Medical Device Link.

Originally Published IVD Technology April 2005

Tenth Anniversary

Top 10 Persons in the IVD Industry

The following list presents 10 persons who have made a significant impact on the IVD industry. IVD Technology’s editorial advisory board and reader board members were first asked to nominate potential candidates for this list. The board members were told that potential nominees should be those persons who have had a considerable influence on the IVD industry. The board members were then asked to select from the compiled list of all the nominees those persons who they thought should be on this final list. Efforts were made to ensure that this list reflects contributions in both the regulatory and scientific areas. Presented in alphabetical order, the following persons were most frequently selected by the board members.

Arnold O. Beckman, PhD

Arnold Beckman was the founder and chairman emeritus of Beckman Instruments Inc., now known as Beckman Coulter Inc. (Fullerton, CA). He is considered one of the leading inventors of scientific instruments. He created such devices as the pH meter and the spectrophotometer, which revolutionized the study and understanding of human biology. He was also recognized as a great philanthropist. In 1977, he formed the Arnold and Mabel Beckman Foundation, which has contributed more than $400 million in support of scientific research and education. He died last year at the age of 104.

Jay S. Epstein, MD

Jay Epstein is the director of FDA’s Office of Blood Research and Review (OBRR) and is a recognized leader in blood safety regulations. At FDA, he is responsible for policy development and scientific review related to the safety, efficacy, and availability of blood and blood products, and for approving diagnostic tests for AIDS and other retroviral infections. Under his leadership since 1993, OBRR has implemented blood donor screening and testing for numerous agents (e.g., HIV, hepatitis C virus, West Nile virus) and has introduced new technologies such as nucleic acid–based blood testing.

Anthony S. Fauci, MD

Anthony Fauci is the director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID; Bethesda, MD). At NIAID, he oversees an extensive research portfolio of basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses. He has greatly contributed to basic and clinical research on the pathogenesis and treatment of immune-mediated diseases. He has also pioneered the field of human immunoregulation by making a number of basic scientific observations that serve as the basis for the current understanding of the regulation of the human immune response.

Steven I. Gutman, MD

Steve Gutman is the director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). Certified by the American Board of Pathology, he was a clinical pathologist and chief of the laboratory service at the Buffalo Veterans Administration Medical Center (Buffalo, NY). In 1992, he joined FDA’s division of clinical laboratory devices as a medical officer. He was later promoted to division director in 1993. He received an MD from Cornell University Medical College (New York City) and an MBA from the State University of New York at Buffalo.

Fred D. Lasky, PhD

Fred Lasky is director of regulatory affairs at Genzyme Diagnostics (Cambridge, MA). With more than 20 years of experience in regulatory affairs and quality systems compliance, he is active in developing standards for the IVD industry. He has served on projects through the Clinical and Laboratory Standards Institute (Wayne, PA) on the linearity of quantitative methods, quality control, and alternate-site testing. He also contributes to the international standards arena by participating in ISO technical committee 212 and working on documents on quality management in the clinical laboratory, traceability, risk management, and device labeling.

Kary B. Mullis, PhD

Kary Mullis received the Nobel Prize in chemistry in 1993 for his invention of the polymerase chain reaction (PCR) process. Conceptualized by Mullis in 1983, PCR is hailed as one of the monumental scientific techniques of the 20th century. He received a PhD in biochemistry from the University of California, Berkeley. He has worked and consulted for a number of companies, including Cetus Corp. (Emeryville, CA), Xytronyx Inc. (San Diego), Abbott Laboratories (Abbott Park, IL), and Specialty Laboratories (Valencia, CA). He is currently a distinguished researcher at Children’s Hospital Oakland Research Institute (Oakland, CA).

Donald M. Powers, PhD

Don Powers is president and principal consultant of Powers Consulting Services (Pittsford, NY). He works with clients to develop regulatory strategies, prepare submissions, assess regulatory compliance with FDA and EU requirements, review technical files, improve quality management systems, evaluate risk management programs, and respond to regulatory actions. He previously held several positions at Ortho-Clinical Diagnostics (Rochester, NY), including director of worldwide regulatory affairs. He is an active member of ISO technical committee 212 and the Clinical Laboratory Standards Institute (Wayne, PA). He holds a PhD in biochemistry from Cornell University (Ithaca, NY).

J. Craig Venter, PhD

Craig Venter became the first president of Celera Genomics (Rockville, MD) in 1998. At Celera, he sequenced the human genome using the whole-genome shotgun technique, new mathematical algorithms, and new automated DNA-sequencing machines. In February 2001, he published the completed sequence of the human genome in the journal Science. In addition to the human genome, Venter and his team at Celera sequenced the fruit fly, mouse, and rat genomes. He is currently the president of the J. Craig Venter Institute and the J. Craig Venter Science Foundation (Rockville, MD).

James O. Westgard, PhD

James Westgard is a professor in the department of pathology and laboratory medicine at the University of Wisconsin Medical School (Madison, WI). He is faculty director of quality management services for the clinical laboratories at the University of Wisconsin Hospital and Clinics. He is also a cofounder and principal of Westgard QC Inc. (Madison, WI), which provides tools, technology, and training for laboratory quality management. His extensive interest and work in quality control led to the multirule control procedure that is often referred to as the Westgard Rules.

Alan H. B. Wu, PhD

Alan Wu is director of clinical chemistry and toxicology at San Francisco General Hospital and a professor in the department of laboratory medicine at the University of California, San Francisco. He received BS degrees in chemistry and biology from Purdue University (West Lafayette, IN) and a PhD in analytical chemistry from the University of Illinois (Urbana, IL). He completed a clinical chemistry fellowship at Hartford Hospital (Hartford, CT) and is certified by the American Board of Clinical Chemistry. Since 1999, he has been the co-editor-in-chief of Clinica Chimica Acta.

Copyright ©2005 IVD Technology