FDA on The Exciting Future of Clinical Trial Regulatory Affairs

The 2024 DIA conference hosted a session, Regulatory Affairs of the Future is Now, which was a dynamic and thought-provoking one that gathered leading experts in the field to discuss the evolving landscape of clinical trial regulatory affairs. The conference featured insightful presentations from distinguished professionals, emphasizing the need for adaptability, collaboration, and continuous learning in the face of rapid technological advancements.

Speakers at the conference included Lina AlJuburi, Nicole Mahoney, Maria Florez, and Dr. M. Khair ElZarrad, each offering unique perspectives and expertise. Together, they provided a comprehensive overview of the challenges and opportunities in regulatory affairs, highlighting the critical role of regulatory science in advancing public health and ensuring patient access to innovative treatments.

Lina AlJuburi’s Opening Remarks

Lina AlJuburi, PharmD, MSc, Head of Global Regulatory Science and Policy for North America at Sanofi, highlighted the crucial role of regulatory science in public health, emphasizing that the field must evolve alongside the industry. AlJuburi recounted her early career at the FDA’s Center for Drug Evaluation and Research (CDER), where she contributed to the Office of New Drugs. AlJuburi emphasized the importance of digital technologies in drug development and regulatory processes. She highlighted how AI and machine learning streamline clinical trials and predict outcomes more accurately, speeding up drug development and identifying potential safety issues earlier. AlJuburi discussed the shift from celebrating regulatory approval as the final milestone to prioritizing patient access. She stressed that ensuring products reach patients who need them requires a strategic approach to navigating healthcare systems, reimbursement policies, and distribution networks. Continuous learning and adaptability are essential, and her team at Sanofi embraces new tools and methodologies, such as using real-world evidence to complement clinical trial data.

The Importance of a Growth Mindset

Nicole Mahoney, PhD, Executive Director of US Regulatory Policy & Intelligence at Novartis Pharmaceuticals, discussed the skills and mindset required for future clinical trial regulatory affairs professionals. Mahoney emphasized the need for a growth mindset, which involves embracing challenges, learning from criticism, and persisting in the face of setbacks. This approach is crucial in a rapidly evolving industry due to technological advancements. She highlighted the role of AI in regulatory affairs, describing how it is used to analyze vast amounts of data, identify patterns, and predict outcomes, thereby accelerating decision-making processes and improving the accuracy of regulatory assessments.

Mahoney stressed the importance of cross-functional collaboration. Regulatory professionals must work closely with various departments, including research and development, clinical operations, and commercial teams, to ensure that all aspects of drug development are aligned with clinical trial regulatory requirements. She shared examples from Novartis, where internal training programs help employees develop data analytics, digital health, and AI skills. Mahoney also emphasized the need for continuous learning and staying updated with the latest developments by attending conferences, participating in training programs, and engaging with professional organizations.

The Role of Digital Transformation

Maria Florez, MA, Senior Consultant at Tufts Center for the Study of Drug Development, provided an in-depth look at digital transformation in the pharmaceutical industry. She emphasized that organizations must become data-driven to make informed decisions and optimize operations. Florez highlighted that changing mindsets and behaviors within organizations is essential for embracing digital transformation. She provided examples from her research showing that successful digital transformations often involve employees challenging standard practices and embracing experimentation.

Florez also discussed the importance of technical skills in digital transformation. She highlighted three critical areas: proficiency in data science and machine learning, knowledge of digital health technologies, and data privacy and cybersecurity expertise. These skills enable regulatory professionals to harness the power of digital technologies and ensure that data is used responsibly and securely. Florez also emphasized the need for soft skills such as adaptability, continuous learning, and effective communication. She shared insights from Tufts University, where interdisciplinary training programs help students develop a well-rounded skill set, combining technical knowledge with critical thinking and problem-solving abilities.

Challenges and Opportunities in Regulatory Policy

Dr. M. Khair ElZarrad, PhD, MPH, Director of the Office of Medical Policy at FDA’s Center for Drug Evaluation and Research (CDER), discussed the challenges of technological advancements in modern policymaking. He emphasized the need for regulatory agencies to be more responsive and agile, highlighting the importance of public-private partnerships and the expanded role of academia in shaping regulatory policies. ElZarrad addressed the inherent challenges in the current clinical trial regulatory environment, noting that regulatory agencies often take years to develop and implement new guidelines, which can be a significant barrier in a rapidly evolving industry.

ElZarrad cited the example of the COVID-19 pandemic to illustrate the need for agility. During the pandemic, regulatory agencies had to adapt quickly to facilitate developing and approving vaccines and treatments. This demonstrates the importance of having mechanisms to expedite regulatory processes without compromising safety and efficacy standards. He also highlighted the potential of real-world evidence (RWE) in regulatory decision-making, explaining that the FDA is exploring the utility of RWE to complement traditional clinical trial data. Public-private partnerships and robust and flexible regulatory workforces are crucial for modern clinical trial regulatory policy, and continuous training and education are essential to ensure that regulatory professionals are equipped with the latest knowledge and skills.

Engaging Future Talent

A recurring theme throughout the conference was attracting and nurturing new talent in regulatory affairs. The speakers discussed various strategies for engaging students and professionals from diverse backgrounds, emphasizing the need for early outreach and mentorship. Nicole Mahoney highlighted Novartis’ efforts to partner with universities and graduate programs to develop curricula that include regulatory science, digital technologies, and leadership skills. She stressed the need for experiential training opportunities, such as internships and fellowships, to give students hands-on experience in the field.

Maria Florez emphasized the importance of diversity and inclusion in fostering innovation. She shared insights from her research at Tufts, showing that diverse teams are more creative and better at problem-solving. Florez stressed the need to reach out to students from various educational backgrounds and underrepresented communities, citing successful outreach programs such as partnerships with historically black colleges and universities (HBCUs) and community colleges. Lina AlJuburi discussed Sanofi’s initiatives to engage new talent, including mentorship programs and collaborations with academic institutions, emphasizing the importance of promoting the mission and impact of regulatory affairs to inspire young people to pursue careers in the field.

Summary

In conclusion, the 2024 DIA conference emphasized the urgent need for clinical trial regulatory affairs professionals to adapt to a rapidly changing environment. Embracing digital transformation, fostering a growth mindset, and enhancing collaboration were identified as key strategies for success. As the industry continues to evolve, the insights and recommendations from this conference will be invaluable in guiding regulatory affairs professionals toward a future where they can thrive and contribute significantly to public health.