The I All-Russian Scientific and Practical Conference with International Participation "Pharmaceutical Chemistry: Practical Implementation of Applied Science" brought together industry experts to discuss current challenges and solutions.
The track "Bioanalytical Studies at the Stages of Drug Development and Registration" was moderated by Timofey Komarov (SPHFA, CFA LLC) and Elizaveta Fisher (Sechenov University, LFI LLC), setting the tone for a rich discussion.
As part of the business program, speakers addressed key issues related to process optimization and regulatory requirements.
Maria Popova (CFA LLC) spoke about the advantages of centralized management of subcontractors, emphasizing that creating a unified digital platform makes it possible to reduce regulatory risks, optimize logistics, and ensure a high level of scientific expertise.
Elizaveta Fisher (LFI LLC, Sechenov University) provided a detailed overview of the requirements for the Comparative Dissolution Kinetics Test (CDKT) and the EAEU regulatory framework, including the new drug registration rules that come into force in 2025.
Experts also discussed practical aspects of bioanalytics and methodology.
Dmitry Grebyonkin (Exacte Labs LLC) examined the features of using enzyme-linked immunosorbent assay (ELISA), noting its indispensability for complex biological molecules, despite the advantages of mass spectrometry in result control.
Polina Karnakova (CFA LLC) emphasized the importance of ensuring that bioanalytical work complies with regulatory documentation to guarantee data reliability and reduce sponsor risks during early phases of clinical trials.
Evgeny Vishnyakov (SPHFA) spoke about the objectives of Dissolution Comparative Kinetics Studies (DCKS), which make it possible to prove bioequivalence without clinical trials, illustrating the methodology with practical case studies.
Special attention was paid to the challenges of study planning and innovative developments.
Evgeny Melnikov (Sechenov University) stressed that the lack of pharmacokinetic data necessitates pilot studies and close interaction among all process participants.
Yulia Yatskovskaya (CFA LLC) presented a unique enzyme-linked immunosorbent assay methodology developed for the study of an innovative ultra-long-acting insulin. Its successful validation became an important step in the fight against diabetes mellitus.
Timofey Komarov (CFA LLC) summarized 10 years of the center's work, noting the explosive growth in research on biotechnological drugs, particularly monoclonal antibodies. He emphasized that the COVID-19 pandemic accelerated the development of this field but created new challenges in the form of logistical difficulties and the need for import substitution of test systems.
Igor Shokhin and Natalia Bagaeva (CFA LLC) presented the evolution of release assessment methods. The speakers demonstrated that modern regulatory kinetics tests and PBPK modeling can predict drug success with high accuracy. They also noted the critical importance of close interaction between developers and analysts to increase the predictive value of studies.
The track "Bioanalytical Studies at the Stages of Drug Development and Registration" was moderated by Timofey Komarov (SPHFA, CFA LLC) and Elizaveta Fisher (Sechenov University, LFI LLC), setting the tone for a rich discussion.
As part of the business program, speakers addressed key issues related to process optimization and regulatory requirements.
Maria Popova (CFA LLC) spoke about the advantages of centralized management of subcontractors, emphasizing that creating a unified digital platform makes it possible to reduce regulatory risks, optimize logistics, and ensure a high level of scientific expertise.
Elizaveta Fisher (LFI LLC, Sechenov University) provided a detailed overview of the requirements for the Comparative Dissolution Kinetics Test (CDKT) and the EAEU regulatory framework, including the new drug registration rules that come into force in 2025.
Experts also discussed practical aspects of bioanalytics and methodology.
Dmitry Grebyonkin (Exacte Labs LLC) examined the features of using enzyme-linked immunosorbent assay (ELISA), noting its indispensability for complex biological molecules, despite the advantages of mass spectrometry in result control.
Polina Karnakova (CFA LLC) emphasized the importance of ensuring that bioanalytical work complies with regulatory documentation to guarantee data reliability and reduce sponsor risks during early phases of clinical trials.
Evgeny Vishnyakov (SPHFA) spoke about the objectives of Dissolution Comparative Kinetics Studies (DCKS), which make it possible to prove bioequivalence without clinical trials, illustrating the methodology with practical case studies.
Special attention was paid to the challenges of study planning and innovative developments.
Evgeny Melnikov (Sechenov University) stressed that the lack of pharmacokinetic data necessitates pilot studies and close interaction among all process participants.
Yulia Yatskovskaya (CFA LLC) presented a unique enzyme-linked immunosorbent assay methodology developed for the study of an innovative ultra-long-acting insulin. Its successful validation became an important step in the fight against diabetes mellitus.
Timofey Komarov (CFA LLC) summarized 10 years of the center's work, noting the explosive growth in research on biotechnological drugs, particularly monoclonal antibodies. He emphasized that the COVID-19 pandemic accelerated the development of this field but created new challenges in the form of logistical difficulties and the need for import substitution of test systems.
Igor Shokhin and Natalia Bagaeva (CFA LLC) presented the evolution of release assessment methods. The speakers demonstrated that modern regulatory kinetics tests and PBPK modeling can predict drug success with high accuracy. They also noted the critical importance of close interaction between developers and analysts to increase the predictive value of studies.