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.