Pharmaceutical New Product Planning: The Role of Medical Affairs Critical in Defining New Paths for Success

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New product planning (NPP) groups have continually played a critical role in encouraging successful product launches. In today’s marketplace, the function has been forced to evolve in order to cope with various forces that have been driving industry changes and challenges. Some of the challenges that medical affairs new product planning groups are faced with include:

  • Growing safety concerns
  • Payer-controlled environments
  • Depleted pipelines
  • Personalized medicine
  • Enormous costs
  • Competition from generics
  • Fewer approvals

The role of Medical Affairs in NPP groups is critical – as they are expected to hand over a clear roadmap to the brand team. The map can be extremely useful in helping to fully understand the steps needed to successfully launch & manage the new drug.

Although the nature of new product planning activities is constantly changing, there are some key Medical Affairs activities that should always be harnessed for success, regardless of the size of your group. Knowing which responsibilities to focus on in each of the stages of NPP is the first of many steps to success.

Pre-Clinical: Some of the key activities involved in the initial stages of NPP activities include identifying KOLs, creation of the Target Product Profile, and becoming aware of and familiar with the competitive landscape. This stage can set the tone for all of the following phases of planning, so it is critical to start out on the right foot.

Phase I: Use feedback from KOLs to guide clinical trials and establish market-driven endpoints. Until Phase 2, it will be difficult to have too many specifics about the drug, as dosing and effects are still being dealt with. Use the information you have received and begin designing a publications strategy to get the attention of the medical community. Publications can shape the entire conversation among all affected parties – including scientists, medical practitioners, regulators, and marketers. It is extremely beneficial to set up a publication strategy and strongly adhere to it throughout the NPP process.

Phase II: Use publications to create a buzz at launch. We found that the majority of the activities that take place in Phase II are pre-marketing efforts. Dosing & effects of the drug are still being dealt with at this point – so it is still difficult to know all of the specifics of the drug. However, now that groups are gaining more information about the drug, it is essential to prepare for key activities, such as positioning and branding.

Phase III & Beyond: After Phase III, many benchmarked participants mentioned that their NPP activities significantly drop off. Specifics about the results of the publishing strategy should be shared during this phase. This is also the time to make clear to doctors the implications for their patients.

From our research, “Pharmaceutical New Product Planning: Role and Activities for Medical Affairs,” we found that NPP plays only a minor role at some benchmarked companies after Phase III. Despite this, Medical Affairs NPP is critical to the development and deployment of new drugs, especially from the pre-clinical phase to phase II of drug development. Adhering to the development milestones and guidelines will ensure that goals are met and will help successfully launch the new drug.

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