We’ve Moved

This is the last post on this site. This blog has now officially migrated to our parent web site, so you’ll now find it, and all new postings, on http://www.pharmamanufacturing.com/onpharma/

CRADA Targets Drug Development Bottlenecks, Welcomes Participants

FDA and the California-based IT company, Conformia, have been at work for the past few years on a cooperative research and development agreement (CRADA) designed to analyze knowledge management within the drug industry and FDA, to pinpoint what is making drug development so costly.  Initial findings from the first phase of the CRADA, a blinded research study called “Challenges and Opportunities in Pharmaceutical Development,” will be released this Summer. Anjali Kataria, principal investigator on the CRADA and chief marketing officer for Conformia recently discussed some of the obstacles preventing industry and FDA from improving the overall drug development and approval process.

The fundamental problem is one of data transfer and knowledge management. Today, the most senior scientists at some pharma companies spend 30-40% of their time on mundane administrative tasks, and simply looking for data that already exist.  The same holds for FDA; at both organizations, a great deal of important information is still kept on paper, in scattered databases and in the heads of key staffers.

Information management must be improved, the research suggests.  But so must organizational thinking. In order for the industry to move to a true “Quality by Design” drug development model, FDA must improve the connection between review and inspector teams for small molecule drugs, while senior managers within the industry must get directly involved in  promoting the crossfunctional culture that QbD demands.

Both CRADA partners welcome and encourage more industry participation in this important research.  Pharma companies can take part in joint FDA/Industry workshops on QbD. So far, three of these workshops have been held in Washington,  involving over 200 participants in pharma biotech, and generics manufacturing, some of whom had not been exposed to QbD concepts and had never applied them to FDA submissions or their internal processes.

 These workshops, Ms. Katari says, allow top managers from very different companies to discuss crossfunctional implementation, and specific ways to apply ICH Q8 and 9; they also offer a neutral, open venue in which FDA and the industry can communicate issues and problems in the spirit of “continuous improvement.”

 Companies can also participate in case histories.  Currently, biopharma unit operation case histories are being developed, but the CRADA will establish a chemistry manufacturing and control information management (CMC -IM )working group to analyze real life mock submissions and apply quality systems management principles and knowledge management strategies.

Originally, nine pharma, biopharma and generics companies took part in this research, but Ms. Kataria expects the number to increase to 25 by this summer.

We will be covering this research in much greater depth in our magazine and web site, but for more information on the CRADA and how to participate in the conferences and case studies, visit crada@conformia.com, or contact Conformia at 408-625-3881.

-AMS 

Pharma Sales Reps Suing for Overtime: $1 Billion Potentially at Stake

Pharmaceutical Executive’s Beth Herskovits has just reported that tens of thousands of pharma sales reps across the country are suing their current and former employees for overtime and the equivalent of “time and a half. ” $1 billion in settlements could be at stake. 

The old days immortalized by Jamie Reidy are apparently over, with reps saying they are pressured to make 40-50 doctors office visits a week only to find they aren’t welcome.  Their calls are scripted and leave little room for independent decisionmaking, the article says. 

Although some companies like Merck are using virtual sales tools, the article says, time management has become a critical issue and investing in better customer relationship management tools and technologies might help, so that info on specific doctor’s needs and preferences would be recorded and accessible. To read the article, click here.

One in Four Diagnoses of Depression is Wrong

The New York Times recently reported on research from a journal of psychiatry that one in four people who are diagnosed with “depression” are simply struggling with a very real “life problem,” rather than an organic mental condition.  I’d bet the numbers could even be higher. Here’s the article.

CEOs Fight Back: “Save the Salary” Movement Picks up Steam

Thanks to a reader’s recent comment, just learned about this important if controversial movement, spearheaded by Occidental Petroleum CEO Ray Irani.  More on this here.

(This belated April Fool joke courtesy of Dieter Prucker, The Cantankerous Consultant.)

Caliper, Pfizer to Explore New Therapeutic Indications for Drugs in the Pipeline

In the future, perhaps any and all new indications for drugs will be discovered and brought forth before approval.  Moving in this direction is a new project involving Pfizer and Caliper, which will perform in-vivo tests evaluating new indications for drugs in Pfizer’s pipeline.  For more, here is the press release.

Pharma and BioPharm Construction Will Rise 5% in Second Quarter

More from Industrial Info, as reported on Reliable Plant’s website.

Pharma CEO to Run for Presidency of Nigeria

Isa Odidi, CEO of Toronto-based drug-delivery specialist IntelliPharmaCeutics Corp. is running for President in his native Nigeria (while retaining dual Canadian citizenship).  He’ll have his work cut out for him if elected, but here’s more on the candidate.

-AMS

Driver of the Year Award Winners

A bit of lunch hour frivolity.

As a woman driver, I take great exception to the male chauvinist joke that some male colleagues were circulating and chuckling about today.  Here, in any case, is what they were laughing at:  winners of the 2006 “woman driver of the year” award.

It’s just such snickering, heard from uncles and other males in the family, that kept me from actively driving until I was in my 30s.  So did living in New York City, where cab drivers can put the fear of God into anyone trying to negotiate driving in midtown and owning/parking a car is an act of defiance and foolishness. ”Not driving” is still a badge of honor in New York City (and even, I’ve learned, in Chicago) for a (now shrinking) segment of the population, so it was cute to read of the NYC couple who decided to forget about air travel and hail a cab—–to Arizona.  For more, read on.  

PillSafe, The Self-Destructing Pill Container

Nothing like injecting a little “Mission Impossible” into your daily dosage. PillSafe, a pill container designed to self-destruct when it falls into the wrong hands, has been developed as a way to prevent illegal drug diversion.   Prototypes are being tested at the University of Kentucky, and many technical issues must be solved….and cost would be high. For more, read on.