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Gene Therapy

Gene Therapy

Gene therapy is a technique where a gene is inserted into a person’s cells to prevent or treat a serious disease. The added gene may be a healthy version of the gene that is mutated in the patient, or it could be a different gene that inactivates or compensates for the patient’s disease-causing gene. For example, in patients with severe combined immunodeficiency (SCID) due to a mutation in the gene for the enzyme adenosine deaminase, a functioning version of the gene can be inserted. The...

Gene Therapy

Gene Therapy

Gene therapy is a technique where a gene is inserted into a person’s cells to prevent or treat a serious disease. The added gene may be a healthy version of the gene that is mutated in the patient, or it could be a different gene that inactivates or compensates for the patient’s disease-causing gene. For example, in patients with severe combined immunodeficiency (SCID) due to a mutation in the gene for the enzyme adenosine deaminase, a functioning version of the gene can be inserted. The...

Microorganisms in Medicine and Therapeutics

Microorganisms in Medicine and Therapeutics

Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.

What is Genetic Engineering?

What is Genetic Engineering?

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...

Drug Regulation

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

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Related Experiment Video

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Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

Published on: January 24, 2025

Gene therapy oversight: lessons for nanobiotechnology.

Susan M Wolf¹, Rishi Gupta, Peter Kohlhepp

¹Faculty Member in Center for Bioethics at University of Minnesota, USA.

The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics

|February 4, 2010

Summary

Human gene therapy oversight offers a model for nanobiology research. This dual system, involving institutional and federal review, provides lessons for regulating emerging technologies.

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Area of Science:

Biotechnology Law and Ethics
Human Subject Research Oversight
Nanomedicine Regulation

Background:

Gene therapy research oversight involves multiple layers: institutional review boards (IRBs), institutional biosafety committees (IBCs), the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) and its Recombinant DNA Advisory Committee (RAC), the Office for Human Research Protections (OHRP), and the Food and Drug Administration (FDA).
This complex structure aims to ensure the safety of human participants in novel biological research.
The Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) provides parallel oversight, including protocol approval and product regulation.

Observation:

The existing gene therapy oversight framework is already being adapted to address nanobiotechnology applications within gene transfer research.
Analysis of public opinion, scientific literature, and expert elicitation provides insights into the effectiveness and public perception of current oversight mechanisms.
The evolution of the dual oversight system highlights a responsive approach to scientific advancement.

Findings:

The current gene therapy oversight model integrates institutional, federal, and regulatory bodies to manage complex research.
Nanobiotechnology is being incorporated into gene transfer research, necessitating an adaptable oversight structure.
Evaluation suggests the gene therapy oversight system is addressing emerging technologies, though further refinement may be needed.

Implications:

Lessons learned from gene therapy oversight can inform the development of robust regulatory frameworks for nanobiotechnology research involving human participants.
Establishing clear guidelines for nanobiology research oversight is crucial for fostering innovation while safeguarding public safety.
The success of the gene therapy model suggests a multi-tiered approach is effective for overseeing novel biotechnologies.