November 8-11, 2021 - 7th Statistics Workshop


Accelerating Drug Development: How QbD, Regulatory Partnerships, and
Pandemic Learning
Can Further Expedite Meeting Patient Needs

A Virtual Meeting
10:00am - 2:00pm EST // 16:00 - 20:00 CET

Registration Open

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 / Organizing Committee

Kristi GRIFFITHS, Co-Chair, Eli Lilly and Company Julia O’NEILL, Co-Chair, Moderna
Rick BURDICK, Burdick Consulting Chuck MILLER, Merck
Catherine CHENG, Novartis Gene Therapies Guillermo MIRO-QUESADA, AstraZeneca
JoAnn COLEMAN, Spark Therapeutics Laura PACK, Seagen
Katherine GIACOLETTI, Synolostats, LLC José RAMIREZ, Amgen
Theodoro KOULIS, Genentech Tara SCHERDER, Synolostats, LLC
Ruojia LI, Bristol-Myers Squibb Tim SCHOFIELD, IABS, CMC Sciences, LLC
Tsai-Lien LIN, FDA/CBER Christian SEIFERT, Boehringer-Ingelheim
Jia LIU, Pfizer Meiyu SHEN, FDA/CDER
Areti MANOLA, Janssen Stan ALTAN, Janssen


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