Biotechnology gene therapy represents a promising field, marking the intersection between genetics, technology and medicine. Recently, we've witnessed a boom in gene therapy research as new techniques, such as recombinant DNA technology, emerge. Many researchers see biotech gene therapy as the key to curing various deadly diseases, such as Alzheimer’s, Parkinson's, diabetes, spinal muscular atrophy, muscular sclerosis and various forms of cancer.

If you're interested in becoming a gene therapy company, consider these major issues in gene therapy biotechnology:

1. The U.S. Food and Drug Administration (FDA) is the government body in charge of regulating gene therapy development.

2. The FDA's Center for Biologics Evaluation and Research (CBER) manages the approval process for new gene therapy products.

3. The National Institutes of Health evaluates the scientific processes involved in specific biotechnology gene therapy research.

4. The regulatory process for gene therapy in the field of biotechnology is complex, requiring specific expertise in the field of biotech regulatory affairs.

5. Biotechnology gene therapy research occurs at private companies and medical research centers, such as universities and the health institutes.

Action Steps
The best contacts and resources to help you get it done

Hire a company to conduct market research on biotechnology gene therapy products

Various companies offer gene therapy research services. They'll provide your company with detailed information about current trends in the gene therapy market.

I recommend: Contact MarketResearch.com, is a provider of global market research. This company offers the Alert-Me service, giving you regular customized reports for your area of interest. Global Information, another market research company, offers a wide array of market research, such as projections, trends and industry forecasts. Both companies also offer sales and marketing strategies.

Keep up with biotech gene therapy regulatory affairs

Before a gene therapy pharmaceutical company can market a product, the product must go through testing trials, which occur under the guise of the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER). Drugs undergoing development and testing in foreign countries are subject to local jurisdiction.

I recommend: The U.S. Food and Drug Administration maintains an area on their website detailing cellular and gene therapy. You'll also find information regarding the product approval process and gene therapy patient tracking. Check the European Medicines Agency for information about regulatory affairs in Europe.

Track the progress of human gene therapy clinical trials

At any given time, there are numerous gene therapy products in the clinical trial phase of research. During this phase, researchers test gene therapy products in humans to determine their efficacy. Various organizations and websites track the progress of clinical trials.

I recommend: Go to the U.S. National Institutes of Health for a list of gene therapy drugs currently in the clinical trial phase. Also, Gene Therapy Net, provides links to domestic and international gene therapy clinical trial databases.

Review bioethical issues pertaining to the development gene therapy in biotechnology

Ethicists debate various issues pertaining to gene therapy. One concern is the cost of gene therapy, which potentially limits its availability for lower income patients. Another concern surrounds the potential for gene therapy to move beyond treatment and into the field of designer genetics.

I recommend: Get a crash course in bioethics research at the Taylor and Francis Group sponsored bioethics website. Also, check out their blog, which is a good source for hot topics in bioethics. Subscribe to The Hastings Center mail list to receive regular updates on bioethics research.

Tips & Tactics

Helpful advice for making the most of this Guide

• •  Join professional organizations, such as American Society of Gene therapy, that support research and development in the genetic therapy biotech field.