For emerging biotech companies at the beginning of their product development journey, with so much needing to be done and with limited time and few resources, it is easy to focus on immediate actions, as there is no spare time to plan. But without thinking about all that needs to be in place at key points throughout the journey to approval — infrastructure, processes, awareness, beliefs, behaviors and evidence — short-term activities may be less effective, leading to inefficient use of resources, putting a timely and successful launch at risk.
Approval, however, is only part of the journey. A new product can only truly be fully successful if it is accessible to the widest population that can benefit from it and achieve the greatest improvement in outcomes. This starts with a comprehensive but agile strategy that reflects the entire process — from concept to commercialization to real world experience.
Rachel Hatfield, Managing Partner at MEDiSTRAVA, an Inizio company, explores the importance of forming a future-focused, effective development and commercialization strategy to help biotechs overcome the hurdles of bringing their assets to market.
Maximizing uptake of a new product without having to compromise on how the company is reimbursed for it requires more than just innovative technology, great science and an existing unmet need. It requires a holistic assessment of the likely value of the product many years down the line when it actually gets approved and enters the market, taking into account the needs and expectations of evolved treatments and guidelines, regulatory environments and patients, payers and wider healthcare professionals.
Having built a comprehensive analysis of what the future is likely to look like, a strategic plan can then be developed that reflects not just what needs to be done, but by when and in what order. This encompasses product development, evidence generation planning, trial design and all-stakeholder engagement, as well as communications on the individual asset, and the wider pipeline and organization. This enables coordinated and aligned cross-functional strategic and tactical plans to be developed, which accelerate the achievement of milestones and put companies on the best path to success.
An insight-informed plan enables effective resource and team planning, including distribution and scale-up, and allows innovations to be brought to market faster, getting novel therapies to patients with significant unmet needs at speed. In addition, such an approach helps to instill confidence across investors, the clinical community and wider stakeholders in the direction being taken for product development and in the company itself.
Having the ability to envision the end of a drug development journey at the beginning can be challenging for many companies, big or small. Working with an expert commercialization partner can help ease this process, as they bring their in-depth and extensive expertise in product launches across diverse technologies, disease areas and geographies. Via close collaboration and provision of guidance on an effective planning process, commercialization partners can help biotech companies position and communicate their products most effectively and navigate the dynamics of market entry, optimizing their practices and approach. A clear direction distinguishes the company from the rest, putting confidence in the product and placing the biotech in a stronger position in the market.
All biotech companies justifiably believe in and are inspired by their science — this is what drives progress. However, what may not always be fully appreciated is the challenge of getting external stakeholders to even become aware of the novel product, let alone buy into its promise and potential benefits. When looking at a single specialty, there may be many hundreds of pipeline therapies and devices in development, all vying for recognition by investors and the clinical community. Getting heard above the “noise” requires an evidence-based approach to targeting communications and data release. This involves understanding where audiences go for information and what motivates them to invest time in reading about a new product. Tracking the factors influencing the conversation is also key, allowing companies to see how readily their specific narrative is being picked up and adopted.
There is always a concern for companies about the right time to start communicating about their technology. Sensitivities regarding intellectual property and competitors gaining an insight into the technology or development process are understandable. However, without early, thoughtful communications regarding a new mechanism of action or technology, there may be too little awareness of its potential benefit and place in treatment, leading to delays in adoption or suboptimal pricing and access. There is also the risk that companies lose ownership of their own “story,” allowing competitors or wider stakeholders to shape the narrative. An experienced commercialization partner helps to develop a strategy that balances the need for understanding among those influencing launch and uptake, with the requirement to keep proprietary knowledge in-house for as long as possible.
Forming this alliance early can also help with navigating the scientific and clinical story of your product, focusing on how this will be received by investors and patients to ensure product success. With foresight and all likely scenarios considered, a strategy for success can be created from the start, avoiding the need for reactive planning at a later stage.
Collaborating with a specialist partner can provide invaluable insight into commercialization strategies, ensuring the best approach is adopted from the start. Employing a strategy that uses foresight to “begin at the end” means resources are used more efficiently. In addition, having a clear and agile plan, based on commercial and clinical insights of what market you will be entering at launch, and a process in place to track success and adapt the approach as needed, builds confidence in investors and clinical stakeholders, providing reassurance that all factors that could impact on success have been fully considered.
Inizio Biotech is an experienced strategic partner, working to amplify the value and impact of medical affairs activities and creating effective strategies for commercialization success. By challenging collaborators to think longer-term at the beginning, employing the best commercialization strategy and prioritizing the outcome, we set projects and our biotech partners up for success. To get our insight into your next commercialization project, contact us today.
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