Author information Copyright and License information Disclaimer. It enabled continuing research, wide-spread CF diagnostic testing and newborn and carrier screening, and facilitated development of CF therapeutics. Food and Drug Administration FDA approval, companies researching therapeutic options would want some form of exclusivity to protect those long-term, large investments. Additionally, the CFF was able to attract more interest in therapeutics research by performing a market analysis to predict how much a pharmaceutical company might expect to make if it were to develop a successful CF treatment. This mucus makes it difficult for patients to clear lung infections, which are the leading cause of death in CF. The Hopkins patent expired in April In that instance, the U of M was informed that a laboratory was advertising CF testing, while not adhering to quality control standards or the professional medical guidelines for testing and counseling.

That is, mutations affect a large protein pore responsible for conducting negatively charged chloride atoms through the cell membrane. Standards of care are published statements that describe the level of care that the client with cystic fibrosis or other diseases can expect from nurses. A child, age 14, is hospitalized for nutritional management and drug therapy after experiencing an acute episode of ulcerative colitis. In the United States, an inventor can publicize the discovery or invention before filing a patent application, but many other jurisdictions do not have such a grace period and any public announcement vitiates the subsequent ability to get worldwide patent protection. David is concerned that his wife is going to leave him. Exclusive licensing is quite common as an incentive to startups, and in this case a particular vector system was covered. As genetic mapping technologies improved, especially in the s with the discovery and implementation of restriction fragment length polymorphisms, the pace of discovery rapidly increased.

Collins also donated all of his patent royalties to the CFF, rather than accepting them as personal income. We have a quiet room you can use that is private and close by. After ten years of working with the CFTR licensing strategy, Ritchie thinks that there is very little, if anything, that he would change about it, and that this strategy would be suitable for other universities and institutions to use: 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.


hesi cystic fibrosis case study

The precise molecular definition of CF led to genetic subtyping; to earlier and much more precise diagnosis, and thus improved medical management; and to the first genotype-specific treatment. Despite the rush to publicize an important discovery and a news leak that forced quick action to preserve world-wide patent rights, careful deliberation and engagement of key stakeholders enabled the U of M and the HSC to develop a licensing strategy that held up well over time.

HESI Case Studies-Pediatrics-Cystic Fibrosis (Debbie Baker) –

Although this particular licensing strategy is currently only used by the U of M with respect to the CFTR patent, Ritchie does draw from it to help draft other licensing agreements with other entities:. The drug has only been approved for those with a p. Hi there, would you like to get such a paper? Providing small, frequent meals 3.

hesi cystic fibrosis case study

Which statement by the mother supports the diagnosis of CF? NumberDecember The U of M holds all licenses within the U. These features led to the development of a licensing model that has not only allowed the patent holders to avoid the controversy that has plagued other gene patents, but has also allowed research, development of new therapeutics, and wide-spread dissemination of cysstic testing for cystic fibrosis.

hesi cystic fibrosis case study

An early diagnosis is the first step in effectively managing the disease, and genetic testing has been used in carrier screening, prenatal genetic testing, and diagnosis. Impact of gene patents and licensing practices on access to genetic testing and carrier screening for Tay-Sachs and Canavan disease.

Pediatric Cystic Fibrosis Case Study

CF is caused by mutations in the cystic fibrosis transmembrane conductance regulator CFTR gene on chromosome 7, which encodes a chloride ion channel. The Hopkins patent flbrosis in April Which rationale best supports this referral?

Thus, CFF research funding can be directly used for research purposes without concern for downstream licensing risks. After ten years of working with the CFTR licensing strategy, Ritchie thinks that there is very little, if anything, that he would change about it, and that this strategy would be suitable for other universities and institutions to use:.


Severity of cystic fibrosis in patients homozygous and heterozygous for delta F ribrosis. The final therapeutic patent is exclusively controlled by Vertex with a royalty agreement to CFFbut if the CFTR DNA sequence, method, and mutation patents had been exclusively licensed, developing and using ivacaftor would have been contingent on clearing diagnostic rights, making the situation more complex.

Pediatric Cystic Fibrosis Case Study

What information will the nurse include when teaching about the sweat test? This agreement benefits the U of M since the CFF takes over the administrative burden of handling non-exclusive licenses, and it benefits the CFF by having a low sub-licensing fee agreement with the U of M. Although such a clause was not initially written into the non-exclusive license, the first licensee insisted that such a clause be added to stydy terms of the license agreement.

The job growth rate for RNs will surpass job growth in …. 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: What action by the nurse fibrossi warranted?

In spite of the rush to file the patent application, considerable thought and attention were devoted to constructing an appropriate licensing strategy to allow use of the CFTR gene sequence in various applications, including carrier screening, diagnostics, therapeutics, and research. How about receiving a customized one?

Guideline for the Licensing of Genetic Inventions. Linkage studies with cystic fibrosis of the pancreas. Administering flbrosis enzymes before meals as prescribed 2.

Identifying the genetic basis of cystic fibrosis Cystic fibrosis CF is a genetic disorder long known to be inherited as an autosomal recessive character, and to be highly variable in its severity, duration, and spectrum of symptoms.

Identification of the cystic fibrosis gene: