Commercialization of BioPharma Products in the USA—A Practical Guide (2nd Edition)
The discovery, development, and commercialization of a pharmaceutical product are highly complex processes. The commercial environment requires collaboration with diverse stakeholders such as patients, providers, payers, and policy makers to create value for the product. The commercial success of a product is critical in maximizing its potential and the shareholder return.
This book outlines commercial imperatives, strategic choices, as well as cardinal imperatives for success along each step of the BioPharma value chain. It shows how BioPharma companies can achieve differentiated positioning for their products in this value-driven competitive healthcare environment in the USA. It’s intended for anyone involved in commercial and investment decisions in the BioPharma industry.
Pharmaceutical companies produce innovative medicines to assist patients in improving the quality of their lives. The discovery, development, and commercialization of a pharmaceutical product are highly complex processes and they get further compounded due to the regulatory nature of the industry. The commercial environment entails collaboration with diverse stakeholders to create value for the product. The commercial success of a product is contingent on the evidence and value offered and the differentiated positioning that it attains, both of which are critical in maximizing its potential and the shareholder return. Commercialization of BioPharma Products in the USA—A Practical Guide, explains over six chapters the commercial imperatives and strategic choices for a sustained and successful pharmaceutical enterprise.
Chapter 1, BioPharma Industry Overview, deals with the overview of the pharma industry – how striking the right balance in managing challenges and exploiting opportunities will lead to value creation in the pharmaceutical industry. It starts by reasoning why pharma industry will continue to grow and how rigorous discovery and development activities are spinning out novel drug candidates. The delicate balance between potential to succeed (unmet needs continue to exist in virtually every disease area that can be targeted with the emerging technologies and innovation) and economic uncertainties in every step of the value chain (discovery, development, manufacturing, and commercialization) is explained. The pharma ecosystem—its various components and organization—shows the importance of four key stakeholder groups (patients, providers, payers, and policy makers) during all stages of the pharma model. This chapter explains how the patents protecting intellectual property are acting as backbone to the industry to keep the fundamental economic structure intact. The macro-level trends and potential opportunities and challenges impacting the industry are also addressed in this chapter.
Chapter 2, BioPharma Model and Economics, explains the basic structure of the pharma model—the discovery, development and commercialization sub-modules, and their corresponding economics. This chapter elucidates the key elements in each module, knowledge of which is imperative to appreciate the underlying complexity and subsequent commercial strategic requirements for execution. Under discovery model, it shows the importance of developing the Drug Value Profile (DVP) for a product as soon as it is discovered to assess the value it creates for potential stakeholders as well as the pharmaco itself. The development model outlines the Value-Based Study (VBS) Design which revolves around defining the evidence/value outcome requirements and generating them via clinical trials using adaptive design principles to make the development process more efficient and effective. The commercial model outlines how the product’s clinical, economic, and strategic (CES) value proposition must be developed using the outcomes from the clinical trials and communicating the same to concerned stakeholders in order to achieve optimal product positioning and maximal access and adoption. In addition to that the pharma economics and pharma model success imperatives are outlines in this chapter.
Chapter 3, Product Value, deals with the fundamental questions surrounding product value proposition and how it needs to be developed to articulate the clinical, economic, and strategic (CES) outcomes generated from the clinical trials. The CES value proposition sets the foundation for value-based pricing (VBP) discussion which is a key component in understanding the product potential. The likely success of the product is gauged through demand forecasting using patient treatment flow (PTF) models which allow the pharmaco to assess strategic positioning issues that must be addressed to understand the treatment process and competitive dynamics. The last section explains the structured way by which a product’s true valuation can be assessed based on the likely positioning that the product may attain in the market place. The product valuation drives key strategic and investment decisions during each step of the pharma model.
Chapter 4, Product Positioning, is the soul of successful commercialization and attaining optimal positioning is a fundamental requirement for commercial value creation, which in turn is contingent on payers providing access, providers prescribing the product based on the treatment protocols, patients using the product and being compliant while policy makers laying out conducive environment that assures optimal product access and funding. This chapter takes a comprehensive approach in explaining how best to work with the different key stakeholders to create demand and to lay out the required foundation for the product to be commercially successful. There are three key steps in product positioning, (i) understanding the decision-making process of each stakeholder and defining positioning imperatives for success, (ii) customizing the CES value proposition to address the positioning imperatives and preferences of stakeholders to make the product attractive, and (iii) communicating the customized product CES value proposition to the stakeholders via personal and non-personal promotional channels to create value. This chapter further defines performance measures to ensure continual optimization of positioning efforts.
Chapter 5, Product Operations, explains the end-to-end process management that cumulatively convert raw materials into finished pharma products for utilization by patients, who are the ultimate end users. This chapter explains how proper alignment between product demand and supply is critical to ensure optimal supply chain operations. The key elements of manufacturing and distribution processes and the methodologies to create value through these processes are comprehensively discussed in this chapter. The commercial requirements in terms of ensuring that the product is readily available at the time of launch and afterwards for patients who are in need are addressed as well.
Chapter 6, Product Value Creation, outlines product life cycle management strategies that must be considered to maximize the investments into the product while also potentially extending the product life. The second section outlines product roadmap with key strategic, clinical, manufacturing, and regulatory activities that must be overseen from discovery through commercialization. The structured approach required for planning and resource allocation to drive these activities along the BioPharma model have been discussed. The chapter closes with a broader discussion on different business models and potential value creation mechanisms that BioPharma companies must consider to refine and reposition the BioPharma model.