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Innovation management: experience from the Danish ... - Urenio

Biotechnology clustersInnovation management:experience from the Danishbiotech cluster of AarhusPlans for a Biotech Cluster within theThessaloniki Innovation Zone(prepared for Aristotle University of Thessaloniki,School of Architecture, Jan 18, 2008)Iordanis Arzimanoglou, , Ph.D.Alexander Innovation ZoneThessaloniki, Greece


BioKorea 2007 Conference• Biotechnology Companies• Pharmaceutical Companies• BioResearchInstitutions• Venture Capital Investors with focus innovativebioproducts• Bioternd: Bio-clustersclusters/Bionetworks/Innovation Zones-Promotepolicies to support the bio industry,-Identifytechnology transfer opportunities,-Networkwith bio companies and research centers across theworld-AttractInvestment into big companiesAlexander Innovation ZoneThessaloniki, Greece


The 10 th Annual BioCEO andInvestor ConferenceNew York, Feb 11, 2008BIO CEO MISSION: BIO brings together biotechnology CEOs, members of theinvestment community and other key industry supporters in a neutral and collaborativeforum to examine investment opportunities and issues affecting the industry.TARGET AUDIENCE: Public and private equity investors, research analysts, investmentbankers and senior-levelindustry executives focused on investment trends and businessdevelopment opportunities in the biotechnology industry.Why Companies Attend:• Present company story to an audience of target investors• Meet one-onon-oneone with investors, analysts, invest.bankersand potential corporatepartners• Hear panel discussions and keynotes by veteran investment and company executives• Network with peers, investors and potential partners attending the conference• Get the pulse on the current and proposed investment trends in biotechnologyWhy Investors Attend:• Hear from and meet one-onon-oneone with management from the top biotech companies• Evaluate fresh investment opportunities including compatible, complementary andcompetitive companies• Attend candid panel discussions with leading clinical experts and company experts onthe latest therapies and technologies in developmentAlexander Innovation Zone• Get a ‘big‘picture’ overview of the industry and the issues affecting Thessaloniki, investmentsGreece


BiotrendBioclusters/BioregionsBionetworksBiopartnering organizationsBiomedical Science andTechnology Strategy UnitsAlexander Innovation ZoneThessaloniki, Greece


Biopolis, Singapore:biocluster with pharma R/D centersPharmaceutical giant GlaxoSmithKline invested $37 Mon aresearch facility focusing on new therapies forAlzheimer's,Parkinson's and other neuro-degenerative diseases. Thefacility will be housed in the state-ofof-the-art laboratoriesofthe Biopolis, Singapore's high-end biomedical researchcenter, GSK said in a statement.Singapore’s Concern: : What might happen if the bigpharmaceutical companies decide to move their R/DdeptsAlexander Innovation ZoneThessaloniki, Greece


Biocluster formation aroundPfizer’s Research TechnologyCenter (RTC)• RTC involves innovative science to identifyand validate drug discovery targets for Pfizer• RTC is surrounded by 300 biotechcompanies and world-leading leading researchhospitals and academic institutions(biocluster formation)• The result of the biocluster is a growingnumber of partnerships and eventually adynamic portofolio for PfizerAlexander Innovation ZoneThessaloniki, Greece


European bioclusters, bionetworks• Medicon Valley Alliance• Netherlands Genomics Initiative (NGI), Netherlands• Flanders inter-university Institute of Biotechnology(VIB) Belgium• BioLondon: London Biotechnology NetworkThe above-organizations organizations aim to optimally integrate theopportunitiesoffered by the genomics and biotechnology research in theirrespectivecountries in order to create a continuous stream of new bio-businessactivityAlexander Innovation ZoneThessaloniki, Greece


Medicon ValleyAcademy/Alliancebiocluster (2 countries involved)biocluster• MVA is a world class life science clusterorganization organization for the Danish-Swedish life science cluster• MVA is a non-profit, fee based memberorganization taking cross border initiativescreating synergies and value for over 250members which include companies, hospitalsand universitiesAlexander Innovation ZoneThessaloniki, Greece


Medicon Valley Alliancebiocluster success• According to 3i, one of the biggest EuropeanVCs with capitalization around 8 bn EuroMedicon Valley Alliance has been verysuccessful in marketing its biocluster. As aresult of the cluster success, British investorskeep an eye on MVA companiesAlexander Innovation ZoneThessaloniki, Greece


Finnish model for biodevelopmentacross all the biochain: BioTurkuclusterAlexander Innovation ZoneThessaloniki, Greece


London Genetics techtransfer bionetwork• Seven London institutes created “London Genetics”bionetwork with focus on tech transfer to generateand manage partnerships between leadingresearchers and the biotech and pharma industry• Consortium is composed of: King’s CollegeLondon, Univ. College London, Imperial CollegeLondon, Quenn Mary, St George;s Univ. ofLondon, The London Scholl of Tropical Medicineand Hygiene, and The Institute of Cancer ResearchAlexander Innovation ZoneThessaloniki, Greece


US biopartnering organizations• Science Center in the Greater Philadelphia region: : itconnencts scientists growing companies andinternational companies, and VCs and focuses onforming and funding new life sciences and technologycompanies• New Jersey - Commission on Science and Technology• US Georgia office of Science & technology: : a divisionspecializing to recruit and support technology and lifesciences companies• The state-sponsoredsponsored Biomedical Research &Technology Transfer Office and Fund, OhioAlexander Innovation ZoneThessaloniki, Greece


Scandinavian networks in medicaltechnology (3 countries involved)• Finland, Norway and Sweden joined forces toinform the US life sciences industry about the strongcompetencies in the Nordic countries• The objective was to partner small Nordic medtechcompanies (specialized networked cluster) with UScorporations and VCs thereby attracting moreforeign investments in house• The medtech industry in Denmark accounted for31% of the turnover in the Danish healthcare systemin 2006Alexander Innovation ZoneThessaloniki, Greece


Commercialization of bioresearch:Strong EU political impactA European strategy for more growth & jobs:• What policies are required to exploit R/Dbreakthrough opportunities• A biotech strategy at a regional European level ispromotedthe Gent/Flanders region, Belgium orthe Aarhus region, , Denmark orthe Thessaloniki region, , Greece, etc.3rd European Business Summit, Brussels, Alexander Mar. Innovation 2004ZoneThessaloniki, Greece


Danish experience:Aarhus biotechnology clusterAlexander Innovation ZoneThessaloniki, Greece


Aarhus Biotechnology ClusterExperience from DenmarkAarhusCopenhagenAlexander Innovation ZoneThessaloniki, Greece


Aarhus remarkableachievements• Nobel Prize: Prof. Jens Chr. Skou was awarded theNobel Prize in Chemistry in 1997 for his pioneeringwork in Physiology: the first discovery of an iontransporting enzyme.• Descartes Prize: Prof. Lars Fugger was awarded theprestigious “little Nobel Prize” in 2002 for his worktackling Multiple Sclerosis• Research standard in clinical research: the Institute ofClinical Medicine (AU) produces 1.5 – 2‰ of theworld's clinical research publications in peer-reviewedreviewedjournalsAlexander Innovation ZoneThessaloniki, Greece


Aarhus biotech clusterInnovation/first ranks• First company in Europe to sign an agreementwith Affymetrix to use its chip for molecularprofiling and develop molecular classifiers• First company in Denmark to produce GMOplants as a vehicle to develop a therapeutic toolagainst vitamin B12 deficiency, which can lead toAlzheimer• First Biomedical Engineering education withfocus on entrepreneurship, 1999• Danish pioneers in introduction &implementation of electronic patient Alexander journalsInnovation ZoneThessaloniki, Greece(EPJ)


Aarhus competitive researchfields due to innovation• Nanotech-center center (www.inano.dk(www.inano.dk)• The PET center (www.pet.au.dk(www.pet.au.dk)• X-ray crystallography• Water and salt centre, (www.waterandsalt.au.dk(www.waterandsalt.au.dk):Nobel laureate: Schou• RNA analysis/delivery Centre (www.sirna.dk(www.sirna.dk)• Biomedical EngineeringAlexander Innovation ZoneThessaloniki, Greece


Aarhus, DenmarkLife Sciences and Biotechnology ClusterProducts and ServicesHealth Care ITPervasiveHealth CareDevices forrehabilitationDisposablesDiagnosticdevicesDiagnosticKitsDrugDiscovery:technologyplatformAlexander Innovation ZoneThessaloniki, Greece


Aarhus ongoing collaborationwith big bioindustryGeneral Electric, Philips, Ferring, , BavarianNordic, Novo Nordisk, Danisco, Lundbeck,Cambridge Antibody Technology, Arla FoodsAlexander Innovation ZoneThessaloniki, Greece


BMF/Biomedical Science Park,Aarhus, DenmarkBioMedico Forum (BMF) is a biotechnology research andbusiness strategy organization with overall aim to gaincompetitive advantage for the Aarhus region, Denmark.Morespecifically, the tprimary goals are to:design strategy,catalyze,support, andcoordinatebiotechnology development in the respective regionAlexander Innovation ZoneThessaloniki, Greece


BMF/Biomedical Science Park:Members of the bionetwork University Departments/Divisions Hospital Divisions >50 Biotech and Med Tech start-up companies >20 Biotech-support firms with different businessobjectives e.g. IPR, bank high tech investment depts,consulting, regulatory affairs Regional authoritiesAlexander Innovation ZoneThessaloniki, Greece


BMF strategy:Aarhus biocluster as a virtual organizationStrategy Development for the Aarhus bioclusterin Denmark. According to this strategy, weenvision the entire region as one virtual bio-organization.networked(New Economy strategy model: Specializedregion vs self-contained regional cluster)Alexander Innovation ZoneThessaloniki, Greece


BMF strategy:Aarhus biocluster as a virtual organizationBMF role includes:• Design strategy and business development planfor the entire bioregion/biocluster• Coordinate activities within the biocluster• Acquire profound knowledge of the worldwidebiotrends (e.g. biodefense in Denmark, is one ofthe fastest-growing new sectors to developsensors, vaccines, etc)Alexander Innovation ZoneThessaloniki, Greece


BMF strategy:Aarhus biocluster as a virtual organizationBMF role to:• Gather a critical mass under Aarhus regionumbrella• Focus on IP protection and commercialization ofbreakthrough discoveries• Tackle the seemingly problem: companyproprietary information vs sharing criticalknowhow• Develop the feeling of ownership from eachcompany and everyone involvedAlexander Innovation ZoneThessaloniki, Greece


BMF strategy:Innovation in foreign investmentpolicyBMF & Invest in DenmarkBMF provides “Invest in Denmark” (the Danishnational inward organization) with criticalinformation about the Aarhus biocommunity.In addition, Aarhus scientists and managers train“Invest in Denmark” employees stationedabroad, so to better represent Danish bio-interests internationally.Alexander Innovation ZoneThessaloniki, Greece


BMF marketing strategy:Innovation in promoting the clustervia specific-target audience journals• Exposure of Danish competencies to MEPs, EC,using influential magazines like EU Parliament• ”Finance International” to access CEOs worldwideScandinavian Life Sciences journal• Access to US bio-community via journals like:Pharmaceutical Discovery (formerPharmaGenomicsAlexander Innovation ZoneThessaloniki, Greece


Alexander Innovation ZoneThessaloniki, Greece


The ParliamentIssue 173, 15 th December 2003p. 47Alexander Innovation ZoneThessaloniki, Greece


Spring 2005, p. 120 -121Alexander Innovation ZoneThessaloniki, Greece


Scandinavian Life Science JournalIssue 1 – 2005, p. 31 - 32Alexander Innovation ZoneThessaloniki, Greece


BMF strategy:Innovation in Match-making activityvia Embassy channels• Switzeland: Ambassador to help us in gettingconnected with the senior management of theSwiss Pharma: Novartis, Roche• United States: Ambassador and First Secretaryarranged for meetings with US biotechs andinfluential US-based academics• Canada: Ambassador, IRAP network linked uswith GenomeCanadaAlexander Innovation ZoneThessaloniki, Greece


Innovation in in R/D policyIdeaPolicyScienceTechnologyVC BankingsectorLobbyingIntellectualPropertyPublic-PrivatePartnershipsAllianceManagementThe very rich Lundbeck fund is to dedicateEuro 35 M to help Danish researchers tostay in Denmark to research. One ofDenmark’s largest money tanks theLundbeck fund will now attract the bestDanish brains abroad to return home toresearch to be of benefit to Denmark,writes “Berlingske“Business”.Alexander Innovation ZoneThessaloniki, Greece


BMF strategy:Innovation in biomapping activityWestern Denmark electronic biomap projectAn innovative mapping project to:• accurately map the Western Denmarkbioregion to reveal biocompetencies for thepurpose of attracting foreign investments andestablishing research and business bio-partnership• to surface hidden know how potential, whichpreviously was not fully recognizedAlexander Innovation ZoneThessaloniki, Greece


Network ViewDatabase ViewGeographical ViewAll playersBioinformaticsMedicaltechnologyF&ACompaniesBMFHealth Biotech& BiomedicalSupportiveAcademiaProduct- basedPlatform- basedHospitalsView All 5 divisions Select AreaAlexander Innovation ZoneThessaloniki, Greece


Western Denmark BiocompetenciesBiocompetenciesTechnologyProductSearch:Network ViewList ViewKeywordsPop-upwhen Mouse– over theUNIT ofpossibleinterestBvsbd bdbDbbC ABCCBBiotechnologyBiologyEnvironmentcomGeneticsFavorites:•Cbvbbfx•Vcxvfafa•Xvcvfagf•Bxvhg⊗⊗⊗⊗BioinSelect: X All □ CompaniesCompanies □ Academia/HospitalsAlexander Innovation ZoneThessaloniki, Greece


BMF overall strategy:Aarhus biocluster to gain competitiveadvantage in the global marketTo facilitate partnership between Danish andforeign Biotechs/Pharma for codevelopment andout-licensing of Danish technology/bio-products• To help Aarhus companies to gain competitiveadvantage in the fierce world Bio-arena• To considerably impact as biocluster in EuropeAlexander Innovation ZoneThessaloniki, Greece


Aarhus biocluster, DenmarkBiotech company categories• Selected Drug Discovery Biotech companies• Selected Non-Drug Discovery Biotechcompanies• Selected Medical Technology companies• Food and food-supplementcompaniesAlexander Innovation ZoneThessaloniki, Greece


Aarhus biocluster, DenmarkSelected Drug Discovery Biotechcompanies (moderate at national level)• Action Pharma: Acute myocardial infarction and inflammatory diseases• ReceptIcon: Treatment of drug-related related adverse effects (organ damage) e.g.renal cancer• Cobento: Production of recombinant therapeutic proteins in GMO plants fortreatment of vitamin B12 deficiency, which can lead to dementia and depression• Borean Pharma: Trimerization technology platform leading to development of humanprotein drugs of high specificity. Application in a wide spectrum m of diseases• Cell Cure: Development of patient-specific therapeutic protocols for metastatic Ca• Senentek: development of advanced treatments for anti-aging aging (HQ in California)Alexander Innovation ZoneThessaloniki, Greece


Biotech company: Action PharmaEstablished: 2000, Locations: HQ in Aarhus, office in Copenhagen,Focus: Discovery and development of new drugs and treatment concepts withinwdiseases associated with ischemia and inflammationKey company information:• R&D pipeline with pre-clinical validated targets• Company completing clinical development of selected program• Orphan drug indication and hence “fast track” regulatoryadvantages• Strategic collaborations with two European biotech companies• Several bn $ markets with attractive commercial perspectives• Busin. . model: out-licensing opportunities supported by strongIPR• Acquired total venture capital in excess of $ 3 M (2000-2005) 2005) fromlocal VCs: Incuba Ventures, Vækstfonden.Alexander Innovation ZoneThessaloniki, Greece


Action Pharma (II)(www.actionpharma.com)Dermatitis (include atopic dermatitis and psoriasis), SIRS = systemic inflammatory response syndrom; AMI = acute myocardialinfarction; ARF = acute renal failure; COPD = chronic obstructive pulmonary disease (with focus on acute inflammatory excerbations).Alexander Innovation ZoneThessaloniki, Greece


• Aros Applied Biotechnology: Gene expression analysis by oligonucleotide chips andmicro-array service provider. European pioneer in Affymetrix chip analysis• DNA Technology: Custom-made made oligonucleotides and molecular diagnostic kits• ProteoTarget: Phage display technology focused on malignant cell proliferation• Loke Diagnostics: Chlamydia and Mycoplasma molecular diagnostic products andvaccine developmentAarhus biocluster, DenmarkSelected Non-Drug Discovery Biotechcompanies(moderate at national level)• Pipeline Biotech: Pharmacological CRO offering pre-clinical and pharmacokineticstudiesAlexander Innovation ZoneThessaloniki, Greece


AROS Applied Biotechnologywww.arosab.comEstablished: 2000, by scientists at the Mol. Diagn. . Lab, AUH (University spin out).Key contact: Torben Ørntoft. . Employees: 7A leading microarray service provider and CRO for thepharmaceutical industry and the academic community. Aros wasthe first European institution to purchase an Affymetrix system(1999), and went into a business partnership with Affymetrixthat has continued without interruptions ever since. Thus AROS is iofficial Service Provider for the complete product line ofAffymetrix's genomic chip platforms.Alexander Innovation ZoneThessaloniki, Greece


Aarhus biocluster, DenmarkSelected Medical Technology companies(strong nationally & competitive in Europe)Development and production of equipment for• Vivox: control of temperature & gas composition• Curatio: Wound cleaning• Danish Myo Technology: Myographs for physiology and pharmacology studies• HistOtech: Preservation of the stereology/3D structure of pathological sections• Med. Engineering: Pulse measuring and other handheld measurement devicesNRT: X-ray equipment development providing for GE and Philips among others• Pysiotech: Physiotherapy and rehabilitation• Unisense: Microsensors for environmental & IVF purposesAlexander Innovation ZoneThessaloniki, Greece


Aarhus biocluster, DenmarkFood and food-supplementcompanies(very strong, internationallycompetitive)Modern biotechnology is an integrated part of the Aarhus foodlarge corporations: Arla, , Aarhus United, Compact, Ceres,Danisco and Danish Crown - and SMEs, which possess long trackrecord & experience in:•Sugar and sugar-derivates•Dairy products and derivates•Oil and derivates•Diverse equipment and machinery with focus on the foodindustryAlexander Innovation ZoneThessaloniki, Greece


UniversityAarhus County& MunicipalityAarhus Food industryInvest in DenmarkAarhusUniversityHospitalBMFBiomedicalScience ParkStart-upbiotech andmed techcompaniesAarhus biocluster,DenmarkBiomedicalEngineer.Invest: pre-seed, seed,VCsIPRFirmsEUfundingBiotechcompaniesBigPharmaBIOMARKETAlexander Innovation ZoneThessaloniki, Greece


Innovation ZoneEnvironmentimpact onNew bioeconomyAlexander Innovation ZoneThessaloniki, Greece


InnovationZone/environmentAn Innovation Zone/Environment• Needs to have access to first class research(first Max Plunk Institute outside Germany)• Supports the commercialisation of researchideas• Is critical to new technology innovativeSMEs• can generate growth for the entire respectiveregionAlexander Innovation ZoneThessaloniki, Greece


Innovative start-ups give birth toNew Economy• In any industry over 80% of all start-ups failwithin five years• What are the critical factors for a newtechnology company-usually a spin out froma university-to to sustain, become innovativeand achieve commercialization of its patent-protected research discoveries?Alexander Innovation ZoneThessaloniki, Greece


Critical factors for new technologystart-up companies to grow andsustain• Breakthrough research results to base yourbusiness plans• Follow scientific and technology trends• Access to key business development personnel(technology valuation, licensing, ..)• Intellectual Property (patent portofolio)• Negotiating Partnership/AllianceManagement• Innovation Zone environment/clusterAlexander Innovation ZoneThessaloniki, Greece


Dubai Innovation Zoneworld class cluster and businesshub• DuBiotech (Dubai biotechnology park)• The Foundation for research and innovation• Dubai internet city• Dubai media city• Knowledge village and academic cityAlexander Innovation ZoneThessaloniki, Greece


Thessaloniki Innovation Zone:Actions Accomplished•Completion of legislative framework inaccordance with EU regulations•Creation Creation of Alexander Innovation Zone S.A.(AIZ)•Operation of A.I.Z started mid summer 2007•Initial Initial funding received early Nov. 2007 after itwas seriously cut from that originally requested.As a result no personnel yet nor company officesrentAlexander Innovation ZoneThessaloniki, Greece


Thessaloniki Innovation Zone area(current situation)RESEARCH INSTITUTES &TECHNOLOGY PARKTECHNOLOGY MUSEUMLarge private owned land(land reserve forInnovation Zone)THESSALONIKITECHNOPOLISunder construction(10 ha.- 70 tenants)IT firms3 Business Incubators(35 incubatees)THE SEALarge state owned land(land reservefor Innovation Zone)Alexander Innovation ZoneThessaloniki, Greece


•Strategic Strategic Plan for the Thessaloniki Innovation Zone(Under the auspices of Ministry of Macedonia-Thrace)•Thessaloniki Innovation Zone land surveys, Spatialplanning, Master Plan (Under the auspices of Ministry of MacedoniaThrace)Thessaloniki Innovation ZoneAlexander Innovation Zone S.A.:.:Actions in progress(Under the auspices of Ministry of Macedonia-• Large state & private owned plots survey for candidateareas to become part of the Innovation Zone [SedesSedes old militaryairport (50 ha), AFS area adjacent to Technopolis, , (30 ha), Min. of Agriculture (18 ha)]• Incentives for companies to settle within the Zone(preliminary work completed)Alexander Innovation ZoneThessaloniki, Greece


Plan for a Biotech clusterwithinthe Thessaloniki InnovationZone areaAlexander Innovation ZoneThessaloniki, Greece


1. Institute of Biomedical andBiomolecular Research (IBBR)The Institute of Biomedical and BiomolecularResearch(IBBR) was created in 2007. IBBR goals are in thesupportof biomedical research based on a multidisciplinaryapproach amongst various scientific thematic areas in:• Biomedicalinformatics,• Biomedicalengineering,• Molecularmedicine, and• Pharmacogenetics/pharmacogenomicspharmacogenomics.Alexander Innovation ZoneThessaloniki, Greece


1. Institute of Biomedical andBiomolecular Research (IBBR)The Institute aims in supporting researchdevelopmentin the basic as well as applied biomedicalarea. Thedevelopment, assessment and standardization ofinnovative research as well as spin-offbiotech andbiomedical engineering companies for the supportand uptake of innovative applications, , services andproducts aimed at medical practice with emphasis s ondisease prevention and non-invasivetreatment ofdiseasesAlexander Innovation ZoneThessaloniki, Greece


2. Economou-KoskinasBrain & Intelligence Institute,Thes/nikiSectors and Divisions• Basic Neurosciences• Structural and Functional Neuroscience• Behavioral and Cognitive Neuroscience• Applied Neurosciences• Decisions and Policy Making• Mind and Creativity• Special Education ApplicationsAlexander Innovation ZoneThessaloniki, Greece


Atlas of Cytoarchitectonics of the Adult Human Cerebral CortexEconomo C von, Koskinas GN, Triarhou LC (2008) Karger, , Basel, p. 171What we group under the name of the sciencesis, as the application of the word in the pluralshows, no single entity, but consists of manyseparate fields of knowledge, which often lie farapart. Through the increase of such knowledge,these fields increase, and their boundaries,originally far apart, approach each other moreand more. The investigation of these borderzones then becomes one of the most interestingproblems in science and a new branch ofscience itself, whereby the experience andmethods of one speciality are applied to theother and entirely new points of view arereached that lead to fruitful work in both fields.– Constantin von Economo * (1931)Alexander Innovation ZoneThessaloniki, Greece


3. Investing in biomarkertechnologyThe use of biomarkers in BioPharma R&D and diagnosticswill enable more precise, predictive and preventive clinicalcare. Biomarker-enabled R&D is evolving into a newdiscipline with a strong patient focus. Many organizationsthat believe in biomarker enabled R&D, are investing inbiomarker technology. Many leading companies, such asNovartis, Eli Lilly, Bristol-Myers Squibb, Pfizer and Bayer,have developed new R&D processes based on theuse of biomarkers throughout the clinical trials process forcardiology, oncology and neurology.IBM Global Business ServicesAlexander Innovation ZoneThessaloniki, Greece


3a. Biomarkers & Imaging fieldIn the imaging field, biomarkers are increasingly beingused non-invasively to assess• patients’ localized disease progression and• response to drug candidatesBiomarkers can help determine whether• the drug reaches the target,• it affects biological activity,• and, if it does, whether that effect leads to thedesired clinical outcomeIBM Global Business ServicesAlexander Innovation ZoneThessaloniki, Greece


3b. Biomarkers in clinical trialsInnovative strategies are needed for biomarkerdiscovery and validation that parallel theapproach to therapeutics. A collaborativeapproach to biomarker discovery usingstandardized tissue and biological fluidspecimens, ideally collected as part of clinicaltrials, has the potential to Fasttrack biomarkerdiscoveryAlexander Innovation ZoneThessaloniki, Greece


3c. Biomarkers pave the way forInformation-Based MedicineBiomarkers are becoming a foundation for informationbasedmedicine in determining who should be treated,how and with what. For biomarkers to reach their fullpotential, alone or in combination, they must undergotheir own development process. Biomarker developmenthas lagged significantly behind therapeutic developmentbecause of scientific, economic and regulatory factors. Itis important to accelerate biomarker development and tohelp biomarkers advance in parallel with therapeutics,but, they must be tested with established therapiesIBM Global Business ServicesAlexander Innovation ZoneThessaloniki, Greece


3d. Biomarkers Value forthe biotech companiesBiomarkers provide increasing value as companiesmove along the path from drug discovery to productlaunch because:• Costs go up at each progressive stage.• More knowledge is needed to reduce risks atprogressive stages.• Regulatory “proof” requires more rigor as oneapproaches approval “stage-gates.”• Technique and technology must be “locked down”through the multiyear clinical phasesIBM Global Business ServicesAlexander Innovation ZoneThessaloniki, Greece


3e. Biomarker Consortium: Innovationin PPP NIH approach to speed upclinical useThe Biomarker Consortium is a program sponsored by the Foundationfor the National Institutes of Health to bring private and publicpartners together to support the NIH vision. Its strategy is to create“harmonized approaches” to speed up biomarker value and formal useto promote research, regulatory approval, and more informed decisions.The Consortium carefully develops policies to address IP concerns,data sharing, antitrust issues, grantee/contractor selection,confidentiality and conflicts of interest. Currently, the BiomarkerConsortium is focusing on three projects:• Neuroscience: Major Depressive Disorder – identifying its genomicbiomarkers• Metabolic diseases: Such as diabetes• Oncology: FDG-PET for lung cancer and lymphomaIBM Global Business ServicesAlexander Innovation ZoneThessaloniki, Greece


4. Outsourcing biomanufacturing inthe Thessaloniki Innovation ZoneBiotech companies will rely upon an outsourced businessmodel like the 60% of pharma industry. This is true forbioregions as well. A region doesn’t have to build itself upasanother San Diego. For instance a company in Seattle canhave manufacturing in Carolina, marketing offices inNewJersey, and clinical trial in Kansas. Regions with specificstrengths in this outsourced business model will beinterconnected with each otherAlexander Innovation ZoneThessaloniki, Greece


Roche Holding AG to Invest about$400M to Expand Biotech Operations• 1/18/2008ZURICH (MarketWatch(MarketWatch) -- Roche HoldingAG Friday said it plans to invest $391 millionto expand biotech drug research,development and production at sites inSwitzerland and Germany.Alexander Innovation ZoneThessaloniki, Greece

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