Clinical Trials – CA Work Experience Program

Day 6 – Shipping Out!!

Today was actually quite the action-packed day! As soon as I entered the office this morning, I headed straight to the conference room to meet Kaitlin, DeShara, and Taylor. DeShara and Taylor put together a 2-hour presentation on what they do in Clinical Operations. They both do a lot of the miscellaneous stuff. However, they seem to enjoy it a lot! It seems like they get to do a lot of various tasks such as going over contracts, invoices, and making budgets. Their jobs are essential to the well-being of the company. Taylor and DeShara are also hilarious. We were laughing for the majority of the presentation! They also have a very funny relationship. Through them, I realized that wherever you end up working, you will always make friends that can make your time there worthwhile. They also showed me a picture of them fighting over coffee which was plastered throughout the office quite some time ago (see funny picture below). I look forward to making these sorts of friends when I have a job someday!

After the meeting was over, Kaitlin and I went to get Erika so we could review our graphics and tables we made from the Brachyury data. Erika liked mine for the most part, but they do need some editing. I accidentally used the repeated data that made it look like there were 2000 people in the study instead of 10- whoops! Kaitlin made the same mistake in some of her visuals too. We can change our SAS code for that tomorrow. As 12 approached, we became more and more excited. Today, we were to go to ALMAC, the storage facility for Bavarian Nordic’s products. However, we decided to stop in downtown Durham for lunch. We met Janelle and Stephanie at this cute sandwich shop. Stephanie is stationed in Munich and is here on a business trip for the week. It was so nice to meet her! Over lunch, I learned that she is originally from France, speaks 4 languages, and used to work in a lab. I always thought that careers have these set paths that you must follow, but Stephanie showed me that there are many ways to get there. I also learned that you do not have to stick with one career your whole life.

After an enlightening lunch, we drove off to ALMAC where we were greeted by Lori. She is the person Janelle is in contact with concerning Bavarian Nordic’s products. After speaking with her, we were able to get a tour of the facility. When the warehouse manager came to greet us he said “I didn’t realize it was bring your kid to work day,” which was only kind of really upsetting. Brushing his remark off my shoulder, I focused on the tour. It was so cool to see all the precautions with handling and shipping medicine. We also got to peek inside one of the assembly rooms for the vaccines. I imagined it to all be automated by machines, but it turns out humans have to do it! I felt bad for the people who had to do it, though, because they have to be in a windowless room for hours on end in complete silence. All these measures are taken to avoid distraction and mistakes. Once we were done exploring the facility, we thanked Lori and the warehouse manager and headed back to Bavarian Nordic. Tomorrow, I have to get up bright and early to help interview another candidate for the job opening!

Day 5 – Finally, Some Data!!

Today was not the most eventful day. When I arrived this morning, I found Kaitlin sitting at her desk. Then, I asked her what we were doing this morning. She wasn’t so sure either, so we went to find Erika. Erika explained to us that Kit, the IT guy at Bavarian Nordic, came back from his vacation today so we would finally be able to install the software we needed to view the Brachyury data. We had been trying to get this software since last week! However, she told us Kit was currently in a meeting so he wouldn’t get to us for another hour. In that time, Kaitlin and I looked through the study details, which were hard to understand. We did this for about two hours when we realized Kit hadn’t helped us yet. Unfortunately, someone else needed his help and that was more pressing. Therefore, we kept reading for a while longer.

When Kit was finally able to help, he was able to get the software up and running in about 10 minutes. By that time, we were ready for lunch. After Kaitlin and I ate our meals, we were finally able to view the Brachyury data and manipulate it using the SAS programming skills we learned last week. We were supposed to meet with Dorian to talk about pharmacovigilance, but there was a death in a study that required her immediate attention. Instead of meeting with Dorian, Kaitlin and I met with Erika to get started making graphs and tables. This time was extremely helpful because all the raw data was really overwhelming.

Once we were all set up, Kaitlin and I sat in the conference room working on making sense of some of the data. It was really hard to figure out what data to compare and find out whether the graphs we were creating would be helpful. Kaitlin and I worked until 4. At that time, Erika had said we deserved to go home. After those few hours, I finally have a better understanding of SAS programming in the real world. I also got a better look at Erika’s job and what it entails. Tomorrow, we will look at the visuals that Kaitlin and I made to see what we can glean from them!

Day 4 – Programming… again

Today started out very similar to yesterday. Once again I was able to start at 9. When I arrived at Bavarian Nordic, I quickly went into the conference room. Janelle told us that they would be interviewing an applicant for a Clinical Trials Manager this morning and that we were welcome to sit in. Kaitlin and I very excitedly agreed. The applicant’s name was Josh and had been in the ClinOps field for quite some time. Kaitlin and I sat quietly towards the end of the table and observed as Bavarian Nordic employees asked Josh a variety of questions. Most of them were the standard interview questions like “what’s your greatest weakness?” and “explain a time where you faced conflict.”

After the interview had finished, we said goodbye to Josh and stayed behind with Janelle and Ms. Handelsman to discuss the candidate. We discussed his various strengths and weaknesses and how he presented himself in the interview. It was very helpful to see the reflection process after an interview. I now feel like I am more prepared for upcoming interviews if I have the chance to do some in the fall. I learned that you should never lie in an interview because they can easily see through it. It is also important to ask lots of questions to show that you have done your research and you are engaged. In addition to this, it is imperative to maintain good body language and eye contact.

Once we had finished debriefing, Kaitlin and I went back to our SAS training. After a couple hours of programming, we stopped for lunch. Midway through my lunch, Ms. Eason stopped to check up on me. It was really cool telling her all I learned. That gave me a chance to reflect a little bit on the last 4 days. Once lunch was over, I went back to my desk for more programming. After a grueling couple hours, I finished the SAS training. I was overcome with joy for a split second until I remembered that I was not done with my training. Erika instructed us to complete one more online lesson dealing with the formatting of data. These chapters were much quicker. Once I was finished, I saved my certificates and headed out for the weekend. It was a very tiring day, but I will have a chance to rest up over the weekend so I can be ready to hit the ground running next week!

This took way more work than it should have…

Day 2 – Take Me Out To The Ball Game!!

As I walked into Bavarian Nordic this morning, I was quickly swept into a conference room. There, I took my seat and observed the Skype call that Ms. Handelsman and Janelle were conducting. They often have early morning meetings because the other part of the company is housed in Europe and there is a time difference. This meeting was a Brachyury core team meeting. They discussed various updates and ideas for the upcoming phases of the clinical trial. They might as well have been speaking in Danish because I didn’t understand much of it! All the employees in Denmark and Germany are fluent in English so there is not a communication barrier. After the meeting concluded, I stayed behind and asked Ms. Handelsman some questions that occurred to me during the meeting.

After Ms. Handelsman had to leave to attend another meeting, Erika shuttled me and Kaitlin into another conference room where we learned about statistics through a video and practice problems. We also went through a very long lecture about biostatistics for beginners. I noticed that Erika really loves her job! I hope that I will fall in love with whatever job I have in the future. Once we finished our lectures and practice, we moved into a real-world example. Erika printed copies of the Brachyury statistical analysis plan for us to study. It was so thick it must have taken a whole tree to print! After some hardcore reading, we decided it was time for lunch.

Kaitlin and I ate our lunch in the very luxurious break room and talked. She is going to graduating in December and is excited to be working in the clinical trials industry. She also gave me some good advice about college (i.e. visit the college you want to go to before you decide (she did not)).

We picked a very good week to come because today was the company’s annual outing to the Durham Bull’s game. Janelle, Kaitlin, and I all piled into Erika’s van and headed to Durham. We were met with TONS of traffic and a deficit of parking spaces. We had to park very far away so we were a little late to the game. We talked and watched the game and munched on nachos and French fries. After a fun couple hours, it was time to head back to Bavarian Nordic. We were lucky enough to be given free parking since we were so far away! Once again, we got into Erika’s van and started the drive. When we got back, I thanked Erika for driving and headed home. The morning was very informative and the afternoon was very fun! All in all, it was a great day.

We watched Ninjago while sitting in traffic!

Day 1 – Clinical Trials!!

Today was my first day at Bavarian Nordic! Bavarian Nordic is a biotechnology company that specializes in vaccines. I will be spending the next two weeks in their clinical trials department learning about biostatistics and clinical trial managing. After struggling to find the right building, I finally found the “Bavarian Nordic” sign in front of some extremely intimidating frosted glass doors. I was rather early, so I waited outside until I saw another girl looking at the directory. I had a feeling she was the other intern from NC State. I think she had a feeling I was the high school intern too because she introduced herself. Kaitlin is very nice and passionate about statistics! We tried pushing and pulling the door for an embarrassing minute. Turns out we needed to be buzzed in. Once the lady at the front desk let us inside, we were greeted by Erika. Erika works in biostatistics and put together our whole agenda. After introducing us to everyone, she led us to the break room.

In the break room, she had set up a whole breakfast buffet to welcome us! It was very nice of her! Once we had finished eating and mingling, Erika set us up with desks and computers. However, there were some technical difficulties with sharing folders with me and Kaitlin because the IT guy is out. After we got all situated at our desks, we headed towards the conference room where we would spend the next couple hours. Ms. Handelsman started off by giving us a brief history of Bavarian Nordic and all the products it produces. Bavarian Nordic is widely known for its production of Imvamune, a vaccine for smallpox. The US stockpiles this vaccine in case smallpox gets weaponized. Bavarian Nordic also has many other vaccines still in the trial phase. The one I will be focusing on is Brachyury.

For lunch, we stopped at some food trucks because the power went out and there was no way to heat up our food. Once we ate, we went straight back to the conference room to meet with Janelle. Janelle is one of the leaders of the Brachyury project. She gave us some background on why it is being studied. Brachyury is a protein that is expressed by many types of tumors. Too much of it can make it hard to treat a tumor. Bavarian Nordic’s potential vaccine could increase survival rates in cancer because its goal is to cause a Brachyury-specific response by the immune system. I will continue to be researching and looking at data from the ongoing clinical trial in my next 2 weeks.

After a long day in the conference room, I was tasked with completing an online training for Clinical Research by the NIH. After a lot of reading, I finally passed and got my certificate. My certificate signaled the end of my very rewarding day. I am very excited to see what the rest of the week holds!