After a rained-out first attempt to host the “Orphan Drug Boot Camp” event in July, the event successfully took place on August 15, 2018 in Silver Spring, MD. The event started out with refreshments and networking, fostering vibrant conversations between both returning and new WIB members.
Networking was followed by introductions from WIB-Capital Region leadership and talks from the panelists Katherine (Katie) Laessig, a Vice President of Therapeutic Strategy in Strategic Drug Development group at IQVIA, and Malia Segar, an Associate Director, Regulatory Affairs at IQVIA Orphan Drug Unit. The topics covered included definitions of rare diseases and Orphan Drugs for pediatric and adult applications, the regulatory processes for Orphan Drugs and differences between the regulatory processes for Orphan Drugs versus regular drugs, common misconceptions about Orphan Drug regulation, examples of breakthrough Orphan Drugs, and changes in the processes for Orphan Drug development. The presentations facilitated vibrant discussions and thought provoking questions from the audience. At the end, many attendees and the speakers stayed for some last refreshments and discussion of the session.
Overall, all the attendees were able to get a deeper understanding of the Orphan Drug development process and those who came with no prior knowledge left having learned something new. We would like to thank IQVIA for sponsoring this great event and the speakers for taking time to come and speak to WIB-Capital Region.
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