Scientific Fraud and Layoffs

A couple of interesting news articles going around this weekend.

I look forward to Jason Balog’s Biotech “blog” in the FNP every month.  He has an interesting take this week talking about the recent layoffs at Pfizer.  The layoffs announced are all in R&D and are attributed to a lack of productivity.  No new drugs in the pipeline and some memorable failures.  As Jason puts it:

At $7.5 billion, Pfizer has one of the largest research and development budgets. But in the last couple of years Pfizer has terminated several high-profile projects and has produced no new blockbusters. Consequently, Pfizer is facing the impending loss of patent protection for its best-selling drug with no product(s) ready to replace the loss.

As internal research and development departments continue to produce disappointing results, management has started to look for external means to fill the pipeline. The result has been a rapidly increasing number of acquisitions of promising molecules or entire operations from smaller companies. However, even with the uptick in acquisitions, internal research and development departments have largely stayed intact.

Pfizer’s recent announcement is therefore more significant than it might first appear. With the recently announced layoffs, Pfizer seems to be tacitly admitting its research and development activity has failed and that a change in how big pharma does business may be required in the future.

So these actions are lock step with the belief that Big Pharma will be looking to acquire a number of small biotechs to grow their product pipeline. For example, AZ acquiring MedImmune right here in our back yard. We also know Pfizer has talked a lot about Stem Cells and Regenerative Medicine. If anyone’s listening, I can be bought, cheap. Under 9 figures. Give me a call.

In other, more local news I was reading about Kai Hagen’s rants in the Gazette.  Apparently, he’s the only county commissioner opposed to the Waste to Electricity project.  Even more better, he accuses the other commissioners as relying on “scientific fraud” as a basis of their choice ot support the “Incinerator”.

According to the article:

“The frequent assertion that WTE [waste-to-energy] as we have proposed … helps with our national energy crisis, is more environmentally friendly than practical and economically competitive alternatives or is in any way responsible from a climate change perspective is misguided at best,” Hagen wrote in the e-mail.

“It is a myth that one could reasonably describe as scientific fraud. And to date, too many decision-makers in the county have been complicit in perpetrating that fraud. We can do better than that. And, fortunately, we still have the opportunity to do so.”

Those who read FredCoBio regularly may know I am not a subscriber to the global warming conspiracy theory. Having reviewed the data and the proposed theories and models, none present any compelling evidence that humans are responsible for “climate change”. Certainly climate change is happening. It happens every day. I believe the overwhelming evidence is that the current, and historical, changes are “purely natural” and our ability to predict future “catastrophes” (which are certain to occur whether or not humans inhabit the planet as they have before human inhabited the planet) based upon measurements only possible for the past 25 years (100 years would be stretching it) is not appreciating the scientific method and falsely leading people (i.e. the media) to sensationalize their self fulfilling prophecy in hopes of getting themselves funded. Humans are a part of nature and matter in the universe and matter can be neither created nor destroyed.

My main point in disagreeing with Kai is that this is not a precident setting proposal.  Fort Detrick and Frederick Memorial Hospital (I think) already have WTE incinerators.  It’s common at hospitals and other places that generate a lot of biomedical waste.  Why?  Because sending it to a landfill isn’t an option and handing it over to a waste hauler gets damn expensive real fast.  Oh, and why wait for the waste to decompose and generate Methane, which we’ll gladly harvest and convert to electricity?  Same stuff, different day.  In terms of geological time, not relevant.

And neither are humans.  So y’all might as well come out to BioBeers East ‘09 on Thursday 2/12 to celebrate the demise of humanity, extinction of non-beer drinking psychopaths and generally embrace your inner science geek.

PS:  I did not intend to imply that either Jason or Kai are dinosaurs by throwing my rant into this post

9 PM UPDATE:  Pfizer looking to acquire Wyeth for $60 billion.  Yeah, that’s the ticket I was looking to punch…

BioBeers East ‘09: The first Installment of the Year

At long last, I have arranged the first installment of BioBeers East ‘09!

Mark your calendars:  Thursday, February 12th from 4:30-7 PM at the Flying Dog Brewery.

For the un-indoctrinated, BioBeers is a chance to meet and mingle with 60-70 like-minded individuals and embrace your inner biogeek over a frosty beer.  Our goal is to foster, in an informal and relaxed setting, the exchange of ideas, business opportunities and general mischief and promote Frederick County as the exclusive Biocluster in the world!

I would like to especially thank James Matan and the Matan Companies for sponsoring this month’s event.  In case you are not aware, Matan is the group awarded the contract for constructing the new 700,000 sq ft SAIC facility @Riverside, as well as listing and providing a vast number of other commercial properties in FredCo and surroundings.

Please RSVP, because we need to have some idea of head count and also feel free to invite others to attend.

I know the Matan guys would like to say a few words, but I would also like to ask one of you out there to volunteer to present (10 minutes max) some scientific research or promote some gadget you’re working on.

I am also asking for a couple people to bring other assorted munchies, chips, pretzels, sushi, whatever.  Just an in-kind donation for all the beer and food (sandwiches from aka Frisco’s) Matan is picking up.  Come on, I know you’re out there!

Teva and MedImmune Invest in FredCo Bio?

In two separate articles on the news wires this morning, Israeli pharma Teva (also a factor in MoCo Bio although I could find no mention of this site on their web site) have teamed with Lonza, parent of Lonza-Walkersville, to develop “biosimilar” drug compounds.  According to this press release:

Teva and Lonza will cooperate to develop, manufacture and market a number of affordable, efficacious and safe generic equivalents of a selected portfolio of biologic pharmaceuticals.

“We had identified biosimilars as a major growth driver for Teva in our long-term strategy and have been augmenting our knowledge base, capabilities and infrastructure to position Teva as a leader in this market”, said Shlomo Yanai, Teva’s President and Chief Executive Officer. “This strategic partnership bolsters our biologics capabilities. Lonza is an ideal partner for Teva in this field with its deep knowledge and experience in biopharmaceutical development, large scale manufacturing and state of the art manufacturing facilities. Combined with Teva’s global leadership and expertise in clinical development and marketing of generic pharmaceuticals, the joint venture generates significant opportunities and benefits for both companies.”

Not sure if or when any of this will “trickle down” to FredCo, but one would think some of the biologicals and models may be developed at the Walkersville facility. I’ll try to get more information.

In another story which may or may not have implications for FredCoBio, the MedImmune venture of Astra-Zeneca raised another $22MM in series D financing for the acquisition of Hydra Biosciences of Cambridge, Mass.  They are were a private company that exploit ion channels, although they have never initialted a clinical trial.  Likely this would be more of an interaction with the R&D side of things in MoCo, but this activity may be the next round of manufacturing expansion in FredCo a few years down the road.

Paying it Forward

A long-time associate, Larry Vaughn, formerly in HR at LTI is now a recruiter (yes, I am using the nice description). He asked if I’d do a favor and post a position he’s working on in MoCo. Here ’tis:

VP, Fill & Finish with our pharma client in MD. They are constructing a facility which is ~40% complete and they will be using a BFS process for aseptic filling. Need 10+ years related experience. This is a very attractive opportunity with a public pharma company with products on the market and a robust pipeline of novel compounds. Is there someone in your network that I should be speaking with regarding this attractive opportunity? Any networking assistance you can provide will be greatly appreciated and we will be glad to return this professional courtesy anytime.

You can contact Larry directly or drop me a line and I’ll send you over his way.

Larry Vaughn, Senior Consultant
Advantage ONE Executive Search, LLC
Biotech and Pharmaceutical Practice
615-507-1717
301-305-3595 Cell
lvaughn@advantage-search.com
www.advantage-search.com

FNP reports on Lonza Expansion

Today in the Frederick News-Post there was a report of the Cell Therapy expansion at Lonza-Walkersville.  I am not entirely sure if this is new news, or just a report on the progress of an expansion project started last year will the clearing and grading behind the warehouse? I had reported on this in July, based on a Lonza press release.  Good news in any event.  As otehr businesses and economy struggles, FredCoBio rolls on!  And 80 more bioscience jobs.  I suspect these positions will be filled through AeroTek Scientific Staffing, as they have been in the past.  If you’d like an intro to any of the fine people there, drop me a line.

You can read the FNP article HERE, here’s the summary:

The growing market for its cell therapy program spurred the expansion. The 44,000-square-foot building will house three Class 10,000 cell production sites and office space. The Class 10,000 designation requires specific clean room qualifications for the successful production of tissue cells.

The new building will be joined to the existing warehouse at Lonza with a two-level connector to allow for convenient movement of personnel, materials and products.

Planning for the new building began in 2007, the same year Lonza acquired the bioscience division of Cambrex. Completion of the new building is expected in the fall of this year.

Is it already the New Year?

I must apologize for being a lame blogger this year, thus far.   Although I have not been doing a tremendous amount of lab work, I have been running to and fro trying to relocate myself over to FITCI@Hood and collecting Christmas Trees for the goats.

I’ve also started plans for the first BioBeer of 2009.  Looks like it’ll have to wait until February, since everyone was slow recovering from the holidays and now they’re booked through the end of the month.  I know I have plenty to do between now and the end of the month.

But in my lull, there were a couple stories meriting some attention.

First, I guess no one will be surprised to hear that the Tech Council of Maryland will be asking for more funding this year.  According to the Baltimore Business Journal, there will be requests for doubling funding for the state’s biotech tax credit, amongst other things.  I tried, unsuccessfully, to get this tax credit two years ago when I was going to dump $100K into my own biotech venture.  Apparently, you need to have greased someones palms already to qualify.  Maybe I’ll try again this go around?

And in a story that may have gone unnoticed, the GlobeNewswire via COMTEX News Network released a story about Anthersys of Cleveland: “Athersys Receives IND Authorization for Multistem in Treatment of Ischemic Stroke“  In case you don’t know, IND means “Investigational New Drug”.

According to the article “Athersys, Inc. (Nasdaq:ATHX) announced today that it has received authorization from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial evaluating the safety of administration of its “off-the-shelf” adult stem cell product, MultiStem(r), in the treatment of ischemic stroke.

The Phase I study will be a double-blind, placebo controlled dose escalation trial evaluating the safety and maximum tolerated dose of single-dose administration of MultiStem following an ischemic stroke. The trial is designed to include up to 48 patients and will be conducted at multiple clinical centers in the United States.”

from Athersys' web site

So this is very good news for Frederick’s own Lonza-Walkersville, as you may read through this Feb ‘07 Press release:

Athersys engaged Lonza to assist it in the scale-up and manufacturing of its clinical grade product, using Athersys’s production processes. “We are excited about this relationship and our role in supporting Athersys’s entry into the clinic with its MultiStem(R) product,” said David Smith, Vice President, Cell Therapy Bioservices at Lonza. “Athersys’s production process has proven to be robust and scalable, providing a strong foundation for conducting clinical development.”

Yet another example of Frederick leading the world in Stem Cell production technologies for research and therapy.

I also wanted give a shout out to Smart Company Magazine for some very good taste (in naming this blog “featured blog”) in their new web site design and a couple articles about Ft Detrick and SAIC in their print edition this month.

Also congratulations to Dr Jeffery Hung at SABiosciences for being put in the same catagory as Affymetrix, Roche, Aligent and Illumina with a nice excpert in the MicroArray article in GEN.

FredCoBio Wordle

Just for fun, I created a Wordle, or “word cloud”, for the blog today.  I liked it so much, I thought I’d share it:

ImQuest Submits new IND

In a story I saw today on the PR newswire, ImQuest has submitted an Investigational New Drug (IND) application to the FDA, which was apparently approved.  The Phase I clinical trails being in 1Q ‘09.

From the story:

ImQuest Life Sciences announced today the successful submission of an IND application to the Food and Drug Administration to initiate human clinical trials for their lead pyrimidinedione HIV inhibitor IQP-0410. ImQuest anticipates initiating their Phase 1 studies in the first quarter of 2009. IQP-0410 is a novel small molecule inhibitor of HIV which primarily acts as a nonnucleoside reverse transcriptase inhibitor (NNRTI). The compound possesses a second mechanism of action which prevents the entry of HIV into target cells and significantly raises the potential genetic barrier to resistance with IQP-0410 therapy. Preclinical pharmacokinetic and toxicology studies have demonstrated the potential for once per day dosing and a high safety margin for the compound. IQP-0410 has been found to inhibit HIV replication at sub-nanomolar concentration levels and to have highly significant activity against all clinical virus strains evaluated as well as against multi-drug resistant virus strains obtained from patients failing long courses of therapy with currently approved RT and protease inhibitors. The compound is well suited for use as a component of primary HAART regimens as well as a salvage therapy option. Preclinical studies have also demonstrated the ability of the compound to be used in combination with all other approved HIV drugs.

Let’s hope everything goes well in clinical testing. this could mean a significant advancement in HIV treatment and a novel approach to treating other viral infections.

We’ll have to make ImQuest buy more than chips for the next BioBeers, though…..

Happy New Year from FredCoBio

I wanted to make the first post of the year not so much of a retrospective on 2008 as “forward looking statement” of things to come in 2009.  Yes, I know it’s already January 6th.  It was nice taking some time off to do a lot of nothing, but things must get done in ‘09.

So first a look back at the Top Stories in FredCoBio.  I could try to come up with a “Top 10″, but I think  we’ll just leave it at the “Top 6″ (in no specific order):

1)  BioBeers: My personal highlight, at least.  What started as an idea for a small gathering, borrowed from a group of bloggers in Colorado, turned into a party of 70 some odd biogeeks from almost every Biotech in the County.  I have more people offering to “sponsor” than I can accommodate, but we haven’t exceeded to hospitality or capacity of the Flying Dog Tasting Room, yet.   Stay tuned for the first BioBeers’09 event coming in January.

2)  The Bruce Ivin’s tragedy:  Enough said about this one, event though there is another article in the FNP today releasing autopsy results.  Although deemed guilty by the FBI and most media outlets, the sentiment remains strong that he was innocent and driven to suicide by having his life’s work confiscated and his reputation ruined.  This was a huge national story, broken by the LA Times several days after I had the chance to “break the story” upon hearing of his death at one of our BioBeers events on the day of his death.

3)  Stem Cell expansion in the region:  The growth in the region of the “big guys”, with Lonza breaking ground on a huge new Cell Therapy expansion and Invitrogen making the Executive Way facility Ground Zero for their Cell Culture/Stem Cell research group’s Open Innovation Center.  Also, LifeLine Cell Technology in Walkersville is growing rapidly, with the contract to supply SC lines to ATCC and signing a deal to supply Millipore.  Not to mention some of the great stuff going on at Ft Detrick and the Regenerative Medicine facility being coordinated through FT Detrick Command.

4)  SAIC expansion, another huge plus for FredCoBio.  They’ve already built the new Charles River facility to make the research animals and now another potential 700,000 sq feet of lab space and space for “synergistic partners”.  Can’t wait for this facility to be opened and see what comes of it, aside from a promise for a cure for some forms of cancer within 5 years of opening.

5)  FITCI graduates:  This year things are so slow at FITCI because so many companies got the boost they needed to fly the coop and go out on their own.  I don’t think it’s fair to ignore Akonni , SABiosciences or ImQuest, because they’ve been so successful and boast beautiful new facilities.  But keep your eyes out for HSRL, who just moved up to Thurmont into a refurbished bowling alley and IBT, who won a huge grant (but then moved to MoCo).

6)  SciFoo What an experience, being one of 200 people in the world invited to an “Unconference” at Google.  I continue to build relationships with people I met there and have a number of projects going on with members of the SciFoo campers.  For me, probably one of the most incredible and rewarding scientific ventures of my career.  I was watching some sessions of the Pacific Symposium on Biocomputing via live streams and FriendFeed.  By the way, if you’re not on FriendFeed, you need to be. It aggregates Twitter, your blogs, Reader streams etc.  and those of all your “friends”.  Just be prepared to spend several hours a day reading it.

So that was my quick wrap up of highlights of 2008, but let’s look forward to 2009.

I am aiming to make BioBeers a monthly event this year, starting this month.  I am also planning (perhaps, planning and not promising) to  have a FredCoBioBarCamp.  This is a traditional Unconfernce with no agenda other than talking about science.  We’ll meet to discuss topics on Day 1, and run sessions on Day 2.  I’ll need to find a venue/host and a sponsor for beer and food, but should be doable.  This will likely be a late summer/fall event.  I’d also like to see how much interest there would be in a FredCoBio Golf outing. I know I can get a 4-some just about any day the sun is shining, but maybe a bigger event (something like the old MdBio annual outing) would be nicer.

This year is also going to be the year of Open Science. I am already subscribed and playing around in a couple of DIYbio projects, like Gel Box 2.0 and the Cheap, hand-help PCR machine, not to mention OpenWetWare and stuff.  I am actually going to mingle with the NoVa Biotech scene tonight at an event called Cafe Scientifique in Arlington this evening.

And with so many different stories about how Biotech is going to fall flat on it’s face because of the “market crisis” or how bad 2008 was but how much worser 2009 is going to be and then how Biotech stnocks outperformed every other sector and how the federal Government continues to throw billions and billions of dollars into Ft Detrick.

Ok, to be Fair, Jason Balog stated:

The life sciences industry is no different. Although investment dollars continue to flow into the life sciences industry, the way those dollars are being invested is changing. Money that traditionally supported early stage companies is drying up as investors become more conservative and selective with their investments. The effects include daily stories about small companies downsizing, refocusing or shutting down in some instances. This is not an unusual story restricted to the life sciences industry, nor will the loss of some small companies have a current effect on the life sciences industry as a whole.

Unlike other industries, however, the life sciences industry is becoming increasingly reliant on small companies to be the future innovators, and it is feared that a significant loss of small companies in the life sciences industry now could have a profound effect on the future.

And although I agree with some of his essay, I think he underestimates the power of this region, particularlly due to reliance on federal Government funding, and how resilient we are. I don’t think there is a better place to be in than Frederick County in Biotech in 2009.

And add to that, MedImmune has recently announced plans to hire an additional 800 people in 2009, not just high paying scientific positions, but support people as well.

My only resolution this year is to stop starting new blo0gs.  I have already broken this resolution, as I joined FITCI’s own Rob Galioto in blogging the Innovative Entrepreneurs.  I can’t even spell the word, which either means I am a spell check junkie, never did well in English or maybe I just am one?

In any event, Happy 2009 Frederick County Biotech!  Pitch me a line if you want to contribute to the blog, BioBeers, FCBBC or anything else and thank you all for reading.