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The Secret Life of APIs

Girish Malhotra, President & Founder, Epcot International
Tuesday, February 26, 2013 11:00 EST

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Girish Malhotra
Girish Malhotra  
3/6/2013 12:49:44 PM
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Re: why blockbusters?
One drug I named has about 2800 patients.

In my book QbD is natural and never called it by that name. If my operation/processes could not produce the exact same quality everytime, your did not work there. Thus quality first time and all the time was the design basis. Off-line testing and waiting was not part of the design. I hope that helps unless I am not clear on your question. Thanks.

angelodp
angelodp  
3/6/2013 12:39:27 PM
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Re: why blockbusters?
Without looking up those expensive drugs I'd estimate that some are so-called targeted therapies but none are truly "personalized." Can anyone comment on that? Or is personalization something that is tested into a product after it has been approved, thrrough the use of biomarker or genetic tests?

But truly, why are APIs today not subject to QbD? Or am I missing the point? There are certainly quality attributes of drug substances that would lend themselves to designing in those qualities vs. testing in.

Girish Malhotra
Girish Malhotra  
3/6/2013 12:16:31 PM
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Re: why blockbusters?
Agree that the blockbuster model might not die.

Personalized medicine: Many technologies and issue need to overcome before this becomes economic.

In 2012 a drug, Kalydeco, approved by FDA will cost about $294,000 per year. I am not sure who will cover it. There are 13 drugs approved in 2012 that cost $100,000 to $300,000 per year. I wonder who will pay for them or would any health plan pay for them.

Qbd should not be new to API. It is just a chemical that has disease curing value. Yes done right QbD should be a natural but is not. 

angelodp
angelodp  
3/6/2013 8:54:05 AM
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why blockbusters?
The blockbuster model will never die because the industry's vast human-resource and physical infrastructure is built upon products that serve tens of millions, not mere thousands. I still need to be convinced that personalized medicine can sustain any reasonable business model, absent situations where insurers pay for half-million-dollar per year drugs (fat chance). With respect to QbD, weren't APIs always part of the equation? 

aureusaqua
aureusaqua  
2/26/2013 3:06:13 PM
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Re: The Holdup?
Thank you for sharing with us your point of view of Qbd & PAT. Yes I agree Qbd is a systematic way of thinking the brings science back to the pharmaceutical product development. In API we use something similar (but not well developed)which we call "back up data" and in fact it was an effort to define the  design space of the process we were developing. I'll be waiting your next posts related to QbD application in API industry. Thank you again.

 

Charles Butcher
Charles Butcher  
2/26/2013 12:26:22 PM
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The Secret Life of APIs

Girish, I Googled 'QbD "technology platform"' and I certainly see the confusion you refer to. You're absolutely right: QbD is a way of thinking, not a set of technologies, though of course it will often affect the choice of technology.

Thanks for this great introduction. APIs are where quality issues start, and I'm looking forward to learning more in your next post.


Girish Malhotra
Girish Malhotra  
2/26/2013 12:01:53 PM
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Re: The Holdup?
Thanks. There is no "Hold UP". I will call it a hesitation and applies to APIs and formulations. In upcoming blogs I will try to explain how we can have and even exceed regulatory reuirements. It does not cost any more money than what we spend today. Thanks.

Alison Diana
Alison Diana  
2/26/2013 11:34:50 AM
User Rank Survivor (White Belt)
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The Holdup?
Are companies doing this because it's the status quo -- and any industry finds change challenging? Is it because of cost concerns? Or are there other issues that are making it difficult to change the way companies handle APIs?

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