Operational Issues to Get Your Company Up and Running
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  • 1. Opera&onal  Issues  to  Get   Your  Company  Up  and  Running   Where  do  you  start  a;er  you  have  the  idea   January  21,  2014   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   1  
  • 2. The  Panel   •  Moderator:       –  Mirena  Bagur,  CONTeXO   •  Panelists:   •  Corey  McCann,  consultant/VC/entrepreneur,  MPM  Capital   •  Bret  Siarkowski,  CEO  of  Biofficient  Inc.   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   2  
  • 3. Top  Line   •  •  •  •  •  •  Funding   Plan:  Product/Strategy/Market   Team   Planning/Milestones   Important  To-­‐Do’s   Addendum   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   3  
  • 4. Funding   •  Funding  strategy:   –  Funding  to  what  milestone  and  amount  needed   –  Runway   –  Key  value  inflec&ons  along  the  way   –  How  much  to  exit  or  break-­‐even   •  Subsequent  rounds   •  5  year  budget   •  Stage  of  Development   –  Target  firms  –  sector;  stage;  round  size;  total  capital   requirements;  exper&se   •  Know  where  they  are  in  their  fund   •  Talk  to  Strategic  Partners  early  –  develop  rela&onship  (Cau&on)   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   4  
  • 5. Deal  Size,  Funding  Sources  and  the  Company  Lifecycle   Deal     Size   PE;  II   VCs   Early  VCs   Angels   FF   Idea   Alpha   Beta   Source:    CONTeXO  Group,  Spring  2011   1.0   Commercial   Rollout   #TCNlive   2.0,     expansion   Lifecycle     Stages   5  
  • 6. Business  Plan  Overview   •  Describe  the  business         –  Therapeu&c,  diagnos&c,  device,  IT   –  Prepare  business  plan  /  presenta&on     •  Will  we  develop  ourselves  or  with  a  partner  (outsource)   •  What  does  the  market  look  like       •  Current  and  historical  regulatory  landscape   •  What  are  the  barriers  to  entry   •  What  are  the  comparables  that  show  our  model  will   work   •  What  is  the  financing  necessary  to  get  to  exit   •  What  is  the  exit   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   6  
  • 7. Team   •  You  cannot  do  it  alone:  Lose  “I”  from  vocabulary   –  Get  the  right  people  on  the  bus  –  define  roles  and   responsibili&es   •  Core  competency,  can  they  handle  uncertainty,  flexibility,   perseverance,  same  vision  and  alignment   –  Experience  (complementary)  for  founding  team,  KOLs  and   advisors   •  Consider  Virtual  Model  where  possible   –  Allows  flexibility  to  hire  the  best  and  most  experienced  for   a  variable  cost     –  Sets  an  appropriate  pace  for  growth   •  Key  ques&on  about  choosing  team  members:   –  Personality  fit:  Do  you  like  them?     Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   7  
  • 8. The  Team   “The  right  team”  (2-­‐4  people)   –  Strong  technical  founder   •  More  than  just  an  idea  person   •  Has  to  understand  the  whole  thrust  behind  the   technology  and  the  industry  dynamic  around  it.   –  A  sales-­‐oriented  entrepreneur   •  Drives  the  other  parts  of  the  business  and  sells  the   vision  to  investors  and  other  stakeholders   –  Full  &me  employees  (FTEs)   –  Partners   –  Poten&al  customers   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   8  
  • 9. Planning   •  •  •  •  Regulatory   Planning  Considera&ons   Budget  -­‐  &ed  to  milestones/inflec&on  points   Addi&onal  to-­‐do  items   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   9  
  • 10. Regulatory   •  Major  Factor  in  Success  and  Funding   •  Credible  exper&se   –  Avoid  landmines   –  Know  the  challenges     •  Define  risk  mi&ga&on  strategy   •  Iden&fy  Path:   –  Therapeu&c,  device,  diagnos&c,  IT   •  IND,  PMA,  510(k)   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   10  
  • 11. Planning  Considera&ons   Sector   Device   (drug  delivery,   implanted,  valves,   monitoring;  etc)   DiagnosGc     TherapeuGc   (drugs,  vaccines,   biologics)     Some  drug  delivery     Healthcare  IT  /  Services   IP     Yes  -­‐  FTO   YES   Patent  Life  Important   10  years  to  develop   Countries   Know  How   Design  /  Method   Regulatory   PMA/510K   Companion?   510K/PMA;  CLIA   IND   HIPAA   Stark  Law   Prototype/   Demonstra&on   √√√√  (seeing  is   believing)   Depends  on  diagnos&c   No   √√√  demonstra&on  –  talk   to  end  user   Animal  Data   YES   YES   MUST   N/A   Publica&on   Important   Important   MUST   N/A   Scale  Up   Manufacturer  ?     GMP   Manufacturer?    GMP   CMC  –  manufacturing   GMP   Must  have  or  clear  path   Reimbursement   Current  or  new  CPT     HCPCS   Compara&ve  Effec&veness   YES   Federal  and  State   Distribu&on   Think  through  –  alone   or  partner;  countries   Important  –  Central  Labs   Think  through    -­‐  alone  or   partner;  by   Countries   Must  have   Launch/Market  trajectory   US/EU/ROW   Adop&on  -­‐  uptake     US/EU/ROW     Adop&on  -­‐  uptake   #TCNlive   11  
  • 12. Important  “To  Do’s”   –  Human  Resources   –  Legal   –  Accoun&ng   –  Insurance   •  Bank:  need  an  account  before  applying  for  grants   •  File  with  D&B  for  D-­‐U-­‐N   •  •  •  •  –  Necessary  to  apply  for  grants  with  NIH/Government  (non-­‐ dilu&ve!)     Website/Email  -­‐  secure  domain  name   Company  name/logo  –  Corporate  Iden&ty     Business  Cards   Networking  –  both  for  content  and  context   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   12  
  • 13. Addendum   Plan  Overview   Development  Plan   Legal  –  Corporate  and  IP   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   13  
  • 14. Plan  Overview   •  Describe  the  business         –  Therapeu&c,  diagnos&c,  device,  IT   –  Prepare  business  plan  /  presenta&on     •  Will  we  develop  ourselves  or  with  a  partner  (outsource)   •  What  does  the  market  look  like       •  Current  and  historical  regulatory  landscape   •  What  are  the  barriers  to  entry   •  What  are  the  comparables  that  show  our  model  will   work   •  What  is  the  financing  necessary  to  get  to  exit   •  What  is  the  exit   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   14  
  • 15. Development  Plan     •  Extremely  important  for  you  and  investors   •  GANTT-­‐    &me  and  resources   –  Iden&fy  key  milestones  that  drive  demonstrable  value   inflec&on  ($$$  -­‐  how  much  necessary  for  each  point)   •  •  •  •  •  •  Prototype  –  device/IT   CMC   Animal  data   FDA  discussion   IND   Phase  1   •  How  will  you  execute   –  CRO   –  Joint  development  –  strategic  discussions  -­‐  stage   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   15  
  • 16. Legal  –  Corporate  Structure   •  Incorpora&on  –  C  Corp,  LLC   –  Form  of  company  may  affect  who  you  target  for  funds   •  Capitaliza&on  Table:  ownership  split  with  founders   –  Op&on  plan  /  agreement  (plan  ahead)   •  Key  documents   –  Employment  agreements   –  MA  Law   •  Key  Filings   –  Delaware   –  Tax   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   16  
  • 17. Legal  -­‐  IP   •  Intellectual  Property  firm  not  always  the  same   as  Corporate     •  Licensed  IP  in?    Op&on  Agreement   •  Review  terms  closely   •  Cost  /  &me  period  for  op&on  agreement   •  Addi&onal  IP  needed   •  Provisional  patents/Filed  patents  –  expense   •  What  is  the  short  /  long  term  IP  strategy   Download  slides:  bit.ly/tcnLifeSci2014   #TCNlive   17