Reine Escalona

Interview with Andrew Thomson

What is extrapolation?
How can we use extrapolation in paedriatics?
What are the main challenges?

Paedriatic research always comes with challenges and understanding paedriatic submission is very important. There’s always a lack of treatment in this area. In this episode, you’ll understand what you can do to get evidence through extrapolation for the children population.

Stay tuned while Andrew and I talk about the following:

Why are we raving about this conference?
Why is this the best conference I have been attending?
What are the other activities beside the scientific part of the conference?

This is a special episode while Benjamin and I talk about the upcoming PSI conference and what you can expect from it. This will be a face to face conference in Gothenburg, Sweden!

Here are some of the points we talked about:

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In today’s episode, we discuss the process with the FDA publishing a timeline of planned public workshops, draft guidance documents and final guidance documents for 4 documents, originally planned to finish in end 2021 and its objective to explore the factors that need to be considered when developing COA-based endpoints.

Stay tuned as we also talk about the following points:

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 from the apps listed in the DIGA registry?

In today’s episode, Dr. Stefan Walzer and I discussed the goal of the Digital Health Application.

Stay tuned and listen while we talk about the following points:

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 and more. E.g. we talk about the importance of calibrating the relevance of the existing items in the questionnaire and developing new ones in order to reach more accurate measurements resulting in good PROs.

Stay tuned and listen while we also cover the following points: