ERA-NET PathoGenoMics

1. ERA-NET PathoGenoMics Industry Discussion Paris, 24th May 2005

2. 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 • US distribution project • Board of the Young Entrepeneur Association (ANJE) Antonio Soares Vaz Pereira SA, Portugal

3. 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 Antonio Soares Vaz Pereira SA, Portugal

4. 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 Antonio Soares Vaz Pereira SA, Portugal

5. 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 Antonio Soares Vaz Pereira SA, Portugal

6. 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 R&D • Clinical trials • Product/Drug • Diagnostic Research • Products / Diagnostic kit • Clinical Laboratory Antonio Soares Vaz Pereira SA, Portugal

7. Global perspective of Molecular Tools Industry • Global Research Market • $23 Billion • $10 Billion US • Invitrogen > $1,2 Billion Sales • BD Biosciences > $0,7 B Sales • Qiagen > $0,5 B Sales • Clinical Laboratory Market • $10 Billion US • Global Biotech Market • $29 Billion Antonio Soares Vaz Pereira SA, Portugal

8. 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 R&D resources • Gov´t research grants (e.g.SBIR) • Joint Development • Collaborative R&D with Academia • Research Grants Antonio Soares Vaz Pereira SA, Portugal

9. 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) Antonio Soares Vaz Pereira SA, Portugal

10. 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 Antonio Soares Vaz Pereira SA, Portugal

11. 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) Antonio Soares Vaz Pereira SA, Portugal

12. 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 Antonio Soares Vaz Pereira SA, Portugal

13. 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 Antonio Soares Vaz Pereira SA, Portugal

14. NSC ERA-NET Research Group Industry Antonio Soares Vaz Pereira SA, Portugal

15. “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 Antonio Soares Vaz Pereira SA, Portugal

16. 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 Antonio Soares Vaz Pereira SA, Portugal

17. 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/R&D) 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). Antonio Soares Vaz Pereira SA, Portugal

18. 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/R&D needs, • increasing private sector commercialization of innovations developed through Federal SBIR R&D • increasing small business participation in Federal R/R&D, • 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 R&D and to increase private sector commercialization of technology developed through Federal R&D. 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. Antonio Soares Vaz Pereira SA, Portugal

19. 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. Antonio Soares Vaz Pereira SA, Portugal

20. 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.(…) Antonio Soares Vaz Pereira SA, Portugal