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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. Vasalgel production has continually been delayed. Human tr ...
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Non-governmental Organization
A non-governmental organization (NGO) is an independent, typically nonprofit organization that operates outside government control, though it may get a significant percentage of its funding from government or corporate sources. NGOs often focus on humanitarian or social issues but can also include clubs and associations offering services to members. Some NGOs, like the World Economic Forum, may also act as lobby groups for corporations. Unlike international organizations (IOs), which directly interact with sovereign states and governments, NGOs are independent from them. The term as it is used today was first introduced in Article 71 of the UN Charter, 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 generally defined as nonprofit entities that are independent of governmental influence—although they may receive government funding. According to the United Nations Department of Global Communic ...
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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. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research." 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. The EBM Pyramid is a tool that helps in visualizing the hierarchy of evidence in medicine, from least authoritative, like expert opinions, to most authoritative, like systematic reviews. Adoption of evidence-based medicine is necessary in a human Rights-based approach to development, rights-based approach to public health and a precondition ...
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Pharmaceutical Industry
The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing or preventing disease or for alleviating symptoms of illness or injury. Pharmaceutical companies may deal in generic drugs, branded drugs, or both, in different contexts. Generic materials are without the involvement of intellectual property, whereas branded materials are protected by chemical patents. The industry's various subdivisions include distinct areas, such as manufacturing biologics and total synthesis. The industry is subject to a variety of laws and regulations that govern the patenting, efficacy testing, safety evaluation, and marketing of these drugs. The global pharmaceutical market produced treatments worth a total of $1,228.45 billion in 2020. The sector showed a compound annual growth rate (CAGR) of 1.8% in 2021, ...
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Medscape
Medscape is a website providing access to medical information for clinicians and medical scientists; the organization also provides continuing education for physicians and other 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. The first editor of Medscape was a P.A. named Stephen Smith. In 1999, George D. Lundberg became the editor-in-chief of Medscape. For seventeen years before joining Medscape he 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, In ...
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Proof-of-concept
A proof of concept (POC or PoC), also known as proof of principle, is an inchoate realization of a certain idea or method in order to demonstrate its feasibility or viability. A proof of concept is usually small and may or may not be complete, but aims to demonstrate in principle that the concept has practical potential without needing to fully develop it. A proof of value (PoV) is sometimes used along proof of concept, and differs by focusing more on demonstrating the potential customer 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 of a "proof-of-concept prototype" in his magazine column "Carsten's Corner" (1989): The column also provided definitions fo ...
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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 sufficiency of disclosure, 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 la ...
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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 in India were slowed by insufficient volunteers, and the results were published in 2023. Beginning in 2011, a contraceptive product based on RISUG, Vasalgel, was under development in the US by the Parsemus Foundation, who were unable to bring the product to market over the next decade. In 2023, the patent for Vasalgel was acquired by NEXT Life Sciences, which plans to bring the technology to market under the name Plan A for Men. 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. ...
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Male Contraceptive
Male contraceptives, also known as male birth control, are methods of preventing pregnancy by interrupting the function of sperm. The main forms of male Birth control, contraception available today are condoms, vasectomy, and Coitus interruptus, withdrawal, which together represented 20% of global contraceptive use in 2019. New forms of male contraception are in Clinical trial, clinical and Preclinical development, preclinical stages of research and development, but as of 2025, none have reached Approved drug, regulatory approval for widespread use. They could be available before 2030, assuming smooth development and clinical trials. These new methods include topical creams, daily pills, injections, long-acting implants, and external devices, and these products have both hormonal and non-hormonal mechanisms of action. Some of these new contraceptives could even be unisex, or usable by any person, because they could theoretically incapacitate mature sperm in the man's body before ...
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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 most of the world's List of national legal systems, 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. Supporters of intellectual property laws often describe their main purpose as encouragin ...
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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 protocols for a certain substance, mode of exposure, exposure environment, duration of exposure, 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 industry ...
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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). However, 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 ...
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Animal Testing
Animal testing, also known as animal experimentation, animal research, and ''in vivo'' testing, is the use of animals, as model organisms, in experiments that seek answers to scientific and medical questions. 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 Basic research, 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 testing, toxicology, including Testing cosmetics ...
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