Hello, my name is William Ettouati. I'm a Pharm.D by background. And today, I'm going to teach a class in marketing of pharmaceuticals. again, like I've told you before this is a 30,000 feet view of the marketing aspect. I spent about ten years in new pharm funding and marketing talking about pricing, long strategy, launch drugs around the world both in the US, Europe and Japan. so I will try to give you an understanding of what marketing was before, what it is becoming today and some of the major changes in the area. Alright? So with that, let's go. So here, the objective of the course where going to go through traditional marketing, the four Ps as it's known. to you guys, business students we'll go about FDA regulatory rules. We'll talk about Pharma New Business Models. This 3.0 that was asked before. You know, this is again more of a a consulting term than anything else. The novel approach, which I call the four, which I call the four Cs, which are really a lot more important. And finally give a brief conclusion. So, what does make a drug a success? And, to me, that's really, really interesting. And, and there's many different answers you can have. So, is it a great ad campaign? Is it promotion to the physicians? Do we address unmet medical need? do we also go after, you know is our drugs so much better than, and has so much less side effect that, you know, this is fantastic? At the end of the day, you know, there's a very clear there is a very clear answer to this, which is that if your drug is not going to sell and if there is no market, nobody is going to care. Okay, nobody is going to put money as you heard from a number of the speakers throughout the class, that unless you can demonstrate you actually are going to have a return on investment. That's going to make sense, that's going to continue to fuel your organization nobody is going to want to go and develop a drug. That is a really big issue right now in oncology. for example, you just had a panel discussing [UNKNOWN] oncology for drugs that are already generic. Where a lot of, even the generic manufacturers don't even want to manufacture these drugs, because they can't make money out of it. So, that's really, really important. Another thing that people always think about, you know they think, well, gee, marketing, okay, well marketing is when the drug is approved. If you do marketing when the drug is approved, don't even bother. you know, marketing starts almost at IND filing. I've been in product teams where marketing started even earlier than that, when there was already a lead candidate and they were going through GRP talks. New product planning is very involved and usually it's part of these multifunctional teams. And another thing that's very important but that has changed over the years, is this word, which is pharmacoeconomics before in a reimbursing products. And the payers are playing more and more of a role on the commercial side. So with that in mind, let's talk about the four Ps. Product, Place of, or Market, Price and Promotion. The product, well, element of the idea product. This is, you know, my dream. Let's say I am a product manager and my RND says, okay, we are going to develop a new drug for hypercholesterolemia or for cancer x. What do you want? Well, let me give you my wish list. I want to be first in class. I want to be best in class, then I want to make sure that you're going to predict what's going to happen in the future, so nobody can come in and cut, undercut me. I want to have, I want to treat billions of people, 'kay? I want a simple dosage, one pill, hop like a candy. You know, hopefully it taste good as well. for my life cycle strategic plan, I want to make sure that that drug is going to have multiple drug delivery systems. Because, when the patent runs out, I'm like magic pill, then I can introduce the cream, and I can introduce the sustained release formulation, and I can introduce the suppository, and you name it, 'kay? So I want to make sure that we are looking at that, superior efficacy and our safety data, you know, no problem, it's like a sugar pill. of course, I want outstanding pharmacoeconomic data because, you know, managed care is going to come to me breathing on my neck, even though, I do one the drug. I want to ensure, increase the viable. Well, it's great that 3% of the patients reduced their weight in three months, but big deal, they still drop that with a major MI, you know six months later, that doesn't really help me. I want something where I can show survival data, and then more importantly, you know, I think with all of this, then I will have what is called sustainable competitive advantage versus all of the competitors. Well, let me ask you this, how many drugs do you think have that? I don't know of any of personally, okay? So that's, you know, that's the pie in the sky marketing dream. So with that since that doesn't exist, pharma has been going after a number of different business models. the first one is differentiated. So obviously, differentiated model, which is where everybody wants to go, is you are at this first in class or best in class, there are no generic and there is product innovation, so you have, you know, an, an, medical need. And the payer has very little influence, because all the physicians wants it, the patient want it. So they are pressured by the patient and the physician. Well, that's a great place to be in. Pharma, Big Pharma and New BioTech wants to be here. Then there's the commodity business. The commodity business is generics. It's the Teva of the world, it's the Dr. Reddy of the world, it's the Shine. it's all these guys who basically, there is no differentiation who are going to compete on price. Okay? potentially in some instances, if you are also a me-too, let's say there is no generic yet, but you are a me-too, you're going to price your drug at a lower price, so you can actually get on the formulary, even though you're not generic. Here, the payers have a great state, because they control the budget. And if you can show me reduction in the hospital budget or my insurance payments, then I'm going to be very happy. And then there is what I call the transitional. And some of these companies fall in the in the mix, you know, Novartis for example. Nobody thinks about Novartis as being somewhere playing on both sides. Well, Novartis plays on the differentiated market and they played in the generic business, okay? Okay, Sandoz, which is part of[ Novartis, actually is very big in biosimilars. Teva which came, and they came from the, you know, primarily from the the, the rendered business, Teva which was a generic company originally, now, is moving towards on the other side, because, and they are applying two different business models. 'Kay? So, when you have a new product and you're on that project team. You're in new product planning, you have to start developing a marketing plan. Well, the pharmaceutical business is very different than the tire business, 'kay? even though I'm not saying tires are not regulated, but nowhere near what's a drug is and you have one entity that you have learned about throughout this course, which is called the FDA, the Food and Drug Administration, and these guys writes the rules. Okay, they tell you what, how you're going to be able to sell it, what you're going to be able to sell, which is what is in your PDR, the Physicians' Desk Reference your going to have your label. And what you have on your label is what you are going to be able to detail, not all the time. and you, if you develop, if you really change from that, you're going to have big problems and we'll talk a little bit about this. So, product label is, and that's why it's so important for marketing to come in very early on. Because, if you are on a new product planning new product planning team from the beginning, from the moment that actually that drug is doing GRP talks and you are thinking about the indications. Well, you can start guiding what type of indication you're going to go after, what type of dosage you are going to use. So, you can start helping your development team, and you heard this from Dr. Quart, that, you know, they had to think about the market very, very heavily, they did a lot of marketing research. Well, you do a lot of that, even before, you know, four or five years or six years before you actually even are on the market. Before you even know if you're going to get approved to be on the market. So there's already a huge investment that's made in that area. you're going to have to think about key brand messages. You're going to have to think about the communication strategy for each stakeholder. Your pricing, you better have a really good pricing strategy. As I told you before, you know, I, I consider the US still the wild west from that perspective. Because you charge as much as you can, plus what the market would, you know, plus 10%. that's changing very, very aggressively. Anywhere around the world, the government tells you how much your drug is going to be reimbursed and that's what you're going to get. Now, in hospital settings, it's sometime different so another thing which they don't always control the hospital setting, but what the hospital setting has is they have the formulary for each hospital settings. And usually they have a little book and the Pharm.D is usually in charge of that, at least in, in a number of countries in Europe. And they say, okay, well, show me your pharmacoeconomic data, and that by the way, did you do them in our hospitals? Because if you did it somewhere else, then your pharmacoeconomic data is not valid for us. So that's another thing you're going to have to think very early on as you develop your clinical plan, you know, where you want to do your your clinical development. Everything has to be linked to the clinical strategy. The other thing is at the end of the day, I mean the physicians still prescribes and you still have to think about the physicians, because he is really quite important. But, as you will see later on, the physician is becoming less and less available, as well as less and less of a decision maker in actually saying what, as you, as a patient, are going to receive in term of a drug.