Personalized Medicine: Developing Drugs Tailored Specifically to Your Genetic Make Up with Dr. Alberto Gutierrez

The ‘Nifty Fifty (times 4)’, a program of Science Spark, presented by InfoComm International, are a group of 200 noted science and engineering professionals who will fan out across the Washington, D.C. area in the 2014-2015 school year to speak about their work and careers at various middle and high schools.

Meet Nifty Fifty Speaker Dr. Alberto Gutierrez

Alberto Gutierrez_2015 Nifty Fifty SpeakerWelcome to the age of Personalized Medicine -- an emerging era of medical science which involves the development of drugs and other treatments that are tailored specifically to an individual patient, or a group, with certain genetic characteristics.

"Medical science is now capable of creating treatments that are guided by the patient's unique genetic information," says Alberto Gutierrez, Director of the Federal Drug Administration's (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health.

In his post, Alberto is at the forefront on a national level of approving and regulating Personalized Medicine technology.

"These treatments can be specifically tailored to provide individuals with maximum health benefits while posing the minimum of risks," he says. "We're approaching an era when 'one size fits all' medications will no longer be the doctor's only option."

Advances in these and other cutting-edge areas of medicine stand to bring more innovative medical products to the market, especially in helping people with chronic and life-threatening diseases, Alberto and other experts predict.

For example, in August 2011, the FDA approved Vemurafenib for the treatment of metastatic melanoma patients with the BRAF V600E mutation. The drug was designed specifically to target the V600E mutant BRAF protein. The drug approval occurred concurrently with the FDA's approval of a novel genetic test (BRAF V600 Mutation test) which is real-time PCR-based in vitro diagnostic using DNA extracted from fogsnealin-fixed, paraffin-embedded human melanoma tissue.

And in 2013, the FDA gave the green light to four next-generation gene sequencing (NGS) devices for clinical use, enabling physicians to take a broader look at their patients' genetic makeup, which can help doctors in better diagnosing disease or identifying the cause of symptoms.

"Before NGS," Alberto explains, ¨sequencing genes associated with a particular disease was a long and costly process. Today, we have the capability to read and interpret large segments of DNA very quickly in a single test, and this information-rich technology is becoming more accessible for use by physicians in the care of their patients.¨

In addition, Francis S. Collins, MD, PhD, director of the National Institutes of Health (NIH), called the FDA's clearance of these high-throughput gene sequencing devices for clinical use a "landmark move that will help to realize the promise of personalized medicine."

Alberto joined the FDA in 1992 as researcher and reviewer in FDA's Center for Biologics Evaluation and Research working on vaccine adjuvants and method development for determination of purity and structure of vaccine components. In 2000, he joined the the FDA's Center for Devices and Radiological Health as a scientific reviewer, becoming a Team Leader for Toxicology in 2003, Director of the Division of Chemistry and Toxicology Devices in 2005 and Deputy Director of the Office of In Vitro Diagnostic Devices in 2007 and Director in 2009.

He earned his Bachelor's degree from Haverford College, and his Master's and Doctorate degrees in Chemistry from Princeton University. Alberto has over 10 years of experience in research in the area of structural organic and organometallic chemistry.

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