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Translational Medicine Turning Basic Research into Medicines and Treatments.

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Presentation on theme: "Translational Medicine Turning Basic Research into Medicines and Treatments."— Presentation transcript:

1 Translational Medicine Turning Basic Research into Medicines and Treatments

2 From Idea to Pill or Device The odds are not good Between 1979 and 1983, 101 discoveries reported that could lead to a medical treatment. Only 5 received license for clinical use. Only 1 was a popular treatment. Source: Am. J. Med. 114 (2003) 477

3 Even When an Idea Is Translated, It Takes a Long Time From journal report or patent to product: Range: 14 to 44 years Median: 24 years Source: Science. 321 (2008)1298

4 Illustration of the Process

5 Identify a Target For medical devices and appliances: IDENTIFY YOUR TREATMENT OBJECTIVE Examples: make more effective or longer lasting artificial joints, develop an artificial heart, For pharmaceuticals: IDENTIFY A BIOCHEMICAL REACTION THAT CONTROLS THE BODY FUNCTION THAT NEEDS TREATMENT. Examples: insulin regulates blood sugar, leptin controls appetite.

6 H 2 S: A Target Example Yes, we do mean that smelly gas from rotten eggs. The human body makes it too, and it is a signaling molecule that relaxes blood vessels (and lowers blood pressure).

7 Now We Have a Target for Developing a New Blood Pressure Medicine Strategy: develop a chemical that 1.activates the enzymes that make H 2 S, OR 2.stimulates formation of the body chemical that naturally activates the H 2 S enzymes (calcium-calmodulin)

8 The Development Process Understand the relevant science Develop a prospective treatment Develop an assay system (How will you measure the treatment effect?) Test it in a suitable animal model. Preclinical trials. Begin a formal clinical trial process Get approval fromFDA to market

9 Clinical Trials at TAMU College of Veterinary Medicine

10 Veterinary Drug Development Dr. Heather Wilson Veterinary Small Animal Clinical Sciences College of Veterinary Medicine and Biomedical Sciences Texas A&M University

11 Preclinical Trials Must be done in experimental animals. Purpose: 1.Confirm expected effects. 2.Get an idea on proper doses. 3.Establish toxicity.

12 The Clinical Trial Process Four Phases: I test a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. II test a larger group of people (100-300) to see if it is effective and to further evaluate its safety. III large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments IV post marketing studies delineate additional information including the drug's risks, benefits, and optimal use

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