Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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WEBINAR - UW ITHS/GCTL: Your local Gene&Cell Therapy Lab providing clinical trial support
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Location
Webinar - Link will be emailed to attendees on the day of the event. USA
Registration Info
Registration is required before Friday, October 31, 2025 at 11:30 AM
Payment In Full In Advance Only
Registration closes 30 minutes before meeting start time.
Meetings and webinars are scheduled on Pacific Standard Time or Pacific Daylight Time, whichever applies.
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You will receive an email confirmation of your completed registration followed immediately by a separate email with the subject "Event Videoconference Notification." The Zoom link, Meeting ID, and Passcode for this webinar meeting will be in the second email on the event date. If you don't receive the instructions within this time frame, please contact us at info@orcanw.org as soon as possible.
PAID FEES ARE NON REFUNDABLE.
For webinar events, payment is REQUIRED at the time of registration.
About this event
TOPIC: Service and support provided by UW ITHS and GCTL for the Biotech and Pharmaceutical communities
TOPIC DESCRIPTION: ITHS: The Institute of Translational Health Sciences is dedicated to speeding science to clinic practice for the benefit of patients and communities throughout Washington, Wyoming, Alaska, Montana, Idaho, (WWAMI) and beyond. ITHS promotes this translation of scientific discovery to practice by fostering innovative research, cultivating multi-disciplinary research partnerships, and ensuring a pipeline of next generation researchers through robust educational and career development programs. More than 6,500 researchers from over 220 different organizations across the five-state WWAMI region have collaborated with us to attract grant funding, build their research teams, develop research tools, move research projects forward, and engage with patients and the community. GCTL: In operation since 2000 and located in the University of Washington Medical Center, we provide comprehensive bench-to-bedside cGMP services for investigator and industry-sponsored studies. Our 2200 sq.ft. clean room facility has four ISO 7 suites to develop and manufacture gene modified or ex-vivo manipulated cells for novel gene and cell therapy products. Our services include but are not limited to: Modern cGMP Manufacturing Facility for the production of therapeutic cell products for human trials (Pre-clinical, Phase I/II) Collaboration to develop and transfer manufacturing processes Quality Assurance oversight and release of products Qualified and trained staff for production operations Aseptic manufacturing suites with either positive or negative air flows allow for different types of projects including cell isolation and purification, cell banking, product shipping and storage, formulation etc. al.
SPEAKERS: Tong Sun, Kelly Young, Clare Shen
SPEAKER BIOGRAPHIES: Tong Sun is the Executive Director of the ITHS and Assistant Dean for Translational Health Sciences at the University of Washington. He brings a diverse background in microbiology, gene therapy, and business, holding degrees from Wuhan University, MD Anderson Cancer Center, and the McCombs School of Business at UT Austin. Prior to UW, Dr. Sun was Vice President at Houston Methodist Research Institute, where he led major translational research initiatives and established key infrastructure to support innovation in medical product development.
Kelly Young is the QA Manager for GCTL. Kelly has over 30 years of experience in various Quality roles working for companies including Genzyme, GE Healthcare, Dendreon and Watson Pharmaceuticals.
Clare Shen is the manufacturing supervisor at GCTL. With a Ph. D in Pharmacology and over a decade of experience in the clinical production field, she has a strong foundation in basic research that enhances her understanding of complex protocols in translational and clinical research.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied towards re-certification/ continuing education from the following organizations:
1.5 pts |
RAC recertification from RAPS |
1.5 CEUs |
CCRP recertification from SOCRA |
1.5 CEUs |
CIP recertification from PRIM&R |
All attendees must be registered. Access to education content is a benefit of membership or guest attendance. The link to the webinar is intended for the registered person ONLY and any access/distribution of materials beyond the individual registrant is strictly prohibited. Viewing rights are not transferable and cannot be combined by multiple parties without express permission. Thank you for your understanding.
This webinar will be recorded.
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