Fast Facts

• No 2 Ranked PharmD program (most recent ranking in US News & World Report) • Ranked #2 in NIH Funding, 2010 • 105 Faculty , 600 PharmD students, 110 Graduate students • Over 200,000 sq ft of research/teaching space (3 buildings) equipped with state-of-the art VTC and distance education technology

Academic Programs
PharmD
Medicinal Chemistry & Natural Products Molecular Pharmaceutics

PhD
Pharmacotherapy & Exp. Therapeutics

MS
Pharmaceutical Outcomes & Policy

Health System Pharmacy

Synthetic Chemistry Chemical Biology Bio- and Chem-informatics Structural Biology Target Discovery & Validation

Medicinal Chemistry and Natural Products

Drug Delivery Formulation Gene Delivery Nanotechnology Material Science Bioengineering

Molecular Pharmaceutics

Drug Metabolism & transport Pharmacogenomics PK/PD Modeling & Simulation Clinical Trial Design Clinical Pharmacology
Pharmaceutical Scientists

Pharmacotherapy and Experimental Therapeutics

Disease Targets Leads

Formulation and Drug Delivery

Disposition, Safety & Efficacy in Clinic

Novel Therapies Novel Technologies

Center for Integrative Chemical Biology and Drug Discovery

Center for Nanotechnology in Drug Delivery

Institute for Pharmacogenomics and Individualized Therapy

Discovery to Practice
Discovery Optimization Assessment Outcomes Practice

Medicinal Chemistry & Natural Products

Molecular Pharmaceutics

Pharmacotherapy & Experimental Therapeutics

Pharmaceutical Outcomes & Policy

Pharmacy Practice & Experiential Education

Disease targets, Leads

Formulation and Drug delivery

Disposition, Safety and Efficacy in clinic

Effectiveness of delivery, Compliance

Evaluation, Development, Education

Center for Integrative Chemical Biology & Drug Discovery (CICBDD)
Vision: The Center will be an innovative and sustainable scientific
Director: Stephen Frye force in the creation of new small molecule therapeutics to improve public health and to transform the drug discovery paradigm.
Center Initiated Projects in Chemical Biology
“prospective science”

Center Capabilities
Assay Development
Protein expression and purification Cell-based or in vitro Multiple platforms and readouts

Target Proposals from UNC Faculty
“responsive collaborations”

CICBDD staff & joint faculty

Compound Screening
Up to 100K compounds possible HTS

small target drug molecule leads validation ‘probes’

Medicinal Chemistry
SAR projects 11 internal chemists + 4 FTE’s in China and access to more as needed Compound synthesis

Computational Chemistry
Design of screening sets Virtual screening Structure-based design

• Access to novel biological targets discovered by UNC faculty across therapeutics areas - targets validated with small molecules • Research focus on innovative targets in chromatin biology & epigentics • NCI-designated Comprehensive Chemical Biology Center • Leadership with industrial track record of discovery of FDA approved drugs

Features of CICBDD

The Center for Nanotechnology in Drug Delivery (CNDD)

Director: Russ Mumper

The focus of the CNDD is to safely and effectively translate new drug and imaging discoveries into clinical trials using nanotechnology with the goal to improve human health.

Center for Nanotechnology in Drug Delivery (CNDD)
Five Critical Areas/Disciplines:
1 Chemistry & Biomaterials
Inst. for Advanced Materials

CNDD Science Objectives:
First in human, proof of safety and utility

2 Formulation & Drug Delivery
School of Pharmacy

3 Therapeutic & Diagnostic Targets
Carolina Center of Cancer Nanobiotechnology Excellence

4 Nanotoxicology
RTP EPA, NIEHS

5 Phase I/II Clinical Trials
UNC CTSA

Federal Agencies (NIH, NSF) State of NC Private sector (VC, Industry) UNC students UNC Academic/Research Units UNC-Chapel Hill

CNDD Stakeholders

CNDD Academic Objectives:
World leader in research, training, and intellectual property creation

CNDD Business Objectives:
Sustainable business Model with ROI for All stakeholders

The Hamner-UNC Institute for Drug Safety Sciences (IDSS)
Director: Paul Watkins

Mission: Integrate clinical medicine with cutting-edge systems biology and in silico modeling platforms to make drugs safer and advance drug development.

A Platform for Integrated Drug Safety Research Predictive Safety Assessment
in vitro in vivo clinical postmarketing surveillance

Computational Systems Modeling

The Vital Partnership of Drug Discovery + Drug Delivery in Clinical Development

Drug Discovery
New Molecular Entities
(problems) Stabilize NMEs

Drug Delivery
Facilitate in-vitro screening

Small molecules
Unstable Insoluble Efflux substrates Poor permeability

Increase cell accumulation Range of dosage forms for various routes of administration in preclinical animal efficacy models Advantageously affect ADME and pharmacokinetics Minimize toxicity, Safe (GRAS materials) Cost-effective Scalable under GMP The Essence of Skills in the Center for Nanotechnology in Drug Delivery CMC sections of IND

Nucleic-acid based
Unstable Poor permeability Require intracellular Accumulation

+

IIncreased Probability of Clinical Success

Peptides/proteins
Unstable Poor permeability

IPIT is a collaboration of investigators, scientists,
Director: Howard McLeod

and clinicians across allied health schools within UNC with the unifying goal of expediting the path from basic research discoveries to clinical practice.
Lineberger Comprehensive Cancer Center School of Pharmacy Carolina Center for Genome Sciences

Associate Directors: Oncology research Federico Innocenti Pre-clinical PGx Timothy Wiltshire Policy and Ethics Lynn Dressler PGx Applied Technology Karen Weck Clinical PGx James Evans PGx Evidence-based Practices Dan Jonas

IPIT

School of Nursing School of Public Health

School of Medicine

Research Areas
Preclinical Pharmacogenomics Policy & Ethics Pharmaco-economics

Evidence-based medicine Clinical Pharmacogenomics Applied Technology

Medical Decision Making/Outcomes Phenotype-driven therapy

Translational Biomedical Research at UNC

Partial List of Key Partners: Depts. Chemistry, Physics, Mathematics, & Computer Science Biomanufacturing Research Institute and Technology Enterprise (BRITE) School of Medicine Lineberger Comprehensive Cancer Center (LCCC) UNC Neuroscience Center Carolina Cardiovascular Biology Center North Carolina Center for Nanoscale Materials (NCCNM) Institute for Advanced Materials, Nanoscience and Technology (IAM) UNC Institute for Nanomedicine Carolina Center of Cancer Nanotechnology Excellence (CCCNE) Biomedical Research Imaging Center (BRIC) Bryson Center for Human Genetics North Carolina Translational and Clinical Sciences (TraCS) Institute (via NIH CTSA)
Industry
Research Triangle Park

Chemistry & Biology
- High-throughout synthesis & screening - Bioassay development - Cheminformatics Validated targets Confirmed leads

Center for Exploratory Cheminformatics Research

CICBDD

Nanotechnology & Engineering
- Materials discovery; Nanoengineering - Pharmaceutics; formulations - Biological stability; Nanotoxicology Stable, lead formulations

In-Vivo Screening
- Biological transport; delivery - Pharmacokinetics; ADME Efficacious pre-clinical lead formulations

Genomics & Biology
- Gene expression - Pharmacogenomics

IPIT

Industry

Link molecular genetics to efficacy

UNC

Research Triangle Park (RTP)

Pharma/Biotech companies

Relationships
Area Universities Pharmacy Spinoffs
Qualiber NeuroGate Oriel Therapeutics

Capture Pharmaceuticals

Chemical Biology and Medicinal Chemistry

Glycobiology

Functional Proteomics

David Lawrence, Ph.D.

Michael Jarstfer, Ph.D. Harold Kohn, Ph.D.

Andrew Lee, Ph.D.

Stephen Frye, Ph.D. Qisheng Zhang, Ph.D.

Jian Liu, Ph.D.

Rihe Liu, Ph.D.

NIMH-Psychoactive Drug Screening Program

Natural Products

Chemoinformatics, Bioinformatics, & Computation

Bryan Roth, MD, Ph.D.

K.H. Lee, Ph.D.

Alexander Tropsha, Ph.D.

Formulation & Drug Delivery

Radiopharmaceutics & Imaging

Sam Lai, Ph.D.

Russ Mumper, Ph.D.

Moo Cho, Ph.D.

Rudy Juliano, Ph.D.

Michael Jay, Ph.D.

Leaf Huang, Ph.D.

Michael Jay, Ph.D.

Richard Kowalski, Ph.D.

Protein Dynamics – NMR

Pediatric Pharmacotherapy

Andrew Lee, Ph.D.

Angela Kashuba, Dhiren PharmD Thakker, Ph.D.

Michael Cohen-Wolkoweitz

Metabolism/Transport/PK/PD/Pharmacometrics

Kim Brouwer PharmD, Ph.D.

Dhiren Thakker, Ph.D.

Mary Paine Ph.D.

Philip Smith, Ph.D.

Julie Dumond, PharmD

Adam Persky, Ph.D.

Mechanisms of Hepatotoxicity

Cardiovascular Pharmacology

Kim Brouwer PharmD, Ph.D.

Roy Hawke PharmD, Ph.D.

Paul Watkins, M.D.

Jo Ellen Rodgers, Craig Lee, Herbert, PharmD PharmD, Ph.D. Patterson PharmD

Pharmacogenomics/Cancer Parmacotherapy

Infectious Diseases

Howard McLeod, Tim Lynn PharmD Wiltshire, Ph.D. Dressler, DrPH

Federico Innocenti, MD, Ph.D.

Amanda Angela Kashuba, William Zamboni, PharmD PhD, PharmD Corbett, PharmD

William Zamboni, Christine PhD, PharmD Walko, PharmD

Russ Mumper, PhD

Julie Dumond, PharmD

Sam Lai, Ph.D.

Transplant Pharmacotherapy

Outcomes Research

Robert Dupuis, PharmD

Betsy Sleath, Ph.D.

Mary Susan Blalock, Roth McClurg, Ph.D. MPH, Ph.D.

Joel Farley, Ph.D.

Jaya Rao, MD

Lynn Dressler, DrPH