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Blogs

Gates Institute News and Stories

Cell and Gene Therapy

Cell and Gene Therapy    Biotechnology    Bioengineering

Navigating Operational Complexities in Phase I GMP Cell Therapy Manufacturing: A Compliance Perspective

In the rapidly evolving field of cell therapy, the transition from research to clinical application is filled with challenges, particularly within Good Manufacturing Practice (GMP) production during first-in-human, early-phase clinical trials. These trials set the groundwork for both safety (primarily) and efficacy (secondarily) as therapies advance toward commercialization. Understanding the operational intricacies involved in manufacturing cell therapy products for these trials is crucial for stakeholders, including sponsors, innovators, investors, and regulatory compliance professionals.


Author Nidhi Kotecha | Publish Date June 11, 2024
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Cell and Gene Therapy    Biotechnology

Gates Institute Taps Leading Biotech Experts for New Advisory Board

Five individuals with biotechnology expertise have been recruited by Gates Institute to form a new scientific advisory board.  They will provide strategic and scientific input to guide specific cell and gene therapy programs, with a focus on increasing patient impact, prioritizing near- and long-term goals, and exploring new platforms, said Gates Institute Executive Director Terry Fry, MD.


Author Toni Lapp | Publish Date June 10, 2024
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Research    Regenerative Medicine    Cell and Gene Therapy    Organ donation

From Organ Donor to Clinical Research Expert

From an early age, Cheri Adams, program director of regulatory strategy at the Gates Institute, knew she would pursue a career in medicine. But it was her experience as an organ donor that led her to a career in clinical research.


Author Mary Guiden | Publish Date April 02, 2024
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Research    Cancer    Advancement    Cell and Gene Therapy

Nephrologist Aims to Explore CAR T Therapy for Solid Tumors

Chimeric antigen receptor (CAR) T-cell therapy has shown great promise in the treatment of certain leukemias and lymphoma, but results in solid tumors have not been as impressive.


Author Toni Lapp | Publish Date March 18, 2024
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Funding    Cell and Gene Therapy   

Gates Grubstake Fund Awards over $1.4 Million to CU Anschutz Researchers

Gates Institute recently announced four recipients of the 2023 Gates Grubstake Fund. These awards are designed to support investigators who are researching and developing regenerative medicine-related technologies. The awards of up to $350,000 are made annually in a process administered in collaboration with CU Innovations. The fund made awards totaling over $1.4 million to University of Colorado Anschutz researchers in 2023.


Author Toni Lapp | Publish Date January 08, 2024
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Cell and Gene Therapy   

Gates Institute Names Navin Pinto as Medical Lead

Navin Pinto, MD, a professor in the Department of Pediatrics at the University of Colorado School of Medicine on the CU Anschutz Medical Campus, has been named medical lead at Gates Institute. In this role, he’ll work in partnership with the Investigational New Drug and Device (IND/IDE) Office to oversee Gates Institute-supported clinical trials, providing expertise drawn from his extensive experience with chimeric antigen receptor (CAR) T-cell therapy. 


Author Toni Lapp | Publish Date January 08, 2024
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Cell and Gene Therapy

Gates Institute’s Top Stories of 2023

It’s been a banner year for the Gates Institute, which celebrated its launch in May 2023, consolidating the Gates Biomanufacturing Facility with the administrative team of the former Gates Center for Regenerative Medicine as well as the regulatory expertise of the Clinical Investigation and Regulatory Sciences (CELLS) team under one umbrella. The year has seen the launch of a new chimeric antigen receptor (CAR) T-cell clinical trial and continued enrollment of three existing CAR T-cell trials. The Gates Institute newsroom detailed these activities, as well as other areas of cell and gene therapy research in the works.  


Author Toni Lapp | Publish Date December 21, 2023
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Pediatric Cancer    Blood Cancer    Regenerative Medicine    Cell and Gene Therapy

Gates Biomanufacturing Facility Deploys CAR T-Cell Process Improvement

Since receiving FDA approval in 2017, chimeric antigen receptor (CAR) T-cell therapy has shown remarkable success in treating patients with certain blood cancers such as lymphoma and leukemia. A complex biomanufacturing process is required to produce the therapy, which is performed for each individual patient. The process begins with apheresis, generating a leukopak containing the patient’s white blood cells. From there, T cells are isolated, genetically engineered to create CAR proteins that enable T cells to attack cancer cells, and multiplied in a laboratory. They are then reintroduced to the patient.


Author Toni Lapp | Publish Date December 14, 2023
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Research    Bone Cancer    Animal    Cell and Gene Therapy

Trial Launched to Test CAR T-Cell Therapy in Dogs Diagnosed With Solid Tumors

Dogs are like humans in many ways, sharing similar physiology as well as biological needs. Our four-legged friends are also vulnerable to some of the same diseases that we face, making the intersection of human and animal medicine an intriguing subject for study.


Author Mary Guiden | Publish Date November 07, 2023
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Research    Regenerative Medicine    Cell and Gene Therapy

Gene Therapy Protocol Could Offer New Treatment for Skin-blistering Diseases

Epidermolysis bullosa (EB) is a skin-blistering disease that can be devastating for those with severe forms of the condition. Research is underway to grow genetically corrected skin by Gates Institute investigators Ganna Bilousova, PhD, and Igor Kogut, PhD, associate professors of dermatology at University of Colorado School of Medicine, in collaboration with Dennis Roop, PhD, professor of dermatology and associate director of the Gates Institute. Their work could lead to effective therapies for EB as well as other diseases.


Author Carie Behounek | Publish Date October 27, 2023
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Regenerative Medicine    Cell and Gene Therapy

Technology Transfer: The Key to Moving Scientific Discoveries Forward

At the surface, technology transfer is exactly what it sounds like; the transfer of technology from one entity to another. When working with your friendly neighborhood cGMP facility (the Gates Biomanufacturing Facility, or GBF), that simple phrase, technology transfer, should take on a whole new meaning.


Author Guest Contributor | Publish Date September 26, 2023
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Research    Blood Cancer    Clinical Trials    Cell and Gene Therapy

Behind the Scenes of a CAR T-Cell Trial

Blood cancers – leukemia, lymphoma and myeloma -- are the third-leading cause of cancer deaths in the United States, with more than one-third of patients succumbing to their disease within five years of diagnosis. In 2017, the Food and Drug Administration approved the use of chimeric antigen receptor (CAR) T-cell therapy for lymphoma and certain leukemias in patients for whom other treatments had failed. Research has shown that about 85% of such patients achieve remission, but about 60% of these eventually relapse. Gates Institute at the University of Colorado Anschutz Medical Campus is on the forefront of research to improve the efficacy of this groundbreaking treatment.


Author Toni Lapp | Publish Date September 15, 2023
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Research    rare disease    Regenerative Medicine    Cell and Gene Therapy    Gates Summer Internship Program

Student With Rare Genetic Condition Searches for a Cure at Gates Institute

Few college seniors can say they are working in a world-renowned lab to develop therapies for a genetic disorder that plagues 1 in 5,000 people worldwide.


Author Carie Behounek | Publish Date July 28, 2023
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Leukemia    Cancer    Clinical Research    Clinical Trials    Cell and Gene Therapy

New CAR T-Cell Trial Enrolling Patients at CU Anschutz

Enrollment has begun for a new phase 1 study of chimeric antigen receptor (CAR) T-cell therapy at UCHealth University of Colorado Hospital for adults with B-cell acute lymphoblastic leukemia (B-ALL). The trial is the first launched through the newly formed Gates Institute, and it will be the fourth for which the Gates Biomanufacturing Facility produces the CAR T product for research at CU Anschutz Medical Campus.


Author Toni Lapp | Publish Date July 13, 2023
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Clinical Trials    Regenerative Medicine    Cell and Gene Therapy

Executive Director Brings Start-up Experience, Biologics Expertise To GBF Leadership Role

Like many start-ups, the Gates Biomanufacturing Facility’s path to becoming sustainable has been full of twists and turns. The facility, known internally as the GBF, was launched in 2015 with no customers and no jobs in the pipeline, but many capital needs. The visionaries at University of Colorado Anschutz Medical Campus and the Gates Frontiers Fund saw biomanufacturing capabilities as being key to the success of the nascent Gates Center for Regenerative Medicine, and took a leap of faith.


Author Toni Lapp | Publish Date June 12, 2023
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Research    Faculty    Clinical Trials    Giving    Dermatology    rare disease    Regenerative Medicine    Cell and Gene Therapy

Cracking the Code for Once 'Incurable' Diseases

When Dennis Roop, PhD, joined the University of Colorado School of Medicine to lead the Gates Program for Stem Cell Research in 2007, the first postdoc he recruited was Ganna (Anya) Bilousova, PhD, a Ukrainian researcher who had recently completed graduate training in biochemistry at CU.


Author Carie Behounek | Publish Date April 21, 2023
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Gates Institute In the News

The Denver Post

CU studying use of patients’ own reprogrammed cells to attack cancer as alternative to more chemo

news outletThe Denver Post
Publish DateMarch 14, 2024

A study at University of Colorado’s Gates Institute on the Anschutz Medical Campus is looking at CAR-T in adult patients with acute lymphocytic leukemia, a cancer of the blood and bone marrow, whose first round of chemotherapy either failed or gave a disappointing response that suggests it won’t work for long, executive director Dr. Terry Fry said. (The institute is named for rubber manufacturer Charles C. Gates.)

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UC Davis News

UC Davis Graduating Student Poised to Help Those With Rare Condition

news outletUC Davis News
Publish DateDecember 12, 2023

Encouraged by his care team at the Colorado hospital to apply for an internship at the Gates Institute research lab, Mann spent this summer surrounded by researchers helping develop novel therapeutics for Ehlers-Danlos Syndrome (EDS). He worked on an experiment that used cells from EDS patients to grow skin samples for study. The lab is investigating the use of exosomes — secreted by most cells and present in tissues and body fluids — as a vehicle for therapeutic intervention.

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Colorado Bioscience Association

Building a Life Sciences Pipeline: Cell and Gene Therapy Momentum

news outletColorado Bioscience Association
Publish DateMarch 06, 2023

When you talk to Terry Fry, M.D., about why the Gates Institute is one of the best locations in the country to work in cellular and gene therapy, he has a lot of insight. As the executive director of the Gates Institute, a pediatric oncologist, and a pioneer in the development of chimeric antigen receptor (CAR)-T cell therapies, Dr. Fry has an intimate understanding of what it takes to get a drug from initial research phases to commercial manufacturing.

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Genetic Engineering & Biotechnology News

University Creates Innovative Model for Running a GMP Manufacturing Facility

news outletGenetic Engineering & Biotechnology News
Publish DateFebruary 08, 2023

The University of Colorado has adopted an innovative model for running an academic GMP manufacturing facility without extensive endowment funding. The Charles Gates Biomanufacturing Facility is one of only a few GMP facilities able to manufacture cell- and protein-based therapies for both academic researchers and industry.

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