Biopharmaceuticals and Risk Management: What do ICH Q8 and Q9 mean?

New draft guidance from the ICH indicates that process development should include risk assessment, definition of ’design space’, and suitable designed experiments to define a safe operating range. How to define your own strategy on process development given the rapid pace of development, the difficulty of defining the process and the product early in development, and the ever-changing regulatory environment.How can this guidance be applied given the rapid pace of development, the difficulty of defining the process and the product early in development, and the ever-changing regulatory environment? This talk discusses approaches to defining your own strategy.

• Defining risks for a biopharmaceutical
• "Design space": What is it?
• Process development as a risk reduction strategy
• Process validation to document process performance
• Reducing risks in the change control program
• Reducing compliance risk: handling exceptions and complaints
• How safe is safe enough-at clinical and commercial stages?

• Development scientists
• QC and analytical methods development scientists and managers
• QA managers and personnel
• Manufacturing
• Regulatory affairs

Instructor Profile
Paula Shadle, Ph.D., has over 20 years of hands-on and executive experience in biopharmaceutical and pharmaceutical process development and quality, 35 publications and 4 process patents. Dr. Shadle has written over 35 technical publications and was co-inventor on four process patents, and teaches adult education for the University of Wisconsin, the Parenteral Drug Association, PQRI and the Institute for International Research. In 2000, Dr. Shadle received the Judith Pool Award for excellence in teaching and mentoring from AWIS. She was on the planning committee for the 2001-2003 PDA-FDA Meetings, and is Member-At-Large in the West Coast Chapter of PDA. She has spoken at several EBC briefings, and is a member of the Parenteral Drug Association, the American Society for Quality, the Association for Women in Science, and the California Separations Society (CaSSS). Dr. Shadle is on the editorial board of the journal BioPharm International, and often writes about quality and science. She is currently Member-At-Large in the West Coast Chapter of PDA, Treasurer of the East Bay Chapter of AWIS (Associate for Women in Science), an organization that mentors and supports women in the sciences.

Dr. Shadle received her B.S. and Ph.D. in biochemistry at the University of California and postdoctoral training at the Max-Planck Institute in Germany. She worked in technical and quality control/assurance positions of increasing responsibility at Chiron Corporation, Scios Inc., GlaxoSmithKline plc, and Bayer Corporation before founding Shadle Consulting. At GSK she was director of downstream process development, then of biopharmaceutical quality operations, overseeing QA, QC, analytical methods and validation. At Bayer Corporation, Dr. Shadle was director of quality control of marketed products.

Dr Shadle founded Shadle Consulting in 2001, which offers consulting services for biotechnology and biopharmaceutical firms in quality, process development, and strategic planning of quality systems. Services provided include internal and external audits, GMP training, QC laboratories, and QA systems. Experienced with clinical trials materials, process validation, and more.

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