Monday, September 22, 2008

Panel: Stem Cell Nations

Bernie Siegel is introducing the new panel. These are superstars . . .

Linda Powers of Toucan Capital, which is a VC that funds many, many enterprises in stem cell research.

Bob Klein of the California Institute for Regenerative Medicine, rock star in the hESc world

Chris Mason from the University of London

Fanyi Zeng of the Shanghai Stem Cell Institute

Moderator is Tom Still of the Wisconsin Technology Council, who is now saying that he's convinced Chris Mason that Wisconsin weather is always like this (70's and sunny, sweet, sweet air . . .)

Here's Bob Klein, author of Prop 71.

I'd like to make it clear that I understand that funding of this research is a support function. Quotes Schwarzenegger: The scientists and doctors who make it happen are the action heroes of the 21st century.

Thanks Governor Doyle of Wisconsin, who has been another strong leader, along with Schwarzenegger.

Wants to focus on two governing principles w/respect to CIRM.

What have we done to advance research outside the federal restrictions?

Ahem. Prop 71, which was approved by 59% of CA voters in November 2004, established the CIRM and authorized $3B in principal and $3B in interest to fund stem cell research inCA. This is not operating capital taken out of the budget, and it was important to do it that way.

We don't fund operating costs. We fund intellectual capital to carry us into the 21st century.

Prop 71 also wrote hESc into the CA constitution and banned human cloning.

The independent citiens oversight committee is made up of the governing board of the CIRM and 14 other members. There is a grants working group made up of scientists from outside the state of CA; it's their job to review grants.

By June of 2009, they will have committed $1B $19M in funds.

A lot of this money is in the form of high risk loans; if we put $500M into loans, when that money cycles we have $600M . . .and when that money cycles we have $700M.

There will be much more than $3billion in the end, is the point. He's going through his spreadsheet--not line by line but hitting highlights to show that one effect of Prop 71 has been to expand donor participation far above any levels ever seen before.

Next will be private industry and the contribution they can make. The goal is to get to a Phase 1 trial with human beings within 48 months.

Fine, all this was approved in 2004, but the US just spent many hundreds of billions of dollars on financial rescue. 2004 was the worst financial year since the 50's for CA -- and they still managed to get the signatures to get it on the ballot.

On a national basis, if the program is not disease-specific you will get the money you need. The states have an advantage because if they use the bonds method, it's obvious you're financing capital--and you're not stealing from existing hospitals and public programs to do it.

In the last century, we invested in physical capital--roads and bridges and infrastructure. This century the capital will be intellectual.

We're talking about interventionist therapies, like the Salk vaccine. The cost per year to have juvenile diabetes is $15,000/year for the life of the child. It's worth an investment to save that money, when you multiply that child by how many of him there are, and how many other conditions there are that eat up dollars and productivity.

In CA our perspective is that stem cell research will not advance as a competition; it will advance as a global war on diseases and conditions.

Next is Linda Powers, who has been an investor, a professor at Georgetown, a leader of seminars for scientists on how to be entreprenurial.

So, how are we doing?

What's the progress in research and translation to the clinic?

What's the progress in economic development?

I spent 7 years building a family of 16 stem cell companies. We're in the trenches every day. A lot of states have been glavanized by CA's leadership. NY has started with $600M over 11 years. MD has made 3 kinds of grants. CT has created investigaor grants. NJ has invested $279M into 5 facilities. One of them puts stem cell treatment into the same facility as a hospital.

In MD, there are 3 separate grants, all coming from general budget funds, not bonds. We've created a level playing field for all cell types. "let the best cells win"

To get grants, researchers must spell out specifically what the translation plans are . . . they have physicians on their review board to make sure these plans are robust.

On the scientific front, there has been an explosion of papers in the last few years from around the world.

There are right now nearly 200 clinical trials underway today--all of them using adult stem cells--and aimed at a wide range of conditions.

Shows a Forbes Cover that says "Stem Cells Get Real"

Both the military and medical tourism are helping to accelerate regenerative medicine. It's very important to be cautious about how balance here . . . we need a middle ground where offshore approaches that are different from ours are not just dismissed because we don't understand them. Transparency must be the goal.

Economically, there have been lots of new stem cell companies formed in just the last year . . . there are lots of business models and a full pipeline of products.

Next will be Dr. Chris Mason, who "symbolizes the strength of what's going on in the UK"

(Read this with a very elegant British accent, please) In the UK, there has always been strong public and political support.

We have established centers of excellence, willingness to collaborate, and infrastructure.

The UK stem cell initiative was a 10 year plan beginning in december 2005. funding was 1,300M per year

We created both national and local networks.

Martin Evans
got a Nobel Prize in 2007. They have a stem cell bank under construction. They've enjoyed strong UK Government support for translation. They need to translate both into the clinic and into successful commercial practice.

Their clinical trials will be easier to implement than in some places becaue they have a single healthcare service.

They've had partnerships with private companies, including big pharma, have already spent about $100M on regenerative medicine.

They've made themselves a leader in creating global standards for quality,safety, and performance.

They've funded international missions, especially in the far east, and they're keen to collaborate.

Regenerative Medicine is a new journal they established in 2006.

To sum up: UK is as small island with lots of enthusiasm!

Last speaker is Fanyi Zeng from the Shanghai Stem Cell Institute

In 1978 the society of medical genetics was created; the focuse was disease screening and early diagnosis. In 1982 they won a NIH developing grant, which funded them for 10 years.

Mmmmm. Full brain syndrome attack here. She's giving us the history of what they've done in China in the last 30 years, carried out in the context of the giant economic progress there.

They hope to have a trillion dollars invested by 2020, which, she points out, would put them ahead of the USA in terms of who leads. They have very robust funding resources. They could not have done this without the opening of the door in 1978 or without funding from the NIH, or without great planning and support from their government.

They have a national strategy. What a concept.

They have 50 research groups, 30 of which are working on iPS technology. They're constantly looking for investment partners. I bet.

So, now the panel is asked to evaluate who the leaders are right now and who they will be in ten years.

Powers says the people here obviously represent countries that are leaders, along with Australia . . . India not so much. Klein says that Canada is emerging as a player, because they have an economic surplus. Adds that we in the USA have a limited window of time to get to that therapeutic breakthrough.

How does the UK go about collaboration so successfully? His microphone is not close enough to his face, unfortunately . . .

What will change on January 20th, 2009?

Klein says that the states must continue to step up. Stanford was offered money to build a center, which they rejected because they could not depend on the stability of the federal government. States can provide longterm stability because they don't have to depend on year to year budgeting processes; they can use bonds. One of the UK's centers of excellence came from CA; he left the USA because of funding restrictions.

Powers says that there are lots of things holding hESc back in the USA and Bush is only one of them. She names the piddling amount spent at NIH on adult stem cells and on medical research in general. There are also regulatory hurdles,the specific regulatory requirements to simply get into the clinic.

In the usA we draw no distinctions in regulation between implanting a patient's own cells and those of someone else--which seems wrong.

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