On September 18-19, the annual educational course of the cluster of biomedical research of the Skolkovo Foundation for the Development of Innovative Drugs was held. Representatives of start-ups, pharmaceutical companies and contract research organizations met at the event. The seminar consisted of theoretical and practical parts.
Natalia Vostokova, Chief Operating Officer of IPHARMA, spoke on September 18 with the first report on the topic "Clinical Development of Drugs: Science as a Business":
• Critical points of clinical development
• What the regulator wants: how to take into account all requirements
• Minimizing risks or minimizing costs
Within the framework of the seminar program, topical reports were made by the staff of the Center for Scientific Advising (CSA) on all stages of developing innovative medications from the idea to registration. Representatives of start-ups and pharmaceutical companies shared their experience in coordinating the preclinical and clinical development program with American, European and Russian regulatory agencies under the scientific advisory procedure.
The second day saw the presentation of the concepts of developing two drugs from start-ups "Domestic Pharmaceutical Technologies" (innovative targeted drug for the treatment of cancer) and "PharmaDiol" (anticoagulant of a new generation). During the expert evaluation and discussion between the participants of the session, general recommendations were developed on further steps of start-ups.