Hello, my name is Dr. William Ettouati. I am Director of Industrial Relations and Health Sciences Associate Clinical Professor at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California San Diego. This is our first lecture for the DDC course. And what we are going to cover today is the objectives of the course. We'll give you a brief pharmaceutical and biotechnology industry landscape overview. We'll try to look at what the future is going to bring, as well as how drug discovery and development has changed from a product centric way of thinking all the way to a patient centric. So let's go over the objectives. As you heard from our introduction video, the course is split up in really three big pieces. One is a discovery process, the second one is clinical development including regulatory affairs, both from an NDS standpoint in the US and as well from the EMA standpoint in Europe. We will also cover intellectual property strategy which is extremely important in the pharmaceutical industry, as well as commercialization strategy. Another thing that will be important is that we will talk about is the ability of working in multifunctional teams. And this will be part actually potentially of another course later in the future. So with that, let's talk about the landscape as it was in 2014 and 2015. First of all, R&D in 2014 showed a recorded number of new active substances launched in their first markets, in their first market in 2014, which is quite important actually. As you can see in this slide, a number of deals have happened also, many, many deals, over 430 deals have happened that were signed in 2014, so very active industry from that standpoint. A number of products were first in class. A number of products also were orphan drugs and we'll talk about what orphan drugs are later on. What's interesting is if you look at the number of NME, so new molecular entity, first-world launchers between 2005 and 2014, is you can see that there was a period where the numbers went down to about from 28 to 21 from 2005 to 2007. And then we have been going back up since then to actually about 46 in 2014. So what's really interesting is that also many new drugs have been launched in cancer, in HPV, in eye disorder,and about a third of these new launches were for rare indications, which is quite important because you will see as we go along throughout course, that there has been a change in the market from the perspective of going after blockbusters versus rare indications. 2015 was an absolutely record year from the perspective of number of new chemical entities being approved by the agencies. 43 of them, new active substances, either NME, New Molecular Entity, or BLA, which is Biological Active Substances were approved by the agency. IMS states that there will be over 225 new drugs approval and most of them in cancer related therapeutic area space, and we'll go a bit more detail later on from that perspective. This slide shows you as well, the different types of molecules that were approved both new mechanism, existing mechanism and non-new active substances. Let's talk about the approval process which from my perspective is a barometer of industry innovations. As I showed you 2015 was one of the biggest years in terms of getting drugs approved. What has happened also is that we have seen a decline in early development pipeline, from the standpoint of, it is really important to fail fast than cheaply, because when you fail early in clinical stage development or even better in pre-clinical, it's going to cost you a lot less money. And from the standpoint, that's one other thing that the industry has been getting much better at. The other thing is that as of December of last year, the FDA had given 37 approval to drugs designated as breakthrough therapies and we will talk about that later on. 17 of them first time approval for novel drug. The other thing that's important is that there is right now about 2,000 compounds that are in late phase clinical development. As well as a number of other new active substances that are expected to be launched on average for each year over the next five years, about 40 to 50 of them. So that's quite productive. Now, one other thing that is really important to understand is that unfortunately pharmaceutical drug development is a business of failure, but if you are going to fail you want to fail early. The first, the top graph, shows you basically, the percentage of success for a drug to go from one stage to the next. And as you can see, as you are moving down the pipeline and you're moving from let's say pre-clinical to phase one to phase two to phase three to submission, your probability of success is much higher. And that's important, that's what you want because then you are going to save money from that prospective. The other thing to look at is that the global pharmaceutical sales probably will reach over a trillion dollars for the first time by the end of 2014 on a global basis. And that's important to understand as well. And that encompasses absolutely everything. This is a chart that's kind of interesting. Sort of busy, I apologize. But this really gives you an idea of the new active substances available since 1996, some of the key issues here is obtaining the greatest value for the dollar that we spend on drugs, having vital biopharmaceutical sector that produces vaccine, effective treatment, and cures. Affordable care for patients. And here you have the cumulative number of launches,five years, novel, active substances and so you can really look at the graph and see all the different areas and different therapeutic areas. I'm not going to go into detail into this, you can see that from the slide. 2015 was really a year with a lot of pharma marketing controversies, especially in the US, but also in Europe and other places. In the US, pricing has been one of the key issues that has come up. You probably have heard about Turing Pharmaceuticals. This company that bought Noel drug, and hiked this price by over 5,000%. That made a huge amount of scandals. The CEO ended up basically losing his job, being I believe also pursued by the SEC for insider trading, and all sorts of really not very good things. So Pharma has really had, I would say, a black eye from some of these issues on the pricing, and we will talk more about this in subsequent lectures about the pricing of pharmaceuticals. Insurers, pharmacy benefit managers, physicians, even presidential candidates, question pharmaceutical pricing, especially in the US, which basically I will show you later on. Is a big issue. PBM's have increased the number of drugs that they exclude this from their formularies just based on pricing. Not based on efficacy, not based on safety. So from that standpoint there has been a lot of pressure. The American Medical Associations has been calling for a ban on DTC which is direct to consumer advertising, which for RX products, prescription products, which the US is actually the only country in the world, one of the only country in the world where you can do direct to consumer advertising and another thing that was very interesting and we will talk a bit more later about this is that Pfizer was looking to do a mega-acquisition of Allergan or I should say maybe merger or merger with Allergan. And we will see what happen or you maybe already knows since we are now in 2016. But the idea was basically for Pfizer to move its tax domicile to Ireland. Now a lot of people have argued that, well, it was also for synergies, but at the end of the day I think that's It was probably for tax situations rather than anything else.
