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the center for

|"advancing innovation

The	
  Avon	
  Founda-on,	
  Na-onal	
  Cancer	
  Ins-tute	
  and	
  	
  
Discussion Document: July 6, 2009
Center	
  for	
  Advancing	
  Innova-on	
  Business	
  Plan	
  and	
  Startup	
  Challenge	
  
	
  
University	
  Presenta-on	
  
	
  
By:	
  	
  
Rosemarie	
  Truman,	
  Founder	
  and	
  CEO,	
  The	
  Center	
  for	
  Advancing	
  Innova-on	
  

	
  

October	
  16,	
  2013

	
  
What	
  is	
  the	
  Challenge:	
  Develop	
  a	
  business	
  plan	
  and	
  launch	
  a	
  startup	
  using	
  10	
  near-­‐
term,	
  commercially	
  viable	
  inven-ons	
  
	
  
Challenge	
  Overview	
  
•  Business	
  Plan	
  (BP)	
  and	
  Startup	
  Contest	
  using	
  10	
  near-­‐term,	
  commercially	
  viable	
  inven8ons	
  conceived	
  
and	
  developed	
  by	
  inventors	
  from	
  the	
  NCI	
  and	
  an	
  Avon	
  Founda8on	
  (AF)	
  grantee	
  
•  Challenge	
  teams	
  will	
  par8cipate	
  in	
  three	
  phases:	
  LeFer	
  of	
  Intent,	
  Business	
  Plan	
  and	
  Start-­‐up	
  	
  
Goals:	
  
•  Breast	
  Cancer	
  (BC):	
  Increase	
  survivability	
  and	
  improve	
  the	
  standard	
  of	
  care	
  in	
  areas	
  of	
  unmet	
  need	
  
•  Technology	
  Transfer	
  (TT)	
  Memorandum:	
  “Accelerate	
  and	
  increase	
  the	
  volume	
  of	
  Federally	
  funded	
  
technology	
  transfer	
  in	
  support	
  of	
  high	
  growth	
  businesses”	
  
•  Economic	
  Growth:	
  Spur	
  economic	
  growth	
  across	
  the	
  na8on	
  through	
  new	
  startups	
  and	
  jobs	
  
•  Entrepreneurship	
  Learning:	
  Provide	
  a	
  plaLorm	
  for	
  Universi8es	
  to	
  expand	
  their	
  entrepreneurial	
  
programs	
  
•  Business	
  Model:	
  Create	
  new	
  business	
  models	
  in	
  TT,	
  transla8onal	
  research	
  and	
  R&D	
  funding	
  
Phases:	
  Three	
  phases	
  -­‐	
  Challenge	
  Teams’	
  Opportunity:	
  	
  
•  Business	
  Plan	
  Prize:	
  Up	
  to	
  100	
  teams	
  will	
  par8cipate,	
  10	
  teams	
  per	
  inven8on.	
  There	
  will	
  be	
  one	
  $5K	
  
prize	
  per	
  inven8on	
  ($50k	
  in	
  total	
  awards)	
  	
  
•  Start-­‐up	
  Phase	
  Seed	
  Funding:	
  Up	
  to	
  30	
  successful	
  start-­‐ups	
  will	
  apply	
  and	
  poten8ally	
  be	
  awarded	
  
funding	
  which	
  could	
  range	
  from	
  $100K	
  to	
  over	
  $1MM	
  	
  
•  Funding	
  will	
  come	
  from	
  venture	
  capital,	
  economic	
  development	
  corpora8ons,	
  Avon	
  Founda8on	
  or	
  
other	
  private	
  sources.	
  Funding	
  will	
  not	
  be	
  provided	
  from	
  the	
  NIH	
  	
  
2

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
Who	
  are	
  the	
  key	
  players?	
  	
  
Judges/Mentors	
  

Seed	
  Funders	
  
•  Economic	
  
Development	
  
organiza8ons	
  
•  Venture	
  capital	
  
•  Private	
  equity	
  
•  Angel	
  investors	
  

• 
• 
• 
• 
• 

Breast	
  Cancer	
  Survivors	
  
Venture	
  Capitalists	
  
Successful	
  Serial	
  Entrepreneurs	
  
Industry	
  Execu8ves	
  and	
  Experts	
  
Founda8on,	
  NCI	
  and	
  CAI	
  Core	
  Team	
  

Core	
  Partners:	
  	
  
•  The	
  Avon	
  Founda8on	
  
•  Na8onal	
  Cancer	
  Ins8tute	
  
•  The	
  Center	
  for	
  Advancing	
  Innova8on	
  
Universi8es	
  

Supporters	
  
BIO	
  
	
  
	
  
SoPE	
  
	
  
	
  
CoFoundersLab	
  
	
  

•  Students	
  gain:	
  real-­‐world,	
  cross-­‐discipline,	
  
entrepreneurship	
  experience;	
  gain	
  exposure	
  to	
  experts	
  
•  Universi/es	
  gain	
  publicity	
  for	
  providing	
  	
  entrepreneurial	
  
student	
  opportuni8es	
  and	
  new	
  way	
  to	
  create	
  jobs	
  

3
Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
Challenge	
  Topics:	
  Novel,	
  Commercially	
  Viable	
  Breast	
  Cancer	
  Inven-ons	
  
NCI	
  Inven-on	
  Example	
  
Breast	
  Cancer	
  Challenge	
  Topics	
  

Therapeu8cs:	
  5	
  
Diagnos8cs:	
  5	
  
Prognos8cs:	
  1	
  	
  
Vaccine:	
  1	
  
Health	
  IT:	
  1	
  
Device:	
  1	
  
Delivery	
  Method:	
  1	
  

Note:	
  some	
  inven8ons	
  have	
  more	
  than	
  one	
  use	
  	
  
and	
  cover	
  2	
  or	
  more	
  of	
  the	
  above	
  

4

#1	
  -­‐	
  Diagnos-c	
  from	
  Biopsies	
  with	
  
SoYware	
  Analysis	
  
Title:	
  	
  Breast	
  Cancer	
  Diagnos-c	
  
Based	
  on	
  Spa-al	
  Organiza-on	
  of	
  
Genes	
  in	
  the	
  Cell	
  Nucleus	
  
	
  
Execu-ve	
  Summary	
  

	
  
Category:	
  Diagnos8cs/Health	
  IT	
  
Disease	
  Focus:	
  Breast	
  Cancer	
  using	
  tumor	
  
biopsies	
  	
  	
  
Basis	
  of	
  Inven-on:	
  Gene	
  (DNA)	
  	
  
How	
  it	
  works:	
  	
  Uses	
  the	
  3D	
  placement	
  of	
  
genes	
  to	
  detect	
  breast	
  cancer	
  in	
  8ssue	
  
Patent	
  Status:	
  Patent	
  issued	
  in	
  Europe	
  
(validated	
  in	
  Germany,	
  UK,	
  France),	
  
pending	
  in	
  US,	
  Canada	
  
Lead	
  Inventor:	
  Tom	
  Misteli,	
  PhD	
  
Development	
  Stage:	
  	
  In	
  vitro	
  and	
  
retrospec8ve	
  in	
  vivo	
  

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
Who	
  can	
  par-cipate?	
  

	
  Challenge	
  TEAM	
  

Team	
  Design:	
  	
  
Mandatory	
  Requirements*	
  
Business	
  
Legal	
  
Medical/Scien8fic	
  
Seasoned	
  
Entrepreneur	
  

	
  
•  Over	
  18	
  years	
  old	
  
•  At	
  least	
  three	
  students	
  on	
  the	
  team	
  
*Note:	
  two	
  inven8ons	
  require	
  addi8onal	
  disciplines	
  
Inven8on	
  #1:	
  computer	
  science;	
  inven8on	
  #3:	
  engineering	
  

5

Other	
  Key	
  Notes	
  on	
  	
  
Who	
  May	
  Par-cipate	
  

	
  
Students:	
  
•  Graduate	
  and	
  undergraduate	
  
Students	
  
•  Post-­‐docs,	
  those	
  in	
  residency	
  
	
  
Anyone	
  else	
  beyond	
  the	
  three	
  
mandatory	
  students	
  
	
  
Others	
  Areas	
  of	
  Recommended	
  
Knowledge	
  Sources:	
  
•  Business	
  development	
  
•  Payers	
  
•  Key	
  Opinion	
  Leader	
  
•  FDA/Regulatory	
  
•  Venture	
  Capital	
  
•  Clinical	
  Research	
  Outsourcer	
  

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
Overview	
  of	
  Phases:	
  100	
  teams	
  enter;	
  a	
  poten-al	
  of	
  30	
  startups	
  

Planning

Phase 1:
Letter of Intent

10	
  
Inven-ons	
  

10	
  Teams	
  for	
  
Each	
  Inven-on	
  

Inven-on	
  1	
  

•  Select	
  an	
  
inven8on	
  
•  Form	
  a	
  
team	
  

6

•  Enter	
  your	
  
core	
  team,	
  
mentors,	
  
advisors	
  and	
  
collaborators	
  

Phase 2:
Business Plan

Phase 3:
Startup

Post-Contest

3	
  Teams	
  per	
  
3	
  Startups	
  for	
  Each	
   “Startup	
  Winner”	
  
Inven-on	
  Go	
  to	
  Ph3	
  
Inven-on	
  
Has	
  Licensing	
  
Agreement	
  and	
  
Seed	
  Funding	
  

Inven-on	
  1	
  

•  Business	
  Plan	
   •  Revise	
  Business	
  
•  Pitch	
  
Plan	
  	
  
•  Elevator	
  
•  Launch	
  Startup	
  
Speech	
  
•  Apply	
  for	
  seed	
  
funding	
  
•  Apply	
  for	
  a	
  
license	
  

•  Collaborate	
  
with	
  the	
  NCI	
  or	
  
AF	
  grantee	
  
University,	
  
Clemson	
  
•  Launch	
  a	
  
Product	
  

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
Lecer	
  of	
  Intent:	
  Guidelines,	
  Deliverables	
  and	
  Key	
  Dates	
  
Phase	
  1:	
  
10	
  Teams	
  for	
  
Each	
  Inven-on	
  

Inven-on	
  1	
  

7

Letter of Intent
Deliverables:	
  
•  LeFer	
  of	
  Intent	
  form	
  (it	
  contains	
  a	
  CDA	
  click	
  through)	
  
•  Prize	
  Alloca8on	
  Form	
  
•  Resumes	
  (one	
  package	
  containing	
  all	
  resumes	
  of	
  core	
  team	
  members,	
  
mentors,	
  and	
  advisors)	
  
•  Join	
  Wiggio;	
  create	
  group	
  and	
  invite	
  CAI	
  to	
  your	
  group	
  
•  OPTIONAL:	
  Stakeholder	
  Analysis	
  and	
  Collaborators	
  
	
  
Guidelines:	
  
•  Augment	
  your	
  team	
  with	
  Venture	
  Capitalists	
  who	
  may	
  provide	
  funding	
  
•  Iden8fy	
  collaborators	
  that	
  can	
  provide	
  seed	
  funding	
  and/or	
  services	
  to	
  
your	
  start-­‐up	
  (e.g.,	
  legal,	
  accoun8ng,	
  valua8on,	
  etc.)	
  
•  Include	
  team	
  members	
  that	
  have	
  relevant	
  inven8on	
  experience	
  
•  Prepare	
  a	
  strong	
  LOI	
  with	
  all	
  disciplines	
  required,	
  mentors	
  and	
  advisors.	
  
We	
  are	
  accep8ng	
  strong	
  teams	
  on	
  a	
  rolling	
  basis	
  
	
  
Key	
  Dates:	
  October	
  1st,	
  2013	
  to	
  November	
  29,	
  2013	
  
•  Start	
  accep8ng	
  LOIs:	
  October	
  1st;	
  Stop	
  accep8ng	
  LOIs,	
  December	
  1st,	
  2013	
  
•  Receive	
  final	
  LOI	
  communica8on	
  by	
  December	
  4th	
  ,	
  2013	
  
	
  

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
Challenge	
  Team	
  Member	
  Defini-ons	
  
Challenge	
  Team	
  Defini-on:	
  The	
  “Challenge	
  Team”	
  is	
  made	
  up	
  of	
  the	
  Team	
  
Leader,	
  Core	
  Team	
  Members,	
  Advisors,	
  Mentors	
  
	
  
A	
  Team	
  Leader	
  is	
  our	
  single	
  point	
  of	
  contact	
  for	
  the	
  Challenge	
  and	
  accountable	
  
for	
  deliverables	
  
	
  
A	
  Core	
  Team	
  Member	
  is	
  accountable	
  for	
  deliverables	
  

	
  
A	
  Mentor	
  has	
  domain	
  experience	
  and	
  will	
  ac8vely	
  work	
  with	
  the	
  team	
  on	
  a	
  daily/
weekly	
  basis	
  to	
  review/complete	
  deliverables	
  

	
  
An	
  Advisor	
  has	
  domain	
  exper8se	
  and	
  the	
  team	
  uses	
  for	
  Q&A	
  sessions,	
  e.g.,	
  KOL	
  

	
  
A	
  Collaborator	
  is	
  an	
  organiza8on	
  that	
  can	
  improve	
  your	
  probability	
  of	
  success;	
  
they	
  will	
  include	
  seed	
  funders,	
  services	
  firms,	
  etc.	
  
8

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
Business	
  Plan:	
  Guidelines,	
  Deliverables	
  and	
  Key	
  Dates	
  
Phase	
  2:	
  

Business Plan
Deliverables:	
  
3	
  Teams	
  per	
  
•  10	
  page	
  business	
  plan	
  or	
  a	
  business	
  model	
  canvas	
  
Inven-on	
  Go	
  to	
  Ph3	
   •  1	
  minute	
  elevator	
  pitch	
  posted	
  on	
  YouTube	
  
•  5	
  minute	
  live	
  pitch	
  via	
  Skype	
  or	
  video	
  conferencing	
  to	
  judges	
  
•  10	
  page	
  pitch	
  deck	
  (maximum	
  10	
  pages	
  Powerpoint	
  or	
  Prezio)	
  
	
  
Guidelines:	
  
•  Begin	
  with	
  the	
  end	
  in	
  mind.	
  Make	
  sure	
  you	
  understand	
  	
  
•  Seed	
  funders	
  criteria	
  for	
  investment	
  
•  NIH	
  or	
  Clemson’s	
  license	
  agreement	
  requirements	
  
•  Leverage	
  CAI’s	
  templates/guidelines	
  for	
  your	
  business	
  plan,	
  regulatory	
  
strategy,	
  development	
  plan,	
  and	
  commercializa8on	
  plan,	
  etc.	
  	
  
•  Check	
  the	
  criteria	
  we	
  are	
  using	
  to	
  assess	
  deliverables	
  
Key	
  Dates:	
  	
  
•  Deliverables	
  due:	
  February	
  3rd	
  (can	
  be	
  submiFed	
  early)	
  
•  Pitches:	
  February	
  3rd	
  to	
  February	
  13th	
  	
  
•  Award	
  Announced:	
  February	
  19th	
  	
  
Prize:	
  $5K	
  for	
  each	
  of	
  10	
  winning	
  teams–	
  one	
  award	
  per	
  inven8on	
  	
  
9

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
Start-­‐up:	
  Guidelines,	
  Deliverables	
  and	
  Key	
  Dates	
  
Phase	
  3:	
  

Start-up

3	
  Startups	
  for	
  Each	
   Deliverables:	
  
•  Revised	
  regulatory	
  strategy,	
  commercializa8on	
  plan	
  and	
  development	
  plan	
  
Inven-on	
  
•  Start-­‐up	
  incorpora8on	
  
•  Seed	
  funding	
  applica8on(s)	
  
•  NIH	
  or	
  Clemson	
  licensing	
  applica8on	
  
	
  

Inven-on	
  1	
  

Guidelines:	
  
•  Incorporate	
  your	
  start-­‐up	
  as	
  soon	
  as	
  possible	
  
•  Revise	
  your	
  deliverables	
  by	
  gaining	
  addi8onal	
  input	
  from	
  KOLs,	
  payers,	
  the	
  
FDA,	
  VCs,	
  poten8al	
  collaborators,	
  CROs,	
  CMOs,	
  service	
  providers,	
  etc.	
  
•  Parallel	
  process	
  your	
  deliverable	
  crea8on	
  –	
  especially	
  seed	
  funding	
  and	
  
licensing	
  applica8on;	
  there	
  could	
  be	
  a	
  “chicken	
  or	
  the	
  egg”	
  scenario	
  
	
  

Key	
  Dates:	
  	
  
•  Start	
  date:	
  February	
  20,	
  2014	
  
•  Deliverables	
  due:	
  June	
  17,	
  2014	
  
•  Awards	
  announced:	
  June	
  27,	
  2014	
  (or	
  later)	
  
Defini-on	
  of	
  Success:	
  Start-­‐ups	
  launched	
  a	
  company;	
  raised	
  capital	
  and	
  in-­‐
licensed	
  an	
  inven8on.	
  	
  Successful	
  start-­‐ups	
  are	
  honored	
  with	
  a	
  “Start-­‐up	
  
Medal	
  of	
  Honor”	
  in	
  an	
  awards	
  ceremony	
  
10

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
Post-­‐Challenge	
  Expecta-ons	
  

Avon	
  Founda-on:	
  Ongoing	
  partnering	
  to	
  ensure	
  success	
  
	
  
	
  
	
  
NCI/Clemson	
  University	
  Research	
  Founda-on:	
  Ongoing	
  Collabora8on	
  
	
  
	
  
	
  
The	
  Center	
  for	
  Advancing	
  Innova-on:	
  Ongoing	
  coaching/mentoring	
  
	
  
	
  

EVENTUALLY:	
  NEW	
  BREAST	
  CANCER	
  PRODUCTS/SOLUTIONS	
  ON	
  THE	
  MARKET	
  

11

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
More	
  on	
  the	
  inven-ons,	
  page	
  1	
  of	
  2	
  
#1	
  –	
  Health	
  IT	
  Inven8on	
  –	
  Detects	
  Breast	
  Cancer	
  based	
  on	
  Spa8al	
  3D	
  Gene	
  Placement	
  
Tom	
  Misteli,	
  Patents	
  issued	
  in	
  Europe	
  (validated	
  in	
  Germany,	
  UK	
  and	
  France)	
  pending	
  in	
  US/Canada	
  
In	
  vivo	
  and	
  in	
  vitro	
  data	
  
#2	
  –	
  Therapy/Vaccine–	
  Slows	
  tumor	
  growth,	
  preven8ng	
  metastasis	
  post	
  surgery	
  
Dennis	
  Klinman,	
  Patent	
  pending	
  in	
  the	
  US,	
  pre-­‐clinical	
  in	
  mice	
  
#3	
  –	
  Device/Therapeu8c/Vaccine–	
  Collagen	
  composite	
  8ssue	
  replacement	
  material	
  as	
  a	
  
reconstruc8on	
  plaLorm	
  with	
  an8-­‐tumor	
  capabili8es	
  
Karen	
  Burg,	
  Patent	
  issued	
  in	
  the	
  US,	
  human	
  breast	
  8ssue	
  tested	
  in	
  pre-­‐clinical	
  
#4	
  –	
  Therapeu8c/Diagnos8c	
  –	
  Binds specifically to a cancer cell target and inhibits the tumor growth	
  
Mitchell	
  Ho,	
  US	
  patent	
  pending,	
  in-­‐vitro	
  data	
  also	
  mouse	
  xenograph	
  models	
  
#5	
  –	
  Therapeu8c/Vaccine–	
  S8mulates	
  immune	
  response	
  for	
  tumor	
  inhibi8on	
  
Alan	
  Krensky,	
  Patent	
  Pending	
  in	
  US,	
  Canada,	
  Australia,	
  and	
  Europe,	
  pre-­‐clinical	
  in	
  mice	
  
	
  
12

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
More	
  on	
  the	
  inven-ons,	
  page	
  2	
  of	
  2	
  
#6	
  –	
  Therapeu8c–	
  Small	
  molecule	
  that	
  works	
  with	
  current	
  drugs	
  to	
  enhance	
  their	
  effec8veness	
  
Nayda	
  Tarasova,	
  US	
  patent	
  issued;	
  Europe,	
  patent	
  pending;	
  pre-­‐clinical	
  in-­‐vitro	
  
#7	
  –	
  Two	
  Inven8ons	
  Vaccine	
  and/or	
  Drug	
  Delivery	
  –	
  PlaLorm	
  to	
  deliver	
  proteins	
  to	
  cancer	
  cells	
  –	
  
much	
  less	
  toxic	
  and	
  more	
  specific	
  than	
  current	
  models	
  
Deb Chatterjee,	
  Patents	
  issued	
  in	
  US;	
  another	
  pending,	
  in	
  vitro	
  and	
  in	
  vivo	
  data	
  
#8	
  –	
  Diagnos8c–	
  Uses	
  genes	
  to	
  detect	
  Cancer	
  and	
  associated	
  stage	
  
Steven	
  Libus,	
  US	
  patent	
  pending,	
  retrospec8ve	
  human	
  data	
  from	
  clinical	
  trials	
  
#9	
  –	
  Diagnos8c–	
  Predict	
  pa8ents	
  survival	
  rate	
  and	
  guides	
  treatment	
  
Stephen	
  HewiF,	
  Pending	
  in	
  U.S.,	
  Canada,	
  Europe,	
  Australia,	
  Japan,	
  Israel,	
  and	
  New	
  Zealand,	
  more	
  
than	
  a	
  thousand	
  samples	
  of	
  human	
  data	
  	
  
#10	
  –	
  Diagnos8c–	
  Determines	
  the	
  effec8veness	
  of	
  chemotherapy	
  for	
  a	
  pa8ent
	
  	
  
Sherry	
  Yang,	
  US	
  patent	
  granted;	
  Pending	
  in	
  Europe,	
  Canada,	
  Australia,	
  and	
  Japan,	
  data	
  from	
  >1500	
  
human	
  8ssue	
  samples	
  
13

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
SUMMARY:	
  Key	
  Dates	
  
Under	
  the	
  “Overview”	
  Sec-on	
  on	
  hcp://www.breastcancerstartupchallenge.com	
  
Key	
  Dates	
  
LeFer	
  of	
  Intent	
  	
  
	
  
Oct	
  1-­‐Nov	
  29	
  2013	
  
• 8/30/13	
  –	
  10/1/13:	
  Form	
  
team	
  
• 10/1/13:	
  Submit	
  LOI	
  
• 11/29/13:	
  LOIs	
  due	
  
• 12/4/13:	
  Communicate	
  to	
  
teams	
  

Ongoing	
  

14

Business	
  Plan	
  
	
  
Dec	
  2	
  2013	
  –	
  	
  
Feb	
  19	
  2014	
  
• 12/2/13:	
  Launch	
  BP	
  effort	
  
• 2/3/14:	
  Deliverables	
  due	
  
• 2/3/14	
  –	
  2/13/14:	
  Virtual	
  
pitches	
  with	
  teams	
  
• 2/19/14:	
  Award	
  top	
  
teams	
  for	
  each	
  inven8on	
  

Start-­‐up	
  
	
  

Feb	
  20,	
  2014-­‐	
  	
  
June	
  27,	
  2014	
  	
  
• 2/20/14:	
  Launch	
  SU	
  effort	
  
• Ongoing:	
  Revise	
  BP;	
  
create	
  SU;	
  apply	
  for	
  
funding	
  and	
  license	
  
• 6/17/14:	
  Deliverables	
  due	
  
• 6/27/14:	
  Announce	
  
successful	
  start-­‐ups	
  

An8cipated	
  Post-­‐
Contest	
  Ac8vi8es	
  
• Conduct	
  discussions	
  
regarding	
  collabora8ve	
  
R&D	
  agreement	
  
• Con8nue	
  R&D	
  on	
  
inven8on	
  
• Con8nue	
  raising	
  capital	
  

•  Provide	
  mentoring	
  /	
  guidance	
  to	
  teams	
  
•  Receive	
  ques8ons	
  and	
  filter	
  to	
  SMEs	
  as	
  necessary	
  
•  Review	
  rolling	
  BP	
  and	
  SU	
  deliverables

Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
Key	
  Links	
  
Challenge	
  Website	
  
	
  
hFp://www.breastcancerstartupchallenge.com	
  
	
  
LeFer	
  of	
  Intent	
  Forms	
  –	
  For	
  Teams	
  
Team	
  Leader	
  	
   hFps://www.surveymonkey.com/s/TeamLeadLOISurvey	
  	
  
Core	
  Team	
  Members,	
  Mentors,	
  Advisors	
  and	
  Collaborators:	
  
	
  
hFps://www.surveymonkey.com/s/BCSChallengeCDAForm	
  	
  
Wiggio	
  Links	
  –	
  For	
  Teams	
  
	
  
	
  Main	
  Group	
  
	
  hFp://wiggio.com/group_open_join.php?
	
  groupid=1838019&password=CAI1234&ref=1787839	
  

	
  
Team	
  Collabora8on	
  
hFp://wiggio.com/group_open_join.php?
groupid=1848688&password=CAITEAM&ref=1787839	
  
15	
  

Proprietary	
  and	
  Confiden8al	
  to	
  The	
  Center	
  for	
  Advancing	
  Innova8on.	
  Do	
  not	
  distribute	
  outside	
  The	
  Center	
  for	
  Advancing	
  Innova8on	
  
	
  
Connect	
  with	
  us!	
  

Facebook	
  	
  -­‐	
  Breast	
  Cancer	
  Start-­‐up	
  Challenge	
  
	
  
TwiFer	
  -­‐	
  	
  @BCSChallenge	
  	
  

Ques-ons:	
  Contact	
  Rosemarie	
  Truman,	
  	
  
rt@thecenterforadvancinginnova-on.org	
  

16	
  

Proprietary	
  and	
  Confiden8al	
  to	
  The	
  Center	
  for	
  Advancing	
  Innova8on.	
  Do	
  not	
  distribute	
  outside	
  The	
  Center	
  for	
  Advancing	
  Innova8on	
  
	
  

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University cross discipline presentation oct 16, 2013

  • 1. the center for |"advancing innovation The  Avon  Founda-on,  Na-onal  Cancer  Ins-tute  and     Discussion Document: July 6, 2009 Center  for  Advancing  Innova-on  Business  Plan  and  Startup  Challenge     University  Presenta-on     By:     Rosemarie  Truman,  Founder  and  CEO,  The  Center  for  Advancing  Innova-on     October  16,  2013  
  • 2. What  is  the  Challenge:  Develop  a  business  plan  and  launch  a  startup  using  10  near-­‐ term,  commercially  viable  inven-ons     Challenge  Overview   •  Business  Plan  (BP)  and  Startup  Contest  using  10  near-­‐term,  commercially  viable  inven8ons  conceived   and  developed  by  inventors  from  the  NCI  and  an  Avon  Founda8on  (AF)  grantee   •  Challenge  teams  will  par8cipate  in  three  phases:  LeFer  of  Intent,  Business  Plan  and  Start-­‐up     Goals:   •  Breast  Cancer  (BC):  Increase  survivability  and  improve  the  standard  of  care  in  areas  of  unmet  need   •  Technology  Transfer  (TT)  Memorandum:  “Accelerate  and  increase  the  volume  of  Federally  funded   technology  transfer  in  support  of  high  growth  businesses”   •  Economic  Growth:  Spur  economic  growth  across  the  na8on  through  new  startups  and  jobs   •  Entrepreneurship  Learning:  Provide  a  plaLorm  for  Universi8es  to  expand  their  entrepreneurial   programs   •  Business  Model:  Create  new  business  models  in  TT,  transla8onal  research  and  R&D  funding   Phases:  Three  phases  -­‐  Challenge  Teams’  Opportunity:     •  Business  Plan  Prize:  Up  to  100  teams  will  par8cipate,  10  teams  per  inven8on.  There  will  be  one  $5K   prize  per  inven8on  ($50k  in  total  awards)     •  Start-­‐up  Phase  Seed  Funding:  Up  to  30  successful  start-­‐ups  will  apply  and  poten8ally  be  awarded   funding  which  could  range  from  $100K  to  over  $1MM     •  Funding  will  come  from  venture  capital,  economic  development  corpora8ons,  Avon  Founda8on  or   other  private  sources.  Funding  will  not  be  provided  from  the  NIH     2 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 3. Who  are  the  key  players?     Judges/Mentors   Seed  Funders   •  Economic   Development   organiza8ons   •  Venture  capital   •  Private  equity   •  Angel  investors   •  •  •  •  •  Breast  Cancer  Survivors   Venture  Capitalists   Successful  Serial  Entrepreneurs   Industry  Execu8ves  and  Experts   Founda8on,  NCI  and  CAI  Core  Team   Core  Partners:     •  The  Avon  Founda8on   •  Na8onal  Cancer  Ins8tute   •  The  Center  for  Advancing  Innova8on   Universi8es   Supporters   BIO       SoPE       CoFoundersLab     •  Students  gain:  real-­‐world,  cross-­‐discipline,   entrepreneurship  experience;  gain  exposure  to  experts   •  Universi/es  gain  publicity  for  providing    entrepreneurial   student  opportuni8es  and  new  way  to  create  jobs   3 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 4. Challenge  Topics:  Novel,  Commercially  Viable  Breast  Cancer  Inven-ons   NCI  Inven-on  Example   Breast  Cancer  Challenge  Topics   Therapeu8cs:  5   Diagnos8cs:  5   Prognos8cs:  1     Vaccine:  1   Health  IT:  1   Device:  1   Delivery  Method:  1   Note:  some  inven8ons  have  more  than  one  use     and  cover  2  or  more  of  the  above   4 #1  -­‐  Diagnos-c  from  Biopsies  with   SoYware  Analysis   Title:    Breast  Cancer  Diagnos-c   Based  on  Spa-al  Organiza-on  of   Genes  in  the  Cell  Nucleus     Execu-ve  Summary     Category:  Diagnos8cs/Health  IT   Disease  Focus:  Breast  Cancer  using  tumor   biopsies       Basis  of  Inven-on:  Gene  (DNA)     How  it  works:    Uses  the  3D  placement  of   genes  to  detect  breast  cancer  in  8ssue   Patent  Status:  Patent  issued  in  Europe   (validated  in  Germany,  UK,  France),   pending  in  US,  Canada   Lead  Inventor:  Tom  Misteli,  PhD   Development  Stage:    In  vitro  and   retrospec8ve  in  vivo   Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 5. Who  can  par-cipate?    Challenge  TEAM   Team  Design:     Mandatory  Requirements*   Business   Legal   Medical/Scien8fic   Seasoned   Entrepreneur     •  Over  18  years  old   •  At  least  three  students  on  the  team   *Note:  two  inven8ons  require  addi8onal  disciplines   Inven8on  #1:  computer  science;  inven8on  #3:  engineering   5 Other  Key  Notes  on     Who  May  Par-cipate     Students:   •  Graduate  and  undergraduate   Students   •  Post-­‐docs,  those  in  residency     Anyone  else  beyond  the  three   mandatory  students     Others  Areas  of  Recommended   Knowledge  Sources:   •  Business  development   •  Payers   •  Key  Opinion  Leader   •  FDA/Regulatory   •  Venture  Capital   •  Clinical  Research  Outsourcer   Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 6. Overview  of  Phases:  100  teams  enter;  a  poten-al  of  30  startups   Planning Phase 1: Letter of Intent 10   Inven-ons   10  Teams  for   Each  Inven-on   Inven-on  1   •  Select  an   inven8on   •  Form  a   team   6 •  Enter  your   core  team,   mentors,   advisors  and   collaborators   Phase 2: Business Plan Phase 3: Startup Post-Contest 3  Teams  per   3  Startups  for  Each   “Startup  Winner”   Inven-on  Go  to  Ph3   Inven-on   Has  Licensing   Agreement  and   Seed  Funding   Inven-on  1   •  Business  Plan   •  Revise  Business   •  Pitch   Plan     •  Elevator   •  Launch  Startup   Speech   •  Apply  for  seed   funding   •  Apply  for  a   license   •  Collaborate   with  the  NCI  or   AF  grantee   University,   Clemson   •  Launch  a   Product   Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 7. Lecer  of  Intent:  Guidelines,  Deliverables  and  Key  Dates   Phase  1:   10  Teams  for   Each  Inven-on   Inven-on  1   7 Letter of Intent Deliverables:   •  LeFer  of  Intent  form  (it  contains  a  CDA  click  through)   •  Prize  Alloca8on  Form   •  Resumes  (one  package  containing  all  resumes  of  core  team  members,   mentors,  and  advisors)   •  Join  Wiggio;  create  group  and  invite  CAI  to  your  group   •  OPTIONAL:  Stakeholder  Analysis  and  Collaborators     Guidelines:   •  Augment  your  team  with  Venture  Capitalists  who  may  provide  funding   •  Iden8fy  collaborators  that  can  provide  seed  funding  and/or  services  to   your  start-­‐up  (e.g.,  legal,  accoun8ng,  valua8on,  etc.)   •  Include  team  members  that  have  relevant  inven8on  experience   •  Prepare  a  strong  LOI  with  all  disciplines  required,  mentors  and  advisors.   We  are  accep8ng  strong  teams  on  a  rolling  basis     Key  Dates:  October  1st,  2013  to  November  29,  2013   •  Start  accep8ng  LOIs:  October  1st;  Stop  accep8ng  LOIs,  December  1st,  2013   •  Receive  final  LOI  communica8on  by  December  4th  ,  2013     Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 8. Challenge  Team  Member  Defini-ons   Challenge  Team  Defini-on:  The  “Challenge  Team”  is  made  up  of  the  Team   Leader,  Core  Team  Members,  Advisors,  Mentors     A  Team  Leader  is  our  single  point  of  contact  for  the  Challenge  and  accountable   for  deliverables     A  Core  Team  Member  is  accountable  for  deliverables     A  Mentor  has  domain  experience  and  will  ac8vely  work  with  the  team  on  a  daily/ weekly  basis  to  review/complete  deliverables     An  Advisor  has  domain  exper8se  and  the  team  uses  for  Q&A  sessions,  e.g.,  KOL     A  Collaborator  is  an  organiza8on  that  can  improve  your  probability  of  success;   they  will  include  seed  funders,  services  firms,  etc.   8 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 9. Business  Plan:  Guidelines,  Deliverables  and  Key  Dates   Phase  2:   Business Plan Deliverables:   3  Teams  per   •  10  page  business  plan  or  a  business  model  canvas   Inven-on  Go  to  Ph3   •  1  minute  elevator  pitch  posted  on  YouTube   •  5  minute  live  pitch  via  Skype  or  video  conferencing  to  judges   •  10  page  pitch  deck  (maximum  10  pages  Powerpoint  or  Prezio)     Guidelines:   •  Begin  with  the  end  in  mind.  Make  sure  you  understand     •  Seed  funders  criteria  for  investment   •  NIH  or  Clemson’s  license  agreement  requirements   •  Leverage  CAI’s  templates/guidelines  for  your  business  plan,  regulatory   strategy,  development  plan,  and  commercializa8on  plan,  etc.     •  Check  the  criteria  we  are  using  to  assess  deliverables   Key  Dates:     •  Deliverables  due:  February  3rd  (can  be  submiFed  early)   •  Pitches:  February  3rd  to  February  13th     •  Award  Announced:  February  19th     Prize:  $5K  for  each  of  10  winning  teams–  one  award  per  inven8on     9 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 10. Start-­‐up:  Guidelines,  Deliverables  and  Key  Dates   Phase  3:   Start-up 3  Startups  for  Each   Deliverables:   •  Revised  regulatory  strategy,  commercializa8on  plan  and  development  plan   Inven-on   •  Start-­‐up  incorpora8on   •  Seed  funding  applica8on(s)   •  NIH  or  Clemson  licensing  applica8on     Inven-on  1   Guidelines:   •  Incorporate  your  start-­‐up  as  soon  as  possible   •  Revise  your  deliverables  by  gaining  addi8onal  input  from  KOLs,  payers,  the   FDA,  VCs,  poten8al  collaborators,  CROs,  CMOs,  service  providers,  etc.   •  Parallel  process  your  deliverable  crea8on  –  especially  seed  funding  and   licensing  applica8on;  there  could  be  a  “chicken  or  the  egg”  scenario     Key  Dates:     •  Start  date:  February  20,  2014   •  Deliverables  due:  June  17,  2014   •  Awards  announced:  June  27,  2014  (or  later)   Defini-on  of  Success:  Start-­‐ups  launched  a  company;  raised  capital  and  in-­‐ licensed  an  inven8on.    Successful  start-­‐ups  are  honored  with  a  “Start-­‐up   Medal  of  Honor”  in  an  awards  ceremony   10 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 11. Post-­‐Challenge  Expecta-ons   Avon  Founda-on:  Ongoing  partnering  to  ensure  success         NCI/Clemson  University  Research  Founda-on:  Ongoing  Collabora8on         The  Center  for  Advancing  Innova-on:  Ongoing  coaching/mentoring       EVENTUALLY:  NEW  BREAST  CANCER  PRODUCTS/SOLUTIONS  ON  THE  MARKET   11 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 12. More  on  the  inven-ons,  page  1  of  2   #1  –  Health  IT  Inven8on  –  Detects  Breast  Cancer  based  on  Spa8al  3D  Gene  Placement   Tom  Misteli,  Patents  issued  in  Europe  (validated  in  Germany,  UK  and  France)  pending  in  US/Canada   In  vivo  and  in  vitro  data   #2  –  Therapy/Vaccine–  Slows  tumor  growth,  preven8ng  metastasis  post  surgery   Dennis  Klinman,  Patent  pending  in  the  US,  pre-­‐clinical  in  mice   #3  –  Device/Therapeu8c/Vaccine–  Collagen  composite  8ssue  replacement  material  as  a   reconstruc8on  plaLorm  with  an8-­‐tumor  capabili8es   Karen  Burg,  Patent  issued  in  the  US,  human  breast  8ssue  tested  in  pre-­‐clinical   #4  –  Therapeu8c/Diagnos8c  –  Binds specifically to a cancer cell target and inhibits the tumor growth   Mitchell  Ho,  US  patent  pending,  in-­‐vitro  data  also  mouse  xenograph  models   #5  –  Therapeu8c/Vaccine–  S8mulates  immune  response  for  tumor  inhibi8on   Alan  Krensky,  Patent  Pending  in  US,  Canada,  Australia,  and  Europe,  pre-­‐clinical  in  mice     12 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 13. More  on  the  inven-ons,  page  2  of  2   #6  –  Therapeu8c–  Small  molecule  that  works  with  current  drugs  to  enhance  their  effec8veness   Nayda  Tarasova,  US  patent  issued;  Europe,  patent  pending;  pre-­‐clinical  in-­‐vitro   #7  –  Two  Inven8ons  Vaccine  and/or  Drug  Delivery  –  PlaLorm  to  deliver  proteins  to  cancer  cells  –   much  less  toxic  and  more  specific  than  current  models   Deb Chatterjee,  Patents  issued  in  US;  another  pending,  in  vitro  and  in  vivo  data   #8  –  Diagnos8c–  Uses  genes  to  detect  Cancer  and  associated  stage   Steven  Libus,  US  patent  pending,  retrospec8ve  human  data  from  clinical  trials   #9  –  Diagnos8c–  Predict  pa8ents  survival  rate  and  guides  treatment   Stephen  HewiF,  Pending  in  U.S.,  Canada,  Europe,  Australia,  Japan,  Israel,  and  New  Zealand,  more   than  a  thousand  samples  of  human  data     #10  –  Diagnos8c–  Determines  the  effec8veness  of  chemotherapy  for  a  pa8ent     Sherry  Yang,  US  patent  granted;  Pending  in  Europe,  Canada,  Australia,  and  Japan,  data  from  >1500   human  8ssue  samples   13 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 14. SUMMARY:  Key  Dates   Under  the  “Overview”  Sec-on  on  hcp://www.breastcancerstartupchallenge.com   Key  Dates   LeFer  of  Intent       Oct  1-­‐Nov  29  2013   • 8/30/13  –  10/1/13:  Form   team   • 10/1/13:  Submit  LOI   • 11/29/13:  LOIs  due   • 12/4/13:  Communicate  to   teams   Ongoing   14 Business  Plan     Dec  2  2013  –     Feb  19  2014   • 12/2/13:  Launch  BP  effort   • 2/3/14:  Deliverables  due   • 2/3/14  –  2/13/14:  Virtual   pitches  with  teams   • 2/19/14:  Award  top   teams  for  each  inven8on   Start-­‐up     Feb  20,  2014-­‐     June  27,  2014     • 2/20/14:  Launch  SU  effort   • Ongoing:  Revise  BP;   create  SU;  apply  for   funding  and  license   • 6/17/14:  Deliverables  due   • 6/27/14:  Announce   successful  start-­‐ups   An8cipated  Post-­‐ Contest  Ac8vi8es   • Conduct  discussions   regarding  collabora8ve   R&D  agreement   • Con8nue  R&D  on   inven8on   • Con8nue  raising  capital   •  Provide  mentoring  /  guidance  to  teams   •  Receive  ques8ons  and  filter  to  SMEs  as  necessary   •  Review  rolling  BP  and  SU  deliverables Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation
  • 15. Key  Links   Challenge  Website     hFp://www.breastcancerstartupchallenge.com     LeFer  of  Intent  Forms  –  For  Teams   Team  Leader     hFps://www.surveymonkey.com/s/TeamLeadLOISurvey     Core  Team  Members,  Mentors,  Advisors  and  Collaborators:     hFps://www.surveymonkey.com/s/BCSChallengeCDAForm     Wiggio  Links  –  For  Teams      Main  Group    hFp://wiggio.com/group_open_join.php?  groupid=1838019&password=CAI1234&ref=1787839     Team  Collabora8on   hFp://wiggio.com/group_open_join.php? groupid=1848688&password=CAITEAM&ref=1787839   15   Proprietary  and  Confiden8al  to  The  Center  for  Advancing  Innova8on.  Do  not  distribute  outside  The  Center  for  Advancing  Innova8on    
  • 16. Connect  with  us!   Facebook    -­‐  Breast  Cancer  Start-­‐up  Challenge     TwiFer  -­‐    @BCSChallenge     Ques-ons:  Contact  Rosemarie  Truman,     rt@thecenterforadvancinginnova-on.org   16   Proprietary  and  Confiden8al  to  The  Center  for  Advancing  Innova8on.  Do  not  distribute  outside  The  Center  for  Advancing  Innova8on