Better Fetch the Holy Hand Grenade: Rabbit Fever on the loose

In the film [Monty Python & the Holy Grail], King Arthur’s Knights of the Round Table are led to the Cave of Caerbannog by Tim the Enchanter, and find that they must face down both the Rabbit and the Black Beast. The Cave of Caerbannog (“caer bannog” being Welsh for “turreted castle”) is the home of the Legendary Black Beast of Aaaaarrrrrggggghhhhh. This is guarded by a monster which is initially unknown.^[4] King Arthur and his knights are led to the cave by Tim the Enchanter, and find that they must face down its guardian beast. Tim verbally paints a picture of a terrible monster with “nasty, big, pointy teeth!“, so terrifying that Sir Robin soils his armour. When the guardian appears to be an innocuous white rabbit^[5], surrounded by the bones of the fallen, Arthur and his knights no longer take it seriously. Ignoring Tim’s warnings (“a vicious streak a mile wide!“), King Arthur orders Bors to chop its head off. Bors confidently approaches it, sword drawn, and is immediately decapitated by the rabbit to the sound of a can opener. Despite their initial shock, Sir Robin soiling his armor (again), and Tim’s loud scoffing, the knights attack in force, but are driven to “run away!” as the rabbit leaps and attacks, killing Gawain and Ector. The Holy Hand Grenade of Antioch is then used to defeat the beast and allow the quest to proceed.^{[6] from Wikipedia}

All kidding aside, there is a story floating around the net.  And it’s very interesting. Via MicrobeWorld

Researcher at Army Lab Infected With Rabbit Fever

A researcher at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in Frederick, Maryland, has contracted rabbit fever—also known as tularemia, USAMRIID officials announced today. The illness is caused by the bacteria Francisella tularensis, one of several biosafety level 3 pathogens that scientists work with at USAMRIID. The researcher, a woman who was working on a project to develop a vaccine against the disease, is “recuperating at home and is responding well to antibiotics,” according to a press release issued by the institute.

Rabbits, rodents, and other animals harbor the microbe. Nearly 200 cases of tularemia in the United States are reported to the Centers for Disease Control and Prevention every year; most of them are caused by bites from ticks and flies and from handling animals infected from the disease. The illness can also be contracted by inhaling airborne bacteria in the lab.

story originally from blogs.sciencemag.org

Also, a great write up in the Frederick-News Post I did not notice.  Right under my nose.  I’ve just soiled my armor, again.

In the News

I didn’t want to scoop this story too early, but FredCoBio, and BioBeers specifically, will be featured on Jason Balog’s Biotech blog in the News-Post tomorrow. Stay tuned for the post.

I wanted to post some neat slides being shown in the Lunchroom at MedImmune for the Open House they had last weekend, but alas the slides are not for public consumption.

A couple interesting facts about the new MedImmune Frederick Manufacturing Facility: over 355,000 sq ft under roof.  It is the tallest building in Frederick at 6 stories.  The facility will make Synagis and is being built with the capacity to make other products, potentially FluMist.

FredCoBio: MIA

Geesh, I just realized that I haven’t posted in nearly a month.  So much news to catch up on I don’t know where to start.

The reason I haven’t posted is that I have been working a contract at MedImmune, aiding in the commissioning of their new Frederick facility where they will be scaling up Synagis.  It’s a wonderful product, a monoclonal antibody called  palivizumab, which protects preemies and high risk babies from lung infections.  It’s very busy here and I expect it to continue to be busy through the end of the year (at least that’s how long I think my contract will be running).  I really don’t know how much of what I see here is considered “confidential” so I’ll keep quiet.  Suffice to say, big bioreactors and 4-5 contractors for every MedImmune employee on site.

It’s kind of fun running into the other contractors all over town in different bars and restaurants.  Especially now that MedImmune has already received $453 million in contracts since May, but Frederick doesn’t have much to do with making the H1N1 vaccine.  A lot of the people here do travel to Philadelphia where that product is packaged, though.

Speaking of swine flu, I gave a talk tat the NIH last week on the Commercial uses of Stem Cells.  My focus was on the “commerce”  created specifically by Stem Cell research, staying away from the Therapeutic elements.

Check it out:

Enough shameless self promotion.

Frank from SAIC-Frederick sent me this press release, which I have not seen covered elsewhere:

FOR IMMEDIATE RELEASE

Amplimmune Enters Into Broad Alliance with NCI

Collaboration Will Focus on

Potential New Therapies for Cancer and Autoimmune Disease

FREDERICK, Md., Oct. 13, 2009 — Amplimmune, Inc., has entered into a broad agreement with the National Cancer Institute (NCI) for further advancement of two Amplimmune product candidates into therapies for cancer and autoimmune disease.

Under the Cooperative Research and Development Agreement (CRADA), Amplimmune will collaborate on multiple projects with NCI and its contractor, SAIC-Frederick Inc., under the umbrella of the NCI’s Advanced Technology Partnerships Initiative (ATPI). The goal of ATPI is to accelerate the translation of cancer and AIDS research into clinical therapies, diagnostics, and treatments. NCI-Frederick’s prime contractor, SAIC-Frederick is facilitating these partnerships for NCI.

The collaborations will focus on furthering development of Amplimmune’s AMP-110 and AMP-224 therapeutic biologic candidates. AMP-224 blocks activation of the PD-1 receptor and inhibits immune evasion typically induced by tumors or infectious disease pathogens. AMP-110 is being developed as a biologic to treat autoimmune/inflammatory disease and has been demonstrated to attenuate key inflammatory pathways that contribute to a wide range of different autoimmune diseases.

“We are very pleased to establish this broad CRADA with the National Cancer Institute,” said Michael Richman, Amplimmune’s President and CEO.  “We look forward to collaborating with investigators at NCI and feel that these collaborations will have a significant impact on accelerating development and advancing AMP-224 and AMP-110 into the clinic,” he added.

“We value the opportunity to collaborate with Amplimmune on development of their leading therapeutic biologic candidates to treat cancer and immune disorders.  This partnership reflects the true potential of NCI’s ATPI—to accelerate leading innovations into clinical application in the fight against cancer, through strategic partnerships.  We look forward to working closely with our colleagues at Amplimmune on our shared goals under the CRADA,” said David Hoekzema, SAIC-Frederick’s Vice President of Business Development.

About Amplimmune Inc.

Headquartered in Rockville, Md., Amplimmune is focused on developing novel biologics targeting key co-stimulatory/co-inhibitory molecules that rebalance the immune system and are intended for treating cancer, autoimmune disease, infectious disease, and transplantation. With its strong development focus, Amplimmune is rapidly advancing two lead molecules toward clinical development: one in the area of cancer and the other in the autoimmune disease setting. AMP-224 will be advancing into a phase 1 clinical trial for cancer in 2010. Working closely with its founders at Johns Hopkins University and other collaborators, Amplimmune is expanding its technology base in the area of immune co-stimulatory/co-inhibitory molecules and has assembled a large foundation of reagents, models, know-how, and intellectual property to further develop its product pipeline as well as to discover novel biomarkers, ligands, and receptors. For more information: www.amplimmune.com.

About SAIC-Frederick

SAIC-Frederick, Inc., a wholly owned subsidiary of Science Applications International Corporation (SAIC), a Fortune 500^® company, is the operations and technical support contractor for the National Cancer Institute’s research and development center in Frederick, Md.  This is a national laboratory dedicated to rapidly translating basic research into new technologies for diagnosing, treating, and preventing cancer and AIDS. SAIC-Frederick maintains a full suite of advanced technologies in areas such as nanotechnology, genomics and imaging; operates the federal government’s drug and vaccine manufacturing facilities; operates the high-performance Advanced Biomedical Computing Center; and supports more than 300 clinical trials for patients in the United States and around the world.

Information about the NCI’s Advanced Technology Partnerships Initiative can be found at ATPIhome.com

Contacts:  Frank Blanchard,  SAIC-Frederick, Inc.  (301) 846-1893  blanchardf@mail.nih.gov

Gary Fanger, Amplimmune Inc. (301) 309-9800  fangerg@amplimmune.com

They’ve also been awarded (SAIC-Frederick that is) $300MM in ARRA funding (the Stimulus hits Frederick County) and have heard rumors through my contacts in SAIC_Fred purchasing that the money is going to be released soon, in the form of several new hires and loads of contracts.  Stay tuned and I will try to give FredCoBio companies and inside edge.

And speaking about big money and Big SAIC-Frederick Projects, Matan recently announced they’ve secured $300MM in financing for the Riverside Park project:

Contact : Noelle Schilling

Tel   (301) 815-9980   Cell (301) 471-7552

Email nschilling@mataninc.com

Matan Companies Teams with Federal Capital Partners to Finance The National Cancer Institute At Riverside Research Park in Frederick Maryland

(September 30, 2009-Frederick, MD) The Matan Companies has teamed up with Federal Capital Partners (FCP) to complete the financing for the development of the National Cancer Institute’s 330,000 square foot Advanced Technology Research Facility (ATRF) at Riverside Research Park in Frederick Maryland.  The state-of-the art 200 million dollar office and laboratory facility will commence construction immediately and is slated for delivery in mid 2011.    As part of the larger 177 acre Riverside Research Park, the National Cancer Institute’s 62 acre campus will have expansion capacity for another 570,000 square feet, reserved for life-science and advanced technology partner organizations.  “This site will be the center of an intensive new effort to bring together government, industry, academic, and nonprofit partners, working side-by-side, utilizing technological resources second to none, to more rapidly translate our latest genetic and molecular discoveries about cancer into effective new treatments that benefit patients,” said John E. Niederhuber, M.D., director of the National Cancer Institute.   With SAIC-Frederick, Inc. as its prime contractor, the new facility will be the only Federally Funded Research and Development Center (FFRDC) in the country focused exclusively on biomedical research and development, and concerted technology and R&D partnership efforts toward reducing the burden of cancer.

Matan and FCP partnered to secure the 52 million dollar construction financing from Wells Fargo Bank and US Bank.  “Today’s financing environment demands creative approaches to bring large, high profile projects like this to the market.  The ATRF is one of the largest private biotech developments in the country to secure construction financing and it is a credit to everyone involved,” stated Mark Matan, Principal of the Matan Companies.   Matan Companies will develop and manage the project.

“We are incredibly excited to have formed this partnership with the Matan Companies to bring this very important project to fruition,” said Esko Korhonen, Managing Partner of FCP.  “The diligent work by our teams resulted in consummating a great financing package and we appreciated the opportunity to work with Wells Fargo, US Bank, Jones Lang LaSalle and Cassidy & Pinkard to get this deal completed.”

Cassidy and Pinkard helped to secure the equity and debt for this transaction and Jones Lang LaSalle represented the Tenant.

About Riverside Research Park

Riverside Research Park is the first biomedical research and development park of its kind in Frederick Maryland.  The 177 acre site has all necessary infrastructure and utilities in place and is ready to build.  Riverside delivered its first tenant in the Spring of 2008, a 54,000 sf facility for Charles River Labs.   Riverside can accommodate up to 1.8 million square feet of lab, R &D, and office space.    “Frederick has a vibrant biotech community servicing NIH, the National Cancer Institute and Fort Detrick, but until now there hasn’t been a destination for these companies to come together in a collaborative campus type environment in this market.   Riverside Research Park provides just that and there has been a very high level of interest from companies looking to co-locate with the National Cancer Institute” said J.P. Matan, Director of Leasing for Matan Companies.   Located within the city limits of Frederick and less than three miles from the main gates of Fort Detrick,  Riverside is uniquely positioned to provide private sector companies, government agencies, and universities a secure and collaborative work environment. Abundant green space, water features, walk/jogging trails, courtyards, and chance meeting spaces will all add to the collaborative work environment and campus like feel of Riverside Research Park.    For more information please visit: www.riversideresearchpark.com

About Federal Capital Partners

Founded in 1999 by partners Esko L. Korhonen and Lacy I. Rice, Federal Capital Partners (FCP) is a real estate investment and development company headquartered in Washington DC.  Other partners include Alex Marshall and Tom Carr, former Chairman and CEO of CarrAmerica Realty Corp. who joined FCP as a partner in early 2007.  Since its inception, FCP has acquired more than $1.2 billion of real estate assets consisting of multi-family, office, retail and industrial assets.  In 2008 FCP raised a 240 million dollar co-mingled, private equity fund which it is currently investing in multiple product sectors in the Mid Atlantic region.  FCP has established a strong reputation in the greater Washington DC metropolitan area real estate markets as an investor with a keen eye for indentifying unexploited markets and product sectors.

About Matan Companies

Headquartered in Frederick Maryland for over 30 years, Matan Companies is one of the regions premier commercial real estate and development firms.   Founded on the principle of providing a comprehensive, full-service approach to all disciplines involved in commercial real estate, Matan has assembled an in-house professional staff with a proven track record in the disciplines of asset management, investment sales, debt placement, property management, leasing, development and construction.  Matan’s knowledge of the local market and established history, including certainty of closing, expeditious due diligence and timely settlement dates, sets the company apart from the competition.  This full service approach gives Matan the ability to control every phase of the real estate investment process.  Matan’s primary geographic focus is Frederick, Maryland and the I-270 Corridor.  Matan’s current portfolio consists of over 3.2 million square feet in 30 buildings with an additional 3 million square feet in the development pipeline.

About NCI-Frederick and SAIC-F

With SAIC-Frederick (SAIC-F) as its prime contractor, NCI-Frederick, is home to a cadre of researchers studying cancer and HIV/AIDS and is host to NCI’s Advanced Technology Program, which encompasses nanotechnology, high-performance computing, genomics, and biomedical imaging, among other areas.  SAIC-F, a wholly owned subsidiary of Science Applications International Corporation (SAIC), a Fortune 500^® company (NYSE: SAI) – is the operations and technical support contractor for the National Cancer Institute’s research and development center in Frederick, Md.  This is a national laboratory dedicated to rapidly translating basic research into new technologies for diagnosing, treating, and preventing cancer and AIDS. SAIC-Frederick maintains a full suite of advanced technologies in areas such as nanotechnology, genomics and imaging; operates the federal government’s only drug and vaccine manufacturing facilities; operates the high-performance Advanced Biomedical Computing Center; and supports more than 300 clinical trials for patients in the United States and around the world.    “The NCI has identified an urgent need to convert basic research findings into effective cancer treatments that can be delivered to patients right away,” said Larry O. Arthur, Ph.D., president of SAIC-Frederick. “The consolidation of our operations into modern facilities will enable us to do just that, with the specific goal of shortening timelines, reducing costs, and increasing productivity—all of which will benefit cancer patients and people at risk for cancer.”  More information about the NCI’s Advanced Technology Partnerships Initiative (ATPI) can be found at www.atpihome.com.

NCI at Riverside Research Park Building Rendering:  https://www.box.net/shared/static/r2a6uoimhs.tif

Additional Contacts:

Esko Korhonen                                    Frank Blanchard                                 Joe Carter

Federal Capital Partners                     SAIC-F                                                  Wells Fargo

202-386-7160                                      301-846-1893                                      202-303-3016

esko@fcpdc.com Blanchard@mail.nih.gov carterjl@wellsfargo.com

Jeff Jacobson                                       Paul Collins                                           Pete Briskman

US Bank                                                Cassidy & Pinkard                              Jones Lang LaSalle

703-442-5482                                      202-463-2100                                      301-214-1144

Jeffrey.jacobson@usbank.com pcollins@cassidypinkard.com Pete.Briskman@am.jll.com

I actually could’ve broken this story before the press release, but I was busy and didn’t want to annoy one of my bestest BioBeers sponsors.  But do check out the new Riverside Park web site.  It’s awesome.

And speaking about more rumors, sadly, this one is NOT a rumor. Marilgen, in my home town of Ijamsville (just a mile or so north of the MoCo line), was acquired by Origene. My sources tell me that the few employees left at Marilgen have been offered positions at OriGene and will be relocated to Rockville (boo, hiss).  Marilgen has been struggling for a year or so since one of their primary investors decided to pull their cash out.  I have a lot of personal ties to Marligen, since most of the people there, in their hayday, were former LTI colleagues of mine and half of the Vialing depertment I used to run at LTI. Sherry Challberg hired me in 1988 and moved me to Maryland, for which I am eternally grateful.

This makes me think that it’s already time to schedule the next BioBeers.  I think I’ll make a new post with a poll on which day of the week to have the next one.  I’ve been trying to rotate it around because everyone has different schedules.

FredCoBio and the Immaculate Confection

This may be a bit of a stretch to link Mary Spiro’s piece, “Gummi guts: artist Jason Freeny bestows rubbery confection with internal organs“ in the Baltimore Examiner with FredCoBio, but here’s the catch:  The artist is from Middletown and it’s biotech, geeky stuff.  Also, really cool stuff.

"Immaculate Confection" by Jason Freeney via Baltimore Examiner

There are a number of cool images on Jason’s web site MoistProuctions, and a neat slide show on Mary’s Baltimore Examiner piece as well as an interview.  Although he’s in Manhattan now, you can find more of the former FredCo resident on his blog and his Facebook Page:  Gummi Fetus.

All this talk almost makes me want to comment on the recent banter spewed forth by the RTLifer’s about one of our largest Biotech companies, but instead I’ll ask you to enjoy this YouTube video of a Gummi Bear (fetus)being destroyed for the sake of science (via joannelovesscience.com)

By the way, you trolls, if you’re so committed to your mission, why not take a pledge to never use a single product that was developed using Stem Cells?  Same thing to those trolls destroying Pharma Execs (and at one point in time threatening me and my family) claiming to be Aminal Rights Activists:  Don’t use any drugs or products that used Aminaml Testing?  Why not?  It would be the right things to do.

On another note, I saw an interesting article in the FNP yesterday that Emergent Biosolutions is pulling out of Frederick.  This caught me by surprise because I didn’t even know they were in Frederick.  According to their Press Room, they’ve owned these buildings since 2004, but never renovated or improved them.  Building in Gaithersburg instead.  OK, you win some and you lose some.  I thought I heard somewhere that they won a contract fo9r H1N1 vaccine, but I may be mistaken.

I somehow missed Balog’s Biotech “Battle over biosimilars” last Sunday in the FNP.  Personally, I think giving the “biosimilars” more protection, mimimizing the competition will have the opposite effect of putting new products on the shelf faster.  It will stop competition dead in it’s tracks at the expense of the people needing these new therapies and ultimately, more people will die.  The US Patent System is broken and archane and needs to be overhauled thrown out the window.

I would also be remiss if I didn’t mention a write up in FNP last week about MedImmune.  The new facility is on schedule to open in 2011.  I also learned, informally, that Synagis will be the first product produced there, but the plans are to move to more “flexible” manufacturing to permit other uses in the future.

Phot by Sam Yu via Frederick News Post

I will be making a guest appearance at the Frederick County Workforce Service’s Center at noon on Wednesday 8/12 for a “Lunch-n-Learn”.  If you’re looking for work, then I might suggest you attend.  You may not “learn” anything, but it’s all about the networking.  I know I have been through the Center more than once in the past 9 years.  I think it’s the least I can do to return the favor.

And speaking of networking, I am working on the next BioBeers with a target date of Thursday 8/27.   Pencil it in.  We can discuss fetal Gummi bear stem cell research…

Breaking News: MedImmune Wins the Swine Flu Lottery

There is scant information in the press release from FierceBiotech, but the news is good, if not predictable:

MedImmune has received a $90 million order from the U.S. government for a live attenuated vaccine that can be used against the H1N1 outbreak. The vaccine developer says this could be the first of many new orders for a swine flu jab. And the company, the biotech arm of AstraZeneca, says it will begin shipping the first of 10 million doses of its seasonal flu vaccine in August.

I haven’t been blogging about the Swine Flu “pandemic”, but I was pretty sure MedImmune would be the first in line with bids in to nab a development contract..

Oh, it’s made the Washington Post now, too:

Under the deal with HHS, MedImmune will continue to make its seasonal flu vaccine, but will now also develop a vaccine targeted specifically at the H1N1 virus that has caused World Health Officials to raise the pandemic alert level to the fifth of six stages.

The WaPo article is a bit more complete, but I think it’s funny how you look at things depending upon your perspective.  WaPo says “Gaithersburg based”  MedImmune won the contract, whilst Reuters more accurately states “AstraZeneca gets $90 million US flu vaccine order.”   In any event, the R&D (which is the major reason for the grant money) will likely be spent in Rockville, but they should be making the vaccine in the new Frederick facility.  Good news!

Also good news and good reads, in the Frederick News-Post yesterday:  Balog’s Biotech — Postcard from BIO

Opportunities Abound!

A couple of quick notes as I procrastinate finilizing Grant application and cell culture duties.

Some really cool news from International Stem Cells came out yesterday.  From their web site:

WEDNESDAY, MAY 27, 2009

International Stem Cell Corporation Reports Positive Pre-Clinical Trial Results From Human Corneal Epithelial Cells

International Stem Cell Corporation (OTCBB:ISCO), the first company to perfect a method of creating human “parthenogenetic” stem cells from unfertilized eggs, has received positive early results from animal trials designed to improve photorefractive keratectomy (PRK), a form of corrective laser eye surgery that offers an improved alternative to LASIK.

PRK is generally thought to be safer and produce better long-term results than LASIK, but has not been used as frequently because of patient discomfort following surgery and a longer healing time. By combining ISCO’s human corneal cells with a proprietary surgical device developed by Paul H. Chen, M.D., who is conducting the trials, ISCO and Dr. Chen believe that cellular enhanced PRK can replace LASIK for many of the hundreds of thousands of patients who now use LASIK.

The first stage animal trials just completed demonstrated that ISCO’s corneal cells manufactured by ISCO’s subsidiary, Lifeline Cell Technology, encouraged corneal-defect healing in the animals. The trials are the first step toward gaining Food and Drug Administration (FDA) approval to test the efficacy of using ISCO’s cells to improve healing after corneal surgery, and could result in the first FDA approved use of human cells produced by ISCO.

Jeffrey Janus, President of ISCO and CEO of Lifeline, noted that “The cells used in these trials are derived from donated human tissue processed using proprietary techniques devised by ISCO’s subsidiary, Lifeline Cell Technology. However, ISCO’s parthenogenic stem cells can also produce human corneal cells. Corneal cells derived from ISCO’s parthenogenetic stem cells may provide a consistent and reliable source of corneal cells that could eliminate entirely the need for donated human tissues.”

This work is being done in collaboration with Dr. Chen, who has developed the cell transfer technology. Dr. Chen is an eye surgeon at North County Laser Eye Associates, and he is on staff at Scripps Memorial La Jolla and Scripps Encinitas Hospitals.

For more news and information on International Stem Cell Corporation please visit http://www.IRGnews.com/coi/ISCO where you can find the CEO’s video, a fact sheet on the company, investor presentations, and more

Maybe those of you who aren’t in the Biotech field don’t know how important it is to have “preclinical” data, which allows you to apply to the FDA for permission to run clinical trials. Your preclinical data had better be air tight and good.  Of course, the material was made by LifeLine in Walkersville, so it must be good. And for the sake of full disclosure and shameless self promotion, I am providing processed tissues for some other things that LifeLine is doing and I want them to do well.  Rumor has it they’ve installed additional, temporary space.  So all you people that I have telling to pay attention to little LLCT and ISCO, pay attention.

In other news, I was “tipped off” that a new RFP was posted on the SAIC-Frederick web site.  This is a pretty big one, but you’re going to need animal facilities. You can find the whole SOW and all the required documents  HERE, but this is the meat of it:

Solicitation No. S09-159  GLP Safety Testing of Vaccines Developed by Vaccine Research Center (VRC) Manufactured for Clinical Trial Use

Due date June 30, 2009

Perform GLP safety studies suitable for submission to the FDA for support of an IND application.

o Confirm AAALAC accreditation prior to initiating the study

o Work with the VRC to develop and finalize protocols. The VRC and the Subcontractor will sign off on the protocol and retain a copy

o Purchase and quarantine of suitable animals as specified in the protocol

o Housing of animals (1 animal per cage), test animals and control animals in separate rooms

o Administer injections of vaccine as directed in study protocol

o With VRC’s help, acquire and become trained to use Biojector and any other specialized injection devices

o Provide clinical evaluation and assess other measurements of health as specified in the protocol

o Euthanize animals and perform a gross necropsy in accordance with study protocol

o Collect blood and tissue from animals; send aliquot of blood to VRC for immune analysis and send tissues for other analysis as directed by VRC

o Run clinical chemistry and hematology tests as specified in protocol

o Run biodistribution studies as specified in protocol

o Analyze histopathology of preserved tissues as specified in the protocol

o Perform statistical analyses of test results and provide updated historical data for gender-matched unimmunized or placebo-controlled animals for comparison as specified by the protocol

o Audit test results

o As appropriate, investigate deviations of the protocol, procedures, or unexpected test results (e.g. moribund or found-dead animals) and report such investigations to VRC staff in a timely fashion.

o Provide unaudited interim, unaudited, and audited, signed final report as indicated in the protocol

• Interim clinical observations and measurements via email on a bi-weekly basis as indicated in the protocol. Interim (“unaudited”) report transmitted electronically to Project Coordinator and the VRC Project Lead (contact information listed below)

• Final report – One hard copy of this report can be sent to the VRC Project Lead and an electronic pdf version can be provided to Project Coordinator.

I hope they get as many interested parties as the last request, but haveing GLP animal facilities may make it tough.

Inside the BSL4 facility at NBACC: Popular Science and Social Media

I was tipped off on twitter by BioBeers nube @SusanF826 about an article running in Popular Mechanics showing off the insides of the new BL4 facility at NBACC.  Those of you already following me either on FriendFeed or Twitter, this is already old news.  But for those not so early adapters, I think you’ll find it interesting (if you haven’t figured out how to go directly to the link via the hyperlink I inserted above).  The Abstract is rather sensational, but the rest of the article is quite informative.

Left: The air-lock entrance to the lab’s hot zone. Right: A biohazard suit protects Peter Jahrling, chief virus hunter at the Integrated Research Facility in Fort Detrick,

Virus Hunters: Inside Maryland’s New Biosafety Level 4 Lab

The swine flu has killed more than a hundred people in Mexico with reports of at least 40 infections in the United States. Could the flu cause a pandemic? Health researchers don’t think so now, but the Center for Disease Control still suggests Americans take precautions by washing hands, covering coughs and staying home if taken ill. Behind closed doors, the NIH continues to study dangerous diseases of all varieties, preparing to stop the next outbreak before it begins. PM got an early inside look at American’s newest infectious disease research laboratory, to see how scientists study the world’s deadliest pathogens.

Rather odd that they’ve tied the H1N1 “pandemic” on this project, as there is no connection what so ever (unless you believe this drivel).  Although there are cooperative arrangements between USAMRIID, NIAID and the CDC, there is not “swine flu” research going on in this facility.  But of course, the consipracy theorists will continue to insists this facility will be the demise of mankind and not play a role in saving it.

Catching Up

I’ve been busy in the lab the past couple days and haven’t had a chance to update an number of interesting stories I’ve stumbled across.  First things first.  you all need to be reprimanded for being Web 2.0 phobic.  Thus far, only 6 people have signed up on the FredCoBio Google Group.  Shame on you.  What are you waiting for, Christmas? Sign up here by selecting the “Join This Group” mouse over in the right column.  In all fairness, this is partially my fault since I didn’t have things set up correctly in the first announcement.

Now on to some interesting news.  As reported in the Frederick News Post, in the Gazette and then picked up by a number of other News feeds, Life Technologies won a $250,000 from the Governator and will be adding at least another 50 jobs in Frederick.  this at a time when Osiris is paring back in Columbia and other non-bio groups are laying off in Frederick.  I am so glad to see Life Tech is getting everything back on track.

In a very significant report I was reading this morning, Qiagen (HQ in the EU with facilities in MoCo) has come out with a $5 HPV test that will likely save millions of lives in the developing world. This effort was funded, in part, by the Bill & Melinda Gates foundation.  I know this is directly FredCoBio, but only the most dedicated reader will recall that the first generation of this HPV test is what brought yours truly to the Free State.  The Old Molecular Diagnostics Division of Life Technologies chaperoned the HPV test through FDA approval and I am proud to have participated in the effort.  unfortunately, this was in 1989 and it’s taken nearly 20 years for this test to find a significant market for growth and the good science to back it up.  There are even some who believe this was the first DNA diagnostic test approved by the FDA and most of it was done by Frederick Countians.  We knew 20 years ago this test would eventually replace the Pap smear and this may finally be the straw that breaks the Pap smears speculum.

In other interesting news, the NCI has announced Priorities for Stimulus money spending over the next couple of years.  It is not specifically stated in the article, but these priorities are certain to shape the way the new NCI-Frederick at Riverside Park is going to be deployed and I can’t wait to see the results.

And finally, an interesting publication from NCI-Frederick in the April 7th issue of the journal Cancer Cell.  NCI-Frederick researchers, working with a team from the university of Maryland show that expression of RNF6 was increased in human prostate cancer tissues that do not respond to androgen ablation and is required for prostate tumor growth under androgen depleted conditions.  In plain English, this may result in a significant breakthrough i the treatment of advanced prostate cancer.

More Positive ImQuest Results

In a PR Newswire release, ImQuest is coming forth with more data on their original anti-HIV microbicide and a new topical cream.  The data on their lead candidate, IQP-0410, lead to the safe daily dosing of the compound.  From the release:

The highly attractive safety profile, ability of the compound to positively interact in combination with other HIV drugs, and the high intrinsic genetic barrier to resistance of the clinical candidate, was emphasized in these presentations. ImQuest, in collaboration with their drug development partner Samjin Pharmaceutical Co. Ltd of Seoul, Korea, have recently engaged in an effort to develop more active pyrimidinediones possessing this higher genetic barrier to resistance. It is believed that these compounds will prolong the therapeutic utility of the pyrimidinediones by preventing HIV from easily evading the action of the drug and will allow ImQuest to develop even more potent HIV inhibitors following the entry of IQP-0410 to Phase 1 human clinical trials in early 2009.

General 2, 4 (1H,3H)-Pyrimidinedione Structure

Interestingly, the mechanism of action of these compounds seems to be both an inhibition of viral reverse transcriptase and inhibition of viral attachment by binding some cell surface “conformational marker”, as shown in THIS POSTER (warning PDF).

This is also the first time I recall reading about their topical cream, IQP-0528.  This is a vaginally applied topical used “as both a gel and an intravaginal ring product in combination with other highly active microbicide products” to block transmission of HIV.

Great work, guys!

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…..