iSpeak Blog

Emerging Leader Hacker to GAMPer in 10 Weeks

Peyton Myers
Peyton Myers

The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.

Before last year, I did not know what a hackathon was. I learned about the 2023 ISPE International Emerging Leader Hackathon after being awarded an ISPE Foundation Professional Development Grant. I discovered ISPE while interviewing for internships with equipment suppliers to the pharmaceutical industry. I applied for the ISPE Foundation Professional Development Grant to learn more about the industry. When I was informed that I had received one of the grants, I was excited that I would be exposed to highly technical information, technical presentations, and networking across the pharmaceutical industry. I still had no idea what a hackathon was. As I started reading the material I discovered that ISPE hosts hackathons at the ISPE Europe Annual Conference and ISPE Annual Meeting & Expo. The hackathons enable Emerging Leaders to explore novel solutions, grow their knowledge, and work in teams on topics that are trending in the pharmaceutical industry.

The idea of participating in a hackathon appealed to me because I am working on a degree in international business with a minor in German at Appalachian State University. The hackathon and the opportunities it presented such as the ability to be mentored support my growth in understanding international business. As I planned for the hackathon, I knew that my background in international business would likely be different from those of my peers, who I assumed were likely pursuing STEM-related majors. The hackathon is challenging because the problem statement is unknown until you arrive at the event. The whole goal of the hackathon is to develop a team-oriented mentality, work with mentors, create an approach for the problem assigned, and present the team solution to the overall group. Building the team is the main focus. I am very familiar with teamwork since in high school, I was a wrestling team captain and saw teams form out of very different sets of individual skill sets and personalities.

I met the rest of my team at the 2023 ISPE International Emerging Leader Hackathon at the 2023 ISPE Annual Meeting & Expo. There were six of us in total with various backgrounds. Here was the prompt we were given: “Based on data given by Genentech, determine a more sustainable approach to single-use technologies.” Nothing in my international business program had prepared me for the long technical discussions about layers of polymers used in single-use technologies or the design of bioreactors and the concepts of reuse, recycling, and reprocessing. I knew that behind every process issue, there are business issues to solve. I was looking for a different set of parameters than my other engineering-focused team members, as the impacts of technical changes always have a business driver. Return on investment, schedule, consumables costs, facilities costs, and production losses are all business drivers that must be considered for every change.

My group was great to work with. We all brought different perspectives and knowledge to the effort. The team proposed a standardized practice of single-use system design to leverage commonalities to reduce manufacturing variability and reduce storage needs for multiple sets of single-use systems. We posited that this could simplify manufacturing, as well as changes to the process, storage conditions, training, and automation.

After the hackathon, I took advantage of the networking opportunities at the conference and discovered the pharmaceutical industry relies on data analytics, one of my main interests. I have always had an intense interest in applied data analytics and data validation with applications of artificial intelligence (AI) and machine learning (ML). As I made rounds through the 2023 ISPE Annual Meeting & Expo, I found one of my hackathon coaches, Brandi Stockton, Co-Chair of the ISPE AI/ML Special Interest Group (SIG) and Chair of GAMP® Americas, outside of the expo hall and approached her to give thanks for assisting my group during the hackathon and to discuss the 2023 ISPE Annual Meeting& Expo. As we discussed some of the key topics of the event we came upon the subject of AI and ML, discovering similar interests in that field. I was asked to follow up with Stockton about possibly joining the ISPE AI/ML SIG.

After having a more detailed discussion with Brandi about experiences and interest in the space of AI/ML, I was added to the AI/ML SIG and given the opportunity to join the GAMP Americas Steering Committee as well as an Emerging Leader representative. This group focuses on good practice in the application of computer systems to the pharmaceutical industry with certain members having their focuses in areas such as computer system validation (CSV), computer software assurance (CSA), blockchain, AI, and ML. I have enjoyed learning more from deeply nuanced conversations within these two groups. It was refreshing to see real-life applications because, in college, we tend to only study concepts and theories. I viewed AI and ML as the application of how I could use my background in data analytics and felt I could make contributions under that aspect of GAMP.

I enjoy working with members of the committee who are utilizing data analytics within their technical and business worlds. The meetings with the GAMP Americas Steering Committee, paired with the AI/ML SIG focusing on emerging areas of AI/ML, have allowed me to continue to expand my understanding of ML. The AI/ML SIG has been formed to understand how AI can be used in regulated processes in the pharmaceutical industry. For example, the industry now has an abundance of records of data that can be used. In the pharmaceutical industry – this data can be used to manage risks, reduce costs, and improve patient health. Failures can be fed into a control framework to model key variables during a process (temperature, pH, dissolved oxygen levels, length of processes, etc.).

The SIG meetings provide a place to learn and have meaningful conversations about approaches, limitations, and use of ML and AI. I am looking forward to utilizing this technology which I believe can help change the face of the pharmaceutical industry, improve patient outcomes, and improve the way everyday people interact with their health.

In the past few months, my life has seen a growth in knowledge, experience, and outlook. Although a new challenge can elicit a fear response, I have been taught to, “step into fear” by my mother. I have modified her recommendation to fit my view of the world: “Step off the cliff of fear. Fall and/or fly.” I believe that those who never step off the cliff will never find out what is next. Those who do take a step may fail and may struggle, but they also just might thrive. A courageous and growth-focused individual is willing to step into fear (push past their comfort zone) and then facilitate the difficulties they face (falling and flying). Once one steps out they are never the same person.

A year ago, I was only a student. Now I am a member of ISPE, the ISPE GAMP Americas Steering Committee, and the ISPE GAMP AI/ML Special Interest Group (SIG). I have begun assisting with webinars, workshops, and other means to drive the industry forward toward previously unused concepts. All of this is due to the interaction with people who are in ISPE SIGs and Steering Committees. I am looking at my career after college in an entirely new way, and I appreciate how many people I have been able to learn from as all have been willing to talk, listen, teach, and learn in a way that has helped me to continue to grow. I’d like to specially thank people like Stephen Ferrel who provided review and guidance during the creation of this blog post.

I look forward to learning, growing, and building great friendships along the way. I was impressed by how many of the 2023 ISPE Annual Meeting & Expo attendees were long-time friends and partners – even though they do not work for the same companies. I look forward to meeting future attendees at a conference or a meeting soon. My advice is to get involved. It could change your future.

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