Therapeutic discovery project

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The Qualifying Therapeutic Discovery Project Tax Credit was included in the Health Care Reform Bill to foster medical, life sciences, and biological innovation in the U.S. Many firms across the country could potentially be eligible for a Credit or Grant under this program. [1] The Bill enables Treasury to allocate a maximum of $1 Billion in tax credits or grants to eligible companies. Treasury with guidance from Health & Human Services will accept, review, and certify applications. Potentially eligible companies should consult with their respective tax professionals to assess eligibility.

A tax credit is a tax incentive which allows certain taxpayers to subtract the amount of the credit they have accrued from the total they owe the state. It may also be a credit granted in recognition of taxes already paid or, as in the United Kingdom, a form of state support.

Innovation in its modern meaning is "a new idea, creative thoughts, new imaginations in form of device or method". Innovation is often also viewed as the application of better solutions that meet new requirements, unarticulated needs, or existing market needs. Such innovation takes place through the provision of more-effective products, processes, services, technologies, or business models that are made available to markets, governments and society. An innovation is something original and more effective and, as a consequence, new, that "breaks into" the market or society. Innovation is related to, but not the same as, invention, as innovation is more apt to involve the practical implementation of an invention to make a meaningful impact in the market or society, and not all innovations require an invention. Innovation often manifests itself via the engineering process, when the problem being solved is of a technical or scientific nature. The opposite of innovation is exnovation.

United States Federal republic in North America

The United States of America (USA), commonly known as the United States or America, is a country comprising 50 states, a federal district, five major self-governing territories, and various possessions. At 3.8 million square miles, the United States is the world's third or fourth largest country by total area and is slightly smaller than the entire continent of Europe's 3.9 million square miles. With a population of over 327 million people, the U.S. is the third most populous country. The capital is Washington, D.C., and the most populous city is New York City. Most of the country is located contiguously in North America between Canada and Mexico.

Details of the project

Taxpayer person or organization subject to a tax on income

A taxpayer is a person or organization subject to pay a tax. Taxpayers have an Identification Number, a reference number issued by a government to its citizens.

To invest is to allocate money in the expectation of some benefit in the future.

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.

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National Institutes of Health Medical research organization in the United States

The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late 1870s, and is now part of the United States Department of Health and Human Services. The majority of NIH facilities are located in Bethesda, Maryland. The NIH conducts its own scientific research through its Intramural Research Program (IRP) and provides major biomedical research funding to non-NIH research facilities through its Extramural Research Program.

An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases.

The Low-Income Housing Tax Credit is a dollar-for-dollar tax credit in the United States for affordable housing investments. It was created under the Tax Reform Act of 1986 (TRA86) and gives incentives for the utilization of private equity in the development of affordable housing aimed at low-income Americans. LIHTC accounts for the majority of all affordable rental housing created in the United States today. As the maximum rent that can be charged is based upon the Area Median Income ("AMI"), LIHTC housing remains unaffordable to many low-income renters. The credits are also commonly called Section 42 credits in reference to the applicable section of the Internal Revenue Code. The tax credits are more attractive than tax deductions as the credits provide a dollar-for-dollar reduction in a taxpayer's federal income tax, whereas a tax deduction only provides a reduction in taxable income. The "passive loss rules" and similar tax changes made by TRA86 greatly reduced the value of tax credits and deductions to individual taxpayers. Less than 10% of current credit expenditures are claimed by individual investors.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is one of the institutes and centers that make up the National Institutes of Health, an agency of the United States Department of Health and Human Services (HHS).

The National Heart, Lung, and Blood Institute (NHLBI) is the third largest Institute of the National Institutes of Health, located in Bethesda, Maryland, United States. It is tasked with allocating about $3.0 billion in tax revenue per year to advancing the understanding of the following issues: development and progression of disease, diagnosis of disease, treatment of disease, disease prevention, reduction of health care disparities within the American population, and advancing the effectiveness of the US medical system. NHLBI's Director is Gary H. Gibbons (2012-present).

Coluracetam chemical compound

Coluracetam (INN) is a nootropic agent of the racetam family. It was initially developed and tested by the Mitsubishi Tanabe Pharma Corporation for Alzheimer's disease. After the drug failed to reach endpoints in its clinical trials it was in-licensed by BrainCells Inc for investigations into major depressive disorder (MDD), which was preceded by being awarded a "Qualifying Therapeutic Discovery Program Grant" by the state of California. Findings from phase IIa clinical trials have suggested that it would be a potential medication for comorbid MDD with generalized anxiety disorder (GAD). BrainCells Inc is currently out-licensing the drug for this purpose. It may also have potential use in prevention and treatment of ischemic retinopathy and retinal and optic nerve injury.

Medical research research

Biomedical research encompasses a wide array of research, extending from "basic research", – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine.

Medical laboratory scientist Healthcare professional who works in the laboratory

A medical laboratory scientist (MLS), also traditionally referred to as a clinical laboratory scientist (CLS), or biomedical scientist (BMS), is a healthcare professional who performs chemical, hematological, immunologic, histopathological, cytopathological, microscopic, and bacteriological diagnostic analyses on body fluids such as blood, urine, sputum, stool, cerebrospinal fluid (CSF), peritoneal fluid, pericardial fluid, and synovial fluid, as well as other specimens. Medical laboratory scientists work in clinical laboratories at hospitals, reference labs, biotechnology labs and non-clinical industrial labs.

The Canadian Scientific Research and Experimental Development Tax Incentive Program provides support in the form of tax credits and/or refunds, to corporations, partnerships or individuals who conduct scientific research or experimental development in Canada.

The Research & Experimentation Tax Credit or R&D Tax Credit is a general business tax credit under Internal Revenue Code section 41 for companies that incur research and development (R&D) costs in the United States. The R&D Tax Credit was originally introduced in the Economic Recovery Tax Act of 1981 sponsored by U.S. Representative Jack Kemp and U.S. Senator William Roth. Since the credit's original expiration date of December 31, 1985, the credit has expired eight times and has been extended fifteen times. The last extension expired on December 31, 2014. In 2015, Congress made permanent the research and development tax credit in a measure of the government spending bill.

Trevena Inc is a clinical stage biopharmaceutical company, headquartered in Chesterbrook, Pennsylvania, USA, and is involved in the discovery and development of G-protein coupled receptors (GPCR) biased ligands. Trevena was founded in 2007 with technology licensed from Duke University, which originated in the labs of company founders Robert Lefkowitz winner of the 2012 Nobel Prize in Chemistry and Howard Rockman. Trevena's approach to drug discovery is based on utilizing ligand bias, or functional selectivity, at GPCR targets to produce drugs with improved efficacy and reduced side effect profiles. Trevena was named one of the top 15 US startups of 2008 by Business Week.

The Railroad Track Maintenance Tax Credit, also known as the 45G Tax Credit, is a federal income tax credit for track maintenance conducted by short lines and regional railroads in the United States. The credit granted an amount equal to 50% of qualified track maintenance expenditures and other qualifying railroad infrastructure projects. It was inserted into the tax code by the American Jobs Creation Act of 2004, and was taken into effect on January 1, 2005 with an expiration date of December 31, 2009. Following the Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010, signed into law on December 17, 2010, the tax credit was retroactively extended for 2010 and the expiration date moved to January 1, 2012. United States fiscal cliff legislation retroactively reinstated the tax credit for 2012 when signed into law January 2, 2013. The tax credit was effective thru December 31, 2013.

Orphan Drug Act of 1983 Law passed in the United States to facilitate development of orphan drugs

The Orphan Drug Act of 1983 is a law passed in the United States to facilitate development of orphan drugs—drugs for rare diseases such as Huntington's disease, myoclonus, ALS, Tourette syndrome and muscular dystrophy which affect small numbers of individuals residing in the United States.

NIH Intramural Research Program

The NIH Intramural Research Program (IRP) is the internal research program of the National Institutes of Health (NIH), known for its synergistic approach to biomedical science. With 1,200 Principal Investigators and over 4,000 Postdoctoral Fellows conducting basic, translational, and clinical research, the NIH Intramural Research Program is the largest biomedical research institution on earth. The unique funding environment of the IRP facilitates opportunities to conduct both long-term and high-impact science that would otherwise be difficult to undertake. With rigorous external reviews ensuring that only the most outstanding research secures funding, the IRP is responsible for many scientific accomplishments, including the discovery of fluoride to prevent tooth decay, the use of lithium to manage bipolar disorder, and the creation of vaccines against hepatitis, Hemophilus influenzae (HIB), and human papillomavirus (HPV). In addition, the IRP has also produced or trained 21 Nobel Prize-winning scientists.

A patent box is a special very low corporate tax regime used by several countries to incentivise research and development by taxing patent revenues differently from other commercial revenues. It is also known as intellectual property box regime, innovation box or IP box. Patent boxes have also been used as base erosion and profit shifting (BEPS) tools, to avoid corporate taxes.

Research and Development (R&D) Tax Credits are a UK tax incentive designed to encourage companies to invest in R&D. Companies can reduce their tax bill or claim payable cash credits as a proportion of their R&D expenditure.

The Research and Development Expenditure Credit (RDEC), introduced in 2013, is a UK tax incentive designed to encourage large companies to invest in R&D in the UK. Companies can reduce their tax bill or claim payable cash credits as a proportion of their R&D expenditure.

The US carries out 46% of global research and development (R&D) in the life sciences, making it the world leader in medical research.

References

  1. 1 2 "Therapeutic Discovery Project Credit" (PDF). askican.org.
  2. "Qualifying Therapeutic Discovery Project Program". grants.nih.gov.