Michigan Firm Wins Another NIH Contract To Assist With Cancer Research Development

October 15, 2010

The National Cancer Institute has awarded a second contract to Regulatory Affairs Associates of Farmington Hills to undertake a one-year program, with two optional continuation years.

This contract provides regulatory consulting for up to 100 NCI medical device development programs. “The NCI award is recognition of the outstanding resources we have here,” Oakland County Executive L. Brooks Patterson said. “One of the goals of Oakland County’s Medical Main Street is to help companies commercialize their products and procedures and get them to the patients more quickly. Regulatory Affairs Associates is helping streamline the delivery of these advanced technologies for the benefit of the companies and the patients.”

RAA was selected for its many years of experience, dedicated staff, and innovative approach to medical device development. RAA has worked with many cancer medical devices and diagnostic tests. Just this week, RAA helped a new surgical device company succeed with their first FDA site inspection.

Every medical device researched and developed through National Cancer Institute’s program funding must be approved by FDA in order to become a treatment option for physicians and patients. The expert FDA regulatory advisors at RAA know the testing and data presentations that FDA requires. Now they will be available to programs that have NCI research funding. This reduces the time and money needed for testing by creating collaborations between FDA and the NCI researchers. It is expected to bring more cancer test procedures and medical apparatus to patients sooner.

RAA will direct NCI grant and contract recipients navigate the complicated regulatory path to FDA approval and commercial acceptance. It is one of the NIH’s translational medicine implementation practices; to move break-through research from design to controlled engineering and clinical tests, to medical practice for cancer patients. Cancer researchers will begin receiving this assistance very quickly.

The NCI medical device and diagnostic test programs will follow a very simple application process to take advantage of this opportunity. The projects will be reviewed and regulatory experts assigned to create a regulatory process tailored to each project. Progress will be tracked and improved upon as the projects proceed through their rigorous scientific and medical testing process.  The process will be benchmarked to ensure ‘best practices’ results; offers researchers increased opportunities to engage with knowledgeable and innovative drug developers.

To find out more about this program, contact Stephen Goldner at sgoldner@regaffairs.net or www.regaffairs.net.

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