Pharma, Pharmaceutics and Biotechnology Conference

In a nutshell, the development of drugs is a very complex, multifaceted process by which an exciting therapeutic idea transforms into an effective medication for the use of patients. The session will cover the various stages of drug development with the focus on innovative approaches and problems encountered in developing therapies for infectious diseases.

Drug development primarily starts with the discovery process wherein there is identification of the potential therapeutic targets, usually because of an understanding of the disease mechanisms. This stage includes high-throughput screening, structure-based drug design, and optimization of lead compounds to enhance their efficacy and safety. Once identified as a promising candidate for a drug, it undergoes laboratory or animal studies for preclinical research into the drug's pharmacokinetics and pharmacodynamics, besides its safety.

The drug then goes to clinical trials, which are divided into three phases. In Phase I, first safety would be concerned because it will be administered to small numbers of healthy volunteers in order to determine its best dosage and possible side effects. Further studies in larger patients would continue in Phase II to test the efficiency of the drug and enhance its safety. The number of subjects in Phase III trials is much larger and aims at determining whether the studied drug is better than those existing today or even better than the placebo.

Consequently, this phase leads to providing it with all the data it needs for approval by regulatory agencies. This is the regulatory environment in which drug development takes place. The FDA and EMA, influential regulatory agencies globally, insist that new drugs intended for marketing in the markets should be backed by a comprehensive data from clinical trials. There is an adequate documentation and observance of GCP standards.

The whole drug development process is also changing dramatically with the advantage of technological breakthroughs, including artificial intelligence, and trends in personal medicine in its aim to streamline discovery and maximize outcomes for patients. Challenges in developing drugs against infectious diseases-the areas of antimicrobial resistance and the need for rapid responses to emerging pathogens will be covered in this session.

The attendees would get an overall view of the drug development process, from discovery to market entry, encompassing clinical trials, all built on innovative strategies versus the regulatory landscape shaping the future of therapeutic development.