Transcript Industrial perspective: Development of an MTA harmonious with a

Designing the Microbial Research Commons
Industrial Perspective: Development of an MTA
harmonious
with a Microbial Research Commons
Stephen J. McCormack, PhD
National Academy of Sciences
October 8, 2009
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EXELA
Commercial Application of Microbial Resources
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Microbes have had commercial and “societal” value for
millennia
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Since the initiation of modern biotechnology; microbes and
microbial collections have formed the underpinning of basic
research and of billion dollar products
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We have just “scratched the surface” of the commercial
potential of microbes
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Global standards or principles are applied to the
characterization, access and licensing of these microbes
and collections
EXELA
Industrial Benefits to Liability Rules
Postulate: Diverse licensing strategies and techniques have
elevated the transaction costs and other barriers for
relatively simple collaborative research projects.
Liability rules: Access to all microbial resources and
collections will eliminate any of the competitive advantage
from sequestering materials and data from other
organizations.
Caveat: a substantial amount of the data and collections are in
private organizations and companies
EXELA
Case Study: American Type Culture Collection
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ATCC is an independent, private, non-profit
501(c)(3) biological resource center (BRC) and
World Federation of Culture Collections (WFCC)
organization.
As a biological resource center
– As a research organization
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To provide reliable, qualified and low priced biological
materials for the advancement of basic research
EXELA
Case Study: ATCC History
Established in 1925 when a committee of scientists
recognized a need for a central collection of microorganisms
that would serve scientists all over the world. ATCC began
at the McCormick Institute in Chicago and moved to
Georgetown University in Washington, DC in 1937
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1949 first patent culture deposit
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1981 accepts patent materials from any country that has
signed the Budapest Treaty
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1997 initiates the first of the ATCC Special Collections and
moved to Manassas, Virginia
EXELA
ATCC Mission #1
“ATCC is a global nonprofit bioresource center and
research organization that provides products,
technical services and educational programs to
private industry, government and academic
organizations.
Our mission is to acquire, authenticate, preserve,
develop and distribute biological materials,
information, technology, intellectual property and
standards advancement and application of scientific
knowledge.”
EXELA
ATCC Mission #2
“To acquire, authenticate, preserve, develop and
distribute biological resources and knowledge to
scientific researchers.
We strive to be the preferred provider of high-quality
biological reference standards which, along with
products and services developed in-house,
enable science to touch people’s lives.”
EXELA
ATCC Collection
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Collection Holdings
3,400 human, animal and plant cell lines
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8 million cloned genes
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microorganism collection
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18,000 strains of bacteria
2,000 different types of animal viruses
1,000 plant viruses
49,000 yeast and fungi strains
2,000 strains of protists.
Research and Development
Standards and Services
Distribution and Technical Support
EXELA
Value Add Proposition
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ATCC Special Collections:
Johns Hopkins University
– MR4 (Malaria)
– Mantle Cell Lymphoma Cell Bank
– National Park Service
– NIH Human Microbiome Project
– Yeast Genetic Research
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EXELA
Disincentive to Research Commons
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Sequestering of biological resources and data
allows for a “perceived” monopoly on the
downstream application of research discoveries
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The academic research group or commercial firm
could then take advantage of all the value of this
data and collection without any competition
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Only when sharing and distribution will provide a
greater possible “upside” to the owner then the
material and data will be disseminated
EXELA
Commercial licensing program:
Sterility testing
Vaccine manufacture
Food & beverage manufacture
— yogurt, soda, infant formula
Product testing
Clinical diagnostics
Wastewater treatment and
septic additives
Contract pharmaceutical
manufacture
Drug development
Contract research — drug
discovery, preclinical services,
screening
Medical devices
Nutraceuticals
Gene expression databases
Genome sequencing
instrumentation
Government contracts
High-throughput technologies
Proficiency testing
Research reagents and tools
Stem cell R&D
Toxicology testing
Veterinary pharmaceuticals
EXELA
Model MTA: Definition of Commercial Use
“Commercial Use” means the sale, license, lease, export,
transfer or other distribution of the Biological Materials to a
third party for financial gain or other commercial purposes
and/or the use of the Biological Material:
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(a) to provide a service to a third party for financial gain;
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(b) to produce or manufacture products for general sale or
products for use in the manufacture of products ultimately
intended for general sale,
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(c) in connection with ADME testing;
ATCC Standard MTA
EXELA
Model MTA: Definition of Commercial Use
“Commercial Use” cont’d
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(d) in connection with drug potency or toxicity testing which
does not include either screening multiple cell lines for
potential inclusion in a screening assay system or screening
multiple compounds in a system for internal research
purposes only;
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(e) in connection with proficiency testing service(s), including
but not limited to, providing the service of determining
laboratory performance by means of comparing and
evaluating calibrations or tests on the same or similar items
or materials in accordance with predetermined conditions; or
ATCC Standard MTA
EXELA
Model MTA: Definition of Commercial Use
“Commercial Use” cont’d
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(f) for research conducted under an agreement wherein a
for-profit entity receives a right whether actual or contingent
to the results of the research.
Conclusion: the definition of Commercial Use is not very
simple in application or determination
ATCC Standard MTA
EXELA
ATCC Technologies Available for Licensing
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Master cell banks of Vero cells for vaccine manufacture
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Mycoplasma detection kit
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Speciation kit
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Materials in ATCC special collections
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Pre-1980 cell lines in ATCC collection (not subject to the
terms and conditions of Bayh-Dole)
EXELA
Considerations: Liability Rules
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If WFCC organizations pursue value-add research
and bundling strategies the collections will move up
the value chain towards approaching commercial
products
-this may invalidate such a liability rule approach
Culture collections should not deviate from their
purpose of basic accessioning of biological material
for preservation, maintenance and distribution
EXELA
Semicommons: commercial and
non-commercial value in the same application
Sterility testing
Vaccine manufacture
Food & beverage manufacture
— yogurt, soda, infant formula
Product testing
Clinical diagnostics
Wastewater treatment and
septic additives
Contract pharmaceutical
manufacture
Drug development
Contract research — drug
discovery, preclinical services,
screening
Medical devices
Nutraceuticals
Gene expression databases
Genome sequencing
instrumentation
Government contracts
High-throughput technologies
Proficiency testing
Research reagents and tools
Stem cell R&D
Toxicology testing
Veterinary pharmaceuticals
EXELA
Pushing the limits of liability rules
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In certain cases the mere characterization of a
microbe can create immediate commercial potential
for products (e.g. H1N1)
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The microbes or microbial collections should meet
certain non-commercial qualifications for entry into
the Microbial Commons
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Discoveries and advances in scientific
understanding will continually move the line for
what is eligible under the liability rules.
EXELA
Conclusions
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Commercial Use of Microbial Cultures is very
difficult to define because the value changes over
time and subjective to begin with at the time of
appraisal
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A multifaceted system may be required to form a
Microbial Commons that will enable broad and
effective access to data and biological materials
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The WFCC and ECCO will have to continue to
leads with MTA agreements that will form the core
of these Microbial Commons
EXELA