Boston, Mass - FDA's ONDC director to keynote at CCT conference

01/01/2005

BOSTON, Mass.-Moheb Nasr, Ph.D., director of the Food and Drug Administration’s (FDA) Office of New Drug Chemistry, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, will deliver the keynote address on March 22 at the CleanRooms 2005 Contamination Control Technology (CCT) Conference & Exhibition at the World Trade Center here.

The event, which runs March 22-23, is sponsored by the CleanRooms Group of Pennwell, publishers of CleanRooms magazine.

The focus of this year’s conference is on the important role that the contamination control community plays in providing cross-industry fertilization of ideas, knowledge and experiences. The CCT conference program, designed for professionals in pharmaceutical/biopharmaceutical, healthcare, food, microelectronics, government regulations, research and university environments, will address the latest research and development efforts in contamination control, the meaning and impact of current and pending regulations, and new and emerging contamination control technologies.

Dr. Nasr joined the FDA in 1989 as a research chemist, and in 1998 became director of the Division of Pharmaceutical Analysis. In 2002, he served as acting director of the Office of Testing and Research. His research interests include pharmaceutical analysis, chromatography, spectroscopy, chemical kinetics, and reaction mechanisms.

As director of the Office of New Drug Chemistry, Dr. Nasr oversees responsibility for bringing the chemistry, manufacturing and controls (CMC) review process of new drugs together under one organization. The office seeks to “speak with one voice” for new drug chemists while they remain collocated with clinical review divisions-a relationship that the FDA says ensures the close collaboration with other members of the review team.

“In order to take advantage of a more flexible regulatory approach, [we] will have to share more critical drug development information,” says Dr. Nasr. He is urging a team approach in assessing manufacturing processes, with a new focus on integrating the review and inspection functions.

Dr. Nasr’s keynote address before the entire conference and exhibition audience will be at 11 a.m. on Tuesday, March 22. Throughout the two-day event, contamination-control professionals will be able to select topics from six focused tracks, ranging from advanced contamination control technology to basic training, standards, and practical information and tips that can be applied to the production process.

For registration information for the 2005 CCT Conference and Exhibition, contact Lisa Gowern (603-891-9267; [email protected]). For exhibitor information, contact Jeff Gallagher (603-891-9147; [email protected]).