Passing the Healthcare Innovation Torch: From Medicinal Chemistry, Through Biotechnology, to Digital...

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In the middle of the 20th century, pharmaceutical companies were highly respected and patients depended on their physicians to make healthcare decisions for them. Drugs were a key part of a physician’s “toolkit.” As we entered the era of blockbuster drugs, most drugs were small molecules created by chemical synthesis, but biotechnology was beginning to emerge as a possible source of new therapeutics. Meanwhile, direct-to-consumer pharmaceutical advertising began to empower patients. Fast-forward to today and we see pharmaceutical companies suffering degraded reputations and values, patients being empowered by the Internet and social media, and average life expectancies increasing by a decade. Digital health technologies are posed to explode and the top 10 pharmaceuticals by sales will soon all be biologicals!

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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

Mar

ket G

row

th

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    

Cha

nge

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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