Article | August 8, 2023

How To Combat Several Major Regulatory Obstacles Facing Cell And Gene Therapy Manufacturers

Cell & Gene Therapy

Cell and gene therapies offer groundbreaking opportunities to treat previously intractable diseases. Rather than only managing symptoms, gene therapy addresses a disease’s root cause by modifying the expression of a patient's genes or by repairing or replacing abnormal genes. The common goal of cell and gene therapy researchers, clinicians, manufacturers, and regulators is translating these vital therapies into safe and effective options to improve patients’ lives. Proper oversight from regulatory authorities is critical to ensure that this is accomplished in a practical, ethical, and clinical evidence-based manner.

Due to their specialized nature, cell and gene therapies come with their own unique impediments to approval, including evolving regulatory expectations, rare study design considerations, and a lack of animal models. In terms of regulatory roadblocks, it isn’t possible to make general policy that can be applied across the spectrum of these therapeutics. Download the full article to learn more about why it is crucial for sponsors to leverage broad collaboration and engagement with both patients and regulatory agencies to increase the potential of cell and gene therapies and improve accessibility.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Pharmaceutical Online? Subscribe today.

Subscribe to Pharmaceutical Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Pharmaceutical Online