The second annual GRx+Biosims conference brought together a range of experts and leaders around the most urgent issues facing our industry. A healthy contingent from the Food and Drug Administration (FDA) demonstrated a firm commitment on the part of regulators to communicate openly with the manufacturers of generic and biosimilar medicines. Uniformed members of the United States Public Health Service Commissioned Corps offered a constant reminder of the collective mission of all the attendees, speakers and presenters.
Breakout sessions allowed panelists to drill down on scientific and legal issues. For the first time an interactive expo was held, with more than two dozen presenters. Another GRx+Biosims first was the Complex Product Workshop, organized in partnership with FDA.
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The keynote addresses covered topics of concern to AAM member companies. Many speakers, including Alonza Cruse (Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, CDER, FDA) and Patrizia Cavazzoni, M.D. (Deputy Director for Operations, CDER, FDA), outlined robust quality controls for drugs manufactured domestically and overseas. Sarah Yim, M.D. (Acting Director for Therapeutic Biologics, Office of New Drugs, Therapeutic Biologics and Biosimilars Team, CDER, FDA), and Ronald Piervincenzi, PhD (Chief Executive Officer, United States Pharmacopeia Convention), offered illuminating historical perspectives, showing how far we’ve come since the early days of the pharmaceutical industry.
Former FDA Commissioner Scott Gottlieb, M.D., concluded his Day 3 remarks by noting,
“Generic medicines are safer than they’ve ever been.”
AAM CEO Chip Davis joined Dr. Gottlieb onstage along with Apotex CEO Jeff Watson and Sandoz CEO Carol Lynch for a wide-ranging discussion that covered biosimilar uptake and drug shortages, among other topics. He also announced that our annual Access! conference, traditionally held in the winter, will take place May 11-13, 2020, in Washington, D.C.
Social Media Highlights — #GRxBiosims
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GRx+Biosims 2019 Sponsors
We are grateful to platinum sponsor Mylan and all the sponsors that made GRx+Biosims 2019 a success.
By Erica Klinger, AAM Marketing Director