Brian Cicali

Brian Cicali, Ph.D., M.S.

Assistant Professor

Department: Pharmaceutics
Business Phone: (407) 313-7050
Business Email: bcicali@ufl.edu

About Brian Cicali

Brian Cicali received his B.S. in pharmacology and toxicology from the Philadelphia College of Pharmacy, his M.S. in computational science from Stockton University, and his Ph.D. in pharmaceutical sciences from the University of Florida College of Pharmacy. He has previously held positions at GlaxoSmithKline (2013-2015), Tabula Rasa HealthCare (2016-2018), and worked as an ORISE predoctoral fellow at the U.S. F.D.A. (2019, 2020). He has received numerous awards for his research and publications including a Distinguished Research Fellowship from Stockton University (2016), the Dr. Allen J. Speigel Endowed Graduate Fellowship (2019) from University of Florida’s Department of Pharmaceutics, the Robert and Stephany Ruffolo Graduate Education and Research Fellowship (2021) from the University of Florida College of Pharmacy, the CPT:PSP award for most outstanding paper of 2019, the 2020 Most Informative Scientific Report from Simcyp academic awards, highlighted as a young leader in pharmacy by the Canadian Health Network (2022), and multiple poster awards from various conferences. Brian also serves in multiple leadership roles within national and international organizations, including the International Federation of Pharmaceuticals (FIP), American College of Clinical Pharmacology (ACCP), the International Society of Pharmacometrics (ISoP), and the American Society of Clinical Pharmacology and Therapeutics (ASCPT). His research interests focus on the use of quantitative clinical pharmacology methods to optimize drug safety and efficacy, as well as the integration of real-world evidence into clinical pharmacology analyses.

Teaching Profile

Courses Taught
2023-2024
PHA6131 Physiologically-Based Modeling
2023
PHA6418 Model-Informed Drug Development
2024
PHA6185 Life Cycle of a Drug

Research Profile

Open Researcher and Contributor ID (ORCID)

0000-0002-7932-8599

Publications

2024
Applying Physiologically Based Pharmacokinetic Modeling to Interpret Carbamazepine’s Nonlinear Pharmacokinetics and Its Induction Potential on Cytochrome P450 3A4 and Cytochrome P450 2C9 Enzymes.
Pharmaceutics. 16(6) [DOI] 10.3390/pharmaceutics16060737. [PMID] 38931859.
2023
Comprehensive Physiologically Based Pharmacokinetic Model to Assess Drug-Drug Interactions of Phenytoin.
Pharmaceutics. 15(10) [DOI] 10.3390/pharmaceutics15102486. [PMID] 37896246.
2023
Model-Based Analysis of In Vivo Release Data of Levonorgestrel Implants: Projecting Long-Term Systemic Exposure
Pharmaceutics. 15(5) [DOI] 10.3390/pharmaceutics15051393. [PMID] 37242635.
2023
Requirements, expectations, challenges and opportunities associated with training the next generation of pharmacometricians
CPT: Pharmacometrics & Systems Pharmacology. 12(7):883-888 [DOI] 10.1002/psp4.12970. [PMID] 37452453.
2022
Determining the Exposure Threshold for Levonorgestrel Efficacy Using an Integrated Model Based Meta-Analysis Approach.
Clinical pharmacology and therapeutics. 111(2):509-518 [DOI] 10.1002/cpt.2457. [PMID] 34674227.
2022
Development of a Translational Exposure-Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products.
Clinical pharmacology and therapeutics. 112(4):909-916 [DOI] 10.1002/cpt.2690. [PMID] 35723889.
2022
Macrolide Treatment Failure due to Drug-Drug Interactions: Real-World Evidence to Evaluate a Pharmacological Hypothesis.
Pharmaceutics. 14(4) [DOI] 10.3390/pharmaceutics14040704. [PMID] 35456537.
2022
Physiologically Based Pharmacokinetic Modeling to Assess the Impact of CYP2D6-Mediated Drug-Drug Interactions on Tramadol and O-Desmethyltramadol Exposures via Allosteric and Competitive Inhibition.
Journal of clinical pharmacology. 62(1):76-86 [DOI] 10.1002/jcph.1951. [PMID] 34383318.
2021
A Pharmacoepidemiologic Approach to Evaluate Real-world Effectiveness of Hormonal Contraceptives in the Presence of Drug-drug Interactions.
Epidemiology (Cambridge, Mass.). 32(2):268-276 [DOI] 10.1097/EDE.0000000000001302. [PMID] 33196560.
2021
A Valid Warning or Clinical Lore: an Evaluation of Safety Outcomes of Remdesivir in Patients with Impaired Renal Function from a Multicenter Matched Cohort.
Antimicrobial agents and chemotherapy. 65(2) [DOI] 10.1128/AAC.02290-20. [PMID] 33229428.
2021
Comparative pharmacovigilance assessment of mortality with pimavanserin in Parkinson disease-related psychosis.
Journal of managed care & specialty pharmacy. 27(6):785-790 [DOI] 10.18553/jmcp.2021.27.6.785. [PMID] 34057395.
2021
Comparison of contraceptive failures associated with CYP3A4-inducing drug-drug interactions by route of hormonal contraceptive in an adverse event reporting system.
Contraception. 103(4):222-224 [DOI] 10.1016/j.contraception.2020.12.002. [PMID] 33345974.
2021
Correction for Ackley et al., “A Valid Warning or Clinical Lore: an Evaluation of Safety Outcomes of Remdesivir in Patients with Impaired Renal Function from a Multicenter Matched Cohort”.
Antimicrobial agents and chemotherapy. 65(7) [DOI] 10.1128/AAC.00943-21. [PMID] 34137640.
2021
Quantitative Assessment of Levonorgestrel Binding Partner Interplay and Drug-Drug Interactions Using Physiologically Based Pharmacokinetic Modeling.
CPT: pharmacometrics & systems pharmacology. 10(1):48-58 [DOI] 10.1002/psp4.12572. [PMID] 33217171.
2021
Risk Assessment of Drug-Induced Long QT Syndrome for Some COVID-19 Repurposed Drugs.
Clinical and translational science. 14(1):20-28 [DOI] 10.1111/cts.12882. [PMID] 32888379.
2021
Safety signals for QT prolongation or Torsades de Pointes associated with azithromycin with or without chloroquine or hydroxychloroquine.
Research in social & administrative pharmacy : RSAP. 17(2):483-486 [DOI] 10.1016/j.sapharm.2020.04.016. [PMID] 32327397.
2021
Use of Drug Claims Data and a Medication Risk Score to Assess the Impact of CYP2D6 Drug Interactions among Opioid Users on Healthcare Costs.
Journal of personalized medicine. 11(11) [DOI] 10.3390/jpm11111174. [PMID] 34834526.
2020
Assessing the impact of cystic fibrosis on the antipyretic response of ibuprofen in children: Physiologically-based modeling as a candle in the dark.
British journal of clinical pharmacology. 86(11):2247-2255 [DOI] 10.1111/bcp.14326. [PMID] 32335930.
2020
Breaking the rules for studies using real-world observational data: the case of direct-acting anticoagulants and antiepileptic drugs.
European heart journal. Cardiovascular pharmacotherapy. 6(3):155-156 [DOI] 10.1093/ehjcvp/pvz053. [PMID] 31593242.
2019
Reproducibility of Quantitative Systems Pharmacology Models: Current Challenges and Future Opportunities.
CPT: pharmacometrics & systems pharmacology. 8(4):205-210 [DOI] 10.1002/psp4.12390. [PMID] 30697975.
2016
Syntheses and analytical characterizations of N-alkyl-arylcyclohexylamines.
Drug testing and analysis. 8(8):801-15 [DOI] 10.1002/dta.1861. [PMID] 26360516.

Grants

Nov 2023 – Apr 2024
A Pooled Population Analysis to Evaluate the Efficacy and Safety of Lomitapide in Patients with Homozygous Familial Hypercholesterolaemia (HoFH) on Stable Lipid lowering Therapy
Role: Principal Investigator
Funding: AMRYT PHARMA
May 2023 – May 2024
Physiologically-based Pharmacokinetic (PBPK) Modeling of Drug-drug interactions (DDI) for TEV-56268
Role: Co-Investigator
Funding: TEVA PHARMACEUTICALS USA
Feb 2023 – May 2023
A Phase III, Single-arm, Open-label, International, Multi-centre Study to Evaluate the Efficacy and Safety of Lomitapide in Paediatric Patients with Homozygous Familial Hypercholesterolaemia (HoFH) on Stable Lipid-lowering Therapy
Role: Co-Project Director/Principal Investigator
Funding: AMRYT PHARMA
Nov 2022 ACTIVE
Characterizing efficacy and safety of hormonal contraceptives by combining pharmacometrics and RWE
Role: Co-Investigator
Funding: BILL & MELINDA GATES FOUNDATION
Nov 2017 – Jan 2024
Application of physiologically-based pharmacokinetic models to inform dosing recommendations for hormonal contraceptives co-administered with other medications
Role: Project Manager
Funding: BILL & MELINDA GATES FOUNDATION

Contact Details

Phones:
Business:
(407) 313-7050
Emails:
Business:
bcicali@ufl.edu
Addresses:
Business Mailing:
6550 SANGER RD
ORLANDO FL 32827
Business Street:
6550 SANGER RD OFC 420
ORLANDO FL 32827