Dr. Brandon Klee, PharmD, MS

Dr. Klee brings nearly a decade of specialized expertise in pharmacometrics, the quantitative science of how drugs behave in the human body. His research experience spans several of the most respected institutions in his field, including St. Jude Children's Research Hospital, PTC Therapeutics, the University of Florida Center for Pharmacometrics, and the U.S. Food and Drug Administration.

Pediatric Oncology Research at St. Jude Children's Research Hospital

At St. Jude Children's Research Hospital, the world's leading pediatric cancer research institution, Dr. Klee developed and validated population pharmacokinetic models for pediatric oncology therapeutics, including high-dose methotrexate therapeutic drug monitoring. This is work with direct life-or-death stakes, where modeling-driven dosing protects children from both treatment failure and severe organ toxicity.

He contributed to peer-reviewed research on liposomal irinotecan bioanalysis in children with solid tumors, published in the Journal of Chromatography B. St. Jude's work has helped raise childhood cancer survival rates from roughly 20% at its founding to over 80% today, and Dr. Klee's modeling supports the dosing decisions that protect children undergoing treatment.

Rare-Disease Drug Development at PTC Therapeutics

At PTC Therapeutics, a commercial-stage rare-disease biopharma with multiple approved therapies including drugs for Duchenne muscular dystrophy and spinal muscular atrophy, Dr. Klee built one- and two-compartment population pharmacokinetic models in NONMEM, the gold-standard software platform used for FDA and EMA regulatory submissions. He authored model analysis plans and exposure-response modeling analysis plans that supported rare-disease drug development programs, performing the kind of regulatory-grade modeling that determines whether a drug reaches patients who often have no alternative therapies.

Clinical Research at the University of Florida Center for Pharmacometrics

At the University of Florida Center for Pharmacometrics, widely regarded as one of the top pharmacometrics programs in the United States and a consistent pipeline to the FDA, Dr. Klee led a clinical research study assessing cannabidiol (CBD) and methylphenidate drug interactions in healthy volunteers, addressing a genuine and growing gap in pediatric ADHD care as CBD use has expanded. He was first author on the resulting publication in Medical Cannabis and Cannabinoids.

He also conducted pharmacogenomic analysis of ADHD treatment response in pediatric patients and co-authored a review on aminoglycoside therapy against carbapenem-resistant bacteria in Expert Review of Anti-Infective Therapy. Dr. Klee has also completed a regulatory assignment at FDA headquarters in Silver Spring, Maryland, a competitive placement typically reserved for those identified early as regulatory or research-track.

Education and Technical Expertise

Dr. Klee holds a Doctor of Pharmacy (PharmD) and a Master of Science in Pharmaceutical Sciences, both from the University of Florida College of Pharmacy.

His technical toolkit spans the full modern pharmacometrics stack, including NONMEM, Monolix Suite, Phoenix WinNonlin, R, and Python, with expertise in:

• Population PK/PD modeling

• Exposure-response analysis

• LC-MS/MS bioanalysis

• Clinical study design under Good Clinical Practice (GCP)

  
  

He has completed advanced programs through ICON (Advanced Features of NONMEM 7.5, Introduction to NONMEM/PDX-POP), Lixoft (Pharmacometrics Spring School, Monolix Suite), Certara University (Intermediate PK/PD Modeling), and Cognigen Simulations Plus.

Publications and Professional Affiliations

Dr. Klee's peer-reviewed publications and contributions span pediatric oncology bioanalysis, drug-drug interaction pharmacology, and antimicrobial pharmacokinetics, published in:

• Journal of Chromatography B

• Medical Cannabis and Cannabinoids

• Chemico-Biological Interactions

• Expert Review of Anti-Infective Therapy

He is a member of the International Society of Pharmacometrics (ISoP) and the Association for Diagnostics & Laboratory Medicine (ADLM), formerly the American Association for Clinical Chemistry (AACC), and serves as a peer reviewer for Clinical Therapeutics.

At ArcQubit, Dr. Klee serves as Senior Healthcare Researcher, anchoring the healthcare and life sciences domain expertise underpinning product decision-intelligence workflows. As ArcQubit builds the bridge between classical computing and quantum-enabled AI for immediate business value, Dr. Klee's work ensures that the healthcare pillar is grounded in the same regulatory rigor, clinical credibility, and modeling discipline demanded by pharma, pediatric oncology, and FDA submission environments.