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Tuesday, January 24, 2017
With the majority of my clinical experiences under my belt, come
October it was time to drive the four hours to Indianapolis to begin my
rotation at one of the world’s largest pharmaceutical companies.
Lilly, like most
large companies, specializes in a handful of therapeutic areas: oncology
(gemcitabine, pemetrexed, cetuximab, among others), neuroscience (the largest
Alzheimer's development program on Earth), diabetes (Humalog, Humalin), and
bio-medicines. The Bio-medicines unit covers a handful of smaller focus areas,
including men's health, cardiovascular, pain, and others. While they have a
global presence, their headquarters in Indianapolis also houses most of their
production facilities, which I will discuss more later. For more background on
Lilly, here is their
Wikipedia page.
I had no idea what
to expect going in--my preceptor is a clinical research scientist in Early
Phase Oncology Clinical Development. I would quickly discover what that means!
Day 1:
I stayed about 20
minutes from Lilly's technology campus (about a 10 minute drive from their
headquarters) at a friend's house whose family generously offered to allow me
to stay with them (great coincidence!). The day began with a few hours of
onboarding (filling out paperwork, safety training, etc.) after which I drove
to the main campus to meet my preceptor.
All of the
buildings on the main campus are connected underground, including the parking
garages! The campus is massive--with restaurants, dry cleaning, a bank, a gym,
track, and soccer fields, and other amenities on-site. We spent most of the
morning discussing my preceptor's role and where I would be fitting in. It
breaks down like this:
My preceptor is a
clinical research scientist. As a PharmD in this role, he is responsible for
the day-to-day operations of his clinical trials. This could mean ensuring
enrollment is on-track, monitoring incoming safety and efficacy data (blinded!),
and importantly, answering clinical questions from the providers at the research
sites regarding eligibility, enrollment, side-effects, clinical management, and
anything and everything in between for any of the sites scattered around the
world.
Outside of the
Phase III trial he is responsible for, he is required to put on his early phase
hat from time to time. This might mean working with the pre-clinical
development group to identify promising leads or providing recommendations for
unmet medical needs that could drive a new project, authoring study reports,
protocol, or manuscripts, or designing trials. This is a role with an
incredible diversity of responsibilities and work types--perfect for precepting
a student!
Day 2 and
Beyond:
Typical days
worked like this: I could arrive anywhere between 6 and 9 AM, staying until 3
to 6 PM. I was issued a company laptop that allowed me to work from home
provided I had no in-office responsibilities (though I always cleared these
days with my preceptor). I opted to arrive early and leave early to avoid the
minimal traffic that Indianapolis developed along my route.
The work environment is highly interdisciplinary and they use an
open-office environment. With your laptop you can sit more-or-less wherever you
would like, lock into a dock (with a large screen and peripherals) and work
there all day or move around. Few people have permanent desks but there is tons
of space to sit a group around a table, and space to work alone for a while if
you need to as well. I was struck by walking down the halls and overhearing
conversations by engineers, pharmacists, statisticians, physicians, PhDs of all
flavors, and more!
My major projects
could be summarized as follows:
Safety
Monitoring or Other Reporting:
As I have a
computer science background, I asked for data-centric projects where possible.
I was routinely given blocks of data to crunch and provide recommendations.
Usually, this was blinded adverse event data from a trial. With pivot tables
and a little VBA these usually went quickly. Other reporting included analyzing
concomitant medications and correlating those with outcomes, or doing
demographic breakdowns for relevant groups. Notably, one project had me examine
the different subtypes of cancers in these trials and examine the rates and
locations of metastasis and correlate these with other relevant biomarkers--are
there patterns? Are these in-line with literature, if it exists? Clinical
trials are valuable sources of medical knowledge even outside the medication
they are testing--we've learned a lot!
Medical
Information and Writing
A major responsibility
of the CRS is medical writing--whether that be trial manuscripts, clinical
study reports (a data summary of a clinical trial), or communication with
healthcare providers. I was tasked with authoring a manuscript for a Phase I
dose-escalation trial that had not yet made it to publication. I had the
opportunity to dig deep into a clinical study report, learn a disease-state
inside and out, and work with the primary investigators (physicians and
pharmacists) to report what they had found. When I left, the study was squarely
in the hands of the medical writers who were polishing and editing the final
draft!
As part of the CRS
role, my preceptor received anywhere from 5-10 eligibility or clinical
questions from the research sites worldwide. He passed many of them on to me,
where I was responsible for evaluating their question, examining the protocol
and literature where appropriate, providing a recommendation, and drafting a
response.
Protocol
Authorship
My final major
project was built around a handful of pre-clinical compounds that Lilly had
been working on for some time. They targeted a genetic mutation that is
believed to drive the growth of several cancers. It was left to me to examine
the literature and define where the greatest unmet medical need existed;
meaning which cancers lack available treatments and have high rates of
mortality (e.g. pancreatic cancer) versus a cancer that the mutation might be
less common in, or the cancer has powerful existing therapies available. This
was much more complicated that I initially expected, given that even
identifying people with the mutation consistently was a problem. What assays
should we use and how do they work? There were over a dozen methods that were
not correlated with each other, and then attempting to work out how they
correlated with outcomes was another hurdle.
This culminated in
authoring a protocol synopsis: taking everything I had learned and transforming
that into a study summary including information like: what cancers, who are we
targeting, how do we identify them? What inclusion and exclusion criteria
should be used to that effect? What are the treatments we'll use? What study
design? What endpoints will be used and how are they measured? And much, much
more!
Other
Lastly, Lilly has
a structured program for visiting P4 students where you will meet dozens of
practicing pharmacists from roles all over the company. There were usually 2 or
3 weekly, plus any other one-on-one meetings that you could schedule anywhere
you'd like. One of the pharmacists works in the manufacturing facility, so we
got a tour and saw how many of their drugs are made! Incredible to see!
I had a wonderful
time at Lilly, and now there are even more opportunities to go! I hope this
gives you a good idea of what I did while I was there--I definitely learned
that this is where I want to end up!
Michael Harrison
(mhar)
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