Module 2 discussion preparation- Swarnali Dasgupta

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1 Module 2 discussion preparation Swarnali Dasgupta Northeastern University Course name- BIOT5219 11290 The Biotechnology Enterprise SEC 01 Fall 2023 Section number- 01 Instructor’s name- Tina Karunaratne NUID- 002727749 Module- 02 09/20/23

2 1. Who is in charge of discovery and pre-clinical development? The discovery and pre-clinical development of new drugs is a responsibility of research scientists along with their research teams in pharmaceutical development labs or research institutions. New drugs are discovered using a variety of techniques: researching on a disease that helps to understand how to stop the disease progression, testing possible drug products, or working on new techniques altogether (Office of the Commissioner, 2018). Medicinal chemists, toxicologists and clinical pharmacologists also participate in discovery of drugs, wherein medicinal chemists are responsible for finding new potential drug molecules, toxicologists look at how such drugs are metabolized and clinical pharmacologists provide information related to dosing strategies during pre-clinical development (Holbrook & Garneau-Tsodikova, 2017). 2. What is the enterprise value of “Drug Trials Snapshot”? (meaning : why would a company review Drug Trials Snapshot?) “Drug Trials Snapshots” provide key information regarding demographic data, i.e. who participated in important clinical trials that were a part of the original FDA approval of a new drug (Center for Drug Evaluation and Research, 2023b). This makes it easy for biotechnology companies to keep a tab on the latest scientific advancements as well as good practices in drug development. Companies can also keep tabs on the drug trial snapshots to stay updated on the safety of drugs developed by other competitors. Apart from this, such data can also help a company assess the market value of any potential drug that they develop (Dow, 2017).

3 3. Go back to the US FDA's “Drug Trials Snapshot” and select a drug of interest. What drug or biologic did you select, and why? I selected the drug BARHEMSYS (amisulpride). I selected this drug because it treats a very common condition of Postoperative Nausea and Vomiting (PONV). Nausea, vomiting and retching make postoperative recovery unnecessarily complicated and patients often find PONV’s pain worse than the postoperative pain (Feinleib et al., 2023). Hence, I decided to select BARHEMSYS as my drug of interest, especially because it targets an often overlooked but important condition affecting a large number of people. 4. What does your drug or biologic do for patients? BARHEMSYS treats PONV, which is postoperative nausea and vomiting in patients. It can be used alone or along with another drug for the prevention of PONV. Patients who received BARHEMSYS reportedly had lesser nausea and vomiting and needed lesser supplementary medicine to prevent or treat PONV, than people who received the placebo drug (Center for Drug Evaluation and Research, 2020).

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4 References Center for Drug Evaluation and Research. (2020). Drug trials snapshots: BARHEMSYS. U.S. Food And Drug Administration . https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-ba rhemsys Center for Drug Evaluation and Research. (2023a). Drug trials snapshots. U.S. Food And Drug Administration . https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots Center for Drug Evaluation and Research. (2023b). Drug trials snapshots. U.S. Food And Drug Administration . https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots DeVito, S. C. (2017). The need for, and the role of the toxicological chemist in the design of safer chemicals. Toxicological Sciences , 161 (2), 225–240. https://doi.org/10.1093/toxsci/kfx197 Dow, A. K. (2017, May 4). FDA Launches Drug Trials Snapshot to Provide the Public with Information about the Clinical Trials Supporting New Drug Approvals | Health Law Advisor . Health Law Advisor. https://www.healthlawadvisor.com/2014/12/02/fda-launches-drug-trials-snapshot-to-provi de-the-public-with-information-about-the-clinical-trials-supporting-new-drug-approvals/ Feinleib, J., MD, PhD, Kwan, L., MD, & Yamani, A., MD. (2023, February 14). Postoperative nausea and vomiting . UpToDate. Retrieved September 20, 2023, from https://www.uptodate.com/contents/postoperative-nausea-and-vomiting#H2659650314

5 Holbrook, S. Y. L., & Garneau-Tsodikova, S. (2017). What is medicinal chemistry? – Demystifying a rapidly evolving discipline! MedChemComm , 8 (9), 1739–1741. https://doi.org/10.1039/c7md90030a Office of the Commissioner. (2018). Step 1: Discovery and development. U.S. Food And Drug Administration . https://www.fda.gov/patients/drug-development-process/step-1-discovery-and-developme nt

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