Chelsea Therapeutics - Northera NOH 2011 Market Research Plan

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Market research plan supporting the commercialization of Northera for NOH (neurogenic orthostatic hypotension).

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Chelsea Therapeutics - Northera NOH 2011 Market Research Plan

  1. 1. By  Will  Roettger   Principal  Consultant   20/20  Market  Insights,  LLC   November  8,  2010  
  2. 2. Will  Roettger  is  an  established  career  professional  in  the  pharmaceutical  and   biotech  industry.  Having  worked  for  Novartis,  AstraZeneca,  Merck,  Alexion,  and   Dendreon  he  has  developed  expertise  across  the  therapeutic  areas  of  oncology,   hematology,  and  immunology  for  pipeline  and  launch  products.  He  has  been   instrumental  in  establishing  marketing  intelligence  as  a  core  capability  in   support  of  clinical  and  commercial  new  product  development,  solving  the  many   commercial  challenges  that  high-­‐priced  specialty  products  face  from  a  patient,   provider,  and  investor  perspective.  Additionally  he  has  supported  two  specialty   product  launches,  providing  actionable  insights  and  recommendations  by   integrating  market  research  findings  with  competitive  intelligence.  As  a   principal  for  20/20  Market  Insights,  LLC,  he  is  dedicated  to  providing  clients  with   clear  vision  into  competitor  landscapes,  strategies,  and  product  assessments   that  drive  strategic  business  decisions  in  new  drug  development.   Contact  Information:   Will  Roettger   Principal  Consultant   20/20  Market  Insights,  LLC   908-­‐391-­‐4362   will.roettger@gmail.com   2  
  3. 3. 4  
  4. 4. 5  
  5. 5. 6  
  6. 6. 1.  Chelsea  Therapeutics.com   7  
  7. 7. 8  
  8. 8. 9  
  9. 9. 1.  FDA.gov.     10  
  10. 10. 1.  FDA.gov.     11  
  11. 11. 1.  FDA.gov.     12  
  12. 12. 1.  FDA.gov.     2.  Shire.com,  August  17,  2010  press  release   13  
  13. 13. 1.  Clinical  Trials.gov   14  
  14. 14. 1.  Clinical  Trials.gov   15  
  15. 15. 16  
  16. 16. 17  
  17. 17. 18  
  18. 18. Pre  Launch   19  
  19. 19. Pre  Launch   20  
  20. 20. Pre  Launch   21  
  21. 21. Post  Launch   22  
  22. 22. Post  Launch   23  
  23. 23. 24  
  24. 24. 1.  CAR,  Update  on  NOH,  Kaufamm,  March  2008,  vol.18,  suppl.  125      
  25. 25. 1.  Merck  Manual  2009-­‐2010,  Ch  86,  Section  11.     2.  Rutan,  GH,  Hermanson,  B,  Bild,  DE,  et  al.  Orthostatic  hypotension  in  older  adults:  The  Cardiovascular  Health  Study  CHS  Collaborative  Research   Group.  Hypertension  1992;  19:508.     3.  J  Gerontol  A  Biol  Sci  Med  Sci  (2000)  55  (8):  M458-­‐M462.  Diagnostic  Yield  and  Development  of  a  Neurocardiovascular  Investigation  Unit  for  Older   Adults  in  Hospital.  Liesl  Allcock   4.   Allcock  LM,  Ullyart  K,  Kenny  RA,  Burn  DJ  (2004)  Frequency  of  orthostatic  hypotension  in  a  community  based  cohort  of  patients  with   26   Parkinson’s  disease.  J  Neurol  Neurosurg  Psychiatry  75:1470–1471  
  26. 26. 27  
  27. 27. 28  
  28. 28. Secondary  Data   Market  Insight   Study   TPP  Testing   ATU  Tracker   Segmentation   Positioning   Messaging   29  
  29. 29. Physician  Insights   Patient  Insights   Concept  Testing   Detail  Aid  Testing   Pricing  Research   30  
  30. 30. Medical  Claims/ EMR    Data   Rx  Data   ATU  Tracking   Analytics   Message  Recall   Analytics   31  
  31. 31. Northera™  NOH  Global  Market  Research     Plan  (2010-­‐2012)   2  0  1  0      G5      G5   June   May     Apr   Mar   US   Jan   US   2  0  1  1   2  0  1  2   Forecast   ATU   Market   Product  Form    Detail  Aid   Tracker  –   Model  I   Insight  &   &  Packaging   Development   pre  launch   Segmentatio Research   (Qual)    TPP  Testing     n     Concept   Patient/ Positioning   (Quant)   Patient  Ed   Branding     Developmen Support  Group     Ideation   Developmen  TPP  Testing    Detail  Aid   t  (Qual)   Insight  Study   (Qual)   t   (Qual)     Development   Positioning   Concept   (Qual)   (Quant)   Evaluation   Developmen (Quant)   t  (Quant)   PEST  Evaluation   Strategy  Development   Launch      G5   Dec   Aug   US   Jul   Jun   May   Apr   US   Mar   Feb   Jan   US   Dec   Nov   Oct   US    G5   Nov    G5   Oct    G5   DDMAC   NDA   Feb   Phase  III  Trial   Data  (306)   Sep   Phase  III  Trial   Data  (301)   Forecast   Model  II   ATU   Tracker   (baseline )   EU  Market   Insight  &   Segmentatio n     Messag e  Recall   ATU   Tracker   (Wave   1)   Product   Persistency / Complianc e  Study   Ongoing  Performance  Analytics/SFE   Tactics  32  evelopment   D Performance  Assessment  
  32. 32. SCOPE US US US US US US US US US US US US US US US US US 2011 - 2012 Positioning - Ideation (Qual) Positioning - Evaluation (Quant) Branding TPP Testing (Qual) TPP Testing (Quant) Patient Support Group Insight Study (Qual) ATU Tracker - Pre Launch Concept Development (Qual) Concept Test (Quant) Detail Aid Development (Qual) Detail Aid Test (Quant) Product Packaging Research Patient Ed Development ATU Tracker - Baseline ATU Tracker – Wave 1 Message Recall Product Persistency/Compliance Study COST 40,000 75,000 60,000 40,000 75,000 30,000 65,000 30,000 70,000 40,000 75,000 60,000 30,000 60,000 60,000 60,000 65,000 $ 935,000 Sub Total 1.  Does  not  include  data  purchases  such  as  IMS,  SDI,  Datamonitor,  Decision  Resources,  etc.   33  
  33. 33. %  Time   %  Time   35%   50%   30%   40%   25%   10%   8%   Primary   Secondary   CI   2%   SFE   Primary   34   Secondary   CI   SFE  
  34. 34. 35  
  35. 35. 1.  Manhattan  Research’s  –  e-­‐Pharma  Physician  Report.     2.  SK  &  A  Research  Survey     36  
  36. 36. 1.  Manhattan  Research’s  –  e-­‐Pharma  Physician  Report.     2.  SK  &  A  Research  Survey     37  
  37. 37. 1.  Manhattan  Research’s  –  e-­‐Pharma  Physician     38  
  38. 38. 39  
  39. 39. 40  
  40. 40. 41  
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  43. 43. 44  
  44. 44. 1.  JAMIA  2010;17:403-­‐410  doi:10.1136/jamia.2010.005660,  Cornelia  M  Ruland,  Effects  of  a  computer-­‐supported  interactive   tailored  patient  assessment  tool  on  patient  care,  symptom  distress,  and  patients'  need  for  symptom  management  support:  a   45   randomized  clinical  trial  
  45. 45. 1.  Online  Depression  Assessment  Tool  Validated,  Preferred  by  Patients  Friday,  July  30,  2010  -­‐  Elsevier  Global  Medical  News  By   Damian  McNamara.  http://www.medconnect.com.au//tabid/84/s25/Pain-­‐Anaesthesia/ct1/c337854/Online-­‐Depression-­‐ 46   Assessment-­‐Tool-­‐Validated-­‐Preferred-­‐by-­‐Patients  
  46. 46. 47  
  47. 47. 48  
  48. 48. Will  Roettger   Principal  Consultant   20/20  Market  Insights,  LLC   908-­‐391-­‐4362   will.roettger@gmail.com   49  

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