For life science companies, the journey from groundbreaking scientific discoveries to commercial success is a complex and multifaceted one. In this blog post, we’ll explore how the intersection of evidence-based laboratory and clinical science and strategic commercialization efforts is key for life science company success.
Navigating Life Science Company Discovery, Development, and Commercialization Success
As one looks across the life sciences industry and the companies within it – whether they be in the US or outside of the US, or are pharmaceutical, biotechnology, or medical technology focused, I would venture to say that a very small percentage were founded based on a commercial idea or innovation.
And if I’m right about that, then it’s probably reasonable to say that most life science companies were founded based on novel and transformative science, technology, engineering, mathematics (STEM) knowledge, insights, and new discoveries.
You might be thinking, “Who doesn’t know that?! You would indeed be correct; everyone knows that the success of life science companies is rooted in science – innovative, sound, and reproducible science.One of the key themes in this blog post is that life science company science or STEM – as important as it is – is undoubtedly NECESSARY, but it is NOT SUFFICIENT for life science company success. Transformative science has the power to revolutionize the world of healthcare, offering new therapies, diagnostics, and technologies, but this is only the starting point.
The Importance of Strategic Commercialization
Beyond the laboratory-based bench science, there are many areas of specialization that life science companies must establish competencies in – through either their own acquisition and mastery, outsourcing, or through establishing partnerships. Areas such as clinical trials, operations and development, regulatory affairs, human resources, manufacturing, business strategy, and obtaining venture capital investment funds represent just several of those topic areas.
While these areas are vital, one of the most challenging areas for many life science companies is navigating the intricacies of market access, a vital and complex aspect of overall commercialization. Market access encompasses the crucial elements of coding, coverage, and payment that determines how accessible products and therapies will be to patients and the providers who write the prescriptions for the patients.
As I’ve learned through my engagements with life science companies of all types (i.e., in the US, outside of the US, pharmaceutical, biotechnology, medical device, digital health), arguably the most challenging area to master is strategically, operationally, and tactically positioning the life science company capably for the particular medical intervention’s commercialization related to coding, insurance coverage, and payment (or reimbursement) in the regional markets of interest. My hypothesis on why this is one of the greatest areas of challenge is because these are not typically the strengths and connected to the background of most life science company founders – they are most often scientists.
Timing Is Key: Market Access Early in the Journey
Considering these challenges, it's crucial to address market access early in the life science journey. The strategic, operational, and tactical timing of your market access efforts can be the linchpin between groundbreaking science and real-world impact. By starting early (i.e., during phase 2 clinical development), developing a robust market access strategy, engaging with key stakeholders, and remaining adaptable, companies can navigate the complexities of these activities to ensure their innovations reach the patients who need it most via a strong picture of market access. Here are some quick tips:
• Start with the end in mind. Consider long-term market access goals from the outset of product development and define value proposition while establishing a clear understanding of the product's unique selling points.
• Engage with key stakeholders. Building relationships with payers, healthcare providers, and patients to better understand their needs will help shape product development and evidence generation efforts. Their support can significantly influence market access decisions.
• Stay agile and adaptable. Forecast potential challenges and opportunities as part of your strategic planning, anticipating changes in payer policies, evolving healthcare regulations, and shifts in reimbursement models. Continuously monitor the ever-evolving healthcare landscape and be prepared to adjust your strategy accordingly.
The Impact of the PIE Act on Payer Engagement
I would like to stress again that effective engagement with payers and customers is crucial. This is where the Pre-approval Information Exchange (PIE) Act comes into play, for example. The PIE Act allows life science companies to share valuable information about the benefits, efficacy, and cost-effectiveness of their products with payers ahead of Food and Drug Administration (FDA) approval. This is an example of a proactive approach that can influence payer decisions even before FDA approval, potentially expediting patient access to innovative healthcare solutions.
Certainly, many of these rudimentary strategic points are commonly well understood by long-standing, multi-billion-dollar, multinational life science companies. The mere fact that a company grew to such a size, means that they needed to have mastered to a significant level the art of commercialization. It does not mean that the Merck’s, GSK’s, Pfizer’s, Genentech’s, and J&J’s of the world do not need help with commercialization. It is just that the help they need in support of their commercialization is very different than for companies that haven’t yet traveled the pathway to commercialization – and are trying to do so for the first time (at least it’s their first time in the US).
In conclusion, life science discovery, development, and commercialization company success is a tale of two essential halves. The first is the pioneering science and transformative STEM insights that fuel innovation. The second, often less heralded but equally vital, is the strategic prowess that enables these innovations to thrive in a competitive market. Furthermore, with evolving industry trends and regulatory changes like the PIE Act, life science companies can have additional means and channels of facilitating early and constructive interactions with payers and other key strategic enablers of payment, bridging the gap between groundbreaking science and real-world impact.
Thanks for reading!
Questions for You
1. What challenges do you think life science companies face in terms of market access strategy and timing of strategy implementation?
2. What are your thoughts on the Pre-approval Information Exchange (PIE) Act and its potential impact on payer engagement and patient access to innovative healthcare solutions?
3. To what extent do you feel that progressive value-based payment models, with significant risk held by payers, can serve an important role in positioning life science companies to develop and implement strong, capable market access strategy for innovative, high-cost new therapies?
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