Marketing Activities and Market Research Throughout The Rx Product Life Cycle – Reference
Pharmaceutical product development takes from six to nine years. A myriad of individuals from multi-discipline teams are involved. Marketing is responsible for a significant number of activities, from the initial market/commercial assessment to the development and update of the product's life cycle plan (LCM). All this work effort should be coordinated and conducted in incremental steps, over a number of years, to maximize the benefits of marketing and market research investments. This is often difficult as people change throughout the multiyear development cycle.
The Marketing Activities and Market Research Throughout The Rx Product Life Cycle - Reference was prepared to assist the members of product development teams, life cycle management teams, marketing, and market research plan the timely marketing inputs and market research that are required for a successful product. The report is a result of customer interfaces, customer questions, observed customer needs, pharmaceutical management interviews and internal MMC team work and discussions. Each required marketing and/or market research activity is described, the purpose is listed, who generally uses the information is outlined, who is responsible for generating the information is defined, and what information should be gathered and how it should be organized (key elements/contents) is presented. The report is written from the perspective of how a large company would staff the effort. In turn, the guide can be utilized by both large pharmaceutical organizations as well as small start-up companies.
The Marketing Activities and Market Research Throughout The Rx Product Life Cycle - Reference was prepared to assist the members of product development teams, life cycle management teams, marketing, and market research plan the timely marketing inputs and market research that are required for a successful product. The report is a result of customer interfaces, customer questions, observed customer needs, pharmaceutical management interviews and internal MMC team work and discussions. Each required marketing and/or market research activity is described, the purpose is listed, who generally uses the information is outlined, who is responsible for generating the information is defined, and what information should be gathered and how it should be organized (key elements/contents) is presented. The report is written from the perspective of how a large company would staff the effort. In turn, the guide can be utilized by both large pharmaceutical organizations as well as small start-up companies.
COPYRIGHT AND USE RESTRICTIONS
PREFACE
INTRODUCTION
HOW TO USE THIS GUIDE
TERMS AND ACRONYMS
ORGANIZATIONAL ISSUES
RX PRODUCT DEVELOPMENT TIMELINES
DRUG DISCOVERY (2-10 YEARS)
Where Market Activities Fit In During The Drug Discovery Phase
1. Initial Market/Commercial Assessment
2. Initial Market Research
3. First Development Title
PRECLINICAL DEVELOPMENT (1-2 YEARS)
Where Market Activities Fit In During Preclinical Development
4. Market Research Plan
5. Consideration of Future Indications
6. Target Core Data Sheet (Target Product Profile/Target Package
Insert (TPP/TPI)
IND/CTX SUBMISSION
Where Market Activities Fit In During IND/CTX Submission
7. Preliminary Health Economic Strategy
PHASE I CLINICAL TRIALS: NORMAL VOLUNTEERS (UP TO 2 YEARS)
Where Market Activities Fit In During Phase I
8. Preliminary Pricing Assessment
9. Phase I Product Communication
10. Concept Testing
11. Health Economic Protocol Phase II Input
12. Non-Proprietary Name
13. Preliminary Strategic Product Plan
14. Preliminary Pricing Strategy
PHASE II CLINICAL TRIALS: PATIENTS PROOF OF CONCEPT STUDIES (UP TO 3 YEARS)
Where Market Activities Fit In During Phase II
15. Phase II Product Communication
16. Packaging Requirements for Stability
17. Therapeutic Area Communications Plan
18. Trademark Research
19. Agency Selection
20. Publication Plan
21. Trademarking
22. Preliminary Product Life Cycle Plan
23. Key Countries for Phase III Studies
24. Health Economic Protocol Input (Phase III)
PHASE III CLINICAL TRIALS: PATIENTS (UP TO 5 YEARS)
Where Market Activities Fit In During Phase III
25. Update of Market/Commercial Assessment
26. Targeting Research
27. Pricing Research Plan
28. Pre-Approval Communications Plan
29. Product Positioning Market Research
30. Core Concepts Development
31. Final Name Selection
32. Preliminary Global Pricing Plan
33. Global Marketing Communications Planning & Development
34. Strategic Product Plan
35. Phase III Product Communication
36. Pricing Research
37. Strategic Training Team
38. Trademark Registration
39. Marketing Subsidiaries Strategic Product Plans
40. Marketing Advisory Board
41. Update of Market Assessment and Strategic Product Plan
42. Decisions on Secondary Packaging
43. Communications Research
44. Preliminary Global Pricing Plan Update
45. Core Sales Training Materials Development
46. Trademark Review
NDA FILING/PREPARE FOR LAUNCH
Where Market Activities Fit In During NDA Filing/Launch Preparation
47. Pre-Launch Product Communication
48. Health Economic Summary
49. Product Positioning
50. Core Launch Plan
51. Core Patient Package Insert
52. Sales Forecast
53. Global Launch Communications Plan
54. Life Cycle Management Plan.
55. Global Marketing Launch
56. Core Launch Conference Materials Development
57. Launch Kit
58. Global Pricing Plan
59. Marketing Support Studies
POST-APPROVAL/LIFE CYCLE MANAGEMENT
Where Market Activities Fit In Post-Approval / After Launch
60. Post-Launch Health Economic Strategy
61. Post-Launch Product Communication
62. Review/Revise Global Pricing Plan
63. Update Life Cycle Management Plan
PREFACE
INTRODUCTION
HOW TO USE THIS GUIDE
TERMS AND ACRONYMS
ORGANIZATIONAL ISSUES
RX PRODUCT DEVELOPMENT TIMELINES
DRUG DISCOVERY (2-10 YEARS)
Where Market Activities Fit In During The Drug Discovery Phase
1. Initial Market/Commercial Assessment
2. Initial Market Research
3. First Development Title
PRECLINICAL DEVELOPMENT (1-2 YEARS)
Where Market Activities Fit In During Preclinical Development
4. Market Research Plan
5. Consideration of Future Indications
6. Target Core Data Sheet (Target Product Profile/Target Package
Insert (TPP/TPI)
IND/CTX SUBMISSION
Where Market Activities Fit In During IND/CTX Submission
7. Preliminary Health Economic Strategy
PHASE I CLINICAL TRIALS: NORMAL VOLUNTEERS (UP TO 2 YEARS)
Where Market Activities Fit In During Phase I
8. Preliminary Pricing Assessment
9. Phase I Product Communication
10. Concept Testing
11. Health Economic Protocol Phase II Input
12. Non-Proprietary Name
13. Preliminary Strategic Product Plan
14. Preliminary Pricing Strategy
PHASE II CLINICAL TRIALS: PATIENTS PROOF OF CONCEPT STUDIES (UP TO 3 YEARS)
Where Market Activities Fit In During Phase II
15. Phase II Product Communication
16. Packaging Requirements for Stability
17. Therapeutic Area Communications Plan
18. Trademark Research
19. Agency Selection
20. Publication Plan
21. Trademarking
22. Preliminary Product Life Cycle Plan
23. Key Countries for Phase III Studies
24. Health Economic Protocol Input (Phase III)
PHASE III CLINICAL TRIALS: PATIENTS (UP TO 5 YEARS)
Where Market Activities Fit In During Phase III
25. Update of Market/Commercial Assessment
26. Targeting Research
27. Pricing Research Plan
28. Pre-Approval Communications Plan
29. Product Positioning Market Research
30. Core Concepts Development
31. Final Name Selection
32. Preliminary Global Pricing Plan
33. Global Marketing Communications Planning & Development
34. Strategic Product Plan
35. Phase III Product Communication
36. Pricing Research
37. Strategic Training Team
38. Trademark Registration
39. Marketing Subsidiaries Strategic Product Plans
40. Marketing Advisory Board
41. Update of Market Assessment and Strategic Product Plan
42. Decisions on Secondary Packaging
43. Communications Research
44. Preliminary Global Pricing Plan Update
45. Core Sales Training Materials Development
46. Trademark Review
NDA FILING/PREPARE FOR LAUNCH
Where Market Activities Fit In During NDA Filing/Launch Preparation
47. Pre-Launch Product Communication
48. Health Economic Summary
49. Product Positioning
50. Core Launch Plan
51. Core Patient Package Insert
52. Sales Forecast
53. Global Launch Communications Plan
54. Life Cycle Management Plan.
55. Global Marketing Launch
56. Core Launch Conference Materials Development
57. Launch Kit
58. Global Pricing Plan
59. Marketing Support Studies
POST-APPROVAL/LIFE CYCLE MANAGEMENT
Where Market Activities Fit In Post-Approval / After Launch
60. Post-Launch Health Economic Strategy
61. Post-Launch Product Communication
62. Review/Revise Global Pricing Plan
63. Update Life Cycle Management Plan
