Guest Post: Learning About Regulatory Affairs Through a Virtual Internship

by Casey Colleran (BSE 2021, MSE 2022)

In this guest post, recent Penn Bioengineering graduate and master’s student Casey Colleran writes about her experience in virtual internship at Janssen Pharmaceuticals.

Casey Colleran

During the summer of 2020, I was privileged enough to join the Global Regulatory Affairs team at Janssen Pharmaceutical Companies of Johnson & Johnson. Despite the uncertainties brought on by COVID-19, Janssen was able to bring together a group of five interns to participate in this virtual internship. This remote opportunity provided me with a valuable understanding of Regulatory Affairs, and the pharmaceutical industry. Throughout the 11 weeks, I was able to work alongside Regulatory Scientists in several functional areas of the organization. I learned about the regulations that govern the pharmaceutical industry, and the strategy that goes into communicating with the FDA and other health authorities.

As we rotated through each of these functional areas, myself and the other interns were also able to observe how the pandemic impacted the organization. We were asked to develop our own solutions on how to address these new challenges. Through this task, I learned how to present information in a meaningful way, analyze anecdotal data, improve processes, and communicate across different networks. As a team, myself and four other interns developed probing questions to help us understand how the COVID-19 pandemic has impacted the regulatory landscape, and the different strengths and opportunities employees observed in Janssen’s response to the pandemic. As we rotated through the different functional areas of Janssen’s Global Regulatory Affairs group, we used that time to ask our questions, and make note of anecdotal data that would provide us more insight as to how to address the new challenges brought on by the pandemic, and the virtual work environment. We then created a “COVID-19 Playbook” which broke down the main themes we had heard in our responses, such as the need for a more flexible organization, more efficient and effective communication, improved connectivity in the virtual workplace, and more. We developed suggestions on programming and guidelines that would help strengthen each of these areas, and presented these suggestions to the Senior Leadership Team.

Summer 2020 Janssen interns

Leadership development opportunities were also focal to the internship. I was paired with several amazing mentors who provided me with personalized feedback on how to become a more effective leader. The culture of the organization was extremely welcoming, and I cherish the relationships that I was able to build with my colleagues, so much so that I joined Janssen as a part time contractor this past year. Through this role as a contractor, I have been able to learn more about the day-to-day activities of a Regulatory Scientist through hands-on activities. As a contractor, I have been an integral part of a new “FLEx” Program. As a part of this program, I offer support to Regulatory Scientists by taking on their more routine submissions, giving them the opportunity to work on more strategic based activities, and focus on their personal growth and learning. It has been such a wonderful experience to work closely with these Regulatory Scientists who are still early in their career, as we have been able to learn from each other as well. It has also given me a greater understanding of the regulatory landscape, and by taking part in this new program I again get to see much of my feedback be considered and implemented.

I am so grateful that I had the opportunity to work in such an amazing environment, developed so many skills, and built a network that led me to additional opportunities in Regulatory Affairs at Janssen.

Bioengineering Graduate Students Take the Annual BETA Day Online

By GABE Outreach Chairs and Ph.D. students David Gonzalez-Martinez and David Mai

BETA Day Biomaterials workshop

Every spring, the Graduate Association of Bioengineers (GABE) at Penn partners up with iPraxis, an educational non-profit organization based in Philadelphia, to organize BETA Day, an event that brings together Bioengineering graduate students and local Philadelphia grade school students to introduce them to the field of bioengineering, the life of graduate students, and hands-on scientific demonstrations. Due to COVID-19 restrictions, we adapted the traditional in-person BETA Day into a virtual event on Zoom. This year, we assembled kits containing the necessary materials for our chosen demonstrations and worked with iPraxis to coordinate their delivery to partner schools and their students. This enabled students to perform their demonstrations in a hands-on manner from their own homes; over 40 students were able to participate in extracting their own DNA and making biomaterials with safe household materials.

Michelle Johnson presents on her work in robotics

The day began with a fantastic lecture by Michelle Johnson, Associate Professor in Bioengineering and Physical Medicine and Rehabilitation, who introduced students to the field of rehabilitation robotics and shared her experience as a scientist. Students then learned about DNA and biomaterials through lectures mediated by the graduate students Dayo Adetu and Puneeth Guruprasad. After each lecture, students broke into breakout rooms with graduate student facilitators where they were able to get some hands-on scientific experience as they extracted DNA from their cheek cells and fabricated alginate hydrogels. Michael Sobrepera, a graduate student in Dr. Johnson’s lab, concluded the event by giving a lecture on the process of robotics development and discussed where the field is heading and some important considerations for the field.

Dayo Adetu, Bioengineering Master’s student and GABE President, teaches the students about Genetic Engineering

While yet another online event may seem unexciting, throughout the lectures students remained exceptionally engaged and raised fantastic questions ranging from the accessibility of low income communities to novel robotic therapeutic technologies to the bioethical questions robotic engineers will face as technologies advance. The impact of BETA day was evident as the high school students began to discuss the possible majors they would like to pursue for their bachelor’s degrees. Events like BETA Day give a glimpse into possible STEM fields and careers students can pursue.

Guest Post: Penn Bioengineering Lab Classes in the Time of Coronavirus

By Solumtochukwu (Somto) Egboga

Stephenson Lab student employees (L to R): Seth Fein (BSE 20, MSE 21), Nicole Wojnowski (BSE 22), and Somto Egboga (MSE 21)

Since the country began shutting down in March, I have joined the majority of the world in calling the times “unprecedented”: The word, which I rarely used before the pandemic, is now a staple of my lockdown lexicon. In March, we all got the email that changed the trajectory of the rest of our semester and the school year. Since then, COVID-19 has been impacting lives here at Penn, around the nation, and the world. Hanging out with friends and family on Zoom, managing work and school from home, social distancing, wearing masks everywhere, and constantly washing hands have been the reality of our new normal for months.

It has been almost ten months since the World Health Organization declared COVID-19 a pandemic and this has posed a global crisis like nothing most of us have experienced in our lifetime. At Penn, the campus community including students and staff have rallied to keep each other safe, all while doing what is possible to ensure that lectures, teaching, and research are possible in ways that uphold the university’s mission of “strengthening the quality of education and producing innovative research and models of healthcare delivery by fostering a vibrant inclusive environment and fully embracing diversity.”

BE students Alexa Rybicki, Ifeoluwa Popoola, and Caitlin Frazee meet for BE 309 in the Gather.Town virtual lab space.

In Penn Engineering’s Bioengineering Department, the Stephenson Foundation Educational Laboratory & Bio-MakerSpace has been at the heart of ensuring that lab-based classes run as smoothly as possible given the circumstances. First off, during the summer, the lab launched a Slack site that not only kept students engaged and connected through fun, daily “Questions of the Day” but also gave them the opportunity to reach out to our staff and obtain their expertise for coursework and personal projects. The staff at the Stephenson Lab also supported and continue to support Senior Design students (BE 495) with their projects by ordering, receiving, packaging, arranging pickups, or mailing supplies needed to complete their Senior Design projects. In addition, class time takes place using Gather.Town to recreate our Bio-MakerSpace virtually. In other classes, video tutorials of some of the experiments students were missing out on were produced over the summer and made available to students so they could learn by seeing what the lab staff were doing in the videos. For the Bioengineering Modeling, Analysis, and Design (BE MAD) class (BE 309), in addition to videos, our lab Engineer, Michael Patterson, developed software through which students can enter design criteria and have experimental data emailed to them.

Picking up lab supplies outside in the Engineering complex

The staff at the lab also supported a Rehabilitation Engineering course (BE 514) taught by Michelle Johnson, Associate Professor in Physical Medicine and Rehabilitation and Bioengineering, by putting together supplies that enabled students in the class to reengineer toy bunny rabbits to be more accessible to children with disabilities. Optical Microscopy (BE 518), another Bioengineering course, taught by Christopher Fang-Yen, Associate Professor in Bioengineering and Neuroscience, offers students an introduction to the fundamental concepts of optics and microscopy. The staff at the lab put together kits and made them available for pickup by the students in the class.

In a time when the shape of education looks vastly different from what we anticipated this year, the Bio-MakerSpace has been instrumental in ensuring that students still have access to resources that make their learning experience an enriching one. In these unprecedented times, the lab has been able to encourage students to keep up and be engaged with their coursework while also fostering creativity in students, virtually and remotely. While we may not know what life after the pandemic will look like, one thing to be sure of is that the Stephenson Lab will always be a reliable place for Penn students to get support for personal projects and coursework when needed.

Solumtochukwu (Somto) Egboga is a Master’s Student in Bioengineering, graduating December 2020. She also is a student employee for the Stephenson Foundation Bioengineering Laboratory & Bio-MakerSpace.