AAIPharma appointed Scott Neilson to COO. He has held senior operations positions in clinical research and has a broad spectrum of functional experience including finance, regulatory affairs, human resources and business development. Neilson will be responsible for AAIPharma’s global drug development services operations and report to Ludo Reynders, CEO and president. “As a company, we have made significant progress across the major lines of business over the last three years,” said Reynders. “Scott’s appointment underscores our commitment to continuing this progress and our goal of a global leadership position in the markets we serve.”

ExecuPharm appointed Lauri Sirabella VP, clinical strategic business development at ExecuPharm. She will report to Maria Larson, CEO. Sirabella will focus on developing strategic opportunities to further expand ExecuPharm’s position as a leader in pharmaceutical and biotechnology staffing and outsourcing.

Advanced Clinical Research Institute (ACRI), a Phase I through Phase IV clinical research center, announced a strategic partnership with Clinesian, a global contract research organization (CRO). The partnership enables a seamless integration of study conduct with full CRO services, including project management, monitoring, quality assurance, data management, biostatistics and medical writing. Both companies are located in southern California. “By offering CRO services through one of our strategic partners, ACRI continues to provide the quality service and convenience our pharmaceutical customers have come to expect,” said Dennis Riff, medical director, ACRI. Here’s the release.

The industry filed 28 new molecular entities (NMEs) in 2007, up from 21 filed in 2006, according to Parexel International’s newly released “US Drug Approval Trends and Yearbook 2008/2009.” Said Mark Mathieu, director of publications at Parexel: “NME and NAS approvals are key measures of new drug productivity in the biopharmaceutical industry, and these measures tend to improve based on the volume of new drug submissions. The recent increase in the number of NME submissions is an encouraging sign.”

AmeriStart signed a sales, marketing and business development services contract with Factory CRO. AmeriStart will promote Factory CRO’s clinical research capabilities in the North American medical device market. AmeriStart CFO David Worrell noted, “Factory CRO has world-class capabilities in the key therapeutic areas of diabetes, wound healing, and orthopedics. Because Factory understands the regulatory environments across Europe, they are often able to start a clinical trial in as little as eight weeks.” Factory CRO is the latest addition to the AmeriStart portfolio of world-class CROs and other service providers to the life sciences industry. Here’s the release.

Alquest, a specialized CRO, recently helped client Biotest Medical Diagnostics earn BLA (biologics license application) approvals through the Office of Blood Research and Review in the Center for Biologics Evaluation and Research at the FDA. Alquest assisted the German manufacturer with project management and BLA submissions and supplements, and in developing chemistry manufacturing and controls (CMC) systems and procedures. Alquest also performed statistical analysis of the clinical data for the final clinical report. Finally, Alquest functioned as Biotest’s U.S. regulatory contact in supporting communications, interactions and responses with FDA. “We are pleased to be able to support the commercialization of Biotest’s exciting automated systems and Blood Grouping Reagents,” said Alquest president Ann Quinlan-Smith. “Our team worked diligently with Biotest staff over a period of two years to earn these approvals.” 

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