Panel: International perspectives: Collaboration Opportunities

Moderator is Doug Sipp of the RIKEN center for developmental biology . . . talking about the difficulty of regulatory issues from country to country.

Northern Europe does not like primate research; there's a saying that in Scandinavia it's easier to do human trials than primate trials.

The US has famously lost ground due to the president's position.

Globally there are 3 large organizations: ISCF, ISSCR, and, oy . . . lost it, sorry
In the USA there's the Alliance for Stem Cell Research
In Europe, a similar organization
In Asia, another one whose acronym is SNAP

It's not a competitive effort, it's a collaborative one.

Introduces Dr. Stephen Minger from King's College, London. He's not a Brit, though, but an American transplant. There's a strong collaborative effort there, existing in a very tight-knit community of people working with stem cells.

He sits on a board that will be the regulatory body that makes policy for how stem cells will be used. Also has a role in creating collaboration between UK scientists and Chinese scientists.

Says that in China stem cell biology is surging ahead very quickly; have the best equipped labs in the world at this moment because the gov't has funded them very well. Chinese scientists who were trained at US universities are heading back in droves because they can work in a much more friendly environment. I tell my students, "Don't look west, look east."

Next is Marilyn Robertson of the Scottish Stem Cell Network.
Wants to talk about the role of networks . . the stakeholder group is quite diverse, including all the networks mentioned just above . . . there are

scientists, clinicians and health professionals
patients and caregivers, patient charities and advocacy groups
lawyers and ethicists, policy makers and government
industry, subject matter experts, biotech and big pharma, suppliers and maunfacturers
investors, public and private, banks and insurance
the general public

The job of networks is to bring all these groups together.

They do a lot of work:

Provide links between stakeholder groups
Run training events for members
Support enterprise development
Fund research
Lobby policy makers
Provide information to inform the public debate
Support teachers in schools and colleges
Act as the contact for international researchers

She's talking about the Scottish Stem Cell Network

You can check out their agenda at the link, but one important thing she just said is that in a couple of weeks they'll be hosting a group of immunologists to get them involved now in figuring out how to make therapies that don't require immunosuppression to keep transplants from being rejected.

Glyn Stacey, director of the UK Stem Cell Bank

"I'm one of those scientists who feels very scared if I don't have a powerpoint presentation . . . apologize for that . . . "

So, what is a stem cell bank? It's a collection of stem cells housed in tubes and kept in a state of suspended animation. It allows scientists to strictly keep and control quality.

You'd want to know as a patient that the cells you're going to get are exactly the same as the ones the last guy got . . . that's what the banks are about.

People have to understand that this is a new and dynamic field with techniques yet to be optimised . . . it's going to take steady nerves to persevere.

So, he's describing the process they followed to get the banking underway. Started with forming a steering committee that forbade them from creating a conflict of interest by doing research on their cells or from forming any commercial relationships. Next was to create what he calls a Human Tissues Authority to control the supply for research and clinic, maintain a quality forum, establish a a patient depositary, and give advice to big pharma and others.

Challenges

1. the cells they're working with were altruistically donated, which will eventually be turned to commercial products . . . not clear how this should be handled

2. there are complex ethical issues which are changing as time passes as well as across international boundaries

3. the scientific development is very fast and requires heavy investment to keep up and assure quality

4. there is a broadening user community which means we're looking at new disciplines, and that implies a need for training

5. progress to therapy will involve problems and failures, must plan ahead for how to deal with that

He has a slide up that shows the extent of international coordination, talking fast now, but I think he just said that they jointly published a very rich data set available to all the members . . .

Last speaker is Derek Hei, who is a prof at UW Madison and a bioengineer.

Talking about how to evolve the stem cell banks; he's leading the effort in the US

they want divers banks of human cell lines, they want genetically modified cell lines, they want disease mdels developed from iPS cells
they want to do technology transfer . . cell banking practices including culture freezing and testing methods

(editorial comment . . . may just be me, but I'm getting a very strong feeling that many of the presenters here are aware that they're climbing on top of a very big wave and are working very hard to keep their balance and ride it safely to shore.)

We have 21 cell lines available through the NIH registry. One of the challenges faced as the cells are shared worldwide with other investigators is how to share the information about them.

So they made a website (the national stem cell bank) that gives every detail of what has happened w/respect to those lines, giving researchers clear history about what they're getting.

Support for translational researchers is a major goal of the national stem cell bank . . . will want to create a GMP grade collection of stem cells so that when investigators want to take their therapies to trial they have a ready source of cells to do so.

Questions?

Why is there not more interest from the insurance industry in supporting hESc?

Robertson says that we don't really know, but of course we'd welcome it . . . possibly they don't understand what the benefits might be.

Hei: Wants to clarify that the cell banks will be undifferentiated cells . . . there's a lot of work to be done to nudge them into specific cell types, and it's likely that insurance companies won't get on board until after a lot more work has been done.

Question: What about contamination? What about manufacturing to most common HLA lines?

Hei: We've been concerned all along about our lines picking up pathogens that we've been unable to detect, which is why we continue to test them as time passes. From our point of view it's important to get cells into researchers' hands right now.

Stacey: We're going to have to move forward . . . basically he's saying that even though it will be very expensive and issues will continue to be complex, we have to make choices.

Question: The british are the only ones that now allow putting a human nucleus into an animal egg . . . where is that going?

Minger: In our lab we're going to go forward with it, because there is still so much to be learned . . .makes a comparison between this and not giving up on hESc just because we have iPS.