What is Clinical Development? [Article]

This past Monday, our fellows kicked off our Summer Webinar Series! The five-part series is meant to give prospective applicants and those interested in industry more information on the functional areas of our fellowship program. In addition to hosting the series, the fellows have also written a series of blog articles on their functional area that will be published every Wednesday following the webinar.

The first webinar’s topic was on Clinical Development and was hosted by one of our first year Novartis fellows, Rowshan Chowdhury.

Clinical Development in the Pharmaceutical Industry

Drug development is a lengthy process by which new medications are brought to patients. This process can last anywhere between 10-20 years depending on how long it takes to complete the discovery and testing phases . From what starts out as almost 5000 “hits,” 10 might make it to clinical testing. If we are lucky, we will find one new medication that the FDA approves. So how does this process work?

The first thing to keep in mind is that drug development should begin and end with the patient. In the discovery phase, we have to identify the mechanistic link to the disease we are treating. The pathology drives the target that we aim to use throughout screening.

Once we find a promising target (and have a patent in hand!), we now have to characterize the preclinical safety profile using animal models. Following these preclinical toxicology studies, an Investigational New Drug (IND) or Clinical Trial Application (CTA) filing, Investigator’s Brochure, and Clinical Trial Protocol are submitted to regulatory authorities and clinical sites to begin testing in humans.

Clinical testing is split into Phases I-IV with each part serving a different purpose. In Phase I, we are concerned with the safety, tolerability, and the pharmacokinetic/pharmacodynamic (PK/PD) profile of our new entity. If the results support it, we move on to a larger Phase II trial where we further characterize the safety profile of our candidate drug in addition to determining the efficacy of it. We can then take our drug to Phase III testing. These trials are called pivotal trials and are used to confirm previous findings, compare the new drug to the current standard of care or placebo, as well as the adverse effect profile. Phase IV testing is used to assess the long term safety and effectiveness of our now FDA approved drug.

So where does the pharmacist fit into this process? Realistically, it can be at any point within the drug discovery phase, but it’s dependent however on their training. For example, trial managers are involved in the development, start-up, maintenance, and close out of clinical studies. This role entails key deliverables such as being a compiler for an Investigator’s Brochure, contributing to the annual program update to health authorities, running dose escalation meetings, managing day-to-day operations, contributing to the clinical study report, as well as other key project management aspects of the trial. Pharmacists are trained in the areas of clinical research and drug development. Combined with their clinical knowledge, they are able to effectively transition into this managerial position.

The value of a clinician extends beyond the confines of our traditional roles. Being involved in this process affords pharmacists the opportunity to make a large-scale impact on the lives of patients for years to come.

Rowshan Chowdhury, PharmD, is a Translational Clinical Oncology Post-Doctoral Fellow with MCPHS University and Novartis

Missed the webinar? Head over to the link below to watch the recording! Please note that you will be asked to provide a name and email to access the replay. We ask for a login for administrative purposes for the Recruitment Team who organizes our webinars.

Webinar Replay Link (the video does take some time to load once you hit play)