The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Commercialization course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug commercialization. This course will cover pharmacoeconomic, marketing strategy, intellectual property strategy, portfolio management, managed markets and strategic alliances. It will also have a lecture case study from startup to success. In addition, the course will discuss post-marketing clinical trials or Phase 4 trials. These are conducted after a new drug has been approved by the regulatory agencies and launched. In these studies, the new drug is prescribed in an everyday healthcare environment using a much larger group of patients. This enables new treatment uses for the new drug to be developed, comparisons with other treatments for the same indication to be made, and determination of the clinical effectiveness of the new drug in a wider variety of patient types, and more rare side effects, if any, may be detected . Pre-marketing strategy should be instigated as early as Phase 1 clinical trials to ensure that the market's needs are incorporated into the new drug's overall development. Later phases when clinical results are presented at international medical conferences the marketing strategy is then refined in order to develop an awareness amongst the medical community who will be prescribing the new drug. In addition to the marketing strategy, pricing strategy and a tactical plan will be developed. Promotional material, and the sales force will be trained so that when the product is approved they can promote the drug to physician, pharmacist and nurses. This course is intended as part 3 of a series: Drug Discovery (https://www.coursera.org/learn/drug-discovery), Drug Development (https://www.coursera.org/learn/drug-development) and Drug Commercialization. We would highly recommend that you take the courses in order since it will give you a better understanding on how a drug is discovered in the lab before being tested in clinical trials and then launched in the market place.
Marketing Pharmaceuticals & Biotechnology Drugs I
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From the course by University of California San Diego
Drug Commercialization
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From the lesson
Marketing Pharmaceuticals & Biotechnology Drugs, Williams Ettouati, Pharm.D.
Meet the Instructors
Williams S. Ettouati, Pharm.D.Director, Industrial Relations & Development; Health Sciences Associate Clinical Professor, N.S.
Skaggs School of Pharmacy and Pharmaceutical Sciences
Joseph D. MaAssociate Professor of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Sciences
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.
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