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 Indica'on   Target   Screen   Hit   Lead   Candidate   Regulatory/

IND   Phase  0   Phase  1   Phase  2   Phase  3  

SBW-­‐α  

SBW-­‐β  

SBW-­‐γ   SBW-­‐δ  

SBW-­‐ε  

SBW-­‐α  • Whole   genome   transcriptomics   and  gemomics  • Proteomics  • Biomarker  discovery  and  valida'on  • Genome-­‐wide   bioinforma'cs   and  computa'onal  systems  biology  

SBW-­‐β  • Virtual   HTS,   ligand,   target,   and  reverse  docking  •   Library  design  • In  silico  ADME  models  • In  vitro  assay  development  

SBW-­‐γ  • In   silico   bioac'vity,   adverse   effect  and  toxicity  predic'on  • Scaffold  hopping  and  op'miza'on  • Experimental   logP,   logD,   logS,   pKa  analysis  • Plasma  protein  binding  • PAMPA  permeability  • Metabolic  stability  

SBW-­‐δ  • In  vitro  metabolism  • CYP  iden'fica'on  and  inhibi'on  • Metabolite   iden'fica'on,   MIST,  different  species  • PAMPA,  Caco-­‐2,  MDCK  permeability  • In   vitro   cytotoxicity,   prolifera'on,  membrane  integrity  • In  vivo  pharmacokine'cs  • In  vivo  disease  models  • Safety  pharmacology  • In  vivo  toxicology  

SBW-­‐η  

SBW-­‐ε  • GLP  in  vivo  toxicity  • GLP   in   vivo   safety,   ICH   Core   Ba^ery  etc  

SBW-­‐η  • Sample   size   es'ma'ons   and   power  analysis  • Randomiza'on  • CRF  design  • Database   design,   data   entry   and  valida'on  • Sta's'cal  analysis  and  repor'ng  • Medical  wri'ng  

What suites you best?

Fee  for  service    

Consulta've  model    

Protocol  based    

Price  /  study  

Risk  sharing  model    

Collabora've  model    

Milestone  based    

Fixed  price  /  project  Your  preference  

 Based  on  your  need  

 Personal  customer  care  

Levels Of Engagement

Level 1 Repeated utilization of services from individial unit

Master agreement for repeated services

Level 0 Outsourcing of individual analytics - internal capactiy

extension and internally unavailable tasks

Individual service(s), NDA & agreement with the corresponding unit

Level 3 Managed project involving many types of expertise in

combination with sponsor’s expertise

SBW involvement in focused areas of discovery, like LI, LO

etc. Involvement of multiple units from SBW, sharing of

related project data

Level 4 Complete Drug Discovery / Development project

partnership

Close co-work, possibly in-site, possibly external funding applied,

involving risk-sharing

Level 2 Utilization and coordination of services from multiple

units

Master agreement with SBW, confidentiality and

expertise from multiple units

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  HQ  Helsinki,  Finland  

Toxis  Finland  

In  vivo  animal  models  

Novamass  Finland  ADME  analy'cs  

4Pharma  Finland  

Clinical  trials  data  

management  

Biodix  India  

Discovery  biology  and  

‘omics  

Medachem    India  

Medicinal  chemistry  

Infodix    India  

Bioinforma'cs  chemoinforma

'cs  

SBW  Finland    SBW  India  SBW  Sweden    SBW  Switzerland  

SBW Organization

Benefits of working with SBW •  Easy access to world-class complimentary research skills

•  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