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 V
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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
Let's talk about the new business model. the new marketing model basically is the
four Cs, customers, you know. Profiling is going to be very important.
Each customer is different. Which is why I think you know one could
say equal personalized medicine. We are not two alike.
We all metabolize drugs differently. the cost is going to be very important.
And more importantly than the cost is the value.
Do I want, you know, so you're telling me that drug costs $200,000, okay?
And you are telling me it's going to prolong my life for one month?
And I'm still going to be in an ICU? An Intensive Care Unit, hooked up to
tubes, highly sedated, but yet I'll have one more month to live?
I'm not sure that's great value. so that's also going to be very
important. Reimbursement, outcomes trial come
before, during, and after. It's never-ending story.
You can't just say, well, gee, you know, we did one for microeconomic studies and
apply it to everyone. That's not going to work.
Convenience, you know? If you have a drug, and I have to take 20
pills for it, and each pill is a gram which is you know about this larger than
a quarter. I am not going to want to chew on that
thing. I don't want to eat it, okay?
So, I mean, that's another thing, or if you tell me, well the only way I can take
this drug, is by doing a really nice intramuscular injection.
And it's going to be really painful for the next hour, and it's going to swell my
arm, I'm going to think twice about it. And that's why you have compliance
issues. Because people have side effects.
So convenience becomes also very important, it's also important for the
physicians, you know, he doesn't want to see sales rep.
Just send me a link to your website, send me an eDetailing.
You don't waste my time that way and I don't waste patients time.
And then communications, I don't want you to tell me what I need to do, why is it
good for me. I want to know why.
I want to be able to ask questions. I want to be able to have interactions.
You know, if I come and see the doc, I'm going to go and say, hey, you know, you
are giving me that drug, but it really is not working.
And by the way, I did some research and here's what I am finding out.
A two way street. A lot of people have a very tough time
with that. You are questioning their authority?
How dare you. I know it all.
I went and spent eight years in school, did two years of fellowship later on.
And you are telling me that this is not working for you?
You know, I mean, so, same thing. Family is going to be in the same
situation. You know, patient might come and say,
hey, you know, doctor, look, this drug really doesn't work for me.
And by the way, I looked on the internet, and I pulled out the Physician's Desk
Reference product label, and I read it really attentively, and here's what I
found. So, the power, again, is going to be
very, is very important from the internet perspective, and that's where you need to
have communication. Well, there's a new, you know, there is a
new actually, not so new, but there is a site, Sermo.
Which is for physician where there is a lot of discussions that is going on right
now from that perspective. Launch performance, again, at the end of
the day, I told you, it's a matter of sales.
Well, what's interesting in this graph is, when you're looking at this and you
can pay a primary care specialty care. and really, you know, the total,
specialty care usually, the launches are a lot more successful.
Why? Because you address a really a true
medical need, also because they are many, many generic alternatives.
So even if you don't have a generic yet in your class, there might be a class
substitution that can be available. New followup business model, which is
what we see happening right now, and this is fascinating to me.
Everybody's saying, forget the blockbusters, one size fits all, even
though they still dream, could we find one?
Of course, if we can find one, you know, we can get billions of dollars very
quickly. That magic pill is still in the back of
everybody's head. But let's go after the orphan drug
business. There are 1,795 projects in development
as of October 2011. That is a huge number.
More, less than 200,000 people in the U.S.
Total estimated about 25 million people in the U.S.
Again, I don't have all the number on a global basis.
and, you know, what's interesting is that, if you look at the orphan drug
approval, they account for 30% approval in a most recent five year period.
And these are all the things that people are going after and then some.
This is a non-exclu, exclusive list. there is also a number of other
references you can get to. So, a lot of companies, if you look at
how they have been switching their business model, they are shrinking their
sales force. They are shrinking their R and D.
They're becoming a lot more efficient. They are doing, 50% of their R and Ds now
for the outside world, because they realize they don't have all the expertise
in house, they cannot. And they are basically going after on
medical need, even if it's for a small patient population.
Mastering the shareholder complexity. Again, we have talked about all this.
You have to deal with all these people. KOL stands for Key Opinion Leaders.
And you have to work across, you know, the adoption, the acceptance, the
approval. And you have, it, it's really tedious
work on a commercial perspective. So you can actually, when the drug is
finally approved, everybody is onboard, the physician knows about it, the patient
knows about it. The payer, the insurance.
So you have to really have a different perspective from that standpoint.
How do you address the payer effectively? Well there are a number of steps.
you have to identify and understand how the disease flow is for each you know set
of lets say hospitals or clinics and so forth.
Who controls the phone at the end of the day?
You know, you can be sending yourselves for, to see the doc.
If the doc has no prescribing power, if the drug is not on the formulary list,
you waste money, you waste time, it's useless.
First you need to get it on that list, or on that book that says, yes your drug was
approved and the pharmacist agreed. You know, or whoever is the
administrator. and you have to develop dossiers for each
of the payers. and really continue to monitor.
I mean, that's another thing that's very important.
It changes all the time. It's not because two years ago, somebody
told you yes, we will accept another formulary of that profile.
People change jobs. organization goes through reorganization
you know, reorganization, so you have to look at that.
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