Frank has been working on the development of guidelines for benefit to risk for more than 15 years and was a flagship member of the Benefit Risk Action Team (BRAT) which developed a set of guidelines that are used today by many and served as the basis for many institutions benefit to risk framework. In addition, for 3 years he was an advisor to the Center for Innovation in Regulatory Science (CIRS) on benefit-risk guidelines and helped develop their extension of BRAT, called UMBRA. Frank was instrumental in establishing a governance structure with GSK for benefit to risk evaluation and review resulting in a standard template for benefit to risk required for use from first time in man through the marketed lifecycle of a product. He has given over a dozen invited papers on this topic over the last 5 years and in particular been engaged in patient-level benefit to risk issues. He can help an institution implement a framework for benefit/risk or help describe and evaluate benefit/risk characteristics of an individual treatment.