Capabilities

Indiana Center for Biomedical Innovation (ICBI)

In patnership with Indiana CTSI and IU School of Medicine, the newly created Indiana Center for Biomedical Innovation (ICBI) at IU Health is geared to fill the critical gap between innovation and commercialization at IU. It will house start up companies created and based on IU innovation. ICBI is located on the 5th floor of the Noyes Research Building on the Indiana University Health Methodist Hospital campus. 

IU Clinical Trials Office

The IU-CTO serves to establish Indiana University, its strategic partner, IU-Health and its other research collaborators as a premier enterprise for sponsored clinical trials. The mission of the IU-CTO is to enhance the clinical research engagement process; streamline contracting for industry sponsored clinical trials; optimize budgeting and study support/facilitation processes; create an optimal environment and workforce for clinical research; increase clinical trial participation and the number of clinical trials across the enterprise, and engage key sponsors to enhance our partnerships. 

Phase I Clinical Trials

The Indiana University School of Medicine has established a unique phase I clinical trial facility in alliance with Covance, a drug-development service company, under the guidance of the Indiana Clinical and Translational Sciences Institute. The IUSM-Covance alliance provides the best in clinical expertise, patient recruitment, and laboratory facilities from IUSM along with the regulatory and clinical trial management capabilities of Covance.

The IUSM-Covance phase I unit has developed excellent partnerships with industry for clinical trials. In addition, oncology phase I trials are conducted at the Hoosier Cancer Research Network, the community clinical research arm of the IU Simon Cancer Center.

Pediatric Research and Clinical Trials

The Children’s Clinical Research Center at Riley Hospital for Children is a unique facility dedicated to pediatric research. The laboratory and research space is specifically designed for flexibility to accommodate the growing emphasis on collaborations between basic and clinical researchers.

Pediatric clinical research at IU has significantly contributed to health improvement of children with various conditions, including the first effective treatment for the tumors of a genetic disorder, neurofibromatosis type 1; toddlers’ use of insulin pumps once reserved for older patients; use of cooling techniques to prevent brain injury in newborns after difficult births; and a drug newly approved to treat children with hepatitis.

Indiana CTSI-Associated Clinical Research Centers

In addition to the Hoosier Cancer Research Network and IUSM-Covance phase I units, three other clinical research centers (CRC) associated with the Indiana Clinical and Translational Sciences Institute are located on the IUPUI campus. These include a general CRC at University Hospital, a neuroscience CRC at Goodman Hall, and a children’s CRC at Riley Hospital for Children. The Indiana CTSI Clinical Research Center provides space, nursing, and sample processing support to conduct academic and industry-sponsored clinical studies.

Rare Diseases Clinical Research

IUSM is one of the participating clinical centers in the Rare Diseases Clinical Research Network, which works to improve availability of rare disease information, treatment, clinical studies, and general awareness for both patients and the medical community. A number of rare diseases are managed through the biochemical genetics program at Riley Hospital for Children, including hyperammonemias, organic acidopathies, galactosemia, glycogen storage diseases, lysosomal storage disorders, Tay-Sachs disease, Hurler syndrome, hyperlipoproteinemias, carnitine deficiency disorders, and Prader-Willi syndrome.

Personalized Medicine

Genomic studies combined with individual testing enable researchers to determine a patient’s susceptibility to disease, predict the patient’s response to a particular drug, and enable matching with the right therapies. Personalized medicine has the potential to eliminate unnecessary treatments, reduce the incidence of adverse reactions, increase drug efficacy, and ultimately improve patient outcomes.

The IUSM pharmacogenomics and pharmacometrics programs are internationally recognized. The highly successful program in pharmacometrics was developed in collaboration with industry partner Eli Lilly and Company.

Drug Discovery and Molecular Therapeutics

The Indiana Drug Discovery Alliance (IDDA), an initiative of the Indiana Clinical and Translational Sciences Institute, aims to promote and support promising early-stage drug discovery research and facilitate collaborative translational research partnerships. IDDA provides access to synthetic chemistry and supports their biological evaluation in disease models through internal and external collaborations.

Indiana Biobank

The Indiana Biobank, in collaboration with other centers at IUSM, serves as a critical source of biological specimens. The current collection includes more than 16,000 samples that are linked to participants’ electronic medical information. The repository includes DNA from blood, cell lines, plasma, serum, RNA, peripheral blood mononuclear cells, and brain and other tissues. The Biobank partners with the National Institutes of Health-sponsored Alzheimer’s Disease Neuroimaging Initiative (ADNI) and National Cell Repository for Alzheimer’s Disease (NCRAD) to perform genome-wide and biological pathway analysis, functional neuroimaging, and biomarkers research.

Other capabilities include genetic analysis, gene expression, SNP arrays, and next-generation sequencing. The Biobank also partners with the Regenstrief Institute for health informatics studies. The samples and medical information, which include more than 8,000 variables encompassing clinical, laboratory, and outcomes data, are made available to scientists performing research.

Medical Genetics

The IU Molecular Genetics Diagnostic Laboratory, also known as the DNA LAB, is a clinical diagnostic laboratory that provides testing for inherited and acquired diseases and identity testing for bone marrow transplantation engraftment. The facility is equipped with real-time PCR devices, an ABI DNA sequencer, and tissue culture rooms.

Imaging

New imaging methods are being developed for research and clinical applications using technologies such as magnetic resonance imaging (MRI) and positron emission tomography (PET), which permit in vivo examination of the structural, functional, neurochemical, metabolic, and cellular/molecular properties of the brain in humans and in animal models. The combination of genomics, biomarkers, and imaging methods provides powerful data on brain mechanisms, disease processes, and treatment response from a systems biology framework. Scientists at the George M. O’Brien Research Center for Advanced Renal Microscopic Analysis are developing new optical methodologies for nephrologic and urologic research.

Animal Models

Preclinical models for basic and translational research reside in various therapeutic areas and laboratories of research experts. Examples include use of the euglycemic-hyperinsulinemic clamp, techniques to assess skeletal muscle insulin signaling, vascular function, acute chronic kidney disease, pulmonary hypertension, chronic pulmonary obstructive disease (COPD), emphysema, stroke, post-traumatic stress disorder (PTSD), Nonalcoholic steatohepatitis (NASH) and pain. IUSM has a large-scale breeding colony of Ossabaw swine, a model for metabolic syndrome and heart disease.

In addition, a core animal facility maintains many standard models such as models of diabetes, obesity, dyslipidemia, xenograft and orthotopic models of cancer, and various transgenic strains. The animal core also offers a humanoid metabolic syndrome animal model that can be used to study multiple organ diseases and utilize cutting-edge imaging and molecular technologies, technical expertise, consulting on study design and data analysis, and tissues from several previous and ongoing studies.