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Visions and revisions: a talmudic reading of the CFR.

I THOUGHT ABOUT WRITING ON chromium in Chinese-made capsules, or the budget-busting perils of Alzheimer's R&D, Or the slowdowns in emerging market sales for major pharma. But instead I decided to tell you about Daf Yomi.

[ILLUSTRATION OMITTED]

Daf Yomi is a tradition that began in Poland in 1923 in which people study one page each day of the Talmud, Judaism's book of laws (and interpretations and Opinions, since that's what were good at). Since the 63 tractates of the Talmud add up to a few thousand pages, the process of Daf Yomi takes seven and a half years to complete. And the day after the cycle is done, it starts all over again.

I only found out about Daf Yomi a week into the current cycle this past August and, since I'm the sort of guy who won't watch a movie if he misses the opening credits, I figure 1 can wait until 2020 for the next jumping-on point. (Who's with me?)

Adam Kirsch, the great literary critic who's both younger and braver than me, jumped onto this Daf Yomi cycle and is chronicling his readings weekly at the Jewish website Tablet, discussing Talmud from his "basically secular" perspective. Mr. Kirsch's first post (bit.ly/NOldq6) left me intrigued by the notion of working one's way through a massive book of rules and interpretations. And, as is my wont, I thought about its parallels in pharma.

Over the years, I've heard stories from readers about seemingly routine FDA inspections that led to flurries of observations. In most instances, the readers would reassure me that they followed GMP, only to be confounded by inspectors' interpretations and opinions of the rules. I'm not comparing an FDA inspector with Rabbi Hillel, but is it that much of a stretch to see the pharma/biopharma segment of the Code of Federal Regulations (CFR), and its analogs in other countries, as a modern version of the rabbis' debates over the meaning of scripture and the laws? Like the Talmud (and later commentaries), it's a constant interplay of interpretations and attempts at comprehending the modern world in terms of basic, long-standing laws. Instead of Gehenna, we get warning letters and (gulp!) consent decrees.

According to Mt Kirsch, an early page of the Talmud advises, "As Rabbi Shimon ben Lakish, said, anyone who engages in Torah study, afflictions keep away from him." Nowadays, we can hope for such benefits from sticking to GMP, but keeping a steady dialogue with the FDA.

News from the Board

We added a number of members to our Editorial Advisory Board this issue: Shaukat Ali, Ph.D. of BASF, Balaji V. Kadri of PharmaForm, Steve F Massah of Gilead Sciences, Paul Titley of Aesica and Falguni Vaidya of Bristol-Myers Squibb.To find out more about them, visit www.contractpharma.com/staff

RELATED ARTICLE: What I'm Reading

Pharma

Altered States

Oliver Sacks, New Yorker-nyr.kr/NCIcU9

Comment: The famed neurologist and author discusses his experiments tweaking his personal neurochemistry back in the 1960s in this excerpt from his new book, Hallucinations. There's a lot of (largely illicit) pharma involved in this story, but Dr. Sacks also documented the experience so well that it's a pretty illuminating trip. As it were.

Non-Pharma

The Early History of Rome (Books l-X) Titus Livy-amzn.to/PQxIXp and amzn.to/PiuMzJ Comment Roman history and poetry comprise a huge lacuna in my education, so I spent the summer with Livy (and Virgil, Ovid and Horace). You'll learn a lot about our present day by reading up on Rome's transition from kingdom to republic. (And presumably, the transition from republic to empire, but I haven't gotten that far yet.)

The Wrong Side Absolutely Must Not Win

A. Barton Hinkle, Reason-bit.ly/SBhi4h

Comment: A humorous piece on the similarities in the rhetoric and propaganda of the two parties. November 7th can't come soon enough, in my opinion ...

What are you reading?

Let me know--at gil@rodpub.com, www.goodreads.com/groth, www.linkedin.com/groups?gid=1775433 or www.facebook.com/contractpharma--and the first respondent wins a prize!

Gil Roth

Editor * gil@rodpub.com/twitter.com/contractpharma

P.S.: In the same spirit, this issue features a tongue-in-cheek celebration/mash-up of the 400th anniversary of the King James Bible and the centenary of the Sherley Amendment, The Good Book of Manufacturing Practice (pp. 80-84).
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Title Annotation:FROM THE EDITOR
Author:Roth, Gil
Publication:Contract Pharma
Date:Sep 1, 2012
Words:727
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