diagnostic medicine and the choice of markers in drug development signals a shift towards a personalized health care system.
On June 16, 2017 the representatives of the FSI “SID& GP” visited the SPF vivarium of the Institute of Cytology and Genetics of the SB RAS and Koltsovo Biotechnopark The parties exchanged experience and knowledge and outlined areas for further cooperation in the field of drug development and research aimed at the development of the pharmaceutical industry in the Russian Federation.
- Leading world regulatory agencies discussed the future of remote GMP inspections at ISPE Global Pharmaceutical Regulatory Summit
- Competition announcement for the best symbol of the GxP Academy
- The National scientific center for pharmaceutical evaluation and projects expertise was established on the basis of FSI “SID&GP”
- The Eurasian Academy of Good Practices will host the first GxP-Fest
- The Opening of the GxP Academy unites regulators from the EAEU countries.