Kristine Tran, PharmD Candidate
Today, Dr. Elinore Chung was the guest speaker and the topic was drug development and medical affairs. Dr. Chung currently works in clinical development at Regeneron Pharmaceuticals. I learned a lot about the different phases of drug development. Drug discovery can occur between two to five years. Interestingly, we can discover monoclonal antibodies in eight months. The first stage of drug development and it is known as preclinical phase. Phase 1 is where we test healthy volunteers and safety is the major priority. Phases 2-4, on the other hand, are important for efficacy. FDA considers phase III, which confirms efficacy and it is a larger scale than phase 2. I learned that it takes 1 billion dollars and 10 years to bring a new drug to the market. Overall, I thought this seminar was very interesting because I was able to learn a lot about the process of drug development.
Heather Nguyen, PharmD Candidate
Dr. Elinore Chung’s seminar on Drug Development & Medical Affairs was very informative, and I was able to learn the whole process through her presentation. The whole drug development process may take up to 10-15 years to get a drug approved. Discovery of the drug and drug design may occur within 3-5 years, while the clinical trials (phases 1-4) may take 2-10 years. However, Dr. Chung says she rarely sees any drugs that are developed within 2 years and that is a bit aggressive. She goes over each of the phases in drug development and informs us that each phase focuses of safety. Efficacy is monitored and more volunteers are recruited after Phase I of drug development. She stresses the important of phase 4 clinical studies as it is the phase that catches any safety concerns that were not monitored or caught in the previous phases. She also talks about MSLs, also known as Medical Science Liason, and they are involved once the drug goes through approval. MSL is involved in delivering scientific presentations, competitive intelligence gathering, medical publications, training or supporting sales forces, etc. She works in the MSL and informs us about the positives and challenges of her occupation. One of the challenges is that MSLs are under a lot of regulation and under a lot of pressure.