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SBW	
  Discovering	
  Success	
  
Cascading	
  service	
  models	
  with	
  SBW	
  -­‐	
  a	
  Finnish-­‐Indian	
  
   research-­‐service	
  corpora<on	
  with	
  comprehensive	
  
    exper<se	
  in	
  drug-­‐discovery,	
  func<onal	
  foods	
  and	
  	
  
                  chemical	
  safety	
  industries	
  
SBW in a nutshell

•    Contract Research Services for Pharmaceutical and Biotech customers

•    Headquarter in Helsinki, Finland, offices / laboratories in total 7 cities in
     Finland, Sweden, UK and India
      •  Discovery informatics: bioinformatics, chemoinformatics, structural / SBD
         informatics
      •  Discovery biology; biomarker analytics and discovery
      •  Early and preclinical toxicology
      •  In vivo pharmacology
      •  ADME / DMPK
      •  Biostatistics, clinical data management and data warehousing


•    140+ pharma/biotech customers in more than 20 countries. Organic
     revenue increase 2007-2008 around 50%. More than 60 professionals.

•    Owned by Helsinki University Funds and Tooltech Pvt Ltd (Indian CAD/CAM
     and engineering simulations, offices in 7 European countries, India and US)
SBW Solutions for Drug Research
                                                                                                                                                       Regulatory/
    Indica'on	
             Target	
               Screen	
                   Hit	
                   Lead	
                  Candidate	
                 IND	
                       Phase	
  0	
                Phase	
  1	
              Phase	
  2	
           Phase	
  3	
  




                    SBW-­‐α	
                                                                                                                                                                                                SBW-­‐η	
  
                                    SBW-­‐β	
                                                                                                           SBW-­‐ε	
  

                                                                            SBW-­‐γ	
                                   SBW-­‐δ	
  


SBW-­‐α	
                                                         SBW-­‐γ	
                                                                   SBW-­‐δ	
                                                                       SBW-­‐η	
  
• Whole	
   genome	
   transcriptomics	
   and	
                  • In	
   silico	
   bioac'vity,	
   adverse	
   effect	
                     • In	
  vitro	
  metabolism	
                                                   • Sample	
   size	
   es'ma'ons	
   and	
   power	
  
gemomics	
                                                        and	
  toxicity	
  predic'on	
                                              • CYP	
  iden'fica'on	
  and	
  inhibi'on	
                                      analysis	
  
• Proteomics	
                                                    • Scaffold	
  hopping	
  and	
  op'miza'on	
                                 • M etabolite	
   iden'fica'on,	
   MIST,	
                                      • Randomiza'on	
  
• Biomarker	
  discovery	
  and	
  valida'on	
                    • Experimental	
   logP,	
   logD,	
   logS,	
   pKa	
                      different	
  species	
                                                           • CRF	
  design	
  
• Genome-­‐wide	
   bioinforma'cs	
   and	
                       analysis	
                                                                  • PAMPA,	
  Caco-­‐2,	
  MDCK	
  permeability	
                                 • Database	
   design,	
   data	
   entry	
   and	
  
computa'onal	
  systems	
  biology	
                              • Plasma	
  protein	
  binding	
                                            • In	
   vitro	
   cytotoxicity,	
   prolifera'on,	
                            valida'on	
  
                                                                  • PAMPA	
  permeability	
                                                   membrane	
  integrity	
                                                         • Sta's'cal	
  analysis	
  and	
  repor'ng	
  
                                                                  • Metabolic	
  stability	
                                                  • In	
  vivo	
  pharmacokine'cs	
                                               • Medical	
  wri'ng	
  
                                                                                                                                              • In	
  vivo	
  disease	
  models	
  
                                                                                                                                              • Safety	
  pharmacology	
  
                                                                                                                                              • In	
  vivo	
  toxicology	
  

                                SBW-­‐β	
                                                                                                                SBW-­‐ε	
  
                                • Virtual	
   HTS,	
   ligand,	
   target,	
   and	
                                                                     • GLP	
  in	
  vivo	
  toxicity	
  
                                reverse	
  docking	
                                                                                                     • GLP	
   in	
   vivo	
   safety,	
   ICH	
   Core	
   Ba^ery	
  
                                • 	
  Library	
  design	
                                                                                                etc	
  
                                • In	
  silico	
  ADME	
  models	
  
                                • In	
  vitro	
  assay	
  development	
  
What suites you best?


  Fee	
  for	
  service	
                                         Risk	
  sharing	
  model	
  
            	
                                                                	
  
Consulta've	
  model	
                                           Collabora've	
  model	
  
            	
                                                                	
  
  Protocol	
  based	
                                              Milestone	
  based	
  
            	
                   Your	
  preference	
                         	
  
   Price	
  /	
  study	
                    	
                   Fixed	
  price	
  /	
  project	
  
                               Based	
  on	
  your	
  need	
  
                                            	
  
                              Personal	
  customer	
  care	
  
Levels Of Engagement
           Close co-work, possibly in-site,                                     Level 4
         possibly external funding applied,                Complete Drug Discovery / Development project
                     involving risk-sharing                                partnership

      SBW involvement in focused
     areas of discovery, like LI, LO
       etc. Involvement of multiple
                                                                           Level 3
                                                    Managed project involving many types of expertise in
        units from SBW, sharing of
                                                          combination with sponsor’s expertise
                related project data

    Master agreement with
   SBW, confidentiality and
                                                               Level 2
                                        Utilization and coordination of services from multiple
expertise from multiple units
                                                                units



                                                 Level 1                             Master agreement for
                            Repeated utilization of services from individial unit    repeated services




                                Level 0                              Individual service(s), NDA &
         Outsourcing of individual analytics - internal capactiy     agreement with the
             extension and internally unavailable tasks              corresponding unit
Discovering Success together
                                                with SBW
•  Program Management Services
–  We act as your tactical, logistical and scientific interface with our
   drug discovery resources.
–  Diverse scientific expertise from Discovery Biology to Preclinical and
   Clinical Development.
•  Business Models
      - We aim to form strategic alliances with our customers, where
      entire drug discovery programs are contracted and payment is
      based on mutually agreed milestones and success.
•    BPO – Business Process Outsourcing
•    Joint development
•    Academic collaboration
•    Indian delivery capabilities
•    Risk and Reward sharing models
•    EU, Government and competitive funding
SBW Organization

                                                            SBW	
  HQ	
  
                                                            Helsinki,	
  
                                                            Finland	
  

        Toxis	
            Novamass	
          4Pharma	
                 Biodix	
                 Medachem	
             Infodix	
  	
  
       Finland	
             Finland	
          Finland	
                 India	
                   	
  India	
           India	
  
In	
  vivo	
  animal	
       ADME	
          Clinical	
  trials	
      Discovery	
                Medicinal	
        Bioinforma'cs	
  
       models	
             analy'cs	
            data	
              biology	
  and	
            chemistry	
        chemoinforma
                                             management	
                ‘omics	
                                          'cs	
  




             SBW	
  Finland	
         	
  SBW	
  India 	
  SBW	
  Sweden                   	
     	
  SBW	
  Switzerland	
  
Benefits of working with
•    Easy access to world-class complimentary research skills SBW
•    Access to state of the art infrastructure at a fraction of the price
•    Cost efficient Indian delivery capabilities and Nordic work ethics
•    More than 600 projects delivered to over 120 customers
•    A large service platform for drug discovery & development
•    With parallel offering of in silico and in vitro/in vivo based services
•    Fixed deliverables, duration and investment




                                                                     Beginning
Joint R & D Collaboration
It is a New	
  business	
  concept for collaborating on early
discovery projects, where the parties together share the
ownership, risk and potential reward of the project.
The project is divided into smaller engagements with specific
milestones. The parties agree jointly on the activities, efforts
and duration of each engagement within the project.

     SBW will carry portion of the risk by utilising:
     Our Mixed-Model delivery capabilities
     Where we offer our Indian resources at cost basis
     Finnish project management and study directors
     Pre-determined deliverables and milestones
     Low cost and fast delivery for each engagement
Milestone Baseline price estimates
FTE	
  MSc	
  /	
  MONTH	
  OFFSITE	
  	
  (India) 	
     	
        	
   	
     	
     	
  700	
  eur	
  
FTE	
  PhD	
  /	
  MONTH	
  OFFSITE	
  	
  (India) 	
     	
        	
   	
     	
     	
  1500	
  eur	
  
	
  
In	
  silico	
  tox,	
  ADME	
  and	
  bioac'vity	
  predic'on 	
               	
     	
  20	
  eur	
  
Omics	
  data	
  analysis	
  (microarray,	
  proteomics) 	
                     	
     	
  65	
  eur	
  
In	
  vitro	
  Cytotoxicity	
  (LDH	
  &	
  MTT) 	
       	
        	
   	
     	
     	
  20	
  eur	
  
Maximum	
  tolerated	
  dose	
  in	
  rat	
          	
   	
        	
   	
     	
     	
  3000	
  eur       	
     	
     	
  	
  
MALDI-­‐TOF/TOF	
  (Bruker	
  Ultraflex) 	
                	
        	
   	
     	
     	
  90	
  eur	
  
NMRs	
  (300	
  MHz	
  and	
  400	
  MHz	
  Bruker	
  DPX)	
  /	
  hour         	
     	
  20	
  eur	
  
FTIR	
  with	
  IR	
  microscope	
  (Perkin-­‐Elmer)	
  /	
  1st	
  scan	
      	
     	
  20	
  eur	
  
500	
  MHz	
  LC-­‐NMR	
          	
      	
   	
    	
   	
        	
   	
     	
     	
  request	
  
UHR-­‐Qq-­‐TOF	
  (Bruker	
  MaXis) 	
               	
   	
        	
   	
     	
     	
  request	
  	
  
LC-­‐MS/MS	
  LTQ	
  XL	
  Linear	
  Ion-­‐trap	
  (Thermo) 	
           	
     	
     	
  request	
  	
  
LC-­‐MS	
  APCI/ESI	
  Probe	
  (Finnigan	
  Mat) 	
                	
   	
     	
     	
  request	
  
GC	
  with	
  capillary	
  column	
  headspace	
  (Shimadzu) 	
                 	
     	
  request	
  
What can we do for you
•      World-­‐class	
  CRO	
  services	
  with	
  experience	
  and	
  excellent	
  instrumenta'on	
  

•      Deliver	
  Europe	
  and	
  India	
  

•      Broad	
  service	
  plaporm	
  from	
  early	
  discovery	
  to	
  marke'ng	
  authoriza'on.	
  We	
  have	
  
       been	
  involved	
  in	
  projects	
  from	
  target	
  iden'fica'on	
  to	
  successful	
  drug	
  registra'on.	
  

•      More	
  than	
  600	
  projects	
  delivered	
  to	
  over	
  120	
  customers	
  in	
  over	
  20	
  countries.	
  
       Including	
  companies	
  form	
  small	
  virtual	
  biotechs	
  to	
  global	
  big	
  pharma	
  
	
  
•      Bundled	
  Services	
  and	
  Plaporms	
  with	
  overall	
  project	
  management	
  

•      Business	
  process	
  outsourcing	
  possibility	
  

•      Joint	
  R&D	
  collabora'on	
  with	
  industry	
  and	
  academia	
  
	
  
•      Pay	
  per	
  service,	
  FTE,	
  milestone	
  based	
  and	
  risk-­‐reward	
  sharing	
  business	
  models	
  
SBW Sponsors and
                                    partners




Over 120 pharma and biotech customers in 20 countries

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SBW's Comprehensive Drug Discovery Services

  • 1. SBW  Discovering  Success   Cascading  service  models  with  SBW  -­‐  a  Finnish-­‐Indian   research-­‐service  corpora<on  with  comprehensive   exper<se  in  drug-­‐discovery,  func<onal  foods  and     chemical  safety  industries  
  • 2. SBW in a nutshell •  Contract Research Services for Pharmaceutical and Biotech customers •  Headquarter in Helsinki, Finland, offices / laboratories in total 7 cities in Finland, Sweden, UK and India •  Discovery informatics: bioinformatics, chemoinformatics, structural / SBD informatics •  Discovery biology; biomarker analytics and discovery •  Early and preclinical toxicology •  In vivo pharmacology •  ADME / DMPK •  Biostatistics, clinical data management and data warehousing •  140+ pharma/biotech customers in more than 20 countries. Organic revenue increase 2007-2008 around 50%. More than 60 professionals. •  Owned by Helsinki University Funds and Tooltech Pvt Ltd (Indian CAD/CAM and engineering simulations, offices in 7 European countries, India and US)
  • 3. SBW Solutions for Drug Research Regulatory/ Indica'on   Target   Screen   Hit   Lead   Candidate   IND   Phase  0   Phase  1   Phase  2   Phase  3   SBW-­‐α   SBW-­‐η   SBW-­‐β   SBW-­‐ε   SBW-­‐γ   SBW-­‐δ   SBW-­‐α   SBW-­‐γ   SBW-­‐δ   SBW-­‐η   • Whole   genome   transcriptomics   and   • In   silico   bioac'vity,   adverse   effect   • In  vitro  metabolism   • Sample   size   es'ma'ons   and   power   gemomics   and  toxicity  predic'on   • CYP  iden'fica'on  and  inhibi'on   analysis   • Proteomics   • Scaffold  hopping  and  op'miza'on   • M etabolite   iden'fica'on,   MIST,   • Randomiza'on   • Biomarker  discovery  and  valida'on   • Experimental   logP,   logD,   logS,   pKa   different  species   • CRF  design   • Genome-­‐wide   bioinforma'cs   and   analysis   • PAMPA,  Caco-­‐2,  MDCK  permeability   • Database   design,   data   entry   and   computa'onal  systems  biology   • Plasma  protein  binding   • In   vitro   cytotoxicity,   prolifera'on,   valida'on   • PAMPA  permeability   membrane  integrity   • Sta's'cal  analysis  and  repor'ng   • Metabolic  stability   • In  vivo  pharmacokine'cs   • Medical  wri'ng   • In  vivo  disease  models   • Safety  pharmacology   • In  vivo  toxicology   SBW-­‐β   SBW-­‐ε   • Virtual   HTS,   ligand,   target,   and   • GLP  in  vivo  toxicity   reverse  docking   • GLP   in   vivo   safety,   ICH   Core   Ba^ery   •   Library  design   etc   • In  silico  ADME  models   • In  vitro  assay  development  
  • 4. What suites you best? Fee  for  service   Risk  sharing  model       Consulta've  model   Collabora've  model       Protocol  based   Milestone  based     Your  preference     Price  /  study     Fixed  price  /  project   Based  on  your  need     Personal  customer  care  
  • 5. Levels Of Engagement Close co-work, possibly in-site, Level 4 possibly external funding applied, Complete Drug Discovery / Development project involving risk-sharing partnership SBW involvement in focused areas of discovery, like LI, LO etc. Involvement of multiple Level 3 Managed project involving many types of expertise in units from SBW, sharing of combination with sponsor’s expertise related project data Master agreement with SBW, confidentiality and Level 2 Utilization and coordination of services from multiple expertise from multiple units units Level 1 Master agreement for Repeated utilization of services from individial unit repeated services Level 0 Individual service(s), NDA & Outsourcing of individual analytics - internal capactiy agreement with the extension and internally unavailable tasks corresponding unit
  • 6. Discovering Success together with SBW •  Program Management Services –  We act as your tactical, logistical and scientific interface with our drug discovery resources. –  Diverse scientific expertise from Discovery Biology to Preclinical and Clinical Development. •  Business Models - We aim to form strategic alliances with our customers, where entire drug discovery programs are contracted and payment is based on mutually agreed milestones and success. •  BPO – Business Process Outsourcing •  Joint development •  Academic collaboration •  Indian delivery capabilities •  Risk and Reward sharing models •  EU, Government and competitive funding
  • 7. SBW Organization SBW  HQ   Helsinki,   Finland   Toxis   Novamass   4Pharma   Biodix   Medachem   Infodix     Finland   Finland   Finland   India    India   India   In  vivo  animal   ADME   Clinical  trials   Discovery   Medicinal   Bioinforma'cs   models   analy'cs   data   biology  and   chemistry   chemoinforma management   ‘omics   'cs   SBW  Finland    SBW  India  SBW  Sweden    SBW  Switzerland  
  • 8. Benefits of working with •  Easy access to world-class complimentary research skills SBW •  Access to state of the art infrastructure at a fraction of the price •  Cost efficient Indian delivery capabilities and Nordic work ethics •  More than 600 projects delivered to over 120 customers •  A large service platform for drug discovery & development •  With parallel offering of in silico and in vitro/in vivo based services •  Fixed deliverables, duration and investment Beginning
  • 9. Joint R & D Collaboration It is a New  business  concept for collaborating on early discovery projects, where the parties together share the ownership, risk and potential reward of the project. The project is divided into smaller engagements with specific milestones. The parties agree jointly on the activities, efforts and duration of each engagement within the project. SBW will carry portion of the risk by utilising: Our Mixed-Model delivery capabilities Where we offer our Indian resources at cost basis Finnish project management and study directors Pre-determined deliverables and milestones Low cost and fast delivery for each engagement
  • 10. Milestone Baseline price estimates FTE  MSc  /  MONTH  OFFSITE    (India)            700  eur   FTE  PhD  /  MONTH  OFFSITE    (India)            1500  eur     In  silico  tox,  ADME  and  bioac'vity  predic'on      20  eur   Omics  data  analysis  (microarray,  proteomics)      65  eur   In  vitro  Cytotoxicity  (LDH  &  MTT)            20  eur   Maximum  tolerated  dose  in  rat              3000  eur         MALDI-­‐TOF/TOF  (Bruker  Ultraflex)            90  eur   NMRs  (300  MHz  and  400  MHz  Bruker  DPX)  /  hour    20  eur   FTIR  with  IR  microscope  (Perkin-­‐Elmer)  /  1st  scan      20  eur   500  MHz  LC-­‐NMR                    request   UHR-­‐Qq-­‐TOF  (Bruker  MaXis)              request     LC-­‐MS/MS  LTQ  XL  Linear  Ion-­‐trap  (Thermo)        request     LC-­‐MS  APCI/ESI  Probe  (Finnigan  Mat)          request   GC  with  capillary  column  headspace  (Shimadzu)      request  
  • 11. What can we do for you •  World-­‐class  CRO  services  with  experience  and  excellent  instrumenta'on   •  Deliver  Europe  and  India   •  Broad  service  plaporm  from  early  discovery  to  marke'ng  authoriza'on.  We  have   been  involved  in  projects  from  target  iden'fica'on  to  successful  drug  registra'on.   •  More  than  600  projects  delivered  to  over  120  customers  in  over  20  countries.   Including  companies  form  small  virtual  biotechs  to  global  big  pharma     •  Bundled  Services  and  Plaporms  with  overall  project  management   •  Business  process  outsourcing  possibility   •  Joint  R&D  collabora'on  with  industry  and  academia     •  Pay  per  service,  FTE,  milestone  based  and  risk-­‐reward  sharing  business  models  
  • 12. SBW Sponsors and partners Over 120 pharma and biotech customers in 20 countries