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.

Biotech Event Hosts Partnering “Speed Dating”

There were around 1,100 attendees at this year’s Biotech Showcase 2011, which was held at the Parc 55 Wyndham Hotel in San Francisco and ran from January 10th to the 12th.  Some of the attendees came from the nearby J.P. Morgan Healthcare Conference being held at the same time.  During this event, around 195 public and private companies came to give presentations and seek partnering deals or funding from investors.  In the area of partnering, there was a designated room with numbered tables that companies seeking funding could give their pitch to interested investors.  It reminded me a bit of speed dating.

The event began with a panel briefing on the Regenerative Medicine annual state of the industry report.  There was also a lunch plenary in which a panel discussed the future of Personalized Medicine and how it will effect private and small-cap life science firms.

I sat in on some of the company presentations.  The companies were given only 15 minutes to describe their products or technology.  Neil Campbell, President and CEO, at SuperNova Diagnostics spoke about the company’s AmpCrystals technology, which is based on a proprietary chemical-nanotechnology. AmpCrystals are capable of being triggered on-demand to produce visible long-lasting fluorescence.  Campbell went on to say that AmpCrystals improve immunoassay performance and can be applied to DNA testing (detection and quantitation of DNA).  SuperNova offers low-cost simple testing lab performance.  Campbell said that most of its customers are strategic.  He also said that they are looking for partners.

Another presentation I sat in on was given by David Levison, Founder of cardiovascular genomic diagnostics company, CardioDx, Inc., Levison said “we really need cardio-diagnostics.”  Their two tests include Corus CAD and Corus SCA.  The Corus CAD test costs $1,195.  It indicates the likelihood of the patient having obstructive coronary artery disease.  The process involves the doctor drawing blood from the patient using their test and then sending the sample to CardioDx where it is analyzed and the doctor receives the results in one day.  The company has seen strong doctor adoption and re-order rates.  The average doctor orders over 10 tests.  Levison said that they did not expect them to order over 10 so they are very pleased about that.  He also said that one third of the tests are being paid for today by doctors.