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 IV
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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
Promotion, that means launching the drug aligning the organization, so everyone
needs to be aligned clearly. you need to have customized the
interaction for key customers. Partner with the payers, very early on I
told you about this as well. you need to, one of the things we didn't
talk about in this class at all is manufacturing, but think about it, you
know? So you are developing your forecast, you
have the marketing guru in your organization.
And you have developed the forecast. What if you are wrong either up or down
or hundredfold? In terms of what the demand is going to
be. You can either have major product
shortage, and if that's the case. You lose the sale, okay?
And you lose, I mean you have a huge problem, and that has happened.
And that's, you know I mean I'm not saying that's a good thing.
But it's better to be in that direction. Or you overshot your forecast, and you
doubled upped three manufacturing plants. And you invested hundreds of millions of
dollars, because for that, it's really expensive.
And guess what? The drug is a flop.
And you don't even sell 10% of your forecast.
So that's another thing you have to think about when you are looking at your
promotion. And you have to think about what kind of
impact. And more and more today, marketing is
being put under the microscope as to, okay, you're going to do that program,
you're going to do that tactical plan. What's the return on investment on this?
What do I get out of my, five minutes, $50 million Super Bowl commercial?
Okay? What's the return on investment?
And then finally, you want to know if the customer well, that commercial on that,
that you had, really was horrible. And that's another issue when you think
about global positioning. Because these drugs are positioned
globally on the global market. So you have a strategy.
You usually have a central strategy on a worldwide basis.
But one other thing that's very interesting is that you have to adapt, to
adapt the strategy at the local level. You do not market a drug, and I know
because I did this for a number of years, the same in Korea as you do it in Spain.
Okay? The cultures are very different, the
approach are very different. The wording of what you use, I mean I've
seen some stuff, you know, total crack up, where people would have slogans
translated in other language, was almost like an insult.
and so that's one of the things where you have to be very careful about.
And at the same time, you have to plan your budgets.
And each units have to really understand that.
And I think pharma has become better in that area, which is, has to be with
customer satisfaction. Again promotions, it's going to address,
you know, payers, patients, providers, manufacturer.
Different tactics based on where you are, which countries, and costs.
Market share is going to be in sales, are going to be driven obviously by you know,
the broadest indications. The more patients, the more you're
going to sell. but to be honest, if you have a targeted
patient population and you are the only drug.
You're probably going to be much more successful as well.
Sustainable competitive claim. and again we have to look, we have looked
at all that. The other thing that's important that we
didn't talk as much is the timing of line extensions, and that's very important.
That's part of life cycles strategic plan.
Let's say I have a great drug, and it, let's take you know, one that just came
off patent. Lipitor came off patent, $12 billion in
sales. Well, they didn't have it for long.
You know, they didn't have, maybe they could have had a sustained release
formulation or a Lipitor Plus. Or, you know, do another type formulation
where they actually had even better control.
So, that's where you see vanishing your brand equity that you have, that $12
billion that you had in sales. Almost overnight become 1.2 billion or
120 million. I mean, look at the amount of investment
if you think about, you know, in the consumer market, you know, I gave you
Nike, Apple, Coke. You look at these brands, they are still
selling very strong. But they are always working on their
brand, they are always launching new products.
Some of them are flops, but they are always trying to capitalize on that
brand. But the same goes true for a
pharmaceutical. If you have a series of line extensions
and you are able to do that, you know, smartly enough.
you are going to capitalize on that. And that's going to be a lot cheaper than
trying to rediscover when you drive, where you start from ground zero.
The other thing is reimbursement is going to be critical.
and that's going to be really critical as well.
So, when you look at customers, what do they think and feel about the drug, well,
these are all the interesting pieces. So at the top you have the intangibles
and at the bottom you have what I call really tangible.
Again, I'm not going to go through all of this, but you know, the perceived value's
important, what does it say about my company.
you know, what you have in terms of how does it make me feel?
You know, do I, do I really like to work here as a company?
and then you look at all the other things on the outside.
So again, all of these pieces are important and questions to ask yourself
when you are going to go and launch your drug.
So, in terms of promotion, so promotion is really the application of your
marketing strategy, okay? You have your sales force, which is the
typical, you know, thing that pharma has been using.
Thousands of reps going after thousands of GP's.
Well that's dangling and we will talk about it.
Other means of promotions is direct to consumer advertising.
That's very different. In the, the US is the only country in the
world where you can do Direct to Consumer Advertising, and I mean direct to
patient. That's the end consumer, not the
physician. that is also changing very rapidly.
You know, TV, print magazine, internet, a lot of social media.
that's right now not extremely well regimented, that's also going to be a lot
more regimented. But what's interesting to me if you look
at the promotional spending and that comes out of a study that was published.
Actually a paper that was published in March 2013 actually.
I just got that paper yesterday, I thought that it was very interesting.
Is if you looked at it and you have the reference right here.
If you looked at it you know, it peaked at $5.9 billion in 2006, declined by 25%
to 4.4 billion by 2010. I think the numbers are probably even
lower today. So people obviously are not seeing the
return on investment. what's also interesting is that 370
million top for the 15 smalls 15 top small molecules.
and then on, only 33 million for the top 15 biologics.
It's not completely surprising if you look at the percentage or so of sales.
In the sense that for biologics, the sales force are a lot smaller and you
don't as big as a target audience that you can reach, you, you have to reach.
Medical science liaison, publications. And one of the things to remember is
promotion, very often, at least the way it has been done up until now was a one
way street. You know, you are passive, you are
receiving the stuff, you don't really interact with it.
Of course, FDA and other regulatory agencies are regulating all this.
You're asking about the change of power, this is kind of an interesting slide.
That shows that basically, the decision makers have dropped substantially, and if
you look at the physician, this was done between 2008 to 2013.
That was project to 2013, you look at the physicians, most of the country is.
The physicians have very little decision making power compared to the national
payers, the local payers. The patient groups have gone up
substantially. And some opinion leaders are still
important in some countries, but in others they have really gone down.
Here's what's happening to the pharma sales reps, a lot of primary care
physicians. get paid by the office visit, especially
if you nice care situation, it's the number of patient you see a day.
So a lot of physicians say, you know what, I don't have time to talk right now
just drop off the samples, which is really primarily a US custom.
And then the other thing is in a lot of offices now, you see this.
You know this stop sign. No Pharma Sales Reps allowed.
Okay? So with that and, and also besides the
fact that it's not very efficient, you know?
I think Pharma is changing their, their motto.
Which is why you see a lot of companies basically getting rid of their or
actually shrinking their pharma sales force.
I talked about the FDA. The FDA has what is called an office of
prescription drug and promotion. Their mission is to protect the public
health by assuring prescription drug information is truthful, balanced, and
accurately communicated. I'm not going to go through all of this.
We had a lecture on the importance of the FDA, and why the FDA was, was created.
But they regulate all the promotional pieces that are being put on the market.
And if you have, if you are crossing the boundaries, they will send you warning
letters. They'll fine you for it substantially.
so that's again, you know, quite important to understand.
the prescription drug advertising must be accurate, balancing the risk and
benefits. Which is why where sometimes you hear
advertising on the radio, they go on and speed at you know, 200 miles per hour
about the side effects. Or like on the TV when you have the, the
ad coming up. After that, you have the package insert
in invisible fonts. Flora, that's you.
Yes, question? >> I have a question about the off
label. >> Yes.
>> You can see up on that slide. >> Yes.
>> Do you see the FDA starting to developing regulations around that?
>> So I don't work for the agency so I can't really answer that directly.
All I can say is that a physician can prescribe a drug off label, that's his
prerogative. Okay, that's one of the things which is
basically, if the physician, they don't want to second guess what the physician
is doing. Now, where they are going to crack dawn
on, let's say you are a sales rep and you come to me.
And you know that Doc X over here, Doc Smith over here, is prescribing
off-label, and he's seeing some good results.
And you come to Doctor Jones over here. And you tell him, hey you know your
colleague is really working and prescribing that drug for that
indication. That by the way I know is not approved,
but you should really use it there. The FDA's going to be down your neck,
okay? because you are basically promoting
off-label usage. That's a huge issue.
So they are definitely enforcing that. What they cannot enforce is against
telling physicians, you will not prescribe this drug unless it's for that
indication. Now, in a hospital setting, they have
protocols, and they have to follow protocols.
So again, you know,there is other measures being put in place from that
prospective.
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