The Organizational Role of Medical Affairs in Early Product Development to Define the Holistic Evidence Strategy — What Crosstalk?

Pharmaceutical-related headlines today are filled with references to access and reimbursement decisions related to value-based care and value-based pricing. While regulatory approval remains necessary for marketing authorization, meeting regulatory requirements for safety and efficacy is no longer sufficient to show the value of a new therapy. Value is being defined and assessed by an ever-increasing and varied group of stakeholders across the healthcare ecosystem. Measures such as cost-effectiveness and patient-reported outcomes and quality of life now can be critical to a drug’s reimbursement, uptake and utilization. Therefore, successful new product development and commercialization require that the right evidence to substantiate value is available at the right time to the right stakeholders. Given that evidence generation, and subsequently, value substantiation, is both costly and time consuming, planning should begin in early development (Phases I-IIb).


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