FLH's Brian Malkin Speaks at Montgomery County Department of Economic Development Program: Innovative Strategies for New Product Development
On February 5, 2014, FLH Partner Brian J. Malkin will present a special breakfast program for early-phase biotechnology companies: "Innovative Strategies for New Product Development". The event will be held at the Montgomery County Department of Economic Development offices in the Shady Grove Innovation Center, 9700 Great Seneca Highway, Rockville, Maryland 20850 from 8-10 am.
The program will begin with networking and then launch into Mr. Malkin's presentation designed to help you take your innovative biomedical research to the commercial product stage. Mr. Malkin will share his insight from working with biotechnology companies and working as a Regulatory Counsel at FDA for over 9 years at FDA in the Office of the Commissioner and the Center for Drug Evaluation and Research, where he was worked on all types of FDA-regulated products.
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:
Director, Life Sciences Strategy
Montgomery County Department of Economic Development
111 Rockville Pike, Suite 800
Rockville, Maryland 20850