Requirements and Benefits of 21 CFR Part 11 Compliance

For Indian laboratories, the decision to implement  informatics applications that support compliance with 21 CFR Part 11 delivers multiple benefits. They are protecting their access to regulated markets in the US and other countries while implementing electronic processes and procedures that can reduce costs while enhancing their ability to deliver world class results.

PerkinElmer Completes $600M Caliper Acquisition

PerkinElmer is pleased to announce that today it completed the acquisition of Caliper Life Sciences, an exciting milestone in PerkinElmer’s evolution. The purchase, announced in September.

Bringing Caliper into PerkinElmer will significantly strengthen leadership position in the growing area of personalized medicine, providing pharmaceutical companies and clinicians with the tools and knowledge they need to enable individualized diagnoses and treatments. PKI's work moving ahead in this emerging field will be made possible by an outstanding team of people from Caliper and PerkinElmer collaborating together to leverage the combined power of their knowledge and expertise to deliver insight-driven innovations.

Bio-discovery and Caliper will combine to form PerkinElmer’s new Life Sciences & Technology (LST) Strategic Business Element (SBE). In a statement today, Robert Friel, chairman and CEO of PerkinElmer, said that he is confident that joining together these two organizations will create powerful momentum and inspire new ways to develop targeted solutions to meet customer needs across the in vitro to in vivo value chain, from disease research to drug discovery to clinical applications. It will also enable PKI to expand its offerings across our biomedical, diagnostics, environmental and food safety end markets.

Kevin Hrusovsky, who had been Caliper's CEO, will now take on the role of president of life sciences and technology for PerkinElmer, where he will head a newly combined $500 million business, "which integrates the former Caliper organization with PerkinElmer's existing research business," Friel said.

PerkinElmer Announces Financial Results for the Third Quarter of 2011

PerkinElmer reported after the close of the market on Thursday that revenues in the third quarter rose 8 percent year over year, but it missed analyst estimates on the top line.

Total revenues in the quarter ended Oct. 2 rose to $453.7 million, compared to $419.1 million a year ago but fell short of Wall Street estimates of $469.6 million. On an organic basis, revenues were up 4 percent year over year.

The firm has made a number of purchases throughout 2011 and in the quarter those acquisitions contributed more than $20 million to the top line, CFO Frank Wilson said on a conference call after the release of the company's earnings results.

The Human Health segment grew revenues to $207.4 million, up 7 percent from $194.5 million a year ago, while Environmental Health climbed to $246.3 million, a 10 percent increase from $224.6 million a year ago.

On the conference call, Chairman and CEO Robert Friel said that during the quarter, growth was seen across all major geographies and most end markets.

The Waltham, Mass.-based company grew sales in Europe in the low-single digits. While 30 percent of the company's business is tied to Europe, Friel said that much of that is in end markets that will not be significantly impacted by the challenging macroeconomic environment there. Only about 5 percent of total revenues is tied directly to government spending that could be exposed to austerity measures in Europe, he said.

The US grew in the mid-single digits, and while macro conditions will be challenging, he said that the company is seeing improving birth rates, which could benefit its newborn screening business, and continued demand for environmental and safety products.

The US academic/government end market represents about 10 percent of revenues, with a large portion of PerkinElmer's exposure in that market in the newborn screening space, which is primarily state funded. Friel said that as long as he's been with the company, he has never seen a decline in funding for newborn screening from states, and in the third quarter, PerkinElmer's newborn screening business grew.

In developing geographies, business rose in the double-digits, and PerkinElmer expects that to continue, Friel said

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JGI's Community Sequencing Program - Plans for 2012

The Department of Energy's Joint Genome Institute has chosen 41 research projects out of 152 applicants to use its sequencing services under its 2012 Community Sequencing Program, JGI said Thursday.

Researchers for this year's CSP program, which provides the scientific community with access to JGI's high-throughput sequencing technologies, proposed projects to study plant-microbe interactions, how microbes are involved in carbon capture and greenhouse gas emission, and metagenomics.

“These selections truly take advantage of the DOE JGI’s massive-scale sequencing and data analysis capabilities,” DOE JGI Director Eddy Rubin said in a statement.  “The projects span the globe and the unexplored branches of the tree of life, and promise to yield a better understanding of the interplay between climate, ecosystem, and organism.  Still other projects are targeting improvements in biofuel feedstock production, focusing on the potential of microorganisms to improve feedstock growth and prevent devastating diseases that hinder yields.”

The winning projects involve a wide range of microbial sequence-based research efforts focused on DOE JGI's core mission areas.

University of North Carolina at Chapel Hill Principal Investigator Jeff Dangl and his team plan to study the rhizosphere, the region where microbes in the soil colonize and interact with plant roots, and how it is involved in plant growth and productivity. Dangl's lab will focus on the microbiomes of maize, Arabadopsis, and a mustard relative, among others.

Another project, headed by Professor Jill Banfield at the University of California, Berkeley, plans to study genomes from microbial communities located at a DOE bioremediation research site in Colorado. The team seeks to identify novel rare microbes that might be useful for environmental cleanup of metals and radionuclides.

A group led by University of Vienna Investigator Michael Pester will study the greenhouse gas emissions of microbial communities that reside in peatlands, which are known carbon sinks that contain methane-producing microorganisms.

Another project, proposed by US Department of Agriculture Research Molecular Biologist Jo Anne Crouch, will study species of a grass-infecting fungus in order to find ways to protect potential bioenergy feedstocks from diseases caused by fungal pathogens.

A complete list of the 41 CSP 2012 sequencing projects is available on JGI's website.

Toronto Genomics Center Lands $5M from Genome Canada

The Centre for Applied Genomics (TCAG) at the Hospital for Sick Children in Toronto has reeled in C$5.1 million (US$5 million) from the Ontario Genomics Institute to support its operations, OGI said today.

TCAG provides a range of core services including gene and genome sequencing; microarrays and genotyping; cytogenomics and biobanking; and statistical and informational services.

The two years of funding was awarded under the Genome Canada Science and Technology Innovation Centre Competition.

TCAG was founded in 1998 and it provides research support to labs involved in a wide array of genomic disciplines including human health, agriculture, and plant and animal studies.