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DIA/FDA Oligonucleotide-Based Therapeutics Conference

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Session 5 Track 3: ICH Q14 Regulatory Perspective and the Impact on Process Analytical Technology

Session Chair(s)

Claus Rentel, PhD

Claus Rentel, PhD

  • Vice President, Analytical Development and Quality Control
  • Ionis Pharmaceuticals, Inc., United States
A new quality guideline, ICHQ14, on analytical procedure development is being developed. The intent of this guideline is to harmonize scientific approaches of analytical procedure development in both traditional and enhanced approaches. Thus, resulting in improved regulatory communication between industry and regulators by facilitating efficient and science-based change management. The session will include presentations from a member of the working group as well as industry experience implementing PAT for an oligonucleotide therapeutic. The presentations will be followed by a panel discussion.
Learning Objective :
  • Understand concepts of an enhanced approach to analytical method development and Quality by Design (QbD) principles like Risk Assessment, Design Space, and Control Strategy
  • Introduce ICH Q14 principles to analytical method validation
  • Learn about applications of PAT and the use of multivariate models in oligonucleotide manufacturing
  • Understand regulatory acceptance of strategies differing from traditional analytical method validations

Speaker(s)

Daniel Hill, MBA

Speaker

Daniel Hill, MBA

  • Associate Director Digital Development and Analytics
  • Biogen, United States
Nina S. Cauchon, PhD, RAC

Speaker

Nina S. Cauchon, PhD, RAC

  • Director Regulatory Affairs CMC
  • Amgen, United States
Bryan Castle, PhD

Panelists

Bryan Castle, PhD

  • Executive Director, Synthetic Molecule Design & Development
  • Eli Lilly and Company, United States
Bogdan Kurtyka, PhD

Panelists

Bogdan Kurtyka, PhD

  • Senior Process Quality Assessor
  • FDA, United States
René Thürmer, PhD

Panelists

René Thürmer, PhD

  • Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
  • Federal Institute for Drugs and Medical Devices, Germany

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