Reine Escalona

Patient-reported outcomes and the FDA Patient-Focused Drug Development Guidance

Interview with Rachael Lawrance The FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making. In today’s episode, we discuss …

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Apps on prescription paid by the government

Interview with Dr. Stefan Walzer What is a DIGA?Why is Germany so important for DIGAs? Nowadays, there are a couple of available apps being used in several countries that collect user information, such as heart rate combined with algorithms that calculate certain health risks that the user may be vulnerable to. What differentiates these apps …

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What does it take to develop good patient-reported outcomes?

Interview with Antoine Regnault Why do companies want to develop new patient-reported outcomes (PRO)?How does the process start when we want to develop a new questionnaire?What are the key areas to look into for understanding the quality of a PRO?What guidelines exist on developing new PROs? In today’s episode, Antoine and I answer these questions …

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What is the current state of Launch and Lifecycle work and how did it evolve?

Interview with Jenny Devenport What is medical affairs? Launch and Lifecycle?How has this area evolved over the last 2 decades?What is the current state across the industry in terms of the role of statistics in this space? This is a series of episodes and today’s content is the first episode. Join Jenny and I while …

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