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Biomarker Development Tops Priorities for FDA's Critical Path Opportunities

The US Food and Drug Administration last week released a list of high-priority research projects for its Critical Path Initiative and highlighted biomarker development as one of the "most important areas for improving medical product development."

In particular, it empowered a newly formed Predictive Safety Testing Partnership to develop guidelines for biomarker use. The Partnership includes Bristol Myers Squibb, Johnson & Johnson, Merck, Novartis, and Pfizer and will be coordinated by the Critical Path Institute.

The Critical Path Opportunity Report is the first specific blueprint for the agency's Critical Path Initiative, an effort to streamline the drug-approval process by applying new strategies and technologies.

Among the 76 projects outlined, biomarker development and clinical trial reform were areas cited by researchers as most likely to improve the efficiency of product development.

In a statement announcing the priority list, the FDA said it would rely on "partnerships and consortia to accomplish a majority of the projects," as well as "a new, cooperative partnership among the primary ... divisions of HHS."

The agency said it would identify additional specific research projects for the initiative over the next few weeks.

Jim Greenwood, president and CEO of the Biotechnology Industry Organization, said the Report "cited substantial opportunities for better diagnoses, more efficient drug development, and safer and more effective therapies, such as the identification and qualification of new safety and efficacy biomarkers. These advances will play an essential role in helping industry, regulators and other stakeholders deliver on the promise of personalized medicine."


Pall's New Center of Excellence in Bangalore Will Have Proteomics Component

Pall has opened a Center of Excellence in Bangalore, India, that will include a process proteomics lab for chromatography and down-stream systems, Pall said this week.

The center will also offer clients validation services for FDA approval.

"The process proteomics facility is a service to our customers," said Holly Haughney, vice president of Pall BioPharmaceuticals Marketing Asia. "In addition, we will have a training facility because while there is a very well-educated technical force [in India], we've found that much of it is theoretical."

Haughney recently relocated to the Bangalore office, along with Vinay Joban, general manager of Pall Life Sciences India.

Pall's biopharm business in Asia grew by 14 percent over the last fiscal year, the company said in a statement.


Ciphergen's Chief Financial Officer Resigns

Ciphergen announced this week the resignation of Matthew Hogan as the company's senior vice president and chief financial officer.

Hogan will continue to provide consulting services to Ciphergen three days per week for up to six months following his resignation on March 22, Ciphergen said in an 8-K filing with the US Securities and Exchange Commission.

Daniel Caserza, Ciphergen's corporate controller since 1999, will serve as interim chief financial officer while the company seeks a permanent replacement for Hogan. Caserza was promoted in April 2005 to vice president of Ciphergen.

Prior to joining Ciphergen, Caserza served as corporate controller for various companies: Intellisys Group from March 1998 to April 1999; Swan Magnetics from June 1997 to March 1998; and Edify from June 1995 to June 1997. Caserza also previously worked in public accounting with Deloitte Haskins & Sells. He received a BS in mathematics from Santa Clara University and an MBA from Santa Clara University Graduate School of Business.


Proteopure Bags $100K from PLSG for Protein Isolation Technology

Pittsburgh Life Sciences Greenhouse said this week it has invested $100,000 in Proteopure, a spinout of Carnegie Mellon University.

Proteopure is developing 2DE preparation kits using spin columns to bind and isolate proteins. It is expected to be commercially available this year.

PLSG is a public/private partnership founded by the University of Pittsburgh, Carnegie Mellon, UPMC Health System, and the Commonwealth of Pennsylvania.


New Indiana Cardiology Institute to Use IU's Genomic, Proteomic Resources

A new public/private non-profit organization will use the genomic and proteomic research facilities at the Indiana University School of Medicine to conduct heart disease studies, BioCrossroads, which co-founded the entity with IU, said this week.

The organization, called the Fairbanks Institute, will coordinate a long-term health study integrating patient data to focus efforts on heart disease prevention and treatment. It will focus on other diseases as well, with the help of a $10 million start-up donation from the Fairbanks Foundation.

The institute will take advantage of Indiana University's genomic and proteomic divisions and of the Indiana Genomics Initiative, according to a statement.

It will also collaborate with the public-private collaboration BioCrossroads and with the Regenstrief Institute.


NIH Awards ISB $16.3M to Create New Systems Bio Center in Seattle

The Institute for Systems Biology has received a five-year, $16.3-million grant from the National Institutes of Health to fund the operation of a Center for Systems Biology in Seattle, ISB said last week.

The new center will be located at ISB's research and office building, and will "foster collaborative research among the diverse set of researchers at ISB," the ISB said in a statement.

The center will be the sixth of its kind in the US. Other systems biology centers have been established at Harvard University, Princeton University, University of Washington Friday Harbor Laboratories, Massachusetts Institute of Technology, and Case Western Reserve University.


Sigma-Aldrich to Provide Complementary Protocols From Cold Spring Harbor Laboratory Press

Sigma-Aldrich will provide complementary protocols from Cold Spring Harbor Laboratory Press, the company said this week.

The agreement will enable researchers to freely access a new set of protocols each month through the Featured Protocols section of BioSupplyNet.com, an online directory of laboratory supplies. "Given the diversity of research tools needed to explore genomic and proteomic applications, we recognize the need for easily accessed protocols," Diane Gaige, eMarketing manager at Sigma-Aldrich, said in a statement.

The company said it will "extend [the resource] further by creating an easy-to-use materials list for each protocol."

The Scan

CDC Calls Delta "Variant of Concern"

CNN reports the US Centers for Disease Control and Prevention now considers the Delta variant of SARS-CoV-2 to be a "variant of concern."

From FDA to Venture Capital

Former FDA Commissioner Stephen Hahn is taking a position at a venture capital firm, leading some ethicists to raise eyebrows, according to the Washington Post.

Consent Questions

Nature News writes that there are questions whether informed consent was obtained for some submissions to a database of Y-chromosome profiles.

Cell Studies on Multimodal Single-Cell Analysis, Coronaviruses in Bats, Urban Microbiomes

In Cell this week: approach to analyze multimodal single-cell genomic data, analysis of bat coronaviruses, and more.