BPD’s 6^th Annual Cell and Gene Therapy (CGT) Symposium and Vendor Show will be held Friday, Apr. 25, from 8:00 a.m. to 5:00 p.m. at the Friday Conference Center in Chapel Hill, NC.

CGT companies and CDMO operations in North Carolina continue to locate new manufacturing sites here. Register to attend this affordable, full-day Cell and Gene Therapy event. Registration includes free parking adjacent to the Friday Center, free Wi-Fi, all-day beverages, snacks and lunch.

Learn about technical advances and challenges in this field from speakers, plus what suppliers and service providers can offer to support your CGT process and product development projects. Last year’s 2024 BPD CGT Symposium included 420 registered attendees, 20 Sponsors, and 24 Vendor tables.

Agenda

8:00 – 9:00 a.m. |  Attendee Check-In/Registration

9:00 – 9:05 a.m. |  Opening of Symposium and Welcome by Platinum Sponsor: Kymanox

9:05 – 10:20 a.m. |  Speaker Session I

9:05 – 9:10 a.m. |  Speaker Introductions

9:10 – 9:45 a.m. |  “FDA’s latest guidance: Everything You Always Wanted to Know About Cell and Gene Therapy Development, But Were Too Afraid to Ask” – Maria Oyaski, MS, MA, RAC (US, EU); Consulting Regulatory Scientist, Oyaski Regulatory Consulting

9:45 – 10:20 a.m. |  “Viral Vector Manufacturing: The Decision for Fed-batch vs. Continuous Biomanufacturing” – Jeff Odum, BS, MS, CPIP; SME, NC Biosource

10:20 – 11:00 a.m. |  Morning Break, Visit Sponsor and Vendor Tables, and enjoy Networking

11:00 – 12:15 a.m. |  Speaker Session II

11:00 – 11:05 a.m. |  Speaker Introductions

11:05 – 11:40 a.m. |  “How to Measure Potency: Strategies, Challenges, and Real-World Solutions for Cell & Gene Therapies” – Joseph Newcome, MS; Senior Director, Analytical Method Development, WuXi Advanced Therapies

11:40 – 12:15 p.m. |  “Shaping the Future of Cell and Gene Therapy with AI and Machine Learning” – Robin Newman, B.S. Chemical Engineering, EIT; Project Manager, Amgen

12:15 – 1:45 p.m. |  Lunch Break, Visit Sponsor and Vendor Tables, and enjoy Networking

1:45 – 3:05 p.m. |  Speaker Session III

1:45 – 1:55 p.m. |  Announcements and Speaker introductions

1:55 – 2:30 p.m. |  “Cell Therapy Manufacturing Ramp-Up Case Study” – Stephen Lane; Industrial Analyst II: Modeling & Simulation and George Todorov, Senior Process Specialist, GST; IPS – Integrated Project Services

2:30 – 3:05 p.m. |  “Novel Analytical Technologies for Cell and Gene Therapy” – Scott R. Burger, MD; Principal Consultant, Advanced Cell & Gene Therapy

3:05 – 3:45 p.m. |  Afternoon Break, Visit Sponsor and Vendor Tables, and enjoy Networking

3:45 – 5:00 p.m. |  Speaker Session IV

3:45 – 3:50 p.m. |  Speaker Introductions

3:50 – 4:25 p.m. |  “Differential Replication and Rescue of scAAV vs. ssAAV Vectors and Impact on Residual Plasmid DNA Impurities” – Chunping Qiao, PhD; Associate Director, Novartis

4:25 – 5:00 p.m. |  “Automating PAT models for Continuous Process Verification” – Bruce Greenwald; DeltaV Business Development Director, Emerson

5:00 – 5:05 p.m. |  Thank you to Organizers, Sponsors, Vendors, and Attendees

(Exit by 5:30 p.m.)