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Cystic Fibrosis Case Study

Cystic Fibrosis Cystic Fibrosis
Cystic Fibrosis. 69. CASE STUDY. A male child was born in 1980. He did not gain weight normally and had frequent, loose, foul-smelling bowel movements.

Cystic Fibrosis Case Study

The center for public genomics is a national center of excellence for ethical, legal and socialimplications research, funded by the national human genome research institute under grant p50 hg003391. The finaltherapeutic patent is exclusively controlled by vertex (with a royalty agreement to cff), but if the dna sequence, method, and mutation patents had been exclusively licensed,developing and using ivacaftor would have been contingent on clearing diagnostic rights, making thesituation more complex. As genetic mapping technologiesimproved, especially in the 1980s with the discovery and implementation of restriction fragmentlength polymorphisms, the pace of discovery rapidly increased.

Impact of gene patents and licensing practices on access to genetic testing andcarrier screening for tay-sachs and canavan disease. Beyondthis single exclusive license, disante does not recall ever exploring the terms andconditions of an exclusive arrangement. The u ofm licensing officials were familiar with discussions at nih.

Prior to this analysis, there was an assumption that with cf being a rare, orphandisease that any cf treatment would not generate much revenue. Although thislicensing model may not be applicable to all gene patents, it serves as a model in which gene patentlicensing can successfully enable innovation, investment in therapeutics research, and protectintellectual property while respecting the needs of patients, scientists, and public health. Diana wetmore said that the foundation felt very strongly about non-exclusivelicensing for the gene patents, a message relayed back to the u of m throughfrancis collins, who advocated on behalf of the cff.

Thus, cff research funding can be directly used forresearch purposes without concern for downstream licensing risks. The cff, in turn, gives the u of man annual report detailing its active licensees. The up-front payment for kits was25,000, and for laboratory-developed tests was 15,000 (and could be negotiated)the standard royalty for laboratory developed tests was 6 but depending on volume and otherfactors, the actual royalty rate was often in the range of 3.

This license is for research purposes only thecff license is not for diagnostic purposes. . A final important factor that played into the licensing discussions was the mission ofthe u of m technology management office.

Because the university wants to benefit the public by helping the cff achieve their mission ofhelping cf patients, they have a lower licensing fee for the cff license than they otherwise mighthave obtained because keeping costs low helps the cff fund research projects to which they thenoffer sub-licenses. Identification of the cystic fibrosis gene chromosome walking andjumping. As of 2009, the u of m was issuing about 12 license agreements each year, arate that has stayed constant since 1998 when david ritchie joined the u of ms office oftechnology transfer. Cf is caused bymutations in the cystic fibrosis transmembrane conductance regulator ( ) gene onchromosome 7, which encodes a chloride ion channel. Not much was known about whether a potential protein-basedtherapeutic could be developed, since the function of the gene was not yetknown, other than hints it was an ion channel for chloride.


Case Study: Cystic Fibrosis in the Newborn. - NCBI


Neonatal Netw. 2018 May 1;37(3):164-168. doi: 10.1891/0730-0832.37.3.164. Case Study: Cystic Fibrosis in the Newborn. Saravia PA, Riley C. Cystic fibrosis ...

Cystic Fibrosis Case Study

Cystic Fibrosis Patents: A Case Study of Successful Licensing
One case study focused on genetic testing for cystic fibrosis (CF). In the process of preparing this case study, we found no evidence that the licensing practices ...
Cystic Fibrosis Case Study In january 2012, The sub-license fees are paid by the cff on an annual basis. 1891/0730-0832. The contents of this publication are solely the responsibility ofthe center for public genomics (duke university) and not necessarily the views of nih, nhgri, or thekauffman foundation. While the u of m administers all u. Cystic fibrosis management warrants an interdisciplinary team because this disorder affects various organ systems. Gene patents and licensing case studies prepared for the secretarysadvisory committee on genetics, health, The up-front payment for kits was25,000, and for laboratory-developed tests was 15,000 (and could be negotiated)the standard royalty for laboratory developed tests was 6 but depending on volume and otherfactors, the actual royalty rate was often in the range of 3. Thiscell line is covered by a u of m patent, so if the cff funded this type of research withoutsub-licensing rights, the funded company would have to apply for a license with the u of m to dotheir research. Get Adobe Flash player · Visit Teach. Beyondthis single exclusive license, disante does not recall ever exploring the terms andconditions of an exclusive arrangement. This license is for research purposes only thecff license is not for diagnostic purposes.
  • PRIME® Clinical Case Study: Cystic Fibrosis Amidst the Zest for Life ...


    This lower diagnostic testing price has had the additional benefit of enablingmany states to implement cf screening into newborn screening programs. John riordan, both then at thehospital for sick children (hsc) in toronto, formed a very intense collaborationto speed up the pace of discovery by pooling their complementary approaches and skills. One further, somewhat surprising, feature of the cf licensing scheme was thehumanitarian licensing of some of the same patents for developing ways to prevent or managediarrheal diseases. That is, mutations affect a large protein poreresponsible for conducting negatively charged chloride atoms through the cell membrane. There was one exception, apatent that was exclusively licensed.

    However, by showing that there wereenough patients, that cf would require a chronic therapy (as opposed to a one-time therapy or oneused just when symptoms are exacerbated), and that a therapy would add to cf patients lifeexpectancy, an estimated 200800 million per year could be generated by a cftreatment. Discussionswith several other non-licensed companies are currently ongoing, suggesting that enforcement issuesare always present with any patented technology. Unitedstates, an inventor can publicize the discovery or invention before filing a patent application, butmany other jurisdictions do not have such a grace period and any public announcement vitiates thesubsequent ability to get worldwide patent protection. Several firms also developeddifferent multi-allele or full gene sequence-based tests or test kits that became availablecommercially. Diarrheal disease is a major cause of mortality in resource-poor regions,killing an estimated 1.

    The search for the genetic underpinning of cf began in the 1950s with unsuccessfulattempts to identify linkage with known blood groups. U of m granted the cff a license allowing the cff to sub-license limitedfields of the technology to interested parties. Beyondthis single exclusive license, disante does not recall ever exploring the terms andconditions of an exclusive arrangement. Kerem b, rommens jm, buchanan ja, et al. Wetmore says that there was no needfor the cff to hold a diagnostic license sincethe non-exclusive diagnostic license agreements developed by the u of m enabled companies to competein the diagnostic market, thus preventing a monopoly that might have driven up the price ofdiagnostic testing. The u of m and the hsc wanted to make a distinction between thecompanies and hospitals that would do in-house testing (so-called homebrewdiagnostics or laboratory-developed tests) and companies that would manufacture and selldiagnostic kits. Indeed, improved management of pulmonary infections is one of the main reasonsthat mortality and morbidity of cf have dramatically fallen. While the initial plan was tofile a patent application prior to the publication of the findings, there was a news leak that thecf gene had been found so the technology licensing offices had to rush to file the application. Collins as an hhmi investigator), supported filing for a patent toprotect this discovery. Although the licensing strategy developed by the u of m, the hsc, and the cff has workedwell for cf and the gene patent, this strategy would not necessarily besuccessful when applied to other diseases or other gene patents.

    1 Jun 2013 ... A 15-year-old teenager with a “zest for life” faces not-so-“normal” challenges with management of her cystic fibrosis. The nurse case manager ...

    Cystic Fibrosis Case Study Flashcards | Quizlet

    Cystic Fibrosis Case Study study guide by coxcyb includes 28 questions covering vocabulary, terms and more. Quizlet flashcards, activities and games help you ...
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    U of m granted the cff a license allowing the cff to sub-license limitedfields of the technology to interested parties. From 20042009 it was also co-funded by the us department of energy. Although acompany may try to argue for better licensing terms by using arguments like the technologyis over 15 years old and therefore is not worth much, or the f508mutation is just one of thousands of mutations that can cause cf and therefore should be worth asmaller percentage of the overall royalty stream, ritchie counters with the fact that themost favored nation clause has been a part of all of their licensing agreementsand that the u of m is not willing to change that because it would require a cascade of changes forall licensees Buy now Cystic Fibrosis Case Study

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    Cook-deegan r, derienzo c, carbone j, chandrasekharan s, heaney c, conover c. Cf genetic testing widespread, thus enabling newborn screening to help diagnose cf early inlife. In order to learn more about how this successful licensing model came about, we expandedthe previous case study by interviewing key players in the process senior technology licensingspecialist at the university of michigan office of technology transfer (now retired) who managed thelicensing agreements for the former senior technologylicensing specialist at the university of michigans technology management office (now theoffice of technology transfer) who was present during the who was the vice president ofdevelopment and alliance management for the cystic fibrosis therapeutics foundation at the time ofthe interview Cystic Fibrosis Case Study Buy now

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    Unitedstates, an inventor can publicize the discovery or invention before filing a patent application, butmany other jurisdictions do not have such a grace period and any public announcement vitiates thesubsequent ability to get worldwide patent protection. Disante recalls that even though the final decision was not up to collins,his thoughts, his feelings, his concerns were very important to us, so we listened tothose. Genetics in medicine official journal of the american college of medical genetics. It was obvious that diagnostic and therapeutic applications might developfrom understanding the molecular details of the gene mutated in cf. Hsc and the u ofm, a few patents only assigned to the hsc or the u of m, and patents awarded to third wavetechnologies, johns hopkins, and others (see appendix 1 of chandrasekharan, ) Buy Cystic Fibrosis Case Study at a discount

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    The precise molecular definition of cf led to genetic subtyping to earlier and muchmore precise diagnosis, and thus improved medical management and to the first genotype-specifictreatment. Although this model may not be successful when applied to patents that covergenetic mutations that influence rare diseases or diseases without a stable and savvy patientadvocacy organization, it has held up well over the past two decades through negotiations with avariety of companies. Disante recalls thatthere wasnt a particular individual or institution that they were trying to target withtheir licensing strategy the main thing was to help the public and cf patients. While the initial plan was tofile a patent application prior to the publication of the findings, there was a news leak that thecf gene had been found so the technology licensing offices had to rush to file the application Buy Online Cystic Fibrosis Case Study

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    From the perspective of the u of ms technology licensing office, thisleft management of licensing to a trusted nonprofit entity with much greaterexpertise in global health, while promoting the u of ms goal of ensuring worldwide use ofthe technology. Kerem b, rommens jm, buchanan ja, et al. Thiscell line is covered by a u of m patent, so if the cff funded this type of research withoutsub-licensing rights, the funded company would have to apply for a license with the u of m to dotheir research. Use of the drug is tied directly to subtyping through genetic testing. There were 1820 active licenses at the time of our 2009 interview.

    Gene patents and licensing case studies prepared for the secretarysadvisory committee on genetics, health, and society Buy Cystic Fibrosis Case Study Online at a discount

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    All of the interested stakeholders, including the u of m, the toronto hsc, the cysticfibrosis foundation (cff) as represented through robert beall, and the howard hughes medicalinstitute (which funded dr. A final important factor that played into the licensing discussions was the mission ofthe u of m technology management office. While the u of m administers all u. Identification of the cystic fibrosis gene genetic analysis. The original patents from jhu, and the patent on the inhibitory drug itself (us patent7,495,103, expiring may 20, 2027) are all embodied in the clinical decision pathway.

    The recent development of the drug ivacaftor (kalydeco, vertex pharmaceuticals)is worth noting, because it illustrates the tight linkage that is emerging between some geneticsubtypes and treatment Cystic Fibrosis Case Study For Sale

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    Wetmore says that there was no needfor the cff to hold a diagnostic license sincethe non-exclusive diagnostic license agreements developed by the u of m enabled companies to competein the diagnostic market, thus preventing a monopoly that might have driven up the price ofdiagnostic testing. Diarrheal disease is a major cause of mortality in resource-poor regions,killing an estimated 1. This meant that the license had to be affordable tosmall nonprofit operations. Richie from the u of m called the laboratory, letting them know about the u of mspatent rights and suggesting they get a nonexclusive license, but also noting that such licensingcame with commitments to abide by professional standards For Sale Cystic Fibrosis Case Study

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    Wetmore says that there was no needfor the cff to hold a diagnostic license sincethe non-exclusive diagnostic license agreements developed by the u of m enabled companies to competein the diagnostic market, thus preventing a monopoly that might have driven up the price ofdiagnostic testing. There was pressure to select one of these companies for an exclusiveagreement, in part because it would have been more lucrative initially. There were 1820 active licenses at the time of our 2009 interview. Disante was flooded with phone calls from companies interested in securing an exclusivelicense from the u of m. Although such a clause was not initially written into thenon-exclusive license, the first licensee insisted that such a clause be added to the terms of thelicense agreement Sale Cystic Fibrosis Case Study

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