Bernard Siegel JD, Talks Up Progress in Stem Cell Research

On May 18, 2011, I listened to a BIOtechNOW podcast about stem cell research.  BIOtechNOW’s Tracy Cooley interviewed Bernard Siegel, J.D., Founder and Executive Director of the non-profit Genetics Policy Institute based in Wellington, Florida.  She asked him about recent developments in stem cell research.  He said that it is “moving forward rapidly” and that in general, the field is not just focusing on basic fundamental research, but on also on translational medicine.  Siegel said there have been a large number of clinical trials with tissue specific stem cells and even a few with human embryonic stem cells (hESCs).

However, there are a lot of problems and challenges in the field that have to be overcome to really take the promise of stem cell research into reality and treatment and cures, he said.  According to Siegel, these include regulatory, reimbursement, and intellectual property issues. When asked what he thought about the realistic outlook for stem cell research in the next 5-10 years, he said that “we’re going to see tremendous progress.”  He is hoping that we will find a way to overcome the regulatory and political hurdles related to hESCs. Unfortunately, in the U.S. there is still a roiling debate over the use of these cells in fundamental research that isn’t going to be resolved anytime soon, he said.

Siegel also talked about the Sherley v. Sebelius case involving human embryonic stem cells (hESCs).  He said that case shocked the scientific community when, in August 2010, Judge Royce Lamberth of the U.S. District Court for the District of Columbia entered a preliminary injunction to halt federal funding of hESC research and so the matter was taken up on appeal.  On April 29, 2011 the U.S. court of appeals in Washington D.C. entered its ruling and that court vacated the preliminary injunction that had been entered by the trial judge.

According to Siegel, while this is a good thing for the deal, it has not brought the certitude that is needed in order to move the deal forward.  He said that researchers need certitude so that they can hire their post docs.  They need to know that when they begin an experiment there will be enough funding to carry it through to the end.  However, this court case puts all of this in jeopardy.  Siegel also added that this appellate decision has not resolved the case entirely and that there are two critical issues for which the trial judge can enter a judgment again in favor of the plaintiffs.

Siegel’s organization, Genetics Policy Institute, has filed an “amicus curiae” brief, which means a “friend of court brief,” presenting legal arguments in the case in support of the government’s position.  Not only do we see the battle reflected in a federal court case but right now there are many, many states that are considering anti hESC legislation, he said.  His overall optimism related to the field of stem cells and hESC research is tempered by the political debate.

The Genetics Policy Institute has built a coalition called the “Stem Cell Action Coalition,” that is comprised of 70 different organizations such as the American Academy of Urology, the Cell Transplant Society, and the Alpha One Organization.  The focus of the coalition is to bring about public awareness and to really show to the public, the accomplishments in the field of hESC research.  Siegel feels that the Stem Cell Action Coalition fills an unmet need in the debate and will help bring about the day when human stem cells can really reach their full potential.

Low-Cost sequencers to Drive Growth in NGS Installed Base

First quarter announcements by two early makers of low-cost NGS machines suggests that brisk sales of the platforms will likely boost the overall installed base of NGS machines deployed into labs worldwide.  In mid-April, a spokes person from Roche 454 Life Scicences said that “We are pleased with the rapid adoption of the GS Junior System in the market.”  The person also said that 454 had “placed hundreds of GS Junior instruments in laboratories worldwide.”

To me, “hundreds of instruments” could be interpreted as at least 300-400 instruments. That’s quite a lot of 454 GS Junior instruments shipped since its launch last May. Most of what I have read about the GS Junior suggested that the instument have limited utility and may  have disappointed some users.  Brisk sales of the GS Junior is a surprise to me.

Life Technologies made an announcement about its low-cost Ion Torrent sequencer as part of its first quarter financial release. They said that their Q1 orders were greater than what they had expected.  They said the the strong order rate suggests that they might sell more Ion Torrent PGMs over the next 12-months that will exceed the installed base of the leading NGS instrument.  I assumed that he was referring to the installed base of the Illumina GA series of NGS machines. The Univ. of Birminkgham website shows that the self-reported installed base for Illumina GAs to be over 660.  I suspect that this website lags the real installed base by a few hundred. I read that LIfe Technologies had initial orders for 60 or so PGMs.  So I would expect that exceeding their original expections could be interpreted as 100 to 130 shipments for the PGMs for Q1. If LIfe’ shipment estimates do materialize, then sometime next April the installed base of Ion Torrent PGMs will reach about 670.

I estimate that the accumulated installed base of 454 GS Junior machines that might be deployed by next April would be about 650. So together, The installed base for the two low-cost NGS platforms might reach an installed base of 1,320 instruments.

If I assume that Illumina’s MiSeq instrument rolls out sometime in August and they have a run rate that is similar to the Ion Torrent, they might ship about 400 by next April.  Add that number to the mix and a conservative guestimate of the installed base for low-cost NGS machines might reach 1,720 machines by then. I can see that democratization of DNA sequencing will begin to take effect in mid-2012.