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

  • Kristi Griffiths co-Chair ; Eli Lilly and Company
  • Julia O'Neill co-Chair ; Moderna
  • Stan Altan Janssen
  • Rick Burdick Burdick Consulting
  • Catherine Cheng Novartis Gene Therapies
  • JoAnn Coleman Spark Therapeutics
  • Katherine Giacoletti Synolostats, LLC
  • Theodoro Koulis Genentech
  • Ruojia Li Bristol-Myers Squibb
  • Tsai-Lien Lin FDA
  • Jia Liu Pfizer
  • Areti Manola Janssen
  • Chuck Miller Merck
  • Guillermo Miro-Quesada AstraZeneca
  • Laura Pack Seagen
  • Jose Ramirez Amgen
  • Tara Scherder Synolostats, LLC
  • Tim Schofield CMC Sciences
  • Christian Seifert Boehringer-Ingelheim
  • Meiyu Shen FDA