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Joshua J. Gagne, Pharm D.
Research Fellow, Brigham and Women's Hospital
Associate Professor of Medicine, Harvard Medical School

Brigham and Women's Hospital
Department of Medicine
Phar Epid & Phar Econ
75 Francis Street
Boston, MA 02115

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Research Narrative:

As a pharmacoepidemiologist, my main research theme is the development and application of epidemiologic and statistical methods for rapidly generating comparative effectiveness and safety information shortly after medical products enter the market.  Most of this work focuses on large administrative claims databases, but more and more we're looking to integrate additional data sources such as EHR and lab data.  I conduct a large portion of my work within the context of FDA's Mini-Sentinel pilot project, part of FDA's Sentinel Initiative, which aims to develop the infrastructure, methods, and governance to monitor the safety of regulated products in near-real-time using large electronic healthcare databases.  We've recently built an in-house prototype of a semi-automated active drug safety monitoring system that can be rapidly deployed across a distributed network of electronic healthcare databases.  The key features of the system are that it identifies initiators of a drug(s) of interest and a comparator(s) of interest, propensity-score matches them to control for confounding by a large number of variables, follows the patients for outcomes of interest, and applies algorithms to generate alerts when a safety issue is suspected.  We've had great success in applying the system to multiple drug-outcome examples.  In a retrospective validation, the system was able to detect cerivastatin-induced rhabdomyolysis a year before the drug was withdrawn from the market and rofecoxib-induced myocardial infarction more than two years before rofecoxib's withdrawal.  The system has not generated any false positives for a growing number of negative controls.  I'm also interested in general epidemiologic methods advancement for improving causal inference and in other areas of appropriate drug use and drug policy.

Jefferson Medical College, 2011, MS
Harvard School of Public Health, 2008, SCD
University of Rhode Island, 2005, Pharm D.

Publications (Pulled from Harvard Catalyst Profiles):

1. Straub L, Gagne JJ, Maro JC, Nguyen MD, Beaulieu N, Brown JS, Kennedy A, Johnson M, Wright A, Zhou L, Wang SV. Evaluation of Use of Technologies to Facilitate Medical Chart Review. Drug Saf. 2019 Sep; 42(9):1071-1080.

2. Connolly JG, Schneeweiss S, Glynn RJ, Gagne JJ. Non-Vitamin K Antagonist Oral Anticoagulants and Angioedema: A Cohort and Case-Crossover Study. Drug Saf. 2019 Jul 18.

3. Bohn J, Schneeweiss S, Glynn RJ, Toh S, Wyss R, Desai R, Gagne JJ. Controlling Confounding in a Study of Oral Anticoagulants: Comparing Disease Risk Scores Developed Using Different Follow-Up Approaches. EGEMS (Wash DC). 2019 Jul 15; 7(1):27.

4. Desai RJ, Kim SC, Curtis JR, Bosco JLF, Eichelberger B, Barr CE, Lockhart CM, Bradbury BD, Clewell J, Cohen HP, Gagne JJ. Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars. Pharmacoepidemiol Drug Saf. 2019 Jul 12.

5. Gagne JJ, He M, Bateman BT. Errors in Exclusion of Data and Reported Trends of Prescriptions in Study of Opioid Prescriptions Dispensed to Children and Adolescents. JAMA Pediatr. 2019 Jul 01; 173(7):697.

6. Khan NF, Bateman BT, Landon JE, Gagne JJ. Association of Opioid Overdose With Opioid Prescriptions to Family Members. JAMA Intern Med. 2019 Jun 24.

7. Easter SR, Bateman BT, Sweeney VH, Manganaro K, Lassey SC, Gagne JJ, Robinson JN. A comorbidity-based screening tool to predict severe maternal morbidity at the time of delivery. Am J Obstet Gynecol. 2019 Jun 20.

8. Dommasch ED, Kim SC, Lee MP, Gagne JJ. Risk of Serious Infection in Patients Receiving Systemic Medications for the Treatment of Psoriasis. JAMA Dermatol. 2019 May 10.

9. Wang SV, Li N, Rice DS, Grosskreutz CL, Dryja TP, Prasanna G, Lii J, Gagne JJ. Using Healthcare Databases to Refine Understanding of Exploratory Associations Between Drugs and Progression of Open-Angle Glaucoma. Clin Pharmacol Ther. 2019 Apr 30.

10. Desai RJ, Wyss R, Abdia Y, Toh S, Johnson M, Lee H, Karami S, Major JM, Nguyen M, Wang SV, Franklin JM, Gagne JJ. Evaluating the use of bootstrapping in cohort studies conducted with 1:1 propensity score matching-A plasmode simulation study. Pharmacoepidemiol Drug Saf. 2019 Jun; 28(6):879-886.