Every so often, one gets a major reminder of the strategic importance of manufacturing and the largely invisible "CGMP set" to the drug industry and, yes, its bottom line. Former FDA chief Mark McClellan gave pharma a good one years ago with his famous "potato chips and soap flakes"  comment, immortalized in a Wall Street Journal piece. Typically, manufacturing continues to be thought of something that will get done....quietly, invisibly, wherever and by whomever.

Some slighting asides were made during one session at BIO, on biopharma capacity...they weren't part of the official powerpoint presentations, but came unofficially during the Q&A, and they showed that some people in the industry may continue to see Ireland as an expensive place to do business.  One wonders whether the speaker was looking only at short term costs.

I spent yesterday afternoon at the Forum for Medical Innovation in downtown Chicago, hosted by the Council for American Medical Innovation and moderated by former U.S. House of Representatives majority leader Dick Gephardt. The event also featured AstraZeneca CEO David Brennan as a guest speaker. David Brennan

From Chemical Engineering Progress, Girish Malhotra presents his prescription for the pharmaceutical industry----QbD, PAT and control all play a key role, and chemical engineers will make it happen. The ultimate goal will be entirely new business models for pharma. Mr Malhotra discusses a new "Open Lab" open source R&D initiative in India that involves Sun Microsystems.

John Graham of the conservative California think tank, the Pacific Research Institute, just published a research report, Leviathan's Drug Problem, arguing that FDA is overstaffed, overfunded and unproductive. He traces patient wait times for new medicines as contributing to far more loss of life than food contamination.

It all depends on how you look at things. According to new data, the number of new drugs approved by FDA in 2008 rose and was the highest it's been in three years. Not so fast, says blogger Merrill Goozner, who argues that numbers don't reflect what is really an ongoing "innovation drought" in the pharma pipeline.

The Competing Globally track also featured a presentation on Quality by Design, made by Russ Somma, President, SommaTech LLC, who worked for several years at Novartis and is also an editorial advisor on PharmaQbD.com.  Mr. Somma joked that the industry never had quality by accident, "We don't just lumber along and wait to fall apart, but the question is: Did you ask the right questions at the right time?" There's a need to better define process needs and required capacity early on.

Yesterday's announcement that Eli Lilly had sold off its Greenfield, Indiana, R&D facility to Covance is perhaps not just a big deal, but really a bellwether move that may signal a trend of Big Pharma companies not just outsourcing aspects of their R&D operations but selling them off altogether. As the above-linked article suggests, the time for companies like Lilly to assume the role of financiers who aggregate data may be closer to reality.

Your thoughts on the significance of the deal? We'll be keeping a close eye on this one, and include expert input in posts to come.

--PWT

A paper by James Evans recently published in Science, explores the impact of the Internet on research publications.  The problem:  Fewer and more recent sources are being cited.  For a video interview with Evans, click here.

Emil Ciurczak expounded on this theme a while back, describing this as the "Cool Hand Luke" effect....what we have, he says, is a "failure to communicate."

For more, click on and on.   

The Illinois-based marketing company JP Group had some interesting insights on the implications this trend has for new product development and marketing. Concepts could apply to any form of product development.  (cut and pasted, unattractively, below....)

AMS

Long Tail. Or Short Tail.

The Internet: Promoter of diversity or instrument of uniformity?

Have you heard of the “Long TailTheory”? First published in Wired magazine in 2004, the theory says that, because the Internet places an almost infinite amount of data at our fingertips, we are bound to expand the range of information we use.The 80/20 rule, which, in this case,means that 20% of the data is used 80% of the time (and that the “tail,” 80% of the data, is rarely used at all), wouldlose some of its meaning. Why limityourself to the same small portion ofdata everyone else uses when you haveall of it at your disposal?

The theory has something comforting in that it balances the cold blandness of computers and the information age: Itposits that computers can help uncover hidden nuggets and thus make the world more diverse. It also promises higher quality: Rather than having to shoehorn an oft-used fact into an argument, one can search for the mostappropriate fact, no matter how small orapparently trivial.

The problem is that the nice theory is not supported by the facts.

Most recently, a University of Chicagoresearcher1 demonstrated that the sources of citations in recent academic journal articles, rather than coming froma broader range of authors than in pre-Internet days, actually come from a smaller number of sources than before. They even seem to, in confirmation of a

1 James Evans, Ph.D., as cited in TheEconomist, July 17, 2008. His research is reported in the current issue of Science magazine.

trend that is contrary to that of the LongTail theory, use the same references more frequently. In other words, the tailis getting shorter, not longer. The question is, why?

To date, the most satisfying answer isthe loss of “serendipity;” i.e., what occurs when you find something otherthan what you were looking for. As Pek van Andel2 defines it, "Serendipity is looking in a haystack for a needle anddiscovering a farmer's daughter." Old research tools, whether gathering upinformation from books or by talking toother human beings, made room for serendipity. The only reason, for instance, that I know of the existence ofthe “ocarina” is the illustration of that odd musical instrument on the same dictionary page as “occlusion,” the word I was probably looking up. Thatknowledge of ocarina did enrich me ever so slightly even if I have never hadan opportunity to use it until this day.Research done the traditional way offers many serendipitous events, small opportunities to learn something new,or to make an association that leads to an unexpected and therefore more creative conclusion.

In a way, the Internet makes our research process too efficient because itreturns only the precise answers to thequestions we pose. And the more adept one is at searching, the narrower the range tends to be. What results is akin to creating intellectually closed communities in which we are next to other people who think like we do, andisolated from those who think

2 Ig Nobel Laureate

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otherwise. A kind of gerrymanderingbased on intellectual curiosity. Within those communities all questions are answered using the same research toolsleading to the same conclusion. One can imagine consumers all using the sametoothpaste, or bar-soap, just because asearch engine told them to.

Which brings us to how all of this applies to marketing: We think it more fruitful for a marketer of consumer products to find ways to preserve and nurture serendipity to avoid the trap of“me-too-ism” in product innovation andpositioning.

How can one nurture serendipity, the“accidental” discovery of a new productor idea?

A method we practice for our clients isa) to create an environment where the unexpected can happen, and b) to ensure that people with high sagacityare there to observe and draw insightful“learnings” from the event. This meansthat your consumer research must include a dash of creativity so as to elicit answers you have not heard before. For instance, if working on new shampooconcepts, throw one in the mix that promises to leave some of the naturalskin oils on the hair. If working on a pasta sauce, propose one that is blandand contains absolutely no herbs, spices,vegetables or meats. If working on a desktop organizer, offer one that lets your desk look disorganized, and so on.Good or bad, those ideas will force the consumers reacting to them to think

along new, different lines – and perhaps to suggest refinements to these ideas that are the first step in leading you to a truly new and different product.

Then make sure that your research isobserved and analyzed by individualscapable of recognizing a good idea when they see it, i.e., who are well versed in the science or in the marketingof your product category and who thinkconceptually. Those are rare birds, but they exist. For instance, you can evensupplement your team by doing whatwe call “hiring the target.” So, if youare working on positioning a product to teens, retain a couple of 15-year olds to attend your meetings, your ideation session and your research as well. Theirideas may spark some in you; they’realmost guaranteed to see things in waysyou can’t.

In a way, the internet’s effect on reducing the diversity of the ideas wecome across, the shortening of the tail ifyou will, creates excellent opportunitiesfor those who can think out of the box,for the intellectually-accident-prone who are naturally exposed to serendipity.

By Jacques Chevron & Phil Glowatz JP Group

Consultants in New Product Development,Positioning and Brand Strategy

1925 Kentwood Court Darien, IL 60561Ph.: (630) 985-1785 E-mail: Jacques@JPGroupUSA.com

Researchers at the Salk Institute in La Jolla have discovered a drug (for more, read on) that appears to provide the same benefits as exercise:  improved endurance and metabolic function-----in mice. What's next?