First Product Commercialization

US and EU master plan for first product commercialization prepared for a company transitioning from R&D to commercial focus.

Challenge

Our client, the head of commercial for an emerging biotechnology company, is preparing his organization to launch its first commercial product into a competitive rare disease market. From the very beginning, our client’s focus was on the scientific and clinical challenges of developing a platform powered by cutting-edge mechanisms of action that would potentially be applicable to dozens of distinct disorders. With a groundbreaking first product launch looming, our client recognized the urgent need to dramatically expand both the organization and the mindset of their scientifically and medically focused leadership. Clarion was engaged to guide the leadership team through the complex series of decisions needed to effectively grow the organization into a commercially-capable enterprise. With an eye towards the unique challenges of launching a product in a competitive rare disease market, Clarion worked closely with key functional area leads to craft a detailed global commercial master plan to meet the client’s particular needs.

Solution

Clarion worked collaboratively with our client to develop a high-level master plan to launch the company’s first product in a competitive rare disease market through a series of orchestrated meetings and workshops with functional area leads and leadership team members. Through engaging the scientifically-focused client on the commercial challenges it would face over the next two to three years, the executive management team emerged with a clear set of objectives to guide complex decisions in the short and medium-term future.

Commercialization Roadmap

  • Critical-path launch work streams, activities, and cross-functional interdependencies anchored to key milestones and critical decision points provided leadership with a detailed guide to execute the commercialization strategy
  • Robust U.S. and European launch governance, supporting global structure, and key performance indicators tailored by Clarion to suit the organization’s specific needs

Organizational Capabilities, Design, and Scale-up Plan

  • Enterprise capability requirements to facilitate transition from a scientific organization to one with business and commercial functions
  • Organizational design, detailed role profiles, and timing to guide client activities across the organization
  • Budget modeling and benchmarked financial implications provided leadership with a realistic understanding of costs associated with growing into a commercial organization

Organizational Engagement Strategy

  • Cross-functional communication, coordination and alignment
  • Critical path work stream support to provide individual stakeholders with the benefit of Clarion’s launch and commercialization experience
  • Strategic program management

Impact

Our client is an emerging company commercializing their first product and needed help with critical decision, strategy and tactics – for them it was make or break. Clarion helped them transition from a scientific organization to an organization that has clear commercial objectives. With the benefit of Clarion’s assistance, they initiated activities to build the company’s commercial organization with a clear, shared vision of goals and challenges. Clarion continues to work intensively with this client as they transform from a scientifically-minded enterprise to a market leader that proactively addresses patient needs.

The Clarion Difference

  • Unique expertise: Over 15 years of experience supporting new product commercialization for emerging leaders in biotech in need of business and strategic support as they transform medicine
  • Proprietary data: Financial database of budget spend by quarter through launch/curated-launch budget database, organizational capabilities, and comprehensive set of US and EU launch activities provided the client the benefit of Clarion’s deep experience as they commercialize their first product
  • Strategic insights: Leverages scientific know-how and business insights to develop and pressure-test a tailored strategy that fits our client’s needs today and into the future
  • Products & markets: Clarion’s broad therapeutic area experience including primary care, specialty, oncology, rare and ultra-rare diseases provides the perspective and confidence to guide organizations and individuals in overcoming challenges, regardless of their nature
  • Collaborative nature: Ability to drive seamless integration across functional teams and act as an extension of direct client contact to translate strategic plans into successful actions

Clarion’s value was in its ability to blend our company’s unique situation and market knowledge into discrete, tailor-made tasks that met our company’s distinct priorities."

— Senior Director, Launch Excellence

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