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Organizing to Prepare for Launch: No Longer Uncertain, Messy, and Intense

SVA Life Sciences helps biopharmaceutical leaders navigate their successful commercialization journey – a common goal in our line of work and of the clients we support. Our true differentiator in reaching this goal, however, is the way we pay mind to both the launch of the corporate entity and the launch of the product itself. We use our understanding of the inner workings of each side of an emerging organization to target the pain points and alleviate them.

The adventure into commercialization is a notoriously uncertain, messy, and intense period in the life of emerging and even established organizations. We recognize and bring these issues to the forefront and provide our clients with sustainable solutions that make this otherwise complex process a well-structured, sure-footed system.

Our mindset and strategies center around the following 3 goals:

  1. CLARIFY

    We Take-on Uncertainty by aligning stakeholders on your commercialization destination, scenarios, options, and expectations.
  2. ARCHITECT

    We Tame Messiness by designing a fit-for-purpose organizational structure to execute with imperfect information and evolving plans.
  3. BUILD

    We Ease Intensity by relieving your people of “lower 50%” processes, activities, and tasks we can execute on your behalf.

Determining How We May Help You: 3 Common Workstreams

Emerging Life Sciences organizations most often come to us following initiated action to prepare for launch; when something has prompted them to think about commercialization and they’ve realized they need help – positive news, a knowledgeable board member or investor, or a first commercial hire. Initial conversations convey a need to commercialize, but commonly clients seek a better understanding of what that actually entails.

We’ve come to identify 3 workstreams that naturally occur in the process of commercialization, each presenting unique challenges that are not always well-understood by anyone novice in this process. Understanding these 3 workstreams has simplified the way we begin the commercialization journey with our clients. We provide a patterned-out visual of the challenges and needs within each track and what they can expect throughout. This allows us to quickly and easily determine where to start, where we fit in, and how best to help our clients define and reach their goals. The following describes these 3 main workstreams and some common challenges we target from the start to alleviate uncertainty, messiness, and intensity.

  1. Product Supply

    Emerging companies who are moving from a focus in clinical development and clinical product supply to commercial product supply are faced with managing two totally different worlds and issues. The biggest challenge is found in effectively aligning a cross-functional group of people on dozens of topics that need to come together to compliantly ensure enough product is in channel, soon after approval. Process mapping the product journey or path-to-patient is a low cost, practical and effective method for getting this crucial conversation started.
  2. Product Commercialization

    Product commercialization looks different at an emerging company versus an established company, in that emerging companies have a large population and culture coming from an R&D and clinical background, not a commercial background. This presents a challenge in determining how to transition the group mindset from clinical development to commercial. The level of commercial product education and activities that would happen in an established company aren’t yet understood or appreciated in an emerging company.
  3. Corporate Infrastructure

    The corporate infrastructure is most obvious when companies think of building an emerging commercial organization from scratch. In emerging biopharma, the reason this forms its own workstream is because it is only done once, when a company is launching its first product. Once a company has a product under its belt, this workstream is leveraged for each subsequent launch. This is a reapplication of learnings, and the challenge is in building it well, so that any adaptation for other indications or products is seamless and effective.

Examining these 3 workstreams in this way, coupled with our goals to Clarify by Taking on Uncertainty, Architect by Taming Messiness, and Build by Easing Intensity, allows us to think deliberately about what is fit for purpose for our clients. We consider the numerous scenarios a company may face through commercialization from beginning to end, and even look forward to subsequent indications or products.

If you’re preparing for launch and facing challenges like these, let’s talk! We’re happy to share our experience.

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Authored by: Andrew Demarco

Andrew is a Principal with SVA Consulting, LLC, a member of the SVA family of companies. With over 20 years of business and consulting experience, Andrew has a well-honed ability to help leaders and their teams make sense of complex problems, identify solutions and drive meaningful change.

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