Pharma, Pharmaceutics and Biotechnology Conference

The drug development process is a rather very complex and multiple phase-oriented effort that takes a therapeutic concept from the earliest stages of discovery to marketing and the actual distribution on the market, as a viable treatment option. Several steps involve the process involved in discovery and preclinical research, clinical trials, regulatory review, and post approval monitoring. Each step within the processes posed challenges and requires collaboration in a wide range of scientific disciplines.

The first phase of drug discovery initializes the identification of targets which is essentially finding specific biological molecules or pathways that might be modulated for the treatment of a disease. High-throughput screening and lead compound optimization will help one find candidates to be further pursued in research.

Once such a compound has been found, preclinical testing examines the safety and efficacy of the compound in both laboratory and animal studies and, once satisfied, makes the determination that it has been found to be suitable enough for human trials. The following critical stages of drug development are clinical trials. The above stage is divided into three major phases. Phase I determines the safety of the drug in a small number of healthy volunteers or patients.

Now, intensive study is conducted on optimal dosing and pharmacokinetics of that drug. Phase II increases the participant pool while making efficacy a focus again while continuing to examine the drug's safety profile. Phase III enrolls thousands of patients at many research sites to confirm effectiveness and also for assessment of adverse effects, and all data are needed to file with a regulatory agency.

Once the clinical trial is conducted, regulatory agencies like FDA or EMA review the data to ensure this drug has met safety and efficacy standards for approval. Even after the drug receives approval, it is essential for conducting post-market surveillance on all long-term or rare side effects that may appear in the general population. Technology advances and better data analytics have been key drivers of drug development; AI and machine learning help speed up the identification of a target and precision medicine can allow more targeted therapeutic approaches.

In this session, we explore these advances and address issues of regulation and ethics with a special emphasis on the patient-centeredness of drug development. We will take it from these processes and innovations to shed light on strategies that will shape the future of pharmaceuticals and patient care.