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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 activitiesV9ZNZ92  ; &Research needs readily available tools ' MIn 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 toolsF}PP}~S@  ;   9IT 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 Laboratory2ZZ%ZZ Z ZZ ZZZZ%             6.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 BillionZ ZZTZZZZZ Z T   @2   4  ^ 7=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 Govt research grants (e.g.SBIR) Joint Development Collaborative R&D with Academia Research GrantsZ:ZZ3ZZ0Z:30  Z  b    D <"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)2,PePPXP+PAP'PP(PPdP,eX+A  '(d@      =@PathoGenoMics: how to interact with the Molecular Tools industryAA ~  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 networkLZQZQ&   D@PathoGenoMics: how to interact with the Molecular Tools industryAA ~  >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)cZ!Z2ZEZZ'Zc!2E  '@z     F@PathoGenoMics: how to interact with the Molecular Tools industryAA ~  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 6ZZ  BWhat 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 Z   CG It is pardonable to be defeated, but never to be surprised. - SUN TZU, the Art of War*YXX v But& you need to be pro-active and bring the industry in <;; EHUMAN RESOURCES AND MOBILITYRelocation/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 HY(PY(P ? SBIR / STTR PROGRAMSLook 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). RPPpO @ SBIR / STTR PROGRAMSThe 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. 4PPPP4  A SBIR / STTR PROGRAMSIn 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. *Z!               0\~ 0:#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. 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jݼݯ׶ݵׯׯޱҷҷҷذװׯׯׯׯׯׯϵϵϵdcd@d@A@A &i׼ޯ׶޵׵׵޵ׯׯׯׯׯׯ֯֯֯֯֯֯ϵϵϵϵϵcccd@c@@@@ j׼ׯׯݶ޶ׯׯׯذذذذذׯׯׯׯׯׯ֯֯ׯװذذذ̫ݵ׵ׯ׵ݼ޶޶׵ׯׯׯ֯޵޼ݵׯׯׯ֯ݶ޵ݼ׵ݼ޼ݯׯׯׯذذׯ֯ׯݵ޶޼ݯׯׯׯ֯׼޵޶ݼ޵ׯׯׯװ֯޼ݶׯ֯ݶݵ޶׶ݼ׵ݼׯׯװذװذ֯޶ݶ޼޼޼ݼװׯݶݶ޼޵׵ݼݼݯׯ׶޼޶ׯݶذװدׯׯװׯذ֯޶ݶݵ׼ݯׯׯدׯׯ֯ݶש޵޶׵ׯׯݶ޵޼ޯ׵޼ݯׯ׶ݵׯ׵ݶݼ޵ׯׯݶذذװذذװׯׯׯׯװذݶׯݼׯݯׯݶ޶޼޶ׯׯ֯ׯɨݶ޼޵׵ݵݵݼׯ׶ݯ֯ݯ׶޶ݯׯ׵ݶݶ޼޼ذذׯׯװׯׯׯ޵ݵݼׯׯ׵ݶ޵ݯݶׯׯ̶֯ׯɣЯ޼ݯ׵ݶݼݵׯׯ׶ׯ׶޶ׯ׵ݶذذذذذׯװذװׯׯװذ֯е֯ݯ׶׵ݵׯݯׯװׯׯ֯ݵ֨ЯШׯ׶׶׶ݼ޵ׯݵݶׯݶذׯװׯׯװׯݼݶ׼ׯذװׯװЯɨݼݵޯݼݯذذׯװذװذذׯװذ޵ݵׯ׵ذɨʨ޵׵ׯׯݵذذذذ׶޵׼ׯ޼ݯʯ׼޵ݼ޵ݼׯׯ׶ذذذװװذذׯװذׯװװ׶޼޼ݵׯذװׯذׯݶ׶ݶ޶޼׶ݯׯׯׯׯׯذذװװׯذׯװذݶݼذذׯׯذׯݶݶݼ޵ݼݯׯׯׯݶض޶ذذذװװذׯ׮ׯׯװذׯװذذж޵޵ذذׯ׍װׯׯװװݼ޵еר޼׵ݵذذذׯׯװװװׯׯװװе޼دװװذذװװݶУЯ׶޵еֵƀƀaaƀƀƀݼ׵޼ݼ׵̀ƀƤƀƀ̀ƀƤƀƣƀ޼޼޼޼ݼ޼ݶ޶ݶ祀ƤƣƀƤƀƀ̀ƤƤƣƀƤƤƀ޼ݶ޼̥ƤƤƀƤƤƀƀƀ̀̀̀ƀƀ̶ݶݼ޼ݶݼݶذ瀀ƀƤƤƀƣƤƀƀݶ޶ݶƀƥƀ̀̀ƀƀƀƀƀƀƀݶݶݶݶ޼޼޼޼ݵݶذضˣƤƤƤƤƤƀ̥̀ƀƤƀƀƣƀƀƤƣƤƀƣƀƀ׶ݶݶ޼ݼ޼޼ݶ׶׵ˤƣƣƣƤˀ̥̀̀޼ƀƀƀƀˀˀˀ׵׵ݵݶݶ׵׵׵޷޷ذѪ̥̀ݵ̀՜.+,D՜.+,P     Apresentao no ecrjvp Arial Wingdings Proposta ERA-NET PathoGenoMics Background#Is this your view of the industry?Where does the industry fits?'Research needs readily available tools`IT IS IMPORTANT TO REALIZE THAT MOLECULAR TOOLS ARE THE ONLY WAY TO TRANSFER IDEAS INTO ACTION/Global perspective of Molecular Tools Industry>How to introduce new products in the Molecular Tools Industry#WHAT DO THEY REALLY WANT FROM YOU?APathoGenoMics: how to interact with the Molecular Tools industryAPathoGenoMics: how to interact with the Molecular Tools industryAPathoGenoMics: how to interact with the Molecular Tools industryWhat about licenses, IP?Diapositivo 14YIt is pardonable to be defeated, but never to be surprised. - SUN TZU, the Art of WarHUMAN RESOURCES AND MOBILITYSBIR / STTR PROGRAMSSBIR / STTR PROGRAMSSBIR / STTR PROGRAMS$Tools/Assays developments to follow Tipos de letra usadosModelo de apresentaoTtulos dos diapositivosd(PX\ _PID_HLINKSVersionA /http://grants1.nih.gov/grants/guide/index.htmlhttp://www.nih.gov/icd/&_0Antonio SoaresAntonio Soares  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~/     .0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ]^_Root EntrydO)?`\Pictures7Current UserJSummaryInformation( UPowerPoint Document(DocumentSummaryInformation8 H < 0/grants/guide/index.html\http://grants1.nih.gov/grants/guide/index.htmlx.http://www.nih.gov/icd/.http://www.nih.gov/icd/`/ 0DArialngs0TT-ܖ 0ܖDWingdings0TT-ܖ 0ܖ@ . @n?" dd@  @@`` ( Y()      **//..HH,,      /XR$*Wa++lڣLR$a12TL 0AA @8.-/.?O ʚ;G u8ʚ;g4IdId; 0Pppp@  <4dddd l 0T<4KdKd l 0Tg49d9d0  0p@ pp80___PPT10 pp?  %O  =I4 ERA-NET PathoGenoMics (Industry Discussion Paris, 24th May 20056  5 BackgroundtMS, 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),P+P-PWP'PPPP>PPPP PPP2P,+-W'    >   $$((,,200   j              <     /    J"Is this your view of the industry?## ~j 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 companyZ&u  : > 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 activitiesV9ZNZ92  ; &Research needs readily available tools ' MIn 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 toolsF}PP}~S@  ;   9IT 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 Laboratory2ZZ%ZZ Z ZZ ZZZZ%             6.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 BillionZ ZZTZZZZZ Z T   @2   4  ^ 7=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 Govt research grants (e.g.SBIR) Joint Development Collaborative R&D with Academia Research GrantsZ:ZZ3ZZ0Z:30  Z  b    D <"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)2,PePPXP+PAP'PP(PPdP,eX+A  '(d@      =@PathoGenoMics: how to interact with the Molecular Tools industryAA ~  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 networkLZQZQ&   D@PathoGenoMics: how to interact with the Molecular Tools industryAA ~  >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)cZ!Z2ZEZZ'Zc!2E  '@z     F@PathoGenoMics: how to interact with the Molecular Tools industryAA ~  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 6ZZ  BWhat 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 Z   CG It is pardonable to be defeated, but never to be surprised. - SUN TZU, the Art of War*YXX v But& you need to be pro-active and bring the industry in <;; EHUMAN RESOURCES AND MOBILITYRelocation/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 HY(PY(P ? SBIR / STTR PROGRAMSLook 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). RPPpO @ SBIR / STTR PROGRAMSThe 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. 4PPPP4  A SBIR / STTR PROGRAMSIn 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. *Z!               0\~ 0:#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.(& )CPPPPPuPJPCPT    6    /I< - 0L0  $(   r   S     r   S     H   0޽h ? ff9ŋf\l80___PPT10.?`|rJ@J ՜.+,D՜.+,P     Apresentao no ecrjvp Arial Wingdings Proposta ERA-NET PathoGenoMics Background#Is this your view of the industry?Where does the industry fits?'Research needs readily available tools`IT IS IMPORTANT TO REALIZE THAT MOLECULAR TOOLS ARE THE ONLY WAY TO TRANSFER IDEAS INTO ACTION/Global perspective of Molecular Tools Industry>How to introduce new products in the Molecular Tools Industry#WHAT DO THEY REALLY WANT FROM YOU?APathoGenoMics: how to interact with the Molecular Tools industryAPathoGenoMics: how to interact with the Molecular Tools industryAPathoGenoMics: how to interact with the Molecular Tools industryWhat about licenses, IP?Diapositivo 14YIt is pardonable to be defeated, but never to be surprised. - SUN TZU, the Art of WarHUMAN RESOURCES AND MOBILITYSBIR / STTR PROGRAMSSBIR / STTR PROGRAMSSBIR / STTR PROGRAMS$Tools/Assays developments to follow Tipos de letra usadosModelo de apresentaoTtulos dos diapositivosd(PX\ _PID_HLINKSVersionA /http://grants1.nih.gov/grants/guide/index.htmlhttp://www.nih.gov/icd/&_0Antonio SoaresAntonio Soares