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Overview of Drug/Biologic Pre-Market Submissions
Program Speaker:
Ashley Driscoll-Kani
Associate Director, Global Regulatory Affairs,
Intercept Pharmaceuticals
Event Agenda:
DATE: Wednesday 04 June 2025
TIME:
12:00 PM – 12:05 PM Welcome and Announcements
12:05 PM – 12:10 PM Introductions of Speaker
12:10 PM – 12:50 PM Program Presentation
12:50 PM – 01:20 PM Q and A
01:20 PM – 01:30 PM Closing Remarks and End of Session
LOCATION: This event is being offered only virtually. The zoom link will be shared with you via email 1-2 days before the event.
Registration Information:
- Register for the event here
Program Topic:
Join the June SDRAN meeting to hear about the planning and preparation associated with US commercial applications for drugs and biologics. Ashley Driscoll-Kani will be presenting on how Regulatory Strategy can lead teams through these massive submissions and plan for success with the FDA. She will be reviewing basics of the dossier build for both small and large molecules to introduce newer Regulatory Professionals and refresh those with more experience. Additionally she will be discussion the timeline to submission, authoring/review coordination with the cross-functional development team, dossier review best practices, and requests for information triage.
Speaker Biography:
Ashley Driscoll-Kani
Associate Director, Global Regulatory Affairs, Intercept Pharmaceuticals
Currently Ashley is working as an Associate Director in the Global Regulatory Affairs Strategy group at Intercept Pharmaceuticals in San Diego, CA. Intercept Pharmaceuticals is biopharmaceutical company focusing on treatments for patients with non-viral liver diseases. In this role she has focused on regulatory strategies for early and late-stage investigational small molecule products.
Ashley supported applications for clinical and commercial stage products for small molecules, biologics, and cellular/gene therapies. She has assisted and supported preparations for meetings with Health Authorities, and various life cycle management steps in the post-market space. At Halozyme Therapeutics, she worked with large many pharmaceutical business partners on immunotherapy and oncology biologics with clinical and commercial applications all over the world. In 2020, she worked at Fate Therapeutics on cellular and gene therapy early-stage clinical products for various oncology indications. This role required me to diversify my RA skill set mainly through regulatory intelligence work as it is a quickly developing area for both companies and regulators.
In May 2020, she completed SDSU’s Master of Science in Regulatory Affairs program (capstone topic: “Regulatory Considerations for Biosimilars”). She has been a member of Drug Innovators’ Association (DIA) and is currently a member of the Regulatory Affairs Professional Society (RAPS).
Contact
Pricing – Online – Registration (ends Tuesday, June 03, 2025)
| Registrant Type | Event Price | |
| Member | $10.00 | |
| Lifetime | $10.00 | |
| Non-Member |
$20.00
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Cancellation Policy
There will be no refunds for cancellations.
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