Designing the Microbial Research Commons - PowerPoint Presentation

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Designing the Microbial Research Commons

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Industrial Perspective: Development

of an MTA

harmonious

with a Microbial Research Commons

Stephen J. M

c

Cormack, PhD

National Academy of Sciences

October 8, 2009

Commercial Application of Microbial Resources

Microbes have had commercial and “societal” value

for millennia

Since the initiation of modern biotechnology; microbes and microbial collections have formed the underpinning of basic research and of billion dollar products

We have just “scratched the surface” of the commercial potential of microbes

Global standards or principles are applied to the characterization, access and licensing of these microbes and collections

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

Case Study: American Type Culture Collection

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

To provide reliable, qualified and low priced biological materials for the advancement of

basic research

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

1949 first patent culture deposit

1981 accepts patent materials from any country that has signed the Budapest Treaty

1997 initiates the first of the ATCC Special Collections and moved to Manassas, Virginia

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.”

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.”

ATCC Collection

Collection Holdings

3,400 human, animal and plant cell lines

8 million cloned genes

microorganism collection

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

Value Add Proposition

ATCC Special Collections:

Johns Hopkins University

MR4 (Malaria)

Mantle Cell Lymphoma Cell Bank

National Park Service

NIH Human

Microbiome

Project

Yeast Genetic Research

Disincentive to Research Commons

Sequestering of biological resources and data allows for a “perceived” monopoly on the downstream application of research discoveries

The academic research group or commercial firm could then take advantage of all the value of this data and collection without any competition

Only when sharing and distribution will provide a greater possible “upside” to the owner then the material and data will be disseminated

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

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: (a) to provide a service to a third party for financial gain; (b) to produce or manufacture products for general sale or products for use in the manufacture of products ultimately intended for general sale, (c) in connection with ADME testing;

ATCC Standard MTA

Model MTA: Definition of Commercial Use

“Commercial Use” cont’d (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; (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

Model MTA: Definition of Commercial Use

“Commercial Use” cont’d (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

ATCC Technologies Available for Licensing

Master cell banks of Vero cells for vaccine manufacture

Mycoplasma

detection kit

Speciation kit

Materials in ATCC special collections

Pre-1980 cell lines in ATCC

collection (not subject to the terms and conditions of

Bayh

-Dole)

Considerations: Liability Rules

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

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

Pushing the limits of liability rules

In certain cases the mere characterization of a microbe can create immediate commercial potential for products (e.g. H1N1)

The microbes or microbial collections should meet certain non-commercial qualifications for entry into the Microbial Commons

Discoveries and advances in scientific understanding will continually move the line for what is eligible under the liability rules.

Conclusions

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

A multifaceted system may be required to form a Microbial Commons that will enable broad and effective access to data and biological materials

The WFCC and ECCO will have to continue to leads with MTA agreements that will form the core of these Microbial Commons