Doug Kiehl with Eli Lilly

Karen Quatromoni, Director of Public Relations at OMG, introduces the podcast series and its focus on the Digital Twin Consortium (DTC). Bill Hoffman, OMG CEO and Chairman, interviews Doug Kiehl, Senior Director at Eli Lilly and co-chair of the DTC's new pharma and regulatory Working Group. Doug discusses his 30-year tenure at Eli Lilly, the formation of the Disruptive/Transformative Technologies team, and the drivers for digital twin technology in pharma, including industry trajectory and regulatory expectations. He highlights the importance of cross-industry collaboration and the potential of digital twins in manufacturing, compliance, and process validation, emphasizing their role in expediting product development and improving patient outcomes.

Action Items

• [ ] Attract other pharmaceutical companies to join the Digital Twin Consortium and contribute to working group efforts.
• [ ] Develop a charter and focus areas for the Pharma and Regulatory Working Group.
• [ ] Explore applications of digital twins across the pharmaceutical product development and manufacturing lifecycle.

Outline

Introduction and Welcome

• Karen Quatromoni introduces herself as the Director of Public Relations for Object Management Group (OMG) and welcomes Bill Hoffman and Doug Kiehl to the OMG podcast series.
• Karen highlights OMG's role in driving industry standards and building tech communities, and introduces the focus on the Digital Twin Consortium (DTC).
• Bill Hoffman introduces Doug Kiehl, Senior Director at Eli Lilly and Company's Disruptive/Transformative Team and Digital Twin Center of Excellence, and chair of the DTC's new pharma and regulatory Working Group.
• Doug Kiehl thanks Karen and Bill for the introduction and expresses his gratitude for organizing the podcast.

Doug Kiehl's Background and Role at Eli Lilly

• Doug Kiehl shares his 30-year tenure at Eli Lilly, his experience in product development, and his roles in various capacities with government and private industry.
• He mentions his background as a mass spectrometrist and analytical chemist, and his role in forming the Disruptive/Transformative Technologies team at Eli Lilly.
• Doug explains the two main drivers for forming the Disruptive/Transformative Technologies team: industry trajectory and regulatory expectations.
• He highlights his involvement with the Product Quality Research Institute (PQRI) and his role as the chair for the PQRI steering committee, which includes FDA and Health Canada stakeholders.

Formation of the Disruptive/Transformative Technologies Team

• Doug discusses the formation of the Disruptive/Transformative Technologies team one year ago, driven by the need for digital transformation in the pharmaceutical industry.
• He emphasizes the importance of cross-collaborative partnerships, mentioning his liaison with various industries, including defense, Air Force Research Labs, Army Research Labs, and NASA.
• Doug expresses his satisfaction with the Digital Twin Consortium for enabling access to these partnerships and advancing their goals.
• Bill Hoffman acknowledges Doug's impressive background and the strong connection between different industries applying digital twin technology.

Charter and Importance of Digital Twins in Pharma

• Doug outlines the charter of the new working group, focusing on attracting other pharmaceutical companies to join the Digital Twin Consortium.
• He highlights the broad application of digital twin technology throughout the pharmaceutical product development and manufacturing life cycle, including supply chain and post-launch life cycle management.
• Doug mentions the importance of modeling clinical trials to minimize human intervention and expedite decision-making using readily accessible data.
• He expresses his enthusiasm for the working group's potential to achieve substantial milestones and bring forward goals aligned with each company's digital transformation roadmap.

Manufacturing and Regulatory Compliance

• Bill Hoffman inquires about the significance of manufacturing as a major application for digital twins in pharmaceuticals.
• Doug explains the regulatory perspective, mentioning the FDA's partnership with PQRI and the publication of a white paper on AI in advanced manufacturing.
• He discusses the prioritization of manufacturing, supply chain, and point-of-care manufacturing by the FDA, emphasizing the importance of developing standards and guidance.
• Doug highlights the role of digital twins in making manufacturing processes more consistent and robust, particularly in distributed, continuous, and agile manufacturing.

Compliance and Process Validation

• Bill Hoffman asks about the role of digital twins in ensuring compliance.
• Doug clarifies that digital twins can help achieve process validation in a virtual environment, reducing the need for physical product demonstrations.
• He explains the potential cost savings and sustainability benefits of using digital twins for process validation, which can expedite the production of life-saving or life-improving medicines.
• Doug emphasizes the importance of digital twins in meeting regulatory expectations and improving overall industry efficiency.

Challenges and Future Outlook

• Doug discusses the challenges of introducing new technology and the importance of education and collaboration.
• He mentions the need for critical mass and the value of showing examples of successful implementation by other companies.
• Doug highlights the role of the Digital Twin Consortium and OMG in providing tools and resources to help bring digital twin technology forward.
• He reflects on the progress made in the past year and the importance of continued collaboration and education to drive adoption and success.

Conclusion and Final Thoughts

• Bill Hoffman and Doug Kiehl discuss the potential impact of digital twins on the pharmaceutical industry and the broader benefits for patients and society.
• Doug emphasizes the importance of passion and commitment in driving innovation and collaboration within the industry.
• Karen Quatromoni thanks Doug for his insights and concludes the podcast, encouraging listeners to learn more about digital twins and their potential impact.
• The podcast ends with a reminder of the benefits of joining the Digital Twin Consortium and the importance of collaboration in driving digital transformation.