Thomas Kuhn

I don’t have a lot of time for off line reading these days, but I do try to get through a few pages of something thought provoking each week. Lately, that’s been reading Thomas Kuhn’s “The Structure of Scientific Revolutions“. It’s pretty interesting stuff (The Philosophy/History of Science) and definitely related to my profession; I don’t know why I haven’t read it before now. Well, actually I do. I suppose I’ve always felt a little vain.

The author and I share a surname. I believe we are distantly related. I’ve seen a photo of Thomas and the family resemblance is definitely there-He looks a lot like my grandfather.  I will have to check to see how distant our relation actually is.

Anyway, I’ve gotten over feelings of being vain and am slowly making my way through the book. I’ll probably be posting some thoughts on it as I make my way through it, and thought this post would serve to anchor these subsequent posts.

~TJK

And finally Continental takes a hit….

As a frequent business traveler, I’ve been anxiously watching the difficulties in which many airlines are finding themselves. I had been hoping not to see the following story:

Continental Airlines cuts jobs, retires planes

21 minutes ago

NEW YORK (Reuters) - Continental Airlines Inc said on Thursday it would cut 3,000 jobs, or about 6.5 percent of its work force, and retire 67 older planes as it scales down in the face of soaring fuel prices.

The No. 4 carrier is the latest of the major U.S. airlines to announce large cutbacks as they grapple with unprecedented oil prices. On Tuesday, UAL Corp’s United Airlines announced plans to slash jobs and flights, following a similar move by AMR Corp’s American Airlines last month.

Continental said it would cut 3,000 of its 45,000 staff, and retire 67 single-aisle Boeing 737 planes by the end of 2009, on top of the six planes it has already pulled out of service this year.

The airline said it would replace some of those older jets with deliveries of new, more fuel-efficient 737s. Its mainline fleet of about 375 planes would shrink to about 344 by the end of next year, an overall cut of about 8 percent.

It said it would cut flights after the summer season, reducing domestic capacity — or the number of seats for sale on U.S. flights — by about 11 percent in the fourth quarter.

(Reporting by Bill Rigby, editing by Maureen Bavdek)

Seeing as the Pharma belt uses EWR (Newark, NJ) as a primary airport, this is a huge hit. EWR is a hub for Continental so any hit on continental will have an impact on Pharma travel. To be fair, there have been some busier lines and fuller flights on Continental due to the problems that other carriers have been having already, but this is more direct (and doesn’t help the situation).

~TJK

SQA Thoughts after Catching Up on some Work

They say that no good goes unpunished….That goes doubly for attending a week-long off-site conference/training. I’ve been back from SQA for over two weeks now and am just getting to a place that might be called “caught up”.

Overall, the conference was good. I had some time away from the office to recharge, reflect, and learn. I saw some old friends and met a few new ones. The pre-conference train courses were quite good:

1) Basic GLP - Pre-clinical is an area in which I haven’t worked directly and I think it is best to always stretch at these opportunities and learn something new. I came in second in GLP Jeopardy!

2) Current Topics in GCP (formerly entitled Advanced Topics in GCP) - This is one of the areas in which I currently live and breath; so I heartily enjoyed this session. It included several former/current FDA employees who really added a lot to the course and the subsequent discussions.

During the conference proper, I focused primarily on Clinical and Validation sessions. There were a lot of good ideas and questions at these sessions too, but I really find that I get a lot more out of the intimate, all-day training classes because of the opportunity to really drill down into a topic and explore lots of related ideas and experiences.

Anyway, I’d better get back to it. I’ve been implementing a training program at work related to “Good Documentation Practices for Clinical Validation Projects” that has been taking quite a bit of time. It has generated a lot of good discussion and the response has been very good. Time permitting, I may post some of my support materials.

~TJK

SQA Conference

This weekend, I leave for the week-long SQA conference in Memphis, TN. SQA is the Society of Quality Assurance (www.sqa.org), an organization of Quality Assurance Professionals in the Pharmaceutical (and related) industries. I didn’t make it last year, but I’ve been several times in the past and its usually a really great conference for training, sharing ideas, and “re-centering” away from the store, so to speak. We QA people spend a significant portion of our lives clarifying what it is we do…Its nice to spend some time with people  like Don Barzini (in The Godfather) who “don’t need to be told”.

I’m going to be taking a couple of pre-conference training courses, one on basic GLP (which I haven’t done directly in my career) and another on current (advanced) topics in GCP. I had hoped to present this year (probably on the use of Technology in Clinical Research), but with the job change and such, there really wasn’t time to prepare anything….and it was unclear whether I’d be able to go until about a month ago. Next year for sure.

I’ll try to post an ongoing log of my experiences at the conference and associated commentary. Perhaps it will be of interest to those are unfamiliar with the conference or those who just can’t make it this year (budgets being particularly tight at a number of Pharma companies at this point).

~TJK

eHR’s gone bad…

I saw this on the Healthcareguy’s blog and thought it was worthwhile enough to post here too. In my experience, doctors are often not very tech-savvy (since they’ve spent an inordinate amount of time focusing on medicine, it stands to reason that they didn’t have as much time to monkey with computers and such). I could see this lack of tech-savvy make them “targets” of unscrupulous vendors/consultants in the emerging EHR (electronic health records) market.

Hi,

My name is Jim Edison and I work part time for a private, non-profit foundation called www.doctorsinperil.org. The foundation was started after a personal loss of the founder and its mission statement is to assist doctors in obtaining refunds from electronic medical records manufacturers for products that do not work as advertised. The EHR industry is new and many companies are taking advantage of doctor’s natural trust and naitivite. We do not take any money for our services.

We will investigate a complaint filed with us and if there is merit to the complaint, we will use the threat of public exposure to help the doctor or clinic obtain a refund. We also have a legal war chest and a law firm on retainer that may be used for class action lawsuits against companies that ignore our requests or who have a history of widespread abuse.

I am looking for the best way to tell doctors about our service, so please refer me to other popular sites that might allow us to post this announcement. Please feel free to visit our site and register if you have a complaint.

We have recently updated our site with two new sections titled, “Unscrupulous Practices By EMR Companies” and “ADVICE ON PROTECTING YOUR IT INVESTMENT”. They can be found here & here.

Thank you,

James Edison

~TJK

Wow….

In addition to a steady stream of inquiries from headhunters….ahem, recruiters, I also have several automated feeds from Monster, HotJobs, etc. I always know people who are looking to move in Pharma (a small and incestuous industry….we always see the same faces, just under a different sign). I have been aware of the compensation levels for positions with “Chief” in the job title, but it is another thing to see the dollar-figures in print on an actual solicitation….It definitely is a “wow” item:

Jobs Home > Job Search > NY > New York > Diedre Moire Corp. > Chief Medical Officer - Sr. Executive - PharmCo Clinical Research and Medical Affairs - NY
Chief Medical Officer - Sr. Executive - PharmCo Clinical Research and Medical Affairs - NY: Diedre Moire Corp.
View more jobs like this
Job ID 1583
Company Name Diedre Moire Corp.
Job Category Pharmaceutical/Biotech
Location New York, NY
Position Type Full-Time, Employee
Salary $600,000 to $900,000 per year
Experience 2-5 Years Experience
Desired Education Level Bachelor of Science
Date Posted April 1, 2008 (Reposted Apr 16)

Diedre Moire Corp.
View Diedre Moire Corp. profile and job listings
Apply Now: A Better Job Search Experience. Learn Why

Lead large Matrix Organization employing over one hundred medical doctors invloved in Medical Affairs and Clinical Research.

Requires 8+ years managerial experience with a pharmaceutical company and extensive Medical Affairs experience.

$600,000 base salary and comprehensive bonus, stock and perks.

Contact Dr. Gary Shinder, MD at:
609-584-9000 ext 273

Or apply online at:
http://dmc9.com/gls/app.asp

Or email to:
1000001583_10007224@candseek4.com

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid relocation to another venue. CONSIDERED EXPERIENCE INCLUDES: Pharmaceuticals

If you submit an application or resume, which contains your email address, we will use that email address to communicate with you about this and other positions. We use an email quality control service to maintain security and a remove and dead address filter. To cancel receiving email communications, simply send an email from your address with the word “remove” in the subject line to pleaseremove@candseek4.com If you have further concern regarding email received from us, call (609) 584-5499. We will be glad to have a real human being contact you upon request.

~TJK

The Lot of the QA Road Warrior

Over the last few years, I’ve been a lot of really neat places for work: Singapore, London, Argentina, Brazil, Mexico, Canada, and countless domestic (US) locales….and the travel destinations of my auditor colleagues would likely make up the difference for the rest of the world. This all sounds very exciting, very jet set, very sexy.

But the truth of the matter is that a little travel goes a long way. When we go, we sit in a conference room…..a conference room that looks like most other conference rooms….and read documents, interview people, make quick notes on legal pads as the auditees look on nervously. Usually, there’s no need for them to worry…we auditors are just making notes so that we can somehow distinguish their conference room (and the work presented there) from so many others we’ve sat in during the course of our careers.

There are many downsides to my chosen profession: justifying expenses to “Corporate Expense Processors” who may or may not know what we do (usually not), waiting to get our money back, sitting in airports, sitting on planes…sitting on planes on the tarmac….waiting. Actually, there’s a lot of waiting and a lot of time away from our families….this last part is hardest.

Don’t get me wrong, there are upsides as well. We do exercise a fair amount of autonomy and have the opportunity to really make a difference with our specific expertise and skill sets. That makes for a very satisfying career, but tonight, I’m in a mood to lament the woes of life on the road. I’m not one to drone on about the hardness of my lot, especially since I’m very pleased with my recent job change, but I think that it is important to mention the downsides to even the best of situations…..I’m an auditor; they pay me to look for the ugly underbelly. And its hard to turn that off.

Well, I’m on the West Coast, but I’m still on East Coast time….so I’ll be going to bed soon. I wish a good night to all.

Best,

TJK

The difference between eDC and eCRF

I got this LinkedIn question from Chris Connor (Health Industry Insights) about the future of eDC and whether it has “Jumped the Shark”….whether it has peaked.

Has EDC jumped the shark?

A phrase once used exclusively within the entertainment industry, “jumping the shark” has recently entered the public vernacular as a way to mark the point at which something passes the zenith in its popularity.
Electronic data capture (EDC) has ushered in many changes to clinical development. And in many ways, it is transforming the way clinical trials are conducted. But are EDC vendors promising too much? Can EDC become the real-time, transactional system that enables adaptive trial design? Or is EDC an interim technology?
If you have an opinion, I’d love to hear it.
~Chris

His question is a good one that is on the minds of many in the industry (Pharma), including mine. I’ve been meaning to resume my posting here since my move, and this seemed to be a good topic with which to start.

I met Chris at the last ExL Pharma meeting on eHR’s (Electronic Health Records) and eDC (electronic Data Capture). Chris works for what I’d term a Healthcare/Pharma/Technology Think Tank (a HPT3). Well, we got into a discussion at the conference and continued it over dinner. Our backgrounds are pretty different, and yet we still felt the same passion about this geeky medical/science/ethics/technology stuff. It was a really good exchange of ideas.

I have been thinking about eDC a lot of late, mostly because what is commonly called eDC is not eDC. I asked the guy who was at the same ExL Pharma conference presenting for Oracle about whether he was talking about “True eDC”. He was confused and asked for clarification on what I meant. I explained what I meant…My colleagues, both past and present, have heard this before….

What many people are calling eDC is actually eCRF (electonic Case Report Form). A CRF is the standardized form on which the Clinical site (Lay People can think doctor’s office) transcribes relevant data from the medical chart (also called the source) of a clinical trial subject. This form is sent to the sponsor (typically a pharmaceutical company) who enters this data into a computer system and analyzes it to see if their treatment is safe and effective. An eCRF is an electronic form that does the same thing. The clinical site types the data into an electronic form that gets electronically submitted to the sponsor. Essentially, the sponsor is removing a (paper based) step and pushing the data entry from their internal (Data Management) group to the clinical site. That’s eCRF.

Now “True eDC” deals with data being recorded as source in an electronic format. That means that it isn’t written in a paper medical chart. The first time it is recorded (in any manner) it is recorded electronically. For example, an electronic blood pressure (BP) cuff that automatically transmits the BP to a computer system OR a physical exam that is directly typed into a computer system (not written first). eDC can entail structured data fields, free-text entries, or combination of both.

Although the terms eDC and eCRF are used pretty much interchangeably in the clinical/GCP arena (with most using the eDC term, there are very few implementations of “True eDC” (mostly in Self-contained Phase I units). To Chris’ primary question about whether eDC has peaked, I say “No, we haven’t even begun to scratch the surface of what is possible yet”. There’s a long way to go and the benefits of going there will be tremendous….It is also likely that the costs for early adopters will be quite tremendous as well.

Big Pharma is a pretty conservative beast…they will likely be slow to adopt. Over the longterm, this turns the industry on its head. The small Biopharma that traditionally followed what Big Pharma did will now be the leader…and Big Pharma will follow (or slowly become irrelevant). Chris asked if eDC was an “interim technology”. I say all things are transient and all technologies are “interim”. The next ten years will be a very interesting period in the Healthcare/Pharma fields, and I for one will be interested to see where it all goes.

~TJK

A new position

I’ve been quiet over the past couple of weeks because I’ve been tremendously busy. This is my last full week here at sanofi-aventis. I have accepted a new position with another pharmaceutical company and am trying to closeout all open items. 

I am both excited about the new position (which is a QA Validation position supporting Clinical Research) and sad to be leaving my current position. I’ve had the privilege to work with a great team of people here whom I will miss greatly. Still, ours is a small industry. This likely won’t be “goodbye”, but rather “goodbye for now”.

 I will get back to more frequent posting once I have cleaned my proverbial “plate”.

~TJK

Roles for QA

I was scanning through my email subscriptions today and noted an interesting item in my FDA News Drug Daily Bulletin (from the company “FDA News”) advertising one of their publications. Now, most of the time these “industry best practice” white papers are information that is common-sensical or freely available from another source (e.g., compilations of FDA Warning Letters that are available on the www.fda.gov website) so I typically ignore them. However, the tone and posturing of this one caught my eye:

 

Lower Your Site Risk Potential (SRP) Score
Lower Your Site Risk Potential (SRP) Score zeroes in on what this risk-ranking model is and how FDA is using it to classify manufacturing plants and prioritize enforcement. This new management report also goes a vital extra step, showing you how to implement practical strategies that can reduce your score, limit inspections and unlock a host of valuable new business benefits.
To order, go to http://www.fdanews.com/store/product/detail?productId=23141.

 

To me, that is marketing to the worst of us. It doesn’t offer help to actually improve one’s processes, systems, or products so as to have more successful inspections. It implies that by doing certain things, a manufacturer can place themselves “below FDA’s radar” and thereby reduce the number of inspections to which one is subject. That is not to say that the advertisement is selling a lousy or unethical document. I wouldn’t know since I haven’t read it.

The ad did get me thinking about the various roles I play as a QA Auditor though. I was born an optimist, but through my work in QA, I’ve become somewhat of a reluctant realist. There are always those who will seek out “the quick and easy path” rather than the high road. That being said, my role varies depending upon with what I’m dealing:

 

1) In my opinion, most people I meet and with whom I’ve worked are genuinely interested in doing a good job, the right thing, etc.; and for that I am thankful. And as a QA professional, my primary job is to help them do just that. By serving as a fresh pair of eyes, as an uninvolved outsider, I can help those who may be by necessity focused on the trees, see the forest. This is the role I like best, that of an internal consultant.

 

2) In other instances, there are those who are very ready to make what a former mentor of mine liked to call “overly pragmatic decisions”. For situations like this, my role tends to be more akin to that of a traffic cop. Almost everybody slows down when they see a parked patrol car. My presence lets people know that “someone is looking”.

 

3) In the worst cases, I’m there to catch the most aggregious offenders, those who totally disregard ethical or moral considerations; or who are just so sloppy in their practice that they pose a major risk to their subjects, the public, or the research itself. I play the role of the enforcer in these cases. I like this role the least. However, I try to remember that it is because of this minority situation that there will always be a role for Quality Assurance.

 

~TJK