Fast Forward with CTSI Catalyst Awardees

A snapshot of how seven UCSF early stage researchers push boundaries in Therapeutics, Diagnostics, Devices and Digital Health.

With the combined potential to affect the health of tens of millions of people worldwide, recipients of the Catalyst Awards are thinking big. Awardees’ projects range from a first-of-its-kind mobile app to help teenagers diagnosed with schizophrenia to the creation of a fluorescent tag for residual microscopic disease (MRD), which could diminish MRD-related secondary operations for breast cancer patients.

Initiated in 2010 by the Clinical and Translational Science Institute (CTSI) at UC San Francisco, the Catalyst Awards program accelerates promising early research by offering funding support and connecting investigators with more than 100 expert consultants from academia, industry and venture capital who provide technology assessment, professional advice and detailed feedback with a specific focus on product development and commercial viability. These Catalyst Awards advisors support researchers working in four tracks—therapeutics, diagnostics, devices and digital health—and are a key component of what differentiates this innovative program.

“This model for translational research is defined by early, intimate, and individualized academic-industry partnerships,” said June Lee, MD, FAACP, Director of CTSI’s Early Translational Research program, which manages the awards. “Three years in, we are seeing the wide ranging value that the Catalyst Awards offer to UCSF researchers, including six dollars in funding subsequently recruited from diverse sources for every one dollar awarded.”

As evidence of Lee’s point, seven Catalyst Awards recipients report from the the ground on how the Catalyst Awards program has helped their research, and offer insights into new revelations, pivots, updates and challenges that have moved their research forward. See all awardees

Research: PRIME mHealth app aims to improve the lives of individuals living with schizophrenia by enhancing their motivation to improve their quality of life.

“Current treatment approaches are failing to address one of the chief driver’s of disability in this population—impaired motivation. Our team is bridging the latest advances in the neuroscience of reward processing and digital health technology to address this unmet need, using PRIME (Personalized Real-time Intervention for Motivational Enhancement), a mobile health app. Working with IDEO, an award winning human-centered design firm, we have designed an intervention that inspires young people with schizophrenia to engage in health promoting behaviors by harnessing social motivation and gradual success experiences. The Catalyst Awards process played a pivotal role in finding the right strategic partners to move PRIME from a compelling idea to a product that will make a significant impact in peoples’ lives.”

- Danielle Schlosser, PhD | Assistant Adjunct Professor, UCSF School of Medicine | 2013 Catalyst Awards, Digital Health

“Fifty-one million people worldwide have schizophrenia. Over 2.2 million people are diagnosed with schizophrenia in the U.S. and it currently exceeds the cost of treating all the cancers combined, stroke, heart disease, diabetes, and a number of other health conditions.”

Research: Novel mHealth App for Urinary Incontinence (UI) Treatment

The TakeControl mobile health application will deliver a standard self-guided behavioral intervention for UI. The app delivers a proven behavioral intervention for UI in a novel way by using hand-help mobile devices (i.e. iPhone, Android, or flip phone) and includes education on UI, bladder awareness with event tracking (voids, UI episodes), and behavior triggering (timed voids, Kegel exercises).

“The Catalyst Awards supported a pilot, randomized, and controlled trial of our mobile app. We have two potential funders/partners for large-scale studies, pending the results of our pilot study. In addition, our UCSF team (Ob/Gyn, mHealth, Internal Medicine, Urology) is being considered for an NIH contract to collaborate with an NIH network to develop new data collection methods and tools based on mobile technology and using the App developed for the Catalyst Awards as a model. We’re now figuring out where to position this app with several others we are developing – both for dissemination/medical use and for sustainable financial return.”

- Leslee Subak, MD | Professor in Residence, UCSF School of Medicine | 2012 Catalyst Awards, Digital Health

“Incontinence doesn’t kill you, it just takes your life away” is a concern often expressed by women with urinary incontinence (UI). UI is very common, affecting over 13 million women in the U.S. (25% of reproductive age and over 50% of postmenopausal women), and has a profound negative impact on quality of life including depression, social isolation, and increased risk of falling, fracture and nursing home admission. Yet, less than one-third of women with UI discuss it with their healthcare providers.”  

Research: ChemoFilter: Novel Device for High-Dose Chemotherapy Delivery

“The Catalyst Awards program is unique since aside from just being a typical grant mechanism, the program's consultation period is extremely valuable - as valuable as the funding or perhaps even more so since these consultants would ordinarily be quite expensive and their expertise would otherwise be difficult to obtain. Without the Catalyst Awards, we would not have created a startup with a diverse team, have real prototypes for our chemotherapy filter, and a clinical development plan. Additionally, we have been able to conduct 4 large animal (pig) studies that have given us strong evidence for in-vivo proof of concept for our device. This will be key for our efforts to pursue larger NIH grants and private funding. 

In the nearer future this device would impact those undergoing intra-arterial liver cancer treatments worldwide. Liver cancer is the third leading cause of cancer death worldwide with up to 800K new cases each year worldwide. In the longer term future, we want to use this device for patients undergoing chemotherapy in general.” 

- Anand Patel, MD | Resident Physician, UCSF School of Medicine | 2012 Catalyst Awards, Devices

“Liver cancer is the third leading cause of cancer death worldwide with up to 800K new cases each year worldwide.”

Research: Novel Enteric Computed Tomography (CT) Contrast Materials

“Our interaction with the Catalyst Awards program gave us an idea of the potential benefits that outside mentorship could give to increase the commercial value of our laboratory research. We were teamed up with several outstanding mentors who gave us critical insights into how our technology could be monetized either by licensing or through a startup company. Catalyst Awards funding proved to be critical to develop two additional prototype CT contrast agents beyond our initial invention. We have since created a new company, are licensing our technology from UCSF, have a supportive team of advisors and consultants, and are now applying for an NIH Small Business Innovation Research (SBIR) award to introduce our new CT contrast material to clinics in the next several years.”

- Benjamin Yeh, MD | Professor in Residence, UCSF School of Medicine | 2013 Catalyst Awards, Diagnostics

Approximately 20-30 million patients in the U.S. who receive CT scans each year could be affected.

Research: Development of a Real-Time Intraoperative Fluorescent Imager for Microscopic Residual Tumor

“The Catalyst Awards enabled significant progress in turning a proof of concept into a microfabricated prototype. With the award, we were able to custom fabricate key components of our device, including a novel microfabricated fiber optic array, high performance optical filter, and lens array. With the fabrication of a microfabricated prototype, we have been able to visualize a 75 um fluorescent spot, equivalent in size to 100 cells. Our work was presented at the largest international meeting of radiation oncologists (American Society for Radiation Oncology, ASTRO) and awarded the Basic Science Abstract Award, as one of the top 13 basic science abstracts of the conference. Additionally, intellectual property has been filed through UCSF.

To enable in-vivo imaging of microscopic disease, our philosophy is to preoperatively label disease by systemically injecting a fluorescently labeled antibody, in this case an anti-HER2 antibody. We have tested our custom antibody in-vitro and are preparing to do an in-vivo labeling experiment, providing further validation of our experimental plan. We are further developing our prototype and preparing to apply for the next phase of grant funding.”  

- Mekhail Anwar, MD, PhD, Resident Physician, and Catherine Park, MD, Associate Professor, UCSF School of Medicine | 2012 Catalyst Awards, Diagnostics

“Due to the difficulty of identifying microscopic residual disease (MRD), over 25% of the 285,000 women diagnosed each year with breast cancer in the US, treated with lumpectomy, are found to have MRD and require a second operation, or more- representing an additional $2.8 billion dollars of cost to the US health care system annually.”

Research: Recombinant Fusion Proteins that redirect (vascular endothelial growth factor) VEGF to actively kill cancer cells: R1FasL and R1TRAIL 

(testing the efficacy and safety of using an artificial protein, known as R1FasL, in cancer treatment)

“Novel and more effective cancer therapies are urgently needed. The Catalyst Awards helped our team prioritize experiments and secure in vivo proof-of-principle efficacy data with R1FasL molecule in xenograft models of glioblastoma and renal cell carcinoma. In the glioblastoma model, we are excited to find evidence of tumor size decrease and increased survival after only a single intratumor injection. Our next steps include evaluating safety and efficacy of R1FasL in multidose studies.” 

Research: Validation of human herpesviruses (HHV) as a therapeutic target through allosteric inhibition

“Our project seeks to validate proteases in the family of human herpesviruses as therapeutic targets and to develop inhibitors of these enzymes. Through a collaboration with the lab of Adam Renslo, PhD, (enabled by Catalyst Awards funding) we have generated compounds with improved potency and membrane permeability, including a prodrug for which we have evidence of conversion to the active form in cell culture. The Catalyst Awards improved the value of our preclinical leads and shifted the focus of the project to a significant clinical unmet need, cytomegalovirus. Furthermore, it strengthened our application for an National Institutes of Health R01 research grant that was recently awarded and is allowing us to initiate a massive high-throughput screen at St. Jude Children's Research Hospital.” 

- Charles Craik, PhD | Professor, UCSF School of Pharmacy | 2012 Catalyst Awards, Therapeutics

Cytomegalovirus (CMV), a type of herpesvirus, is very common, infecting up to 80% of people in the U.S. by age 40. Birth with CMV infection (congenital CMV) causes more birth defects and childhood deaths than Down syndrome, fetal alcohol syndrome, and spina bifida. Addiitonally, CMV infection is a major cause of death and disease in organ transplant recipients, patients with lymphoid cancers, and HIV-infected patients (CDC.gov)

Research: Allogeneic Human Mesenchymal Stem Cells (MSCs) for the Treatment of Acute Lung Injury (ALI)

(in critically ill patients based on strong preclinical data from this research group and others in multiple experimental models of ALI)

"Catalyst Awards support allowed us to complete the IND (Investigational New Drug) application and receive approval for our Phase 1 & 2 Clinical Trial - activating years one and two our National Heart, Lung and Blood Institute (NHLBI) U01 research grant totaling close to $2,000,000. We received outstanding help in every way: access to experts in the field, help to locate and support an advisor experienced in preparing cell therapeutic IND applications for submission to the FDA, and concrete help with paying for the mesenchymal stem cells for our Phase 1 trial, which was not available from the NHLBI U01 grant (as the U01 grant only covered Phase 2 work). The phase 1 clinical trial began in July 2013 at UCSF.”

- Michael Matthay, MD | Professor in Residence, UCSF School of Medicine | 2011 Catalyst Awards, Therapeutics

An estimated 50,000-75,000 patients develop moderate to severe acute respiratory distress syndrome (ARDS) with treatment needed in the intensive care unit. A large numbers of patients developed severe enough pneumonia to be hospitalized each year in the U.S.

UCSF's CTSI is a member of the Clinical and Translational Science Awards network funded through the National Center for Advancing Translational Sciences (grant Number UL1 TR000004) at the National Institutes of Health. Under the banner of "Accelerating Research to Improve Health," CTSI manages the Catalyst Awards program and provides a wide range of other resources and services for researchers at every stage.

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