Upfront: FDA/Conformia Report CRADA Progress

FDA and Conformia’s CRADA team reports that its next joint workshop on ICH, the first of several that will be held this year, will take place on February 20 and 21 in the D.C. area. The team will receive its 2007 Pharmaceutical Manufacturing Team of the Year award at the workshop. It is being recognized for its efforts to break down communication barriers within industry, FDA, and between the two groups, to streamline and improve drug development.

By Agnes Shanley, Editor in Chief

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FDA and Conformia’s CRADA team reports that its next joint workshop on ICH, the first of several that will be held this year, will take place on February 20 and 21 in the D.C. area. The team will receive its 2007 Pharmaceutical Manufacturing Team of the Year award at the workshop.

It is being recognized for its efforts to break down communication barriers within industry, FDA, and between the two groups, to streamline and improve drug development. Both FDA CDER Director Helen Winkle and Conformia Cofounder and Marketing Director Anjali Kataria describe the workshops as being highly successful. Held with PhRMA and developed strictly on a “not-for-profit” basis, the workshops so far have attracted 16 leading pharma and generic drug companies, and 275 executives at all levels, in areas such as product and process development, analytics, regulatory affairs, quality, IT, manufacturing and operations.

“For some companies, these workshops were the first time these people were sitting together,” said Kataria. Participants are given an opportunity to apply ICH Q8 and Q9 concepts through a “case study” involving a mock drug. They receive the case study and study questions a few weeks before the event, and are asked to review and submit a letter back to the team describing their evaluation of the drug product.

Whereas up to now the focus of the case studies has been small molecules, this year workshops will tackle broader and more complex case studies, which may include biopharmaceuticals. Conformia has developed the first new case study with four prior workshop participants, and will make it available to the drug industry, ICH and other organizations after the workshop. FDA has invited its counterparts from Europe and Japan to February’s workshop.

“We are really looking forward to this discussion, as there are some new developments in Q8R that we want to discuss and the new case study we’ve developed will be in sync with that,” said CDER Director Winkle. FDA has learned the need for a more proactive communication with industry and sharing of more implementation guidance, she said, but also the fact that companies differ in how they implement Q8 and Q9, based on management focus. Conformia found that, since its initial workshops, participants have a clearer understanding of QbD’s concepts.

“The remaining challenge is moving from principles to practice,” Kataria said. Among the key issues are: linking critical quality attributes to safety and efficacy, defining the design space, interpreting risk assessment judgments based on prior experience, and translating QbD understanding into regulatory flexibility. There is also a need to better understand the roles and responsibilities of FDA inspectors

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