Progression of New Drug: From Idea to Public Consumption Chris DeFarlo Writing in the HLTH Professions Unit 2 Prof. Edwards

Preclinical Research and Development Initial Synthesis – Drug has to be designed and created – Has to show a reason for creation Animal Testing Tests have to have shown positive effects in animal studies This phase usually lasts about 6 ½ years

Investigational New Drug Application A company or manufacturer looking to progress from Preclinical R&D must file an IND application with the FDA (Kefauver-Harris Amendment of 1962) FDA has 30 days to review the application and assess the safety of the new drug and then either accept or deny the application. No company can move towards clinical trials without approval from the FDA

Clinical Trials Phase 1 – Determine Safe Dose – Small volunteer groups (<100) – Short time period (weeks to months) Phase 2 – Determine efficacy and confirm dose – Larger groups (hundreds) – Materials are often early versions of final compound Phase 3 – Determine long term patient safety – Large scale group (up to tens of thousands) – Long time study (takes years) Average time to complete Clinical Trials is 7 years, and only 5-10% will get past Phase 3.

New Drug Application Review NDA must include complete preclinical and clinical results and information (everything) FDA must decide if the product is safe enough and has proven a proper efficacy to go into production FDA then sends an approval letter, an approvable letter (says that it can be approved but some changes need to be made), or a Not Approvable Letter Process takes on average 1 ½ years

Post-marketing Surveillance Data still gets collected after market release This is important because it may reveal new side effects or drug interactions This helps us understand with whom and how the medication works best Adverse effects must be reported within 15 days to FDA’s MedWatch program Overall time from initial synthesis to NDA approval is 15 years on average

Timeline Preclinical Research and Development 6 ½ years Clinical Trials 7 years New Drug Application Review 1 ½ years

Reflection I think that this project was a good and useful one to make because it outlines and details the very topic that I am interested in and have been looking into throughout this class. This topic is one that interests me because it is a field that I think a may want to go into after I graduate and may want to have a career in. That is why I think it is extremely important to get a good sense of the overall process of drug creation; because the creation of new drugs and new variations of drugs is the backbone of the pharmaceutical industry, and one that allows us to do a lot of good and try and treat or cure diseases or conditions. It is also key to realize how hard it is to get a new drug approved and how long of a project it is, because if I want to go into this field I need to understand how hard it is and the potential of me spending 13 years on one project and it getting scrapped. I thought that a PowerPoint was an good idea as a platform for presentation because it is easy to show step by step processes in PP. It is a good and easy to follow format that has good flow to it. Finally I based my information off our Pharmaceutics professors lecture on this process because it was very informative and had all of the information right there.

Professional Portfolio Report I think that this could go into my professional portfolio because it is well laid out and it shows where my interest in pharmacy lies as well as my understanding of the process.

Citations Carlo, J. (2013). New drug approval process. Unpublished raw data, Pharmaceutical Sciences,.