ERANET PathoGenoMics

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ERA-NET PathoGenoMics

• Industry Discussion
• Paris, 24th May 2005

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Background

• MS, PhD studies in Antimicrobial resistance
• The Rockefeller University, NY
• UNL, Lisbon
• Distribution of Molecular Tools and Services
• Portugal Biocontec/Merck/VWR
• Spain - VWR
• Central Europe VWR Biotech Business Dev.
• Manufacturing, Services Distribution
• Eurogentec SA
• Liege, Belgium
• Eurogentec NA
• Philadelphia HQ
• San Diego Oligo Production and cGMP services
• Business Development
• Eurogentec SA
• Development of full-genome arrays in
  collaboration with european-based genome
  sequencing teams
• Negotiating new technologies in DNA detection,
  array manufacturing, protein expression, protein
  analysis
• Consulting
• Dualsystems AG

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Is this your view of the industry?

• Someone that uses my work to make loads of money
• The story of the guy next door who is now driving
  a ferrari because he sold the expression vector
  to that US company

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Where does the industry fits?

• Some end-results of research made using public
  EEC funds
• Better understanding of the issues
• Seeding ideas for new research projects
• Know-how in the methodologies used during such
  research
• Molecular tools and assays to be used by industry
• Leads for drug development
• Leads for new clinical perspectives
• Promote economic development through enhancement
  of public health policies and activities

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Research needs readily available tools

• In most european countries researchers no longer
  produce Taq or synthesize oligos because its not
  time efficient
• Researchers
• Make use of existing tools/assays
• Develops new tools to address/resolve new
  questions that current tools/methods cannot solve
• Competition among scientists for funding limits
  availability/sharing of this tools

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IT IS IMPORTANT TO REALIZE THAT MOLECULAR TOOLS
ARE THE ONLY WAY TO TRANSFER IDEAS INTO ACTION

• Molecular Tools/Assays
• Academia Research
• New Tools/Assays
• Publications/Grants
• Biotech Research
• HTS, etc
• Pharma RD
• Clinical trials
• Product/Drug
• Diagnostic Research
• Products / Diagnostic kit
• Clinical Laboratory

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Global perspective of Molecular Tools Industry

• Global Research Market
• 23 Billion
• 10 Billion US
• Invitrogen gt 1,2 Billion Sales
• BD Biosciences gt 0,7 B Sales
• Qiagen gt 0,5 B Sales
• Clinical Laboratory Market
• 10 Billion US
• Global Biotech Market
• 29 Billion

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How to introduce new products in the Molecular
Tools Industry

• Search for and/or aquire
• IP
• License, Selling Rights
• From Universities, researchers
• In-House Development
• Own RD resources
• Govt research grants (e.g.SBIR)
• Joint Development
• Collaborative RD with Academia
• Research Grants

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WHAT DO THEY REALLY WANT FROM YOU?

• Molecular Tools / Diagnostic industry needs
• Database of tested, reliable and unique sequences
  to be used to detect the infectious
  microorganisms
• To produce diagnostic kits
• Database of available full-genomic data and
  subsets important in the study of infection
• To produce genome-wide arrays and subsets
• Database of proteins and antibodies including
  panels of cascades
• To produce protein and antibody arrays
• Why?
• Cost/time of development and validation
• How?
• Using this data with existing technology that has
  not been fully exploited (PCR, qPCR, microarrays)

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PathoGenoMics how to interact with the Molecular
Tools industry

• Develop a network of european molecular tools and
  services companies that will have priority access
  to manufacture and distribute the products,
  methods and assays resulting from this research
• Make a point for priority and low-cost access to
  the participants in the network

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PathoGenoMics how to interact with the Molecular
Tools industry

• Contract with a large lab-supply distributor to
  make products readily available to ERA-NET
  members
• Why? Selling in the US vs Europe
• Currency
• Logistics/taxes
• Language/Protocols
• Price
• Establish/select a storage platform for
  tissue/DNA/strain collection
• 2D tube labeling and storage
• Micronics (NL)
• Matrix (US)
• ABgene (UK)

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PathoGenoMics how to interact with the Molecular
Tools industry

• Produce a catalogue of available research
  products from ERA-NET
• Contract all the needed genomic and proteomic
  services through a public tender for the industry
• provides assurance for the industry investment in
  resources for the long term
• guarantees certification and data
  interchangeability
• leverages costs among network members
• Provides timely access to needed data for members
  from countries where technology is not
  implemented by industry

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What about licenses, IP?

• Set-up a licensing scheme that is included in the
  grants so that results from ERA-NET sponsored
  research can be developed by companies that have
  already pre-agreed to the licensing scheme,
  speeding the transfer of technology to the
  advantage of the ERA-NET researchers

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NSC ERA-NET
Research Group
Industry
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It is pardonable to be defeated, but never to be
surprised. - SUN TZU, the Art of War

• But you need to be pro-active and bring the
  industry in

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HUMAN RESOURCES AND MOBILITY

• Relocation/exchange of technical expertise among
  northern and southern/eastern countries
• Exchange of spatiality industry workers
• Training scientists in the industry
• Training scientists in Technology transfer

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SBIR / STTR PROGRAMS

• Look to the other side
• What Are the Small Business Innovation Research
  (SBIR) and Small Business Technology Transfer
  (STTR) Programs?
• The Small Business Innovation Research (SBIR)
  program is a set-aside program (2.5 of an
  agency's extramural budget) for domestic small
  business concerns to engage in Research/Research
  and Development (R/RD) that has the potential
  for commercialization. The SBIR program was
  established under the Small Business Innovation
  Development Act of 1982 (P.L. 97-219),
  reauthorized until September 30, 2000 by the
  Small Business Research and Development
  Enhancement Act (P.L. 102-564), and reauthorized
  again until September 30, 2008 by the Small
  Business Reauthorization Act of 2000 (P.L.
  106-554).

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SBIR / STTR PROGRAMS

• The SBIR Program includes the following
  objectives
• using small businesses to stimulate technological
  innovation,
• strengthening the role of small business in
  meeting Federal R/RD needs,
• increasing private sector commercialization of
  innovations developed through Federal SBIR RD
• increasing small business participation in
  Federal R/RD,
• fostering and encouraging participation by
  socially and economically disadvantaged small
  business concerns and women-owned business
  concerns in the SBIR program.
• The STTR and SBIR programs are similar in that
  both programs seek to increase the participation
  of small businesses in Federal RD and to
  increase private sector commercialization of
  technology developed through Federal RD. The
  unique feature of the STTR program is the
  requirement for the small business concern
  applicant organization to formally collaborate
  with a research institution in Phase I and Phase
  II.

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SBIR / STTR PROGRAMS

• In what areas is NIH interested?
• The National Institutes of Health (NIH) welcomes
  SBIR and STTR applications from small businesses
  in any biomedical or behavioral research area
  that falls within our mission, which is to
  improve human health. Areas of interest are
  described in the solicitations below. Applicants
  are encouraged to subscribe to the NIH Guide for
  Grants and Contracts and to visit the websites of
  our Institutes and Centers to learn of emerging
  interests and areas of high priority.

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Tools/Assays developments to follow

• Using PNA in nanodevices for FET detection of
  biological molecules
• Integrated Nanotechologies, US
• Proteins, peptides and fragments are more
  informative about disease than genes
• Identifying and characterizing individual protein
  markers to infection by different agents
• Protein profiling patterns from host infected
  tissues
• Why is it important to characterize the
  interaction of a pathogen microorganism with the
  host at the proteome level?
• ()New pharmaceuticals, biologics, and medical
  devices must gain approval from the U.S. Food and
  Drug Administration (FDA) prior to their
  marketing for clinical use. Genuinely new
  products generally undergo human clinical testing
  to demonstrate their safety and effectiveness for
  a specific clinical application to gain this
  approval. Historically, the endpoints of these
  trials were "traditional" ones tied to the actual
  disease being evaluated, such as a decrease in
  mortality or an objective/semi-objective decrease
  in clinical symptoms associated with the
  condition. In the last 10 to 15 years, there has
  been a move by FDA to incorporate "surrogate
  endpoints," including biomarkers, non-traditional
  findings that are related to the presence or
  absence of disease. Often, biomarkers may be
  measured though various imaging techniques.()