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Your patient has been diagnosed with an aggressive form of cancer.
A personalized vaccine could be the best — and the only — answer. JLF can help.
Personalized Neoantigen Vaccines through Expanded Access
Traditional vaccines revolutionized the treatment of disease. In recent years, personalized vaccines have shown promise in combating cancer. In addition, technological advances in genetic sequencing, algorithms to identify neoantigens, and peptide manufacturing have vastly improved the personalized vaccine development process.
Of critical importance, the FDA introduced the “Expanded Access” rule which, as you know, gives an individual the right to try a medical treatment outside of clinical trials when no comparable alternative options are available.
Turn to JLF
The Jaime Leandro Foundation (JLF) is a private nonprofit organization established to deliver breakthrough cancer treatments based on the latest innovations in research and personalized medicine and leveraging the Expanded Access rule — also known as “Compassionate Use.” We bring the critical components together, partnering with expert academic and commercial institutions to develop and deliver therapeutic vaccines personalized for each patient. Learn more.
Partners
Our partners are at the forefront of medicine and science. Each is an industry leader providing cutting-edge expertise and technology. JLF consults with the patient, coordinates with partners, and helps both navigate the entire process.
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Taking the work out of paperwork
We know. Preparing and submitting the paperwork necessary for Expanded Use can be a nuisance, taking you away from the many pressing demands on your time. That’s why JLF will assist with preparation of the FDA Expanded Access application. Upon approval, the FDA issues the patient their own Emergency Use Investigational New Drug (IND) ID, which facilitates distribution of the vaccine when it’s ready to be shipped and administered.
Process & Cost
Developing a personalized vaccine takes about three months at a cost of approximately $80,000. Because health insurance does not cover such individualized treatment, costs are borne by the patient.