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Quality by Design Workshop

Come to the QbD Workshop at WCPB 2013! Get answers to all your QbD questions! Free design space for every attendee! Just kidding…. Quality by Design Workshop. January 30, 2013 Roman Drews , CBER, FDA Sean Fitzsimmons, CDER, FDA Lynne Krummen, Genentech…Roche Group

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Quality by Design Workshop

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  1. Come to the QbD Workshop at WCPB 2013! Get answers to all your QbD questions! Free design space for every attendee! Just kidding…. Quality by Design Workshop January 30, 2013 Roman Drews, CBER, FDA Sean Fitzsimmons, CDER, FDA Lynne Krummen, Genentech…Roche Group Gregg Nyberg, Amgen Inc.

  2. QbD: Experience with QbD Implementation: Abstract: The ICH guidelines on quality by design (ICH Q8,9,10,11) are in place and there have been many discussions about the philosophy of QbD. Furthermore, several companies have by now participated in the FDA QbD pilot program. What are the lessons learned and insights, now that sponsors have had an opportunity to implement enhanced approaches to process development and product understanding in clinical development and at market application? Are FDA reviewers seeing what they expected in QbD filings? How have sponsors addressed challenges associated with CQA and CPP identification, attribute interactions, validity of pilot and small scale models, justification and explanation of statistical models and how non-CPP's are handled? How have regulators seen sponsor companies fall short in these key areas? What benefits or drawbacks have sponsors seen? Have elements of QbD been integrated into standard business practices for all products, or reserved for enhanced QbD design space filings? In this workshop we will explore these questions and more in an engaging and highly interactive format.

  3. April 10-13, 2013 San Francisco, CA

  4. Areas for Discussion What is the degree of adoption of QbD practices by Sponsor companies? For those companies that have adopted QbD practices, what are the biggest practical challenges? How can these be addressed? What challenges are presented in compiling and reviewing filings based on enhanced approaches? What are some best practices?

  5. Adoption of QbD by Sponsor companies: • How does the biotech industry currently view Quality by Design: a new standardized approach to product and process development, or a specialized/optional exercise applied to selected products? • At your company, have elements of QbD been integrated into standard business practices for all products, or reserved for some portion of the product portfolio • For programs that are developed using QbD concepts, is your company’s strategy to file design space claims in the original BLA or is that viewed as either optional or something deferred until post-approval? Why? • If your company considers filing a design space claim, what approach (process-wide or unit op specific) has been most commonly used? • What should be considered when deciding to claim a “process-wide” design space compared to design space on selected unit operations? • If sponsors provide multivariate data to support the Process Description, but do not claim a Design Space, how do the expectations of regulators change regarding reporting of changes within the licensed ranges? • How does the biotech industry currently view the benefit/cost of implementing the QbD approach?

  6. Application of QbD: • What are the biggest practical challenges impeding full implementation of QbD (i.e. including design space approval?) • CQA and CPP identification? • Accounting for attribute interactions? • Validity of pilot and small scale models? • Justification and explanation of statistical models? • Providing assurance of how changes to CPPs or non-CPP's will be handled post-approval? • How effectively has risk management been applied as part of QbD? Is there a need or benefit for industry standards and sharing of best practices?

  7. Submission and review of QbD filings: • Are Regulators seeing what they expected in QbD filings? • How understandable have risk assessments and their conclusions been to reviewers? • What aspects of QbD are most challenging to summarize in the CTD format? • What part of the QbD related information/data should be submitted in the original submission and what part should be available for Health Authority review during the inspection ? Are there regional differences in practice? • Has inclusion of some elements of QbD become a standard for all product filings? Will this be the case in the future?

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