FLH Partner Brian J. Malkin will present a special breakfast program for early-phase biotechnology companies: “Innovative Strategies for New Product Development” on February 5, 2014. The program will be held at the Montgomery County Department of Economic Development offices at 111 Rockville Pike, 8th Floor, Rockville, Maryland 20850 from 8-10 am.
Planned topics include:
- Drug Development Trends
- Special Regulatory Approval Strategies
- Opportunities for Extending the Market
- Protecting Your Investment
- Raising Capital to Finance Research and Commercial Products
- Other Regulatory Considerations.
Specific topics include special FDA regulatory approval strategies (e.g., priority review, fast track, breakthrough therapy, accelerated approvals, orphan drugs, and 505(b)(2) NDAs), drug repurposing, patent protection and exclusivities, labeling, and manufacturing considerations.
A light breakfast will be served along with refreshments. Following an initial networking session, Mr. Malkin will cover the above topics in an intimate setting where the audience can participate and ask questions and offer additional insight to one another in a dynamic and informal environment.
If you would like to attend, please RSVP by January 29, 2014 to:
Janis Pitts Director, Life Sciences Strategy Montgomery County Department of Economic Development 111 Rockville Pike, Suite 800 Rockville, Maryland 20850 240-777-2016 Janis.Pitts@MontgomeryCountymd.gov