We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Drug Products » Cell & Gene Therapy Strategies for Successful BLA Submissions - Webinar Recording/ Transcript

Other Options

USB Audio Recording/Transcript - March 28, 2019

$287.00

USB Audio Recording/Transcript - March 28, 2019

$258.00

USB Audio Recording/Transcript - March 28, 2019

$244.00

USB Audio Recording/Transcript - March 28, 2019

$230.00

USB Audio Recording/Transcript - March 28, 2019

$215.00

Cell & Gene Therapy Strategies for Successful BLA Submissions - Webinar Recording/ Transcript

$287.00
Drug Products

Product Details

Cell & Gene Therapy Strategies for Successful BLA Submissions: Best Practices for Phase I to FDA Approval

“The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications. Based on this activity, we anticipate that the number of product approvals for cell and gene therapies will grow in the coming years, reflecting significant scientific advancement and the clinical promise of these new innovations.”

— Scott Gottlieb, FDA Commissioner, January 15, 2019 announcement

Gottlieb goes on to say that he predicts the FDA “will be approving 10-20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rates of these products.”

Sponsors need to prepare. The FDA is already getting ready by staffing up the review group for cell and gene therapy products and planning new guidance documents and policies to help sponsors.

Scott R. Burger, MD — Principal, Advanced Cell and Gene Therapy — discusses the FDA’s requirements for successful BLAs and how to comply and make you aware of the common mistakes and how to avoid them. He’ll help you understand:

  • What the FDA requires for a successful cell therapy or gene therapy BLA
  • What reviewers in the Office of Tissues and Advanced Therapies expect to see
  • How a cell or gene therapy BLA fits into the framework of the CTD
  • How the earlier stages in development affect the content of the BLA
  • What the January 2019 announcement by FDA Commissioner Gottlieb about the surge of cell and gene therapy products entering early development means for you

It’s time to get prepared for the unique challenges of BLAs for cell and gene therapy products.

  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing