Tell us about what you do and how long you have worked at the House Institute Foundation.
I am a Clinical Research Coordinator. I am responsible for all research activities from the start, including writing the study protocol, facilitating its submission to the Institutional Review Board (IRB) and other regulatory paperwork to ensure everyone follows FDA guidelines, good clinical practice and human safety rights. I have been at the House Institute for one year and three months.
What changes have you seen in your time here?
I started with one research project and it has become a flood of research projects from various doctors and now the fellows as well! This has been an ever-growing position for me for internal studies as well as external studies or sponsored clinical trials.
What keeps you invested in your work?
The doctors keep me on my toes. They always have some interesting idea, and it is fun to help bring their ideas to fruition. Their research and the things they are interested in is always growing. I’m especially drawn to the surgical trials, but I do enjoy all research.
What do you like most about your job?
Helping people. I also like going into the operating room. I have only seen brain surgery and removal of tumors, but I hope to observe the placement of a cochlear implant one day when restrictions lift again. I am in the nitty gritty with regulatory work, so being in the operating room can really bring the research to life for me.
How would you like your story to help others?
I grew up in the inner city in Pennsylvania. As a person of color, I did not see examples of myself in research. I would like to show other little girls that this path, or any other they set their minds to, is possible.
What drew you to the House Institute?
I was curious to learn about a new therapeutic area that I had no prior knowledge of but a personal connection to since my mom has single-sided deafness. She does not use a hearing aid or cochlear implant, so this was all new to me. I was also attracted to the hands-on opportunity of helping to rebuild the research program that had downsized and was expanding again. I started college as a chemistry major and ended up switching to biochemistry since it was more health based, and I like that much more. I had done a lot of research in labs at my undergraduate program including a little bit of clinical research at the Hospital University at Penn, and this steered what I wanted to do after college, it was just a matter of where. I ended up at House!
What are you most proud of during your time at the House Institute thus far?
I am most proud of helping Dr. Derebery obtain a $100,000 dollar grant from CURES (the Controlled Substance Utilization, Review and Evaluation System) for a Meniere’s disease study with allergy patients (who also have Meniere’s). We will be seeing if a drug already approved for allergy patients will also help the fluctuation of Meniere’s disease. I helped work on the budget for the trial and am now working on the IRB submission. Hopefully, this trial will start at the end of January. There can be some roadblocks which is a normal part of the process.
Tell us more about the process to get studies off the ground. It can be quite time consuming!
Several of our studies require that we go through an IRB (Institutional Review Board) to ensure that the study is safe for human subjects and won’t cause any unnecessary harm or serious side effects. An IRB also holds us accountable to make sure we are staying accordant to the protocol and good clinical practice. Once a study proposal is approved by the IRB, we need to find a sample population: participants who meet certain criteria. We search our patient database, find those who qualify as candidates, and send out information to invite them to be a part of the study.
Once a study participant has gone through a screening process and is confirmed, they get reviewed by the physician and go through the study requirements and informed consent. Then they start the treatment process. This could require as few as one to two visits, and some trials can even be integrated in your planned surgery and regular surgery follow ups. After completing the trial and gathering all the data, we run statistical analyses with the hopes of publishing a paper in a medical journal, so our findings can become known to the public. For drug trials, the goal is to eventually apply for FDA approval which would allow the drug to be on the market and potentially covered by insurance companies.
Drug trials and medical device trials take four phases. The first phase is for safety. We figure out the dose people can tolerate and the side effects. Phase two is more focused on efficacy. How is the treatment benefiting you? Phase three considers the true benefits and short-term effects. Phase four incorporates thousands of patients and a placebo group to identify if there is a true benefit, and to determine long-term effects. If you are someone who gets the placebo, you may be offered the treatment later at no cost which can be a nice incentive for participating. All of this can take a couple of years. We primarily focus on phases one and two for most of our trials. We are one of 60 sites for sponsored trials (these tend to be pharmaceutical companies who have tested a drug in their laboratory and are now looking to see how it will benefit people in clinical practice).
In addition to sponsored trials, we do other kinds of innovative research. Most of the House doctors are involved with their own investigator-led projects. In this case, a physician at House Clinic will find some commonality in their patient population and identify things that could change or be treated better. Neurosurgeon Dr. Lekovic and neurotologist Dr. Peng, for example, are using a fluorescent dye called indocyanine green to highlight tumors on the brain so they can better distinguish healthy tissue from diseased tissue when doing a tumor resection. Often a little extra brain tissue is removed to make sure the entire tumor is fully gone and won’t grow back. The technique they are experimenting with will hopefully lead to a procedure that is more precise where less tissue can be removed. This study is currently underway and accepting participants.
What research project stands out for you in your time at House?
The natural history of NF2 study, because this is the longest running study we have with the greatest number of patients — almost 500 and counting. Some of the patients enrolled in the study have had care through House Clinic spanning the past 30 years. It is very extensive. NF2 (neurofibromatosis type 2) is a rare genetic disease and we are one of the few clinical practice sites that specializes in it. The hallmark of the disease is that patients develop benign brain tumors on their vestibulocochlear nerve (the cranial nerve responsible for hearing) thus their hearing is impaired.
The natural history and treatment of NF2 study analyzes the lifespan of the disease. In this study there is no drug or introduction of a medical device. If that were to happen, those participants would break off into another branch of the study. Instead, we are tracking what happens along the course of the disease through clinical symptoms, office visits, MRI scans, radiology reports, surgeries, and treatment plans. Patients with NF2 from around the world send us their medical records, pathology reports, and surgery plans to be included in this long-term study and to obtain medical advice in the process with collaborating physicians.
What would you like to see happen at House in the next 75 years?
Research takes time! Regulations are always increasing, so it will continue taking longer in some cases to conduct research. People need to understand this and stick with us. Even if we may not find a cure for you, your tissue samples, for example, may help us find a potential treatment or diagnosis step that would help your grandchild. It’s a long-term game.
In the next 75 years, I would also love to see more outreach programs. I hope we engage in more opportunities to work locally to help those who cannot afford treatments. We can also build new partnerships. HBCUs (historically black colleges and universities), for example, pride themselves with amazing marching bands, but no one wears hearing protection. There are so many ways we can continue to expand to meet our mission which also includes education and global health. On the clinical side, I think we are already trying to diversify the population we serve. Increasing access to ear and hearing care for those who need it supports our studies too, because serving a more diverse population will also give us a more well-rounded concept of our research. It is interconnected.
Outside of work, Shanel is launching a custom tie dye and acid wash clothing business featuring 80s style loungewear. She also enjoys spending time with her cat, Suki, a 4-year-old Bengal-tabby mix. Her future aspirations include returning to graduate school to pursue a nurse practitioner degree as she continues her career in the medical field.