Incorporating Gene Therapies into your Supply Chain


1st January, 1970

Incorporating Gene Therapies into your Supply Chain

When looking into treatment options for a number of diseases, gene therapy becomes a promising prospect. Gene therapy is an experimental technique that uses genes to treat or prevent disease as well as compensate for abnormal genes or to make a beneficial protein. This process could soon be used by doctors to treat a disorder by inserting a gene into a patient’s cells, as an alternative to using drugs or surgery. However, researchers must overcome many regulatory challenges before gene therapy will be a practical approach to treating diseases, and this article will be covering those regulations in preparation for the upcoming Clinical Trial Supply New England.

USA Regulations

In the United States, there are a number of guidelines responsible for gene therapy according to the Code of Federal Regulations (CFR).

  • The Office for Human Research Protections (OHRP) mandates that research involving human subjects undergo Institutional Review Boards (IRB), including evaluating research risk to subjects, protocols and informed consent documents.
  • The Department of Health and Human Services (DHHS) is responsible for funding clinical trials through their agency the National Institutes of Health (NIH). The NIH established the Recombinant DNA Advisory Committee (RAC) which is an open forum for issues raised by DNA technology. 
  • The U.S. Food and Drug Administration (FDA) ensure drugs, medical devices and biological products are safe and effective before they are used. Their centre the Biologics Evaluation and Research (CBER) regulates human gene therapies.

Recombinant DNA Advisory Committee (RAC)

The RAC are currently reviewing human gene transfer research on behalf of the NIH. Human gene transfer trials receiving NIH funding are registered with the Office of Biotechnology Activities (OBA). Clinical gene therapy protocols that raise important scientific, safety or ethical considerations are discussed by the RAC at one of its quarterly public meetings.

The U.S. Food and Drug Administration (FDA)

Manufacturers of gene therapy products must test their products to meet FDA requirements. They first must tell FDA of its intentions, test their product in a laboratory and then on research animals. Before studying in humans, they need special permission exemption from FDA before starting, known as the investigational new drug application (IND). This is where, the manufacturer will need to explain how they will conduct the study, the data supporting the study, how patients will be protecting and obtaining the IRB. The FDA will then decide if it’s approved or if further tests are required. 

There’s plenty more where that came from! The Clinical Trial Supply New England conference is returning for its 8th addition and there will be a session by GlobalData PharmSource editor in Chief Peter Shapiro on discovering how to incorporate gene therapies within your supply chain. For more information, please visit http://www.arena-international.com/ctsnewengland/ or alternatively email us at: events@arena-international.com

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