BPD Cell and Gene Therapy Symposium & Vendor Show
Date and Time
Thursday Apr 11, 2019
9:15 AM - 4:00 PM EDT
April 11
9:15 a.m. - 4:00 p.m.
Location
NC Biotechnology Center
15 T.W. Alexander Drive
Research Triangle Park, NC 27709
Fees/Admission
Industry/Faculty - $25
Students - $5
Unemployed Job Seekers - Free
(Job Seekers use code BPDFREE)
Website
Contact Information
Hannah Cole
Send Email
Description
Cell and gene therapies at dozens of companies in the U.S. are being developed at an impressive rate. The combined cell (CAR -T, mesenchymal stem cells, etc.) and gene therapy (viral [AAV, Lenti] and non-viral) sectors are expected to generate an additional 200 IND submissions (with 800 current) as early as 2020, according to a FDA estimate. However, these companies face ongoing challenges including adequate product characterization, new safety risks, and the pivotal need for reliable, plus cost-effective manufacturing solutions. Currently far less standardized equipment and methods or integrated automation is in use for cell and gene therapy product manufacturing, as compared with large molecule, biopharmaceuticals. Six cell and gene therapy speakers, most from the Research Triangle Park, will present bioprocess development, manufacturing, and regulatory updates while also describing the potential to deliver unique, cell and gene therapies to oncologic, genetic, and rare disease patients in need.
Agenda
9:15-9:45 am Registration and Exhibits Open9:45-10:00 am Welcome, Morning speaker introductions
Cell Therapy (10:00-11:45 am)
10:00-10:35 am “Manufacturing Solutions Driving Rapid Clinical Translation of hMSCs and hMSC-Based Therapeutics”
Priya Baraniak, Ph.D., Senior Director, Business Development ROOSTER BIO
10:35-11:10 am “Steps to Reduce Bioburden from Human Livers during Manufacturing of Hepatocytes”
Jeremy Smith, B.S., Head of Quality Control, PROMETHERA
11:10- 11:45 am “Off the Shelf Chimeric Antigen Receptor (CAR) T Cell Therapy for the Treatment of Cancer”
Mark Johnson, Ph.D., Team Leader, Cell Therapy Discovery, PRECISION BIOSCIENCES
11:45 1:15 pm Lunch and Exhibits
1:15-1:25 Afternoon speaker introductions
Gene Therapy (1:25-3:20 pm)
1:25-2:10 pm “Regulatory Obstacles for Starting Cell and Gene Therapy Trials”
Stephanie Pierce, Ph.D., RAC, Regulatory Affairs Scientist, OFFICE OF REGULATORY AFFAIRS AND QUALITY, DUKE UNIVERSITY SCHOOL OF MEDICINE
2:10-2:45 pm “Adeno-Associated Virus Biology and Bioprocessing”
William (Billy) Kish, Ph.D., Senior Scientist, Gene Therapy Process Development, PFIZER (BAMBOO)
2:45-3:20 pm “Innovation in AAV Manufacturing - Vertical Integration and Continuous Improvement”
Jacob Smith, B.S., Director of Process Development, ASKBIO
4:00 pm Symposium and Exhibits close
