 Hi, I'm Russ Reed. I'm the Executive Director of the National Center for the Biotechnology Workforce here at Foresight Tech. I had a long career in the pharmaceutical industry prior to coming to Foresight Tech. And I just want to give you a little information regarding the complexity of the pharmaceutical industry and the biotech industry. And so, you know, in my own case, like you, I was a student and when I graduated I came into the industry and didn't know what I was getting into. And so, I just want to give you a little bit of background to make sure that you're comfortable in your studies and have an idea of where you can go. And so, over my career I've done approximately 15 jobs starting from doing clinical research all the way to becoming the CEO of a small biopharmaceutical company. And so, a couple of things that I want you to keep in mind as you go through your unit. And that is one is that, you know, the fantastic thing about working in the biotech industry is that you can help fuel the world, you can help heal the world, and you can help feed the world. And so, whatever position or whatever company that you'll go into, you have to keep a couple things in mind. One of the things you have to keep in mind is that you're being hired to do your job extremely well. Consider the fact that most of what we know of biotechnology or the pharmaceutical industry involves the making of medicines. And the making of medicines is a very intricate process. It's a process that has many steps. And you're part of that process no matter what you're doing is intricate to the whole process of making the outcome of whatever the medicine should be. And so, you have to do it to the best of your ability. You have to do it to guidelines. You have to do it to standard operating procedures. And at the end of the day, if you do the part that you're doing and you do extremely well, then what will happen is all the other team members in the process will bring what they're doing. It will come together and it will come together as a product. So let me just kind of take you back through what happens. There will be perhaps a scientist working at a university who is working on perhaps trying to discover a new cure for something. And so, they'll be working diligently in their lab. They'll probably be funded by some agency up in Washington. And they'll probably be trying to develop their idea to some point in time. And lo and behold, their research starts to show promise. At that point in time, they'll take that promise and they'll talk to the officials within the university. And the university will think, hey, listen, we think that there's a way that this could be developed into a product. So from that point, more research is being done. Usually, on the bench, you'll hear that expression quite a bit as you're learning your biotechnology program. And what that simply means is doing more experimentation. In a very general sense, depends what kind of experimentation would be required for that particular entity. But the whole idea is to develop the process in such a way that you get what you consider a characterization of the molecule that you might be working on. So maybe you found something for the common cold. Hey, we still don't have a cure for the common cold. Can you imagine that after all these many years of doing great things like discoveries in HIV or cancer therapy? But can we do the common cold? Not yet. So for some of you who are learning here today, you might even be thinking, hey, maybe I can go after that. Well, it takes a team. So the characterization of that molecule that might be the common cold molecule might be just understanding what is that? What is the chemistry of it? What is the pharmacology of it? And what is the safety and the toxicity of it? In other words, to know what are the limits that we could do with that particular entity and how can we prepare it? So all that happens on the bench using many instruments, of which you'll learn a lot about that instrumentation here at the college. You'll actually even get a chance to use some of that instrumentation and you'll become proficient in that instrumentation. So then the molecule in question, hypothetically the one that's for the common cold, is worked up. It's found in what we call the preclinical stage. It's found that it is characterized well. Its pharmacology is good. Its toxicity is good. And how do we know that? Well, we know that through using it in cells. And so at some point in time, then a decision is made to produce that in a slightly larger quantity. And that is what the chemistry of finding that molecule's use really becomes really important, the characterization and the chemistry of it in order to bring it forward so that we can actually produce better quantities of it. So once that happens, and it happens under the right conditions, and what we mean by that in the right conditions is that, you know, we can replicate it. The most important thing is to be able to replicate something on a continuous basis using the chemistry or using the biochemistry and to be able to go forward with it and understand how we can produce it. In some cases, it might be produced by a cell itself. That was what we would call biotechnology where we have manipulated a cell in order to produce this particular substance that you thought that you could cure the common cold with. At that point in time, we've got some pretty good understanding of how to make it. We can produce it in slightly bigger volumes. At that point in time, we want to put it in animals. Usually animal models are used to prove if something is safe and effective. At that point, if we can show that it's better than anything else that exists today using a clinical study or what we call in this case a preclinical study because it hasn't been put in man yet, we'll see if there's evidence to go forward with that molecule and to actually put it into man. And that would be called a clinical study. So at that point in time, we've got what we think is a good molecule. It has shown some good of efficacy. It's shown safety. We've put it into animals. It's showing in animals that it's good, that we should go forward. So what'll happen at that particular point in time is a decision would be made to actually take it into man. First in man study is a very important study. It's your phase one study and you'll read about this in your text. And that's a small group of people, usually not very many, probably just a dozen or so. And what they'll do is they'll take the molecule and they'll usually give it to healthy, normal people. And what'll happen is we'll just test it just to see whether or not the person is comfortable in it. We'll take their blood pressures and so forth and so on. We'll look to make sure that they're tolerating the molecule well and we'll push the dose a little bit just to see whether or not we can understand what is the docible range with this particular molecule that you found that you can use for the common cold. We aren't necessarily looking at this particular point in time to whether or not it actually does anything for the cold. In fact, these people don't even have a cold. They're just normal subjects. So everything comes back. It looks like through blood studies, through very clinical signs, blood pressure, so forth, so on, heart rate. Looks like it's all good. This molecule looks good. So at that particular point in time companies start to become really interested in developing this product further because it looks like it has good potential. So we want to take it into another phase of development and that is called phase two. Phase two is a different kind of test. It's a clinical test where we're taking the product into a larger population. This is a population of people who actually have colds. So what we want to do is perhaps look at it at a couple of dose ranges to figure out what kind of dose is going to be the most effective in these people and what can they tolerate. And in actual fact, what we're looking at is whether or not the cold subsides quicker than cold would normally. And at this point in time, the studies are probably a few hundred people. They could be in multiple sites and we collect all the data, bring it all together and analyze it. And we find out that the higher dose actually has a few more side effects. But the middle dose seems to be the one where there's less side effects, but the dose seems to work well. The normal cold lasts seven to ten days. We find out that the cold actually in this group in this population has probably decreased their symptoms by maybe 50%. So we're at about three days. So this is really great. This means that we've been able to decrease a cold by 50%. Decreasing a cold by 50% for a lot of people would be a great thing. They would love that. And a company would love that. And they would like to take that molecule forward. So what has happened in phase two, after studying it in several hundred patients, we found out that we've been able to decrease a cold by 50% of the time, the symptoms. And at the same time, we've got a safe molecule. It doesn't cause side effects. So what will happen then is we'll decide to go into a broader into a broader phase called phase three, where we do a lot of exposure to very normal people, to people who have a cold, but all kinds of people, the age can arrange from maybe very young people upwards into their 60s. And we'll study the people over time and to make sure that we've got a lot of data to make sure that the people have done well on the molecule that we've discovered for the common cold. And at that point in time, parallel to that in a biotech company or a pharmaceutical company, whichever it might be, people have already seen that the cold that this new drug for the cold has been safe and effective. So they're already planning how to make this product. So we have to know how to make it. We have to find the right ways of doing the chemistry or the biological production of the molecule. And we have to be able to gear that up. So part of what has to happen is doing experimental batches of the drug in question, being able to test them consecutively to make sure that the drug is what we say it is, we have to be able to document that, we have to be able to follow what they call good manufacturing practices. We have to be able to say that document wise, it is the same drug every time and we're trying to produce it so that it can be relied upon. So that package is being made in a biotech company or a pharmaceutical company, because our industry is highly regulated and because we have to get approval by the FDA in order to market things. What is happening is a series of folders of documentations are being made. In addition, you've got your clinical research work that's coming in comes into the forms of data. And then there are people who are considered to be regulatory experts within the company who are putting those together and form it formulating the regulatory package, which then will become the package that is submitted to the regulatory agency for approval of the drug. At the same time, in another parallel fashion, people are testing the drug to make sure that it is of the highest quality. And those are your people that work in quality. You have people that are in quality control. You have people that are in quality assurance. And then you have your people that are in production that are producing. So the people are standing back a bit. And they're checking what the production, the early production is looking at seeing in terms of the molecule, because they're looking at ways of efficiently making lots and lots of this product for everybody who has a cold out there. So at the end of the day, sampling is done. So you may find yourself trained to be a quality assurance technician, which means you're doing a check on what people are making in order to go to production levels. At the same time, you could be in the quality control unit, where essentially what you're doing is you're trying to control to make sure that the product meets the standards of that particular molecule that you need to do. Finally, everything comes together. And we have what we call the regulatory package. And that package would be submitted to the FDA for drug approval. And that usually is a very large package, which then is sent to the FDA. And then there are several meetings with the FDA. And then you actually, your drug becomes part of an advisory committee, which is independent of the FDA, which makes a recommendation to the FDA as to whether or not to prove your drug and approving your drug is a complicated process. But essentially, for most of you who go in a pharmacy on a day to day basis, we'll pick up a bottle of pills that could be tablets that could be capsules could be a liquid could be an ointment could be a cream could be an injectable. But you will notice on that there's a label. And if you really look closely at that label, you'll notice that there are certain numbers on it. There's certain labeling on it. So it's, it's actually saying what it can, what it's for. And at the same time, in the box, usually something that is a prescription medicine, you'll usually find a leaflet of some sort that describes what the compound is, what it does, and the kinds of side effects that it may have when you're taking it, and the dosing that you need to use to comply with the medicine. So in our case now, we've got to the end of phase three, we've got a lot of data. We're at the point in time where we've submitted to, to the government, to the FDA. But we have to just think of one more thing. And that is that, you know, the business of putting products on the market is that's what it is. It is a business. And yes, there has been research that I explained in the university setting. And yes, there has been development that I've been mentioned that is actually either preclinical or clinical. And now there is the packaging to go to the FDA. But on the side, there's the commercial aspect of what we do in the industry. And that is that we will look at the market. So the market for colds, it's a very large market. We'll actually have commercial people who will look at that market, assess it, assess the value of it, assess the value of a compound going into that marketplace, and try to fix a couple of things. One is, what is the cost of the goods of the product in question? And what is the potential market? And what is the pricing that would need in order to make that product accessible by people, but at the same time, pay back on the molecule for all the investment and the research that's been done on it. So in a nutshell, when that is done, and then the FDA comes back and says, we like your cold molecule, the Independent Advisory Committee has approved your molecule, has recommended your molecule for approval. And now we're officially approving your molecule. Then what will happen is the production will have taken it up to a massive amount. You have will have been bottled, it will have been labeled, it will have been packaged, and then it's ready to be distributed. And so what it'll do is it will leave the place, it will go to your pharmacy. And then your doctor will see you as a patient. You'll see you as having a cold. He'll or he or she will prescribe that particular cold medicine. And you'll be the recipient of the cold medicine, you take your cold medicine. And lo and behold, something that you thought you're going to have for seven to 10 days is finished and arrested in three days. And you feel better, you're able to get back to work and research and development and commercialization of that product has done a great job for you, the consumer. So for yourselves, as students, that's a really good scenario for thinking about why you're studying biotechnology and what you could possibly do with it. The case in point is a pharmaceutical or a biological. The case in point is not the broad spectrum of all of biotechnology, but it's the one we probably know the best. And that is the production of safe and effective medicines. So I hope that has helped you today. And if you have any questions, I'm sure your instructors will be happy to help you out. But I am here at the college and very, very happy to give you any advice I can. Thank you.