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Example of Regulatory Strategy Delivery

Parexel offers robust capabilities across the full spectrum of drug development: clinical research, regulatory and commercialisation consulting services, medical support services, and strategic consulting services. This support is customised depending on the need for example, where our various SME's from different functions form an advisory group to work with your company. 

Outlined below are a few examples of how Parexel has delivered Regulatory Strategy capabilities to our clients over the last few years.

 Example 2020:
Cardiovascular Franchise Strategy Development: As it prepares to commercialize its first product, a late-stage pharmaceutical company with several molecules in development enlisted Parexel to be an external thought partner to drive an aligned view across the commercial and R&D organization in order to set the strategy for the cardiovascular franchise for the next 5 years. Our team conducted a robust and systematic approach to articulate the vision for the franchise, informed through numerous internal and external stakeholder interviews, strategy workshops, company analog analysis, and a competitive landscape study. Armed with market insights, our teams collaborated to build a robust and compelling 5 year strategy for the cardiovascular franchise and developed guidance to align the organization across functions around the franchise strategy and created a strategic roadmap for the clinical, commercial, and corporate development teams.

Example 2019:
Strategic Assessment of R&D Services Spinout: In order to inform a client's go/no-go decision of whether to spin out a R&D services business, we assessed the market attractiveness for such services, potential competitors and the ability to attract outside investment as well as alignment with the parent company's strategic priorities. The team elucidated the demand for these services from the biotech industry through interviews, performed a competitive assessment to reveal the client's potential positioning, synthesized key learnings from relevant analogs, assessed which skills to leverage from the parent company vs the spinout, modelled financial scenarios and identified potential investors to determine the viability of the R&D services business as a standalone venture. Ultimately our assessment and facilitation provided the client with the evidence needed to make a data-driven go/no-go decision on whether to proceed with the investment.
 We also conduct business development strategy to assess and prioritize external assets for partnership and significant due diligence work incorporating regulatory strategy support. Some further examples are in the areas of: 

  • Future clinical asset development 
  • Indication expansion for current drug products 
  • Analysis of relevant clinical data and how it can be used to enhance product positioning in the marketplace 
  • Review and analysis of molecules in pre-clinical phases to determine their commercialization opportunities 
  • Evaluation of the development process of early assets 
  • Awareness and knowledge sharing between the R&D organization and commercial teams