People Make the Difference

I came across a post on Pharma Conduct today that referenced an article that appeared in the Christian Science Monitor entitled: People making a difference: Steve Korman.

The article details how Mr. Korman, the CEO of Korman Commuications, has been appealing to his fellow CEOs to resist mass layoffs. The article goes on to say that:

"Korman recoiled earlier this year when he heard Pfizer Inc. CEO Jeffrey Kindler on CNBC explaining that despite the company's $16 billion profit, it planned to cut 8,000 jobs to boost that profit to $20 billion....It was just so cold," Korman says, though in true Korman form, he adds, "I'm sure [Mr.] Kindler didn't mean it to sound that way." But then he returns to his point: "These are not widgets we're talking about.... These are not jobs. These are people, families.... Where are you going to go to find a job these days?"

So, as a Pfizer shareholder, Korman wrote to Kindler and to the CEOs of other companies in which he held stock. He placed ads in The New York Times and The Philadelphia Inquirer."

What is the message that Korman is sending to these CEOs?:

"Stop the "herd mentality" when it comes to mass layoffs. Forgo some short-term profits and stock value and keep people working....His point was that maybe we don't need to make the last dollar."

Now that is a message that we all should be embracing as we roll into the Holiday Season.

Big Pharma - still hungry for Biotech

Big Pharma's appetite for Biotech deals has apparently not been sated. According to an article on Reuters today.

According to the article:
"Even amid aggressive cost-cutting, many big pharmaceuticals companies continue to seek biotech acquisitions in the hope of finding new drugs to replace those lost to generic competition."

However:
"....they will have to pay more than they did a year ago. The average value of U.S. biotech companies is increasing as funding flows back into the sector after a drought caused by the credit crisis....executives at the Reuters Health Summit said they need to make acquisitions and form partnerships to fill holes in their pipeline of new products, even if the terms are not quite as advantageous as they were a year ago."

Why is Biotech in NYC Floundering?

Interesting article in The Scientist about the problems besetting the Biotech sector in NYC.
While acknowledging the city's "lucrative scientific output", the reality is that investments aren't "...yielding as many start-ups as other regions with comparable scientific investment."

Why is this the case?

The answer according to Jonathan Bowles of the Center for an Urban Future, a New York City think tank, "is that 'for a long time [technology transfer offices] put too much emphasis on the blockbuster deal,' ignoring smaller technologies that could have been developed by start-up companies with the help of venture backing"

I find it interest that people are still 'swinging for the fences' and pursuing blockbusters....that strategy really seems somewhat dated in this environment.....

Pfizer's Silence

Pfizer has been very close-lipped about the subject of lab closings and job cuts. Everyone from the Governor of CT to chemists in the lab are on edge.....

Some Good News - Pharma Growing Faster Than Expected

FiercePharma reports here that:

A boost in American insurance will push worldwide drug sales up by 4 percent to 6 percent in 2010, IMS Health predicts. And global growth will continue at a 4 percent to 7 percent clip every year through 2013. Just six months ago, IMS had predicted that U.S. drug sales would fall by 1 percent to 2 percent this year.

It is nice to get some good news.....

Pfizer/Wyeth Site Closings

Derek Lowe comments here on fellow bloggers Eric Milgram's crowd-sourcing approach to which Pfizer /Wyeth sites will be closed.
Milgram's approach is interesting to say the least......

Pharmaceutical Industry Experts Wrong Again!

Recent articles have chronicled the large number of lay-offs that are being experienced in the Pharmaceutical and Biotech Sectors.
FiercePharma had this to say on their website today.

But that is not the whole story.
While it is true that a number of the big firms are downsizing and that some smaller firms are shutting down....My firm seen a large uptick in hiring. While some firms are definitely trying to cut costs in order to deal with their diminished pipelines, other firms are definitely helping to pick up the slack in hiring.

Bottom line - The whole industry is in flux - we are in the midst of a very dynamic time.
But this is still a phenomenal industry to be in....and there are still tremendous opportunities not only in the area of scientific developments....but there are still exist a tremendous number of opportunities that will enable the individual to advance their career.

Years ago the Pharmaceutical industry was being touted as bullet-proof. Major magazines had cover stories where they espoused the theory that the industry was immune to the business cycle. these so-called experts claimed that the industry would continue to experience unparalleled growth with nary a hiccup.

I thought the experts were wrong then.

Now the 'experts' are burying the Pharma industry....now these same experts that years ago called the industry 'bullet-proof' are now sounding its death knell.

The experts are wrong again.

The truth is that there are still tremendous opportunities career-wise in Pharma....And the industry will....once we admittedly go through some more near term pain...emerge much stronger and even more prosperous.

And this is one prediction that will definitely come true.

Are you Single-Minded? Part 2

Labor Day weekend has got me thinking again about the whole concept of work and what makes a person successful. In my last post, I had discussed the importance of single-mindedness.
After I wrote that post, I remembered an article I had read online years ago, In Defense of Workaholism, that did an even better job of of explaining the concept than I did. In the article, the author writes:

"The truth is this: if you want to succeed..., you have to be at least something of a workaholic. No one admits this, but it's true. You need to work hard to establish yourself, to fortify your reputation, to market your services, and to ensure that your clients are happy. The work never stops -- and because of this, you have to keep in close contact with your inner workaholic....Doesn't matter what your gig is, there's almost always a direct correlation between hard work and success. I'm currently on a tour of Europe with the Orpheus Chamber Orchestra, working on a project that should see the light of day by early next year. Each of the musicians comprising the group is an IP -- juggling their Orpheus gigs with all kinds of other projects. Some play for the New York Philharmonic, the American Ballet Theater, or the New York Opera, some teach at Julliard, others do Broadway shows or commercial work, and most do some combination of these. Each of these people is at the pinnacle of the music profession. And, to a person, they all work their posteriors off. They wouldn't be nearly as successful as they are if they sat around playing pinochle half the day, enjoying some mythical "balanced" work life that we're supposed to all aspire to."


Bottom line - if we want to be successful...we need to focus on that goal.

Don't fall for 'The Balanced Life' myth.

And as the old saying goes - "If you try to chase two rabbits, you end up catching neither."

Are you Single-minded?

While the bulk of my posts have focused on developments in the Pharmaceutical industry, I also like to post occasionally on topics related to Career Development.
And along those lines, there is an interesting post here.

We often hear it touted that we should all strive to be well-rounded....that we should work to improve our weaknesses....that we should strive for a balanced life.

David Rendall does not agree with that philosophy. He writes:

"While you are busy diffusing your time and energy broadly in an effort to improve in a variety of different areas, someone else is obsessively developing their strengths and flaunting their weaknesses. They aren't allowing their weaknesses to distract them from focusing on the areas in which they have the greatest potential.

If you want to win, in your career or your business, you need to be singleminded. Don't let your weaknesses and the goal of being well-rounded keep you from a maniacal focus on improving your strengths."

I think his point is valid....Being successful in any one area requires sacrifice....including possibly giving up the pursuit of success in other endeavors.....

Rise in Hiring Activity

Good news for job seekers in the Pharmaceutical/Biotech sector....
We have seen a significant surge in hiring.
I am not sure if this is just a blip on the radar....or if this development is the start of an upward trend.

Nevertheless - for now - there is a lot of hiring going on....

Bristol’s $2.1 Billion Medarex Deal -Brilliance or Desperation?

The Wall Street Journal's Health Blog briefly discusses this week's acquisition of Medarex by Bristol-Myers Squibb here.

The article describes BMS as "an old-line pharma company sitting on a lot of cash ($8.1 billion as of the end of the second quarter, according to Bristol’s latest earnings report this morning) and facing the generic competition for its blockbuster Plavix in a couple of years." On the other side of the aisle, you have Medarex, which is more of the 'New Kid on the Block...the hot upstart Biotech with promising cancer meds in late stage development and testing.

The reality is this....The potential rewards of this acquisition are promising...but the price of admission is high.
According to the WSJ article..."Bristol is paying a 90% premium to Medarex's Wednesday closing price,..."

And a quick glance at Google Finance shows that Medarex earned $10 Million last quarter...but lost almost $47 Million.

So while the potential is there...the question is...Did BMS pay too much for some potential?
Is this a strategically brilliant move? Or is it one that smacks of desperation?

Celgene's Revlimid shows promise as first-line treatment

Reuters reports that:
"Celgene said its multiple myeloma drug Revlimid significantly improved progression-free survival in patients undergoing initial treatment. The study's findings could boost the chance of expanding Revlimid's use outside the U.S., the company said. The product is approved only for patients who failed to respond to other therapies. "

Very nice development for Celgene......

Pharma Death Spiral

Sally Church has another interesting post on her blog where she asks what Pharma companies are in the proverbial 'Death Spiral'.
There is no doubt about it....the Pharma/Biotech industry is going through a very dynamic time.
The reality however is that while there are a number of Pharma and Biotech companies that are in serious trouble, there are an even greater number of companies that are doing well. These companies are poised to not only survive in this new marketplace, but will actually thrive.

There will be losers in the industry...and change is inevitable. But we can rest assured that the industry will continue to thrive. Unless someone invents a pill that totall eradicates illness in all humans, the Pharma/Biotech industry as a a whole will continue to be successful.

Senate panel gives 12-year exclusivity to biotech drugs

The Senate Committee on Health, Education, Labor and Pensions approved a 12-year data exclusivity clause for Bitoech companies before they have to share their drug-making data with generic drug manufacturers. You can read the article here.

There was a strong push by the Obama administration for a seven-year exclusivity limit.

According to the article:

"Biotech companies had pushed for a longer period of data exclusivity because, they say, it can take 15 years and as much as $1 billion to bring a new medicine to patients. They say data exclusivity to recoup money they’ve invested to make the product.

But supporters of a shorter time limit say long-term data exclusivity gives profitable biotech companies an unfair monopoly on the costly drugs. They say their ability to make biosimilars - the lower-cost generic versions of the biotech drugs - will lead to lower health-care costs."

But the 12 year exclusivity period is by no means a done deal...the measure still needs approval buy the full House and Senate.

Stem cells used to repair heart damage

I know....3 posts in one day....But this story is absolutely fascinating...and this is why I love the Pharma/Biotech industry.

Your Biggest Weakness - How to answer this Interview Question

Over on the Recruiter's Roundtable at Yahoo Hotjobs there was a discussion regarding how to field one of the most commonly asked Interview Questions, "What is your Biggest Weakness?"
You can view the whole discussion here.

I thought the advice from Delynn Senna, Executive Director from Robert Half International, was excellent. She replied:

"There are times when I ask job candidates this question. It's not that I want to nitpick or make people feel uncomfortable, but rather I want to see in which areas they feel they need to improve and what they are doing about it. In order to advance professionally, we all need to be able to honestly identify not just our strengths but also our weaknesses and how we can upgrade in these areas.

I recommend that job candidates be upfront during interviews. Don't say you have "no weaknesses" or "work too hard." Instead, tell hiring managers what you are working on improving and what you've done to build your skills in these areas.

One thing to keep in mind: If one of your weaknesses is directly related to the position and could potentially take you out of the running, the opportunity may not be right for you."

Bottom line - the reality is that you should be honest. If you really have a weakness that would inhibit your ability to do the job....then you really should not be interviewing for it.

New Biotech Firms' Discoveries Need More Protection

Just read an interesting article here.

The article states that...

"According to a new study commissioned by the National Venture Capital Association....Early-stage venture capital-backed biotech companies should be able to hold exclusive rights on their medical discoveries for at least 12 years because their investors expect 20% returns to repay them for the “extraordinary (investment) risk.”

However, the article goes on to say that:

"Legislators now formulating a new FDA approval process are assuming a 10% internal rate of return for venture capital fund investors."

The articles closes by saying:

"A shorter exclusivity period would make it difficult for venture capital backers of biotech companies to earn returns on these companies, according to the study by Joshua Lerner, Jacob H. Schiff Professor of Investment Banking at Harvard Business School; and Iain Cockburn, professor of finance and economics and Everett W. Lord Distinguished Faculty Scholar in Boston University's School of Management."

I think the article is spot on.
The reality is this....no one is going to assume risk without the promise of some reward!!
It is that simple.
However Congress seems to believe that Venture Capitalists are going to fall all over themselves to fund companies involved in risky drug projects and that these same Venture Capitalists will assume all of the financial risk if the drugs fail. Yet Congress assumes these same folks are going to do this without the promise of any real Return on Their Investment.

Sometimes this stuff just boggles the mind....

Talent is more expensive than capital

Great post over at Talentism entitled - Start: 20 Rules for Recruiting in the Creative Age.
You can read the whole post here.
But my favorite rule is Rule #1 [also repeated for emphasis as Rule #20].

1.) Talent is more expensive than capital.

Good companies remember this rule. Bad companies never learned it.

Japan approves first generic biotech drug

According just a story in Reuters that just broke here:

Japanese regulators approved a human growth hormone from Novartis AG, the first green light in Japan for a biosimilar or generic version of a biotech drug, the Swiss drugmaker said on Thursday.

Biosimilars are viewed as a promising new market, given the pent-up demand for cheaper versions of extremely expensive biotech drugs, some of which are coming to the end of their patent life.

Somatropin, made by Novartis' generics unit Sandoz, is for treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency, the group said.

It will be interesting to see how this development plays out.....

Nobel laureate Richard J Roberts says "Future is in Biotech"

The recent economic woes have cast a pall over a wide swath of industries. The Pharmaceutical and Biotech industries have been particularly hard hit this time.
And for the first time in my 18 years as a Recruiter, I actually have candidates asking me how to transition out of the Pharma/Biotech fields.

But not everyone is despondent about the prospects for the industry.

Nobel laureate Richard J Roberts opines here that "The futures lies in Biotech."

Roberts says that despite the current economic woes, now is the best time to be in the industry. Roberts goes on to say:

"Recession is the right time for this because there are no competitors. The early bird always gets the worm....We still know very little about biology and the mechanisms of life. So this provides us with a huge opportunity to focus on areas that humanity needs most. Far from being a negative factor, the recession has provided us with an opportunity to plan and consolidate better."

Roberts adds that the "key thrust areas where the biotech industry can catch up are genetically-modified food, bio-energy, stem cell research, synthetic biology and personalised medicine."

Personally I think Roberts is right on the mark. The future for Biotech still burns brightly.

The Power of Weak Ties on Facebook

I just heard about this video and this website on Twitter today.
Shama Hyder has been named one of the 50 Most Influential Women in Social Media and she has a great video over at her site, Shama.Tv that discusses The Power of Weak Ties on Facebook. [Although the value of 'weak ties' extends not just to Facebook, but across all social media. And in fact, I think it is fair to say that, 'weak ties' have value in the 'analog' world as well :)]

I think not that only job seekers, but anyone who is looking to improve themselves, will enjoy this video. It is good stuff!

Creative Marketing Promotion - Free Hair Color For Job Hunting Women

This is a little off-topic from what I usually post about....but I thought this promotion by tng worldwide and Kemon was a really great example of some creative marketing coupled with companies offering a good old-fashioned 'helping hand' to the community. Kemon and tng worldwide are teaming up to offer free hair color for job hunting women in the Detroit area. You can read the details here.
The program is called Hair for Success.
According to the article:

Larry Gaynor, CEO and president of tng worldwide....convinced local salons to donate their time, talent and services for the Hair For Success event, while tng worldwide is supplying the Kemon coloring product that stylists will be using on the women. It is one of the most sought after color products in the industry. Gaynor expects to help 2,000 women during Monday’s event by giving away about $100,000 in professional color treatments.

This program is a great example of 'giving before you get'. And it seems like this event will be a winner for all who are involved.....

Be Professional when Job Hunting

Marvin Walberg has a good article with some basic common-sense tips about how to conduct yourself on your job search. You can read the article here.

One of his tips is as follows:

Get a permanent and appropriate e-mail address. If you want, use one for friends and fun and another for business, using your name or initials — no cutesy names like hotmamma1795@hotmail.com, or — well, you know what we mean.

Now you would think that most people would know that they should use an appropriate email for their business related conversations....but that is not always the case. Years ago, I had a candidate that had an email address that was, shall we say, somewhat pornographic in nature. It was listed at the top of her resume. When I mentioned to her that she may want to consider using another email address for her job search, she balked at the suggestion.

Needless to say, I did not spend any more time working with her.

Palm's Pre Proves The Value of Recruiting Talent

Greg Kumparak over at MobileCrunch writes here about the resurgence of Palm.
How did Palm do it? They went out and recruited the people that they needed. And did they simply post a couple of ads and hope the right people responded to them?
No - Palm went out and aggressively recruited the talent that they wanted and needed from their competitors.

Kumparak writes:

"In early June 2007, Palm was teetering on the edge of obscurity. Their flagship Treo product line had gone stale, numbers were down across the board, and rumors of a sale were abound. On June 4th, 2007 it was announced that Elevation Partners had purchased a 25% equity stake of Palm for $325 million. Flash forward to today; just two years later (almost to the day), Palm has launched the Pre, a phone which managed to nab the attention of just about every blog and blog reader out there.

So what changed? What had that new-found $325 million bought them? Talent. Lots and lots of talent - from their competitors, no less. With a good amount of lucky timing and some decent salary proposals, Palm managed to snatch up at least 8 people who were just oh-so-damn good at what they do, ending up with the Palm Pre and webOS as a result."

The moral of the story....if you want to build a quality organization....if you want to make products that people want to buy....you can't just passively sit back and wait for talented people to beat a path to your doorstep. You have to go out and find them!!!

Worker Burnout

Joel Cheesman writes here that workers who have survived layoffs are increasingly experiencing burnout. Joel writes:

"...according to CareerBuilder’s latest survey of more than 4,400 workers nationwide.

Forty-seven percent of workers reported they have taken on more responsibility because of a layoff within their organization. Thirty-seven percent said they are handling the work of two people. Thirty percent feel burned out.

To accommodate growing to-do lists, 34 percent of workers who kept their jobs after a layoff reported they are spending more time at the office. Seventeen percent are putting in at least 10 hours per day. Twenty-two percent are working more weekends."

Should be interesting to see if these 'burned-out' employees stick around...or if they end up moving on to other companies once the economic recovery begins.

Why should a company hire you?

Just a quick post...
I just got off the phone with a candidate.
I asked him - "Why should my client hire you?"

The candidate's response was to simply list their current job responsibilities.
Basically they rehashed the list of responsibilities that appears on their resume.

That type of answer will not get you hired!

Bottom line - on your interview - don't simply discuss your responsibilities.
Instead focus on talking about your accomplishments.

More on this topic later.....

J&J and the Merck/Schering Reverse Merger

J&J filed for arbitration to end its revenue-sharing deal with Schering-Plough, due to Schering's merger with rival drugmaker Merck.
The problem for J&J is that Merck and Schering designed their deal as a reverse merger.

Here is J&J's problem....This is traditionally how a Reverse Merger works (you can read the complete BioJobBlogger post here):

Generally speaking, a failing or failed publicly traded company that is listed on one stock exchange or another merges with a privately held company. The privately held company takes over the public stock listing and manages the day-to-day operations of the new business. Private companies that engage in reverse mergers are usually looking for cash infusions for product development or a stock listing (without going through an initial public offering) which offers it shareholders immediate cash value. Investors who previously held stock in the public company are either compensated for their shares in cash or given shares (at a negotiated price) in the new entity. Any cash (or assets) left in the public company can be used to develop the formerly private company’s product(s) and if successful, shareholders in the old public company can eventually benefit.

But last I checked, neither Merck or Schering is a private company. So why in the world would they do a reverse merger?

Here's why - Again, according to the BioJobBlogger:

Schering-Plough markets Remicade outside of the US under an agreement with Johnson and Johnson which sells the drug in America. A termination clause in the original marketing agreement stipulates that the ex-US rights to Remicade (and another drug being developed) would revert to Johnson and Johnson if control or ownership of Schering Plough changes. Remicade, a treatment for rheumatoid arthritis, developed by Johnson and Johnson’s subsidiary Centocor, represented $2.1 billion in sales for Schering in 2008. Further, about 70% of Schering Plough’s revenue comes from outside the US. That said, the success or failure of the deal really hinges on whether or not Johnson and Johnson will challenge the change-in-control clause for Remicade. To obviate that possibility, Merck devised an unusual reverse merger strategy in which ownership of Schering Plough will not change hands—at least on paper anyway. Instead, even though Merck is putting up the money to purchase Schering, and Richard Clark, Merck’s Chairman and CEO, will run the newly combined company, Merck would technically become a subsidiary of Schering Plough and consequently there would be no change in Schering Plough management!

It will definitely be interesting to see how the arbitration process plays out.

Where do you find the time?

I sometimes get kidded by my family and friends about the amount of time I spend on the various forms of Social Media. People who think nothing of sitting on the couch and watching a 3+ hour Yankees game...or hunkering down for a night of American Idol are always questioning me as to where do I find the time for my Blog, Twitter, Facebook etc.
Well, this afternoon I was reading Connie Crosby's blog and came across this post. Connie had embedded a video where Clay Shirky talks about this very issue.
Next time I am asked the question regarding where do I find the time...I will point them to this video.

Biotechs To Dangle Data for Cash at Cancer Drug Meeting

An article in today's Bloomberg paints a pretty bleak picture with regards to the prospects for a number of cash poor small biotechs. For some of these companies, this year's American Society of Clinical Oncology meeting will be their last attempt to obtain a much needed infusion of cash.
According to Steven King, Chief Executive Officer of Peregrine Pharmaceuticals Inc.

"Failing to secure a development partnership, or to be sold outright, may force research delays and project shutdowns that can add years to the time it takes to bring a drug to market, or end the effort entirely...The current economy has made this the most important year, of all the years I can remember, for small biotechnology companies to get the attention of potential partners and investors at ASCO."

Steve Elek, head of Health-care Transaction Service for PricewaterhouseCoopers LLC elaborates further that,

“Without access to capital, early-stage biotechnology companies are looking to sell when a year or two ago they would never think of it....Ideally they would be able to move along a little further in the process to maximize value, but the cash burn makes that not feasible for them. I expect to see a lot more biotech M&A activity over the next six to twelve months.”

Not an easy time to be a baby biotech.....

Jeff Kindler and Dunbar's Number

Interesting thought....the size of the group that Jeff Kindler proposes for a successful R&D group is 150 people....which is what Robin Dunbar postulates is the "theoretical cognitive limit to the number of people with whom one can maintain stable social relationships."
Coincidence or not....

Pfizer CEO’s Three Tips for Research Success

Jeff Kindler in today's Wall Street Journal's Health Blog gives this summary of what he feels will lead to success in today's Pharma industry:

1. Each group should have between 100 and 150 scientists — few enough that they can all get together in the cafeteria to talk about what they’re doing.

2. Each should be run by a chief scientific officer prominent in the field.

3. They should be left alone “to create their own culture,” and should be judged, for the most part, on a single metric: Discovering drugs that demonstrate proof of concept.

Bottom line - Kindler's blueprint for R&D success looks striking similar to what GSK is currently doing.

Indian drug sales to US plunge 40%

The Financial Times reports here that Drug Sales that:

"Indian exports of pharmaceutical products to the US fell almost 40 per cent in the five months between October last year and the end of February....The trend is likely to disappoint analysts. India's pharmaceuticals industry was touted as a sector that could weather the global financial crisis."

Interestingly, sales of Pharmaceuticals from companies in China, Israel and South Korea gained dramatically.

Networking: The Most Effective Way to Find a Job

Matt Berndt has an interesting post on his blog entitled - Networking: The Most Effective Way to Find a Job. In his post he cites the following statistic:

According to a survey of 2002-2004 graduates of the UT College of Communication done five years after graduation:

• More than 70% found their first job out of college via their networking activities
• More than 78% found their current job (five years after college) via their networking activities

He goes on to write:

Again, this doesn’t mean they ignored online job boards, they just didn’t depend upon them as their primary means of finding employment.

I agree 110%!!
I always tell candidates that networking....whether by using their own network contacts or by using a Recruiter's network of contacts is by far the most effective way to get a new job. And if you have exhausted your networking options....and are still unable to gain access to a specific company....then by all means use the job boards. But Job Boards should only be a last resort....not your first option.

Swine flu could jump start new drugs

What is bad news from a societal standpoint could benefit companies in the Biotech/Pharma sector.
Fortune Magazine details in an article here what companies stand to gain from the potential Swine Flu pandemic.

The pharmaceutical industry faces unprecedented barriers to evolution

Great article here that details the challenges that the Pharmaceutical industry faces as well as the potential solutions to these challenges. Not a long article - but very well written and informative.

Statins guard against Prostate Cancer

There is a fascinating article that was just posted on Forbes.com. You can read it here.
According to the article:

Several new studies suggest statins help prevent prostate cancer and reduce the risk of erectile dysfunction.

"At this point in time, there seems to be mounting evidence that there may be a future role for statins in prostate cancer treatment or prostate cancer prevention," said Dr. Lionel L. Banez, from the Division of Urologic Surgery and Duke Prostate Center at Duke University Medical Center and lead author of one study.

From a Men's health standpoint, this is great news.

great career advice

Someone just posted this quote on Twitter and I thought it is very sound advice:

"Someone with a job is never secure, someone with a calling is never unemployed."

Medical Devices Face New Scrutiny From FDA

This article appeared in the Wall Street Journal on April 8th.
According to the article:

The Food and Drug Administration asked several medical-device makers to justify their products' safety and effectiveness, as part of a move to require tougher evidence standards before products can be sold.

But here is the kicker:

The agency's request comes in response to a 1990 order from Congress that directed the FDA to gather rigorous evidence before a manufacturer can sell medical devices considered to be in the most risky category, known as Class 3.

But despite several attempts during the 1990s, the FDA hasn't finished implementing the law. In the past five years, it allowed hundreds of new Class 3 devices to be sold based on a less rigorous showing -- called a 510(k), after a section of federal law -- that they are "substantially equivalent" to combinations of other products marketed before 1976. Such evidence often is collected in a laboratory, not with a clinical trial in patients.

I know the proverbial wheels of Justice and Government grind slowly...but this is ridiculous.
This law has been on the books since 1990 and the FDA still has not fully implemented it.
And now the FDA is going back to the Manufacturers demanding more data on products that are already approved and on the market.....And these companies may actually have to go back and run Clinical Trials on already approved products.....Incredible!

Inspirational 97 yr. old doctor

This post is a little different from my standard subject matter. But I figure anyone who is 97 years old and is still working and productive is definitely worth listening to. Hopefully you find Shigeaki's message as uplifting and inspiring as I did. And you can read the whole article here.

An excerpt from the article is pasted below:
At the age of 97 years and 4 months, Shigeaki Hinohara is one of the world's longest-serving physicians and educators. Hinohara's magic touch is legendary: Since 1941 he has been healing patients at St. Luke's International Hospital in Tokyo and teaching at St. Luke's College of Nursing. After World War II, he envisioned a world-class hospital and college springing from the ruins of Tokyo; thanks to his pioneering spirit and business savvy, the doctor turned these institutions into the nation's top medical facility and nursing school. Today he serves as chairman of the board of trustees at both organizations. Always willing to try new things, he has published around 150 books since his 75th birthday, including one "Living Long, Living Good" that has sold more than 1.2 million copies. As the founder of the New Elderly Movement, Hinohara encourages others to live a long and happy life, a quest in which no role model is better than the doctor himself.

Pharma Innovation in Legal Jeapordy

Lawrence McQuillan writes a fascinating and frightening article regarding recent court rulings that will have a potentially tremendous negative impact on drug innovation. You can read the article here.
The recent Supreme Court ruling in Wyeth v. Levine (which held that even when a drug has been approved by the FDA, the drug manufacturer can still be held liable under state law) has garnered a lot of press.
But an even more frightening decision was rendered in CA in the case of Conte v. Wyeth.
McQuillan writes:

In Conte, a California appellate court ruled that those harmed by a drug don’t have to settle for suing just the manufacturer: now they can sue the inventor as well....The case involved plaintiff Elizabeth Conte, who claims to have suffered severe neurological problems after taking a generic version of the antacid drug Reglan. Conte first sued the generic drug’s manufacturer, alleging that the company was liable for the injuries caused by its product. But then she filed suit in California state court against Wyeth, the inventor of Reglan, though she had never taken Wyeth’s product. Incredibly, the appellate court ruled that Wyeth was legally liable for any adverse effects caused by the generic version of its drug. The makers of the generic product got off scot-free....In January 2009, the California Supreme Court decided not to review the decision, so it’s now Golden State law. Wyeth’s warning labels, and those of other drug inventors, will now apply not just to their own products, but also to those of other companies, which they do not control....The Conte ruling carries extremely harmful implications for drug innovation. The typical pharmaceutical company spends more than $1 billion developing a new drug and bringing it to market through a complicated approval process. Given current patent law, the company has just a few years to recoup its investment before generic drugmakers can enter the marketplace and churn out copies sold at a fraction of the original’s price. Making drug inventors responsible for problems with generics makes drug development that much more expensive—so much so that many companies will likely no longer be able to afford it. They’ll pull out of the market, and pharmaceutical innovation will decline. Conte also guarantees that pharmaceutical-company resources that would have been used for R&D will now be spent on legal defense.

In the long-run, the societal costs of these decisions will be staggering. Innovation will be stifled.
Drugs that could be developed that will save and/or improve people's lives will never leave the lab. It truly amazes me that the courts can arrive at these type of conclusions and that these types of decisions can actually be rendered.

Pharma Business Model Blues

Rick Edmonds has an interesting post here entitled -Newspapers, GM and Big Pharma: Sharing the Business Model Blues.
Edmonds writes:

Pharma seems to be where newspapers were a decade ago, even five years ago -- loaded with cash, still highly profitable, but experiencing marked reduction in revenue growth. Cracks have appeared in the pipeline of developing new medicines and selling them for years as high-priced, proprietary brands.

He does not dispense any specific detailed solutions to the problems that beset Big Pharma....but the post is still an interesting read.

New Senate Bill Takes Shortcuts on Path to Biosimilars

Senators Charles Schumer, Sherrod Brown, Susan Collins and Mel Martinez have introduced a bill regarding the approval process for the approval of Biosimilars.

However, according to Biotechnology Industry Organization President Jim Greenwood, the bill proposed by Senators Schumer et. al. is essentially a recipe for disaster.

According to Greenwood:

“While well-intentioned, the bill introduced today by Senators Schumer, Brown, Collins and Martinez follows its companion bill in the House (H.R. 1427, The Promoting Innovation and Access to Life-Saving Medicine Act) through the looking glass to a world of biosimilars that would jeopardize patient safety and undermine future medical breakthroughs.

“The legislation short cuts scientific requirements needed to ensure patient safety and creates an imbalanced system that could chill investment in research focused on discovering new treatments and cures for devastating diseases, such as cancer, Alzheimer’s, Parkinson’s and multiple sclerosis.

“As the U.S. Food and Drug Administration (FDA) has noted, biotech drugs are so molecularly complex that they are almost impossible to replicate accurately with existing science. Even minor differences in the purity of a biotech drug can change its efficacy and safety. With this in mind, any biosimilars legislation should mandate that FDA approval of a biosimilar include clinical trial data demonstrating its safety, purity and potency. Yet this bill includes language that would discourage the FDA from conducting certain clinical trials.

“More, the bill unfairly tilts the playing field toward biosimilars manufacturers. This legislation provides for less data exclusivity than traditional pharmaceutical drugs currently receive under the Hatch-Waxman regime even though every credible study on this issue has found that biologics will need greater data exclusivity than traditional drugs to ensure future medical breakthroughs. Additionally, innovators would be required under the bill introduced today to share detailed information about every applicable patent to biosimilar manufacturers, making it easier for the biosimilar company to bypass valid patents. Innovators, on the other hand, would have no ability to receive relevant information from the biosimilar manufacturer about the molecules, ingredients, and processes they use to create the biosimilar.

“A successful pathway to biosimilars must strike the right balance in ensuring patient safety and providing fair, responsible incentives for continued biotech research into cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS and unmet medical needs. The bill introduced today fails to meet this reasonable metric.

“We urge Congress to ensure that any pathway for approving biosimilars is grounded in sound science, safeguards patient safety, and preserves incentives to develop future breakthrough therapies and cures.”

This topic is sure to be hotly debated over the coming months.....Stay tuned.

The Struggle for Baby Biotechs

Sally Church has a great post on her blog about the coming cash crunch for baby Biotechs.
You can read it here.
Actually you should visit Sally's blog often. Her posts are consistently top-notch.

Contradictory Supreme Court Decision and the Costs to Society

According to an article in the New York Times here - today's Supreme Court decision sets the following scenario:

An injured consumer can sue a drug maker — but not a medical device maker?

That seemed to be the contradictory result of a decision Wednesday by the Supreme Court, ruling that federal law does not protect drug companies from product liability suits in state courts.

In contrast, the Supreme Court ruled last year that federal law does bar such lawsuits against the makers of heart stents, artificial joints and other critical medical devices.

While legal eagles will debate the nuances of today's decision - here is the real issue:

"[Today's]....decision would make companies more reluctant to produce beneficial drugs that come with higher risks."

Everything you ingest, whether it is Steak, Peanut Butter, Aspirin, and even Water, carries with it an element of risk. you cannot eliminate risk.
As a society, the cost of not developing life saving but potentially risky drugs, is a cost that we cannot afford to bear.

Genentech: Worth More Than Pfizer?

I am going to have to file this post under the Category of things I never thought I would be writing - but according to an blog post on the Forbes website last Friday - Genentech is worth more [in terms of Market Cap] than Pfizer.

Matthew Herper writes here that:

"Check this out: This morning, Genentech's market capitalization of $91 billion exceeds that of much-bigger Pfizer ($84 billion.) Pfizer has annual sales of $48 billion, compared to $13 billion for Genentech....Over the past two years, Genentech shares have been basically flat, but Pfizer's stock has plunged more than 40%."

Who would of thought this was possible?

Publish Post

Pfizer wants to become more like J&J - easier said than done

Jacob Goldstein posts at the Wall Street Journal Health blog that Pfizer's Jeff Kindler is quoted by Bloomberg as saying that:

“We are breaking the company down into smaller units so we aren’t dependent on any single product. I am a great admirer of J&J and Abbott’s business model.”

While Kindler expresses admiration for J&J and Abbott, the article goes on to stress that Pfizer is a long way from replicating the business models of those two companies.

Goldstein goes on to write:

If you were about to lose a $12 billion-a-year blockbuster, you too would be eager to be less dependent on any single product. J&J is indeed a famously decentralized company, and Kindler last year said he would reorganize Pfizer into smaller business units.

What’s more, the Wyeth acquisition will help Pfizer diversify into businesses such as animal health, consumer products and vaccines.

But the buy will hardly turn Pfizer into another J&J. Pfizer will likely pull in less revenue from Wyeth’s consumer health division (which includes brands such as ChapStick and Advil) than it drew from its old consumer health business, which it sold in 2006 to J&J.

What’s more, Pfizer still won’t be a player in the medical device business, which has been central to Abbott’s growth and a key piece of J&J’s revenues.

Way back in the ’90s, Pfizer had its own medical devices unit. But the prescription drug business was booming at the time, so the company sold off its medical device business.

The question now is - Does Pfizer intend to go out an acquire a Medical Device company in a bid to remake their company?

Thomas Friedman - Invest in Biotech, Nanotech and Clean Tech

Thomas Friedman has a great piece in yesterday's NY Times. In a nutshell, Friedman thinks we should not be bailing out the economy's losers. Friedman writes:

"Our motto should be, 'Start-ups, not bailouts: nurture the next Google, don’t nurse the old G.M.’s.'"

Friedman elaborates his point when he writes:

"Yes, we have to shore up the banking system, which underpins everything; and finding a fair way to prevent hardworking people, who played by the rules, from losing their homes to foreclosure is both right and essential for stability. But beyond that, let’s think, talk and plan in more aspirational ways. We’re down, but we’re not out. As we invest taxpayer money, let’s do it with an eye to starting a new generation of biotech, info-tech, nanotech and clean-tech companies, with real innovators, real 21st-century jobs and potentially real profits for taxpayers."

Phenomenal stuff...and as usual Friedman is spot on in his assessment of what we need to do as we move forward to the Next Economy.

Career Adventure Blog

I just discovered a great blog by Kristi Daeda called Career Adventure.
Kristi is an HR professional and a Career Coach who I met on Twitter.
The posts on her blog are excellent and full of specific and tangible information that will be of help to any job seeker. Go over to her site and take a look....you will definitely learn something.

Job Hunting is all about Networking

David Rosman writing in the Columbia Business Times has a great article about Job Hunting.
You can read the article here.
Rosman's main premise is that Networking is what is going to help the majority of people find jobs. He also talks about JobAngels, which is "a 'grassroots' non-profit organization whose mission is to connect talented career professionals with those searching for work."
The work of the people involved with JobAngels further underscores the importance of networking.
Rosman closes the article with some solid advice:
There are four “Rosman Maxims” concerning the planning and execution of a career hunt. First, your future employer only cares how you can make them money, save them money or save them time. What you want is not even on the radar.
Second, a résumé will never get you the interview. But a well written, documented and professional résumé will reduce the likelihood of being first on the rejection pile.
Third, “It you tell enough people what you want, you will eventually get it.” Network, network, network. The idea that the majority of jobs are never advertised may or may not be true. However, with many companies now looking for qualified professionals, the more people in the field who know you are available, the higher the likely hood you will hear about the opening.
Fourth, “SW/SW/SW/N.” This goes along with the “If at first you don’t succeed” idea. You are going to get rejection letters; that is a fact of life. Yet another fact, many potential employers may never get back to you. These are not personal rejections. Just put a smile on your face and remember, “Some will. Some won’t. So what. Next!”

Get a copy of The Innovator's Prescription

I am in the middle of a phenomenal book entitled The Innovator's Prescription by Clayton Christensen. The book provides a comprehensive blueprint for repairing our health care system.
I will discuss the book in more detail in later posts. But if you are involved in any way in the Pharmaceutical Industry...drop everything and get yourself a copy of this book. It is not an easy read. It will make you think. But it is absolutely brilliant!

Who is Sanofi-Aventis gonna buy?

Reuters reports that Sanofi-Aventis is in the market to make an acquisition.
The article states that:

Sanofi has been mentioned as a possible buyer of Dutch vaccines maker Crucell (CRCL.AS), which has a market value of about 1 billion euros, and there has also been speculation it could make a play for its U.S. partner Bristol-Myers Squibb (BMY.N), which has a market value of around $45 billion.

My gut feeling is BMS is not a target. BMS is too big. Various other news outlets speculate while Sanofi is willing to open up it's purse strings....their targets are more likely to be small and mid-level companies. And the word on the street is that Sanofi is content to leave the big mega-mergers to Pfizer.

P&G to exit the Pharma Industry

The Financial Times is reporting that P&G may be looking to exit the Pharma industry.
The article states that:

Mr Lafley [P&G's CEO] said that when P&G had been investing heavily in pharmaceuticals in the 1990s, the returns had been well above those from consumer products. “Today, pharma companies trade at multiples at or below consumer products,” he said.

He also drew attention to greater regulatory obstacles within the pharmaceuticals industry, and increased competition from generics that reduces the pay-off of companies’ research and development.

Mr Lafley said that in weighing potential divestitures, its primary focus in making decisions would be “creating maximum value for P&G shareholders”.

This is probably a wise move for P&G. The company never seemed fully committed to the Pharma industry. People in P&G's Pharma division have always told me that they felt that the Company's primary focus was on the Consumer Goods side of the business. P&G is a wonderful Consumer Prouducts company....but developing Pharmaceuticals is a whole lot different than making Shampoos.

Merck to go shopping?

It looks like Pfizer is not the only Pharma Company with it's checkbook out.
The Wall Street Journal quotes Merck's Chief Executive Richard Clark as saying that "Merck would look 'across the whole spectrum' of deals, including a major takeover. 'I don't think in today's world any CEO can categorically rule out any type of transaction,' "

Traditionally Merck has been proud of its internal R&D programs.
But now apparently Merck wants to go shopping too.

Pfizer / Wyeth - The Opportunity Costs for R&D

Derek Lowe has a great post over at SeekingAlpha.com about the drag on productivity that this merger is having on both Companies' R&D Departments. Derek writes:

I’d imagine that things have slowed down a great deal. No one knows what the future will be like, what parts of the company will stay, and which people will be asked to stay with them. How do you make plans under those conditions? For many people, the project they’re working on is now very much a secondary consideration.

Even outside the personal level, there are a lot of paralyzing influences. The same uncertainties about individual jobs apply to development projects. Some of what Wyeth is working on surely overlaps with what Pfizer’s already doing. So which project goes forward? Not both of a matched set, that’s for sure. There are some projects at both companies that are dead in the water, but no one can be sure which ones, and no one will know for some time to come....all this has a ferocious price, when you measure it in opportunity costs. The people caught up in all this could be doing something much more productive with their time, for sure. This sort of thing doesn’t show up on the books. And the longer the process drags on, the worse it’ll be.

Derek is correct....not every cost will show up 'on the books'. And this merger could ultimately prove to be extremely expensive for Pfizer....both in terms of Real Costs and Opportunity Costs.

Pfizer - Wyeth - Bane for Small Biotechs???

The NY Times has an article today entitled "Wyeth Deal May Slow Pfizer Biotech Acquisitions".
The article states,

"Pfizer’s deal to buy a big pharmaceuticals rival, Wyeth, raises questions about how willing — or able — Pfizer will be to enter deals anytime soon with biotechnology companies, many of which are struggling to stay in business."

And, in the article, Oleg Nodelman, portfolio manager at the Biotechnology Value Fund is quoted as saying,

“There are probably 5,000 biotech companies out there that are waiting for a deal to save them."

However, Mr. Nodelman is not totally pessimistic regarding the future of the smaller biotechs.
The article closes by saying that fortunately -

"Big pharmaceutical companies are not the only ones who can buy companies or drugs. In some cases, mid-size biotech companies like Cephalon and Myriad Genetics are outracing larger companies to snap up some drugs.

That is why Mr. Nodelman, at the Biotechnology Value Fund, said he did not expect the Pfizer-Wyeth deal to have much of a braking effect on acquisitions of small companies or their drugs. “All it means is there is one less company that might do a deal with them.”

Geron's Embryonic Stem Cell Trial - Not exactly what the Media is touting

The FDA just approved the first human trial embryonic stem cell derived based treatment.
Geron Corp. has announced that the FDA approved its application to begin trials for an embryonic stem cell -derived treatment for spinal cord injuries.

The media is playing up this development as evidence of a 'Brave New World' with regards to Stem Cell research....that we are at the cusp of new research using Embryonic Stem Cells, and that the new Obama administration is shepherding in this new era in Research.
Forbes.com wrote:

The change has already begun. Just two days after his inauguration, President Barack Obama is set to clear the way for the first human testing of embryonic stem cells on people with spinal injuries, and biopharmaceutical firms like Geron are set to benefit.

Yet the facts say otherwise.

According to an L.A. Times article, even Dr. Thomas Okarma, Geron's CEO,...'the timing of the FDA's decision -- made late Wednesday but announced Friday by the company -- had nothing to do with the change of administrations in Washington....."We have no evidence that there was any political shadow over this process." '

Even more important according to Dr. David van Gend, National Director of Australians for Ethical Stem Cell Research, is the fact that Embryonic Stem Cells (ESC's) are not:

"....being given to patients at last. They are not. They never have been and never can be put into humans, because embryonic stem cells form tumors in animals. Only adult stem cells can be put into humans – and have been used now successfully in thousands of patients.”

Further reading shows that what Geron is actually doing is testing to see if their "hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury", actually works in humans.
Again the distinction is important.....they are not injecting actual ESC's into people....the cells are actually derived from ESC's.

So while the research Geron is conducting is absolutely exciting and promising.....it is not exactly what the Media is touting....

Pfizer and Wyeth - Misery loves company?????

Eben Tessari writes "5 Reasons Pfizer Shouldn't Buy Wyeth" over at SeekingAlpha.com.
You can read his complete post here.

And what is Eben's only justification for the proposed merger? - "Misery loves company."
Not exactly a stellar reason to consummate a $60 Billion merger.

Pfizer - Wyeth Merger - Is it a bad idea?

With all the talk about the proposed merger between Pfizer and Wyeth....I took the time to re-read an article from Fortune Magazine that I had saved on my computer. It was written in August 2007. You can read the article here.
Although some of the details and facts discussed in the article are dated [the article is 18 months old].....I wonder how many of you would agree with the author's conclusions. John Simons' closed his article by writing:

Pfizer could have an investor revolt on its hands if it does decide to propose a Wyeth acquisition. In recent years, top management has sworn off its appetite for big deals, promising a new focus on targeted acquisitions and alliances with smaller (read: more innovative) drugmakers and biotechs. Last winter, incoming CEO Jeff Kindler promised Pfizer would radically change the way it does business. That departure from the old way included a round of difficult cost cutting and "right-sizing" at the company. So, Pfizer needs to continue it's austerity campaign, and "oh yeah", in the meantime, conjure up some novel medicines.

The question is.....is John's assessment still correct in 2009....or is it time for Pfizer to do a deal?
Will this deal make Pfizer's problems go away?
What are your thoughts?...............

Merck goes hunting - Other deals pending???

Merck has made good on its promise to make deal making a priority in 2009.
Last Friday, just 9 days into the New Year, Merck announced that the company had signed a diabetes and obesity drug deal with Galapagos worth up to $233 million. You can read the specifics about the deal here.

And with Pfizer's Jeff Kindler telling the press that Pfizer is willing to do a deal with a big rival....Who knows....2009 may be a very active year on the M&A front.

Missing Pharmalot

Ed Silverman who runs the blog Pharmalot just posted a surprising announcement today.
He is shutting down Pharmalot. You can read his post here.

I thoroughly enjoyed reading Pharmalot daily and I learned a tremendous amount from Ed.
Ed is a tremendous writer and has a Herculean work ethic. As he jokes he lives tethered to his laptop.

Ed....we are going to miss you in the blogosphere. Best of luck!!!