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.
Industry Considerations with Phase III Clinical Trials I
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Drug Development
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Industry Considerations with Phase III Clinical Trials, Katie Lyons, Pharm.D. and Kelly Hogan, Pharm. D.
Rencontrer les enseignants
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
Well, welcome. Thank you guys for joining us today.
So today it's going to be Kelly and I speaking.
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 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
III site for us, or a Phase IV site for us.
And then I worked in-house, and in-house I helped with medical strategy, lead
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 are we,
why are we limited by the facts of what we're limited in, when we're looking at
Phase III research, Phase IV 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 commercial colleagues in the companies.
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
and get ready, because we're going to ask lots of questions.
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, I started in
an AIDS clinical trials unit. And then I went to make rounds with a
critical care trauma surgery team. So my academic career started pretty
early. I joined when I was eighteen.
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 III, clinical trial work. So, Katie and I are going to sort of
divide our lectures today to our strengths, so you get the both the
breadth of 26 years of experience, although we don't look that old, I am
certain. So for the, 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.
So part of our training as industry people is public speaking.
So I worked for four years at Pharmacia, was purchased by Pfizer, so four more
years at Pfizer, and every year I worked at Pharmacia and Pfizer, we had to do a
public speaking workshop. So eight years of public speaking
workshops just to be able to go and present to United, Blue Cross, Blue
Shield and the like so you don't sound like a blubbering idiot when you stand up
in front of people. So when you watch all this fun
technology, it's nothing [LAUGH]. Could I have my first line please.
Oh I would like the clicker. >> i will do it for you but you may
have the clicker. Okay.
So our main objective here today is to give you really a flavor for Phase III
clinical trials, what a pharmaceutical company goes through from the beginning,
because I think you have had many lectures on Phase I, maybe preclinical,
in the past, so you're well aware of the statistics that maybe one molecule in
10,000 makes it from an actual chemical compound to a successful drug that you
might recognize the name of. I always pick on Pfizer drugs because
they're billion dollar products so I'll say Lipitor because I have high
cholesterol thank you very much. Still bitter about that.
but mostly interrupt us as we go because there isn't too much that we haven't been
through between the two of us, so if I don't know, maybe Katie has.
Because of the nature of the pharmaceutical industry, you can even
stay at the same company and work for three different companies.
So we have transitioned through many. So with no further ado, why do we do
pharmaceutical research in the first place?
Do you have any idea? I mean.
Is it just to make money? I w, I know I have some pharmacists and
future physicians in the room, so hopefully it is to work on chronic
diseases that we have, correct? So if you are in the United States, we
spend trillions of dollars on health care.
And I'm sure of it, there are economics to be gained and lost, through all of the
aspects of healthcare. But just speaking for a pharmaceutical
company, if you look at Sony, they spent what, maybe, 9 $11 million on research
and development. I think, Apple spent $17 million and you
go all the way to Microsoft until you get to a software company that made it to $9
billion in last year for R&D. Do you have any idea what the
pharmaceutical industry spends maybe just to get one drug to market?
You should kn- -- okay. So if you should know I'm going to ask
for a volunteer or pick on you, whichever you prefer.
Anybody? Volunteer?
>> [INAUDIBLE] That's right, yeah. So the latest figures I have is 1.7, 1.7
billion from 2009. So it's probably up to $2 billion now.
That's a lot of money. I can take a portion of that and be quite
happy. [LAUGH] So, so what are the, what are the
benefits of doing this research inside the United States, outside the United
States? Well, if you think about the world, I
like to go to Brazil every year, because I have friends there.
And they have something wonderful that we don't have, which is the rainforest.
So if you were a pharmacist and you remember salicylic acid, you remember
that that comes from Willow bark. Right?
And if you are in the chemotherapy realm of life you will remember Vitaxol which
is a chemo drug for many different uses. I see many nods in the back.
Thank you. You'll know that comes from yew tree bark
and needles. So if we just stay inside the United
States and we don't look at the ocean and the desert and -- where would we be
without botox for snake venom? I mean, come on!
We're in Orange County! For goodness' sake!
so we have a lot to be gained from doing research and looking for ways to develop
new drugs outside the United States, but a staggering statistic that you might
have heard before too is is that predominantly the money and the funding
and the research all comes from here, majorly dominated in the United States by
trillions and trillions of dollars compared to the outside the United
States. So -- oh, I see.
You have a click there. So why, why medical research?
Well if we spend billions of dollars on heart disease, stroke?
Have you guys recently heard that the, USFDA was generous enough to donate $500
million for Alzheimer's because the baby boomers are getting older?
It is going to probably be a pandemic. And I laugh, because $500 million is
going to get us maybe, what do you think, three trials?
So there's a lot of work to be done because we need biomarkers, and we need
things to improve that disease state on top of hypertension, diabetes, and the
things that we can prevent and take care of right now.
So, when you're talking about heart disease, I think 2009 we spent like $145
million. That's a lot of money.
So economically we have a burden. Impact of disease.
I think that seven in ten deaths are due to chronic diseases right now in the
United States. About 25 percent of people have some sort
of life-limiting impact. In their daily life, just from a disease.
So you guys are young and I'm still young and by golly, I have been playing tennis
and my foot hurts and I twisted my ankle. And I had a thing on my hip and I'm still
young and I'm still out there but diseases will progress right?
And you guys are going to get older too someday, so, I would hope that some of
you would go into research so that when I have dementia you can cure me.
[LAUGH] So I will let Katie talk to you about how we take it from a chemical
compound all the way through. >> So really when we're looking at
this, and we're looking at the commercialization kind of process,
historically when we looked at developing a product.
It was a very linear approach, and a, what we did the first phase, and then you
move to the next phase, and then you move to the next phase and everything was kind
of neat. Now, it's moved in more of kind of a
parallel structure and things are going at the same time when they can.
And, so you see. Different things kind of move.
Now, some of the things that you do have are, you're still going to have a certain
time for the end of Phase II trial, which is the EOP2.
You're going to have the commit to file and you're going to have the commit to
launch. Those are kind of dead points kind of in
there, and we'll talk a little bit about that and how everything evolves.
But when we're looking at the commercialization process as a whole, the
key thing to keep in mind is it's not done in isolation.
And one of the things that is critical that is going on inside the
pharmaceutical company or any other company is that you can't have the silos.
Because if you're looking at anything you're doing, you're doing it by
yourself, the thought process of what you're going to do with multiple minds in
the room is you're going to come up with a much better result.
Right? And so you're, you need all of those
people in there, and you need as you're moving your compound from Phase I to
Phase II and Phase II to Phase III. You really need to be looking at, all the
time, where is this product going to work?
Are we going to get our bang for our buck?
Is it worth the next hundreds of thousands of dollars that we're going to
put in the next phase of research. Are we going to get that money back out?
Are we going to be able to market this? Is it really going to be taking patient
care forward? And the way for that to look at, the
majority of drugs that are out there are me too drugs.
They're not unique. So you have to keep that in mind too and
really what's worth it and how are we going to move forward?
So, Kelly and I are talking about this latter part today.
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