Day 1 :
Bristol-Myers Squibb Company, Princeton, USA
Keynote: Grace under fire: Strategies for establishing and maintaining top quality under aggressive time-lines
Time : 10:00-10:40
Quality seems a simple concept, yet, it often becomes one of many priorities, and difficult to uphold. In this presentation, practical examples are used to illustrate successful strategies for maintaining high quality under real live pressures. Key concepts encircle the entire operation from personal appreciation to lab design and external collaboration management, and include important mechanisms for constant reality adjustments like fit-for-purpose and ongoing innovation.
Anka G Ehrhardt is Biophysicist and holds a Doctorate in Physiology. She is currently working in the United States for Bristol-Myers Squibb. In her current position at BMS, she directs the fast growing clinical cytometry operation, covering a large portfolio of immuno-oncology and other disease area clinical studies. Her work focuses on biomarkers to drive the development of urgently needed new medicines. In this fast-paced environment, she drives targeted innovation to achieve sustained speed and quality. She is currently on the board of different industry organizations, fostering innovation and collaboration between industry, academia and government organizations.
Hyman Phelps and McNamara P C, USA
Time : 11:00-11:40
The biosimilars industry in the United States is still a nascent one, but hopefully not for long. In 2015, FDA approved the first biosimilars biological product, and several applications for other biosimilar biological products are pending at the agency. Although FDA and industry are tackling the scientific and data requirements for FDA to approve a so-called “Section 351(k) application” for a biosimilar biological product, legal issues abound. Whether it is the requirements or the contours of the “Patent Dance” for resolving patent disputes between biosimilars applicants and reference product sponsors, the availability and the scope of 12-year reference product exclusivity, or the appropriate naming convention for biological products, each issue is critical to the success of biosimilars in the United States and to the future of the industry. And with fast-paced litigation, the landscape for biosimilars seems to change on a monthly or weekly basis. This session will explore the ins and outs of current disputes involving the metes and bounds of the patent dance, non-patent exclusivity, naming and more, and explain what each dispute might mean for the future world of United States Biosimilars.