Good afternoon, and thank you all for coming. I know there's a lot of different panels to choose from, so thank you for coming to ours. My name is Katie Poulin I'm a senior year at Mount Holyoke College. I'm a bio major and a stats minor. 

So today, I'm going to talk a little bit about basics of drug discovery and development. So first, this past summer I worked at Tokai Pharmaceutical, which is a pharmaceutical company located in Boston, Massachusetts. They're working on a drug for prostate cancer. 

So a little bit on how I got this internship is last spring, I was looking on the Mount Holyoke website, and there was an article about an Alum. And she is actually the CEO of this company. I was really interested, how did she get there, what was her career about? Because I was a bio major, I knew I wasn't really interested in research. But I was like, what am I going to do with my bio degree? 

So this is what I found. And I contacted her, and just want to hear how she got to where she is today. And it was a great conversation, learned a lot. And from that conversation, turned into an internship. 

So this past summer, I got to see how the-- I worked, actually, in the clinical department, which I'll talk more about later on. But I got to see from the beginning to the end of drug discovery and development. 

So in this presentation, we're going to start with drug discovery, and we're going to get to one FDA-approved drug. So this is the end goal for all the pharmaceutical company. They want to see their drug on the market actually helping the patients that it's intended for. But how do we get there? 

So drug discovery on average takes 10 to 15 years, and usually costs between $800 million to $1 billion. It takes multiple contributing internal departments and additional external organizations. One fact that I really was surprised about this summer that really stuck with me was that 5,000 to 10,000 compounds enter the research development pipeline, but only one will see FDA approval, which I was very shocked about. 

So drug discovery. First, the scientists need to understand the disease that the drug will be treating in order for it to best help the patient. They need [INAUDIBLE] target identification, so where the target area-- where the drug is affected, where the drug can affect the disease the most. And they need to validate this target site. 

So how does it impact the disease, visit the correct site that they are targeting? And we don't want to target the wrong site. [INAUDIBLE] an unnecessary adverse effects to patients without a benefit will not do any good for any of the patients. 

So before the drug is allowed in any patients, it goes through many frequent testing. And this is safety testing which is usually done in animals. And you may share that and be safe for humans. 

Toxicology, a look at how a drug could be toxic to different organs, to species. It looks at broad range. And ADME, which looks at the absorption of the drug in the body. [INAUDIBLE] how the drug is distributed through the body, how it's metabolized in the body, and finally, how it's excreted from the body. 

So the clinical trials, which is the part near and dear to my heart, because that's where I worked this summer, has three phases. And we're going to go into it a little bit about each one of these. 

So phase one is the initial human testing. And it's usually a healthy group of volunteers. The number of volunteers range from 20 to 100, but this is different for all clinical trials, because it just depends. It discovers if this safe in humans, and it figures out the safe dosing range for the drug. 

But once these questions are answered, depending their answers, the question is asked, should this drug continue, or does it need to stop? All of these are answers that we would want to see, [INAUDIBLE] safe and everything, it will continue to phase two. 

So phase two is a larger study, usually with 100 to 500 patients with the disease. It looks at the drug safety and the effectiveness of the drug. It also looks at the dose strength and schedule for the drug. 

So phase three is the largest, most costliest phase. It usually consists between 1,000 to 5,000 patients with the disease. It's there to produce. It looks at the safety, the efficacy, and the overall benefit the drug has. And to find statistically significant data to use for the FDA. 

There are a large number of sites all around the world, which is necessary because we don't want to create any statistical bias. So in order [INAUDIBLE], yeah. [CHUCKLES] 

It's-- yeah. [INAUDIBLE]. OK. 

So the new drug application. So once all phases are passed, they file a new drug application, which is, on average, greater than only 1,000 pages. But luckily, we can now file it electronically, so we don't have to kill many trees. 

But the final decision lies with the FDA. And in every review is the risk-benefit analysis, the advisory committee evaluation. And they also do a facility inspection. 

So where's galeterone? Galeterone is the drug that Tokai Pharmaceuticals is working in for prostate cancer. It's in its phase three, so it's almost there. They have multiple global sites in the United States, Canada, and the United Kingdom. 

There is galeterone, and it's being looked at. And the active comparator is enzalutamide. And their phase three has 148 patients. 

So my experience. I really got to learn how the industry operates, because I never-- go to school, you don't get to see that. And it was hands-on knowledge, and I just see how it operates. 

I got to discover my future career path, because, again, I was unsure of where I was going to go after college, and this really opened up a few doors. I got to network with people in the industry from US and abroad. I went on a business trip, which was amazing, and got to meet many different people. And I got to take action for my next move after college, and to see this was something I want to do, and understand what is that I like. 

I'd like to thank Tokai Pharmaceuticals for giving me this wonderful opportunity for our mentor and for mentoring us. And for you guys all for coming out today. Thank you.