Parsemus Foundation
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Parsemus Foundation
The Parsemus Foundation is an American non-governmental organization whose objective is to advance low-cost evidence-based medicines not pursued by the pharmaceutical industry. The foundation's focus is on supporting small proof-of-concept studies and then pursuing press coverage of the results, so that the advances change treatment practice rather than disappearing into the scientific literature. Many of the studies supported involve low-cost approaches that are not under patent. Background Founded in 2005, Parsemus is an advocate of research into the plausibility of RISUG (and a method based on RISUG, called Vasalgel), a reversible male contraceptive. The foundation began procuring RISUG's United States intellectual property rights in November 2010, completed the acquisition process in February 2012, and is for the past 8 years conducting toxicology tests as an initial step towards Food and Drug Administration approval. Vasgel production has continually been delayed. Human tri ...
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Non-governmental Organization
A non-governmental organization (NGO) or non-governmental organisation (see spelling differences) is an organization that generally is formed independent from government. They are typically nonprofit entities, and many of them are active in humanitarianism or the social sciences; they can also include clubs and associations that provide services to their members and others. Surveys indicate that NGOs have a high degree of public trust, which can make them a useful proxy for the concerns of society and stakeholders. However, NGOs can also be lobby groups for corporations, such as the World Economic Forum. NGOs are distinguished from international and intergovernmental organizations (''IOs'') in that the latter are more directly involved with sovereign states and their governments. The term as it is used today was first introduced in Article 71 of the newly-formed United Nations' Charter in 1945. While there is no fixed or formal definition for what NGOs are, they are genera ...
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Evidence-based Medicine
Evidence-based medicine (EBM) is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients". The aim of EBM is to integrate the experience of the clinician, the values of the patient, and the best available scientific information to guide decision-making about clinical management. The term was originally used to describe an approach to teaching the practice of medicine and improving decisions by individual physicians about individual patients. Background, history and definition Medicine has a long history of scientific inquiry about the prevention, diagnosis, and treatment of human disease. The concept of a controlled clinical trial was first described in 1662 by Jan Baptist van Helmont in reference to the practice of bloodletting. Wrote Van Helmont: The first published report describing the conduct and results of a controlled clinical trial was by James Lind, a Scottish naval surgeon who conducted rese ...
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Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional drug ...
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Medscape
Medscape is a website providing access to medical information for clinicians; the organization also provides continuing education for physicians and health professionals. It references medical journal articles, Continuing Medical Education (CME), a version of the National Library of Medicine's MEDLINE database, medical news, and drug information (Medscape Drug Reference, or MDR). At one time Medscape published seven electronic peer reviewed journals. History Medscape launched May 22, 1995 by SCP Communications, Inc. under the direction of its CEO Peter Frishauf. In 1999, George D. Lundberg became the editor-in-chief of Medscape. For seventeen years before joining Medscape he had served as Editor of the ''Journal of the American Medical Association''. In September 1999, Medscape, Inc. went public and began trading on NASDAQ under the symbol MSCP. In 2000, Medscape merged with MedicaLogic, Inc., another public company. MedicaLogic filed for bankruptcy within 18 months and sold ...
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Proof-of-concept
Proof of concept (POC or PoC), also known as proof of principle, is a realization of a certain method or idea in order to demonstrate its feasibility, or a demonstration in principle with the aim of verifying that some concept or theory has practical potential. A proof of concept is usually small and may or may not be complete. These collaborative trials aim to test feasibility of business concepts and proposals to solve business problems and accelerate business innovation goals. A proof of value (PoV) is sometimes used along proof of concept, and differs by focusing more on demonstrating the potential customers use case and value, and is usually less in-depth than a proof of concept. Usage history The term has been in use since 1967. In a 1969 hearing of the Committee on Science and Astronautics, Subcommittee on Advanced Research and Technology, ''proof of concept'' was defined as following: One definition of the term "proof of concept" was by Bruce Carsten in the context o ...
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Patent
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A patent is not the grant of a right to make or use or sell. It does not, directly or indirectly, imply any such right. It grants only the right to exclude others. The supposition that a right to make is created by the patent grant is obviously inconsistent with the established distinctions between generic and specific patents, and with the well-known fact that a very considerable portion of the patents granted are in a field covered by a former relatively generic or basic patent, are tributary to such earlier patent, and cannot be practiced unless by license thereunder." – ''Herman v. Youngstown Car Mfg. Co.'', 191 F. 579, 584–85, 112 CCA 185 (6th Cir. 1911) In most countries, patent rights fall under private law and the patent holder mus ...
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Reversible Inhibition Of Sperm Under Guidance
Reversible inhibition of sperm under guidance (RISUG), formerly referred to as the synthetic polymer styrene maleic anhydride (SMA), is the development name of a male contraceptive injection developed at IIT Kharagpur in India by the team of Dr. Sujoy K. Guha. RISUG has been patented in India, China, Bangladesh, and the United States. Phase III clinical trials were underway in India, and were slowed by insufficient volunteers. , a contraceptive product based on RISUG, Vasalgel, was under development in the US by Parsemus Foundation, but funding was uncertain. , RSUG and Vasalgel were still in development and testing. Development Sujoy K. Guha developed RISUG after years of developing other inventions. He originally wanted to create an artificial heart that could pump blood using a strong electrical pulse. Using the 13-chamber model of a cockroach heart, he designed a softer pumping mechanism that would theoretically be safe to use in humans. As India's population grew throug ...
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Male Contraceptive
Male contraceptives, also known as male birth control, are methods of preventing pregnancy that solely involve the male physiology. The most common kinds of male contraception include condoms, outercourse, and vasectomy. In domestic animals, castration is commonly used for contraception. Other forms of male contraception are in various stages of research and development. These include methods like RISUG/VasalGel (which has completed a small phase II clinical trial in humans in India) and ultrasound (with results so far obtained in experimental animals). Methods Surgery Vasectomy is a surgical procedure for male sterilization or permanent birth control. During the procedure, the vasa deferentia of a man are severed, and then tied or sealed to prevent sperm from entering into the seminal stream (ejaculate). Vasectomies are usually performed in a physician's office or medical clinic. CDC research has estimated there is a probability of 11 failures per 1,000 procedures over 2 years ...
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Intellectual Property
Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are patents, copyrights, trademarks, and trade secrets. The modern concept of intellectual property developed in England in the 17th and 18th centuries. The term "intellectual property" began to be used in the 19th century, though it was not until the late 20th century that intellectual property became commonplace in the majority of the world's legal systems."property as a common descriptor of the field probably traces to the foundation of the World Intellectual Property Organization (WIPO) by the United Nations." in Mark A. Lemley''Property, Intellectual Property, and Free Riding'', Texas Law Review, 2005, Vol. 83:1031, page 1033, footnote 4. The main purpose of intellectual property law is to encourage the creation of a wide variety of intellectual goo ...
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Toxicology Testing
Toxicology testing, also known as safety assessment, or toxicity testing, is the process of determining the degree to which a substance of interest negatively impacts the normal biological functions of an organism, given a certain exposure duration, route of exposure, and substance concentration. Toxicology testing is often conducted by researchers who follow established toxicology test protocol for a certain substance, mode of exposure, exposure environment, duration of exposure, or for a particular organism of interest, or for a particular developmental stage of interest. Toxicology testing is commonly conducted during preclinical development for a substance intended for human exposure. Stages of ''in silico'', ''in vitro'' and ''in vivo'' research are conducted to determine safe exposure doses in model organisms. If necessary, the next phase of research involves human toxicology testing during a first-in-man study. Toxicology testing may be conducted by the pharmaceutical indu ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ...
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Animal Testing
Animal testing, also known as animal experimentation, animal research, and ''in vivo'' testing, is the use of non-human animals in experiments that seek to control the variables that affect the behavior or biological system under study. This approach can be contrasted with field studies in which animals are observed in their natural environments or habitats. Experimental research with animals is usually conducted in universities, medical schools, pharmaceutical companies, defense establishments, and commercial facilities that provide animal-testing services to the industry. The focus of animal testing varies on a continuum from pure research, focusing on developing fundamental knowledge of an organism, to applied research, which may focus on answering some questions of great practical importance, such as finding a cure for a disease. Examples of applied research include testing disease treatments, breeding, defense research, and toxicology, including cosmetics testing. In edu ...
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