Navigating New Horizons: Discoveries from the 2024 PDA Annual Meeting

On Wednesday, January 24, 2024, at 6:56 pm, an exciting email notification lit up my screen, announcing that I had been awarded the PDA West Coast Chapter’s 2024 Early Career Professional Scholarship.

Overjoyed, I immediately called my mom to share the news. The significance of this scholarship was immense; it meant I could attend a conference where diverse voices from the biotech/pharmaceutical industry converged, offering a wealth of knowledge and insights.

This achievement held profound significance for me, considering my journey. Both my parents, originally from Myanmar, had migrated to the United States with aspirations confined to traditional careers like medicine and law. Consequently, my own career path had been shaped by this singular focus on medicine, reinforced by my time at the University of California, Santa Barbara, where I graduated with a major in biology and a minor in poverty, inequality and social justice.

Michelle Tu's grandparents

Yet, amidst this pursuit, I came to recognize the limitations of a purely clinical approach. While the desire to impact lives through direct patient care remained, I realized the broader systemic issues at play, particularly in terms of drug accessibility and healthcare disparities. My grandfather's story is a constant reminder of the harsh realities of limited healthcare in developing countries. A stroke at 53 years old in our homeland of Myanmar, a place struggling with infrastructure and medical resources, became a fight against time. The delayed ambulance, caught in traffic with nowhere to yield, underscored the helplessness of even the best medical attention in such circumstances. It was not just about having the right doctors but about a broken system that could not deliver that care effectively. This profound experience sparked my passion for the biotech/pharmaceutical industry. Here, scientific innovation has the power to tackle these global challenges head-on, creating a future where healthcare is not a privilege but a right accessible to all, regardless of location.

Reflecting on my experience at the 2024 PDA Annual Meeting/PDA Week in March, I had the opportunity to engage in various workshops, sessions and invaluable networking opportunities from which I gained eight key insights listed below:

1. The conference started with a dynamic Early and Mid-Career Roundtable spearheaded by Ira Mann, President of IQ Referrals, and moderated by Divyang Patel, Senior Specialist of Commissioning, Qualification & Validation at AtkinsRéalis. The session delved into effective networking strategies and the significance of expanding mentorship networks. Mann highlighted the value of seeking mentors beyond one's immediate team and the importance of reciprocal mentorship, emphasizing that mentorship is a two-way street. It was also a great opportunity for me to connect with peers in the early stages of their careers, reaffirming that everyone is still navigating their professional journey and passion.


2. Richard Horgan, CEO of Cure Rare Disease, shed light on the urgent need for drug development to address rare genetic diseases, inspired by his family's experience with Duchenne muscular dystrophy. Horgan’s insights underscored the pivotal role of innovation in addressing the needs of overlooked patient demographics, challenging the prevailing drug development framework, which often favors diseases affecting larger populations. Additionally, his message resonated with the importance of treasuring moments with loved ones, as life's unpredictability reminds us to cherish every opportunity.


3. During a quality risk management session moderated by our esteemed PDA WCC President Stephanie Lee, the emphasis was placed on fostering a patient-focused learning culture to enhance patient safety and risk mitigation, including better subjectivity recognition and advanced knowledge management. Lorianne Richter, Senior Director of GxP Quality Management System at ALX Oncology, highlighted the transformative impact of this culture in navigating evolving regulatory frameworks like ICH Q9 (R1) on quality risk management. She delved into the dichotomy of compliance versus patient-focused culture across various organizational facets, advocating for a systemic approach to risk management and continual improvement.
   
   Notably, Richter shared her secret on copyright-free images using an artificial intelligence (AI) image creator by Bing, adding another touch of innovation to the discussion. Additionally, Denyse Baker, Associate Vice President of Global Quality External Engagement at Eli Lilly and Company, referenced a poignant quote from Bill Marklein, Founder of Culture Crossing, emphasizing the profound influence of organizational culture on employee well-being and motivation. Baker ended her slide with this quote: “Culture is how employees’ hearts and stomachs feel about Monday morning on Sunday night.”


4. AI took center stage at the conference, sparking significant discussion, particularly with Ghada Haddad, Executive Director of Global Quality Shared Services and Regulatory Intelligence at Merck, delving into its transformative potential. Haddad highlighted how AI and machine learning algorithms can revolutionize risk assessment processes and data analysis, paving the way for more objective decision-making. Nonetheless, she underscored the challenges associated with AI implementation, such as data quality issues and ethical considerations, emphasizing the need for a robust skill set to effectively navigate these complexities. Key skills mentioned included programming, data analysis, problem-solving and continuous learning, all essential in adapting to the evolving landscape of AI technology. As I strive to enhance my proficiency in these areas, I recognize the importance of proactive learning and prevention strategies in harnessing the power of AI for future advancements.


5. Adithya Balasubramanian, (who is new to the world of drug manufacturing) Director of Business Development & Sales at ten23 health, provided insightful perspectives on this process during his presentation. Balasubramanian highlighted the advantages of subcutaneous drug administration, such as reduced healthcare costs and the convenience of home treatment, while also addressing challenges like usability and manufacturability. The discussion encompassed critical testing considerations, including dose accuracy, injection depth and product sterility.
   
   Balasubramanian emphasized the importance of early stakeholder involvement and collaboration throughout the clinical trial phases. Reflecting on my experience as a Women's Health Coordinator at the University of California, Santa Barbara, where I managed a large-scale menstrual outcome distribution program for three years, working with external and internal stakeholders, I recognized the significance of product safety and selection in healthcare initiatives. While my focus was not on manufacturing, I appreciate its integral role in delivering safe and effective treatments. Balasubramanian's presentation definitely piqued my interest in exploring roles within drug product development, particularly in ensuring product compatibility and regulatory compliance.


6. During the final day of the conference, Senior Advisor Scientific Affairs, provided a comprehensive overview of the ongoing US Supreme Court deliberations concerning Chevron deference. These deliberations have significant implications for agency actions, particularly in healthcare and life sciences. The cases under consideration question the validity of Chevron's deference and its application in instances of congressional silence within statutes. The ensuing debate extends beyond the confines of the Magnuson-Stevens Act, raising fundamental questions about agency authority and judicial review.
   
   Justices have expressed concerns regarding the separation of powers, constitutional validity of Chevron deference and the interpretation of ambiguity in statutory language. According to Jaworski, the decision has the potential to reshape administrative law and regulatory governance, leading to increased litigation and challenges to agency decisions. This discussion underscores the intersection of policy and power, highlighting the profound impact on public health and safety. As the legal landscape evolves, it heralds a new era of administrative law, prompting critical reflection and engagement.


7. It was truly inspiring to learn about Amgen's commitment to environmental sustainability from Sharon Michalak, who works as their Process Development Principal Scientist. Their aspiring goal to achieve 100% carbon neutrality by 2027, along with significant reductions in water consumption and waste generation, reflects a commendable dedication to eco-conscious practices. Michalak highlighted their multifaceted approach, which includes fostering a sustainable culture through monthly newsletters, cross-functional discussions and workshops.
   
   Michalak's emphasis on attaining My Green Lab certification underscores the importance of individual and collective efforts to promote greener lab behaviors. Moreover, her point on waste disposal and recyclable programs reminds us of our collective responsibility towards the planet. As we strive for a sustainable future, companies must embrace their role in driving positive environmental change, as the earth should also be considered a patient.


8. Finally, the conference emphasized the significance of networking and community building, prompting me to embrace opportunities to expand my professional circle. While it can feel daunting initially, I learned that stepping out of my comfort zone is essential for personal growth. To alleviate any nervousness, I recommend compiling a list of questions beforehand that reflect both your professional interests and personal curiosity, ranging from serious to light-hearted topics. Above all, remember to stay true to yourself and let your authenticity shine through!

Conclusion

Overall, my experience at the 2024 PDA Annual Conference/PDA Week has been extremely invaluable. It has provided me with a wealth of insights, connections and inspiration to carry forward in my professional journey. It has deepened my interests in policy and patient advocacy, market access, early-phase clinical trial development, product development and regulatory affairs within the biotech/pharmaceutical industry.

Furthermore, I extend my heartfelt gratitude to the PDA organizers, speakers and fellow attendees for contributing to this enlightening and memorable experience. I am especially grateful to the PDA West Coast Chapter for affording me the opportunity to engage and attend this conference. As the saying goes, "Success is not about climbing up the ladder alone; it's about bringing others along with you. A rising tide lifts all boats." This quote illustrates the importance of collective progress and mutual support in achieving success. Together, let us continue to navigate towards greater heights.