The Big Red Biotech Blog

Stem Cell Suit Effects May be Felt for Years

Here's an interesting post/commentary from Nature News on the aftermath of the suit that sought to prevent the NIH from funding embryonic stem cell work.  Even though for now, the court seems to have made it very clear that NIH can fund embryonic stem cells science -- the damage may have been done. The temporary injunction and resulting legal turmoil caused some scientists to leave the field permanently.

"Things have changed permanently. It's not just going to go back to the way it was — not immediately," says Meri Firpo, who researches stem-cell therapies at the University of Minnesota Stem Cell Institute in Minneapolis. 

Candace Kerr, a stem-cell scientist at the Institute for Cell Engineering at Johns Hopkins University had NIH funding for human embryonic stem-cell work at the time of the shutdown, but has since moved entirely to work with induced pluripotent stem cells. She has no plans for future studies on human embryonic stem cells. "The shock of what happened last year, coming out of nowhere, makes us really sceptical about moving forward," says Kerr.

Scepticism appears to be a rational response. Three presidential administrations had interpreted the Dickey-Wicker amendment to permit funding for research on lines of human embryonic stem cells, but not for the creation of such lines, which requires destruction of embryos. In 2001, President Bush restricted the funding to research involving a small number of existing lines. President Obama, lifted this restriction in 2009, prompting the approval of dozens of new stem-cell lines.  Then the suit by opponents of the research which resulted in a temporary stoppage of work pending resolution of the legal issues.

Last week, constrained by the appeals-court decision, the orignal trial Judge Lamberth rejected the plaintiff's lawsuit. His written opinion attacked all of the plaintiffs' key arguments, finding that the Dickey–Wicker amendment's wording is "ambiguous" and that the NIH's interpretation that it allows funding of human embryonic stem-cell research is "reasonable". 

Nonetheless, human embryonic stem-cell research remains vulnerable. The current US Congress is so politically divided it is unlikely to enact a law either explicitly permitting or explicitly prohibiting government funding for the research. And, nothing in this decision and nothing in the Dickey–Wicker amendment stops a new president from quashing research simply by refusing to fund it.

There you have it: a victory for proponents of embryonic stem cell research.  Or is it?  With the continued environment of uncertainty, will enough researchers commit to developing the field's potential — or will they be put off by the lawsuit's lingering shadow?  That's the lingering question.

Posted by Bruce Lehr Aug 2nd 2011.

Stem Cell Suit Over -- For Now

The U.S. District Court for the District of Columbia Chief Judge Royce Lamberth agreed with the with the appeals court’s finding that NIH can interpret Dickey-Wicker to allow funding for research on human embryonic stem cells but not on their derivation because the definition of “research” in the law is ambiguous.

So for now, the suit contesting NIH funding of embryonic stem cell research is out.

PharmTech Talk » Stem Cell Suit Tossed.

Stem cell researchers, their supporters in and out of the science community, and patient advocacy groups are all letting out a sigh of relief. Stephanie Sutter, Assistant to the President and Deputy Senior Advisor, posted yesterday in her blog “For too long, patients and families have suffered from debilitating, incurable diseases and we know that stem cell research offers hope to millions of Americans across the country. President Obama is committed to supporting responsible stem cell research and today’s ruling was another step in the right direction.”

This does not prevent another appeal by plaintiffs.  Ain't the legal system grand?  We may not have heard the end of this for awhile.  Of course, if we do not pass a Federal budget, the NIH may not be funding anything.

Posted by Bruce Lehr July 29th 2011.

Shire Buys Advanced BioHealing for $750M

Shire announced that it will acquire Advanced BioHealing for $750 M to gain access to its Dermagraft skin-substitute as a means of establishing a foothold in regenerative medicine.  Dermagraft had sales of $146 million in 2010 as a treatment for repair of diabetic foot ulcers.

GEN :Shire Buys Advanced BioHealing for $750M as Foundation for Regen-Med Business.

Shire has designs to expand its presence in regenerative medicine in addition to its play in rare genetic diseases.  It believes that it can establish additional indications for Dermagraft as well as improve on its sales in existing and emerging markets. Shire also indicated that it will likely acquire additiona regenerative medicine assets going forward.  Shire will expand the existing advanced BioHealing manufacturing facility in La Jolla, CA.

  

Posted by Bruce Lehr May 18th 2011.

Shire Finds Big Value in Rare Diseases

Here's a good piece on Shire's strategy to focus on rare and orphan diseases.  It recounts the company's success and also points out perceived opportunities in the future. For example, Shire has expressed an interest in seeking out properties in gene therapy and stem cell areas for possible future investment.  It is also seeking additional treatment applicatins for its existing drugs.

Shire Finds Big Value in Rare Diseases, and a Strong Growth Path for its Boston Unit.

Shire's CEO Angus Russell seem well aware that other bigger players are beginning to eye the rare disease area too but feels confident in Shire's ability to add value.  Shire is projecting "mid-teens growth" through 2015.  Why not? With successful drugs like Elaprase for Hunter Syndrome, Vpriv for Gaucher's Disease and Replagel for Fabry's Disease.  The latter two have received a big sales boost due to Genzyme's manufacturing issues with its two drugs.  These drugs now represent 30% of Shire's porfolio sales -- up from 4% in 2005.

 As Russell notes, the world is more holistic now, and factoring in payers, more informed patients, and policy makers looking to reduce costs, "We're seeing the shrinking of that mass marketing [drug] model."

 

Posted by Bruce Lehr May 12th 2011.

Organogenesis Facility Signals Regenerative Medicine Progress

Organogenesis broke ground on the construction of the world's largest automated living cell manufacturing plant in Canton, MA.  A facility that the company says will allow it to leverage its leadership in the regenerative medicine field and allow it to attract resources and jobs over the next decade.

Organogenesis breaks ground on state-of-the-art facility.

I was interested in this announcement as the facility to me represents tanglible evidence that regenerative medicine is moving toward commercialization and actually requires larger scale, automated manufacturing to make product.  Sometimes fields move faster than I give them credit.

Posted by Bruce Lehr April 19th 2011.  

Stem Cell Case Back with Appeals Court

The WSJ reports that rival players are back in the appellate courts to contest Judge Royce Lamberth's August ruling that federally funded stem cell research was illegal.  The lawyer for the two scientists filing the suit argued two points:

• Federal grants to fund stem cell research induce the private sector to create more stem cells (and thus destroy more embryos).
• The two scientists, who work with adult stem cells, are harmed because the presence of embryonic stem cell funding means less for their field

Goverment lawyers contended that Congress intended to make a distinction between promoting the study of stem cells and the creation of stem cells - effectively the government supports the former and not the latter. Judge Thomas Griffith says the goverment's cases "rises or falls" with that distinction and questioned whether the two were intertwined.

Right now, it is not obvious which way the panel of three judges is leaning and the case can be expected to go on for some time.

 
Posted by Bruce Lehr December 7th 2010.

   

Last Brief Filed in Stem Cell Lawsuit

The government's appeal of a 23 August preliminary injunction that briefly shut down stem cell research has been submitted.  Government lawyers argue once again that U.S. District Court Judge Royce Lamberth's ruling was erroneously based on the conclusion that the NIH guidelines for hESC research violate a law barring federally funded research that harms embryos.

Last Brief Filed in Stem Cell Lawsuit - ScienceInsider.

The appeals court has set 6 December for oral arguments.

 

 

 

 

 

Posted by Bruce Lehr November 9th 2010.

Wanna Learn More About Stem Cell Patent Landscape?

If you are interested in learning more about the patent environment surrounding stem cells and in particular induced pluripotent stem cells, I got the webinar for you. 

As related in the Patent Doc blog, Sunlight Research will be offering a webinar entitled "How Are iPSCs Changing the Stem Cell Patent Landscape?" on October 6, 2010 from 12:00 - 12:50 PM (EST).  Dr. Robin Chadwick of Schwegman, Lundberg & Woessner, P.A. will provide insight into the induced pluripotent stem cell (iPSC) patent activities of leading stem cell business and research institutions, illuminating potential commercialization obstacles and co-development opportunities.

The registration fee for the webinar is $147 (single viewer), $197 (2-5 viewers), or $447 (6-20 viewers).  Those interested in registering for the webinar, can do so here.

Posted by Bruce Lehr October 2nd 2010.

hESC Research Gets Stay from Federal Appeals Court

According to the WSJ, a federal appeals court said Tuesday the Obama administration can continue to fund embryonic stem-cell research, reversing for the time being a trial judge's injunction barring the funding.

The one-page order by a three-judge panel of the U.S Court of Appeals for the District of Columbia Circuit said the administration met the legal standard for a stay of the injunction, but didn't discuss the case in detail.

So, hESC cell funding gets a reprieve while the case wends its way further through the court system

Posted by Bruce Lehr September 28th 2010.

Judges Keep Poker-face in Stem Cell Research Ban Appeal

The Federal appeal court of Judges Thomas Griffith, Brett Kavanaugh, and Judith Rogers heard oral arguments from the government lawyer, Beth Brinkmann and plaintiff lawyer, Thomas Hungar, representing the two adult stem cell researchers who brought suit.

Judges Ask Tough Questions of Both Sides in Appeal of Stem Cell Research Ban - ScienceInsider.

The Judges drilled government lawyers on questions as to what real harm hESC researchers would experience if they had to hold research while case decided, and why derivation of stem cells was 'not ok' to be funded by NIH but hESC research using these cells was 'ok'. 

Conversely, the Judges also pointed out to Hungar that the Dickey-Wicker amendment was passed with embryo research in mind and not hESC work. They also noted that the NIH had consistently made the distinction that it would NOT fund stem cell derivation work.

Observers indicated that the Judges seemed well informed on the issues.  They were unsure which way the panel was leaning.  A decision is expected this week as to whether a stay of Judge Lambert's original ruling will remain in place or be lifted - continued research while case is being litigated further or stoppage.

Posted by Bruce Lehr September 28th 2010.

 

Senate Panel: We're from Gov't. We're here to help Stem Cells!

As covered in ScienceInsider blog, the Senate has convened a panel to discuss its response to Judge Lambeth's ruling last month that government funds cannot be used at all for human embryonic stem cell research as this would be in violation of the Dickey-Wicker Amendment.

Senate Panel Weighs In on Threat to Stem Cell Research - ScienceInsider.

Democratic Senate heavy-weights like Tom Harkin (IA) and Arlen Specter (PA), proponents of the research, indicate they are looking at introducing laws that would permanently reverse the effect of the Judge's ruling and restore certainty to the field (in terms of funding anyway).

Senator Arlen Specter (D–PA), a longtime champion of stem cell research who introduced a bill to make hESC research legal on Monday, warned that the outcome of the legal process "is very, very uncertain." He added that Congress "had better get busy."

Posted by Bruce Lehr September 19th 2010.

NIH Rushes to Fill Stem Cell Grants During Stay

Strike while the iron is HOT!

The NIH is hurrying to pass out research grants for hESC work following the DC circuit court's ruling yesterday.  The appeals court granted a temporary stay until September 20th.  After that, all bets are off as to the status of stem cell work until the next ruling.

NIH Rushes to Hand Out Stem Cell Grants During Temporary Stay - ScienceInsider.

In the meantime, Sally Rockey, extramural research chief, alerted NIH Insitutes that "hESC awards should be given priority including non-competing continuations, and new and renewing competing awards."  The NIH hopes to renew 24 ongoing grants and could fund 20 additional new awards that had passed peer review.  The NIH also reactivated in-house research - although cautioned staff to use appropriate stewardship given the temporary stay window. 

On September 20th, the stay may be lifted and embryonic stem cell research could be suspended again pending the outcome of the case.

Posted by Bruce Lehr September 10th 2010.

DOJ Singles in Appeal: Stem Cell Ban 1 Stem Cell Funding 1 in 2nd

The WSJ reports that the Department of Justice has convinced an appeals court that the ban on funding human embryonic stem cell research is stayed pending the next round of deliberations - which could be as short as 10 days.

The US Court of Appeals  for the DC circuit has issued a stay of Judge Lamberth's ruling from last month which determined that the Obama administrations funding of embryonic stem cell research violated a 1996 law (previously violated by extension since its passage by both the Bush and Clinton administrations).

The latest ruling - in what only can be expected to be a vigorous back n' forth - gives both sides a chance to file written arguments prior to September 20th.  Then it is possible that the ban may go back into effect if the DOJ loses that inning.

Posted by Bruce Lehr September 9th 2010

 

Big Pharma Ventures Back iPierian IPSCs for Drug Discovery

The venture capital groups from both GSK and Biogen Idec have provided cash to iPierian - $28 M in cash to be exact.  At present, the funding is strictly as an investment.  Neither venture group is involved in a broader development deal.

iPierian is workng to establish induced pluripotent stem cells (IPSCs) as a drug discovery and testing model.  One Big Pharma can use to test a variety of drugs against differing cell types in vitro. Pluripotent stem cells derive from adult sources and iPierian uses no embryonic stem cells in its work. This type of experimental system should be more resistant to the changes in political winds that embryonic stem cell works suffers from. See Xconomy.

iPierian is still seeking a Big Pharma partner(s) to help it further develop the IPSC system for routine use in drug discovery.

Posted by Bruce Lehr September 8th 2010.

ARVO Opposes Stem Cell Injunction - Backs F. Collins Vision

The Association for Research in Vision and Ophthamology (ARVO), the world's largest international association of eye and vision scientists, released as statement opposing the Federal Court injunction on embryonic stem cell work.

Sight-saving research halted by stem cell ruling.

The statement disputes Judge Lamberth's contention that his ruling would "not seriously harm hESC researchers because the injunction would simply preserve the status quo..."  ARVO members state that their research has already been disrupted as they have been forced to separate infrastructure, equipment and personnel funded by Federal Agencies from those funded by private sources.  The NIH announced earlier this week that it was shutting down all its intramural hESC projects.  Sounds like an effect, does it not?

ARVO states that liberal stem cell policies work in the favor of its members in Australia, Belgium, China, India, Israel, Japan, South Korea, Sweden and the United Kingdom. Members in the United States, Austria, Germany, Ireland, Italy, Norway, and Poland labor under more restrictive policies.

ARVO generally supports Francis Collins, NIH Director, statement that the US will be put at a scientific disadvantage under the injunction that threatens to stop all progress in the field and its future promise.

Posted by Bruce Lehr September 2nd 2010.

Shirley&Deisher - 1 NIH Stem Cell Funding - 0 after 1st inning

The WSJ gives a more in depth profile of the two researchers who brought suit against government funding policies for embryonic stem cell research. Neither knew each other and each was recruited by legal groups seeking to challenge the funding policy.  In reading the article, both seem to be sincere in their opposition but also have activist pasts - so not strangers to controversy.

Both would appear to have a bit of an axe to grind as they work in adult stem cell areas.  The feel that they get short shrift when it comes to government funding, as from their perspective embryonic stem cell work gets favored treatment from government programs.  Having said that, Deisher has never applied for Federal funding and that would seem to weaken any argument that she is passed over or disadvantaged in some way.

Looks like the case will now be picked up by the Obama adminstration on appeal with thoughts of achieving at least a stay until a more permanent ruling is reached.  The political sphere will now also become more involved with members of Congress who oppose the ruling, perhaps looking to pass a law that will effectively nullify Judge Royce Lamberth's ruling.  Drs. Sherley and Deisher will also start their tour of Capitol Hill to garner support for their position.

This is only the beginning of this ballgame I'm sure. Lawyers and law makers are up in the bullpen.

 

 

 

Posted by Bruce Lehr September 2nd 2010.

Will the Stem Cell Ruling Affect Venture Capital Investing?

Here's a piece from Brad Webb, partner at Claremont Creek Ventures, published in Xonomy today. He opines that the recent anti-stem cell ruling (currently being appealed by Obama administration) will have a negative effect on venture capital flowing into stem cell biotechs.

Will the Stem Cell Ruling Affect Venture Capital Investing?.

Yesterday, even the NIH shut down its stem cell funding for internal programs while this situation is being sorted out legally.  This type of political/regulatory back and forth results in strong investor uncertainty. This is not a good thing for continued investment.  It can't help but have a dampening effect.

Posted by Bruce Lehr September 1st 2010.

Where are the cures?

Follow the link to Derek Low's In the Pipeline for a blog post of the same title today.  In it, he highlights the balance that needs to be struck in reporting progress with difficult diseases like Parkinson's, Alzheimer's, etc and reporting that cures are imminent.  There is often a large gap between medical science offering us a glimmer of hope in unraveling the next step toward a cure for one of these complex diseases and an actual clinical therapy - which can be years (or even decades off). You need to be responsible when reporting on progress to strike that proper balance.

However, I was struck by Derek's headline, and somewhat by the irony that this week's stem cell ruling will temporarily (hopefully) derail one promising avenue for the treatment of these disorders - namely stem cell therapies.  Clearly, these are years off but constant political wrangling and start/stops to research are not particularly helpful in reaching a cure. 

Where are the cures?  Apparently not with stem cells for the moment as a result of Lamberth's ruling.

Posted by Bruce Lehr August 25th 2010.

Lamberth Stem Cell Ruling Stems Research Pending Appeal

Judge Royce Lamberth's ruling that federally funded human embryonic stem cell research violates the Dickey-Wicker Law has thrown stem cell research in the USA into temporary (though immediate) disarray. According to stem cell researchers, Lamberth's temporary injunction has halted research at dozens of labs. The University of Wisconsin alone has 34 approved stem cell projects -- 21 of which are federally funded and affected by the ruling.

The ruling calls into question not only research done with 75 new stem cell lines approved by the Obama administration since 2009, but even research with previous cell lines considered to be acceptable by the Clinton and Bush administrations could be at risk under this ruling.

The NIH announced that researchers who are currently working on $131 M worth of grants in 2010 can continue their work.  However, the NIH has suspended all review of new grant applications.  There is currently up to $74 M in new funding requests in 50 grant applications before the NIH - $54 M in renewed funding requests and $20 M in completely new research.  All of this is suspended.

Francis Collins, director of the NIH, expressed concern that the suspension of stem cell funding could do great harm to research in the US - "It has the potential to do serious damage just at a time when we were gaining momentum."  Tim Kamp says, director of the University of Wisconsin Stem Cell and Regenerative Medicine Center, the ruling "will put us at a huge competitive disadvantage to other countries" including programs in Japan, the UK, Australia and China.

The Justice Department stated on Tuesday that it would appeal the ruling. It has asked the district court to put its ruling on hold while the appeals court considers the case.  Beyond that, Democratic Leaders in the Congress are deciding whether to pursue additional legislation to restore stem cell research or to remove Dickey-Wicker from this year's spending bill.  Leaders are exploring legal and political ramifications.

Seeking Alpha reports that a basket of stem cell stocks that they follow were down 5.5% in Tuesday's trading following the ruling. Ironically, several of the companies affected do not work with embryonic stem cells and have programs centered on use of adult stem cells from autologous adipose tissue or bone marrow.  Cytori Therapeutics, Aastrom Biosciences, StemCell Inc, and International Stem Cell Corp are 4 companies who saw their stock drop more than 5% but DO NOT work with embryonic stem cells. Geron IS a company that works with embryonic stem cells that saw its stock drop.  Osiris Therapeutics is a company that works with adult stem cells that actually saw its stock rise. 

Read here for more gory details:  WSJ Health blog, WSJ, Fierce Biotech, Seeking Alpha, and Seeking Alpha (Zacks).

Posted by Bruce Lehr August 25th 2010.

 

 

Milestone: EU receives word of intent to file 1st stem cell based product

As reported in the BiopharmaLife blog, the European Medicines Agency (EMEA) has received word from a European manufacturer that it plans to submit an application for marketing authorization for a stem cell based product.  This is a 1st in the EU!

Normally, EMEA is tipped off by client companies approximately 4-6 months before the formal application is filed.  Thus, the formal filing should take place late in the year in 2010. As yet, the company's identity is a secret.

This may signal just the beginning of a series of filings.  To prepare, the EMEA has been meeting with pharma companies, US and Japan regulatory officials and academic experts in stem cell treatments.

Regenerative medicine may be beginning to make its appearance on a commercial stage and to get itself in position for initial use in treatments of cancers and damaged tissues.

Posted by Bruce Lehr May 15th 2010.