Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
Current/Future Events - Event View
This is the "Event Detail" view, showing all available information for this event.
If the event has passed, click the "Event Report" button to read a report and view photos that were uploaded.
Webinar - Challenges of Outsourcing Gene Therapy Projects
Wednesday, March 6, 2019, 8:15 AM until 10:00 AM
Registration is required before Tuesday, March 5, 2019
Meetings and webinars are scheduled on Pacific Standard Time or Pacific Daylight Time, whichever applies.
Please make sure that the following email address is in your safe sender list: firstname.lastname@example.org. System messages like meeting announcements, registration confirmations, webinar login instructions as well as certificates of attendance are sent directly from this ClubExpress email address.
You will receive an email 2 days prior to the meeting date with the webinar login instructions. If you don't receive the instructions within this time frame, please contact us at email@example.com as soon as possible.
PAID FEES ARE NON REFUNDABLE.
For webinar events, payment is REQUIRED at the time of registration.
The link to the webinar is intended for the registered person ONLY and should not be shared.
All attendees MUST be registered.
TOPIC: Challenges of Outsourcing Gene Therapy Projects
TOPIC DESCRIPTION: The field of gene therapy is currently in a transition period. The first few therapeutic successes and approved products have led to much excitement and investment, but with associated growing pains. Venture startups expect to be able to outsource similarly to Mab projects, but outsourcing options for gene therapy are not nearly as well developed and are often over capacity. At the same time, the impact of breakthrough therapy designation may be increasing regulatory expectations, which challenges assumptions used for development plans.
SPEAKER: Barbara Thorne
SPEAKER BIOGRAPHY: Barbara Thorne has over 25 years of experience in process development of recombinant proteins, viral vectors, and vaccines, and has worked in small biotech, large pharma, and contract manufacturing organizations (CMO), and is currently an independent consultant (Thorne Bio-Consulting LLC). Previously, she was Executive Director of Product Development at Celladon Corporation, a late-stage clinical biotechnology company developing MYDICAR (AAV1/SERCA2a) to treat heart failure, and director of Process Development at Targeted Genetics Corporation (TGC), Seattle WA where she was responsible for developing manufacturing processes for AAV and adenoviral vectors. She has also held various scientific and process development roles at Bristol Myers Squibb, and consulted for biotechnology and contract manufacturing organizations. She received her PhD in molecular biology from the University of Oregon.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification