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UCSF, QLHC and FDA Announce Successful Deployment of Innovative Data Capture System for Clinical Care and Research

UC San Francisco (UCSF), in collaboration with the Quantum Leap Healthcare Collaborative (QLHC) and the U.S. Food and Drug Administration (FDA), has developed the OneSource system to seamlessly integrate clinical care and research data.

OneSource is an electronic data capture (EDC) system which was developed with the goal of radically streamlining the collection and distribution of patient health data for clinical trials. It is based on best practices and open-source data Electronic Health Record (EHR) integration standards to launch seamlessly within widely used EHR platforms.

I-SPY COVID Trial Sponsored by Quantum Leap Healthcare Collaborative Suggests No Clinical Benefit with Addition of Nebulized ZYESAMI When Given by Mouth in Critically Ill Patients with COVID-19

Quantum Leap Healthcare Collaborative (QLHC) announced in collaboration with NRx Pharmaceuticals, Inc. (NRx), that the nebulized form of ZYESAMI® (Aviptadil), in the I-SPY COVID Trial of Critical COVID-19 patients has been stopped. The I-SPY COVID Trial, (NCT04488081) is a phase 2, open label, adaptive platform trial designed to rapidly screen potential agents that could substantially improve treatment for severely and critically ill COVID-19 patients. QLHC is the sponsor of the I-SPY COVID TRIAL.

Quantum Leap Healthcare Collaborative Concludes Famotidine Celebrex combination Does Not Reduce Time to Recovery or Mortality in Critically Ill Patients in the I-SPY COVID Trial

Quantum Leap Healthcare Collaborative (QLHC), the sponsor of the I-SPY COVID Trial, today announced that the Famotidine Celecoxib arm has been dropped from the trial due to futility, based on the low likelihood of success. The Famotidine Celecoxib combination was chosen for testing because of their anti-histamine and anti-inflammatory mechanism of action. 

Quantum Leap Healthcare Collaborative Concludes Cenicriviroc Not Likely to Reduce Time to Recovery or Mortality in Critically Ill Patients in I-SPY COVID Trial

Quantum Leap Healthcare Collaborative (QLHC), the sponsor of the I-SPY COVID Trial, today announced that cenicriviroc (CVC) has been dropped from the trial due to futility, based on the low likelihood of success. CVC was chosen for testing because it is a CCR2/5 inhibitor, which has been hypothesized to potentially prevent fibrosis linked to the inflammation that accompanies critical illness associated with COVID-19.

I-SPY COVID Trial Sponsored by Quantum Leap Healthcare Collaborative Suggests Addition of Icatibant is Unlikely to Impact Critically Ill COVID-19 Patients

The I-SPY COVID Trial, sponsored by Quantum Leap Healthcare Collaborative (QLHC), was designed to rapidly screen agents that show promise for reducing the time to recovery (defined as reduction in oxygen demand) by approximately 50% or risk of mortality in critically ill COVID-19 patients. Today QLHC announced that, in addition to the razuprotafib and apremilast arms, the icatibant portion of the trial has concluded.

Quantum Leap Healthcare Collaborative Concludes Apremilast Not Likely to Reduce Time to Recovery or Mortality in Critically Ill Patients in I-SPY COVID Trial

Quantum Leap Healthcare Collaborative (QLHC), the sponsor of the I-SPY COVID Trial, announced that apremilast (Otezla), made by Amgen, has been dropped for futility. Apremilast was chosen for testing in the I-SPY COVID Trial because it is a phosphodiesterase-4 (PDE4) inhibitor hypothesized to blunt the cytokine storm that accompanies critical illness associated with COVID-19.

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Tracey Heather

Advocate Liaison

As Patient Engagement Lead at Quantum Leap, I manage follow-up data projects for the I-SPY 2 Trial, develop strategies to strengthen patient engagement, and oversee the I-SPY Advocate group. After six successful years raising funds to support Quantum’s mission, I embraced this new role last summer, drawn by the opportunity to make a direct impact on the patients we serve. Each day brings new challenges and insights, and I especially enjoy supporting and collaborating with our inspiring I-SPY Advocates.

Outside of work, I am pursuing a Master of Public Administration with a focus on nonprofit management at SF State. I’m passionate about trail running, skiing, live music, camping, traveling, and collegiate gymnastics—my daughter competes at Oregon State. For the past 5 years, I have volunteered with SF CASA as a mentor to an incredible 18-year-old foster youth whose resilience continually reminds me of life’s true priorities.

Carolyn Clark Beedle

Carolyn Clark Beedle, a 2023 breast cancer survivor, joined the advocate program after successful completion of treatment with the UCSF Breast Oncology Program. Her experience working with a patient advocate during her TNBC treatment led to an understanding that empowering women to advocate for their own health and healthcare will contribute to improved health outcomes and broader access to care. Carolyn began advocating for cancer patients and their families during her treatment, now is a member of the Breast Science Advocacy Core (BSAC) with the UCSF Breast Oncology Program, and currently shares information and research with CFNP associates at La Clinica in the Bay Area to inform and empower their patient population.

Carolyn is continuing her on the ground training as an advocate reviewer with both Quantum Health and BSAC and is enrolled in the Patient Advocacy Training in Health Science course with Stanford Medicine. Her 30+ career in corporate marketing/communications, program development and non-profit leadership augmented by her breast cancer treatment experience serves Carolyn well in representing and communicating the patient voice and perspective.

She received her BA (History/English Lit) and MA (Public History/Research and Record Management) from the University of San Diego, is a proud fifth generation San Franciscan, and active board member with numerous non-profits that support social work and the arts.

Silver Alkhafaji

Silver Alkhafaji is a PhD candidate in the Pharmaceutical Sciences and Pharmacogenomics (PSPG) program at UCSF. She received her Bachelor of Science in Chemical Biology from UC Berkeley. Prior to UCSF, she worked in the Clinical Pharmacology Department at Genentech. Silver’s current research focuses on non-invasive liquid biopsies to predict response and side effects of immunotherapies and endocrine therapies in early-stage breast cancer participants in I-SPY 2.

Silver is interested in clinical outcomes research to advance precision medicine and improve cancer patients’ quality of life. She is passionate about health equity, inclusive research, patient advocacy, and women’s health.
Silver volunteers at the Patient and Family Cancer Support Center at UCSF where she assists in patient navigation and connecting patients and their families with resources that improve their healthcare experience while receiving cancer treatments and/or during survivorship. 

Through her DEI work in her PhD program, Silver raises awareness around issues related to social justice and community building through organizing community-centered events. Additionally, she is a member of the Life Sciences Career Advisory Council at Thrive Scholars, where she enjoys supporting college students of color from economically disadvantaged communities in providing the opportunities they need to thrive at top colleges and in high-trajectory careers. 

Silver is a member of the American Association of University Women (AAUW) Alameda Branch where she focuses her efforts on increasing membership of community college women coming from exceptional backgrounds: student parents, low-income, and first-generation college students.

In her free time, she writes poetry and prose on emotional healing, radical acceptance, and patience. Writing has helped her process difficult situations and connect with people on a deeper level.

Jane Mortimer

Jane is a breast cancer survivor and advocate dedicated to positively impacting the lives of women affected by the disease. Diagnosed with triple negative breast cancer in 2012, she participated in the I-SPY 2 trial at UCSF and has been cancer free for more than ten years.

Her advocacy journey began in 2003 at UCSF as a volunteer with the Patient and Family Cancer Support Center and Decision Support Services and she previously managed the Peer Support program at UCSF. Drawing on her experience in marketing and media strategy, she uses her skills to make a meaningful impact by supporting advocacy and research that improves outcomes for women living with breast cancer.

Jan Tomlinson

In March of 2023 , Jan was diagnosed with a large aggressive triple negative breast cancer and informed that her cancer was the” bad girl” of cancer and offered standard chemotherapy for 24 weeks. Devasted by the diagnosis Jan felt like she had a dire prognosis. After seeking several opinions, she opted to join a Clinical Trial program for her treatment. The trial consisted of significantly less chemotherapy, and monitored closely over a 12-week period, The data predicted a complete pathological response , and she then went immediately to surgery. Pathology reports supported that she had a successful outcome reaching PCR meaning the tumor was gone, and no residual cancer was found in the surrounding tissue or lymph nodes. Jan was thrilled when her surgeon advised her of the results. The experience made Jan want to give back and share information that she received when she was at a critical juncture in her diagnosis. She is so passionate about making sure that everyone knows that the standard of care is one treatment option.

As she says, “ clinical trials have to be on the table” Because she achieved PCR, she expects a great outcome. She wants to share her story and encourage other women to strongly consider and participate in clinical trials. Jan is a UCSF Patient Advocate, involved in several programs they lead. Jan also is a BLACC Cab Member. Jan recently was in Washington DC to participate on a panel on Clinical Trials for ISPY at the National Press Club. UCSF will be hosting the RISE Up For Breast Cancer event where Jan will share her experience with clinical trials.

Deborah Collyar

Deb is a connector who founded Patient Advocates in Research (PAIR) “where research meets reality,” bringing ideas and people together for medical advances that offer real results for diverse patients and families.

Her vast experience between the worlds of tech, communication, strategy, management, policy, and equity bridges gaps between patients, scientists, medical providers, payers, governments, and non-profits.

Deb infuses patient engagement into projects, gathers relevant patient input, and encompasses many diseases, programs and policies at grassroots, national and international levels through companies, academia, and governments.

Key patient insights are delivered throughout discovery, development, clinical trials, results reporting, data-sharing, standards, genomics, and into practice.

Her experience spans translational and clinical research, epidemiology, health outcomes, and health delivery research with academia, federal agencies, companies, and patient communities.