The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Development 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 development. In this course you will learn the different stages of clinical development as well as the regulatory including but not limited to, an Investigational New Drug Application (IND), New Drug Application (NDA), and product labeling. Additionally you will learn how to Incorporate study design methods for consideration in the design of clinical protocols to assess safety, tolerability, and efficacy in multiple therapeutic areas. In this course you will learn the different phases of clinical development: * Phase 1 or early stage clinical trial are conducted primarily to determine how the new drug works in humans, its safety profile and to predict its dosage range. It typically involves between 30 and 100 healthy volunteers. * Phase 2 or Proof of Concept POC studies test for efficacy as well as safety and side effects in a group of between 30 to 200 hundred patients with the disease for which the new drug is being developed. * Phase 3 or late stage clinical development involve much larger group of patients, between a few hundred to thousands, depending on the indication, which will help determine if the new drug can be considered both safe and effective. It will involve control groups using placebo and/or current treatment as a comparison. * Product registration and approval process after a drug is considered safe and effective from Phase 3 trials, it must be authorized in each individual country before it can be marketed. All data generated about the small molecule or biologic is collected and submitted to the regulatory authorities in the US at the FDA, Food and Drug Administration FDA, in Europe the EMA or European Medicines Agency, Japan Ministry of Health and other countries which may require their own national approvals. This course is intended as part 2 of a series: Drug Discovery (https://www.coursera.org/learn/drug-discovery), Drug Development and Drug Commercialization (https://www.coursera.org/learn/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.
New Drug Application, Filing, Product Labeling VI
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來自 University of California San Diego 的課程
Drug Development
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New Drug Application, Filing, Product Labeling, Kelly Hogan, Pharm.D.
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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
Is increasing the spend on pharmaceutical trials?
Increasing, should the, should the pharmaceutical companies increase the
amount of money that they are spending. In order to shorten the time in phase 3
and phase 4 trials? Is that the answer and, and the way to
get drugs out better drugs out faster and get the approvals that they need to
market. >> If they are smart they start with
easy money, right? Hypertension, stroke, diabetes,
depression, obesity, Alzheimer's they start with the biggest chronic illnesses
because that effects the largest number of patients.
So, when I left Pfizer, their infectious disease division was almost closed.
So, what happens to all of us when we get the flu?
It's a virus, we rely on vaccines. So, what we're seeing is research and
development dollars for the lesser, more profitable disease states going down and
down. And what we're seeing is the answer is
not throwing more money at it. It's trying to find these novel
biomarkers to shorten our clinical trials and find other markers that are
acceptable. So, if you're Alzheimer's, you're looking
at beta-amyloid. And if you can, you know, change the
[INAUDIBLE]. We don't know if [UNKNOWN] is what is
actually causing the dementia of age-related dementia.
Or, there was like, 90 different types of dementia out there?
So, I don't think that spending more money will find us more drugs.
What I think will help is if we find a more efficient way to bring these drugs
to market. >> Well you have to consider to, when
you're looking, you would have asked about how many are me too, versus how
many are novel. If you look at the majority of drugs, 80%
about, 75% about of drugs they are submitted down to the FDA.
More than that, probably, actually, are what they call me too, are similar to
something else that's out there. And those innovations, a truly innovative
drug costs more money than a drug that is not truly innovative.
So, that is something to keep in my mind. Now you also have, then you also have the
generic comparators. And when you're looking at a generic
product you have to keep in mind that the blood levels and everything.
They don't have to do the clinical trials, they just have to do blood level
trials and it has to be plus or minus 20%.
So, that's why things like a synthroid or something that has a very narrow
therapeutic range. They say you have to stay on the same
branding name period because that fluctuation will be problematic.
>> Or start with the generic. >> Or start with the generic yeah, you
have to, whatever you start with stay on that same line.
But other products like [INAUDIBLE] were the therapy level isn't as an important
you have to maintain above level but then a generic makes more sense.
And so you have to consider those types of things as well.
And you have to consider Amgen is the biggest what you know, biotechnology
company. They have decided that they're going to
start making generics of, of biotechnology drugs.
Well, it makes sense to their strengths, right, because they already know how to
make biologic products. But, it, it, it's, it's, you know, it's,
it's different than what a lot of people would expect from a, a company like that,
right? But when they did their, their analysis
of, of what's the cost in order to make a new drug.
And a novel drug versus just doing the generics when we already have mat, when
we've mastered that manufacturing technique.
It's better for it, our bottom line to go this route.
>> And I don't know if you heard that magic word Katie just said but, I moved
from drugs to biologicals about two years ago.
And the patents are different on biologicals compared to chemical
compounds for drugs, right? Because the manufacturing process is so
much more in depth and complicated, so the FDA gives us more patent life because
of that. It also makes you less likely to be
purchased by another pharma company. Because who could afford to buy you and
do they want to get into that space. Why would you want to buy Amgen?
Why would you want to do that? But, the biggest threat to my portfolio
now are synthetics. and new technologies to develop biologic
drugs in a mass produced way more like a tablet and a capsule.
So, things were starting to get really interesting out there and technology
plays a big part in that. >> Technology plays part in that but
what are the other things they consider with a traditional product versus a
biologic product. if you look at biologic products,
biologic products are more likely to hold a black box warning.
So, they are more likely to have serious warning associated with those drugs.
>> And so that risk benefit analysis, whether its in development or whether its
in prescribing later, is going to be very different, than a
[INAUDIBLE].
>> [CROSSTALK] >> molecules.
>> I have a back box warning, thanks to my competitors.
We had a safety signal from them and then it scares all the, they pulled all of us
off the market in 2008. And then tested all of our drugs, the
respective companies, based on the adverse event of that one.
Didn't find it in any of the rest of us, but we all got a black box warning
because of our competitor. >> And a black box warnings' what you
see with those warnings the label of what you see.
In order to get something in we've been talking about what is required to get in
to your label efficacy wise. The requirements to get into your label
safety wise are much much lower and. >> Much.
>> [LAUGH] Much lower and what you'll often see happening on that safety
parameter as well. Is that the FDA will do class labelling.
So, anything across that class, it might not happen with your specific drug, but
there's theoretic potential. And so we'll put that warning or that
safety thing across there. >> It happened with the quinolones,
right? Levaquin had that calf muscle pull and
the Achilles tendon thing that happened a couple years ago.
And they put a class warning out for all flouroquinolones that that could happen
that was relatively new. >> Well I mean, even like the SSRI's,
you know, the suicidal Behavior or Homicidal kind of behavior thing.
those were going to be class, kind of labels you'll see with the FDA.
>> What d you think about those fines, the FDA levies in us?
Do you those are exorbitant and ridiculous or do you think they're doing
it to try to prove a point? >> Which [UNKNOWN] [CROSSTALK] ?
>> What, the three billions. >> The settlements, that's actually the
DOJ. >> True.
Department of Justice. [LAUGH].
>> The are doing their job, I think the finds are growing, they have to they're
trying to be a detterant. But, maybe the pharmaceutical companies
have just adapted that to be part of their business model.
That's the big discussion. <<There is a big discussion on that, and,
and I hear last year, I'm, I'm part of a, a a, Federal drug law institute kind of
thing. And I was at a recent meeting, and
someone from the OIG, which is the Office of Inspector General, was looking at
that. And was looking and addressing this main,
this exact question. And one of the things that they're
looking at doing is going after individual people.
[CROSSTALK] >> Individual people.
At the companies. >> At the companies.
>> Criminal. >> Criminally.
>> Like the head of my medical affairs department.
They would just cuff him and take him. >> Put him in jail.
>> The head of marketing, cuffed, jail. To try to deter them from being so
aggressive, blatantly aggressive. >> Yeah.
Blatantly aggressive. So, they're looking at other options to
in order to try to see what would happen. And one of the other things, one of the
main things you have to keep in mind with this, and with these litigations, and
with these settlements. The main reason that the pharmaceutical
companies are settling is they're not, they're going to jury trails.
You don't hear any of these in jury right?
But if they go to jury trial and if they're, if it's settled against the
pharmaceutical company. Than they're no longer eligible for
reimbursement for any of their products from the pharma, from the government.
So that's a real deterrent. [LAUGH] So, that's why they are paying
these settlements. So, there's, there's lots of intricacies
when you're dealing with the business aspects.
And so we hope that this, you know [CROSSTALK].
>> Give you a flavor. >> Some of these things, give you a
flavor of all the different aspects that need to be thought of.
