Höre HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

In this episode, we discuss the very early stages of drug targets and drug development with Dr. Mohd Shahid, PhD. Dr. Shahid’s research involves the IER3 gene, which is an important modulator of the body’s inflammatory response via its action in major immune cells, including macrophages and T-cells, and plays a role in metabolic disorders such as obesity, diabetes, and atherosclerosis, revealing a previously unknown function of this protein. Key Concepts 1. Drug development is a multi-decade journey – human clinical trials occur very late in the process. Drug development often starts before a drug molecule is even conceived by identifying potential drug targets. 2. Chronic inflammation is important for a variety of diseases, including obesity and atherosclerosis. Dr. Shahid’s work focuses on a specific gene, Immediate Early Response 3 Gene (IER3 or IEX-1), and its role in modulating the inflammatory response in these disease states. 3. The research process frequently leads to unexpected discoveries and new lines of inquiry. With Dr. Shahid, his work in obesity and inflammation actually led to a new understanding of the IER3’s role in the interplay between macrophages, inflammation, and energy expenditure. References * Shahid M, Javed AA, Chandra D, et al. IER3 deficiency induces browning of white adipose tissue and resists diet-induced obesity. Sci Rep. 2016;6:24135. Published 2016 Apr 11. doi:10.1038/srep24135 * Shahid M, Hermes EL, Chandra D, et al. J Am Heart Assoc. 2018;7:e009261. DOI: 10.1161/JAHA.118.009261. * Ridker PM, Danielson E, Fonseca FA, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359(21):2195-2207. doi:10.1056/NEJMoa0807646 * Tardif JC, Kouz S, Waters DD, et al. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019;381(26):2497-2505. doi:10.1056/NEJMoa1912388

In this episode, we review the new 2025 ACC/AHA Acute Coronary Syndrome (ACS) guidelines, with a particular focus on guideline recommendations for analgesics, P2Y12 inhibitors, parenteral anticoagulation, and lipid management. Key Concepts 1. Nitrates and opioids are recommended for symptomatic relief of chest pain. Some patients may not be appropriate for nitrates (e.g. recent PDE-5 inhibitor use, hypotension, or right ventricular infarction). Opioids are used for nitrate-refractory angina but have a theoretical risk of delaying the effect of oral antiplatelet medications. 2. Prasugrel and ticagrelor are preferred P2Y12 inhibitors over clopidogrel in most patients. Patient-specific factors, including the use of PCI, play a role in P2Y12 inhibitor selection. 3. Anticoagulation with heparin is recommended in nearly all acute coronary syndrome (ACS) scenarios. Alternative anticoagulants may be used depending on whether PCI/CABG is planned and whether the anticoagulant is used prior to PCI/CABG (“upstream”) or during the PCI procedure itself. 4. LDL goals after ACS have changed again. All ACS patients should have an LDL goal < 70 with a consideration of an LDL goal of 55-69. A variety of non-statin therapies may be added to a high intensity statin regimen if LDL is not at goal. References * Rao SV, O'Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. Published online February 27, 2025. https://www.ahajournals.org/doi/10.1161/CIR.0000000000001309

In this episode, we interview Morgan Anderson, PharmD, BCIDP, a graduate of the RFUMS College of Pharmacy, about her career path from a pharmacy resident, emergency medicine specialist, infectious diseases specialist, and now a medical sciences liaison. The views, thoughts, and opinions expressed in this podcast are solely Dr. Anderson’s own and do not necessarily reflect the views, positions, or policies of her employer. This podcast is conducted in a personal capacity, and any reference to her professional background is for context only. Key Concepts 1. Having a wide breadth of skills and making yourself marketable is important when transitioning between jobs or career paths. Skills like communication and teamwork can be improved and are applicable to a wide variety of careers within pharmacy. 2. Medical Science Liaisons (MSLs) are a common role for pharmacists in the pharmaceutical industry. MSLs are field-based roles within the medical affairs department of the company. MSLs are medical and scientific experts who build collaborative relationships with key thought leaders, facilitate exchange of scientific information and insights, and serve as a conduit between these thought leaders and other areas of the company. 3. Two common career paths to pharmacists becoming an MSL are via a fellowship program or after years in clinical practice. A fellowship program provides a more structured approach, including mentoring and networking, with access to a variety of areas of the company outside of medical affairs. A pathway after clinical practice is more self-directed with less structure, but provides pharmacists with a strong clinical background that can be helpful in an MSL role. 4. Being a scientific communicator, possessing strong emotional intelligence, and being adaptable are critical soft skills that are essential for success in an MSL role. These soft skills can be improved with practice! References * https://www.industrypharmacist.org/ [https://www.industrypharmacist.org/]

In this episode, we discuss the efficacy and safety of semaglutide and tirzepatide for weight loss with a particular focus on the legal, regulatory, and safety aspects of these “compounded” GLP-1 receptor agonist medications. Key Concepts 1. Semaglutide and tirzepatide have growing evidence that their clinical benefits extend beyond the treatment of diabetes. Evidence now shows benefit in a variety of obesity-related disease states regardless of a patient’s diabetes status. 2. Insurance coverage and drug cost is a major barrier to these medications, with cash prices exceeding $1000 per month in the US. There are many companies that are combining telemedicine visits with “compounded” GLP-1s to provide these medications at a reduced cost. 3. The Food, Drug, and Cosmetic (FD&C) Act regulates compounded drugs. These regulations provide the legal context for pharmacies to compound GLP-1 medications. These regulations describe who can compound, what drugs can be compounded, and other unique circumstances (e.g. compounding in the context of a drug shortage). 4. The FDA has released warnings regarding safety risks of compounded GLP-1s. The main safety concern is dosing errors; however, the warnings also include concerns of patients accessing drug products that are outside of the legal scope of the FD&C Act. The recent ADA statement recommends against the use of compounded GLP-1s due to these concerns. References * Karagiannis T, Malandris K, Avgerinos I, et al. Subcutaneously administered tirzepatide vs semaglutide for adults with type 2 diabetes: a systematic review and network meta-analysis of randomised controlled trials. Diabetologia. 2024;67(7):1206-1222. doi:10.1007/s00125-024-06144-1 * Müllertz ALO, Sandsdal RM, Jensen SBK, Torekov SS. Potent incretin-based therapy for obesity: A systematic review and meta-analysis of the efficacy of semaglutide and tirzepatide on body weight and waist circumference, and safety. Obes Rev. 2024;25(5):e13717. doi:10.1111/obr.13717 * Jastreboff AM, Le Roux CW, Stefanski A, et al. Tirzepatide for Obesity Treatment and Diabetes Prevention. New England Journal of Medicine. 2024. https://www.nejm.org/doi/full/10.1056/NEJMoa2410819 [https://www.nejm.org/doi/full/10.1056/NEJMoa2410819] * Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (CMS-4208-P). https://www.cms.gov/newsroom/fact-sheets/contract-year-2026-policy-and-technical-changes-medicare-advantage-program-medicare-prescription [https://www.cms.gov/newsroom/fact-sheets/contract-year-2026-policy-and-technical-changes-medicare-advantage-program-medicare-prescription] * Human Drug Compounding. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding [https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding] * Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. https://www.fda.gov/media/98973/download [https://www.fda.gov/media/98973/download] * FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products. https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded [https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded] * FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss [https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss] * Nomination of Semaglutide Products to the Demonstrable Difficulties for Compounding Lists. https://www.regulations.gov/document/FDA-2017-N-2562-0029 [https://www.regulations.gov/document/FDA-2017-N-2562-0029] * Neumiller JJ, Bajaj M, Bannuru RR, et al. Compounded GLP 1 and dual GIP/GLP 1 receptor agonists: A statement from the American Diabetes Association. Diabetes Care. 2024 Dec 2:dci240091. doi: 10.2337/dci24-0091.

In this episode, we review the recommendations from the 2024 SCCM/ASHP stress ulcer prophylaxis guidelines and highlight three of the more recent landmark critical care trials investigating the role of stress ulcer prophylaxis. Key Concepts 1. After 25 years, the stress ulcer prophylaxis guidelines have been updated by SCCM and ASHP. These guidelines make 13 recommendations in a PICO format. 2. Three large, landmark randomized controlled trials (SUP-ICU, PEPTIC, and REVISE) have significantly contributed to the body of literature regarding stress ulcer prophylaxis. 3. The SCCM/ASHP guidelines recommend stress ulcer prophylaxis in patients with coagulopathy, shock, chronic liver disease, and possibly in neurocritical care patients. They do not specifically recommend prophylaxis in mechanically ventilated patients; this is a controversial recommendation. 4. The SCCM/ASHP guidelines equally prefer proton pump inhibitor (PPI) and histamine-2 receptor antagonists (H2RA) drug therapies given either intravenously or orally. The prophylaxis regimen should be continued until the indication for prophylaxis has resolved or the patient leaves the ICU. References * MacLaren R, Dionne JC, Granholm A, et al. Society of Critical Care Medicine and American Society of Health-System Pharmacists Guideline for the Prevention of Stress-Related Gastrointestinal Bleeding in Critically Ill Adults. Crit Care Med. 2024;52(8):e421-e430. doi:10.1097/CCM.0000000000006330 * SUP-ICU study. Krag M, Marker S, Perner A, et al. Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU. N Engl J Med. 2018;379(23):2199-2208. doi:10.1056/NEJMoa1714919 * PEPTIC study. PEPTIC Investigators for the Australian and New Zealand Intensive Care Society Clinical Trials Group, Alberta Health Services Critical Care Strategic Clinical Network, and the Irish Critical Care Trials Group, Young PJ, Bagshaw SM, et al. Effect of Stress Ulcer Prophylaxis With Proton Pump Inhibitors vs Histamine-2 Receptor Blockers on In-Hospital Mortality Among ICU Patients Receiving Invasive Mechanical Ventilation: The PEPTIC Randomized Clinical Trial. JAMA. 2020;323(7):616-626. doi:10.1001/jama.2019.22190 * REVISE study. Cook D, Deane A, Lauzier F, et al. Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation. N Engl J Med. 2024;391(1):9-20. doi:10.1056/NEJMoa2404245