Tania Simoncelli

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Tania Simoncelli
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Simoncelli in 2014
Alma mater
Employers

Tania Simoncelli is Senior Advisor to the Director of the Broad Institute of MIT and Harvard. [1] Prior to that position, she worked for two years as Assistant Director for Forensic Science and Biomedical Innovation within the Office of Science and Technology Policy. [2] From 2010 to 2013, she worked in the Food and Drug Administration's Office of the Commissioner. [3] From 2003 to 2010, Simoncelli worked as the Science Advisor to the American Civil Liberties Union (ACLU), where she advised the organization on emerging developments in science and technology that pose challenges for civil liberties.

Contents

In December 2013, Simoncelli was named by the journal Nature as one of "ten people who mattered this year" for her work in spearheading the development of the ACLU's successful legal challenge to the patenting of human genes. [4] In August 2017, she was named Director of Policy for Science at the Chan Zuckerberg Initiative. [5]

Simoncelli has spoken, written, and advised on a number of contemporary science policy issues, including personalized medicine, [6] gene patenting, [7] [8] [9] forensic DNA data banks, [10] [11] pesticide testing in humans, [12] and academic freedom. [13] She is co-author with Sheldon Krimsky of Genetic Justice: DNA Data Banks, Criminal Investigations, and Civil Liberties. [14]

Education

Simoncelli received her BA from Cornell University in 1993, majoring in Biology and Society, and her MS degree from University of California, Berkeley's Energy and Resources Group.

Gene patents

From 1982 to 2013, [15] the US Patent and Trademark Office (USPTO) accepted patents on isolated DNA sequences as a composition of matter. Simoncelli has stated that this became a "significant barrier to biomedical discovery and innovation." [16] From 2005 to 2009, Simoncelli, as the American Civil Liberties Union's science advisor, worked with ACLU lawyer Chris Hansen to file a case against Salt Lake City-based Myriad Genetics. Myriad Genetics held a complete monopoly on BRCA testing in the United States as Myriad had held the patents on the gene associated with increased risk for breast cancer, the (BRCA1) gene, since 1995 and on the BRCA2 gene since 1998. The company charged $3000 a test and, in Simoncelli's words, "refused to update its test to include additional mutations that had been identified by a team of researchers in France".[ citation needed ] The lead plaintiff of 20 plaintiffs represented by Hansen in the ACLU-sponsored lawsuit was the Association for Molecular Pathology (AMP). In March 2010, the Southern District Court of New York Judge Robert Sweet ruled in favor of the AMP that all the challenged claims were not patent-eligible. [17] [7] [4] [16] [8] [9] Myriad appealed this decision, and the case went before the United States Court of Appeals for the Federal Circuit, which, although affirming part of the district court's ruling, also partly overturned it, ruling instead that isolated DNA sequences are patent-eligible. [18] Ultimately, the case went before the Supreme Court, which, in a unanimous decision on June 13, 2013, invalidated Myriad's claims to isolated genes in Association for Molecular Pathology v. Myriad Genetics , [19] ruling that merely isolating genes that are found in nature does not make them patentable. [19]

Related Research Articles

<span class="mw-page-title-main">Complementary DNA</span> DNA reverse transcribed from RNA

In genetics, complementary DNA (cDNA) is DNA that was reverse transcribed from an RNA. cDNA exists in both single-stranded and double-stranded forms and in both natural and engineered forms.

<span class="mw-page-title-main">BRCA1</span> Gene known for its role in breast cancer

Breast cancer type 1 susceptibility protein is a protein that in humans is encoded by the BRCA1 gene. Orthologs are common in other vertebrate species, whereas invertebrate genomes may encode a more distantly related gene. BRCA1 is a human tumor suppressor gene and is responsible for repairing DNA.

As with all utility patents in the United States, a biological patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery in biology for a limited period of time - for patents filed after 1998, 20 years from the filing date.

<span class="mw-page-title-main">BRCA2</span> Gene known for its role in breast cancer

BRCA2 and BRCA2 are human genes and their protein products, respectively. The official symbol and the official name are maintained by the HUGO Gene Nomenclature Committee. One alternative symbol, FANCD1, recognizes its association with the FANC protein complex. Orthologs, styled Brca2 and Brca2, are common in other vertebrate species. BRCA2 is a human tumor suppressor gene, found in all humans; its protein, also called by the synonym breast cancer type 2 susceptibility protein, is responsible for repairing DNA.

Forensic identification is the application of forensic science, or "forensics", and technology to identify specific objects from the trace evidence they leave, often at a crime scene or the scene of an accident. Forensic means "for the courts".

DNA banking is the secure, long-term storage of an individual's genetic material. DNA is most commonly extracted from blood, but can also be obtained from saliva and other tissues. DNA banks allow for conservation of genetic material and comparative analysis of an individual's genetic information. Analyzing an individual's DNA can allow scientists to predict genetic disorders, as used in preventive genetics or gene therapy, and prove that person's identity, as used in the criminal justice system. There are multiple methods for testing and analyzing genetic information including restriction fragment length polymorphism (RFLP) and polymerase chain reactions (PCR).

The Council for Responsible Genetics (CRG) was a nonprofit NGO with a focus on biotechnology.

<span class="mw-page-title-main">Myriad Genetics</span> American biotechnology company

Myriad Genetics, Inc. is an American genetic testing and precision medicine company based in Salt Lake City, Utah, United States. Myriad employs a number of proprietary technologies that permit doctors and patients to understand the genetic basis of human disease and the role that genes play in the onset, progression and treatment of disease. This information is used to guide the development of new products that assess an individual's risk for developing disease later in life, identify a patient's likelihood of responding to a particular drug therapy, assess a patient's risk of disease progression and disease recurrence, and measure disease activity.

GeneDx is a genetic testing company that was founded in 2000 by two scientists from the National Institutes of Health (NIH), Sherri Bale and John Compton. They started the company to provide clinical diagnostic services for patients and families with rare and ultra-rare disorders, for which no such commercial testing was available at the time. The company started in the Technology Development Center, a biotech incubator supported by the state of Maryland and Montgomery County, MD. In 2006, BioReference Laboratories acquired GeneDx. Since then, GeneDx has operated as a subsidiary of this parent company under the leadership of Bale and Compton. In October 2016, Benjamin D. Solomon was appointed as managing director.

Sheldon Krimsky was a professor of Urban and Environmental Policy and Planning at Tufts University, and adjunct professor in the Department of Family Medicine and Community Health at Tufts University School of Medicine. He was a fellow of the Hastings Center, an independent bioethics research institution.

<i>BRCA</i> mutation Medical condition

A BRCA mutation is a mutation in either of the BRCA1 and BRCA2 genes, which are tumour suppressor genes. Hundreds of different types of mutations in these genes have been identified, some of which have been determined to be harmful, while others have no proven impact. Harmful mutations in these genes may produce a hereditary breast–ovarian cancer syndrome in affected persons. Only 5–10% of breast cancer cases in women are attributed to BRCA1 and BRCA2 mutations, but the impact on women with the gene mutation is more profound. Women with harmful mutations in either BRCA1 or BRCA2 have a risk of breast cancer that is about five times the normal risk, and a risk of ovarian cancer that is about ten to thirty times normal. The risk of breast and ovarian cancer is higher for women with a high-risk BRCA1 mutation than with a BRCA2 mutation. Having a high-risk mutation does not guarantee that the woman will develop any type of cancer, or imply that any cancer that appears was actually caused by the mutation, rather than some other factor.

On 29 March 2010, the US District Court for the Southern District of New York found several of the patent claims on the BRCA1 and BRCA2 breast cancer genes held by Myriad Genetics to be invalid. The patents were initially issued on the basis that the genes were isolated and purified to a non-naturally occurring state, however the court found, amongst other things, that the purification was not markedly different from a product of nature and thus was not patentable. The ruling may have implications for holders of other gene patents and the patentability of other naturally occurring substances. It has the potential to directly affect the operation of the healthcare and medical research industries, particularly with regards to cancer treatment and prevention, and may alter the accessibility of such therapies to patients.

<i>In the Family</i> (2008 film) 2008 American film

In the Family is a 2008 documentary film, produced by Kartemquin Films, about predicting breast and ovarian cancer and the choices women make when they are faced with the dangers of a possible life-threatening disease. The film's director, Joanna Rudnick, tests positive for the familial BRCA mutation that increases her chances of developing breast cancer by 60%. Faced with these odds, Rudnick must examine her choices of possibly taking her chances or possibly having her breasts and ovaries removed.

A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions, and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.

Christopher A. Hansen is an American civil rights attorney, notable for litigating many cases while at the ACLU, including the AMP v. Myriad Genetics (2013) case at the US Supreme Court and the ACLU's efforts in ACLU v. Reno (1997). Hansen was at the ACLU for 40 years, from 1973 to 2013, retiring as Senior National Staff Counsel, and the ACLU's longest-serving attorney.

Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), was a Supreme Court case, which decided that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” However, as a "bizarre conciliatory prize" the Court allowed patenting of complementary DNA, which contains exactly the same protein-coding base pair sequence as the natural DNA, albeit with introns removed.

<i>In re Roslin Institute</i> (Edinburgh) 2014 decision of the United States Court of Appeals for the Federal Circuit

In re Roslin Institute (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014), is a 2014 decision of the United States Court of Appeals for the Federal Circuit rejecting a patent for a cloned sheep known as "Dolly the Sheep"— the first mammal ever cloned from an adult somatic cell.

The Association for Molecular Pathology is a professional association of individuals serving patients through molecular diagnostics testing. Founded in 1995, the Association has more than 2,800 members in over 50 countries.

Haig Hagop Kazazian Jr. was an American professor in the Department of Genetic Medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland. Kazazian was an elected member of the National Academy of Sciences and the American Academy of Arts and Sciences.

<span class="mw-page-title-main">Patentable subject matter in the United States</span>

Patentable subject matter in the United States is governed by 35 U.S.C. 101. The current patentable subject matter practice in the U.S. is very different from the corresponding practices by WIPO/Patent Cooperation Treaty and by the European Patent Office, and it is considered to be broader in general.

References

  1. ↑ "Tania Simoncelli". Harvard University. Retrieved July 2, 2017.
  2. ↑ The White House, OSTP Leadership and Staff Archived 2013-07-19 at the Wayback Machine
  3. ↑ The White House Blog
  4. 1 2 "Ten people who mattered this year", Nature, 504 (7480): 357–365, 18 December 2013, doi: 10.1038/504357a , PMID   24352276
  5. ↑ https://www.linkedin.com/in/tania-simoncelli-97953972 [ self-published source ]
  6. ↑ U.S. Food and Drug Administration, Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development, October 2013 (Prepared by T. Simoncelli).
  7. 1 2 Park, S.; Simoncelli, T. (Fall 2012), Making the Case Against Gene Patents, vol. 9, The SciTech Lawyer
  8. 1 2 Andrew Ma (September 24, 2013), "HLS Panel Discusses Gene Patents", The Harvard Crimson
  9. 1 2 Alvin Powell (November 14, 2013), Genes Without Patents, The Harvard Gazette
  10. ↑ Simoncelli, T. and S. Krimsky, “A New Era of DNA Collections: At What Cost to Civil Liberties?” American Constitution Society for Law and Policy, August 2007.
  11. ↑ Simoncelli, T., “Dangerous Excursions: The Case Against Expanding Forensic DNA Databases to Innocent Persons,” Journal of Law, Medicine & Ethics, Vol. 34, No. 2 (Summer) 2006, pp. 390-397.
  12. ↑ Krimsky, S. and T. Simoncelli, “Testing Pesticides in Humans: Of Mice and Men Divided by Ten,” JAMA, Vol. 297, No. 21 (June 6) 2007: pp. 2405-2407.
  13. ↑ Simoncelli, Tania, and Jay Stanley. Science Under Siege: The Bush Administration's Assault on Academic Freedom and Scientific Inquiry. New York, NY: American Civil Liberties Union, 2005.
  14. ↑ Krimsky, Sheldon; Simoncelli, Tania (2012). Genetic justice: DNA data banks, criminal investigations and civil liberties. New York: Columbia Univ. Press. ISBN   978-0-231-14520-6.
  15. ↑ "Genes, Law, and the Race to Patent". www.cas.org. Archived from the original on 2013-12-04.
  16. 1 2 Tania Simoncelli (November 2014), Should you be able to patent a human gene?, Ted Talks, retrieved December 31, 2016
  17. ↑ Schwartz, John; Pollack, Andrew (March 29, 2010). "Judge Invalidates Human Gene Patent". The New York Times . Retrieved March 29, 2010.
  18. ↑ "ACLU Challenges Patents On Breast Cancer Genes: BRCA". American Civil Liberties Union. June 26, 2012. Retrieved 2012-06-28.
  19. 1 2 Association for Molecular Pathology v. Myriad Genetics, United States Supreme Court (USSC), June 13, 2013
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