Rx Marketer's Reference Guide, 2nd Edition Report Information
MMC International, March 2012, Pages: 178
The Rx Marketer's Reference Guide, 2nd Edition presents the sequential flow of required product development, launch, and post-launch information. It allows brand managers, the Product Development Team, the Life Cycle Management Team, and other participants to understand their roles and responsibilities and how they fit in the overall commercial aspects of drug development, launch and marketing.
How pharmaceutical products are developed, approved, reimbursed and marketed will be undergoing fundamental changes at least through 2020. The use of genomics, databases, advanced technologies, and biomarkers will speed candidate identification, decrease the size of potential patient populations, enable outcomes-based reimbursement, and, for select products, decrease clinical trial/development timelines.
Biomarker targeting and use of other advanced drug development tools will reduce the risk of clinical failure and will result in the combination of Phase I and II and/or Phase II and III clinical trials – shortening the development timeline. The shift in reimbursement towards only reimbursing those products that show a clinical benefit versus existing products means that not all products will get reimbursed and that products may not be launched in certain markets. Any products that are not therapeutically unique will require earlier commercial assessments versus truly unique drugs. The gradual shift, that has begun, from selling a drug to selling an outcome means that the type of information captured throughout development will have to be tailored to how the product will be positioned and how it will be reimbursed, promoted and sold.
No guide can address all the specific needs required for the successful development of a brand unless it is specifically tailored to that product. The Rx Marketer's Reference Guide, 2nd Edition is a reference tool for Rx marketers and the respective Rx company functions and teams to begin the development of the respective brand plans.
The content is organized to assist the user in defining:
1) the flow of product development activities throughout the product development, launch and post-launch periods,
2) support, through content listings, the development of marketing research that flows from one study to the next, and
3) through checklists, what should be contained in brand planning, marketing and life cycle management plans.
It also provides insights relative to who should be considered for inclusion in the respective product development committees.
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
About The Author
Edmund L. Valentine has over 27 years of global healthcare industry experience. He is the author of Multi-Trillion Dollar U.S. Healthcare To 2020 Gold Rush, Industrializing Healthcare, and has been the editor of multiple editions of MMC International's Trends Shaping U.S. Pharmaceutical Industry Strategies reports as well as therapeutic area reviews. Valentine is Chairman and C.E.O. of MMC International, a strategy, general management, business development, marketing and technology assessment advisory firm primarily focusing on the global healthcare industry. He is a recognized authority on the trends shaping the U.S. healthcare system.
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