PCL469 Winter 2024_SGS2 Questions
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University of Toronto *
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469H
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Health Science
Date
Feb 20, 2024
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PCL469H Winter 2024 L. Edgar SGS2 Gastrointestinal & Respiratory Pharmacology: Mon. Feb. 5
th
2024, 2:00–4:00 pm 2:00 pm Group 3:00 PM Group TA Room Group A Group G Hani Choksi MS2377 Group B Group H Jonathan Chow MS4220 Group C Group I Paolo Giuliana MS2394 Group D Group J Janielle Richards MS3290 Group E Group K Kristen Schulz MY370 Group F Group L Phoebe Yan MY380 Tips to maximize your grade:
Please be prepared to answer the one question you were assigned. Your written response to a question should be a maximum of one 8.5” x 11” document, 12 pt Times New Roman font, minimum 2 cm margins. The one page limit includes all references (i.e. there is no separate page for references). If you are uploading a file to Quercus that is longer than one page then marks will be deducted. Please do not answer more than the one question from the one case study you were assigned. Case Study A: You are a Ph.D. pharmacologist working at a law firm that specializes in evaluating medical malpractice and pharmaceutical intellectual property lawsuits: 1.
A client tells you that her physician prescribed a newly released antihistamine drug to treat her heartburn. After starting the new medication, she began to gain weight and was recently injured in a car accident when driving her vehicle to work. She blames these events on the new drug and claims to have had no improvement in her heartburn symptoms. Propose a hypothesis to explain why this drug is not acting as intended. Include mechanistic details in your answer. What might be a more appropriate use for this drug? 2.
An elderly client with a family history of gastric cancer approaches you claiming that the proton pump inhibitor (PPI) his family doctor has prescribed is ineffective in treating his chronic gastroesophageal reflux disease. He claims the doctor will not agree to increase the PPI dose, which he thinks will help alleviate his symptoms. Does this patient have a case against his family doctor? Why or why not? Include mechanistic details of how PPIs work in your answer. What disease is the patient at risk from without
acid management therapy? 3.
A pharmaceutical company hires your law firm to do a market analysis of drugs to treat seasonal allergies. They claim to have developed an atypical antihistamine that decreases biosynthesis of histamine in mast cells. How might this drug work to relieve the symptoms associated with allergic reactions to environmental allergens? Be specific with respect to mechanism. Which classes of drugs would be the major competitors and how are their mechanisms different than this new drug?
PCL469H Winter 2024 L. Edgar SGS2 Gastrointestinal & Respiratory Pharmacology: Mon. Feb. 5
th
2024, 2:00–4:00 pm Case Study B: You are in a leadership position within Health Canada’s Health Products and Food Branch (HPFB), the federal agency that is responsible for evaluating, approving, and regulating drugs: 1.
A large pharmaceutical company has submitted a new therapeutic for evaluation by HPFB. This drug is intended to treat asthma and is considered a ‘first in class’ therapeutic. The drug is a small molecule that interacts with both Fc
e
RI and Fc
g
RIII and prevents these proteins from binding their cognate (‘natural’) ligands. Propose a mechanism of action for this drug in the context of asthma pathophysiology. Be specific with respect to the cells and molecules/proteins involved. Do you expect this drug to cause any unwanted side effects? Explain your answer. 2.
Another pharmaceutical company approaches HPFB requesting approval to sell a combination therapy of Fluticasone, Dupilumab, and low dose Omalizumab. The drug combination is intended to treat asthmatic patients. Would you recommend the agency approve this therapy? Why or why not? Justify your answer by discussing mechanisms of action, route(s) of administration, and the potential benefit (or not) to the patient. 3.
HPFB approved a drug three years ago to treat asthma that is now in post-market (phase 4) surveillance. Clinicians have submitting disturbing reports indicating that patients initially had reduced asthma symptoms but are now showing no clinical benefit and, in some cases, develop airway constriction that is more severe than before they started treatment. The drug, Breathomab, is an IgG1 antibody against a protein, CCR8, expressed on Th2 cells. How is the drug intended to work (propose a mechanism) and provide a hypothesis as to why patients are no longer responding and developing new symptoms.
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