University Affairs JAN 17, 2020

CU Anschutz Medical Campus

➧ CU Anschutz Researchers are integrated into 2 world class hospital systems and adjacent to the VA medical center

➧ Supports the quick translation of lab discoveries to the clinic

Anschutz Medical Campus

➧ Over 5000 Faculty 76% increase since 2010

➧ Sponsored research –topped $550 million in 2019 31% growth in the last 5 years

Biomedical research pipeline

Basic biomedical research

Translational research

Clinical research

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Types of clinical trials

Many types of clinical trials

Two Main Categories

•Interventional•Non-Interventional

Sponsors of Clinical Research Trials

Institution – University of Colorado

Federal Government – NIH

Foundations, Associations, etc.

Pharmaceutical and device companies

US Funding for Medical Research by Source, 1994-2012➧ Largest funders

are the NIH and pharmaceutical companies.

➧ Foundations and Charities play a smaller, but important role.

JAMA. 2015;313(2):174-189. doi:10.1001/jama.2014.15939

https://www.aip.org/fyi/2019/fy20-budget-request-national-institutes-health

National Institutes of Health

➧ Grant applications and funding rates since 1998

➧ Success rate has fallen from the mid 30% range to around 20%

➧ The Number of applications continues to rise

➧ It is a very competitive landscape.

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CU Anschutz Funding by Type

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Developing a clinical trial

Phases of Clinical Trials

Pre-clinical

Preclinical studies Set the foundation for clinical trialsDetermine the mechanism of the new treatment

Basic Biomedical Research at CU Anschutz: -Example of a shared biomedical research instrument -Used to define the structural biology of molecular

Phases of Clinical Trials

Pre-clinical Phase I

Phase I clinical trialsEarly clinical trial testingIs the drug safe?What is the right dose? Traditionally small (20-75 participants)

The Gates Biomanufacturing Facility

The GBF allows CU Anschutz researchers direct access to protein and cell therapy production

Phases of Clinical Trials

Pre-clinical Phase I Phase II

Phase II clinical trialsExpanded safety and efficacy informationDoes the drug work at this dose?Usually tested in a specific group or disease Larger than phase I trials: typically 30-100’s participants

Clinical Research

➧ Research Team:➧ Principal

investigator➧ Regulatory

specialist➧ Data specialist➧ Research

coordinator➧ Finance support

Phases of Clinical Trials

Pre-clinical Phase I Phase II Phase III

Phase III clinical trialsCompares new treatment to the standard of careOftentimes randomized and carefully regulated with the FDAMay lead to a new approval or application of a drug or device Larger studies – from 100’s to 1000’s of participants

Phases of Clinical Trials

Pre-clinical | Phase I Phase II Phase III

TimelineIt takes years to perform the laboratory and preclinical workThe clinical trial phase of testing can take 5-7 yearsMay take an additional year or 2 for FDA approval

2-5+ years | 5-7 years for clinical trials

Connecting to a clinical trial

Participants involved in clinical trials with CU Anschutz healthcare partners

CU Anschutz and CU Boulder opportunities

➧ The campuses have very complimentary areas of focus and expertise

➧ Many opportunities for CU Anschutz and Boulder to collaborate and accelerate the impact of our research efforts Personalized medicine, data science, immunotherapy, cancer,

mental health, regenerative medicine, innovative medical care, and many other areas.

➧ The offices of the Vice Chancellor for Research on both campuses are in regular contact and focused on this opportunity.

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Discussion