So I'm Sascha Ellers, and I'm the Director
of Clinical Operations. I'm from San Francisco, California.
>> All right. And what does a director of clinical operations do, exactly?
>> So I work with physicians and researchers to run
clinical trials. I take the ideas that the clinical staff, the,
the physicians have with a protocol and I work to implement
that protocol. So I will go out to key opinion leaders,
which are most likely physicians try to recruit them
to participate in the study. I will work with
data that comes out of the study so data
that's from the patients that enrol in the study.
I do monitoring which is basically verifying that the
data that's recorded for our study is accurate and
matches what the data looks like in the patient's
medical records. and then you know all of the,
all of the work that it takes to oversee the study it's
a regulated environment. So it's regulated by the FDA or, if, if, in
some cases research isn't regulated by the FDA but it's always regulated by
good clinical practice and international guidelines
on how to take care of patients.
>> So you have to actually be informed of a
lot of different things to be able to carry this out.
>> Yes.
>> Now for those people
who may be slightly unfamiliar with how clinical trial works, or even what
one is, can you tell us just briefly the significance of a clinical trial?
>> Sure. So, any time you want to test an intervention, be it a drug,
a diagnostic test, or even just changes
in behavior, you want to show that there's
actually a difference, you want to run a
clinical trial. Because that's going to give you
the gold standard. to show you that
there's a difference with your drug or intervention.
So the, the clinical trial itself is a way to ask your question prospectively
design your, your experiment in humans and then implement that study.
>> So this is sort of like the, okay prove that it works kind of thing.
>> Exactly.
>> And this process you said itself is regulated by the government?
>> By the FDA correct.
>> By the FDA. and must you pass a clinical trial to
carry out your test or your diagnostic or whatever you want to
do, is that part of the requirement of ever selling your product?
>> It, it, it depends. so to, to back up there're, there're three phases
of clinical trial development for a drug.
There's phase one where you're looking for your
safety. So you gotta prove that you're not going to do undue harm to people with
your drug. And then in phase two,
you're further refining your safety and you're starting
to look at efficacy.
>> Mm-hm.
>> And then phase three are your large
efficacy trials where you're treating a lot of
patients with the drug at that point. so
that's kind of the basic methodology but then, within
that context, yeah, there is, it is regulated by the FDA. They do have a say in
what they're going to accept from the phase
three trials as something they are willing to approve.
>> Mm-hm.
>> And so, a lot of effort goes
into pu, putting together a study that's going to
meet their requirements.
>> Sounds like it takes a lot of time to do this.
>> Yes.
>> so it's sort of a big commitment from anybody interested.
>> Big commitment for companies, a lot of resources go into these
trials. In academic settings a lot of resources will go into these, these
studies as well. A, a recent example that's been approved is a drug called
Zelboraf. That looks at mutation in the melanoma cancer, called V600E. So
it looks at this mutation and says if the patient is
positive for this mutation, that if the cancer is positive for
this mutation, this would be a good drug for the patient
to try. And if they don't have the mutation, they're probably
not going to respond to the drug at all. So this is
a great example of using genetics in in a clinical study
to select patients. But you can also use the genetic information
to stratify patients if you want to compare patients with the marker
to those without. So it would just be a marker that would be used to look at how
you could break apart those two groups to look
at who did better or, or not in that case.
>> Right, and you said, so that's an example of something
that sort of went through this process and has been approved?
>> Yes. Part of the problem with, with clinical studies is that
you're, you're confined to the population
that you're testing them in. So sometimes
we'll see a signal where we look at the entire data set.
There'll be a signal in a subset of patients, but you don't
really know why you've wasted a lot of money on a negative
trial. One of the opportunities that genetics provides, is to help us
get the right patient on the right trial so that it increases
the likelihood that we're going to have a positive outcome for the trial.
And decreases the risk to the patients, or subjects, of being exposed
to treatments that aren't going to help them. So I think that that's
one of the most exciting things about the future of, of personalized genetics.
>> Mm-hmm.
>> In looking at developing drugs and treatments.
>> Tell us a bit more about your background. How did you get to be a director
of clinical operations? What did you study in
school? What did you do before you got here?
>> Yeah, so I have a bachelor's degree
in Biology. When I finished school, I didn't
really know what I wanted to do. I felt really lucky that I found this this
world of clinical studies so I, I, started
out in the CRO, Contract Research Organization. So
these are companies that serve pharma companies, by
helping to run the clinical trials, this is outsourced.
>> Mm-hmm.
>> To that group, and so I I had my first job in, in a company like that and
from there came into biotech and pharma and diagnostics. And
I found it to just be a lot of fun.
I like to solve problems, right? So it's a great place to apply that.
>> So it sounds like you really get to in, in your job, you really
get to sort of be exposed to a lot of ideas and subjects that deal
with genetics. But you also really get the sort of, I guess I like the,
the verb, wallow, in the, the ethics, too.
And really have to be concerned about procedure,
you have to pay attention to detail, you've got to sort of know
technically what's going on. But you've also got to be able to remember
where you are, and what you're doing with regards to okay, this is
a human study, and these are all the things we have to go through.
>> Yeah, exactly.
>> in general, how would you describe, how difficult is
this job, do you think, compared to other jobs, er?
>> It's difficult, probably, in a different way than somebody who's actually
crunching the data. We have to think through problems
like sometimes we'll have a study that it's, it's well
designed, it, it could yield great data. But we just
can't find the right subjects that want to join the study,
so then a lot of effort goes into recruitment planning
for the study. I've never worked on two studies that
have the same problems, they're always different. So and then,
you know, it builds on it itself. So you learn,
okay we gotta have recruitment plans in place before we start the study.
We've, we've got to think through how we're going to ensure quality data before
we start the study. All of these things that kind of become part of
the methodology, but yeah, every study has
its own issues and the landscape changes.
>> Mm-hm.
>> Early in my career I worked on a drug called
Sutent. I've worked on a phase one study of Sutent in gastrointestinal
stromal tumors. and so when I saw that it was approved, i
thought that was really exciting, I also worked on a drug called Pertuzumab.
>> Mm-hm.
>> it's called Perjeta and it's approved
for metastatic breast cancer, so that's been exciting.
>> If you, if somebody's watching you right now and they're super excited
and they're like wow that sounds like a really cool kind of job.
>> Mm-hm.
>> What advice would you give them to either learn more or
[COUGH].
What advice would you give them to learn more,
or to possibly become a Clinical Operations Director themselves?
>> I guess that the main advice would
be not to just focus on drug companies, to
look across the board for other places that are
running studies, and see if there are opportunities there.
>> Would you recommend anybody who's interested to try
to get work experience before school experience in this?
>> I think work experience is the foot in
the door that will help to land the job,
yeah.
>> And what kind of work experience exactly?
>> so there're entry level positions to running
clinical trials. They're, it's called a clinical trial associate.
>> Okay.
>> but also background in a, in a physician's practice that are,
where they're running studies is another great way to get exposure to it.
>> Well, thank you so much for joining us,
and you know, wish you the best of luck continuing
your clinical operations.
>> Thank you.