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Separate Review Track Proposed for Design Space to Avoid Marketing Application Approval Delays

Aug 30th, 2010

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A separate review track for design spaces could allow more room for industry/regulator dialogue on the issues involved without delaying the clearance process for the marketing application, Health Canada Center for the Evaluation of Radiopharmaceuticals and Biotherapeutics Senior Regulatory Scientist Anthony Ridgway suggested at a CMC Strategy Forum on implementing quality by design (QbD) cosponsored by the biotech science society CASSS and FDA in mid-July.

Ridgway made the suggestion in the context of the discussions at the July forum of the outstanding nexus of issues around defining the design space and its relationship to the control strategy and the quality system, what needs to be filed in applications, and the regulatory implications as the design space knowledge base expands.

July’s meeting was the third of the CMC strategy forums focused on implementing QbD in the biotech context. [Editor’s Note: The dialogue at the first two QbD forums is analyzed in the Sept./Oct 2007 and Sept./Oct 2008 IPQ Reports, respectively.] The forums are held semiannually in the US and once a year in Europe.

The July forum was focused in particular on the key learnings from FDA/industry collaboration in the A-Mab Case Study and in the CDER Office of Biotechnology’s QbD pilot program (IPQ May 2010 Report).

The A-Mab case study, which addresses the application of QbD principles in the development of a hypothetical monoclonal antibody, was the result of a two-year effort by a consortium of seven leading biotechnology companies, known collectively as the “CMC-Biotech Working Group.” A-Mab represents an important reference point for the industry/regulator discussions on how to implement QbD.

CDER’s QbD pilot is ongoing with OBP still accepting volunteers for working with the review office on QbD-oriented applications and supplements.

Ridgway threw out the idea of an independent regulatory pathway for design space as a possible solution to the resource challenges that agencies already face in QbD implementation, particularly smaller ones such as Health Canada, and the need to avoid having the potentially more involved design space discussions jeopardize clearance timelines.

[Ridgway’s analysis is continued for subscribers on page 2. Further discussion of the regulatory challenges and uncertainties around design space by other regulators and industry participants at the QbD CMC strategy forum will be covered in a follow-up “In the News” story this week.]

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