Finally, in Europe a 100% virtual research and People-Generated Data that will allow us to study the relationship between vaccination against Covid-19 and health at 360°, as regards nutrition and lifestyles.

The U.S Food and Drug Administration has released its standards on how it will proceed to analyze experimental vaccines against the SARS-CoV-2.

The Pistoia Alliance, a global, not-for-profit alliance that works to lower barriers to innovation in life sciences R&D, has recently released the latest Unified Data Model (UDM) file format, Version 6. The aim of the UDM project is to create and publish an open and freely available data format for the storage and exchange of experimental information regarding compound synthesis and testing.

Rare disease day was celebrated on the rarest day in the year: February 29th, 2020. There are 7000 known rare diseases, defined as diseases that affect fewer than 200,000 people in the USA. For rare diseases, the challenge is that it is often not feasible to conduct traditional randomized phase III clinical trials.

This is the main topic addressed by FDA Commissioner Stephen Hahn during an all-hands first meeting with FDA staffers.

This is what has emerged from a new study, published in the Journal of the American Medical Association: real-world data sources available nowadays could only replace 15% of the clinical trials that have been considered in research. 

An observational retrospective study has evaluated the combination of tafasitamab (MOR208) with lenalidomide (Revlimid) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who were not eligible for high-dose chemotherapy and stem cell transplant.

Due to the enormous knowledge and expertise gained in the analysis and usage of big data driving digital innovation, it appears that the tech giants will be making a crucial impact in this sector.

Considering the growing interest supported by the improvement of technologies in this sector, the agency is currently investigating when the use of observational data “may be appropriate for evaluating effectiveness from a broad policy perspective and also how individual drug manufacturers submit proposals for using real world data to support marketing applications”.

Until now, companies have considered RWE studies useful mostly for post-approval safety; there are some big opportunities on the Real-World Evidence horizon that industry and regulators will be considering and implementing soon.

A review recently published in the Journal Trends in Pharmacological Sciences analyzed the potential improvements that AI could bring to drug development in the next decade

Launched by Fitbit, Bring Your Own Device is the first digital health technology initiative. It is part of the National Institutes of Health’s All of Us research program and it is developed under the Precision Medicine Initiative. It consists in a fitness tracker that has the goal to collect data from a variety of populations drawing on surveys, physical measurements, EHRs, and digital health technologies.

It’s been 60 years since the first implantable pacemaker was introduced into the market. Today a new monitoring process is available for patients and Hp’s: Medtronic – whose founder created some of the first pacemaker models – has designed a mobile app that enables pacemakers-communication via mobile phone or tablets.

FDA has recently taken action in the real-world evidence field by releasing a new health App: MyStudies App is a standardized digital platform where researchers can collect, organize and analyze a variety of data directly from the real-world environment.