Douglas Kiehl - uventia

Douglas Kiehl

Douglas Kiehl

Douglas Kiehl

Research Advisor


Douglas Kiehl is a Senior Director at Eli Lilly and Company and leads the Disruptive/Transformative Technologies Team (DT3) and Digital Twin Center of Excellence with focus on digital transformation, automation, extractables/leachables and next-gen bioprocess. He serves as a member of the United States Pharmacopeia (USP) Packaging and Distribution Expert Committee, Chair for the Product Quality Research Institute (PQRI) Development Technical Committee, PhRMA Topic Lead for the International Council for Harmonisation (ICH) Q3E Guidance Expert Working Group, Board of Directors for the Extractables/Leachables Safety Information Exchange (ELSIE) Consortium, Chair for the International Society for Optics and Photonics (SPIE) Defense and Commercial Sensing Conference, Executive Governing Council for the Nano-Bio Materials Consortium (NBMC/SEMI) and founding member of the Biomolecule Reactivity Consortium. He has published his work in several peer-reviewed and trade journals, and has organized, chaired and presented at several conferences across multiple industries.

4th Annual Extractables & Leachables
March 7, 2024
What is next in testing and analyzing for extractables and leachables in biopharmaceutical development and release? Recording of 2 days event sessions [18 video sessions].

DAY 2: MARCH 8th, 2024

SESSION: Pharma 4.0/5.0, FDA/FRAME and digital twins: Enabling advanced manufacturing and digital transformation in pharma through cross-collaborative partnerships

◆  What are the current drivers for Digital Transformation in Pharma?

◆  How is Pharma 4.0/5.0 defining the disruptive and transformative roadmap for more expedient operations, product development, advanced manufacturing, supply chain and lifecycle management?

◆  How are digital twins and cross-collaborative partnerships primary enablers for advanced manufacturing and digital transformation in pharma?

Extractables & Leachables Summit
May 19, 2021
Analytical methods for E&L, regulatory updates & compliance, risk based E&L programs, toxicological risk assessment. Recording of 2 days event sessions [13 video sessions].

DAY 1: MARCH 30th, 2021

SESSION: Emerging data visualization approaches for rapid, heuristic interpretation of highly complex mixtures of structurally and compositionally diverse chemical entities associated with e&l and pharmaceutically relevant materials

◆  Challenges with establishing comprehensive profiles from complex mixtures of diverse extractables.

◆  Data visualization/AI approaches to enable heuristic complex mixture data interpretation.

◆  Potential applications in modeling/simulation, rapid decision making and change management.

Speaker Details
Speaker Details