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Q&A: Phase-appropriate CMC Strategies in Drug Product Development

Dr. Xiaohu Deng,Viracta

Q: At what stage companies should start QbD development?
A: Quality by design is a concept. As CMC practitioner, we should always have it in mind.

Q: Most companies even with poorly soluble and poorly bioavailable drugs run FIH with a suspension or active in capsule, is this the correct strategy or should they go with an improved formulation?
A: In the ideal world, yes. However, often it is more a business than scientific decision. Communication/negotiation with other functions to reach a sensible compromise is the key.

Q: Based on your experience, how many discovery drugs make it to Phase I? and How many drugs tested in Phase one make it to Phase III / Commercial?
A: It varies wildly from company to company. There are many papers providing good statistics out there.

Q: What are common reasons a Phase III drug product fails after successfully passing Phase I and Phase II end points?
A: It varies. Mostly toxicity and efficacy.

Q: What are specific barriers to adoption of new manufacturing and formulation technologies that are scientifically shown to improve bioavailability and other parameters?
A: Numerous. There are many companies dedicated to 505(b)(2) pathway, which clearly indicates its benefit. However, one has to critically evaluate return/benefit on investment.

Q: How can excipient manufacturer/distributor can help you to avoid hiccups in the CMC fluency?
A: CMC development is a lengthy and complex process. Everyone have to do their part to make it work. Quality, batch consistency, on time delivery to name a few.

Q: What’s the best way to organize the placebo description in the CTD Module 3?
A: Check out FDA’s guidance for Industry on this.

Q: Please highlight CMC differences between traditional NDA v 505 (b2) filing.
A: This is a big topic to cover. There are many good review articles worth reading.

Q: Do you have any advice for how best to go about selecting CROs and building external collaborations?
A: An excellent and difficult question to answer. There have been countless discussions on the topic and everyone takes different approached tailored to the individual need. One important lesson I have learned is to treat CROs as your extended internal team rather than hired pair of hands, which goes long way.

Q:How long does it take a product from discovery to commercial?
A: It depends. There are many papers providing good statistics out there.