Names & notes: FDA grants Intracel study special protocol assessment

Thursday, July 27, 2006

Intracel, a Frederick biotechnology company developing patient-specific cancer immunotherapies, has been granted a special protocol assessment by the FDA for the execution of a Phase III clinical trial of OncoVAX, a tumor-specific whole cell immunotherapy designed to attack cancer cells in stage II colon carcinoma.

The assessment provides a mechanism for the FDA and sponsors to reach agreement on the design, size, execution and analysis of a clinical trial that is intended to form the primary basis for regulatory approval, according to Intracel information.

If successfully completed, the pivotal Phase III trial could form the basis of a biologics licensing application for OncoVAX in the United States. The study will be conducted in this country and Europe, where Intracel maintains a subsidiary in The Netherlands, with 560 patients enrolled over two years.

McDaniel certifiedin human resources

Melissa J. McDaniel of Frederick, director of human resources consulting with Tandem Partners, a human resources consulting company in Hunt Valley, recently earned certification as a professional in human resources from the Human Resource Certification Institute.

The institute is the credentialing body for human resource professionals and is affiliated with the Society for Human Resource Management.

McDaniel, who joined Tandem Partners in 2005, works with both for-profit and nonprofit organizations on workforce strategy, recruiting and retention, performance management and human resources compliance. She is a national member of the Society for Human Resource Management and its Frederick County chapter.

Loiederman Soltesz hires three for Frederick office

Loiederman Soltesz Associates Inc. of Rockville, a civil engineering firm specializing in land development, has added three employees to its Frederick office.

Joining the company are instrument operators Kristofer Anderton and Richard Phillips, and field survey coordinator David Mack.