HESI CYSTIC FIBROSIS CASE STUDY

Important features of the licensing planning process included thoughtful consideration of potential uses of the patent; anticipation of future scientific discoveries and technological advances; engagement of relevant stakeholders, including the Cystic Fibrosis Foundation; and using separate licenses for in-house diagnostics versus kit manufacture. In January , the Food and Drug Administration approved ivacaftor to treat the roughly four percent of CF patients with the p. 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. 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. Food and Drug Administration FDA approval, companies researching therapeutic options would want some form of exclusivity to protect those long-term, large investments. Please review our privacy policy. How about receiving a customized one?

Although a few companies have gone directly to the U of M for a non-exclusive research license, the university prefers that companies work through the CFF. They are perhaps most important for how they managed to keep out of the way—how the licensing strategy retained freedom to do research and creative use of the patent incentive to promote promising therapeutics while also permitting many approaches to screening and diagnosis by many providers and generating modest revenue for further research and education. Important features of the licensing planning process included thoughtful consideration of potential uses of the patent; anticipation of future scientific discoveries and technological advances; engagement of relevant stakeholders, including the Cystic Fibrosis Foundation; and using separate licenses for in-house diagnostics versus kit manufacture. 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. Three or four licenses had lapsed because research on gene therapy failed to progress to market.

Although such a clause was not initially written into the non-exclusive license, the first licensee insisted that such a clause be added to the terms of the license agreement. 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:.

  HANDSTAND HOMEWORK TUMBL TRAK

We have a quiet room you can use that is private and close by. They are perhaps most important for how they managed to keep out of the way—how the licensing strategy retained freedom to do research and creative use of the patent incentive to promote promising therapeutics while also permitting many approaches to screening and diagnosis by many providers and generating modest revenue for further research and education. Cywtic the play therapy is an intervention and should not cyystic interrupted for vital signs.

Support Center Support Center. At what rate should the nurse set the infusion pump? Annu Rev Genomics Hum Genet.

How about receiving a customized one? CF affects an estimated 70, people worldwide 9over 30, of whom are in the United States 10 which makes this one of the most common genetic disorders in the United States. Fibrozis 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.

Cystic Fibrosis Patents: A Case Study of Successful Licensing

The Hopkins patent expired in April It distinguished the CF licensing process from patenting and licensing of Canavan Disease 4 and BRCA 5 patents for genetic testing, where patent-related controversy dogged the history of genetic diagnostics. A final important factor that played into the licensing discussions was the mission of the U of M Technology Management Office.

One vital aspect of this licensing strategy was the engagement gesi 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

When the CFF was founded ina child born with CF was not expected to survive until elementary school; in contrast, the life expectancy today is over 37 years, and is increasing at the rate of about one year per year.

Hssi is a simple, painless, reliable test that measures the chloride in sweat.

It begins with a brief overview of CF and the science exploring the genetic basis of a devastating disease. Impact of gene patents and licensing practices on access to genetic testing for inherited susceptibility to cancer: Debbie is able to say her first and last names, and to state her age while holding up 3 fingers. Indeed, DiSante recalls receiving many phone calls from biotechnology companies interested in taking out exclusive licenses for gene therapy research. The Language of Life: The inclusion and active participation of the CFF patient advocacy organization was another important factor in the initial patenting and licensing discussions.

  ACPS 5/6 HOMEWORK BLOG

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

Linkage studies with cystic fibrosis of the pancreas. Prior to this analysis, there was an assumption that with CF being a rare, orphan disease that any CF treatment would not generate much revenue. Impact of gene patents and licensing practices stury access to genetic testing for long QT syndrome. Which instruction should the Nurse Educator include when studyy respiratory complications?

Therefore, patenting made sense to the scientists, their nonprofit institutions, and disease advocacy groups. Which adjustment will be required if Debbie has loose, fatty stools?

hesi cystic fibrosis case study

Combo with “Child with Cardiovascular disorder” and 6 others. Identifying the genetic basis of cystlc 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.

This meant that the license had to be affordable to small nonprofit operations.

Pediatric Cystic Fibrosis Case Study

The child will be able to remove mucus from the airway by coughing. 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.

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.