Tuesday, January 24, 2017

Five Weeks at Eli Lilly: A Non-Traditional Experience

Posted by Michael Harrison at 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!


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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