What's on Your QbD Calendar?

Some great events taking shape this fall for Quality by Design, in case you hadn't heard:

Practical Solutions to PAT and QbD Workshop, Oct. 20-21, London

Process Chemmistry in the Pharma Industry (with Special Emphasis on Continuous Manufacturing), Nov. 2-4, Durham, N.C.--James Evans of the Novartis-MIT Center has put together a great panel on continuous mfg.

AIChE QbD Topical Conference, Nov. 8-13, Nashville, TN--the QbD thread runs throughout the event.

Eastern Analytical Symposium, Nov. 16-19, Somerset, NJ

AAPS and ISPE meetings in early November (both in Southern California) will also have plenty of QbD on tap.

--Paul Thomas

Global Outsourcing of Clinical Trials: Patient Concerns and Hope for Change

I've seen a number of news items come across my desk of late about Western companies forging partnerships to outsource clinical trials around the globe, particularly to India. Today's OpEd piece from UK's Guardian looks at some of the growing concern over fair treatment of patients as this trend plays out. The primary concern: "informed consent" can look good on paper but not necessarily be honored and practiced in situations in which trial patients are severely economically disadvantaged.

There are positives about the continued trend towards outsourcing trials overseas, of course. It's an opportunity to speed drug development, and to increase the availability of medications for "local diseases" around the world.

--Paul Thomas

One Man's Experience: Integrating SQL*LIMS with an ERP

A nice case study/best practices article from Jeff Vannest of J and R Consulting on integrating SQL*LIMS with an ERP system, in this case Oracle.

--Paul Thomas

ICH Guidelines Show Their Age (and Difficulty)

Throughout this year, our contributing editor Emil Ciurczak has undertaken a series of articles on the need to update ICH guidances--as, he points out, most of them were developed before the PAT/QbD era in pharma. Emil looks at the guidances through a PAT/QbD lens and offers up ways that they'll need revising (when ICH has time to get around to it).

Thus far he has tackled Q2 (R1), Q7A, and Q6A.

His latest analysis is of ICH Q8. We know what you're thinking--Q8 is one of the seminal documents of QbD. True, says Ciurczak: It's not so much that it needs revising, but that it needs ongoing interpretation. Few in the industry read Q8 in full, he notes, and it seems that few interpret it in quite the same way.

If Ciurczak is game, to be continued . . .

--Paul Thomas

FDA Initiates Study of QbD for Lyo Protein Product Manufacturing

FDA has released a synopsis of a project to study the development of QbD for lyophilized protein parenteral manufacturing. The parties involved in the one-year project include Baxter Pharmaceutical Solutions, Purdue University, University of Iowa, and University of Connecticut.

--Paul Thomas

Good for Mice, at the Expense of Moths

Researchers are investigating the use of insects for preclinical testing, which could relieve mice and other common lab animals of their traditional duties.

--Paul Thomas

U.S. vs. EU: Who's Better at Getting Drugs to Market? Does It Matter?

Joseph DiStefano of the Philadelphia Inquirer looks at the recent research of Dr. Donald Light, a visiting professor at Stanford, with an eye towards the debate over whose system of drug development, Europeans' or Americans', is the more productive.

Light reassesses the work of researchers Henry Grabowski and Richard Wang, who concluded a few years back that enhanced free-market conditions in the U.S. had allowed pharma and biotech companies here to get more drugs to market more quickly.

Not so fast, says Light. In his work, Light figures in the sheer amount of money spent on development (much higher in the U.S.) and whether or not the drugs that got to market really made a difference beyond what drugs were already available to consumers--or, as is often the case, they simply added one more product to the mix.

Dollar for dollar, Light says, and despite more prevalent government cost controls, European development is the more efficient system. (PhRMA wholeheartedly disagrees, as DiStefano's article notes.)

Regardless of which side of the pond you're on, and which public-private system of drug development you lean towards, the research from Grabowski, Wang, Light, et al. points to a greater need, everywhere, for increasing the quality and efficacy of drugs approved. Says Light about the U.S., "only about one in seven new drugs are better than existing drugs." Even if you question his methods, motives, or accuracy, it's a sobering statistic to consider, and a reminder that Quality by Design thinking is needed to keep our attention on what's important--getting truly better drugs to market, faster and cheaper than before, everywhere in the world.

--Paul Thomas

What is Your Favorite QbD Analytical Tool?

There's been an interesting (albeit slow to develop) discussion of late on the Quality-by-Design LinkedIn group regarding users' favorite QbD analytical tool. It would seem a very subjective topic (akin to your favorite flavor of ice cream), but the answers have ranged from NIR imaging to Excel spreadsheets ("It's great for getting agreement between teams prior to selecting process analytical techniques") to HPLC to terahertz imaging. What's yours?

Contributors to the thread offer some useful links to read more about their favorite tools.

(Apologies to the non-LinkedIn readers out there!)

--Paul Thomas

Drug Development, an Interactive Tour

Hadn't seen this video before on PhRMA's Innovation.org web site, but it's well done. A bit sappy (cue the piano music), but it's a good step-by-step look at how drugs get to market. A good one to send all your friends and relatives who wonder: a) how drugs get to market; and b) why it takes so darn long to get there. It's also good for explaining to them what you do--e.g., "See that guy talking about submitting IND's to the FDA--that's what I do all day!"

--Paul Thomas

Got QbD Education? Tell Us About It

We've begun to assemble a comprehensive list of legitimate, ongoing educational opportunities for Quality by Design (and PAT), including university degree courses, career development training, online webinars, and other resources. Visit our QbD Education Resources link on PharmaQbD.com, and let us know if you have items or organizations that you think should be added to the list. Vendor-sponsored opportunities are fine as long as they promote QbD learning and not any specific product or solution.

--Paul Thomas