Early-stage product commercialization continues to challenge even the most skilled and highly respected marketing and drug development organizations. Changing government regulations, pharmacoeconomics, health care practices, and scientific innovations have transformed the drug development landscape in the past decade. As patent protection narrows on many companies' top-selling brands, the race to market profitable products in record time is intensifying. These transformations have been met concurrently with rising drug development costs and diminishing R&D productivity.

These business drivers require organizational and cultural changes within drug companies in order to unite R&D and marketing - and to direct them toward shared objectives early in development. Injecting market input into drug discovery and early clinical development enables marketing and R&D to focus limited resources on the most promising drug candidates. With market information, R&D can develop drug target libraries and hone in on endpoints with the greatest likelihood of fulfilling unmet medical needs. Ultimately, a continuous exchange of information between R&D and marketing enables companies to make more informed portfolio decisions, to serve their markets better, and to achieve higher profits.

This report covers the critical areas in which R&D and marketing need to work together, including portfolio planning, resource allocation, product hand-offs and ownership, and project and product team structures. Best practices and case studies illustrate numerous tools, tactics, organizational structures and strategies used by top-performing pharmaceutical and biotech companies to bridge the gaps between R&D and marketing in early-stage drug development

Best practices and case studies illustrate a variety of tools, tactics, organizational structures and strategies used by top-performing pharmaceutical and biotech companies to bridge the gaps between R&D and marketing in early-stage drug development. This report covers all the critical areas in which R&D and marketing need to work together, including portfolio planning, resource allocation, product hand-offs and ownership, and project and product team structures.

Executive Summary

Profiled Companies

Connecting R&D and Marketing in Portfolio Planning and Resource Allocation

Bridging the Cultural Gap to Unite R&D and Marketing

Building a Marketing-R&D Interface
Transitioning Brands from R&D to Commercial Ownership

lntegrating R&D and Markefing through Organizational Structure

Shepherding Drugs through Development: R&D-Marketing lntegration on Project and Product Teams
Enhancing the R&D-Marketing lnterface on Project Management Teams
Coordinating Early-Stage Marketing Activtties

APPENDIX

Appendix: New Product Pre-Marketing Plan Sample

CHART AND GRAPHICS

Executive Summary

Connecting R&D and Marketing in Portfolio Planning and Resource Allocation

Figure l.1: Portfolio Management Challenges
Figure 1.2: Factors that lnfluence Resource Allocation Processes
Figure l.3: Resource Allocation Process at Company B
Figure 1.4: Five Objectives of Early-Stage Product Marketing Funding Requests

BridgingtheCulivralGaptoUniteR&DandMarkefing

Figure 2.1: Uniting R&D and Marketing for Market-Focused Product Development
Building a Marketing-R&D lnterface
Figure 2.2: Begin with the End in Mind:Marketers on R&D Teams
Figure 2.3: Bridging the Development-Commercialization Gap
Figure 2.4: R&D-Marketing Co-Governance Structures
Figure 2.5: Relationship-Building Structures
Transitioning Brands from R&D to Commercial Ownership
Figure 2.6: Company A' s Five-Point Decision Process
Figure 2.7: R&D lnvolvement in Commercial Assessments
Figure 2.8: Balancing Clinical and Commercial Data in Go/No-go Decisions

CHARTS AND GRAPHICS

lntegrating R&D and Marketing through Organizational Structure

Shepherding Drugs through Development: R&D-Marketing lntegrdion on Project and Product Teams
Figure 3.1: Company D' s Commercial Structure
Figure 3.2: Project Steering Committee Composition at Company F
Figure 3.3: Lifecycle Management Team Membership
Figure 3.4: Early-Stage Commercialization Teams at Company A
Enhancing the R&D-Marketing lnterface on Project Management Teams
Figure 3.5: Company E' s Matrixed Structure
Coordinating Early-Stage Marketing Activities
Figure 3.6: Functional Contributions to Product Marketing throughout Early-Stage Development
Figure 3.7: Stage-Gate Decision-Making Process at Company C