The Transformative Role of AI in Regulatory Science: A Conversation with Paul Kim
The Transformative Role of AI in Regulatory Science: A Conversation with Paul Kim
Paul Kim explores AI's transformative role in regulatory science, highlighting collaboration, transparency, and innovation as keys to addressing challenges and unlocking global opportunities.
By
Paul Kim
January 23, 2025
6
min read
In this article
6
min read
Artificial Intelligence is significantly impacting various sectors, yet few domains present as much potential or encounter as many obstacles as its use in regulatory science. In a recent Katalysts Podcast by Katalyze AI, Paul Kim who is a Life Science and Health Policy Advisor, a Food and Drug Lawyer and a Former Congressional staffer, offered his insights on the transformation of regulatory processes by AI, the challenges involved, and the opportunities available to foster global change.
Artificial Intelligence is significantly impacting various sectors, yet few domains present as much potential or encounter as many obstacles as its use in regulatory science. In a recent Katalysts Podcast by Katalyze AI, Paul Kim who is a Life Science and Health Policy Advisor, a Food and Drug Lawyer and a Former Congressional staffer, offered his insights on the transformation of regulatory processes by AI, the challenges involved, and the opportunities available to foster global change.
Artificial Intelligence is significantly impacting various sectors, yet few domains present as much potential or encounter as many obstacles as its use in regulatory science. In a recent Katalysts Podcast by Katalyze AI, Paul Kim who is a Life Science and Health Policy Advisor, a Food and Drug Lawyer and a Former Congressional staffer, offered his insights on the transformation of regulatory processes by AI, the challenges involved, and the opportunities available to foster global change.
Artificial Intelligence is significantly impacting various sectors, yet few domains present as much potential or encounter as many obstacles as its use in regulatory science. In a recent Katalysts Podcast by Katalyze AI, Paul Kim who is a Life Science and Health Policy Advisor, a Food and Drug Lawyer and a Former Congressional staffer, offered his insights on the transformation of regulatory processes by AI, the challenges involved, and the opportunities available to foster global change.
It’s not about being disruptive for the sake of disruption. It’s about being social actors—partners in this journey.
It’s not about being disruptive for the sake of disruption. It’s about being social actors—partners in this journey.
It’s not about being disruptive for the sake of disruption. It’s about being social actors—partners in this journey.
It’s not about being disruptive for the sake of disruption. It’s about being social actors—partners in this journey.
AI’s Growing Role in Drug and Device Regulation
According to Paul Kim, we are at the early stages of AI integration into regulatory science. Recent FDA data indicates hundreds of submissions incorporating AI technologies, spanning drugs, biologics, and medical devices. Yet, the landscape remains uncharted territory. “The agency itself,” Kim notes, “completely lacks the capacity to address this alone.” Kim explains that tools developed at Katalyze aim to demystify AI algorithms for regulatory agencies, providing transparency.
Artificial Intelligence (AI) and Digital Health Technologies (DHTs) are significantly transforming drug development processes. Both the FDA and EMA have issued guidance for incorporating these technologies into clinical trials. However, there's a critical need for a unified approach to evaluate and implement AI and DHT methodologies as Drug Development Tools (DDTs). The Critical Path Institute, serving as a neutral leader in public-private partnerships, possesses the expertise and infrastructure necessary to address the essential roles of AI and DHTs in drug development. (Read more here)
According to Paul Kim, we are at the early stages of AI integration into regulatory science. Recent FDA data indicates hundreds of submissions incorporating AI technologies, spanning drugs, biologics, and medical devices. Yet, the landscape remains uncharted territory. “The agency itself,” Kim notes, “completely lacks the capacity to address this alone.” Kim explains that tools developed at Katalyze aim to demystify AI algorithms for regulatory agencies, providing transparency.
Artificial Intelligence (AI) and Digital Health Technologies (DHTs) are significantly transforming drug development processes. Both the FDA and EMA have issued guidance for incorporating these technologies into clinical trials. However, there's a critical need for a unified approach to evaluate and implement AI and DHT methodologies as Drug Development Tools (DDTs). The Critical Path Institute, serving as a neutral leader in public-private partnerships, possesses the expertise and infrastructure necessary to address the essential roles of AI and DHTs in drug development. (Read more here)
According to Paul Kim, we are at the early stages of AI integration into regulatory science. Recent FDA data indicates hundreds of submissions incorporating AI technologies, spanning drugs, biologics, and medical devices. Yet, the landscape remains uncharted territory. “The agency itself,” Kim notes, “completely lacks the capacity to address this alone.” Kim explains that tools developed at Katalyze aim to demystify AI algorithms for regulatory agencies, providing transparency.
Artificial Intelligence (AI) and Digital Health Technologies (DHTs) are significantly transforming drug development processes. Both the FDA and EMA have issued guidance for incorporating these technologies into clinical trials. However, there's a critical need for a unified approach to evaluate and implement AI and DHT methodologies as Drug Development Tools (DDTs). The Critical Path Institute, serving as a neutral leader in public-private partnerships, possesses the expertise and infrastructure necessary to address the essential roles of AI and DHTs in drug development. (Read more here)
According to Paul Kim, we are at the early stages of AI integration into regulatory science. Recent FDA data indicates hundreds of submissions incorporating AI technologies, spanning drugs, biologics, and medical devices. Yet, the landscape remains uncharted territory. “The agency itself,” Kim notes, “completely lacks the capacity to address this alone.” Kim explains that tools developed at Katalyze aim to demystify AI algorithms for regulatory agencies, providing transparency.
Artificial Intelligence (AI) and Digital Health Technologies (DHTs) are significantly transforming drug development processes. Both the FDA and EMA have issued guidance for incorporating these technologies into clinical trials. However, there's a critical need for a unified approach to evaluate and implement AI and DHT methodologies as Drug Development Tools (DDTs). The Critical Path Institute, serving as a neutral leader in public-private partnerships, possesses the expertise and infrastructure necessary to address the essential roles of AI and DHTs in drug development. (Read more here)
The Challenge of 20th-Century Regulations in a 21st-Century World
One of the most pressing issues is that current laws were designed for conventional technologies. Kim points out that leaders like FDA Commissioner Dr. Robert Califf have acknowledged the need to modernize regulatory frameworks to better align with emerging innovations.
This gap between regulation and technology can lead to inefficiencies in the drug approval process, which is already lengthy and resource-intensive.
Kim warns against underfunding the FDA, noting that diminished resources would force the agency to retreat into a “turtle shell,” stalling progress. Instead, he advocates for robust funding and a collaborative approach that balances innovation with accountability. Katalyze’s collaborative model is essential in ensuring that AI-powered healthcare solutions meet rigorous standards without delaying patient access.
One of the most pressing issues is that current laws were designed for conventional technologies. Kim points out that leaders like FDA Commissioner Dr. Robert Califf have acknowledged the need to modernize regulatory frameworks to better align with emerging innovations.
This gap between regulation and technology can lead to inefficiencies in the drug approval process, which is already lengthy and resource-intensive.
Kim warns against underfunding the FDA, noting that diminished resources would force the agency to retreat into a “turtle shell,” stalling progress. Instead, he advocates for robust funding and a collaborative approach that balances innovation with accountability. Katalyze’s collaborative model is essential in ensuring that AI-powered healthcare solutions meet rigorous standards without delaying patient access.
One of the most pressing issues is that current laws were designed for conventional technologies. Kim points out that leaders like FDA Commissioner Dr. Robert Califf have acknowledged the need to modernize regulatory frameworks to better align with emerging innovations.
This gap between regulation and technology can lead to inefficiencies in the drug approval process, which is already lengthy and resource-intensive.
Kim warns against underfunding the FDA, noting that diminished resources would force the agency to retreat into a “turtle shell,” stalling progress. Instead, he advocates for robust funding and a collaborative approach that balances innovation with accountability. Katalyze’s collaborative model is essential in ensuring that AI-powered healthcare solutions meet rigorous standards without delaying patient access.
One of the most pressing issues is that current laws were designed for conventional technologies. Kim points out that leaders like FDA Commissioner Dr. Robert Califf have acknowledged the need to modernize regulatory frameworks to better align with emerging innovations.
This gap between regulation and technology can lead to inefficiencies in the drug approval process, which is already lengthy and resource-intensive.
Kim warns against underfunding the FDA, noting that diminished resources would force the agency to retreat into a “turtle shell,” stalling progress. Instead, he advocates for robust funding and a collaborative approach that balances innovation with accountability. Katalyze’s collaborative model is essential in ensuring that AI-powered healthcare solutions meet rigorous standards without delaying patient access.
Unlocking Opportunities in Rare Diseases
Rare diseases present unique opportunities for AI to shine. With over 7,000 known rare diseases, AI-driven tools could accelerate drug discovery and enable personalized treatment strategies.
Kim emphasizes the potential of generative AI and advanced analytics to repurpose existing molecules and develop new therapies tailored to specific conditions. However, the financial model for such endeavors remains a challenge. “Health plans won’t pay for inherently experimental treatments,” Kim notes, highlighting the need for innovative funding mechanisms.
Rare diseases present unique opportunities for AI to shine. With over 7,000 known rare diseases, AI-driven tools could accelerate drug discovery and enable personalized treatment strategies.
Kim emphasizes the potential of generative AI and advanced analytics to repurpose existing molecules and develop new therapies tailored to specific conditions. However, the financial model for such endeavors remains a challenge. “Health plans won’t pay for inherently experimental treatments,” Kim notes, highlighting the need for innovative funding mechanisms.
Rare diseases present unique opportunities for AI to shine. With over 7,000 known rare diseases, AI-driven tools could accelerate drug discovery and enable personalized treatment strategies.
Kim emphasizes the potential of generative AI and advanced analytics to repurpose existing molecules and develop new therapies tailored to specific conditions. However, the financial model for such endeavors remains a challenge. “Health plans won’t pay for inherently experimental treatments,” Kim notes, highlighting the need for innovative funding mechanisms.
Rare diseases present unique opportunities for AI to shine. With over 7,000 known rare diseases, AI-driven tools could accelerate drug discovery and enable personalized treatment strategies.
Kim emphasizes the potential of generative AI and advanced analytics to repurpose existing molecules and develop new therapies tailored to specific conditions. However, the financial model for such endeavors remains a challenge. “Health plans won’t pay for inherently experimental treatments,” Kim notes, highlighting the need for innovative funding mechanisms.
Public-Private Collaboration: The Key to Sustainable Innovation
Kim believes that public-private partnerships are critical to establishing global standards for AI in regulatory science. He envisions a future where governments, private entities, and academia work together to create transparent, accountable systems that ensure safety without stifling innovation.
Drawing from the Health Equity Consortium (HEC), this study illustrates how technology facilitated collaborations between public and private sectors to combat health misinformation, decrease vaccine hesitancy, and enhance access to primary care services in underserved communities during the COVID-19 pandemic. (Read more here )
“We need multilateral engagement, trust, and verification,” Kim explains. He draws parallels to the 1970s Asilomar Conference on recombinant DNA, where scientists voluntarily adopted guidelines to ensure ethical and safe development.
Kim believes that public-private partnerships are critical to establishing global standards for AI in regulatory science. He envisions a future where governments, private entities, and academia work together to create transparent, accountable systems that ensure safety without stifling innovation.
Drawing from the Health Equity Consortium (HEC), this study illustrates how technology facilitated collaborations between public and private sectors to combat health misinformation, decrease vaccine hesitancy, and enhance access to primary care services in underserved communities during the COVID-19 pandemic. (Read more here )
“We need multilateral engagement, trust, and verification,” Kim explains. He draws parallels to the 1970s Asilomar Conference on recombinant DNA, where scientists voluntarily adopted guidelines to ensure ethical and safe development.
Kim believes that public-private partnerships are critical to establishing global standards for AI in regulatory science. He envisions a future where governments, private entities, and academia work together to create transparent, accountable systems that ensure safety without stifling innovation.
Drawing from the Health Equity Consortium (HEC), this study illustrates how technology facilitated collaborations between public and private sectors to combat health misinformation, decrease vaccine hesitancy, and enhance access to primary care services in underserved communities during the COVID-19 pandemic. (Read more here )
“We need multilateral engagement, trust, and verification,” Kim explains. He draws parallels to the 1970s Asilomar Conference on recombinant DNA, where scientists voluntarily adopted guidelines to ensure ethical and safe development.
Kim believes that public-private partnerships are critical to establishing global standards for AI in regulatory science. He envisions a future where governments, private entities, and academia work together to create transparent, accountable systems that ensure safety without stifling innovation.
Drawing from the Health Equity Consortium (HEC), this study illustrates how technology facilitated collaborations between public and private sectors to combat health misinformation, decrease vaccine hesitancy, and enhance access to primary care services in underserved communities during the COVID-19 pandemic. (Read more here )
“We need multilateral engagement, trust, and verification,” Kim explains. He draws parallels to the 1970s Asilomar Conference on recombinant DNA, where scientists voluntarily adopted guidelines to ensure ethical and safe development.
The integration of AI into regulatory science is both a challenge and an opportunity. By fostering collaboration, embracing transparency, and addressing systemic inefficiencies, regulatory agencies can harness AI to drive safer, more efficient healthcare innovation.
Katalyze’s role as a facilitator and innovator ensures that these efforts remain grounded in real-world applications. As Kim aptly states, “It’s not about being disruptive for the sake of disruption. It’s about being social actors—partners in this journey.” The stakes are high, but with the right mix of vision, funding, and collaboration, AI can revolutionize regulatory science and improve outcomes for patients worldwide.
The integration of AI into regulatory science is both a challenge and an opportunity. By fostering collaboration, embracing transparency, and addressing systemic inefficiencies, regulatory agencies can harness AI to drive safer, more efficient healthcare innovation.
Katalyze’s role as a facilitator and innovator ensures that these efforts remain grounded in real-world applications. As Kim aptly states, “It’s not about being disruptive for the sake of disruption. It’s about being social actors—partners in this journey.” The stakes are high, but with the right mix of vision, funding, and collaboration, AI can revolutionize regulatory science and improve outcomes for patients worldwide.
The integration of AI into regulatory science is both a challenge and an opportunity. By fostering collaboration, embracing transparency, and addressing systemic inefficiencies, regulatory agencies can harness AI to drive safer, more efficient healthcare innovation.
Katalyze’s role as a facilitator and innovator ensures that these efforts remain grounded in real-world applications. As Kim aptly states, “It’s not about being disruptive for the sake of disruption. It’s about being social actors—partners in this journey.” The stakes are high, but with the right mix of vision, funding, and collaboration, AI can revolutionize regulatory science and improve outcomes for patients worldwide.
The integration of AI into regulatory science is both a challenge and an opportunity. By fostering collaboration, embracing transparency, and addressing systemic inefficiencies, regulatory agencies can harness AI to drive safer, more efficient healthcare innovation.
Katalyze’s role as a facilitator and innovator ensures that these efforts remain grounded in real-world applications. As Kim aptly states, “It’s not about being disruptive for the sake of disruption. It’s about being social actors—partners in this journey.” The stakes are high, but with the right mix of vision, funding, and collaboration, AI can revolutionize regulatory science and improve outcomes for patients worldwide.
Paul Kim
Paul Kim
Paul Kim
With 30+ years of experience in Washington DC, Paul Kim advises patient advocates, global life science leaders, and innovative emerging companies on FDA and public health policy- developing legislative and policy strategies for regulatory reforms, drafting and enacting Federal legislation, and securing funding or creating effective P3s. Paul's experience extends across drug and device law; rare disease innovation; public health and immunization policy; biodefense policy; and congressional oversight & investigations. Paul has represented leading biotechnology, pharmaceutical and medical device companies, trade associations, and patient advocacy groups before the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), HHS ASPR/BARDA, and Congress.
With 30+ years of experience in Washington DC, Paul Kim advises patient advocates, global life science leaders, and innovative emerging companies on FDA and public health policy- developing legislative and policy strategies for regulatory reforms, drafting and enacting Federal legislation, and securing funding or creating effective P3s. Paul's experience extends across drug and device law; rare disease innovation; public health and immunization policy; biodefense policy; and congressional oversight & investigations. Paul has represented leading biotechnology, pharmaceutical and medical device companies, trade associations, and patient advocacy groups before the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), HHS ASPR/BARDA, and Congress.
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