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By	
  Will	
  Roettger	
  
Principal	
  Consultant	
  

20/20	
  Market	
  Insights,	
  LLC	
  
November	
  8,	
  2010	
  
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	
  
Chelsea Therapeutics -  Northera NOH 2011 Market Research Plan
4	
  
5	
  
6	
  
1.  Chelsea	
  Therapeutics.com	
  

7	
  
8	
  
9	
  
1.  FDA.gov.	
  	
  

10	
  
1.  FDA.gov.	
  	
  

11	
  
1.  FDA.gov.	
  	
  

12	
  
1.  FDA.gov.	
  	
  
2.  Shire.com,	
  August	
  17,	
  2010	
  press	
  release	
  

13	
  
1.  Clinical	
  Trials.gov	
  

14	
  
1.  Clinical	
  Trials.gov	
  

15	
  
16	
  
17	
  
18	
  
Pre	
  Launch	
  

19	
  
Pre	
  Launch	
  

20	
  
Pre	
  Launch	
  

21	
  
Post	
  Launch	
  

22	
  
Post	
  Launch	
  

23	
  
24	
  
1.  CAR,	
  Update	
  on	
  NOH,	
  Kaufamm,	
  March	
  2008,	
  vol.18,	
  suppl.	
  125	
  
	
  	
  
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	
  
27	
  
28	
  
Secondary	
  Data	
  
Market	
  Insight	
  
Study	
  

TPP	
  Testing	
  
ATU	
  Tracker	
  

Segmentation	
  
Positioning	
  
Messaging	
  
29	
  
Physician	
  Insights	
  
Patient	
  Insights	
  

Concept	
  Testing	
  
Detail	
  Aid	
  Testing	
  

Pricing	
  Research	
  

30	
  
Medical	
  Claims/
EMR	
  	
  Data	
  
Rx	
  Data	
  
ATU	
  Tracking	
  
Analytics	
  

Message	
  Recall	
  
Analytics	
  

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	
  
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	
  
%	
  Time	
  

%	
  Time	
  
35%	
  

50%	
  
30%	
  

40%	
  

25%	
  

10%	
  
8%	
  

Primary	
  

Secondary	
  

CI	
  

2%	
  
SFE	
  

Primary	
  

34	
  

Secondary	
  

CI	
  

SFE	
  
35	
  
1.  Manhattan	
  Research’s	
  –	
  e-­‐Pharma	
  Physician	
  Report.	
  	
  
2.  SK	
  &	
  A	
  Research	
  Survey	
  	
  

36	
  
1.  Manhattan	
  Research’s	
  –	
  e-­‐Pharma	
  Physician	
  Report.	
  	
  
2.  SK	
  &	
  A	
  Research	
  Survey	
  	
  

37	
  
1.  Manhattan	
  Research’s	
  –	
  e-­‐Pharma	
  Physician	
  	
  

38	
  
39	
  
40	
  
41	
  
42	
  
43	
  
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	
  
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	
  
47	
  
48	
  
Will	
  Roettger	
  

Principal	
  Consultant	
  
20/20	
  Market	
  Insights,	
  LLC	
  
908-­‐391-­‐4362	
  
will.roettger@gmail.com	
  

49	
  

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Chelsea Therapeutics - Northera NOH 2011 Market Research Plan

  • 1. By  Will  Roettger   Principal  Consultant   20/20  Market  Insights,  LLC   November  8,  2010  
  • 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  
  • 10. 1.  FDA.gov.     10  
  • 11. 1.  FDA.gov.     11  
  • 12. 1.  FDA.gov.     12  
  • 13. 1.  FDA.gov.     2.  Shire.com,  August  17,  2010  press  release   13  
  • 16. 16  
  • 17. 17  
  • 18. 18  
  • 24. 24  
  • 25. 1.  CAR,  Update  on  NOH,  Kaufamm,  March  2008,  vol.18,  suppl.  125      
  • 26. 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  
  • 27. 27  
  • 28. 28  
  • 29. Secondary  Data   Market  Insight   Study   TPP  Testing   ATU  Tracker   Segmentation   Positioning   Messaging   29  
  • 30. Physician  Insights   Patient  Insights   Concept  Testing   Detail  Aid  Testing   Pricing  Research   30  
  • 31. Medical  Claims/ EMR    Data   Rx  Data   ATU  Tracking   Analytics   Message  Recall   Analytics   31  
  • 32. 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  
  • 33. 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  
  • 34. %  Time   %  Time   35%   50%   30%   40%   25%   10%   8%   Primary   Secondary   CI   2%   SFE   Primary   34   Secondary   CI   SFE  
  • 35. 35  
  • 36. 1.  Manhattan  Research’s  –  e-­‐Pharma  Physician  Report.     2.  SK  &  A  Research  Survey     36  
  • 37. 1.  Manhattan  Research’s  –  e-­‐Pharma  Physician  Report.     2.  SK  &  A  Research  Survey     37  
  • 38. 1.  Manhattan  Research’s  –  e-­‐Pharma  Physician     38  
  • 39. 39  
  • 40. 40  
  • 41. 41  
  • 42. 42  
  • 43. 43  
  • 44. 44  
  • 45. 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  
  • 46. 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  
  • 47. 47  
  • 48. 48  
  • 49. Will  Roettger   Principal  Consultant   20/20  Market  Insights,  LLC   908-­‐391-­‐4362   will.roettger@gmail.com   49