SAN DIEGO, November 16, 2016 /PRNewswire/ -- Regen BioPharma Inc. (OTCQB: RGBP), (OTCQB: RGBPP) President and Chief Scientific Officer Harry Lander provides clarity for stakeholders about the therapeutic drug development process. Therapeutic drugs come in many forms, such as small molecules, biologics, gene therapies, nucleic acids, cell therapies and vaccines. Of these, only small molecule drugs have the most well-defined process for getting to market and possess the advantages inherent in the ability to control the chemistry involved in the manufacture of the drug. The typical pathway for creating a small molecule drug involves several steps and can take many years. In fact, taking a drug from an initial idea to market-ready takes, on average, 15 years and well over $1 billion. However, once a lead is identified, the timeline to submission to the FDA for permission to test the drug in humans can be as little as two years. Lander explains each of these steps below so the complexity, expense and time commitment can be better understood by the company's shareholders and other stakeholders. Target Validation: This is typically the most time-consuming part of the process and can take many years. During this step, the target is proven to be critical for the disease being studied and its susceptibility to attack by drugs is evaluated. The experiments utilized in this phase include cellular experiments and animal studies. In the case of NR2F6, Regen scientists and other academic groups unrelated to Regen have published papers going back to 2011 identifying NR2F6 as a critical factor in immune and cancer stem cell regulation. High Throughput Screening: The fastest way to identify small molecules that can bind to and alter the function of a target is to use a process called high throughput screening (HTS). By using this process, it is possible to quickly screen hundreds of thousands of potential small molecules to see if any bind to the target, which is termed "hits". Depending on the target, it can be easy or difficult to find hits. The NR2F6 target is considered a very difficult target, and, as far as the company knows, Regen is the only organization in the world that has identified validated hits against this target. Regen began the process of HTS in early 2016.