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Passing	
  the	
  Healthcare	
  Innova2on	
  
Torch:	
  
From	
  Medicinal	
  Chemistry	
  through	
  
Biotechnology	
  to	
  Digital	
  Technology	
  
Fron2ers	
  of	
  Medicine	
  
MaRS	
  
8	
  May	
  2013	
  
Mar2n	
  Sumner-­‐Smith	
  
Abstract	
  
In	
  the	
  middle	
  of	
  the	
  20th	
  Century,	
  pharmaceu2cal	
  companies	
  were	
  highly	
  
respected	
  and	
  pa2ents	
  depended	
  on	
  their	
  physicians	
  to	
  make	
  healthcare	
  
decisions.	
  Drugs	
  were	
  a	
  key	
  part	
  of	
  a	
  physician’s	
  ‘toolkit’.	
  
	
  
As	
  we	
  entered	
  the	
  era	
  of	
  the	
  blockbuster	
  drugs,	
  most	
  were	
  small	
  molecules	
  
made	
  by	
  chemical	
  synthesis,	
  but	
  biotechnology	
  was	
  star2ng	
  to	
  emerge	
  as	
  a	
  
possible	
  source	
  of	
  new	
  therapeu2cs.	
  Meanwhile,	
  direct-­‐to-­‐consumer	
  
pharmaceu2cal	
  adver2sing	
  began	
  to	
  empower	
  pa2ents.	
  
	
  	
  
Fast	
  forward	
  to	
  today,	
  and	
  we	
  see	
  pharmaceu2cal	
  companies	
  suffering	
  
degraded	
  reputa2ons	
  and	
  values,	
  pa2ents	
  further	
  empowered	
  by	
  the	
  
Internet	
  and	
  social	
  media,	
  and	
  average	
  life	
  expectancies	
  increased	
  by	
  a	
  
decade.	
  Digital	
  health	
  technologies	
  are	
  posed	
  to	
  explode	
  and	
  the	
  top	
  10	
  
pharmaceu2cals	
  by	
  sales	
  will	
  soon	
  all	
  be	
  biologicals!	
  
About	
  me	
  
Martin Sumner-Smith, PhD
Academic – Biotechnology – Bioinformatics – Enterprise – Advisory
1970’s 1980’s 1990’s 2000’s 2010’s
http://en.wikipedia.org/wiki/Kondratiev_wave
Global	
  Core	
  Systems	
  
The world’s 4 trillion dollar challenge, Using a system-of-systems approach to build a smarter planet – IBM
Inefficiency	
  in	
  Healthcare	
  
The world’s 4 trillion dollar challenge, Using a system-of-systems approach to build a smarter planet – IBM
Pharmaceuticals
Digital Health
Biotechnology
Medicinal Chemistry
“…the	
  industry	
  has	
  seen	
  itself	
  as	
  an	
  independent	
  
product	
  supplier	
  to	
  healthcare	
  
rather	
  than	
  as	
  an	
  integrated	
  part	
  of,	
  and	
  
collaborator	
  with,	
  the	
  other	
  par8cipants	
  in	
  the	
  
ecosystem.”	
  
	
  
	
  Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
Market	
  Growth	
  
Patent	
  Expiry	
  
Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
Declining	
  R&D	
  produc2vity	
  
Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
R&D	
  Success	
  vs.	
  Expenditure	
  
Identifying R&D outliers
Peter Tollman, Yves Morieux, Jeanine Kelly Murphy & Ulrik Schulze
Nature Reviews Drug Discovery 10, 653-654 (September 2011)
Identifying R&D outliers
Peter Tollman, Yves Morieux, Jeanine Kelly Murphy & Ulrik Schulze
Nature Reviews Drug Discovery 10, 653-654 (September 2011)
http://www.lek.com/sites/default/files/in_vivo_new_face_of_blockbuster_drugs_l.e.k.pdf
Life	
  Sciences	
  Industry	
  Trends…	
  
•  Blockbuster	
  era	
  comes	
  to	
  an	
  end	
  
•  Strong	
  sales	
  growth	
  but	
  declining	
  expecta2ons	
  
§  P/E	
  for	
  large-­‐cap	
  biopharma	
  fell	
  from	
  35x	
  in	
  2000	
  
to	
  11x	
  in	
  2010	
  
§  Pricing	
  and	
  access	
  pressures	
  
§  Higher	
  scien2fic	
  hurdles	
  
§  More	
  stringent	
  regulatory	
  hurdles	
  
§  Increased	
  compe22on	
  
§  R&D	
  actually	
  destroys	
  value	
  in	
  some	
  
organiza2ons!	
  
Slide	
  19	
  
Time
MarketGrowth
Technology Adoption
Life Cycle
Growth
Market
Mature
Market
Declining
Market
Indefinitely elastic
middle period
End of
Life
A
Fault
Line!
E
D
C
B
The	
  Category	
  Maturity	
  Lifecycle	
  
Category Lifecycle
Slide	
  20	
  
Experiential
Innovation
Marketing
Innovation
Innova2on	
  Types	
  for	
  Mature	
  Markets	
  –	
  Customer	
  In2macy	
  Zone	
  
Customer Intimacy Zone
Enhancement
Innovation
Line Extension
Innovation
There are four types of innovation in the Customer Intimacy Zone
Slide	
  21	
  
Market	
  Access	
  
•  Moore	
  describes	
  this	
  further	
  market	
  
development	
  as	
  ‘frac2liza2on’	
  of	
  core	
  
markets	
  	
  
PC
1970’s 1980’s 1990’s 2000’s 2010’s
First DTG in 1981
Merck’s Pneumovax in Reader’s Digest
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/
http://www.zoloft.com/
Average	
  Life	
  Expectancy	
  
https://www.google.ca/publicdata
TRIZ	
  
Genrich	
  Altshuller:	
  
“Theory	
  of	
  Inven2ve	
  Problem	
  Solving”	
  
	
  
1.  Problems	
  and	
  solu>ons	
  are	
  repeated	
  across	
  
industries	
  and	
  sciences	
  
2.  Pa?erns	
  of	
  technical	
  evolu2on	
  are	
  also	
  
repeated	
  across	
  industries	
  and	
  sciences	
  
3.  Innova>ons	
  used	
  scien2fic	
  effects	
  outside	
  the	
  
field	
  in	
  which	
  they	
  were	
  developed	
  
http://en.wikipedia.org/wiki/TRIZ
http://www.triz-journal.com/archives/1998/12/a/
http://www.lek.com/sites/default/files/in_vivo_new_face_of_blockbuster_drugs_l.e.k.pdf
http://www.lek.com/sites/default/files/in_vivo_new_face_of_blockbuster_drugs_l.e.k.pdf
Therapeu2c	
  Foci	
  
Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
Market	
  Leading	
  “Pharmaceu2cals”	
  
•  In	
  2012	
  the	
  top	
  pharmaceu2cal	
  was	
  a	
  
biological	
  for	
  the	
  first	
  2me	
  
§  Abbvie’s	
  HUMIRA	
  
•  “By	
  2020	
  the	
  top	
  10	
  pharmaceu8cals	
  will	
  all	
  
be	
  biologicals”	
  –	
  Steve	
  Burrill	
  
Sales	
  Erosion	
  aaer	
  Patent	
  Expiry	
  
Small Molecule
Biologicals
Measuring the return from innovation: Is R&D earning its investment? – Deloitte
Ultra-­‐Orphans	
  
http://www.forbes.com/sites/matthewherper/2012/09/05/how-a-440000-drug-is-turning-alexion-into-biotechs-new-innovation-powerhouse/
Alexion’s Soliris
R&D	
  Innova2on	
  
•  Rising	
  costs,	
  especially	
  sunk	
  cost	
  for	
  failures	
  
§  Late	
  stage	
  failure	
  rates	
  too	
  high	
  
•  Declining	
  output	
  
§  Need	
  to	
  simplify	
  opera2ons	
  
•  Costs	
  7x	
  in	
  25	
  years	
  
§  Cost	
  per	
  new	
  drug	
  now	
  $1.1	
  -­‐	
  1.7	
  	
  billion	
  
§  Slow	
  pace	
  of	
  discovery	
  and	
  valida2on	
  
§  Inefficient	
  pa2ent	
  recruitment	
  
•  80%	
  miss	
  deadlines,	
  average	
  90	
  day	
  delay	
  
§  Complex	
  analysis	
  required	
  for	
  trial	
  termina2on	
  
Risk	
  
Mi2ga2on	
  
The future of the life sciences industries:
Transformation amid rising risk – Deloitte
http://www.forbes.com/sites/johnnosta/2013/04/16/digital-health-will-pharma-follow-or-lead/
Life	
  Sciences	
  Industry	
  Trends	
  
•  Tradi2onally:	
  
	
  A	
  high-­‐risk,	
  high-­‐margin	
  business	
  
•  But	
  increasing	
  pressures:	
  
•  Loss	
  of	
  patent	
  protec2on	
  &	
  compe22on	
  from	
  generics	
  
•  Costs	
  of	
  innova2on	
  and	
  R&D	
  skyrocke2ng	
  
•  Reimbursement	
  ceiling	
  and	
  demands	
  
•  Increased	
  transparency	
  required	
  by	
  regulators	
  &	
  others	
  
•  Drive	
  a	
  move	
  to:	
  
	
  Managed	
  risk	
  and	
  more	
  conserva>ve	
  margins	
  
“The	
  life	
  sciences	
  industry	
  stands	
  at	
  a	
  crossroads.	
  
Its	
  business	
  model	
  is	
  broken,	
  
and	
  the	
  surrounding	
  healthcare	
  ecosystem	
  is	
  
changing	
  drama8cally.	
  
	
  
So	
  how	
  should	
  companies	
  respond?	
  
	
  
They	
  can	
  carry	
  on	
  as	
  normal	
  and	
  
poten8ally	
  fade	
  into	
  insignificance	
  
or	
  completely	
  rethink	
  how	
  they	
  engage	
  with	
  the	
  
other	
  stakeholders	
  in	
  the	
  healthcare	
  ecosystem	
  in	
  an	
  
effort	
  to	
  flourish	
  anew.”	
  
	
  
	
  Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
“…you	
  can’t	
  meet	
  the	
  challenges	
  of	
  tomorrow	
  with	
  
yesterday’s	
  tools—and	
  expect	
  to	
  survive.”	
  
	
  
The	
  future	
  of	
  the	
  life	
  sciences	
  industries:	
  Transforma2on	
  amid	
  rising	
  risk	
  
–	
  Deloiie	
  	
  
	
  
Pharmaceuticals
Digital Health
Biotechnology
Medicinal Chemistry
“One	
  of	
  the	
  key	
  drivers	
  for	
  the	
  future	
  lies	
  in	
  using	
  
informa8on	
  to	
  create	
  more	
  personalised	
  care	
  and	
  
standardisa4on	
  at	
  the	
  same	
  8me.	
  We	
  are	
  witnessing	
  
the	
  ‘industrial	
  revolu8on’	
  of	
  healthcare,	
  enabled	
  by	
  IT”	
  
	
  
–	
  PA	
  Consul2ng	
  
“And	
  while	
  the	
  industry	
  remains	
  data	
  rich,	
  it	
  is	
  
weaker	
  when	
  it	
  comes	
  to	
  turning	
  data	
  into	
  insights.”	
  
	
  
Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
From vision to decision: Pharma 2020 – pwc
Engaging	
  the	
  Pa2ent	
  
http://www.ted.com/talks/jamie_heywood_the_big_idea_my_brother_inspired.html
“The	
  shiPing	
  trend	
  in	
  pharma	
  towards	
  increased	
  
adop8on	
  of	
  IT	
  beyond	
  their	
  tradi8onal	
  needs	
  and	
  
exploring	
  new	
  IT	
  avenues	
  in	
  digital	
  marke4ng,	
  
regulatory	
  submissions,	
  predic4ve	
  analysis	
  &	
  cloud	
  
compu4ng	
  has	
  become	
  more	
  evident	
  in	
  the	
  last	
  few	
  
years.”	
  
	
  
IT	
  Life	
  Sciences	
  Summit	
  2012:	
  Technology	
  Enabled	
  Pharmaceu2cal	
  Business	
  Transforma2on	
  –	
  DIA	
  	
  
Change
Time
Achieved
Expected
Gartner’s	
  Hype	
  Cycle	
  
Source: http://www.infoq.com/news/2012/08/Gartner-Hype-Cycle-2012
http://rockhealth.com/2013/04/2013-digital-health-funding-update/
http://www.xcubelabs.com/mhealth-infographics.php
Smartphone/Tablet	
  base	
  features	
  
•  Processor	
  
•  Local	
  and	
  Cloud	
  storage	
  
•  Distant	
  communica2on	
  
•  Time	
  
•  Loca2on	
  
•  Ac2vity	
  
•  Local	
  communica2on	
  
•  Camera…	
  
Wearables	
  
IMS estimates $14 million in 2011
rising to $171 million by 2016
Add-­‐ons	
  
Proteus Digital Health
The	
  Internet	
  of	
  things	
  –	
  M2M	
  
Watson	
  
Where	
  do	
  the	
  data	
  go?	
  
Synergy	
  
“At	
  8:03am	
  you	
  used	
  your	
  asthma	
  puffer	
  
while	
  entering	
  the	
  MaRS	
  concourse,	
  
walking	
  at	
  a	
  moderate	
  pace	
  towards	
  the	
  
Tim	
  Horton’s	
  aPer	
  an	
  unusually	
  long	
  
subway	
  ride.	
  Your	
  pulse	
  was	
  110,	
  blood	
  
pressure	
  135/80,	
  temperature	
  37.2,	
  blood	
  
glucose…”	
  
“Based	
  on	
  data	
  collected	
  to	
  date	
  I	
  es8mate	
  that	
  
there	
  is	
  78.9%	
  probability	
  of	
  an	
  allergen	
  to	
  
which	
  you	
  react	
  present	
  at	
  the	
  following	
  
loca8ons…”	
  
Pa2ent	
  empowerment	
  trends	
  
Thank	
  you	
  
Martin Sumner-Smith, PhD
Email: martins@digitalforhealth.com
Office/Mobile: 1 (416) 727-4426
Web: www.DigitalForHealth.com
Twitter: @martinss
Linkedin: http://ca.linkedin.com/in/martinss

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Passing the Healthcare Innovation Torch: From Medicinal Chemistry, Through Biotechnology, to Digital Technology - MaRS Future of Medicine

  • 1. Passing  the  Healthcare  Innova2on   Torch:   From  Medicinal  Chemistry  through   Biotechnology  to  Digital  Technology   Fron2ers  of  Medicine   MaRS   8  May  2013   Mar2n  Sumner-­‐Smith  
  • 2.
  • 3. Abstract   In  the  middle  of  the  20th  Century,  pharmaceu2cal  companies  were  highly   respected  and  pa2ents  depended  on  their  physicians  to  make  healthcare   decisions.  Drugs  were  a  key  part  of  a  physician’s  ‘toolkit’.     As  we  entered  the  era  of  the  blockbuster  drugs,  most  were  small  molecules   made  by  chemical  synthesis,  but  biotechnology  was  star2ng  to  emerge  as  a   possible  source  of  new  therapeu2cs.  Meanwhile,  direct-­‐to-­‐consumer   pharmaceu2cal  adver2sing  began  to  empower  pa2ents.       Fast  forward  to  today,  and  we  see  pharmaceu2cal  companies  suffering   degraded  reputa2ons  and  values,  pa2ents  further  empowered  by  the   Internet  and  social  media,  and  average  life  expectancies  increased  by  a   decade.  Digital  health  technologies  are  posed  to  explode  and  the  top  10   pharmaceu2cals  by  sales  will  soon  all  be  biologicals!  
  • 4. About  me   Martin Sumner-Smith, PhD Academic – Biotechnology – Bioinformatics – Enterprise – Advisory 1970’s 1980’s 1990’s 2000’s 2010’s
  • 6. Global  Core  Systems   The world’s 4 trillion dollar challenge, Using a system-of-systems approach to build a smarter planet – IBM
  • 7.
  • 8. Inefficiency  in  Healthcare   The world’s 4 trillion dollar challenge, Using a system-of-systems approach to build a smarter planet – IBM
  • 9.
  • 11. “…the  industry  has  seen  itself  as  an  independent   product  supplier  to  healthcare   rather  than  as  an  integrated  part  of,  and   collaborator  with,  the  other  par8cipants  in  the   ecosystem.”      Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
  • 13. Patent  Expiry   Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
  • 14. Declining  R&D  produc2vity   Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
  • 15. R&D  Success  vs.  Expenditure   Identifying R&D outliers Peter Tollman, Yves Morieux, Jeanine Kelly Murphy & Ulrik Schulze Nature Reviews Drug Discovery 10, 653-654 (September 2011)
  • 16. Identifying R&D outliers Peter Tollman, Yves Morieux, Jeanine Kelly Murphy & Ulrik Schulze Nature Reviews Drug Discovery 10, 653-654 (September 2011)
  • 18. Life  Sciences  Industry  Trends…   •  Blockbuster  era  comes  to  an  end   •  Strong  sales  growth  but  declining  expecta2ons   §  P/E  for  large-­‐cap  biopharma  fell  from  35x  in  2000   to  11x  in  2010   §  Pricing  and  access  pressures   §  Higher  scien2fic  hurdles   §  More  stringent  regulatory  hurdles   §  Increased  compe22on   §  R&D  actually  destroys  value  in  some   organiza2ons!  
  • 19. Slide  19   Time MarketGrowth Technology Adoption Life Cycle Growth Market Mature Market Declining Market Indefinitely elastic middle period End of Life A Fault Line! E D C B The  Category  Maturity  Lifecycle   Category Lifecycle
  • 20. Slide  20   Experiential Innovation Marketing Innovation Innova2on  Types  for  Mature  Markets  –  Customer  In2macy  Zone   Customer Intimacy Zone Enhancement Innovation Line Extension Innovation There are four types of innovation in the Customer Intimacy Zone
  • 21. Slide  21   Market  Access   •  Moore  describes  this  further  market   development  as  ‘frac2liza2on’  of  core   markets     PC
  • 22. 1970’s 1980’s 1990’s 2000’s 2010’s First DTG in 1981 Merck’s Pneumovax in Reader’s Digest http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/
  • 24.
  • 25. Average  Life  Expectancy   https://www.google.ca/publicdata
  • 26. TRIZ   Genrich  Altshuller:   “Theory  of  Inven2ve  Problem  Solving”     1.  Problems  and  solu>ons  are  repeated  across   industries  and  sciences   2.  Pa?erns  of  technical  evolu2on  are  also   repeated  across  industries  and  sciences   3.  Innova>ons  used  scien2fic  effects  outside  the   field  in  which  they  were  developed   http://en.wikipedia.org/wiki/TRIZ
  • 30. Therapeu2c  Foci   Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
  • 31. Market  Leading  “Pharmaceu2cals”   •  In  2012  the  top  pharmaceu2cal  was  a   biological  for  the  first  2me   §  Abbvie’s  HUMIRA   •  “By  2020  the  top  10  pharmaceu8cals  will  all   be  biologicals”  –  Steve  Burrill  
  • 32. Sales  Erosion  aaer  Patent  Expiry   Small Molecule Biologicals Measuring the return from innovation: Is R&D earning its investment? – Deloitte
  • 34. R&D  Innova2on   •  Rising  costs,  especially  sunk  cost  for  failures   §  Late  stage  failure  rates  too  high   •  Declining  output   §  Need  to  simplify  opera2ons   •  Costs  7x  in  25  years   §  Cost  per  new  drug  now  $1.1  -­‐  1.7    billion   §  Slow  pace  of  discovery  and  valida2on   §  Inefficient  pa2ent  recruitment   •  80%  miss  deadlines,  average  90  day  delay   §  Complex  analysis  required  for  trial  termina2on  
  • 35. Risk   Mi2ga2on   The future of the life sciences industries: Transformation amid rising risk – Deloitte
  • 37. Life  Sciences  Industry  Trends   •  Tradi2onally:    A  high-­‐risk,  high-­‐margin  business   •  But  increasing  pressures:   •  Loss  of  patent  protec2on  &  compe22on  from  generics   •  Costs  of  innova2on  and  R&D  skyrocke2ng   •  Reimbursement  ceiling  and  demands   •  Increased  transparency  required  by  regulators  &  others   •  Drive  a  move  to:    Managed  risk  and  more  conserva>ve  margins  
  • 38. “The  life  sciences  industry  stands  at  a  crossroads.   Its  business  model  is  broken,   and  the  surrounding  healthcare  ecosystem  is   changing  drama8cally.     So  how  should  companies  respond?     They  can  carry  on  as  normal  and   poten8ally  fade  into  insignificance   or  completely  rethink  how  they  engage  with  the   other  stakeholders  in  the  healthcare  ecosystem  in  an   effort  to  flourish  anew.”      Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
  • 39. “…you  can’t  meet  the  challenges  of  tomorrow  with   yesterday’s  tools—and  expect  to  survive.”     The  future  of  the  life  sciences  industries:  Transforma2on  amid  rising  risk   –  Deloiie      
  • 41. “One  of  the  key  drivers  for  the  future  lies  in  using   informa8on  to  create  more  personalised  care  and   standardisa4on  at  the  same  8me.  We  are  witnessing   the  ‘industrial  revolu8on’  of  healthcare,  enabled  by  IT”     –  PA  Consul2ng  
  • 42. “And  while  the  industry  remains  data  rich,  it  is   weaker  when  it  comes  to  turning  data  into  insights.”     Fade or flourish? Rethinking the role of life sciences companies in the healthcare ecosystem – IBM
  • 43.
  • 44. From vision to decision: Pharma 2020 – pwc
  • 45. Engaging  the  Pa2ent   http://www.ted.com/talks/jamie_heywood_the_big_idea_my_brother_inspired.html
  • 46. “The  shiPing  trend  in  pharma  towards  increased   adop8on  of  IT  beyond  their  tradi8onal  needs  and   exploring  new  IT  avenues  in  digital  marke4ng,   regulatory  submissions,  predic4ve  analysis  &  cloud   compu4ng  has  become  more  evident  in  the  last  few   years.”     IT  Life  Sciences  Summit  2012:  Technology  Enabled  Pharmaceu2cal  Business  Transforma2on  –  DIA    
  • 48.
  • 51.
  • 52.
  • 53.
  • 54.
  • 56.
  • 58. Smartphone/Tablet  base  features   •  Processor   •  Local  and  Cloud  storage   •  Distant  communica2on   •  Time   •  Loca2on   •  Ac2vity   •  Local  communica2on   •  Camera…  
  • 59.
  • 60. Wearables   IMS estimates $14 million in 2011 rising to $171 million by 2016
  • 62.
  • 64. The  Internet  of  things  –  M2M  
  • 65.
  • 66.
  • 68.
  • 69. Where  do  the  data  go?  
  • 70.
  • 71. Synergy   “At  8:03am  you  used  your  asthma  puffer   while  entering  the  MaRS  concourse,   walking  at  a  moderate  pace  towards  the   Tim  Horton’s  aPer  an  unusually  long   subway  ride.  Your  pulse  was  110,  blood   pressure  135/80,  temperature  37.2,  blood   glucose…”  
  • 72. “Based  on  data  collected  to  date  I  es8mate  that   there  is  78.9%  probability  of  an  allergen  to   which  you  react  present  at  the  following   loca8ons…”  
  • 74. Thank  you   Martin Sumner-Smith, PhD Email: martins@digitalforhealth.com Office/Mobile: 1 (416) 727-4426 Web: www.DigitalForHealth.com Twitter: @martinss Linkedin: http://ca.linkedin.com/in/martinss