business

The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recognized that the principles based on sound science and the potential for risk, as described in the WHO Guidelines on post-approval changes, which constitute the global standard for product life-cycle management are providing clarity and helping national regulatory authorities in establishing guidance while improving time-lines for an efficient regulation of products. Consequently, the regulatory situation for post-approval changes and guideline implementation is changing but there is a disparity between different countries. While the guidelines are gradually being implemented in some countries and also being considered in other countries, the need for regional workshops and further training on post-approval changes was a common theme reiteratedmore...

At the present time, gene technologies play a key part in the development of new approaches to the diagnostics and therapy of diseases. Russian scientists have already successfully introduced efficient preparations based on multiclonal antibodies into practice and have advanced developments in the fields of CAR-T therapy and gene-therapy preparations on the basis of recombinant adenoassociated viruses. Some gene diagnostic tools, which essentially improve the efficiency of medical care due to the personalized approach to the therapy of diseases, are also put into practice. The successful introduction of innovative technologies and contemporary methods of diagnostics and therapy is impossible without cooperation between academic science and business. The companies providing the conditions for cooperation with academic science and engagement of specialists of different profiles have hastened the mass introduction of gene technologies and, therefore, the defeat over many earlier incurablemore...

This chapter describes the creation and growth of Biocad, an innovative biotechnology company in Russia founded and headed by a forwardthinking and risk-taking banker, Dmitrii Morozov. Based on his vision and leadership, the company grew from distributing popular generic drugs for the Russian market to developing new medications that management hoped would compete in global markets. The company is a success story in the field of academic and scientific entrepreneurship, and demonstrates how scientific research can be moved from the ivory tower and applied to the commercialization of products in the competitive marketplace. Creating and growing the business was achieved despite a myriad of obstacles stemming from the legacy of the Soviet system and the chaotic environment of transition toward a market economy. These included difficulties in obtaining funding, implementing market-oriented business systems, hiring managers and motivating scientists to shift from a purely academic mindset to onmore...