FDA Promises to Fight Pedigree Injunction

Today, FDA issued a statement in which it vowed to fight the injunction now barring it from requiring extensive pedigree information from small pharma distributors. The injunction, which stems from a lawsuit brought against the Agency by a group of small wholesale drug distributors in New York State, would effectively prevent FDA from strengthening the weakest link in the pharma supply chain. It could also have an impact on the industry’s adoption of RFID and “track and trace” technologies  (which have seen less-than-enthusiastic uptake, given costs, ROI concerns and debates about optimum frequencies, etc.) .  It would also seem to make doing business with smaller distributors even less attractive than it already is for drug manufacturers.  For well-informed discussion of this subject, read Jayne Juvan and Adam Fein.

Here’s FDA’s “official” position statement, as set out in a Q&A on its web site.

A. What is affected by the preliminary injunction?

1. • 21 CFR § 203.50(a). The court order enjoins FDA from implementing 21 CFR § 203.50(a). 21 CFR § 203.50(a)(6), states that information regarding “each prior transaction involving the drug, starting with the manufacture” be included in the pedigree. However, while the preliminary injunction is in effect, pedigrees shall include information regarding prior transactions going back to the manufacturer or the last ADR that sold, purchased, or traded the prescription drugs. FDA encourages wholesalers to include information regarding each prior transaction going back to the manufacturer when that information is available.
   1. • 21 CFR § 203.50(a)(1)-(5). The court order also enjoins FDA from implementing the language in 21 CFR § 203.50 that requires pedigrees to include lot and control numbers, dosage, container size, and number of containers. As described in more detail below, however, the preliminary injunction does not affect the statutory requirement that pedigrees contain the dates of all listed transactions and the names and addresses of all parties involved in those transactions. In addition, since the court did not enjoin implementation of 21 CFR § 203.3(u), a written agreement between a manufacturer and a wholesaler may limit ADR status to a particular lot number(s), dosage, or the number or size of the containers of prescription drugs. We also note that, without the lot number on the pedigree, it would be extremely difficult to track the inventory that matches the pedigree if the inventory is further sold, purchased or traded. Therefore, FDA recommends that the lot or control number, dosage, and the number and size of the prescription drug containers be included on the pedigree even though it is not required while the preliminary injunction is in effect.
   1. • Pedigrees for all current and future inventory are affected by the preliminary injunction as long is it remains in effect.

Shouldn’t Government Scientists Earn More?

Just caught up with the recent Sunderland conflict-of-interest case.

Pearson Sunderland, chief of geriatric psychiatry was not discharged from his NIH position, but given two years probation and will have to pay back the $300,000 in fees that he received from Pfizer over a five-year period.

Such cases are disturbing, and we’re seeing many more of them. 

Not to condone this behavior in any way, but…Could there be an easy way to end this trend and eliminate temptation by simply increasing the salaries of government researchers?

Nobody does (or should) go into biomedical research for the money, of course, but salaries appear to be way off base, if the AAAS annual survey is any indicator. Presumably Dr. Sunderland was paid more than the $110K per year that senior government researchers in his age category earn.  The average salary is just over $70,000 per year.

But I know of rookie marketing people who earn more than that, people who can barely distinguish left from right and who couldn’t really tell you what the technologies they are marketing do, much less encapsulate what the science behind them is.

Considering the time and training, and sacrifice, involved in pursuing a research career, not to mention the need to attract more young people to the field…couldn’t this be an investment in the future?

-AMS 

FDA Gains Permanent Commissioner, but Loses Deputy Commissioner Gottlieb

For many, Dr. Gottlieb had been a breath of fresh air… he’s returning to the American Enterprise Institute. Below, FDA’s official release.

Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs at the Food and Drug Administration announced today that he will leave the agency effective January 16, 2007, to return to the American Enterprise Institute, a Washington-based think tank where he was previously a Resident Fellow prior to joining FDA.

Dr. Gottlieb joined FDA as Deputy Commissioner in July 2005. Since that time has worked on a number of significant policy initiatives including efforts to improve the advisory committee process and to make the agency’s approaches regarding communication of risk information to the public more effective. Dr. Gottlieb also helped to facilitate implementation of important new regulations and policies, including the new drug and biologic products labeling rule and the expanded access rules to help patients with life-threatening conditions gain access to drugs under development. An internist, Dr. Gottlieb continued to practice medicine during his tenure as a public health official.

“Throughout Scott’s tenure at both FDA and the Centers for Medicare and Medicaid Services (CMS), he has served the public health with tireless dedication,” said Commissioner of Food and Drugs Dr. Andrew von Eschenbach. “Scott joined the agency at a critical time and helped to create a forward-thinking policy agenda that bolstered our efforts to transparently provide more timely information to patients and providers so they can have the tools they need to make informed medical decisions. In addition, he worked with other senior leaders at the agency, and in the private and academic sectors to advance the critical path for bringing new effective medical innovations to patients who can safely benefit from them. As Scott embarks on this next phase of his life, I will always be one of his greatest supporters.”

Airline Travel and a New Security Risk

Remember when you were a kid and how you used to look forward to airplane trips?  Of course those days were long ago, and air travel is no longer any fun, as we all know.

But some people should just stay home. 

As I prepare, with the usual tinge of  trepidation, for a plane trip tomorrow, just noticed the following bit of news…about a plane that was just grounded because of a [apologies for the borderline vulgarity here] flatulent passenger. 

You may read the scintillating tidbit for yourself, here.

Newt Gingrich on Health (and Career?)Transformation

 Hadn’t heard about this organization…but you can read its position papers on the web site below. 

 About the Center for Health Transformation

The Center for Health Transformation, founded by former House Speaker Newt Gingrich, is a unique collaboration of public and private sector leaders dedicated to accelerating the adoption of transformational solutions, policies, and technologies in order to create a 21st Century Intelligent Health and Healthcare System characterized by better outcomes and more choices at lower cost. For more information on the Center, please visit www.healthtransformation.net.

Benchmarking Excellence in Drug Development and Innovation

While I hesitate to use hype like “groundbreaking,” we are doing some work with APQC that could be extremely useful to any drug company in examining its drug development and scaleup efforts.  Two surveys on drug development and on “innovation” will focus on drug development and manufacturing, allowing any drug manufacturing company of any size, anywhere in the world, to gauge the effectiveness of its drug development programs, at no cost.  The surveys will provide benchmarks comparing each respondent’s performance to “best in class” [please forgive the expression---at least I didn't say "best of breed"] within global drug manufacturing, and within global manufacturing as a whole.

The surveys are available on www.pharmamanufacturing.com (via the banner on our home page), or click here.

All respondents will receive a detailed benchmarking report, directly from APQC, showing how their practices compare with pharma and overall manufacturing leaders. Results will also be summarized in two feature articles in our magazine and on our web site next year.

AND….If you respond to the first survey by the end of the year, you will also receive a copy of APQC’s publication “Innovation: Putting Ideas into Action.”

The innovation and product development benchmarking project is designed to compare your company’s efforts in terms of generating new product/service ideas; designing, building and evaluating products and services; test marketing for new or revised products and services; and supporting and implementing changes to product manufacturing and service delivery projects.

For those of you who aren’t familiar with APQC , its research provides a comprehensive, independent source of process frameworks, measures and benchmarks that span an enterprise, and examines performance across multiple dimensions of people, process and technology, focusing on cost, cycle time, process efficiency and staff productivity.

Gaining insights like this usually requires working with a consultant.  Plus, having some role models far beyond pharma is probably a very useful thing.

 

So I urge you to take the surveys.  You have nothing to lose but some preconceived notions (and, perhaps, some inefficiency).

 

-AMS

Channeling Barbie: Career Advice for Professional Women

After the last post, decided to quickly check out Mr. McKee’s (the career strategist’s with the schmoozing advice) web site, and found the following item. 

Question:  Are there REALLY any women who behave this way in the work place, because I certainly haven’t seen any Particularly those who include smiley faces on emails to new business contacts….

Excerpt from John McKee’s book….

Acting Like a Girl Instead of a Woman

I’ve never heard a CEO giggle. I doubt very many people have. Being giggly is a bad thing for any woman trying to work her way up the corporate ladder.

Linguist Deborah Tannen, in a study she conducted for her book You Just Don’t Understand: Women and Men in Conversation, found that women laugh 126 percent more often than men. And unfortunately, this laughter is not relegated to personal life.

Young girls giggle, not mature leaders. Doing so is a sign of nervousness and self-consciousness. I’ve heard many women giggle a bit just after saying something, and it diminishes the impact of what they have said. Both the message and its messenger become less credible.

Giggling aside, being overly humorous is not the best approach you can take if you’re a woman who wants to be taken seriously within your organization. Even when the men in your group kid around, it’s a good idea to tone down your involvement. For men, humor is an easy way of appearing to be involved with subordinates without actually having to be involved. When a boss acts funny or playful, he’s not showing care or affection. As we’ve discussed, it’s not personal.

Another common pitfall is being overly familiar in email. One executive I know was floored when she received an email message from a potential client, one she hadn’t met or spoken to, that was similar in tone to the ones her teenage daughter wrote: “I’m soooooo glad you emailed. My computer crashed and I lost all your contact information.” My executive friend was delighted with this reply as it clearly indicated to her who would have the upper hand in this business relationship.

Or the banker who sent an email to her new clients that began, “WOW! Thank you for all of your business!!!” Excessive use of exclamation marks, flowery borders, and smiley faces belong on personal correspondence, not business correspondence.

Ever gone for lunch with a friend who just can’t make up her mind about what to order, or wants the restaurant to make a lot of substitutions? This sort of thing will send all the wrong messages during a business meal.

Men generally don’t worry about what they’re going to eat and neither should women. If you can’t decide on a simple lunch order, how can you be trusted to make critical business decisions? Choose your meal quickly, with a minimum of fuss, and then you can get down to business.

If alcohol is served at your business function, don’t overindulge. Nothing screams “girl” more than being tipsy or, worse, drunk. Don’t try to keep up with the men. Put your hand over your wine glass or, if you’re hosting the event, speak to a member of the staff ahead of time to make sure they go lightly on your refills. Make sure you have plenty of water and drink lots of it.
Giggling is hard to consciously control, but control it you must. It has the same effect that qualifying your statements does—it negates the idea. If you have something to say, tell yourself ahead of time that you will end your sentence with a period, not a giggle. As with much self-defeating behavior, practice, diligence, and time will crack it.
For some, giggling is a stress-relieving habit. If this sounds like you, it will be beneficial to find the underlying reasons for your stress and discover ways to alleviate it in a more productive fashion.
When your boss gets playful with you, you can smile and acknowledge the humor, but don’t get lured in. You have to find a balance between not insulting him and maintaining your professional demeanor.
When shaking hands, make sure your grip is firm.
Treat email correspondence with the same care as a memo written on paper. No smiley faces.
Whether overcome with happiness, anger, or sadness, don’t cry in the office. Go for a walk, go to the washroom, go to your car, but don’t cry in the office. Executives don’t cry.
Don’t chew gum.
Choose your office decorations carefully. No Barbie memorabilia—unless you are the CEO of Mattel.

-AMS
 
 

Small Talk as a Career Advancement Tool (Or, Don’t Skip Out on the Office Holiday Party)

Most scientific and technical types hate small talk, and with good reason.  But, as many a “member of the technical staff” has discovered, that attitude can cost you promotions and keep your career permanently on the “slow track.”  

For all those who are determined to avoid the company holiday party by all means, some advice on holiday schmoozing from John McKee that may actually pay off…(ignore the book title, “How Women in Management Shoot Themselves in the Foot,” because, if anything, many women are a bit more adept at all this than their male counterparts)

Schmooze Your Way to Success at Holiday Office Parties

Expert Tips for Boosting Your Career through Holiday Party Networking and Constructive Holiday Party Etiquette

However right or wrong, fair or unfair, just or unjust, strategic networking at holiday office parties can be a career boon. Indeed, getting in the good graces of those with the power to fast-track your career can be a fortuitous turning point that accelerates your climb up the corporate ladder. But how does one appropriately schmooze without coming off as brown-nosing? And, how does someone aptly parlay friendly party chatter into an opportunity to showcase their talents?

To answer these and other such burning questions in time for the festivities, John McKee, world class business success coach and author of “21 Ways Women in Management Shoot Themselves in the Foot,” offers these tips on how to schmooze your way to career success:

Determine the objective. In advance of an event, expert “schmoozers” think through what the best possible outcome would be relative to career growth. Think through a few realistic scenarios of how you might work toward achieving your objective.

Debrief your guest. As important as it is for you to know who the “important people” are at an event, the same holds true for your guest. The person you have chosen to accompany you to a business function, and how they behave, reflects directly on you – whether positively or negatively.

Early bird special. Arrive at the event early. Make a point of speaking to and thanking your boss and the host of the party, introduce your guest, and generally spread good tidings.. Show your humanity and connect on a different level before things really heat up.

Presence pays…literally. Generally speaking, great schmoozers are interesting and entertaining to those around them, and exude self confidence. It’s imperative to present a comfortable demeanor– however “important” or intimidating the other person may be. Appearing at ease during a time when others are feeling anxious or uncomfortable will make you look more like a “natural leader,” thus making yourself a stand out.

Maintain your visibility. The location where you are situated should be highly visible. Stand in a place that is approachable - not behind chairs or the kitchen door where there is high traffic.

Maximize first impressions. How you introduce yourself to people, especially superiors, is important. Develop more than one way of introduction, and keep in mind that the secret to a good first meeting is self-confidence, poise and emitting a generally affable air.

Due diligence. There’s nothing more awkward than standing face to face with a power player amid uncomfortable silence. Schmooze pro’s always know the right thing to say. Review current news events before the office event so you may participate in – or, even better, start – mainstream conversations about the economy, foreign affairs, and relevant “happenings” around your city. This macro awareness can put you in a whole new light in the eyes of a superior.

The great can articulate. Being able to effectively communicate, off the cuff, what you do for an organization, without gloating or over-inflating, is critically important. Long-winded answers with ebbs and flows can render the actual answer lost in translation. When and if appropriate, use the opportunity to self-promote and impart any new ideas you may have in a way that will not be construed as bragging or credit hogging way.

Nix the narcissism. Rather than focusing on self-talk, make the other person your focal point. Feed their ego by asking him or her open-ended questions, and be sure to include everyone in the conversation –with both questions and eye contact. When it’s your turn to speak, don’t monopolize the conversation, use jargon or terms that others may not understand – they won’t impress!

Calling card critical. Keep business cards with you at all times, which are often forgotten by those attending informal company meetings or social events, and dole out liberally. You want to not only remain top of mind, but also completely accessible, post-event.

Grievances need not apply. A social business event is not the time to clear the air about things, or people, that have been bothering you, nor is it a time to speak at another’s expense. Speaking negatively about others will be a greater loss for your image and career.

Imbibe and socialize with caution. There is no quicker career killer than public displays of drunkenness at a business function. Don’t embarrass yourself by dancing like a crazy person or like a predator at a club, get caught necking or act aggressive in any way.

In the spirit of providing aspiring professionals with a tangible FREE resource that can pay dividends in their upward business mobility, through November McKee is offering FREE registration for his “7 Secrets of Leadership Success” - an online “mini course” packed with proven tips and strategies to speed up a career track - from his Web sites www.BusinessSuccessCoach.net and www.BusinessWomanWeb.com.

Pfizer Ends Clinical Trials for the CETP,Torcetrapib (Illuminate) Due to Safety Concerns

This just in, from Espicom’s Cardiovascular Drug News.  The drug’s development reportedly involved an investment of $800 million, and the class of drugs (cholesterol ester transfer proteins) was expected to become a “gold standard”:

 On 2nd December, the independent Data Safety Monitoring Board (DSMB) monitoring the ILLUMINATE morbidity and mortality study for torcetrapib recommended terminating the trial due to an imbalance of mortality and cardiovascular (CV) events. Pfizer has confirmed that it is stopping all torcetrapib clinical trials, has informed the FDA and is in the process of notifying all clinical investigators in the program, as well as other regulatory authorities.

At the end of October, the cholesterol ester transfer protein (CETP) inhibitor attracted attention due to a negative outcome from the preliminary results of Phase III heterozygous familial hypercholesterolaemia trials in combination with the company’s established statin, Lipitor (atorvastatin), with patients in the combination therapygroup experiencing an increase in systolic blood pressure versus those taking atorvastatin alone. The company stated at the time its belief that this would not alter the favourable clinical profile of torcetrapib+atorvastatin (T/A) in the treatment of CV disease and underscored that the studies were far from complete. Overall lipid results from all the completed trials were positive, generally showing that T/Asignificantly increased HDL cholesterol by 55 to 60 per cent and lowered LDL cholesterol by 10 to 15 per cent over atorvastatin alone (leading to a combined reduction in LDL-C of 50 to 60 per cent).

At its recent research and development meeting, Pfizer highlighted T/A and CETP research as the most important new development in CV medicine in years. Dr John LaMattina, President of Pfizer Global Research and Development, commented that the category “has the potential to change theface of cardiovascular medicine” and that at the end of its comprehensive program, the company expected to have a medicine with “unparalleled efficacy in raising HDL, lowering LDL and with an anti-atherosclerosis indication”. The top-line results of the three pivotal imaging trials wereexpected during the first quarter of 2007, in addition to results of some additional Phase III lipid studies.

Pfizer has, however, terminated ILLUMINATE and in fact, ended the development program for this compound, with participating patients being advised to stop taking the study medication immediately. According to Espicom’s latest Pharmaceutical Companies Analysis report, Pfizer was investing approximately US$800 million in the development of T/A.

Dr Philip Barter, Director of the Heart Research Institute in Australia and Chairman of the Steering Committee overseeing the ILLUMINATE study, clarified how surprised those blinded to the safety data were by the DSMB’s information, stating that it was “totally unexpected and disappointing.” At

1.40pm CET on 4th December, Pfizer’s share price was EUR 18.00 in

Frankfurt, down by 12.83 per cent from the previous day. The company’s CEO,

Jeffrey B Kindler, confirmed that despite the setback, Pfizer’s financial guidance for 2006 is unchanged and that its previously-announced plan for transforming the company will now be accelerated, with a focus on core R&D, manufacturing and commercial operations, as well as procurement and other areas.

Espicom’s Cardiovascular Drug Discoveries had predicted that this CT had the potential to become the new gold standard treatment by 2010, and that by 2012, sales could have reached around US$6.8 billion.

Source: Cardiovascular Drug News

For further information on this and other articles featured in

Cardiovascular Drug News visit:

http://www.espicom.com/prodcat.nsf/structure/SourceLanding?EditDocument&Referer=FM02EB&ProductCode=00000032

For further information and to order your copy of Cardiovascular Drug

Discoveries go to:

http://www.espicom.com/prodcat.nsf/structure/SourceLanding?EditDocument&Referer=FM02EB&ProductCode=00001315

Celebrating Geekiness

It’s always jolting to wake up and find yourself on the other side of the generation gap. Hip-hop is a genre of music that I don’t “get.”  The raw language and some of the fashion statements involved (e.g. the untied shoelaces, unbelted pants sliding dangerously south) have very sad origins (In jail, apparently, prisoners must remove  belts and shoelaces…) So, when I see rich teenagers wearing some of the more extreme hip hop fashions, I don’t know whether to laugh or to feel very angry.

Parental reactions aside, it is an unstoppable and global force–there are likely rap groups in Kazakhstan— there are some artists who do it sensitively, and some of them are clearly very gifted….so I’ll keep an open mind and learn more about it.

But I recently discovered (about a year and a half later than the rest of the world, apparently) that  gangstas aren’t the only ones rapping. In case you are similarly behind the curve, I present some tidbits of “geeksta rap.”  California-based chemical engineer Rajeev Bajaj  is one of the pioneers in this “space,” with lyrics celebrating science, engineering, computer science.  For a sampling of some of his songs, click here. (I liked Free Energy and Metamorphosis) . Another artist is “MC Frontalot” (Here’s a sampling from MC+: “Chip Hop” and “cryptography rap” for the hard-core nerd).  

In fact, nerd rap has become so mainstream that even Weird Al Yankovic is doing it, as evidenced by his new video: White n’ Nerdy. which includes every stereotype in the book (including the sacred pocket pen protector and the view of white guys as nerds…but in reality the geek nation, like the hip hop nation, knows no racial or national boundaries).