The process of negotiating a clinical study agreement between a bio/pharmaceutical company and an academic medical institution can be difficult, in part due to the sometimes divergent goals of the two parties. This audio conference presentation reviews the expectations of both the bio/pharmaceutical company and the academic medical institution when negotiating clinical study agreements. Our speaker addresses in depth the key issues of confidentiality, publication, intellectual property rights and indemnification. The presentation also includes discussion of appropriate language to enable the parties to fulfill their different objectives and legal obligations. Finally, our speaker shares tips and insight on ways to speed up the negotiating process.

This audio conference covers:

• The differing missions of bio/pharmaceutical companies and academic medical institutions that can make it challenging to negotiation clinical study agreements
• The importance of the key terms of confidentiality, publication, intellectual property rights and Indemnification
• Practical and reasonable language for such key terms which accommodates both parties' needs
• How to streamline the process of negotiating clinical study agreements

About the speaker:

Karen A. Mullin, JD, LLM worked as Senior Research Attorney at the Boston University School of Medicine from 1999 till 2011, with responsibility for negotiation of all research-related agreements with industry. She also counseled on matters involving regulatory compliance, conflicts of interest and intellectual property rights.

In August of 2011, she will start a new position as Chief General Counsel/Director of Corporate Relations at The Forsyth Institute, an independent medical research institution affiliated with Harvard University Medical School. Karen also provides legal consulting services through JD Professional Services, LLC.

Karen earned her J.D. degree from Georgetown University Law Center in 1987 and then practiced as a litigator specializing in the areas of medical and legal malpractice defense. In 1995, she completed her LL.M. degree in international business law at the University of London.

She is a member of the Massachusetts Bar, Pennsylvania Bar and District of Columbia Bar.

Who should attend?

• Legal Counsel
• Clinical Study Managers
• Clinical Research Associates