The WIB Chicago Chapter kicked off Women’s History Month by honoring Debra Kurtz, of Kurtz Consulting Inc., whose work on a portable breast pump was a revolution for women in the workplace. Debra shared the inspiring story of how the Medela breast pump came to be and provided insight into her career in the medical device arena.
WIB-Chicago also established the “Volunteer of the Month” award, recognizing volunteers who have had a significant impact in making our chapter run smoothly. The first recipient of this award was Ana Mrejeru, our chapter’s Communications Co-Chair. Ana has done a wonderful job in her position, helping with WIB-Chicago’s social media sites and programming publications.
For the main event, we were delighted to reunite our expert panel from last year’s Biosimilars event to discuss new developments in the regulation and approval of biosimilars. The panel included regulatory expertise from Dr. Sharon Ayd and legal expertise from Kirsten Anderson, Kevin Nelson, and Emily Winfield.
The panelists discussed the recent Amgen v. Sandoz case, its implications in terms of how the statutory scheme will work, both in terms of the “patent dance” and the pre-marketing notice provision, in addition to the likely legal challenges that lie ahead. The panel also discussed risks associated with product development (and strategies to minimize that risk), in addition to the current state of regulatory guidance from the FDA.
Overall, the evening’s discussion made it clear that there are many changes ahead in this field. WIB’s Chicago chapter looks forward to a biosimilars 3.0 panel in 2017. Stay tuned!
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