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 I
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Из курса от партнера University of California San Diego
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
Welcome. thank you guys for joining us today, so
today it's going to be Kelly and I speaking,uh, my name is Katie Lyons, so I
have been in and around industry since 2000.
And before that I was a clinical pharmacist, I taught a little bit and so
had a variety of things. So in the industry I was out in the
field. I was working, I was helping
investigators, develop investigator initiated trials, helping figure out,
look at sites, for the pharmaceutical company to figure out if a site was
appropriate to be a phase three site for us or a phase four site for us.
Then I worked in-house. And in-house, I helped with medical
strategy led global publication plans, helped to figure out kind of what we
needed strategically and what questions we needed to ask and how we plan in the
future that way in the medical aspect. And then I turned and began working in
regulatory and in regulatory what you're looking at is from the rules and
regulation aspects. Really what's going on and why do we, why
are we limited by the facts of what we're limited when we're looking at phase three
research and phase four research is particularly what I did.
So if you look at the regulatory realm you have the regulatory requirements all
the way through the spectrum. And I looked more at the end of
commercialization specifically regulations around that.
worked closely with the commercial colleagues in the company.
So, with that, that's the introduction of me.
I'm going to let Kelly introduce herself and she's going to start and then we're
going to have the both of us get ready because we're going to ask lots of
questions. [LAUGH]
>> Good afternoon, my name is Kelly Hogan, I'm a pharmacist.
Came from the Midwest, graduated from Saint Louis College of Pharmacy.
So as I spoke to my mother today, they're expecting an ice storm and I'm extremely
excited to be with you here in San Diego. So its a marked improvement of where I
came from. my background is, is that I started in an
AIDS clinical trials unit and then I went to make rounds with a, a critical care
trauma surgery team. So my academic career started pretty
early. I, I joined when I was 18 and then I
started in the pharmaceutical industry, about the same time Katie did around
1999, 2000 but my whole spectrum of career has been around, phase three
clinical trial work. So Katy and I are going to sort of divide
our lectures today to our strengths. So you get the both, the breath of 26
years of experience although we don't look that old.
I am certain. [LAUGH] So, so for the most part we hope
that you enjoy our lectures and that you get all your questions answered.
So thanks for letting us come and talk to you today.
>> Regulatory was actually more interesting than I was, I got into
regulatory, just FYI because, I was the person in there always asking questions
because I was a medical reviewer in there and I'm looking at this.
And they're saying 'you can do this'. And you can't do that and I was always
going, well, why can't we do that? I mean, you know, well, well, give me
reasons. No one answered my questions
appropriately so I went to find the answers myself.
drug approval requirements. So, we're looking at certain parameters.
We're looking at, is it safe enough given the parameter, you're going to look and
your approval's going to be based on that phase three population.
So, if you looked at a patient population that was narrow then your indication's
going to be narrow. And and if you sometimes, the other thing
you have to consider is if you evaluated the surrogate marker instead of a
clinical marker then you might get a different type of approval.
What's called a subpar H approval. And you won't get a full approval until
you have more data. So those are other things to kind of keep
in mind. And why that's important is in the
subpart H approvals. FDA has to approve and look at all your
materials before you can send them out and try to promote on them and all those
things. So, but you have to have the adequate
manufacturing, your labels has to be appropriate and it's all going to pend
again on how those studies are designed. And so this is the one I wanted to
change. How did FDA gain the authority?
So this is back where we're getting into the attorneys, so the attorneys are
going to love this slide. [COUGH] There's always typically some
political thing that's going on, right? So, in 1906 we had the Pure Food and Drug
Act that was passed. You know, we're trynig to prevent the
snake oils and all that stuff from going interstate commerce, right?
But the problem with that law is there was no teeth.
There was no way if someone violated that law that you could actually hold 'em
accountable for violating that law. So there's tons of people upset about
that and you heard it was going around around in congress and they were trying
and they were looking for something to go and looking for something to do.
And how do we get this through? And how do we make it a better law?
They couldn't get it through and they couldn't get it through.
Roosevelt people in his cabinet we're trying for years and it didn't happen.
Well then this thing happened and, and this will happen again and again and you
guys have seen it recently even. If something happens where death is
involved especially death of kids, people's ears seem to go up and they seem
to pay a little bit more attention. Well, in 1937, a 107 kids died because
they used antifreeze as a solvent. Not the best choice you would think now.
But, you know, it's [LAUGH] they used that tasted good.
>> Oh yeah, yum. So anyway, we have results and the effect
that we have is the Food Drug Cosmetic Act.
and then what, what happened with that, is this was the first time that a drug
actually had to be safe. prior to the fact that you could market
it. crazy but true.
And so what this was doing is this also then is really what really established
the FDA. And so this is what you'd be in to
establish that kind of regulation on a regulatory effect that kind of went on.
Now a lot of regulations that actually came out of the FDA and how you were
actually regulated in the promotional real with drugs actually came to be
written after the 1962 key for Kefauver-Harris Amendments.
And what happened with that is there's a lot of push Sulfanilamide was causing
some birth defects in Europe and it was up for approval in the United States.
And they prevented based on all of that, they prevented the approval in the United
States. And we saw the changes in the amendments
there. And here we're dealing with they have to
be effective and safe. And that's where we, we saw some changes.
But amiss is then where we began to have the regulations, as I mentioned, for, the
promotion and what related to that. Now, what we see then Is we have the
Modernization Act of 1997 and this deals with how you talk about products and can
a pharmaceutical company communicate about a product before it's launched.
And how do you communicate that way? But the other thing that's very important
is with the laws, no, no that you guys need to think about is and it's going to
actually I'm going to wait on that because it's going to come up on the next
thing. So here the New Drug Application.
So that's the NDA. And when we're putting the NDA together
we're going have again another meeting with the FDA.
We're going to say here this is my packet.
I'm going to give it to you a month ahead of time.
I have all my stuff here. I'm going to have all the clinical data,
I'm going to all the pre-clinical date. I'm going to have all the statistics.
It's this huge file. And you're going to talk to them and
you're going to say is everything in here?
So FDA has three different stages when they do that.
They're going to have this receipt. So, you're going to send it to the FDA
they're going to check to make sure they've received your million-plus pages.
And then in 60 days they're going to say, yes, we've received them.
Then, they're going to kind of look to make sure you have all the main
components. Once you have all the main components,
they're going to say yes, you've filed. And then what they could also do too is,
say we are refusing to allow you to file this because there are key components
that you need in this submission, that you failed to submit.
>> Katie, if I am on Novartis and I am watching Pfizer, what goes public?
So if I want to spy on my competition, what part goes public?
>> You will notice, well, the press releases are going to go public, right?
because those are considered and then you will see a notification that a submission
has occurred. You will not see anything after the fact
that a submission has been received anything on how that process and review
is going until it actually occurs. So these are some of the contents again,
like I had already talked about all that preclinical duff, all of the
pharmacokinetics, all of the clinical information.
Any of the patents because it's very important the attorneys can fight over
the patents later. I mean, and the proposed drug labeling
and the proposed labeling, I'm actually working on a product now with a company
and how long do you think that proposed label is?
Have you guys seen any labels lately? The proposed label to the FDA is 51 pages
long. Now that shows, if that's the main thing
that a physician uses to gather their data about the product.
Last time I checked most physicians do not have time on their schedules to look
at 51 pages, to really analyze [LAUGH] 51 pages to get what's going on.
And that was part of what was also seen with the physician drug labeling changes
that happened eh, about ten years ago.
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