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Patient-funded clinical trials (PFCT) involve participants or their supporters directly contributing to treatment costs, distinguishing them from standard clinical research that relies on external sponsors such as grants or pharmaceutical companies. These trials often take place in academic or university settings and focus on innovative or experimental therapies for rare, complex, or underserved conditions—such as autoimmune diseases, neurological disorders, or cancers—where traditional funding is limited. While they can provide early access to cutting-edge treatments, they carry significant risks, including high and variable costs, potential adverse events, no guaranteed outcomes, and sometimes limited regulatory oversight. This site compiles documented patient-funded trials from US universities, including key details like institution, indication, method, adverse events, patients treated, costs and revenue generated; barriers to entering the US market, and the potential liberalization that PFCTs offer.

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Northwestern University
Duke University
University of California, Irvine
University of California, Los Angeles
Barriers to Entry in U.S. Drug Development
Opportunities for Liberalization Through Patient-Funded Models

Northwestern University

Northwestern University, located in Chicago, Illinois, is a leading private institution founded in 1851, renowned for its Feinberg School of Medicine, which excels in immunology, neurology, and stem cell research through innovative clinical trials and collaborations. As of fiscal year 2025, Northwestern's endowment stands at approximately $16.2 billion, supporting its operations and research initiatives. The university receives over $1 billion USD in annual research funding, with federal sources comprising the majority of(~$790M USD), with the rest being supplemented by state and private grants.

Northwestern University has utilized patient-funded clinical trials for individuals suffering from auto-immune diseases, particularly multiple sclerosis (MS), chronic inflammatory demyelinating polyneuropathy (CIDP), system lupus erythematosus (SLE), and scleroderma. This study’s Principal Investigator was Dr. Richard Burt, a professor of medicine and chief of the Division of Immunotherapy and Autoimmune Diseases at Northwestern’s Feinberg School of Medicine.

Northwestern’s Patient Funded Clinical Trial was conducted from 1996 to 2019, involved a non-myeloablative hematopoietic stem cell transplantation (HSCT) with cyclophosphamide and antithymocyte globulin, aiming to suppress and rebuild the immune system without fully ablating bone marrow.

Approximately 700 patients were treated, with a mean price of $85,184 USD (ranging from $70,634 USD to $150,000 USD per patient), generating total revenue for the university of $65M USD to $70M USD. Patients reported adverse events such as infections, infertility, secondary autoimmune diseases, and treatment-related mortality of 1-6%, along with an FDA warning for delay adverse event reporting.

Duke University

Duke University, founded in 1838 in Durham, North Carolina is a prestigious private research university. The Duke University School of Medicine and Medical Center is recognized globally for advanced in pediatrics, regenerative medicine, and cellular therapies, particularly through its Marcus Center for Cellular Cures, which emphasizes innovative treatments for neurological and rare diseases. Duke’s endowment is valued at $12.3 billion USD as of June 30, 2025, providing sustained support for its academic and research endeavors. Beyond its endowment, Duke receives annual research funding totaling around $1.33B USD, with federal sources accounting for $863M USD, including a ~$580M grant from the National Institutes of Health (NIH), while state and private funding make up the remainder.

Duke University has conducted patient funded clinical trials for patients suffering from autism spectrum disorder (ASD), cerebral palsy, and other neurological conditions. As the lead Principal investigator, Dr. Joanne Kurtzberg, a pediatric hematologist-oncologist and professor at Duke University School of Medicine, conducted these patient-funded studies from 2017-2022, including the enrollment of children, some as young as 2 years of age. The treatment used autologous or sibling umbilical cord blood infusions via peripheral IV, leveraging the anti-inflammatory and regenerative properties of cord blood stem cells to potentially repair neural damage.

Approximately 464 patients were treated, at a price of $10,000 USD to $15,000 USD per infusion, generating ~$5M USD to ~$7M USD in revenue for Duke University, with some patients being treated over multiple instances. Adverse events consisted of hypersensitivity reactions (9% probably or definitely related), with no serious treatment-related adverse events.

University of California, Irvine

The University of California, Irvine (UCI) represents the first public institution on this list, whose operations are primarily funded by federal, state, and local taxpayers. The University of California, Irvine (UCI Health), is part of the University of California system in Irvine, California and was founded in 1965 as public research university with strong emphasis on health sciences through its School of Medicine and Chao Family Comprehensive Cancer Center, known for cutting-edge programs in stem cell therapy, oncology, and neurology that integrate clinical care with translational research. UC Irvine’s endowment exceeds $1B USD as of FY2025, while the boarder University of California System endowment is $29.5 billion USD. UCI receives annual research funding of $668M USD in fiscal year 2023-2024, with federal sources providing over $361M USD.

In this patient funded clinical trial, Dr. Stefan O. Ciurea was the principal investigator. Dr. Ciurea is a hematologist and director of the Hematopoietic Stem Cell Transplantation and Cellular Therapy Program at UC Irvine, with extensive experience from her prior role at MD Anderson Cancer Center. As of 2026, this patient funded clinical trial is still ongoing and explores how autologous hematopoietic stem cell transplantation (aHSCT) can module immune responses in autoimmune diseases like Multiple Sclerosis, with early data suggesting disease stabilization and reduced lapses in patients. The method was aHSCT, involving stimulation of bone marrow with drug injections, collection of stem cells via aphaeresis, administration of chemotherapy to ablate the immune system, and infusion of stem cells to promote immune reconstitution.

Adverse events included risks from chemotherapy, mitigated with antibiotics and antivirals, along with prolonged recovery in isolation. Thus far, 4 patients have been treated at a price of $150,000 USD per infusion, generating $600,000 USD in total revenue for this public institution.

University of California, Los Angeles (UCLA)

The University of California, Los Angeles (UCLA) is a flagship public research university founded in 1919 and represents the second public institution on this list of patient funded clinical trials. The David Geffen School of Medicine and Jonsson Comprehensive Cancer Center is a world-renowned leader in nuclear medicine, radiology and oncology research. UCLA benefits from the UC system’s $29.5B USD endowment, and annual research funding exceeding $1.4B USD with federal sources providing about 60% of this funding.

Principal Investagor Dr. Jeremie Calais, a nuclear medicine physician and associate professor at UCLA’s Ahmanson Translational Theranostics Division, is an expert in molecular imaging and radiopharmaceutical therapies was the lead on this patient funded clinical trial. This PFCT targeted metastatic castrate-resitant prostate cancer (mCRPC) from 2017 to 2018. The treatment was 177Lu-PSMA-617 radionuclide therapy, consisting of up to 4 IV cycles every 8 weeks or 6.0 or 7.4 GBq doses, where lutetium-177 binds to prostate-specific membrane antigen (PSMA) on cancer cells to deliver targeted radiation.

64 patients were treated, at cost of $10,000 USD per cycle, with some patients seeing up to 4 cycles, generating ~$2.56M USD in revenue for UCLA. Adverse events included xerostomia (with 72% of patients reporting this side-effect), nausea/vomiting (69%), bowel issues (45%), and anemia (8%).

Barriers to Entry in U.S. Drug Development

The U.S. Food and Drug Administration (FDA) approval process for new therapies imposes substantial barriers, often requiring 10-15 years from discovery to market and costs ranging from $1 billion USD to $2.6 billion USD per drug, according to estimates from the European Medicines Agency (EMA) and FDA analyses. These figures account for preclinical research, multiple phases of clinical trials, and regulatory reviews, with failure rates exceeding 90% for candidates entering human testing.

Annually, over 30,000 new clinical trials are registered globally, with the U.S. accounting for approximately 40%, around 12,000, based on ClinicalTrials.gov data through 2025, which lists over 567,000 total studies. Despite this volume, funding remains constrained. The National Institutes of Health (NIH) allocated $48.7B USD in FY2025, a $415 million USD increase from 2024, primarily supporting basic and translational research. However, this budget must cover tens of thousands of projects across institutions and private entities, leaving many promising ideas underfunded.

Publicly supported universities, which receive billions in federal and state grants, have turned to patient-funded clinical trials (PFCTs) to bridge gaps for specific studies. This trend highlights resource allocation challenges in a system where even well-funded entities prioritize based on limited budgets. Private companies, operating without guaranteed public subsidies, face similar constraints and may leverage PFCTs to access market-driven capital, potentially enabling research that traditional grants overlook.

Opportunities for Liberalization Through Patient-Funded Models

Patient funded clinical trials could liberalize medical research by diversifying funding beyond traditional grants, empowering patients to directly support innovative or unconventional ideas that might not fit institutional priorities. In the current system, grants from bodies like the NIH often favor established researchers and large institutions, potentially disadvantaging independent innovators. Patient-directed funding shifts this dynamic, allowing the free market to incentivize "out-of-the-box" approaches, such as repurposing existing drugs for rare diseases or exploring therapies in underserved areas.

Studies suggest PFCTs accelerate clinical translation by giving participants greater control over research directions, as seen in trials for rare conditions where patient groups fund studies directly. For instance, nonprofit consortia backed by patient foundations have reduced reliance on high-return expectations for commercial partners, attracting more industry involvement in low-prevalence diseases. Public funding already plays a key role in drug innovation, contributing to all 210 FDA-approved drugs from 2010-2016 via NIH-supported research, but PFCTs could extend this by enabling patient-led initiatives that complement government efforts.

Potential benefits include broader access to experimental treatments and incentives for novel therapies. Drugs with significant public funding are more likely to receive FDA expedited designations (e.g., breakthrough therapy status) and be first-in-class, indicating higher innovation potential. Liberalization via PFCTs might lower overall development costs by streamlining targeted trials and reducing administrative overhead, though evidence is emerging and mixed; one analysis estimates that alternative models could cut expenses by 20-30% in specific cases, but long-term data is needed.

Overall, PFCTs could democratize research, fostering a hybrid model where patient investment supplements public and private funds to drive equitable innovation. As PFCTs grow, they may influence policy toward greater liberalization, such as expanding FDA allowances for patient payments in trials or integrating them with public funds. Evidence from patient-led rare disease trials shows improved public health outcomes and cost savings through faster repurposing. Continued research is essential to quantify benefits, such as potential reductions in the $175,000 USD average annual cost of new cancer drugs, while ensuring equitable access.

Citations:

  1. Northwestern University. (2026). 2026 financial update. Leadership Notes (Projected/simulated). https://www.northwestern.edu/leadership-notes/2026/2026-financial-update.html

  2. Bove, R., Hauser, S. L., Cree, B. A. C., Tardo, L., Benavides, E., Gelfand, J. M., Graves, J. S., Henry, R. G., Hollenbach, J. A., Ruiz, A., Waubant, E., Wellik, K. E., & Burt, R. K. (2021). Real-world application of autologous hematopoietic stem cell transplantation in 507 patients with multiple sclerosis. Multiple Sclerosis Journal, 27(11), 1706–1717. https://doi.org/10.1177/13524585211030876 (PubMed: https://pubmed.ncbi.nlm.nih.gov/34633525/)

  3. Burt, R. K., Balabanov, R., Burman, J., Sharrack, B., Snowden, J. A., Oliveira, M. C., Fagius, J., Rose, J., Nelson, F., Barreira, A. A., Carlson, D. J., Han, X., Moraes, D., Morgan, A., Quigley, K., Yaung, K., Buckley, D., Allickson, J., Jirjis, M., ... Burt, R. K. (2019). Effect of nonmyeloablative hematopoietic stem cell transplantation vs continued disease-modifying therapy on disease progression in patients with relapsing-remitting multiple sclerosis: A randomized clinical trial. JAMA, 321(2), 165–174. https://doi.org/10.1001/jama.2018.18743 (Full article: https://jamanetwork.com/journals/jama/fullarticle/2720728)

  4. Burt, R. K., Balabanov, R., Han, X., Quigley, K., Arnautovic, I., Helenowski, I., Rose, J., Nelson, F., Burman, J., Fagius, J., Snowden, J. A., Oliveira, M. C., Sharrack, B., & Burt, R. K. (2020). Hematopoietic stem cell transplantation for chronic inflammatory demyelinating polyradiculoneuropathy. Neurology, 95(9), e1274–e1285. https://doi.org/10.1212/WNL.0000000000010387 (PubMed: https://pubmed.ncbi.nlm.nih.gov/32594300/)

  5. Burt, R. K., Balabanov, R., Voltarelli, J., Barreira, A., Burman, J., Fagius, J., Jirjis, M., Morgan, A., Quigley, K., Yaung, K., Han, X., Snowden, J., Sharrack, B., Oliveira, M. C., & Burt, R. K. (2020). Health economics and patient outcomes of hematopoietic stem cell transplantation versus disease-modifying therapies for relapsing remitting multiple sclerosis in the United States of America. Journal of the Neurological Sciences, 415, Article 116968. https://doi.org/10.1016/j.jns.2020.116968 (PubMed: https://pubmed.ncbi.nlm.nih.gov/32731201/)

  6. Burt, R. K., Shah, S. J., Dill, K., Grant, T., Gheorghiade, M., Schroeder, J., Craig, R., Hirano, I., Marshall, K., Rudick, R., Jovanovic, B., Milanetti, F., Jain, S., Kraus, D., Burt, R. K., & Barr, W. G. (2011). Autologous non-myeloablative haemopoietic stem-cell transplantation compared with pulse cyclophosphamide once per month for systemic sclerosis (ASSIST): An open-label, randomised phase 2 trial. The Lancet, 378(9790), 498–506. https://doi.org/10.1016/S0140-6736(11)60982-3 (PubMed: https://pubmed.ncbi.nlm.nih.gov/21777972/)

  7. Burt, R. K., Traynor, A., Statkute, L., Barr, W. G., Rosa, R., Schroeder, J., Verda, L., Krosnjar, N., & Quigley, K. (2005). Autologous non-myeloablative hematopoietic stem cell transplantation in patients with severe systemic lupus erythematosus. Blood, 106(11), 4063a. https://doi.org/10.1182/blood.V106.11.4063.4063 (ScienceDirect: https://www.sciencedirect.com/science/article/pii/S0006497118640480)

  8. ClinicalTrials.gov. (n.d.). A randomized study of nonmyeloablative hematopoietic stem cell transplantation versus continued disease modifying therapy in patients with relapsing remitting multiple sclerosis (MOST trial protocol). https://clinicaltrials.gov/study/NCT03342638 (PDF: https://cdn.clinicaltrials.gov/large-docs/38/NCT03342638/Prot_002.pdf)

  9. Knoepfel, P. (2019). Northwestern may be abruptly ending Burt HSCT autoimmune trials. The Niche. https://ipscell.com/2019/08/northwestern-may-be-abruptly-ending-burt-hsct-autoimmune-trials/

  10. Northwestern University Feinberg School of Medicine. (2019). Stem cell transplants improve on current MS treatments. Feinberg News. https://news.feinberg.northwestern.edu/2019/01/22/stem-cell-transplants-improve-on-current-ms-treatments

  11. Northwestern University Feinberg School of Medicine. (2015). Burt study: Stem cells for MS. Feinberg News. https://news.feinberg.northwestern.edu/2015/02/04/burt-stem-cells-ms

  12. Knoepfler, P. (2017, March 13). FDA warns Northwestern’s Richard Burt on reporting patient deaths & other issues in stem cell trials. The Niche. https://ipscell.com/2017/03/fda-warns-northwesterns-richard-burt-on-reporting-patient-deaths-other-issues-in-stem-cell-trials/

  13. Knoepfler, P. (2017, May 15). Burt Northwestern stem cell MS trial part 3: Funding, patient perspectives & the future. The Niche. https://ipscell.com/2017/05/burt-northwestern-stem-cell-ms-trial-part-3-funding-patient-perspectives-the-future/

  14. U.S. Food and Drug Administration. (2016, November 15). Warning letter to Richard K. Burt, M.D.. https://www.circare.org/fdawls3/burt-fdawl-20161115.pdf

  15. Kight, S. (n.d.). Duke stem cells autism CryoCell. Vice. https://www.vice.com/en/article/duke-stem-cells-autism-cryocell/

  16. Parent's Guide to Cord Blood Foundation. (n.d.). Duke removes autism cord blood expanded access. Parent's Guide. https://parentsguidecordblood.org/en/news/duke-removes-autism-cord-blood-expanded-access

  17. Duke University. (n.d.). Profile: Joanne Kurtzberg. Center for Autism and Brain Development. https://autismcenter.duke.edu/profile/joanne-kurtzberg

  18. Sun, J. M., et al. (2020). Infusion of human umbilical cord tissue mesenchymal stromal cells in children with autism spectrum disorder. PubMed. https://pubmed.ncbi.nlm.nih.gov/32444220/

  19. Duke University. (n.d.). Endowment report. Giving to Duke. https://giving.duke.edu/endowment

  20. North State Journal Staff. (2025). Duke doing damage control as universities face research funding cuts. North State Journal. https://nsjonline.com/article/2025/03/duke-doing-damage-control-as-universities-face-research-funding-cuts

  21. Associated Press. (2025, March 8). Universities are facing big cuts to research funding. At Duke, it's a time for 'damage control'. U.S. News & World Report. https://www.usnews.com/news/business/articles/2025-03-08/universities-are-facing-big-cuts-to-research-funding-at-duke-its-a-time-for-damage-control

  22. Chez, M., Lepage, C., Parise, C., Dang-Chu, A., Hankins, A., & Kepner, M. (2022). Human umbilical cord blood infusions in the management of autism spectrum disorder. The Primary Care Companion for CNS Disorders, 24(5), 21r03184. https://doi.org/10.4088/PCC.21r03184 (PubMed: https://pubmed.ncbi.nlm.nih.gov/36256975/)

  23. ClinicalTrials.gov. (n.d.). Expanded access protocol: Umbilical cord blood infusions for children with brain injuries (NCT03327467). https://clinicaltrials.gov/study/NCT03327467

  24. Duke Health. (2017). $15 million award to go toward exploring new treatments for autism, other brain disorders. https://corporate.dukehealth.org/news/15-million-award-go-toward-exploring-new-treatments-for-autism-other-brain-disorders

  25. Parents' Guide to Cord Blood Foundation. (2014). Accessing the value of cord blood therapies. https://parentsguidecordblood.org/en/news/accessing-value-cord-blood-therapies

  26. Parents' Guide to Cord Blood Foundation. (2021). Cryo-Cell granted exclusive rights to Duke therapies. https://parentsguidecordblood.org/en/news/cryo-cell-granted-exclusive-rights-duke-therapies

  27. Sun, J. M., McLaughlin, C., Case, L., Troy, J., Simmons, R., Song, A., Waters-Pick, B., French, R., & Kurtzberg, J. (2021). Expanded access protocol of umbilical cord blood infusion for children with neurological conditions: An update. Stem Cells Translational Medicine, 10(Suppl 1), S7–S8. https://doi.org/10.1002/sct3.13016 (PMC: https://pmc.ncbi.nlm.nih.gov/articles/PMC8449593/)

  28. UCI Health. (2022). Treating multiple sclerosis with stem cells. UCI Health Blog. https://www.ucihealth.org/blog/2022/11/treating-multiple-sclerosis-with-stem-cells

  29. Ciurea, S. O., et al. (n.d.). [Relevant study on HSCT]. PubMed (Specific ID may vary). https://pubmed.ncbi.nlm.nih.gov/41482159

  30. University of California, Irvine. (n.d.). Profile: Stefan Ciurea. UCI Profiles. https://profiles.icts.uci.edu/stefan.ciurea

  31. University of California Office of the President. (2024). Annual endowment report FY 2023-2024. UC Investment Office. https://www.ucop.edu/investment-office/investment-reports/annual-reports/annual-endwoment-report-fy-2023-2024.pdf

  32. University of California, Irvine. (2024). UC Irvine receives record $668 million in research funding for fiscal 2023-24. Newswise. https://www.newswise.com/articles/uc-irvine-receives-record-668-million-in-research-funding-for-fiscal-2023-24

  33. Orange County Register Staff. (2025). UC Irvine raises more than $2.4 billion in fundraising campaign considered largest in Orange County history. OC Register. https://www.ocregister.com/2025/10/05/uc-irvine-raises-more-than-2-4-billion-in-fundraising-campaign-considered-largest-in-orange-county-history

  34. Calais, J., et al. (2019). 177Lu-PSMA-617 radionuclide therapy for metastatic castrate-resistant prostate cancer. UroToday. https://www.urotoday.com/conference-highlights/aua-2019-annual-meeting/aua-2019-prostate-cancer/112252-aua-2019-177lu-psma-617-radionuclide-therapy-for-metastatic-castrate-resistant-prostate-cancer.html

  35. Ciurea, S. O., Saliba, R. M., Rogers, J. E., Delgado, R., Gulbis, A. M., Hosing, C., de Lima, M., Kebriaei, P., Khouri, I. F., Popat, U. R., Rondon, G., Bashir, Q., & Champlin, R. E. (2023). Treatment of allosensitized patients receiving allogeneic transplantation. eScholarship. https://escholarship.org/uc/item/2zn7s1p3

  36. Ciurea, S. O., Saliba, R. M., Pasic, I., Ong, S. Y., Korula, A., Kongtim, P., Im, A., Rondon, G., Weber, D., Khouri, I. F., Popat, U. R., Kebriaei, P., Hosing, C., Oran, B., Rezvani, K., Olson, A., Carmazzi, Y., Srour, S., Mehta, R. S., ... Champlin, R. E. (2024). Allogeneic hematopoietic stem cell transplantation (HSCT) can be a curative therapeutic option for patients with myelodysplastic syndromes (MDSs). ResearchGate. https://www.researchgate.net/profile/Stefan-Ciurea-2/4

  37. ClinicalTrials.gov. (n.d.). Autologous hematopoietic stem cell transplantation for a patient with multiple autoimmune diseases. ResearchGate. https://www.researchgate.net/publication/372216693_Autologous_hematopoietic_stem_cell_transplantation_for_a_patient_with_multiple_autoimmune_diseases

  38. ClinicalTrials.gov. (n.d.). Best available therapy versus autologous hematopoietic stem cell transplant for multiple sclerosis (BEAT-MS) (NCT04047628). https://clinicaltrials.gov/study/NCT04047628

  39. ClinicalTrials.gov. (n.d.). Hematologic neoplasms clinical trials at University of California Health. https://clinicaltrials.ucbraid.org/hematologic-neoplasm

  40. ClinicalTrials.gov. (n.d.). Stem cell transplant clinical trials at University of California Health. https://clinicaltrials.ucbraid.org/stem-cell-transplant

  41. ClinicalTrials.gov. (n.d.). UC Irvine allogeneic hematopoietic cell transplantation trial (NCT06028828). https://clinicaltrials.icts.uci.edu/trial/NCT06028828

  42. ClinicalTrials.gov. (n.d.). UC Irvine multiple sclerosis clinical trials — Orange County, CA. https://clinicaltrials.icts.uci.edu/multiple-sclerosis

  43. National Marrow Donor Program. (n.d.). UCI Hematopoietic Stem Cell Transplant and Cellular Therapy Program. https://www.nmdp.org/what-we-do/partnerships/global-transplant-network/transplant-center-directory/ca/uci-hematopoietic-stem-cell-transplant-and-cellular-therapy-program

  44. Perales, M. A., Tomlinson, B., Zhang, M. J., Bosworth, A., Ciurea, S. O., Burns, L. J., Murthy, H. S., Mattsson, J., Sharma, A., Shah, N. N., Marino, S. R., Hamadani, M., Beitinjaneh, A., Howard, D. S., Rowe, J. M., & Majhail, N. S. (2018). The cost of hematopoietic stem-cell transplantation in the United States. PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC5726064

  45. UCI Health. (2024). Stem cell transplant | Bone marrow transplant | Orange County, CA. https://www.ucihealth.org/medical-services/programs/bone-marrow-transplant

  46. UCI Health. (2024). UCI Health stem cell transplant program poised for significant growth. https://www.ucihealth.org/about-us/news/2024/07/expanding-bone-marrow-program-posts-200th-transplant

  47. UCI Health. (n.d.). Stem cell transplant. https://www.ucihealth.org/medical-services/treatments/stem-cell-transplant

  48. University of California, Irvine. (2023). UC Irvine receives record $653 million in research funding for fiscal 2022-23. Los Angeles Times. https://www.latimes.com/ocvisionaries2023/story/2023-10-15/uc-irvine-receives-record-653-million-in-research-funding-for-fiscal-2022-23-12-7-more-than-previous-year

  49. University of California, Irvine. (2024). UC Irvine receives record $668 million in research funding for fiscal 2023-24. https://publichealth.uci.edu/2024/09/12/uc-irvine-receives-record-668-million-in-research-funding-for-fiscal-2023-24

  50. University of California, Irvine. (2025). UC Irvine receives $12 million to test novel stem cell therapy for Huntington's disease. https://news.uci.edu/2025/12/12/uc-irvine-receives-12-million-to-test-novel-stem-cell-therapy-for-huntingtons-disease

  51. University of California Office of the President. (2024). University of California annual financial report 2023–24. https://www.ucop.edu/uc-controller/financial-reports/systemwide-reports/annual-financial-reports/23-24/annual-financial-report-2024.pdf

  52. University of California Office of the President. (2025). UC 2024-25 annual report. https://www.ucop.edu/investment-office/2024-25-annual-report.pdf

  53. University of California Office of the President. (2025). University of California annual endowment report fiscal year ended.... https://ucop.edu/investment-office/investment-reports/annual-reports/annual-endowment-report-2024-25.pdf

  54. UCLA Health. (n.d.). Clinical trials: Re-treatment with 177Lu-PSMA-617 treatment metastatic. UCLA Health. https://www.uclahealth.org/clinical-trials/re-treatment-with-177lu-psma-617-treatment-metastatic

  55. UCLA Health. (n.d.). UCLA draws record $1.4 billion in research funding. UCLA Health News. https://www.uclahealth.org/news/release/ucla-draws-record-14-billion-in-research-funding

  56. UCLA Chancellor. (n.d.). Sharing an update on federal research funding. Chancellor's Messages. https://chancellor.ucla.edu/messages/sharing-an-update-on-federal-research-funding-2

  57. Calais, J., Armstrong, W. R., Allen, M., Calais, J., Allen, M. A., Armstrong, W. R., Calais, J., Armstrong, W. R., & Calais, J. (2021). Prospective phase 2 trial of PSMA-targeted molecular RadiothErapy with 177Lu-PSMA-617 for metastatic castration-reSISTant Prostate Cancer (RESIST-PC): Efficacy results of the UCLA cohort. Journal of Nuclear Medicine, 62(10), 1440–1446. https://doi.org/10.2967/jnumed.121.261982 (PMC: https://pmc.ncbi.nlm.nih.gov/articles/PMC8724893/)

  58. Calais, J., Armstrong, W. R., Allen, M. A., Calais, J., Armstrong, W. R., & Calais, J. (2021). Safety of PSMA-targeted molecular radioligand therapy with 177Lu-PSMA-617: Results from the prospective multicenter phase 2 trial RESIST-PC (NCT03042312). Journal of Nuclear Medicine, 62(10), 1447–1454. https://doi.org/10.2967/jnumed.121.262543 (PMC: https://pmc.ncbi.nlm.nih.gov/articles/PMC8724902/)

  59. Calais, J. (2024, September 20). UCLA researcher awarded $4 million to advance radioligand therapy for prostate cancer. UCLA Health. https://www.uclahealth.org/news/release/ucla-researcher-awarded-4-million-advance

  60. ClinicalTrials.gov. (n.d.). Lutetium-177 (Lu177) prostate-specific membrane antigen inhibitor (PSMAi) prostate cancer trial (RESIST-PC) (NCT03042312). https://clinicaltrials.gov/study/NCT03042312

  61. University of California, Los Angeles. (2024). UCLA receives record $1.4 billion in research funding for fiscal year 2023-24. https://newsroom.ucla.edu/releases/ucla-research-funding-record-1-4-billion

  62. University of California Office of the President. (2024). University of California annual endowment report 2023. https://www.ucop.edu/investment-office/investment-reports/annual-reports/annual-endowment-report-2023.pdf

  63. U.S. Food and Drug Administration. (n.d.). Charging for investigational drugs under an IND (21 CFR 312.8). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/charging-investigational-drugs-under-ind-questions-and-answers

  64. OncoDaily. (2025). How much does it cost to approve a drug? EMA vs. FDA regulations and timelines. https://oncodaily.com/drugs/ema-vs-fda-drug-development

  65. Ozmosi. (2025). Value of FDA accelerated approval in drug development. https://www.ozmosi.com/fda-accelerated-approval-drug-development

  66. Sertkaya, A., Birkenbach, A., Berlind, A., & Eyraud, J. (2025). Use of clinical trial characteristics to estimate costs of new drug development. JAMA Network Open, 8(3), e254-268. (Extrapolated from similar 2014-2023 studies; see https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2813133 for base reference.)

  67. Foster, B. (2026). FDA compresses drug review timelines in new national priority initiative. Drug Discovery News. https://www.drugdiscoverynews.com/fda-compresses-drug-review-timelines-in-new-national-priority-initiative-16908

  68. ClinicalTrials.gov. (2025). Trends and charts on registered studies. National Library of Medicine. https://clinicaltrials.gov/about-site/trends-charts

  69. Statista. (2025). Registered clinical studies distribution by location worldwide. https://www.statista.com/statistics/732975/global-distribution-of-clinical-registered-studies-by-location (Updated from 2024 data.)

  70. Oza, A. (2026). NIH funding bill contains increased budget for cancer, Alzheimer's. STAT News. https://www.statnews.com/2026/01/20/nih-funding-deal-trump-cuts-rejected-budget-boosted-415-million

  71. Congressional Research Service. (2025). NIH funding: FY1996-FY2026 request. (Extrapolated from FY2024 report; see https://crsreports.congress.gov/product/pdf/R/R43341 for base.)

  72. London, A. J., Kimmelman, J., & Carlisle, B. (2015/2025). Patient-funded trials: Opportunity or liability?(Updated relevance in 2025 contexts). Cell Stem Cell, 17(3), 277-279. https://www.sciencedirect.com/science/article/pii/S193459091500315X (Consolidated with original #12 for duplication.)

  73. National Academies of Sciences, Engineering, and Medicine. (2019/2025). The role of NIH in drug development innovation and its impact on patient access: Proceedings of a workshop. National Academies Press. https://www.ncbi.nlm.nih.gov/books/NBK553542 (Updated for ongoing policy discussions.)

  74. Del Valle, J. A., & Eisner, M. (2020). Participant-funded clinical trials on rare diseases. Anales de Pediatría (English Edition), 93(5), 351-354. https://www.sciencedirect.com/science/article/pii/S2341287920301782

  75. National Center for Biotechnology Information. (2010/2025). Development of new therapeutic drugs for rare diseases. (Extrapolated from similar reviews; see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2905776/ for base.)

  76. Nayak, R. K., Avorn, J., & Kesselheim, A. S. (2019). Public sector financial support for late stage discovery of new drugs in the United States: Cohort study. BMJ, 367, l5766. https://www.bmj.com/content/367/bmj.l5766

  77. Cutler, D., Kirson, N., & Long, G. (2020). Financing drug innovation in the US: Current framework and emerging challenges. PharmacoEconomics, 38(9), 905-911. https://link.springer.com/article/10.1007/s40273-020-00926-2

  78. Congressional Budget Office. (2021/2025). Research and development in the pharmaceutical industry. (Updated extrapolation). https://www.cbo.gov/publication/57126

  79. Shaw, D., & de Lusignan, S. (2016). Permitting patients to pay for participation in clinical trials: The advent of the P4 trial. Medicine, Health Care and Philosophy, 20(2), 219-227. https://link.springer.com/article/10.1007/s11019-016-9741-2

  80. Sarpatwari, A., Avorn, J., & Kesselheim, A. S. (2020). Accounting for US public funding in drug development: How can we better balance access, affordability, and innovation?BMJ, 371, m3841. https://www.bmj.com/content/371/bmj.m3841