Drug Discovery Revolution: What does the FDA Modernization Act 2.0 Mean for the

1. A NEW ERA IN DRUG DEVELOPMENT The FDA Modernization Act 2.0

2. Pure Food and Drugs Act passed. Elixir Sulfanilamide disaster highlights the need for stricter regulations. Food, Drug, and Cosmetic Act (FD&C Act) established the FDA. Prescription made necessary for acquiring any drug. Mandated stricter manufacturing controls and introduced informed consent for clinical trials. Medical Device Amendments introduce the Regulatory Framework for Medical Devices. Orphan Drug Act provided incentives for development of drugs. Food Safety Modernization Act to prevent foodborne illness by focusing on prevention rather than FDAModernization Act2.0 response.

3. Role of FDA The FDA ensures that the foods, medications, and cosmetics we consume are effective and safe. They establish regulations and monitor the production, labeling, and storage of the goods. They inspect cosmetics to ensure they are safe to use, test drugs to ensure they function as intended and are not harmful, as function as intended and are not harmful, as well as inspect food for adulterants. The FDA is committed to our safety and health while we utilize these products free of worries. The Need for Modernization Animal testing limitations Rise of alternative testing methods Ethical concerns High cost and time requirements Unreliable predictors of human drug responses Cell-based assays In Silico modeling Human Microphysiological Systems

4. FDA Modernization Act 2.0 Eliminates mandatory animal testing for drug approval Potential Impact on Drug Discovery Reliable predictors of drug response Reduced reliance on animal testing Faster drug discovery More effective predictors of human drug responses Trials executed on human cells rather than animals Alternative testing systems Lower projected cost for drug discovery

5. What are people saying? "This is the biggest policy development in Congressional history on the fight to replace animal testing with morally and scientifically superior methods." ~ Wayne Pacelle President of Animal Wellness Action "Our drug development paradigm needs a reboot, and this bill moves us in that direction in one simple but meaningful way. Animal tests, in large parts, are not predictive of the human response to drugs, with very high failure rates when the drugs go to clinical trials." ~ Rep. Vern Buchanan President of Animal Wellness Action www.kosheeka.com