I recently attended the Biocom Drug/Device Summit in La Jolla, California. This summit brought together several players concentrating on developing next generation medical products and key investors interested in funding their growth and development.

Participating companies were small, start-up companies and larger, more established companies. Plenary sessions focused on defining the drug/device opportunity, combination products, key players and issues at the intersection of nanotech, microelectronics and regenerative medicine and how the FDA is addressing the new regulatory issues for in vitro diagnostics and combination products.

Over the next week or so, I will be posting the highlights of the plenary sessions I attended while at the summit.

“Combination Products: What’s The Big Deal?”

• Companies developing drugs are licensing the drugs for their reimbursement potential.
• Drug companies are actively developing drugs targeted for combination products as well as actively pursuing new applications of existing drugs. Working with large molecule proteins.
• Device companies are forming partnerships with pharmaceutical companies to develop next generation combination products.
• The FDA is very aware of the regulatory and compliance challenges of combination products.
• Pre-filled syringes, focusing on needle-less injection are regulated as drug products, NOT devices.

Created on Tuesday, January 30th, 2007 at 3:16 pm. | Fled under DDL West, Industry Insights. | Comment Feed