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Patent
Ethicon Endo Surgery Inc. and Janssen Research & Development LLC | Date: 2017-04-12

An apparatus (10) includes a body (40), a needle (30), a catheter (20), and an actuator assembly (66). The needle extends distally from the body. The needle has an inner wall defining a needle lumen. The needle lumen is in fluid communication with a fluid port of the body. The catheter is slidably disposed in the needle lumen. The catheter has a catheter lumen. The first actuator assembly is configured to translate the catheter within and relative to the needle. The apparatus may also include an actuator assembly that is configured to rotate the needle relative to the body. The apparatus may be used to first deliver a leading bleb of fluid to the subretinal space in a patients eye via the needle. The apparatus may then be used to deliver a therapeutic agent to the subretinal space in the patients eye via the catheter.


News Article | April 17, 2017
Site: www.chromatographytechniques.com

When scientists with the pharmaceutical company Pfizer started clinical trials in 1991 on a chemical compound named UK-92480, they aimed to show the drug’s potential therapeutic benefit for a cardiovascular condition caused by restricted blood flow to the heart muscle. Less than two years later, hope that the compound, now better known as sildenafil, could treat angina began to fade. But the drug wasn’t shelved. Rather, scientists began exploring whether one of the drug’s reported side effects—erections—could help men suffering from another condition. The U.S. Food and Drug Administration in 1998 approved sildenafil, under the brand name Viagra, for the treatment of erectile dysfunction. In its first year on the market, sales of the little blue pill topped $1 billion. The transformation of sildenafil into a treatment that’s now been prescribed to tens of millions of men around the world is one of the most well-known examples of a practice known as drug repurposing. The practice isn’t new but it is becoming an increasingly attractive option for academic and pharmaceutical industry researchers, as well as nonprofit organizations and patient advocacy groups—all of whom are seeking ways to cut the time and expense involved in getting new treatments to market. Winning approval for a new drug takes about 14 years on average and costs can exceed $2 billion, according to data from the National Center for Advancing Translational Sciences, or NCATS. The failure rate in the drug development process, meanwhile, is 95 percent. That leaves a vast pool of partially developed chemical compounds that could potentially be tapped for uses other than which they were originally intended. Those repurposed drugs could move to market in less time and for less money than it takes to gain approval for novel drugs by skipping preclinical testing requirements and, possibly, Phase 1 safety and dosing trials. The ability to bypass those stages means a repurposed drug could make it to market in only four years and at a fraction of the cost of a brand new treatment, according to Cures Within Reach. The Illinois-based nonprofit group, which supports medical repurposing research, also notes that the “risks are better known and the chance of failure due to adverse side effects is reduced” with repurposed drugs. While serendipity has largely driven the repurposing of drugs in the past, more deliberate approaches to this practice have been recently developed in a bid to fuel more collaboration between stakeholders and hasten the development of new therapies. A collapsed timeline In 2012, NCATS, an arm of the National Institutes of Health, launched a program called Discovering New Therapeutic Uses for Existing Molecules that makes proprietary drugs that have undergone significant research and development by pharmaceutical companies available to academic researchers. Christine Colvis, the director of drug development partnership programs for NCATS, called drug repurposing “a viable strategy for developing new therapies” and one that is generating more interest and engagement from academic institutions and academic investigators. “There are so many diseases for which there are no treatments or for which current treatments are not adequate or don’t treat all of the patient population,” Colvis, whose team leads the New Therapeutic Uses program, said. “There is just so much unmet medical need out there and when there’s something for a scientist, for a researcher, that’s sort of staring them in the face as a potential thing that could make a difference in people’s lives, it’s hard for them not to pursue that path.” Colvis pointed to research by neurologist Stephen Strit­tmatter of Yale University as one promising example of collaboration between academia and industry that NCATS is supporting. Strittmatter and his colleagues in 2012 published a paper that suggested blocking a protein called Fyn kinase may help treat Alzheimer’s disease. Those findings were released around the same time NCATS launched its New Therapeutic Uses program and made a Fyn kinase inhibitor developed by AstraZeneca available to researchers. AstraZeneca had developed the drug, called saracatinib, to treat cancer. Strittmatter and his colleagues submitted a proposal to test saracatinib as a treatment for Alzheimer’s-related brain abnormalities and received one of the first New Therapeutic Uses awards in June 2013. The research team was able to begin a Phase 2a human clinical trial of saracatinib within about 18 months, compared to the decade it can take to move a new treatment to that stage. “Had AstraZeneca not put that drug on our list of drugs that would be available, we still wouldn’t be investigating this as a potential target for Alzheimer’s disease, and had Dr. Strittmatter not published his paper or had he not seen our funding opportunity announcement, still nothing would be happening,” Colvis said. “But instead now we are in the final year of a Phase 2 trial and hope to see those results in about a year from now.” Partnerships NCATS, in collaboration with AstraZeneca and Janssen Research & Development, LLC, in February announced it was offering $6 million in funding to support additional public-private partnerships between the biomedical research community and pharmaceutical companies. Other NCATS partners for this program include AstraZeneca subsidiary MedImmune, AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Pfizer and Sanofi. Colvis said the types of partnerships NCATS is helping foster are “really just trying to demonstrate a strategy. Our real hope is that other entities start to use this model and this strategy.” “We hope to see this model used around the world in order to really have an impact on health,” she said. While Colvis describes NCATS’ efforts to promote drug repurposing as “disease agnostic,” other groups are embracing the practice in an attempt to find treatments for a specific group of conditions: rare diseases. Findacure, a charity based in Cambridge, England, is working to develop a model to support repurposing existing, generic drugs to help treat patients suffering from conditions that affect fewer than 1 in 2,000 people. (In the United States, a rare disease is defined as a condition affecting fewer than 200,000 people at any given time). “It’s a type of research that can be delivered more cheaply and more quickly and that’s really important in the rare disease space,” said Rick Thompson, Findacure’s head of research. Of the more than 7,000 rare diseases, only around 400 have licensed treatments, according to Findacure. Thompson said it’s difficult for the pharmaceutical industry to actively repurpose generic drugs for rare diseases for two reasons: a lack of profitability due to the small patient population and the difficulty to secure intellectual property. Findacure has developed a new mechanism called the Rare Disease Drug Repurposing Social Impact Bond in an effort to address that gap. The model, which Findacure has been working with Cures Within Reach to develop, would use money the National Health Services in the U.K. saves by treating patients who have rare diseases with repurposed, generic drugs to reimburse the cost of clinical trials that prove the effect of such drugs. “It’s securing returns based on money that’s been saved rather than delivering a high drug price,” Thompson said. The charity has completed a proof of concept study for its model and is now working toward developing a full business plan. Meanwhile, the group recently launched an open call for drug repurposing ideas for rare diseases in partnership with Cures Within Reach and Healx of Cambridge, England. The open call project aims to “demonstrate the huge potential of clinic-led, patient group-led, and researcher-driven innovation in drug repurposing for rare diseases” and show “the need for new funding streams to help these ideas bridge the translational gap,” like Findacure’s Rare Disease Drug Repurposing Social impact Bond. “We think this has real potential to promote and allow this type of generic drug repurposing in the rare disease space to move forward,” Thompson said. “We need some kind of innovation in this space to encourage this type of work.”


Patent
Ethicon Endo Surgery Inc. and Janssen Research & Development LLC | Date: 2017-04-12

An apparatus has a first fluid conduit, a second fluid conduit, a connector member, an first tubular member, a second tubular member, and an inner cannula. The connector member has first and second passageways in which the first and second fluid conduits are positioned, respectively. A portion of the second tubular member is positioned within the lumen of the first tubular member. A proximal portion of the inner cannula is fixedly secured within the lumen of the first tubular member. The inner cannula lumen is in fluid communication with the first and second fluid conduits via the lumen of the first tubular member and the lumen of the second tubular member. The inner cannula may be inserted into the subretinal space of a human eye to deliver a leading bleb of fluid and then deliver a therapeutic agent, without having to withdraw the inner cannula from the subretinal space between the acts of delivering the leading bleb delivering the therapeutic agent.


Patent
Ethicon and Janssen Research & Development LLC | Date: 2015-02-11

An apparatus for delivering therapeutic agent to an eye comprises a body, a cannula, a hollow needle, and an actuation assembly. The cannula extends distally from the body and is sized and configured to be insertable between a choroid and a sclera of a patients eye. The actuation assembly is operable to actuate the needle relative to the cannula to thereby drive a distal portion of the needle along an exit axis that is obliquely oriented relative to the longitudinal axis of the cannula. The cannula may be inserted through a sclerotomy incision to position a distal end of the cannula at a posterior region of the eye, between the choroid and sclera. The needle may be advanced through the choroid to deliver the therapeutic agent adjacent to the potential space between the neurosensory retina and the retinal pigment epithelium layer, adjacent to the area of geographic atrophy.


Patent
Ethicon and Janssen Research & Development LLC | Date: 2015-08-31

An apparatus for delivering therapeutic agent to an eye comprises a body, a cannula, a hollow needle, a cannula actuation assembly, and a needle actuation assembly. The cannula extends distally from the body and is sized and configured to be insertable between a choroid and a sclera of a patients eye. The cannula actuation assembly is operable to actuate the cannula relative to the body. The needle actuation assembly is operable to actuate the needle relative to the cannula. The cannula may be inserted through a sclerotomy to position a distal end of the cannula at a posterior region of the eye, between the choroid and sclera. The needle may be advanced through the choroid to deliver the therapeutic agent adjacent to the potential space between the neurosensory retina and the retinal pigment epithelium layer, adjacent to the area of geographic atrophy.


Patent
Ethicon and Janssen Research & Development LLC | Date: 2015-09-01

An apparatus for delivering therapeutic agent to an eye comprises a body, a cannula, a hollow needle, an actuation assembly, and a detection/visualization system. The cannula extends distally from the body and is sized and configured to be insertable between a choroid and a sclera of a patients eye. The actuation assembly is operable to actuate the needle relative to the cannula to thereby drive a distal portion of the needle along an exit axis. The cannula may be inserted through a sclerotomy incision and advanced through the choroid to deliver the therapeutic agent adjacent to the potential space between the neurosensory retina and the retinal pigment epithelium layer. The detection/visualization system is operable to detect or visualize penetration of the choroid of a patients eye and provide feedback to the operator and/or automatic control of the apparatus based on penetration of the choroid.


Patent
Ethicon and Janssen Research & Development LLC | Date: 2015-08-31

An apparatus for delivering therapeutic agent to an eye comprises a body, a cannula, a hollow needle, and an automated actuation assembly. The cannula extends distally from the body and is sized and configured to be insertable between a choroid and a sclera of a patients eye. The actuation assembly is operable to actuate the needle relative to the cannula to thereby drive a distal portion of the needle along an exit axis that is obliquely oriented relative to the longitudinal axis of the cannula. The cannula may be inserted through a sclerotomy to position a distal end of the cannula at a posterior region of the eye, between the choroid and sclera. The needle may be advanced through the choroid to deliver the therapeutic agent adjacent to the potential space between the neurosensory retina and the retinal pigment epithelium layer, adjacent to the area of geographic atrophy.


Patent
Ethicon and Janssen Research & Development LLC | Date: 2015-06-01

An apparatus has a first fluid conduit, a second fluid conduit, a connector member, an first tubular member, a second tubular member, and an inner cannula. The connector member has first and second passageways in which the first and second fluid conduits are positioned, respectively. A portion of the second tubular member is positioned within the lumen of the first tubular member. A proximal portion of the inner cannula is fixedly secured within the lumen of the first tubular member. The inner cannula lumen is in fluid communication with the first and second fluid conduits via the lumen of the first tubular member and the lumen of the second tubular member. The inner cannula may be inserted into the subretinal space of a human eye to deliver a leading bleb of fluid and then deliver a therapeutic agent, without having to withdraw the inner cannula from the subretinal space between the acts of delivering the leading bleb delivering the therapeutic agent.


Patent
Ethicon and Janssen Research & Development LLC | Date: 2015-06-01

An apparatus includes a body, a needle, a catheter, and an actuator assembly. The needle extends distally from the body. The needle has an inner wall defining a needle lumen. The needle lumen is in fluid communication with a fluid port of the body. The catheter is slidably disposed in the needle lumen. The catheter has a catheter lumen. The first actuator assembly is configured to translate the catheter within and relative to the needle. The apparatus may also include an actuator assembly that is configured to rotate the needle relative to the body. The apparatus may be used to first deliver a leading bleb of fluid to the subretinal space in a patients eye via the needle. The apparatus may then be used to deliver a therapeutic agent to the subretinal space in the patients eye via the catheter.


Patent
Ethicon and Janssen Research & Development LLC | Date: 2015-09-02

A system for storing and delivering a predetermined amount of fluid includes a syringe including a barrel, a flange disposed at the proximal end of the barrel, and a plunger assembly configured to be received in the lumen of the barrel. The plunger assembly includes a piston and a plunger rod. The plunger rod is removably couplable to the piston at the distal end of the plunger rod and includes a thumb press flange at the proximal end of the plunger rod. The system further includes a stop feature that is removably couplable to the syringe or the plunger assembly. The stop feature is configured to arrest distal advancement of the plunger assembly relative to the syringe when the plunger assembly reaches a predetermined position relative to the syringe. The stop thus ensures that a predetermined amount of fluid remains in the barrel.

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