USC+CHLA Alpha Clinic

Network Services

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USC+CHLA Alpha Clinic Network Services

  • The USC+CHLA Alpha Clinic offers support for the production and testing of cell therapies in clinical trials via our USC/CHLA cGMP laboratory, under Dr. Mohamed-Abou-El-Enein’s direction. Our state-of-the-art facility provides a range of fee-for-service options and support, including process development and optimization, product manufacturing and analytical testing. Our goal is to ensure the efficient manufacture, processing, and delivery of cells to support the success of your clinical trial.

    For more information, please visit https://keck.usc.edu/cell-therapy-program/services/.

     

  • At USC+CHLA Alpha Clinic, we understand the complexities and challenges associated with conducting a clinical trial for cell and gene therapy. That is why we are dedicated to providing comprehensive support and resources to ensure a smooth and successful experience for our patients and partners. Our team, led by Dr. Thomas Buchanan, is equipped to assist with pre-award planning and protocol development, IND submissions, clinical trial activation, trial conduct, data analysis, and reporting. Our mission is to be a trusted partner in the development and clinical testing of cell and gene therapies, with a commitment to improving the health and well-being of our communities.

    To request support, please fill out this form or contact us at a-clinic@usc.edu.

  • At USC+CHLA Alpha Clinic, we recognize the significance of including a diverse patient population in clinical trials. Such representation not only mirrors the real-world patient demographic but also ensures that cell and gene therapies are effective for a wide range of individuals. However, achieving diversity in clinical trials has been a persistent challenge in the field of regenerative medicine, impacting elderly patients, pediatric populations, females, racial/ethnic minorities, and patients with unique comorbidities.

    To address this challenge, the USC+CHLA Alpha Clinic is dedicated to providing access to diverse populations through our community engagement initiatives. Our unique location and expertise allow us to engage with local communities and promote diversity in cell therapy trials. Our team of experts, led by Dr. Michele Kipke and Dr. Lourdes Baezconde-Garbanati, has extensive experience in working with diverse communities, and we are committed to ensuring that everyone has access to cutting-edge treatments and therapies.

    To request support, please fill out this form or contact us at a-clinic@usc.edu.

    For Alpha Clinic network partners: 2 hours free, then fee for service, if initial request accepted.

  • The USC+CHLA Alpha Clinic offers workforce training for cell and gene therapy professionals through its “Cell and Gene Therapy Development – Translating Basic Research into Clinical Applications (DSR 599)” course, developed by the USC/CHLA Cell Therapy Program under leadership of Dr. Mohamed-Abou-El-Enein. The course provides hands-on and theoretical training in the cGMP lab, equipping students with the skills needed for product development and clinical testing.

    To register for this program, please visit https://keck.usc.edu/cell-therapy-program/training-education/.

    At USC+CHLA Alpha Clinic, we understand the significance of quality management in clinical trials and the requirement for professionals who are well-versed in regulatory compliance. To fulfill this need, we have established a partnership with the School of Pharmacy to offer Clinical Trial Quality Training. Our program that is led by Dr. Enjoo Pacifici, consists of three comprehensive online self-study modules that aim to equip clinical research professionals with the necessary knowledge and skills to guarantee the quality and compliance of clinical trials.

    To register for this free online program, please visit https://sc-ctsi.org/training-education/courses/clinical-trial-monitoring-module.

  • The USC+CHLA Alpha Clinic offers consultations to help our network partners expand cell and gene therapies to new disease areas and provide opportunities for multicenter trials in the areas of expertise, assisting with technical, regulatory, and inclusivity challenges. We will share our relatively unique expertise in four areas:

    • Vision: Mark Humayun and Dr. Sun Young Lee will describe surgical techniques and imaging methods to assess the effectiveness of stem cell delivery to subretinal space.
    • Musculoskeletal: Denis Evseenko will share specific approaches to cell and gene therapy for bone, cartilage, and joint disorders, including IND development, regulatory strategy, and intellectual property.
    • Pediatrics: Alan Wayne will provide critical expertise, collaboration, and patient access to support the development of cell and gene therapies for pediatric patients.
    • Cranial and Dental: Yang Chai’s team will consult on stem cell-based methods to treat cranial and dental disorders. They will also share experience from the C-DOCTOR consortium on assembling expert teams to support effective clinical product development.

    To request support, please fill out this form or contact us at a-clinic@usc.edu.

    For Alpha Clinic network partners: 2 hours free, then fee for service, if initial request accepted.