Am J Hum Genet. Different license agreements between in-house diagnostic testing and kit manufacture and sale make it possible for many hospitals and clinics to offer in-house CF genetic testing by removing the large financial barrier imposed by a high licensing fee. Could It Be Hereditary? How about receiving a customized one? To assist in the transition to home care, Sarah and her mother received support from a nurse case manager and clinical pharmacist who both were employed by the specialty pharmacy. The drug developed from a long collaboration between CFF and Vertex, including funding from both institutions.
Although pulmonary infections are common in patients with CF, they are consistently difficult to treat and are usually the primary cause of eventual death among these patients.
What action should the nurse take first? Could It Be Hereditary? For other discipline-specific case studies, navigate using the left menu. The development of therapeutics, in particular, would require substantial investments over long periods, and might benefit from patent incentives.
Today, patients with CF have an average life span of 38 years, and some patients live into their 60s. These healthcare professionals worked in tandem to provide medication education and care coordination during the treatment regimen, and medication administration was provided by a home care infusion nurse. In both instances of pulmonary infection, Sarah and her mother were familiar with fibrosia use of inhaled and IV antibiotics.
The drug developed from a long collaboration between CFF and Vertex, including funding from both institutions. Companies wanting to develop CF therapeutics would face a long slog. This paper summarizes what we learned from these interviews and offers suggestions for implementation of a similar licensing model xystic other gene patents.
Cystic Fibrosis Patents: A Case Study of Successful Licensing
Update on carrier screening for cystic fibrosis. Providing small, frequent meals 3. The sub-license fees are paid by the CFF on an annual basis, which gives them an opportunity to make sure that sub-licensees are actively working on the research project; if work ceases then the Caxe stops paying the sub-license fee for that company.
Population variation of common cystic fibrosis mutations. Because the development of any therapeutic would require fibrlsis investment from a biotechnology or pharmaceutical company to bring a product through proof of clinical mechanism, clinical testing, and U.
HESI Case Studies-Pediatrics-Cystic Fibrosis (Debbie Baker) –
Impact of gene patents and licensing practices on access to genetic testing for long QT syndrome. Joan Germana, May 22, Since the licensing of these patents has not impeded clinical access to genetic testing, we sought to understand how this successful licensing model was developed and whether it might be applicable to other gene patents.
cade Managing Innovation for a Better World. In order to learn more about how this successful licensing model came about, we expanded the previous case study by interviewing key players in the process:. Debbie is able to say her first and last names, and to state her age while holding up 3 fingers.
One vital aspect of this licensing strategy was the engagement of the CFF, a patient advocacy organization that reached a licensing agreement with the U of M that enabled it to offer sub-licenses to companies that wish to pursue CF therapeutic research, with the caveat that the CFF fully fund the initial stages of such research. Which rationale best supports this referral? There was pressure to select one of these companies for an exclusive agreement, in part because it would have been more lucrative initially.
The U of M holds all licenses within the U. Which statement indicates a correct understanding of the etiology of CF? It enabled continuing research, wide-spread CF diagnostic testing and newborn and carrier screening, and facilitated development of CF therapeutics. It is also worth noting that the drug resulted from a partnership between a disease advocacy organization and a for-profit firm, and the three-month priority approval process at FDA was expedited by trials that involved patients, ages 6 to One further, somewhat surprising, feature of the CF licensing scheme was the humanitarian licensing of some of the same patents for developing ways to prevent or manage diarrheal diseases.
Cystic Fibrosis Amidst the Zest for Life in Youth
To assist in the transition to home care, Sarah and her mother received support from a nurse case manager and clinical pharmacist who both were employed by the specialty pharmacy.
Cook-Deegan R, Heaney C. Pharmacology Posted on: In the process of preparing this case study, we found no evidence that the licensing practices employed by the patent holders were impeding access to genetic testing.
What laboratory result warrants immediate intervention?