Pharmacy Research Portfolio Final

RESEARCH PORTFOLIO

CONTENTS

TABLE OF

Welcome About the School Core Facilities Clinical Trials Molecular Toxicology Systems Approaches Centers

WELCOME TO

RESEARCH & GRADUATE STUDIES Manisha Patel, PhD Associate Dean of Research and Graduate Studies The Office of the Associate Dean of Research and Graduate Studies (ADRGS), led by Manisha Patel, PhD provides full-scope support for all research and sponsored projects coming into the Skaggs School of Pharmacy and Pharmaceutical Sciences. Dr. Patel is the chief research officer and oversees graduate programs in the Skaggs School of Pharmacy and Pharmaceutical Sciences appointed in her role in December 2022. She has been a faculty member at CU Anschutz since 2002. She has provided service and leadership on various institutional committees including serving as Vice-Chair for the School of Pharmacy’s Department of Pharmaceutical Sciences.​ Dr. Patel received her Ph.D. in Pharmacology and Toxicology at Purdue University, and postdoctoral training in Neuroscience at Duke University. The primary theme of her laboratory's research is to understand the redox and metabolic basis of epilepsy and develop metabolism-based therapies for its treatment.

The office of the ADRGS provides full-scope support for all research and sponsored projects coming into the School of Pharmacy and Pharmaceutical Sciences. In addition, The ADRGS office administers several internal funding opportunities, such as the Skaggs Scholars program and internal ADRGS seed grants. We are proud to support over $18 Million in grant funding in the current fiscal year.

ABOUT UNIVERSITY OF COLORADO SKAGGS SCHOOL OF PHARMACY AND PHARMACEUTICAL SCIENCES

The Skaggs School of Pharmacy and Pharmaceutical Sciences has long been ranked a leader in NIH funding among schools of pharmacy and is routinely ranked as one of the most productive research units on the University of Colorado Anschutz Medical Campus. We are pleased to introduce you to our outstanding faculty, research centers and core facilities.

Mission: To transform human health by inspiring and empowering the research enterprise and graduate education in pharmaceutical and clinical sciences, toxicology, and pharmaceutical outcomes​ Vision: Offer an outstanding, inclusive environment to advance knowledge and improve health outcomes through research and education.​ Find our strategic plan here. https://pharmacy.cuanschutz.edu/research

DEPARTMENT LEADERS Doug Fish, PharmD Professor and Chair​ Department of Clinical Pharmacy In addition to teaching the next generation of pharmacists and providing exemplary patient care, faculty in the Department of Clinical Pharmacy (DOCP) are also highly engaged in research designed to enhance the safe and effective use of drugs and to assess patient outcomes associated with medication use. DOCP faculty conduct clinical research across a wide range of therapeutic areas including oncology, neurology, diabetes, cardiovascular diseases, geriatric medicine, critical care, infectious diseases, and others. The department is also currently developing a new Center for Pharmaceutical Outcomes Research to enhance research in areas such as pharmacoeconomics and cost-effectiveness analysis, pharmacoepidemiology, health policy research, and pharmacy benefits design.

Blake Hill, PhD​

Professor and Chair​ Department of Pharmaceutical Sciences

The Department of Pharmaceutical Sciences is a researchintensive department that has long ranked in the top 10% of all schools of pharmacy in both total and NIH-specific funding. Our research comprises a unique blend of basic and translational science with an emphasis on drug discovery, development, and delivery. Our faculty address real world problems with a direct impact – such as developing first in class inhibitors for colorectal cancer, tracking the ability of the SARS CoV2 spike protein to evade antibody response, and addressing toxicity in populations exposed to synthetic PFAS contaminants. To support our interdisciplinary brand of science, we host multiple centers and core facilities, and constantly invest in new and emerging technologies. As with our other centers and cores, this instrumentation is available to the Anschutz Campus, the state of Colorado, and the greater Rocky Mountain region. Please reach out to us with any questions – we look forward to hearing from you.

BY

THE NUMBERS Top 10th Percentile for US schools of pharmacy research dollars​ 4 Core Facilities 7 Research Centers 10 Major Research Focus areas Over 100 Students enrolled in Master’s and PhD programs for Pharmaceutical Outcomes, Pharmaceutical Sciences and Toxicology​

More Attendees participate school research events each year, including than 250 the Annual School Research Retreat, Symposium, Research in Progress and townhalls.

171,410 sq ft Of lab, research, office, conference and classroom space in the Skaggs School of Pharmacy Building.

More than In supporting awards from NIH, Foundations, Industry, Skaggs $18 million Scholars, internal seed grants, team sciences and collaboration.

Nearly $40 Received from The ALSAM Foundation million Multi-million Gift recently established the Endowed Chair in Translational dollar Research

CORE FACILITIES OVERVIEW CU Skaggs School of Pharmacy and Pharmaceutical Sciences faculty offer a range of services for other researchers on our campus and across the globe.​ We have state-of-art equipment and our research staff are highly trained individuals who ensure results are accurate and prompt.

Drug Discovery and ​Development (D3SR) The D3SR consists of 4 core facilities working iteratively, including (1) highthroughput discovery sciences featuring state-of-the-art robotic automation and instrumentation; (2) drug design and medicinal chemistry; (3) pharmaceutics; and (4) in vivo pharmacology (DMPK and toxicology).

D3SR Services:​ High-throughput Discovery Sciences​ Medicinal Chemistry​ Pharmaceutics​ In Vivo Pharmacology

Research Pharmacy The Research Pharmacy is the investigational drug resource for clinical research studies Personalized Support for studies​ State-of-the-art clean room ​ Comprehensive Services​ Assures drug studies are conducted in a safe, effective and efficient manner. ​ Complies with federal, state and COMIRB regulations concerning investigational drugs.

CORE FACILITIES OVERVIEW

Computational Chemistry and Biology The CCB provides a wide array of advanced tools and services for computational-based simulations and modeling of chemical and biological systems.

Develop and test hypotheses in silico before executing costly experimental methodologies​ Reduce the time and costs involved in cutting-edge research.​ Provide additional mechanistic justification​ Aid in the analysis and communication of results

Mass Spectrometry The MS facility utilizes advanced mass spectrometry instrumentation and techniques to assist researchers with their proteomic, metabolomics, and small molecule research.

Proteomics​ Metabolomics​ Targeted Quantitative Analysis​ Small Molecule Research​ Hands on Workshops

THE LABARBERA LABORATORY & THE CENTER FOR DRUG DISCOVERY

Our Mission Be a Colorado hub for drug discovery & development Provide infrastructure and expertise for drug discovery and development Harness academic innovation for drug discovery & development De-risking academic innovation for commercialization Collaborate with faculty, academic units, and industry to advance academic drug discovery and development

Dan LaBarbera, PhD Professor and Director, the CU Anschutz Center for Drug Discovery Department of Pharmaceutical Sciences Education & Training 2001 - BS Biochemistry 2005 - PhD Medicinal Chemistry 2008 - NRSA NIH Postdoctoral Fellow Multidisciplinary Cancer Research Research Expertise & Interests HTS/HCS Drug Discovery Drug Design & Medicinal Chemistry Cancer Biology & Mechanism of Action Complex Disease Models (e.g. organoids) In vitro & in vivo Pharmacology

daniel.labarbera@cuanschutz.edu

https://pharmacy.cuanschutz.edu/drug-discovery

COMPUTATIONAL CHEMISTRY & BIOLOGY CORE FACILITY

Research Program Focused on the design and chemical synthesis of novel small molecules as candidate therapeutics targeting mechanisms that coordinate between the cell-cycle and metabolism in cancer. ​ Current projects include:​ DNA damage repair targets (WEE1 kinase, thymidine phosphorylase)​ Metabolic reprogramming (AMPK kinase, GSK3β kinase, RSK2 kinase, STAT3/mitoSTAT3)​ Hypoxia-activated prodrugs

Philip Reigan, PhD Professor and Director of Computational Chemistry & Biology Core Facility

Background A medicinal chemist with >20 years of experience in small molecule drug discovery and development in the pharmaceutical industry and academic settings​ Education & Training BSc in Chemistry, Dept Chemistry, University of Manchester, UK ​ MSc in Pharmacology, School of Medicine, University of Manchester, UK ​ PhD in Medicinal Chemistry, School of Pharmacy, University of Manchester, UK​ Postdoctoral Fellow, University of Colorado

Computational Chemistry & Biology Core Deep-learning workstations that use the Schrödinger platform to perform virtual drug screening, drug design, ligand/protein-protein/DNA/RNA docking, molecular dynamics, predictive ADMET.

philip.reigan@cuanschutz.edu

https://pharmacy.cuanschutz.edu/research/corefacilities/computational-chemistry-and-biologycore-facility

MASS SPECTROMETRY FACILITY

Research Program Mass Spectrometry, including metabolomics, lipidomics and proteomics​ Nutrimetabolomics and foodomics​ Understanding role of host:microbiome metabolism in health and disease​ Exposomics​ Role of oxylipins in inflammatory, immune and lung disease

Nichole Reisdorph, PhD Professor and Scientific Director, Mass Spectrometry Facility

Education & Training BS - Northern State University; Aberdeen, SD (Biology)​ MS - University of South Dakota; Vermillion, SD (Biology)​ PhD - University of South Dakota; Vermillion, SD (Biochemistry and Molecular Biology)​ Postdoctoral Fellow - The Scripps Research Institute, La Jolla, CA (Mass Spectrometry)

nichole.reisdorph@cuanschutz.edu

https://pharmacy.cuanschutz.edu/research/ core-facilities/mass-spectrometry-facility

RESEARCH PHARMACY

Research Program When collaborating with the Research Pharmacy, you'll be paired with a dedicated lead pharmacist who provides personalized support for your study. They handle both clinical and administrative aspects of drug research, ensuring compliance with federal, state and COMIRB regulations.

Sam Ellis, PharmD Director of the CU Research Pharmacy

Education & Training Post-Baccalaureate Doctor of Pharmacy, Oregon State University and Oregon Health Sciences University; Joint Degree​ Pharmacy Practice Residency, VA Medical Center, Portland, Oregon​ Post-Doctorate Fellowship, Ambulatory Care, University of Colorado Denver

Execute Good Science We assist in the execution of the scientific, clinical and administrative functions of drug research.

Assure Safety and Efficiency We assure drug studies are conducted in a safe, effective and efficient manner.

Facilitate Compliance Our team helps you comply with federal, state and COMIRB regulations concerning investigational drugs.

sam.ellis@cuanschutz.edu

https://research.cuanschutz.edu/ cu-research-pharmacy

CLINICAL TRIALS OVERVIEW Our faculty participate in a variety of clinical trials, from retrospective chart review to Phase 4 studies with other clinicians from the Anschutz Campus and around the globe.

The Faculty work on issues from restless leg syndrome, to treatment of bloodstream infections and psilocybin efficacy on fear in cancer patients

Clinical Research Serves as Principal Investigator for research into CBD and CBG use for Restless Legs Syndrome (RLS)​ Co-Principal Investigator for research with psilocybin and cannabis in areas such as Parkinson disease, autism, back pain, depression, post-partum and fear of recurrence while in cancer remission.

Jacci Bainbridge, PharmD, FCCP Professor and Vice Chair Research

Education & Training Neurology Residency, University of Colorado (1995 – 1996) Doctor of Pharmacy, University of Colorado (1995)​ Bachelor of Pharmacy, Ohio Northern University (1988)

Areas of Interest Multiple Sclerosis Disease Modifying Therapies and other therapeutics​ Epilepsy, advanced age, refractory polypharmacy strategy, and status epilepticus treatment optimization, transitions of care​ Migraine therapeutic plans​ Sleep disorders​ Movement disorders, Restless Legs Syndrome therapy development, Huntington's disease

jacci.bainbridge@cuanschutz.edu

PRECEDENT Clinical Trial network with University of Pittsburgh Effectiveness of iMIpenem-Relebactam for multidrugˇresistant Pseudomonas AeruGinosa in pnEumonia and bloodstream infections in the United States (MIRAGE)” ​ Ceftazidime-Avibactam versus MeropenemVaborbactam for the treatment of bloodstream infections and/or pneumonia due to carbapenemresistant EnterobacteraLes (CAMEL)

Meghan Jeffres, PharmD Associate Professor

Education & Training Doctor of Pharmacy from the University of Wyoming, Laramie WY​ Residency in Pharmacy Practice at Intermountain Healthcare, Salt Lake City UT​ Residency in Infectious Diseases at Barnes Jewish Hospital, St. Louis MO

meghan.jeffres@cuanschutz.edu

Clinical Research Serve as Principal Investigator and Co-principal Investigator on Phase 1 and Organ Dysfunction Oncology Clinical Trials.

Areas of Interest Oncology developmental therapeutics, Organ dysfunction, biological correlates associated with molecular targeted agents, chemotherapy dose modification and pharmacy-managed supportive care issues in cancer treatment.

Cindy O’Bryant, PharmD Associate Dean for Academic and Faculty Affairs, Professor

Education & Training Doctor of Pharmacy, Mercer University Southern School of Pharmacy (1998)​ Pharmacy Practice Residency, University of California San Diego Medical Center (19981999)​ Oncology Pharmacy Specialty Residency, University of Colorado Health Sciences Center (1999-2000)

cindy.obryant@cuanschutz.edu

CENTER FOR PHARMACEUTICAL BIOTECHNOLOGY OVERVIEW The center offers biophysical characterization and analysis services for therapeutic macromolecules such as protein and antibody formulations.

Background The center was founded in 1997 by Drs. John Carpenter and Ted Randolph as a collaborative relationship between the PhD programs in pharmaceutical sciences at the Anschutz Medical Campus and chemical engineering at the CU Boulder campus.

Problems We Address Native-state assembly energetics and hydrodynamics​ Analysis at high macromolecule concentrations​ High viscosity studies​ Opalescence and phase separation​ Thermodynamic stability​ Osmotic second virial coefficients​ Comparability studies​ High-resolution structure and dynamics​

Methods We partner with pharmaceutical biotechnology companies to address contemporary research questions, and the center holds annual Colorado Protein Stability and Aggregation workshops and conferences on issues critical to industry and academic researchers.

State of the Art Instrumentation Beckman Optima XLA, XLI, XLF Analytical Ultracentrifuges​ 900 mHz Varian Nuclear Magnetic Resonance Spectrometer with cryoprobe​ 600 mHz Bruker Nuclear Magnetic Resonance Spectrometer​ ZetaSizer Helix: Concomitant Raman Spectroscopy/Dynamic Light Scattering​ Prota 3S Ultrasensitive Infrared Spectrometer​ Chirascan-plus Circular Dichroism Spectrometer with Stop Flow

https://pharmacy.cuanschutz.edu/research/research-centers/center-for-pharmaceutical-biotechnology

Research Formulation – expertise in parenteral, topical, and oral formulations​ Liposomes for drug delivery, special emphasis on nucleic acids for tumor treatment​ Exosomes – exploiting the exosomal pathway for drug distribution

Tom Anchordoquy, BS, MA, PhD Professor

Education & Training MA and PhD in Zoology at the University of California at Davis​ Postdoctoral Fellow​at the University of Colorado Boulder and University of Colorado Denver

tom.anchordoquy@cuanschutz.edu

https://pharmacy.cuanschutz.edu/ research/research-labs/anchordoquy-lab

Research Our work is focused in two main areas. First, we are interested in the molecular mechanisms of transcriptional regulation using the nuclear receptor superfamily as a model system. We use a blend of biophysical, structural and cell biological approaches to dissect the various protein-DNA and protein-protein interactions critical to transcriptional activation, and then use this information to synthesize and predict overall behavior. Our second focus is on characterizing the molecular interactions of therapeutic proteins, especially at high concentrations and under formulation/delivery conditions. This work is primarily directed toward monoclonal antibodies, but we are also interested in therapeutic peptides and vaccines.

David Bain, PhD Professor

Education & Training BA, University of Vermont​ PhD, Johns Hopkins University​ Post-Doctoral, University of Colorado

david.bain@cuanschutz.edu

PHYSICAL VIROLOGY AND NANOENGINEERING

“Designer” Nanoparticles

Carlos E. Catalano, PharmD, PhD Professor

Education & Training PharmD, University of California, San Francisco, 1983​ PhD, Medicinal Chemistry, University of California, San Francisco, 1987

Intracellular Delivery of Biologics

carlos.catalano@cuanschutz.edu

Multi-Valent Vaccines

Research Structure-function of dystrophin in muscular dystrophy​ Role of individual domains; Engineering minidystrophins and utrophin for gene therapy​ Structure-function of coronavirus spike proteins​ Allosteric communication; Effect of mutations; Predicting the next variant​ Pharmaceutical biotechnology of protein/antibody therapeutics and AAVs​ Structure, stability, and aggregation; Excipient interactions; Consultant for multiple pharma companies

Krishna Mallela, PhD Professor, Pharmaceutical Sciences Graduate Program Associate Director

Research Career PhD, Tata Institute of Fundamental Research, Mumbai, India (Physical Chemistry)​ Postgraduate Researcher, University of California, San Francisco (Biophysics)​ Postdoctoral Research Associate, University of Pennsylvania, Philadelphia (Biophysics)​ Research Assistant Professor, University of Pennsylvania, Philadelphia (Biophysics and Biochemistry)

Expertise Protein structure (CD, fluorescence, NMR, HDX, cryo-EM), binding (ITC, SPR), stability (DSC, chemical/thermal melts), aggregation (SEC, AUC, flow imaging, particle analysis), biophysics (thermodynamics/kinetics), and protein expression/purification.

krishna.mallela@cuanschutz.edu

https://pharmacy.cuanschutz.edu/ research/research-labs/mallela-lab

COLORADO CENTER FOR NANOMEDICINE OVERVIEW The Colorado Center for Nanomedicine and Nanosafety promotes collaborative effort, stimulates learning, and advances multidisciplinary research and education in the areas of basic and applied nanomedicine and nanosafety, between academic labs and the local and national biotech and pharma companies.

Background The CCNN was established within the Skaggs School of Pharmacy and Pharmaceutical Sciences in 2016.​ The CCNN includes members from University of Colorado Anschutz Medical Campus, other University of Colorado campuses and any other interested, qualifying professionals from the State of Colorado.

Expertise Synthesis and evaluation of magnetic nanoparticles, MRI contrast agents, near infrared probes, ultrasound microbubbles, liposomes, PLGA nanoparticles​.

Toxicity and safety assessment of nanomaterials including cell viability, cellular uptake/dosimetry, cellular and tissue imaging, hyperspectral imaging, biodistribution, inflammatory responses.​ Small molecule, peptide, protein, and nucleic acid loaded nanoparticles for enhanced drug/gene delivery; ligand functionalized nanoparticles for targeted delivery; pure drug nanoparticles and nanotubes; polymeric, protein, and viral capsid nanoparticles.

Goals Lead the discovery of new diagnostics and therapeutic approaches that can be translated and commercialized.​ Provide intellectual, technical and financial resources in the research and service areas of nanotechnology and nanomedicine.​ Promote the penetration of nanomedicine and nanosafety into clinical and translational research.​ Increase the awareness of safety and toxicity issues associated with nanomaterials and the role of environmental nanomaterials in the pathology of disease.​ The CCNN will provide training and education of clinical and basic scientists.

Equipment Fiber optic based near infrared spectroscopy system (FONIRS) 2 NIR wavelengths​ CytoViva Enhanced Darkfield Hyperspectral Microscope​ Malvern Zetasizer​ Perkin Elmer ICP-MS with HPLC and single cell/nanoparticle capability​ Guava flow cytometer with high throughput capability

https://pharmacy.cuanschutz.edu/research/research-centers/colorado-center-for-nanomedicine-and-nanosafety

Jared Brown Lab: Inductively Coupled Plasma Mass Spectrometry (ICP-MS) We can measure elemental concentration (e.g., metals) Also perform single particle analysis Provides nanoparticle size, number, concentration

Jared Brown, PhD Professor Toxicology Graduate Program Director, T32 Training Program in Molecular and Systems Toxicology Director, Colorado Center for Nanomedicine and Nanosafety Co-Director

jared.brown@cuanschutz.edu

https://pharmacy.cuanschutz.edu/resea rch/research-labs/immunotoxicologylab

Collaboration Areas Drug formulation​ Long-acting drug delivery system preparation (implants, microspheres, gels, and nanoparticles)​ Drug quantification in samples of various types including tissues using LC-MS/MS​ Drug delivery and pharmacokinetic assessment

Uday Kompella, PhD Colorado Center for Nanomedicine and Nanosafety Co-Director and Co-founder, Professor

Research Career PhD (Pharm. Sci.) – University of Southern California, Los Angeles, CA​ MPharm (Pharm. Engg.) – Jadavpur University, Kolkata, India​ BPharm (Hons) – BITS, Pilani, India

uday.kompella@cuanschutz.edu

https://pharmacy.cuanschutz.edu/ research/research-labs/ nanomedicine-and-drug-delivery-lab

Translational Bio-Nano Sciences Iron oxide nanoparticles for MRI Immune response for population Immune clearance Biodistribution and tumor targeting of lipid nanoparticles RBCs and exosomes as drug carriers Accumulation of nanoparticles in skin

Dmitri Simberg, PhD Professor, Colorado Center for Nanomedicine and Nanosafety Co-Director

Research Career Ph.D. in Biochemistry from the Hebrew University of Jerusalem.

Postdoc 1: Targeted Nanomedicine at the Burnham Institute.

Postdoc 2: Ultrasound imaging, Department of Radiology, UCSD. Author or co-author on ~100 research papers, reviews, perspectives, and book chapters.

Federal funding > $15 million.

Trained ~30 undergraduate, graduate and postdocs.

dmitri.simberg@cuanschutz.edu

https://pharmacy.cuanschutz.edu/ research/research-labs/ translational-bio-nanosciences-lab

CENTER FOR PHARMACEUTICAL OUTCOMES RESEARCH​(CEPOR) The vision of CePOR is to foster and grow education and research excellence in three primary disciplines: pharmacoepidemiology, pharmacoeconomics, and pharmaceutical and drug related policy.

Collaborations CePOR faculty have an extensive record of successful collaborations with the School of Medicine, Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), Colorado School of Public Health, the Colorado Clinical and Translational Sciences Institute (CCTSI), and the Center for Bioethics and Humanities. These exciting and progressive collaborations bring together a diverse, multidisciplinary, highly experienced group of talented clinicians and researchers.

The Colorado Consortium for Prescription Drug Abuse Prevention Works with partners to focus efforts to advance Colorado’s opioid crisis response​.

Coordinates our state’s response to the crisis of misuse and abuse of prescription medications such as opioids (including fentanyl), stimulants, and sedatives.

Pharmaceutical Value Initiative (pValue) and Institute for Clinical and Economic Review collaboration Aims to apply and test novel methods for value assessment that encourages stakeholder engagement and promotes value-based decision making.

Colorado Medicaid Drug Utilization Review Investigating Patient utilization in CO Managed Care​ Evaluation of Opioid effects on Medicaid members

Rocky Mountain Multiple Sclerosis Center and the Memory Disorders Clinic for the treatment of Alzheimer’s Disease and Related Dementia

https://pharmacy.cuanschutz.edu/research/research-centers/center-for-pharmaceutical-outcomes-research

Colorado Medicaid Drug Utilization Review (DUR) We conduct retrospective, prospective, and concurrent drug utilization review of pharmacy and medical claims for Health First Colorado members.

We prepare modules on different topics, producing one final module and one draft module each quarter.

Each module includes a set of analyses designed to provide evidence to inform prior authorization criteria for therapeutic classes and specific medications as well as possible educational interventions for broad therapeutic issues (e.g., letters to providers and online and peer-topeer education) for the provision of safe, cost-effective drug therapy throughout the state.

Heather Anderson, PhD Associate Professor, Director of Assessment and Outcomes

Education & Research MS in Biostatistics​ PhD in Epidemiology​ 15 years with SSPPS​ Research focuses on Colorado Medicaid DUR, PGx, mental health treatment, and scholarship of teaching and learning

Pharmacogenomics (PGx) and Personalized Medicine We use electronic health record data and genetic data for UCHealth patients in the CCPM biobank to evaluate the implementation of clinical pharmacogenomics within the UCHealth system.

We have also collaborated on a series of analyses that leveraged paid medical and pharmacy claims to describe the use of single-gene pharmacogenomic testing in a U.S. managed care population, describe the use of single-gene pharmacogenomic testing in depressed patients in a U.S. managed care population, and to describe amount of exposure to pharmacogenomic drugs for patients in a U.S. managed care population. heather.anderson@cuanschutz.edu

Pharmacy Closures Research Focus: The causes and effects of pharmacy closures, particularly their impact on medication use.​ Future Plans: Submitted an R01 application to the Agency for Healthcare Research & Quality to study access to pharmacies and medications for Medicare enrollees​.

Kelly Anderson, MPP Assistant Professor and Director of the Pharmaceutical Outcomes Research PhD Program Education & Research PhD in Health Policy and Management​, Johns Hopkins Bloomberg School of Public Health​.

MPP​, University of Virginia Batten School of Leadership and Public Policy​.

Research: High-Cost Prescription Drug Pricing; Medicare Insurance Design; Medicare Advantage; State and Federal Health Policy​ Worked in contract research. prior to academia.

Health Insurance Design Medicare Comparison: Research compares traditional Medicare and Medicare Advantage, focusing on hospitalizations, drug prescribing, and managed care tools like prior authorization.

Performance Measurement and Policy Impact: Developing methods to measure performance in Medicare, addressing selection problems and leveraging discontinuities in provider network regulations.

Recommendations on prior authorization were included in CMS rulemaking. Briefed policymakers on topics such as insulin access and Medicare Part B drug payment.

Payment for High-Cost Prescription Drugs Policy Evaluation: Evaluates state-level insulin out-ofpocket caps and models policy options to improve drug affordability.

Provider Behavior: Studies how financial incentives influence physicians, practices, and hospitals in prescribing high- vs. low-cost drugs, highlighting the complex interplay of stakeholders.

kelly.e.anderson@cuanschutz.edu

https://www.kellyelizabethanderson.com

Research Dr. DiStefano’s research is primarily focused on health technology assessment, prescription drug policy, and direct-to-consumer pharmaceutical advertising.

He is particularly interested in the ethical considerations that arise in each of these research areas.

To advance research in these areas, Dr. DiStefano draws on both empirical research methods and conceptual and normative analysis.

His work has been published in JAMA, Health Affairs, and Value in Health.

Michael DiStefano, PhD Assistant Professor

Education & Research PhD, Health Policy, Johns Hopkins Bloomberg School of Public Health (2021)​ M. Bioethics, University of Pennsylvania (2014)​ AB, Religion, Princeton University (2011)

michael.j.distefano@cuanschutz.edu

R. Brett McQueen, PhD Associate Professor

Research Research in comparative effectiveness research, costeffectiveness applications and methods development, value-based outcomes contracting, and patient preferences research​.

Active in health economics-related societies such as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) through contributions to ISPOR short courses, workshops, issue panels, and research presentations​.

Serves on multiple dissertation committees in the Pharmaceutical Outcomes Research PhD program​.

Director of the Center for Pharmaceutical Value (pValue), exploring multi-criteria decision analysis (MCDA) for health care decision making​.

Served in a PhRMA Foundation Postdoctoral Fellowship in Health Outcomes at SSPPS and most recently was a Health Economist and Researcher with the Research in Real Life (RiRL)/Observational and Pragmatic Research Institute (OPRI) located in Cambridge, United Kingdom.

Education & Research PhD in Pharmacoeconomics, University of Colorado, Denver​ MS in Economics​, University of Colorado, Denver​ BA in Economics​, University of Colorado, Boulder

robert.mcqueen@cuanschutz.edu

Kavita Nair, PhD, FAAN Professor

Education & Research PhD in Pharmacy Administration​, University of Michigan​ MS in Pharmaceutics​, University of Toledo​ BPharm​, University of Delhi, India

Research Primary research interests lie in evaluating the treatment of neurological diseases​.

Examining the comparative effectiveness of disease modifying agents used in the management of multiple sclerosis, myasthenia gravis and neuromyelitis optica spectrum disorder using a combination of several measures to include brain atrophy measurement, clinical cognition, blood biomarkers and patient reported outcomes.​ Other areas of interest involve improving access related issues and assessing the disruption in care for patients with neurological conditions taking infusible agents through collaborations with the Colorado legislature in policy creation and with payers in developing model policy coverage.​ Serves as Chair of the Coding and Payment Policy Subcommittee and member of the Medical, Economics and Practice Committee of at the American Academy of Neurology. Also a member of the Executive Council of Brain PAC for the American Academy of Neurology.

Serves as the Vice Chair for the Board of Directors for the Center for Improving Value in Health Care- the administrative group that managed the Colorado All Payer Claims Database.

kavita.nair@cuanschutz.edu

Research Pharmacoepidemiology and drug safety ​ Emphasis on psychotropic medications; examples:​ Antidepressants and suicide related behaviors Antipsychotics and metabolic disturbances Opioids and use disorders, overdose, overdose deaths​ Prescription Drug Abuse Prevention​ Established Center for Prescription Drug Abuse Prevention​ Coordinate statewide efforts for research, education, policy, and prevention relating to the opioid/fentanyl crisis

Robert Valuck, PhD, RPh Professor and Executive Director of the Center for Prescription Drug Abuse Prevention Education & Research PhD in Pharmacy Administration​, University of Illinois at Chicago​ ​ MS in Pharmacy Administration, University of Illinois at Chicago​ BS in Pharmacy​, University of Colorado

robert.valuck@cuanschutz.edu

https://corxconsortium.org/

CENTER FOR TRANSLATIONAL PHARMACOKINETICS AND PHARMACOGENOMICS Academic and external investigators working in preclinical and clinical development of drugs and biologics, or conducting independent research, can contact Center members directly for opportunities to collaborate and develop appropriate strategies for integration of pharmacokinetics, pharmacodynamics and pharmacogenetics.

Background The center is a collaborative group of pharmacokinetics and pharmacogenomics experts with the scientific and technical expertise, knowledge, and physical resources to conduct high-level translational research in these fields.

Terms

Equipment HPLC with UV, Fluorescence, PDA​ LC-MS (ThermoScientific MSQ)​ LC-MS-MS (ThermoScientific TSQ Quantum)​ UPLC-MS-MS (ThermoScientific Accela-TSQ Vantage)​ Biotage Primer Design Software​ PHASE (for haplotype analysis)

Pharmacokinetics: the study of the time course of absorption, distribution, metabolism, and excretion (i.e., disposition) of drugs in the body.​ Pharmacodynamics: the study of the relationship between drug concentrations and drug response in the body.​ Pharmacogenomics: the study of how genetic variation influences interindividual variability in drug disposition and response. https://pharmacy.cuanschutz.edu/research/research-centers/center-for-translational-pharmacokinetics-and-pharmacogenomics

Research Focus: The study of antiviral drug disposition in humans and how this relates with clinical outcomes.

Pharmacokinetic analyses​ Bioanalysis in biofluids and cells​ Pharmacokinetic study designs​ Stable-labeled isotope tracing​ Regulatory experience

Peter Anderson, PharmD Professor

Education & Research BS Biology University of Minnesota 1991 ​ BS Pharmacy University of Minnesota 1997​ PharmD University of Minnesota 1998​ Antiviral pharmacology fellowship University of Minnesota 2001 (Advisor Courtney Fletcher)​ Faculty University of Colorado 2002-present

peter.anderson@cuanschutz.edu

https://pharmacy.cuanschutz.edu/ research/research-labs/ colorado-antiviral-pharmacology-lab

Research Pharmacogenomics and personalized/precision medicine​ Evaluation of the clinical impact, value, and sustainability of large-scale clinical pharmacogenomics implementation initiatives, with a major focus on the UCHealth system ​ Development and evaluation of novel tools to guide patient selection and maximize the benefit of pharmacogenomics and personalized medicine

Christina Aquilante, PharmD Professor, Endowed Chair in Translational Pharmaceutical Sciences Director of Pharmacogenomics for the Colorado Center for Personalized Medicine Education & Research PharmD with Honors and Distinction, University of North Carolina at Chapel Hill (2000)​ Residency, University of Florida (2001)​ Research Fellowship in Pharmacogenomics, University of Florida (2003)​ Graduate Certificate in Clinical Science, University of Colorado, Anschutz Medical Campus (2008)

christina.aquilante@cuanschutz.edu

Central Themes and Expertise Informing and optimizing safe and effective medication use through pharmacokinetics​ Specialized focus in HIV and other related co-infections (i.e., tuberculosis, hepatitis B/C, COVID-19, mpox), pediatrics, pregnancy, and persons with alcohol and/or substance use disorders​ Pharmacokinetic study design, analysis, and modeling approaches for studies ranging from pilots to large-scale, international studies​ Developing novel bioanalytical methods for quantifying drugs and other moieties in human blood and tissue samples

Kristina Brooks, PharmD Assistant Professor

Education & Research B.S. Neuroscience , University of Michigan (2011) ​ PharmD. University of Michigan (2015) Postdoctoral Fellowship, Clinical Pharmacokinetics Research Unit, Clinical Center Pharmacy Department Postdoctoral Fellowship Department of Pharmaceutical Sciences, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences

Pharmacokinetics What do the drug exposures look like in the target population?​ What factors affect drug disposition?

Efficacy How does PK relate to treatment outcomes?​ Are alternative dosing strategies needed to optimize these outcomes?​ Safety How does PK relate to safety outcomes?​ Are there ways to mitigate side effects?

Adherence Can we develop or modify objective, PK-based measures of adherence? kristina.brooks@cuanschutz.edu

Research Pharmacokinetic and pharmacodynamic modeling and Simulation for small molecules and protein therapeutics. ​ In vitro and in vivo methods for drug metabolism and transport.​ Urinary biomarkers for kidney injury.​ Phase 1 – 3 clinical studies.

Melanie Joy, PharmD PhD Professor Director of Innovation and Commercialization, ​Director of Entrepreneurship Education, SPARK/REACH Program, ​Director of the Center of Excellence Program for Model Informed Drug Development Education & Research PhD (Pharmaceutical Sciences - Molecular Pharmaceutics) University of North Carolina, Chapel Hill, NC​ PharmD, Duquesne University, ​ BS Pharmacy, University of Pittsburgh,

melanie.joy@cuanschutz.edu

https://pharmacy.cuanschutz.edu/research/ research-labs/kidney-disease-pharmacology

Contribution of Genetic Factors to Alcohol Use Disorders​ The goal of the lab is to investigate the genetic underpinnings of reduced sensitivity to alcohol, a wellestablished contributor to alcohol use disorders (i.e., alcoholism, binge drinking). An example of our work is the identification of histone deacetylase 1 (Hdac1), a broad regulator of gene expression, as one of likely many genes that contribute to genetic variation in alcohol sensitivity.​

QTL mapping of loss of righting response acute tolerance pinpoints Hdac1 as a candidate gene. ​

Richard Radcliffe, PhD Professor

Education & Research BS in Biology (Va. Tech, 1984)​ PhD in Neuropharmacology under Dr. V. Gene Erwin (UCHSC, 1996)​ Postdoctoral fellowship under Dr. Jeanne Wehner (Institute for Behavioral Genetics, UCB, 1996-99)​ Postdoctoral training under Dr. Richard Deitrich (CU Anschutz, 1999-2001)​ Faculty, CU Skaggs School of Pharmacy and Pharmaceutical Sciences, 2001-present)​ Sabbatical training, Deep Sequencing Computation and Analysis, BioFrontiers Institute (Dr. Robin Dowell)

Cis-regulation of Hdac1 influences the expression of many other trait-relevant genes.​

Gene expression signature mapping demonstrates that alcohol-dependent alterations in brain gene expression is very similar to altered patterns of gene expression caused by 17 different histone deacetylase inhibitors. ​

richard.radcliffe@cuanschutz.edu

Research Specific Disease Area - Genetics of Substance Use Disorders (Alcohol, Oxycodone, Cannabis)​ Collaborations - Advanced statistical applications including omics and high-dimensional data across a wide variety of disease areas​ Methods/Software Development - Multi-omics network, quantitative genetics, transcriptomics informatics, and general omics methods development ​ Educational Approaches – basic statistics / data science / quantitative genetics / omics statistics / high-dimensional data​ Outreach Area of Interest – medical research career exploration/exposure for rural / under resourced students (undergraduates and high school students)

Laura Saba, PhD Associate Professor, Pharmaceutical Sciences PhD Program Director Education & Research PhD in Biostatistics (University of Colorado Health Science Center)​ BS in Chemistry (Colorado School of Mines)​ Appointments/Affiliated with ​ Secondary Appointment in Department of Biostatistics and Informatics (CSPH)​ Graduate Program Membership in: Pharmaceutical Sciences, Toxicology, Pharmaceutical Outcomes, Computational Biosciences, Pharmacology, Biostatistics​ Fellow at the Institute for Behavioral Genetics at CU Boulder​

laura.saba@cuanschutz.edu

https://www.thesabalab.com/

MOLECULAR TOXICOLOGY

Molecular toxicology focuses on elucidation of molecular mechanisms of toxicity of drugs and pollutants, and includes metabolic, pharmacogenomics, proteomic and metabolomics approaches. These techniques allow studies of individual susceptibility and isolation of predictive biomarkers of toxicity.​

Areas of Research Focus Alcohol Liver Disease​ Autoantigen discovery​ Behavioral Responses​ Bladder Cancer​ Cancer Biology​ Cancer Pharmacology​ CAR-T ​ Cytochrome P450 enzymes​ Drug Metabolism​ Engineered T Cell therapies​ Enzymology​ Epilepsy​

Immunotherapy​ Kidney Disease​ Mitochondrial dysfunction​ Natural Immunosuppression​ Neurodegeneration​ Post-translational modifications​ Quantitative RNA sequencing​ Systems genetics​ Warfare Vesicants​

https://pharmacy.cuanschutz.edu/pharmaceutical-sciences/research-areas/molecular-toxicology

Research Cancer Pharmacology, Cancer Mechanisms, Cancer Prevention, Toxicology of Chemical Warfare Agents and Developing Therapeutics/Drug-repurposing.

Cancer and role of phytochemicals in its prevention and treatment​ Vesicant-induced toxicity and therapeutic development​

Rajesh Agarwal, PhD Professor

Education & Research PhD in Bio-organic chemistry from Lucknow University (1981)​ UCCC Cancer Prevention and Control Program Co-Leader (2009-2023)​ Interim Chair DOPS (20222023)

rajesh.agarwal@cuanschutz.edu

Research CAR T and engineered T cell therapies of autoimmune diseases Mechanisms of T cell mediated metal hypersensitivities Mechanisms of T cell recognition of autoantigens in Type 1 diabetes and RA Redox signaling and drug design in the immune diseases and infectious diseases

Shaodong Dai, PhD Professor

Education & Research B.E., Beijing University of Chemical Technology, China (Biochemical Engineering) PhD, Uppsala Biomedical Centre, Sweden (Molecular Biology) Post-doctoral Fellow, Purdue University (Structural Biology)

shaodong.dai@cuanschutz.edu

Research Quantitative analysis of post-translational modifications using novel mass spectrometry techniques Antibody-based enrichment and click-chemistry targeted assays to study lysine acylation and thiol redox Mechanistic study of metabolically-derived kidney and liver diseases Understand how sirtuins impact protein function in nuclear, cytosolic, and mitochondrial processes Leverage artificial intelligence for biomarker discovery Apply machine learning and artificial intelligence to enhance therapeutic intervention for liver disease Expertise: Analytical biochemistry, bioinformatics, spatial transcriptomics, artificial intelligence, virtual reality, proteomics, post-translational modifications, alcoholassociated liver disease, sirtuin activity, and mitochondrial biology Kristofer Fritz, PhD Associate Professor, Graduate Program in Toxicology

Education & Research BS, La Sierra University, Riverside, CA (Biochemistry) PhD, Loma Linda University, Loma Linda, CA (Biochemistry) Postdoctoral Fellow, University of Colorado

kristofer.fritz@cuanschutz.edu

Research Principal investigator, educator, and scientific leader in the ADME/DMPK field​ Research interests involve the application of bioanalytical, biophysical, and computational techniques to understand and predict drug metabolism and disposition in special population groups including: neonates, pregnant individuals, cystic fibrosis patients, and those exposed to the ubiquitous environmental toxicant PFAS​ R01 funded projects currently include: 1) PBPK modeling of drug-hormone interactions during pregnancy and 2) defining the function of cytochrome P450 enzymes in Pseudomonas aeruginosa to fight antimicrobial resistance

Jed Lampe, PhD Associate Professor

Education & Research Post-doctoral Fellowship in Pharmaceutical Chemistry, University of California, San Francisco​ PhD in Medicinal Chemistry, University of Washington​ MS in Microbiology​, Idaho State University​ BS in Biological Sciences, Walla Walla University

jed.lampe@cuanschutz.edu

https://www.jedlampelab.org/

Research Mechanistic Toxicology​ Tissue-resident Immune Monitoring and Profiling​ Complement- and Immune-mediated Disease​ Preclinical Models of Environmental and Lifestyle Exposures: Obesogens, Western Diet, Alcohol

Rebecca McCullough, PhD Assistant Professor, Toxicology Graduate Program Associate Director

Education & Research Research Associate: Inflammation and Immunity, Cleveland Clinic​ Postdoctoral Fellowship: Inflammation and Immunity, Cleveland Clinic​ PhD: Toxicology, University of Colorado Anschutz Medical Campus​ BS: Biology and Chemistry, Northern State University

rebecca.mccullough@cuanschutz.edu

Research Environmental causes of neuronal injury Mitochondrial (dys)function and oxidative stress in epilepsy and neurodegeneration Neuroinflammation and redox signaling Redox-based small molecule therapeutics

Manisha Patel, PhD Professor, Associate Dean of Research and Graduate Studies

Education & Research PhD: Neurotoxicology (Purdue Univ)​ Postdoc: Neuroscience (Duke Univ)​ NIH funding: R37039587, R01HD21007

manisha.patel@cuanschutz.edu

https://pharmacy.cuanschutz.edu/ research/research-labs/patel-lab

James Roede, PhD Associate Professor

Research Investigation of how an exposure to a single environmental agent, such as the fungicide maneb, augments the transport and cytotoxic properties of pharmaceuticals, dietary components, and/or chemicals arising from the environment or microbiome​ Elucidation of these mechanisms will help to prevent exacerbated toxicity due to alterations in gene expression resulting in enhanced transport of toxicants and xenobiotic interactions​ This mechanism may be directly relevant to neurodegenerative diseases like Parkinson’s disease and neurodevelopmental diseases like autism​ The aim of the laboratory is to utilize both targeted and systems approaches, such as proteomics, metabolomics and epigenomics, to investigate mechanisms of toxicity​ Research Interests: ​ Environmental causes of neurodegeneration e.g. maneb exposure​ Metabolic consequences of mitochondrial dysfunction Proteostasis and neurodegeneration​ Thiol redox dysregulation in mechanisms of toxicity

Education & Research BS, Michigan State University​ PhD, University of Colorado (Advisor, Dennis R. Petersen)​ Postdoctoral Fellow, Emory University (Mentor, Dean P. Jones)

james.roede@cuanschutz.edu

SYSTEMS APPROACHES

These resources facilitate biomarker analysis and allow complete analysis of metabolomics and proteomic changes associated with drugs and toxicants. ​

Thomas Delong, PhD Associate Professor

Background Hybrid Insulin Peptides (HIPs) are autoantigens in Type 1 Diabetes (T1D) formed when proinsulin fragments covalently bond with other beta-cell peptides (Figure 1).

These HIPs contain unique amino acid sequences not expressed in the thymus, allowing HIP-reactive T cells to escape negative selection and subsequently target pancreatic beta cells. We identified the enzyme Cathepsin D (CatD) as responsible for creating disease-relevant HIPs in pancreatic islets of both humans and NOD mice.

Furthermore, our research indicate that elevated glucose levels and innate cytokines promote HIP formation by lowering insulin granule pH and activating CatD (Figure 2).

This may allow HIP reactive T cells to mediate beta-cell destruction in response to environmental stressors.

Importantly, when stressors subside, HIP formation decreases, supporting a multi-trigger model of T1D pathogenesis and establishing a direct link between environmental factors and autoimmunity (Figure 3). A deeper understanding of HIP formation mechanisms could lead to novel targeted interventions for T1D.

Education & Research ​ PhD in Chemistry/Biochemistry Department of Biochemistry University of Erlangen Nuremberg, Germany​ Postdoctoral Fellow in Immunology​Department of Immunology and Microbiology University of Colorado Denver ​

thomas.delong@cuanschutz.edu

Background & Research By 2050: 50 million deaths due to antimicrobial resistance​ There is an incongruence between in vitro antimicrobial sensitivity testing and treatment efficacy due to metabolic cooperation between co-infecting microbes.

We develop and apply novel approaches to elucidate the molecular mechanisms governing the chemical interactions of co-occurring microbes in humanassociated microbiomes to discover new therapeutic strategies for antimicrobial resistance and tolerance.​​

Vanessa Phelan, PhD Associate Professor

Education & Research B.S. – University at Albany, SUNY​Biochemistry and Molecular Biology​ Ph.D. – Vanderbilt University Chemistry​ Postdoctoral Fellow – University of California, San Diego​

vanessa.phelan@cuanschutz.edu

https://www.thephelanlab.com/

Virus-induced senescence (VIS) in aging Hypothesis: VIS induced by neurotropic viruses of the central nervous system is a mechanistic driver of accelerated aging and degenerative processes of the brain.​​

Julio Aguado, PhD Assistant Professor

Education & Research PhD in Systems Medicine 2013 - 2018​European School of Molecular Medicine, University of Milan, Italy​ Postdoctoral Research Fellow 2018-2024​The University of Queensland, Brisbane, Australia​

julio.aguadoperez@cuanschutz.edu

Research Our research interests are radiobiology, tumor microenvironment and metabolism

Gina Bouchard, PhD Assistant Professor

Education & Research ​ BS Pharmacology, University of Sherbrooke, Canada.​ PhD Radiation Science and Biomedical Imaging University of Sherbrooke, Canada.​ Postdoctoral fellowship Stanford University

gina.bouchard@cuanschutz.edu

https://www.bouchardlab.org/

Blake Hill, PhD Professor and Chair Education & Research ​ The CU Anschutz Medical Campus welcomed Dr. Hill in January of 2024 where he continues his work researching mitochondrial homeostasis.​ In 2000, Dr. Hill joined the faculty at Johns Hopkins University, where he began his NIH-funded research program on the molecular basis of mitochondrial homeostasis.​ His postdoctoral training in protein design and engineering was completed at the University of Pennsylvania School of Medicine where he was awarded NIH and George W. Raiziss fellowships. ​ PhD from Yale University (Biophysical Chemistry) in 1995 BS from Kalamazoo College,

Research About Our Lab​ We are an interdisciplinary team dedicated to unraveling how proteins regulate mitochondrial homeostasis in both healthy and diseased cells. Our ultimate goal is to develop innovative drugs that enhance human health.​ Current Focus​ Our research primarily targets proteins involved in mitochondrial fission and fusion, as well as those interacting with mitochondria during apoptosis. We have pioneered a first-in-class inhibitor and are currently testing its effects in various disease models.​ Our Contribution​ Our work not only advances drug discovery but also deepens our understanding of the fundamental biology, chemistry, and physics of protein-protein and protein-membrane interactions. These interactions are crucial for the signaling pathways that play a significant role in human diseases.​

blake.hill@cuanschutz.edu

https://pharmacy.cuanschutz.edu/ research/research-labs/hill-lab

HTTPS://PHARMACY.CUANSCHUTZ.EDU