Jumpstart Bio: Key Considerations and Strategies for Biologics Patent and Regulatory Exclusivities

In this new "normal" we've taken our Jumpstart Bio series to the web! Our Jumpstart Bio webinar series equips drug development and commercialization professionals to anticipate, prepare for, and respond to issues on the horizon for the industry.

During the next session in our Jumpstart Bio Webinar Series, we will provide an in-depth background on biologics patent and regulatory strategies for early stage companies.

Please join Goodwin’s senior patent prosecution partner Theresa Kavanaugh as she provides an overview of the regulatory exclusivity framework for the approval of biologics and biosimilars, and key patent strategy considerations to maximize exclusivity of a biologics candidate in early clinical trials with an eye toward protecting against both other branded and biosimilar molecules. The discussion will cover many aspects of the approval process including the regulatory framework for approval of biosimilars, a discussion on biosimilar/generic litigation challenges and the value for later-stage IP protection.

This webinar has 1.5 hours NY and CA CLE credit available.