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CHI-California Healthcare Institute is a private, non-profit public policy research and advocacy organization, representing more than 250 universities, academic research centers, biotechnology, and medical device companies. [1] Founded in 1993, and based in La Jolla, California, CHI has offices in Washington, D.C., and Sacramento, California. CHI publishes an annual California Biomedical Industry report, [2] providing data on the scope and scale of academic and commercial life sciences research and development within the state. In 2008, [3] the industry employed more than 270,000 Californians and produced revenues in excess of $75 billion.
CHI published a study, Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry, [4] which concluded that device approval times had increased, that approval times in the European Union were faster than those in the U.S., and that "inefficiency at the FDA had resulted in American inventions made available to patients and physicians in other countries first ... [and] has pushed jobs and revenues offshore."
This report was presented at an oversight hearing of the House of Representatives, Committee on Energy and Commerce, on FDA medical device regulation. [5]
The report defended the expedited approval process for devices and said that "Devices, in contrast, may be altered in minor ways -- switching to a new metal alloy, installing a longer-lasting battery, using a better polymer -- so that the effects on the product's safety and efficacy profile are predictable."
The Democratic members of the committee submitted the report to editors of major peer-reviewed journals for evaluation. [6]
CHI's Chairman is Carl Hull, [7] president and chief executive officer, Gen-Probe, Inc.; its President and CEO is David Gollaher.
Board members include:
CHI Membership Members include the University of California, Amgen, University of California, Irvine, Biogen Idec, Stanford, Amgen, Genentech and Gilead Sciences. [19]
Herbert Wayne "Herb" Boyer is an American biotechnologist, researcher and entrepreneur in biotechnology. Along with Stanley N. Cohen and Paul Berg, he discovered a method to coax bacteria into producing foreign proteins, which aided in jump-starting the field of genetic engineering.
Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. One of the world's largest independent biotechnology companies, As of 2022, Amgen has approximately 24,000 staff in total.
Scripps Research is a nonprofit American medical research facility that focuses on research and education in the biomedical sciences. Headquartered in San Diego, California, the institute has over 170 laboratories employing 2,100 scientists, technicians, graduate students, and administrative and other staff.
The Presidential Advisory Council on HIV/AIDS (PACHA) advises the White House and the Secretary of Health and Human Services on the US government's response to the AIDS epidemic. The commission was formed by President Bill Clinton in 1995 and each president since has renewed the council's charter.
Richard D. Nanula was chief financial officer of Amgen Inc. and The Walt Disney Company, chief operating officer of Starwood, and chief executive officer of Broadband Sports. While a principal at Colony Capital, he resigned amid a sex scandal. He is currently the chief executive officer of Lucy Scientific Discovery Inc..
Arthur D. Levinson is an American businessman and is the chairman of Apple Inc. (2011–present) and chief executive officer (CEO) of Calico. He is the former CEO (1995–2009) and chairman (1999–2014) of Genentech.
Charles Weissmann is a Hungarian-Swiss molecular biologist. Weissmann is particularly known for the first cloning and expression of interferon and his contributions to the unraveling of the molecular genetics of neurogenerative prion diseases such as scrapie, Creutzfeldt–Jakob disease and "mad cow disease".
The President's Council of Advisors on Science and Technology (PCAST) is a council, chartered in each administration with a broad mandate to advise the president of the United States on science and technology. The current PCAST was established by Executive Order 13226 on September 30, 2001, by George W. Bush, was re-chartered by Barack Obama's April 21, 2010, Executive Order 13539, by Donald Trump's October 22, 2019, Executive Order 13895, and by Joe Biden's February 1, 2021, Executive Order 14007.
David V. Goeddel is an American molecular biologist who, employed at the time by Genentech, successfully used genetic engineering to coax bacteria into creating synthetic human insulin, human growth hormone, and human tissue plasminogen activator (tPA) for use in therapeutic medicine.
David L. Gollaher was the founding President & CEO of the California Healthcare Institute (CHI), 1993–2014, from which he joined Gilead Sciences. Initially, in 1998, he was a charter member of Gilead's Health Policy Advisotry Board, then, from 2014 to 2018, he served as the company's head of worldwide Government Affairs and Policy. Subsequently, in early 2019, he was appointed Senor Vice President of global policy and government affairs at Vir Biotechnology, an emerging growth biotech company focused on infectious diseases. He retired from Vir in 2021. Previously, in 2018, he was named Senior Fellow at the Leonard D. Schaeffer Center for Health Policy and Economics at the University of Southern California.
Eric Jeffrey Topol is an American cardiologist, scientist, and author. He is the founder and director of the Scripps Research Translational Institute, a professor of Molecular Medicine and Executive Vice-President at Scripps Research Institute, and a senior consultant at the Division of Cardiovascular Diseases at Scripps Clinic in La Jolla, California. He has published three bestseller books on the future of medicine: The Creative Destruction of Medicine (2010), The Patient Will See You Now (2015), and Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again (2019). He was commissioned by the UK from 2018–2019 to lead planning for the National Health Service's future workforce, integrating genomics, digital medicine, and artificial intelligence.
Michael A. Marletta is an American biochemist. He was born in Rochester, New York, the son of Italian immigrants. He graduated from the State University of New York at Fredonia in 1973 with an A.B. degree in biology and chemistry, and from the University of California, San Francisco in 1978 with a Ph.D. degree in pharmaceutical chemistry, where he studied with George Kenyon. He was a postdoctoral fellow with Christopher T. Walsh at MIT from 1978-1980 and continued as a faculty member at MIT from 1980-1987 whereupon he joined the faculty of the University of Michigan, Ann Arbor. He was John G. Searle Professor of Medicinal Chemistry in the college of pharmacy and professor of biological chemistry at the University of Michigan. In 2001, he moved to the University of California, Berkeley to assume roles as Aldo DeBenedictis Distinguished Professor of Chemistry and professor of biochemistry and molecular biology, and served as the chair of the department of chemistry from 2005 until 2010. He was a Howard Hughes Medical Institute Investigator. From January 2012 to August 2014, Marletta was president and CEO of The Scripps Research Institute in La Jolla, California, succeeding Richard Lerner.
Wanda M. Austin is a former president and CEO of The Aerospace Corporation. She was both the first woman, and the first African-American, to hold this position. Austin also served as interim president for the University of Southern California, following the resignation of C. L. Max Nikias. She was both the first woman, and the first African-American, to hold this position.
Onyx Pharmaceuticals Inc. has been a biopharmaceutical company headquartered in South San Francisco, California. The company developed and marketed medicines for the treatment of cancer. Onyx was founded in 1992 by Kevin J. Kinsella and Frank McCormick Ph.D., FRS. McCormick served as the chief scientific officer until 1998, while Kinsella was the firm's chairman. In 2009, the company acquired Proteolix, Inc., a private biotechnology company, for $276 million in cash plus additional milestone payments. In January 2012, the company was named "the top biotechnology takeover target in 2012" through an industry survey. Onyx president and chief executive officer (CEO) Tony Coles had said that Onyx liked its prospects as an independent company and was focused on bringing new therapies to patients. However, at the end of August 2013, Amgen announced it was acquiring Onyx in an agreed $10.4 billion deal.
Roger M. Perlmutter is the former executive vice president of Merck & Co. and former president of Merck Research Laboratories. He is currently a non-executive director of Merck Research Laboratories.
Robert A. Bradway is an American businessman. He is the chairman and chief executive officer of Amgen.
The Institute for Clinical and Economic Review (ICER) is a Boston-based independent nonprofit organization that seeks to place a value on medical care by providing comprehensive clinical and cost-effectiveness analyses of treatments, tests, and procedures.
Jeffrey Leiden is an American physician, scientist and businessman who is the executive chairman of Vertex Pharmaceuticals, a biotechnology company based in Boston, Massachusetts. He was initially appointed to the board of directors of the company in 2009 and was CEO and president from February 2012 to March 2020.
William H.Rastetter, a scientist, entrepreneur and venture capitalist, is the chair of Neurocrine Biosciences, of Fate Therapeutics, and of Daré Bioscience, Inc. in San Diego, California. He was a founding board member and investor in GRAIL, Inc. in Menlo Park, California, and served for a period as the company's interim CEO (2017) and chair (2017-2018). Rastetter is also a director of Regulus Therapeutics and Iambic Therapeutics. He was a partner in the venture firm Venrock (2006-2013), and a trustee at Caltech (2015-2018). He has served as a director (1998-2016) and as chair of Illumina (2005-2016). He advised SVB Leerink (2014-2019) and currently advises Illumina Ventures.
Christopher Henney is an American immunologist and biotechnology entrepreneur who co-founded Immunex Corp. and Icos Corporation, and led Dendreon Corp. to the development of the first FDA-approved cancer vaccination therapy.
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