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Roche NimbleGen commits to GMP and FDA submission for microarrays
MADISON, Wis.—As part of assuring both quality and compliance, and with an eye toward future development and marketing needs, Roche NimbleGen has announced a company-wide initiative to implement good manufacturing processes (GMP) for its suite of DNA microarrays.
The implementation of GMP will cover the full scope of processes from development through manufacturing, it will include all locations, and it is intended as a step toward a subsequent submission to the U.S. Food and Drug Administration for clearance or approval of select array products.
"We have committed our resources to achieving GMP and are continuing our discussions with the FDA to ensure compliance in our processes and products," says Dr. Frank Pitzer, CEO of Roche NimbleGen, adding that Roche is dedicated to providing the research, diagnostic and pharmaceutical markets with the highest quality products possible. "This will enable us to provide the research and diagnostic markets with the high quality genomic tools and products they require."
"As market needs change and progress, the value of the information provided from microarrays has become more interesting for markets outside of basic life science research," adds Dr. Andreas Görtz, vice president of marketing at Roche NimbleGen. "Cytogenetics is one of the first areas where there is interest to move beyond the current research studies, which will require an FDA cleared or approved product."
Roche is reportedly the world's largest biotech company with medicines in oncology, virology, inflammation, metabolism and central nervous system disorders and diseases. Roche also touts itself as "the world leader in in vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management."
Pitzer was named CEO of Roche NimbleGen about two weeks before this announcement, having been brought into that position in part for his extensive background and experience of more than eight years at Roche, which is seen as instrumental in guiding the company through its next stage of growth. Roche noted that "with his successful track record in several key management positions within Roche Diagnostics, he brings a wealth of organizational, commercial, and relevant operating experience in key areas impacting the genomics and life science industry today."
Pitzer most recently served as head of divisional quality and regulatory affairs, reporting directly to the CEO of Roche Diagnostics, and he was also an active member of the Diagnostics Executive Committee.
"We are extremely excited to announce Dr. Frank Pitzer as the CEO of Roche NimbleGen and look forward to expanding the company's position as a leading genomics solution provider," stated Manfred Baier, head of Roche Applied Science. "Frank's leadership skills and extensive experience in the life science industry make him the perfect fit to guide Roche NimbleGen through the next stages of growth. His valuable insight and outstanding management experience will further entrench the company as a leading manufacturer of microarray technologies."