Objectives of the meeting

The pharmaceutical industry, academicians, and global regulators have demonstrated over the past year that drug development can be incredibly accelerated to address urgent, unmet needs. In addition, coupled with that acceleration, the pharmaceutical industry has been on a Quality by Design (QbD) implementation journey for nearly two decades. Acceleration has placed an emphasis on conducting and documenting risk assessments, utilizing modeling to leverage platform knowledge, incorporating digital and technological advances to improve process performance and understanding, and continued refinement and improvement of the information that is submitted to global regulators. What have we learned from these experiences, particularly from the vantage point of CMC statisticians, and what aspects of the near-term dramatic acceleration and longer-term development journey could/should be continued going forward? This workshop will explore the development journeys over a series of sessions by hearing directly from the industry, professors, and global regulators. By focusing each session on themes that cover QbD, Regulatory, Continuous Manufacturing, and Case Studies, the workshop will be an opportunity to help shape the future of drug development through the role of CMC statisticians. Join us for presentations, panel discussions, and breakout sessions to engage directly with speakers, other experts, and each other.

Scientific Committee

  • Julia O'Neill Co-Chair; Moderna
  • Kristi Griffiths Co-Chair; Eli Lilly and Company
  • Stan Altan Johnson & Johnson
  • Timo Bailer Boehringer Ingelheim
  • Cristiana Campa GlaxoSmithKline
  • Catherine Cheng Novartis
  • Joann Coleman Spark Therapeutics, Inc.
  • Jun Gao Health Canada
  • Katherine Giacoletti Merck & Co., Inc
  • Theo Koulis Genentech
  • Ruojia Li Bristol Myers Squibb
  • Jia Liu Pfizer
  • Charles Miller Merck & Co., Inc
  • Guillermo Miro-Quesada AstraZenca
  • John Oleynick Janssen
  • Laura Pack Rezolute
  • José Ramírez Kite Pharma
  • Tim Schofield IABS