CHI-California Healthcare Institute is a private, non-profit public policy research and advocacy organization, representing more than 250 universities, academic research centers, biotechnology

Biotechnology

Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...

 and medical device companies. 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 http://www.chi.org/uploadedFiles/Report_2010_California_Biomedical_Industry_Report_FINAL.PDF report, providing data on the scope and scale of academic and commercial life sciences research and development within the state. In 2008 http://www.chi.org/uploadedFiles/Industry_at_a_glance/2010%20California%20Biomedical%20Industry%20Report%20Highlights%20FINAL%20Ltrhd.pdf, the industry employed more than 270,000 Californians and produced revenues in excess of $75 billion.

FDA device approval reform

CHI published a study, Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry, 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.

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.

CHI Board of Directors

CHI's Chairman is Carl Hull, president and chief executive officer, Gen-Probe, Inc.; its President and CEO is David Gollaher

David Gollaher

David L. Gollaher is the President & CEO of the California Healthcare Institute , and a historian of science and medicine. He completed undergraduate studies at University of California and received his masters and Ph.D. degrees from Harvard University...

.
Board members include:
Susan M. Baxter, Ph.D., executive director, California State University

California State University

The California State University is a public university system in the state of California. It is one of three public higher education systems in the state, the other two being the University of California system and the California Community College system. It is incorporated as The Trustees of the...

;

David W. Beier, senior vice president, global government affairs and corporate affairs, Amgen

Amgen

Amgen Inc. is an international biotechnology company headquartered in Thousand Oaks, California. Located in the Conejo Valley, Amgen is the world's largest independent biotech firm. The company employs approximately 17,000 staff members. Its products include Epogen, Aranesp, Enbrel, Kineret,...

;

Ken Berger, president, specialty diagnostics business, Thermo Fisher Scientific;

Michael V. Drake, M.D., chancellor, University of California, Irvine

University of California, Irvine

The University of California, Irvine , founded in 1965, is one of the ten campuses of the University of California, located in Irvine, California, USA...

;

John M. Dunn

John M. Dunn

John M. "Cockeye" Dunn was a New York mobster involved in the numbers racket and labor racketeering as a top enforcer for his brother-in-law Eddie McGrath...

, executive vice president, new ventures, Biogen Idec

Biogen Idec

Biogen Idec, Inc. is a biotechnology company specializing in drugs for neurological disorders, autoimmune disorders and cancer. The company was formed in 2003 by the merger of Cambridge, Massachusetts-based Biogen Inc. and San Diego, California-based IDEC Pharmaceuticals...

;

Peter C. Farrell, Ph.D., DSc, AM, executive chairman of the board, ResMed

ResMed

Founded in Australia, ResMed is now a global manufacturer of products for the treatment of sleep disorders, particularly obstructive sleep apnea . ResMed employs about 2700 employees worldwide, it has direct operations in 18 countries and distribution in more than 50 countries...

;

David D. Fleming, group senior vice president and corporate officer, Genzyme Corporation;

Michael A. Friedman, M.D., president and CEO, City of Hope

City of Hope National Medical Center

City of Hope National Medical Center, is a private, not-for-profit clinical research center, hospital and graduate medical school located in Duarte, California, United States...

;

Robert B. Hance, president, Abbott Vascular;

Paul Hastings, president and chief executive officer, OncoMed Pharmaceuticals;

Terry Hermiston, Ph.D., vice president, U.S. Biologics Research Site Head, U.S. Innovation Center, Bayer Healthcare Pharmaceuticals;

Steve Krognes, senior vice president and chief financial officer, Genentech;

Peter Barton Hutt, partner, Covington & Burling

Covington & Burling

Covington & Burling LLP is an international law firm with offices in Beijing, Brussels, London, New York, San Francisco, Silicon Valley, San Diego, and Washington, DC. The firm advises multinational corporations on significant transactional, litigation, regulatory, and public policy matters...

;

Tracy T. Lefteroff, National Life Sciences Partner, PricewaterhouseCoopers

PricewaterhouseCoopers

PricewaterhouseCoopers is a global professional services firm headquartered in London, United Kingdom. It is the world's largest professional services firm measured by revenues and one of the "Big Four" accountancy firms....

;

Marcea B. Lloyd, senior vice president, government and corporate affairs and general counsel, Amylin Pharmaceuticals

Amylin Pharmaceuticals

Amylin Pharmaceuticals is a biopharmaceutical company based in San Diego, CA, that was founded in 1987. The company is engaged in the discovery, development and commercialization of drug candidates for the treatment of diabetes, obesity and other diseases. Currently, Amylin produces two drugs,...

;

John C. Martin, Ph.D., chairman of the board and CEO, Gilead Sciences

Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs to treat patients infected with HIV, hepatitis B or influenza. In 2006, Gilead acquired two...

;

Dana G. Mead Jr., partner, Kleiner Perkins Caufield & Byers;

Peter G. Milner, M.D., president, co-founder, member board of directors, ARYx Therapeutics, Inc.

ARYx Therapeutics, Inc.

ARYx Therapeutics, Inc. is an American biopharmaceutical company, headquartered in Fremont, California, focused on developing a portfolio of internally discovered product candidates....

;

Michael A. Mussallem, chairman and CEO, Edwards Lifesciences;

Christian W. Nolet, partner and life sciences leader, west region, Ernst & Young

Ernst & Young

Ernst & Young is one of the largest professional services networks in the world and one of the "Big Four" accountancy firms, along with Deloitte, KPMG and PricewaterhouseCoopers ....

;

Michael Onuscheck, president and senior vice president, neuromodulation, Boston Scientific

Boston Scientific

The Boston Scientific Corporation , is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a range of interventional medical specialties, including interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention,...

;
Richard P. Patrylak, senior vice president, customer sales, marketing and policy, Merck & Company;

David E.I. Pyott, chairman of the board and CEO, Allergan

Allergan

Allergan, Inc., is a global specialty pharmaceutical company. Their product ranges include ophthalmic pharmaceuticals, dermatology products, and neurological products.-Profile:...

;

William E. Rhodes, worldwide president, BD Biosciences;

John D. Stobo, M.D., senior vice president for health sciences and services, University of California

University of California

The University of California is a public university system in the U.S. state of California. Under the California Master Plan for Higher Education, the University of California is a part of the state's three-tier public higher education system, which also includes the California State University...

;

Katie M. Szyman, senior vice president and president, diabetes, Medtronic Diabetes;

Eric J. Topol, director, Scripps Translational Science Institute; chief academic officer, Scripps Health; vice chairman, West Wireless Health Institute;

Keith C. Valentine, president and COO, NuVasive, Inc.;


CHI Membership
Members include the University of California

University of California

The University of California is a public university system in the U.S. state of California. Under the California Master Plan for Higher Education, the University of California is a part of the state's three-tier public higher education system, which also includes the California State University...

, Amgen

Amgen

Amgen Inc. is an international biotechnology company headquartered in Thousand Oaks, California. Located in the Conejo Valley, Amgen is the world's largest independent biotech firm. The company employs approximately 17,000 staff members. Its products include Epogen, Aranesp, Enbrel, Kineret,...

, University of California, Irvine

University of California, Irvine

The University of California, Irvine , founded in 1965, is one of the ten campuses of the University of California, located in Irvine, California, USA...

, Biogen Idec

Biogen Idec

Biogen Idec, Inc. is a biotechnology company specializing in drugs for neurological disorders, autoimmune disorders and cancer. The company was formed in 2003 by the merger of Cambridge, Massachusetts-based Biogen Inc. and San Diego, California-based IDEC Pharmaceuticals...

, Stanford, Amgen

Amgen

Amgen Inc. is an international biotechnology company headquartered in Thousand Oaks, California. Located in the Conejo Valley, Amgen is the world's largest independent biotech firm. The company employs approximately 17,000 staff members. Its products include Epogen, Aranesp, Enbrel, Kineret,...

, Genentech

Genentech

Genentech Inc., or Genetic Engineering Technology, Inc., is a biotechnology corporation, founded in 1976 by venture capitalist Robert A. Swanson and biochemist Dr. Herbert Boyer. Trailing the founding of Cetus by five years, it was an important step in the evolution of the biotechnology industry...

 and Gilead Sciences

Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs to treat patients infected with HIV, hepatitis B or influenza. In 2006, Gilead acquired two...

. CHI Member List http://www.chi.org/uploadedFiles/CHI%20Member%20List%20for_print%20on%20Ltrhd(4).pdf