Adel Malek
Adel Malek, Ph.D., is a Regulatory Consultant and Applied AI Workflow Architect at 3E by Yordas Group. He advises multinationals and industry consortia in the aerospace, electronics, consumer products, and chemical sectors on market access and regulatory strategy as science evolves and jurisdictions diverge. His recent work includes PFAS, nanomaterials, petrochemicals, and the circular economy. He specializes in structured evidence reviews and multi-jurisdictional landscape reports for executive decisions. He also designs and deploys human-in-the-loop AI workflows that allow expert teams to work through dense scientific and regulatory material at scale.
Before joining Yordas, Dr. Malek held senior roles in clinical microbiology and infectious disease diagnostics in the United States and Canada, evaluating new technologies and advising infection prevention teams and clinicians. He holds a Ph.D. in Microbiology and Immunology from Dartmouth and is a former Diplomate of the American Board of Medical Microbiology. He has presented on PFAS at SETAC Europe and on sustainability at PSX, and works closely with the IAEG and AIAG industry associations.
Tuesday Dec 8
Scientific Affairs Committee and Task Force Meeting
Scientific and regulatory professionals are navigating two rapidly evolving areas: the use of generative AI in regulatory workflows and new hazard classes for persistent and mobile substances. This session will explore both topics, providing practical guidance on responsible AI use and an update on the science and regulatory direction for persistent, mobile substances, using trifluoroacetic acid (TFA) as a case study.
AI Governance in Regulatory Workflows: Generative AI is increasingly being incorporated into regulatory work, from label changes to agency responses, raising new questions about how AI-generated outputs may be evaluated by regulators or opposing counsel. This interactive presentation will focus on three capabilities that can help make AI use defensible: governance, human-in-the-loop workflow design, and auditability. Drawing on frameworks from the EPA, FDA, and the Institute of Internal Auditors, this session will include live polling on the risks associated with AI-assisted decisions and a practical workflow design exercise.
Highly Mobile Substances: In 2023 the EU added two hazard classes – persistent, mobile and toxic (PMT) and very persistent, very mobile (vPvM) – for substances that move with water and are only partially removed by conventional treatment. Using TFA as a case study, this session will examine the evolving science and regulatory landscape, including the hazard-versus-risk debate, the path from EU classification to drinking water standards and restrictions, diverging U.S. federal and state PFAS definitions, and key considerations for ingredient portfolios and suppliers.
Speakers:
Adel Malek, Regulatory Consultant and Applied AI Workflow Architect, Yordas Group by 3E
Julius Reitemeier, Senior Scientist, Exponent