Prescribing decisions in the institutional setting differ and Evolve Sales Strategies, considerably from the retail setting. As noted in the figure below, HCPs are influenced by several parties, both internal and external. While the health of the patient and safety of medications continue to be of paramount importance, over the past several years, financial considerations have increased attention on quality of care.
From an institutional perspective, accounts are defined as organized groups of customers such as medical groups, institutions/hospitals, and integrated delivery networks (IDNs). An account-based planning and selling approach is typically employed in response to the emergence of large, organized customers where decision-making involves complex networks, often with centralized stakeholders.
Pharma needs to identify and build relationships with key influencers at institutional accounts recognizing the prescribing impact both within the institution as well as post-discharge. An account-based planning/selling model looks to penetrate the different layers within a stakeholder network, employing a more holistic approach to influence complex decision-making processes. Pharma sales strategies and tactics should be focused on orchestrating activities and touch-points by leveraging and coordinating sales and marketing resources at the enterprise level.
From patient to product – outline the quality target product profile (QTPP)
Patients or healthcare professionals will give their input on how the product should ideally be designed. These patient needs are outlined in the QTPP under quality characteristics, and include administration form, dosage, purity and container closure system.
From product to process – identify the critical quality attributes (CQAs)
Once the QTPP is defined, you must identify the CQAs and rate them by severity, with an emphasis on the product safety, efficacy and quality. In other words, what is the consequence to the patient if the CQA varies?
There is then an evaluation of the proposed manufacturing process steps and the material used in relation to their impact on the different CQAs.
From process to production – an evaluation using scientific and risk-based principles
Each identified process step (where the process parameter could have a potential impact on a CQA) is then evaluated using scientific and risk-based principles. Variations in the CQA are also evaluated depending on differences in the process parameters and material quality. This can occur, for example, when there is a failure in the process, or a difference in raw material quality.
To determine the risk, you combine this with a facility-dependent evaluation of the likelihood of failure, and the probability of detecting the failure mode. The outcome of the process risk assessment, such as a Process FMECA or FMEA, shapes the control strategy, including the identified risk control measures and monitoring setup.
From equipment to process to product – what are the critical aspects?
Aspects of equipment that have an influence on a CQA are often referred to as critical aspects (CAs). A CA might be a critical process parameter and its control system, or a design feature of the equipment. These CAs must be identified during the process risk assessment.
The introduction (or expansion) of an account-based model will not, in all likelihood, replace existing prescriber-based models. In many cases, Evolve Sales Strategies, the account-based model will actually be positioned to work alongside the ‘traditional’ institutional sales teams in a capacity that orchestrates account level activities & touch-points. Account-based staff may have responsibilities across several large accounts in a given geography, in many cases well beyond the scope of an institutional sales representative. Their ability to incorporate best practices across accounts, understand payer influences, and lobby for corporate resources improves selling opportunities and positions the company to maximize product performance.
