by Jennifer Welsh
27th July 2010, "The Scientist.com"
Among stem cell policy changes instituted since U.S. President Barack Obama took office, the National Institutes of Health (NIH) made a controversial move to not renew funding of a key stem cell bank established at the WiCell Institute in Wisconsin. Many scientists worry that without a national center to distribute human embryonic stem cell lines to researchers, the availability, cost and quality of cell lines will suffer as a result. But not all feel this way.
The Scientist spoke with Evan Snyder, a stem cell biologist from the Burnham Institute for Regenerative Medicine in San Diego, who says he doesn't believe the community needs a nationally funded bank. Snyder, whose research focuses on the basic biology of stem cells and their potential applications, believes that in these tough financial times, researchers should do their academic duty and provide their stem cell lines to others at little or no cost, other than that of supplies and shipping.
The Scientist: Does it worry you that the national stem cell bank at WiCell is no longer federally funded to distribute the NIH's approved human embryonic stem cell lines?
Evan Snyder: I would only be upset about the bank being dissolved if somehow the pressure from the government [to share lines] was perceived as relinquished, because there was no longer a bank.
My feeling is that when you've generated a line and you've published it, that it should be made freely available with no strings attached. If everyone does their ethical duty to the scientific community, then the bank is not necessary, other than as a convenience.
TS: So then who should cover the cost of quality control, freezing and distributing the cells?
ES: If a researcher is going to supply cells that he's published, and he wants to be the one controlling those, then he would do that. Some labs don't want to be in the business of supplying lots of cells, or mice, so they will deposit it into Jackson labs. People don't perceive Jackson lab as a profit-making place, they know they are paying simply for the service of maintaining an animal colony and sending it out. I think the initial price that WiCell was charging, $5000 a vial, did not fall into that category. It doesn't take $5000 to do the quality control we are talking about.
TS: Some people would say that stem cell banks are held to different standards of quality control, which isn't -- or can't be -- matched by an academic lab. Do you think that's true?
ES: If you are in a lab making stem cell lines, you are already a sophisticated cell culture lab and you are routinely checking for mycoplasma, karotypes, aberrations and differentiation.
Most of the people that are requesting [lines from WiCell] are academics. To do academic research you just need lab quality control. Going into a clinical trial requires [good manufacturing practice], which is a different story and a whole different cost. What WiCell was supplying wasn't GMP-quality stuff.
TS: When stem cell line distribution falls to individual researchers, you mentioned some problems, such as issues with material transfer agreements. What were the restrictions?
ES: [One research hospital] said any product or discovery that came from the line belonged to [the hospital]. If we were to discover some novel drugs [using their lines, they] would want ownership of those drugs. That inhibits creativity and it inhibits research.
TS: So have you run into that kind of restrictive mindset before? A lot? Is it something that is prevalent in the field?
ES: Some companies will have that kind of restriction, and WiCell initially had it. When the national bank came about, they were forced to modify that. It's rare, however, to encounter it in an academic institution, and I think completely inappropriate and improper.
TS: What do you think is standing in the way of stem cell research?
ES: The biggest obstacle in every aspect is still the biology itself: the biology of the cells and of the diseases. Given that this is the major obstacle, it becomes frustrating when non-biological speed bumps are thrown in the way. Because the biology is so tough everything else should be made excessively easy, to not have to deal with human obstacles and human-derived obstacles.
TS: What would those be?
ES: Red tape, administration, concerns for profits, concern for excessive control, or just bureaucracy for bureaucracy's sake.
An example of this would be obsession over the issue of informed consent for old stem cell lines. That material was obtained with proper and well considered ethical guidelines at the time. The delay in approving those was an example of unnecessary human intervention.
27th July 2010, "The Scientist.com"
Among stem cell policy changes instituted since U.S. President Barack Obama took office, the National Institutes of Health (NIH) made a controversial move to not renew funding of a key stem cell bank established at the WiCell Institute in Wisconsin. Many scientists worry that without a national center to distribute human embryonic stem cell lines to researchers, the availability, cost and quality of cell lines will suffer as a result. But not all feel this way.
The Scientist spoke with Evan Snyder, a stem cell biologist from the Burnham Institute for Regenerative Medicine in San Diego, who says he doesn't believe the community needs a nationally funded bank. Snyder, whose research focuses on the basic biology of stem cells and their potential applications, believes that in these tough financial times, researchers should do their academic duty and provide their stem cell lines to others at little or no cost, other than that of supplies and shipping.
The Scientist: Does it worry you that the national stem cell bank at WiCell is no longer federally funded to distribute the NIH's approved human embryonic stem cell lines?
Evan Snyder: I would only be upset about the bank being dissolved if somehow the pressure from the government [to share lines] was perceived as relinquished, because there was no longer a bank.
My feeling is that when you've generated a line and you've published it, that it should be made freely available with no strings attached. If everyone does their ethical duty to the scientific community, then the bank is not necessary, other than as a convenience.
TS: So then who should cover the cost of quality control, freezing and distributing the cells?
ES: If a researcher is going to supply cells that he's published, and he wants to be the one controlling those, then he would do that. Some labs don't want to be in the business of supplying lots of cells, or mice, so they will deposit it into Jackson labs. People don't perceive Jackson lab as a profit-making place, they know they are paying simply for the service of maintaining an animal colony and sending it out. I think the initial price that WiCell was charging, $5000 a vial, did not fall into that category. It doesn't take $5000 to do the quality control we are talking about.
TS: Some people would say that stem cell banks are held to different standards of quality control, which isn't -- or can't be -- matched by an academic lab. Do you think that's true?
ES: If you are in a lab making stem cell lines, you are already a sophisticated cell culture lab and you are routinely checking for mycoplasma, karotypes, aberrations and differentiation.
Most of the people that are requesting [lines from WiCell] are academics. To do academic research you just need lab quality control. Going into a clinical trial requires [good manufacturing practice], which is a different story and a whole different cost. What WiCell was supplying wasn't GMP-quality stuff.
TS: When stem cell line distribution falls to individual researchers, you mentioned some problems, such as issues with material transfer agreements. What were the restrictions?
ES: [One research hospital] said any product or discovery that came from the line belonged to [the hospital]. If we were to discover some novel drugs [using their lines, they] would want ownership of those drugs. That inhibits creativity and it inhibits research.
TS: So have you run into that kind of restrictive mindset before? A lot? Is it something that is prevalent in the field?
ES: Some companies will have that kind of restriction, and WiCell initially had it. When the national bank came about, they were forced to modify that. It's rare, however, to encounter it in an academic institution, and I think completely inappropriate and improper.
TS: What do you think is standing in the way of stem cell research?
ES: The biggest obstacle in every aspect is still the biology itself: the biology of the cells and of the diseases. Given that this is the major obstacle, it becomes frustrating when non-biological speed bumps are thrown in the way. Because the biology is so tough everything else should be made excessively easy, to not have to deal with human obstacles and human-derived obstacles.
TS: What would those be?
ES: Red tape, administration, concerns for profits, concern for excessive control, or just bureaucracy for bureaucracy's sake.
An example of this would be obsession over the issue of informed consent for old stem cell lines. That material was obtained with proper and well considered ethical guidelines at the time. The delay in approving those was an example of unnecessary human intervention.