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Naviga&ng	
  the	
  
Uncertain	
  Waters	
  of	
  
the	
  FDA	
  
Big	
  Pharma	
  &	
  Mobile	
  Tech	
  
	
  
Meet	
  the	
  Presenters:	
  	
  
2013	
  ©	
  MRM	
  All	
  Rights	
  Reserved	
  
Timothy	
  Makoid	
  	
  
User	
  Exp...
1. Why	
  should	
  we	
  trust	
  big	
  Pharma?	
  
2. What’s	
  holding	
  up	
  innovaFon?	
  	
  
3. What’s	
  the	
 ...
2013	
  ©	
  MRM	
  All	
  Rights	
  Reserved	
  
Why	
  should	
  we	
  trust	
  Big	
  Pharma?	
  
•  Pharma	
  owes	
  ...
2013	
  ©	
  MRM	
  All	
  Rights	
  Reserved	
  
What’s	
  Holding	
  Up	
  InnovaFon?	
  
Actually	
  it’s	
  happening	...
2013	
  ©	
  MRM	
  All	
  Rights	
  Reserved	
  
What’s	
  MLR:	
  
Medical/Legal/
Regulatory	
  
Every	
  pharma	
  comp...
2013	
  ©	
  MRM	
  All	
  Rights	
  Reserved	
  
So	
  what’s	
  the	
  deal	
  with	
  the	
  FDA?	
  
ANer	
  3	
  year...
2013	
  ©	
  MRM	
  All	
  Rights	
  Reserved	
  
So	
  what	
  can	
  we	
  do	
  about	
  any	
  of	
  this?	
  
	
  
• ...
So	
  if	
  you’d	
  like	
  us	
  to	
  talk	
  about	
  
any	
  of	
  these	
  issues	
  please	
  vote	
  for	
  
us	
 ...
Who	
  is	
  MRM?	
  
2013	
  ©	
  MRM	
  All	
  Rights	
  Reserved	
  
CommunicaFons	
   eCommerce	
   PharmaceuFcals	
  ...
2,300+	
  Cra]speople	
  
500+ 	
  	
  Technologists	
  
150+ 	
  	
  Social	
  Architects	
  
300+ 	
  	
  Data	
  &	
  A...
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Big Pharma & Mobile Tech: Navigating the FDA

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Medical & Health initiatives led the way in 2013 at SXSW. But what were missing were Big Pharma and the FDA.The FDA 3 years ago promised guidance on Pharma social practices and 2 years ago promised guidance on Pharma mobile health apps and medical devices. They released preliminary guidance, had a public forum, but never made good on their promise. In the mean time Pharma companies have been trying to couple their drugs with actionable care solutions. The gray area is around patient tracker apps. The original guidance said “anything that helps the doctor make a treatment decision is a medical device”, but the community said, “hold it, how is that different from a paper and pen journal?” The FDA responded at an open forum, yet they never released guidance. So,many pharma companies are afraid of getting a letter. Our discussion will focus on what we can do to improve the submission and approval process of medical apps and devices through the FDA.

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Transcript of "Big Pharma & Mobile Tech: Navigating the FDA"

  1. 1. Naviga&ng  the   Uncertain  Waters  of   the  FDA   Big  Pharma  &  Mobile  Tech    
  2. 2. Meet  the  Presenters:     2013  ©  MRM  All  Rights  Reserved   Timothy  Makoid     User  Experience  InnovaFon  Lead   Benjamin  Weisman     SVP  Director  of  CreaFve  InnovaFons  
  3. 3. 1. Why  should  we  trust  big  Pharma?   2. What’s  holding  up  innovaFon?     3. What’s  the  deal  with  the  FDA?   4. What  can  we  do  about  it?   Our  Presenta&on  Will  Cover:  
  4. 4. 2013  ©  MRM  All  Rights  Reserved   Why  should  we  trust  Big  Pharma?   •  Pharma  owes  you  one…  and  they’ve  got  the  money   •  They’ve  got  great  talent   •  They’re  one  of  the  most  knowledgeable  resources  in  the  world  on  diseases   and  treatments  and  they  have  their  finger  on  the  pulse  of  the  medical  and   HCP  communi&es   •  They  have  endless  amounts  of  pa&ent  and  HCP  data  and  they  know  their   customer  well  
  5. 5. 2013  ©  MRM  All  Rights  Reserved   What’s  Holding  Up  InnovaFon?   Actually  it’s  happening  all  the  &me  behind  the  scenes  but  a   large  por&on  of  well  designed  mobile  health  technology  never   sees  the  light  of  day  because  of       MLR  and  the  FDA.  
  6. 6. 2013  ©  MRM  All  Rights  Reserved   What’s  MLR:   Medical/Legal/ Regulatory   Every  pharma  company  has  a  team  of  lawyers  that  review  anything  released   by  the  company  to  insure  that  they  don’t  release  anything  that  will  get  them  in   trouble  with  the  FDA.  
  7. 7. 2013  ©  MRM  All  Rights  Reserved   So  what’s  the  deal  with  the  FDA?   ANer  3  years  of  promising  guidance  on  Pharma  social  and  mobile  prac&ces,   we’re  s&ll  leN  wondering  what  we  are  and  aren’t  allowed  to  do.   Because  of  this  a  lot  of  MLR  reviewers  are  afraid  to  proceed  without  clear   guidance.   This  accounts  for  millions  of  dollars  of  lost  ini&a&ves  that  could  be  going   towards  helping  pa&ents  deal  with  their  condi&on  and  treatment  and  helping   HCPs  educate  and  socially  communicate  with  each  other  and  their  pa&ents.  
  8. 8. 2013  ©  MRM  All  Rights  Reserved   So  what  can  we  do  about  any  of  this?     •  We  need  to  keep  this  conversaFon  going.  RegulaFon  is  important,  and   that’s  why  we  need  the  FDA  to  provide  us  with  some.  We’re  not  asking   for  free  reign,  just  guidelines  so  we  can  start  innovaFng.   •  Speaking  of  innovaFng,  keep  doing  it.  The  more  health  tech  that  hits   the  market,  the  less  likely  Pharma  can  deny  itself  an  opportunity  to   join  the  movement.  And  the  more  money  spent  on  health  tech,  the   beXer.   •  Communicate  with  the  FDA.  Let  them  know  that  we  want  guidance   now  and  that  they’re  holding  up  innovaFon  in  America.  
  9. 9. So  if  you’d  like  us  to  talk  about   any  of  these  issues  please  vote  for   us  for  SXSW  InteracFve  2014.     Thanks!   2013  ©  MRM  All  Rights  Reserved  
  10. 10. Who  is  MRM?   2013  ©  MRM  All  Rights  Reserved   CommunicaFons   eCommerce   PharmaceuFcals   Technology  AutomoFve  Online  Trading  
  11. 11. 2,300+  Cra]speople   500+    Technologists   150+    Social  Architects   300+    Data  &  AnalyFcs   We  Are:   2013  ©  MRM  All  Rights  Reserved  
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