Fran Zipp, President and CEO of LCS, Presents at FDLI Annual Conference

On May 3, 2018 at the Food Drug and Law Institute’s Annual Conference, LCS’ President and CEO Fran Zipp participated in a panel with CDER Director Janet Woodcock. Other panelists included Margaret Anderson (Deloitte), Daniel Kracov (Arnold & Porter LLP), and Peter Pitts (Center for Medicine in the Public Interest), moderated by Carla Cartwright (JnJ).  After an introductory and informative presentation on current CDER priorities and initiatives by Dr. Woodcock, the panelists covered topics as far ranging as Right to Try, Patient Focused Drug Development, Real World Evidence and the timing and issuance of guidances by FDA. As the only representative with direct industry experience involved in manufacturing and quality, Ms. Zipp’s well-received remarks focused on the need for succinct guidances from FDA, how such are welcomed by industry, how these inform practices within industry. Of particular emphasis was the need for harmonization and consistency in key areas, such as Data Integrity, inspection and filing expectations. She noted that lack of harmonization often leads to confusion which can result in unnecessary disruption and distribution of product, up to and including key shortage products.  She re-emphasized Commissioner Gottlieb’s earlier remarks during the Keynote regarding FDA’s mission as a public health agency, and how industry should be focusing on bringing to fruition FDA’s mission to provide safe, effective drugs (both innovators and generics) to market, including advanced manufacturing technologies such as Continuous Manufacturing. Her remarks clearly resonated with the audience, as she received resounding applause from an audience filled with representatives from FDA and from Food and Drug law firms.