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 II
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Do curso por University of California San Diego
Drug Commercialization
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Marketing Pharmaceuticals & Biotechnology Drugs, Williams Ettouati, Pharm.D.
Conheça os instrutores
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
So let's talk about Product Positioning. Product positioning, brand positioning.
So you want a clear target you know Coke, Nike, everybody knows what that is.
Apple, everybody knows what that is. Well, with your drug, you want to be able
to do the same thing. The blue pill, I'm not sure if I talked
to you about the blue pill, you guys are going to have a smile on your face.
The means you know what it means. Why?
Because it was a great marketing campaign.
Okay. So, marketing is also going to think
about, I want to make sure I'm going to be recognized.
I'll tell you what. The payers could care less.
So you play on emotions. you have to define what the product is
and does. Well, the FDA, you know, once you go and
negotiate the product label, that's going to be in, in the Physician's Desk
Reference. The FDA is going to tell you, well, this
is what it does and this is what you are going to basically advertise.
And yeah, I'm not going to be able to deviate from that.
And then, you're going to have to really convince the audience about what other
benefits. And what is the value that your drug
brings to the patient, the physician, and the payer.
In addition to this, you must address all these questions.
I'm not going to read them for you because you can read them faster than I
can. But one other thing that's very important
from my perspective is that it is relevant to all the target customers.
So here's the magic word that a lot of people forget when they do marketing.
They think, product, product, product, product.
Guess what? The most important is the customer.
So that's one of the first C, by the way, okay?
If you keep in mind the customers, and in that case the customers, one of the big
customers is the patient. You're going to be a lot more successful
in your marketing campaign. Okay?
Because people don't buy products just because the product is cool.
They buy it because either they need it or they can benefit from it.
Let's talk about the place and market. Well, the place definition of the
markets. Let's segment the key customers.
You know we've been talking about personalized medicine.
Who are we marketing to? You're going to have different strategies
for the patients, for the physicians, for the payer.
They are all going to have different needs.
Yet you are all addressing these different needs with that same product.
But you're going to have to have specific strategies for each one of these
segments. Obviously, you know, you want to identify
unmet medical needs. I mean, Doctor Crot showed you, gout had
not been a single new drugs in 40 years. I mean that's a fantastic market to come
in. You are basically dealing against the
generic. Which, yes, I mean granted it's cheap,
but we also saw, that the generic didn't work very well.
Well, if you have a drug that works better, and works in other patient
population, well, nobody is there. So, some of the ideal things I showed you
earlier, about the ideal product profile. I'm going to be first in class because,
you know, 40 years to launch a new drug, I would consider that first in class.
And second of all, you're going to have, you potentially can be best in class
depending on where the competition is behind you.
No, if everybody's falling behind you and they're all going to launch within a
year, then, it's going to be a different story.
the other thing you have to think about is am I going after a specialty market,
like oncology? Am I going after orphan diseases?
What am I going after? Benchmarking is critical, you all know
about this. You don't start, you know, I'm not
going to launch another cholesterol lowering agent that is no better and has
more side effect than Lipitor. Why?
Because it's generic today and everybody is going to prescribe Lipitor.
Therefore, my drug would never make it. So, again, you have to think about the
competition. And not just what is on the market today,
but what is going to be on the market when I actually launch my drug seven
years from now. So I have to do competitive intelligence
looking at what's in the pipeline, not just in big pharma but also in biotech.
The beauty is that most of the clinical trials have to be reported so you can
actually look at what's going on. the other thing is you have to define the
value proposition. You know, what do we have.
Is it one of those for-efficacy safety dosing from microeconomics?
And then you have to develop what is called the S.W.O.T analysis.
And that's not a special police force. its called Strengths, Weaknesses,
Opportunities and Threats. And you guys look at marketing, I don't
have a lot of time to spend on this but that's also a very critical.
for you to develop the business plan of the drug, okay?
Just to give you an idea, and I think I showed you a slide that was not this
similar to this in the past. But I found this was quite interesting
that was published in December 2011 by IMS.
Is if you look at the growth, the percentage in growth, and you look at the
generic. This is in the US you know, this is where
the growth is. The other one, if you look interestingly,
is in biologics. So which is also why a lot of farmer
companies have moved their business strategy from going after, y'know, the
pills to the biologic side, which is growing very, very aggressively.
and that's, that's definitely even interesting, so you have to keep that in
mind as well. The market shift in pharma is an
strategy. We move from the GP to the specialist,
they are going after a lot of orphan indication.
Some of these N of 1 cancer patients that were discussed about before, where you
want to develop you know a specific drug for a specific patient.
Well, I mean that's, that's really personalized medicine.
The issue with that, and that's another thing we'll talk about, is how do they
get reimbursed? How do you your clinical trials if you
have a very, very small population ? So the FDA is also going to have to think
differently than how they are thinking today.
well, why has this switch happened? Why do see all these companies where all
small molecule, large market, like you know, Plavix, like Lipitor like a number
of others. Why do you see all these drugs basically,
who have gone now generics, all these companies now moving towards the
biologics and the orphan drug disease and the small market niche?
Well, it's very simple. There is no generic erosion.
I told you, biologics we had a lecture on that.
There's no clear rule yet as for bio stimulus in the US market, okay?
In other markets, its already happening. Question?
>> Well, from the orphan drug market, you have exclusivity advantages.
>> That's correct. That's correct, you have exclusivity
advantageous. But also, its really rare that two
companies are going to go after orphan disease up until now, that I believe will
change as well. Okay, but there is still a lot of orphan
diseases that can be addressed. So, I think there is still a lot of
things that can be done, where you can be the sole produst that's going to be
launched in that area. it's a lot cheaper.
If you think about it, you know, we a, always throw, and you have heard the
numbers from $3 billion to $1.3 billion. well, if you have a patient population
that's a thousand, let's say, and you do a trial that's maybe 50 patients, well,
it's not going to cost you $1.3 billion to get it to the market.
All right. So that's another thing, it's going to be
a lot cheaper. You're also are not going to have to have
a huge sales force. You're not going to have a huge marketing
budget, because the people who are treating that disease are in very
specific centers. So there again, it's going to be much
better. The FDA is going to, going to give you
also a fast track approval. Because you are meeting a true and met
need, you are the first drug in that area.
And as long as you don't kill the patient, and you have some efficacy, you
are more likely to get a, to get it approved.
These are some of the major changes, and I've given you a link to all these
reports. that you know impact, there were negative
in the short-term but potentially will become positive.
you know, what's interesting to me if you look at 2010 versus where we are going in
the future and we are here somewhere around 2013.
on the down side, you know, your Medicaid debates are increasing annual fees.
The physician payment sunshine rules which we went over.
There is some upside in terms of that there's a reform of insurance practices
with Obamacare. but there is also expanded coverage.
So now, we have 45 million patients, I believe, in the US.
Which is, by the way, the only country in the world in the, I should say the
developed countries. Where you have so many people with no
health insurance, zero health insurance, which means that they start to pay cash,
okay? Everywhere else in the world, you pay
through your taxes. Don't get me wrong.
I grew up in France, so I know all about taxes.
but at least if tomorrow, you lose your job or you become disabled, you don't
have to sell your house, sell a kidney, so you can actually get treatment, okay?
well, with the way, you know the US is, has realized that having, you know 45 to
50 million patients uninsured is an unsustainable business.
Because a lot of these people shop in the emergency room and they can't be turned
away. Rightly so, because we're still ethical.
but at the same time, that's not long-term care, and that's only a band
aid on a hemorrhage. So, that's also going to change and, you
know, that's also one of the other things that.
Pharma is going to have to look at. The Biosimilar regulatory pathway will be
really interesting I think. You know, I mean it's, it's one of these
things where I believe it should be up here on the upside.
Because from my perspective, it's going to make the market a lot more efficient.
Let's talk about price, and that's a very difficult area.
so I told you Generics reached an all time high in market share.
I mean if you look at this, that's really impressive.
If you look at the dollar, they are still only less than 20% of the market.
But in prescriptions, they are now almost achieving 80%.
Okay? Actually in 2013, I believe they are over
80%. very very interesting.
Obviously this is something that, you know, a lot of countries and a lot of
governments are pushing.
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