Stem Cells: Scientific and Commercial Challenges

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Stem CellsScientific and Commercial Challenges

• Scott Stern
• Northwestern University and NBER
• Chicagoland Stem Cell Symposium
• February 2008

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The Challenge of Stem Cell Research

• Stem cell research is likely to be among the most
  important areas of scientific research over the
  next 50 years we just dont know exactly how
• Stem cell research takes place in Pasteurs
  Quadrant where research is simultaneously of
  scientific and commercial interest
• Stem cell research is global local (or even
  national) efforts at regulation have had little
  impact on whether research is actually conducted
  but has had a significant impact on where the
  research is conducted and whether the research
  takes place in an effective institutional
  environment

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While the isolation of stem cells was originally
developed in relatively narrow applications, the
potential applications are enormous. Despite a
decade of work, however, the research is still a
highly exploratory phase
Bone
Skin
Kidney
osteoblasts
Nervous System
Blood
blood cells
neurons astrocytes oligodendrocytes
Vessels
Liver
endothelial cells
liver cells
Pancreas
Heart
Muscle
insulin producing cells
cardiomyocytes
based on Martin F. Pera (2005)
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The traditional distinction between science and
technology fails when knowledge has both basic
and applied value, with implications for
discovery, development and commercialization.
Similar to many other cutting-edge areas of life
sciences research, stem cell research is
conducted in Pasteurs Quadrant, where research
is simultaneously of scientific and commercial
interest
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Over the past several years, despite policy
debates over Federal funding of basic research
for publication purposes, an explosion in patent
applications over various stem cell technologies
Bergman and Graff, NBiotech, 2007
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In Pasteurs Quadrant, we will see fundamental
scientific research in both the public and
private sector, and both universities and firms
will aggressively protect intellectual property
through patents (or even secrecy!). More than
40 of all stem cell patent applications are by
university researchers
Bergman and Graff, NBiotech, 2007
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The Geography of Stem Cell ResearchWhile some
countries support embryonic stem cell research,
others including the United States have
imposed complex restrictions on their use (or
ability to get funding)
NT nuclear transfer
Based on Martin F. Pera (2005)
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Perhaps in part because of these policy
differences human embryonic stem cell research
publications has become increasingly globalized
Owen-Smith and McCormick, NBiotech, 2006
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Indeed, the emerging international stem cell
research network seems to reflect strategies by
researchers to avoid locations or research
materials hindered by IP restrictions or onerous
regulations
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Some Implications

• Stem cells are a general purpose research tool
  of fundamental scientific, commercial and
  therapeutic interest
• We are unlikely to be able to forecast the
  precise ways in which these exciting new
  discoveries will impact clinical practice or the
  human experience
• A proactive debate about the ethics of certain
  practices (and providing effective global
  institutions and policies) ensures that the
  ethical issues are debated in advance of having
  to make hard choices about alternative research
  directions
• So far, most policy has been national and narrow
  providing narrowly tailored exceptions for
  Federal funding that simultaneously undermine the
  effectiveness of the scientific research process
  while having little impact on the actual
  direction and conduct of research
• The United States has begun to cede its early
  lead in stem cell research to other countries
• A great deal of research is now funded by a
  patchwork of private or non-profit funders who
  may actually impose fewer ethical obligations or
  requirements on researchers