Author Archives: Jan De Backer

FDA to support FLUIDDA’s FRI technology in the quest for more affordable drugs

The US Food and Drug administration has issued a letter of support to FLUIDDA after examination of study results where Functional Respiratory Imaging was used to assess bio-equivalence between a generic and a reference drug. Manufacturers of generic drugs are required to demonstrate that their drugs are therapeutically equivalent to the reference drug before they can enter the market. In the field of respiratory medicine demonstrating equivalence is particularly challenging since often the drug is not given as a tablet but through an inhaler. As the drug reaches the sick lung before the bloodstream, relying only on drug concentrations in the blood (as is often the way to assess equivalence) also becomes problematic. These elements make respiratory generic drugs so-called complex generics.

The FDA recognizes the importance of high quality generic drugs to keep drugs affordable without jeopardizing the patient’s health. The conventional way of developing generic drugs uses the classical lung function tests (eg Forced Expiratory Volume in one Second, FEV1) which have limited sensitivity. As a result, traditional clinical bio-equivalence trials require a large number of patients which makes them expensive, thereby defying the point of lower cost drugs as the R&D expense drives drug prices.

The FDA recognizes the potential of FRI to provide better insights into the efficacy of a test drug compared to a reference drug in a small patient population. Using FRI in bio-equivalence trials therefore provides an opportunity to ensure that the generic drug acts in the same way as the original drug and this through smaller, shorter and cheaper clinical trials.

Dr. Jan De Backer, FLUIDDA’s CEO, states: “We are delighted with this new letter of support by the FDA as it highlights another application of our technology. We have previously demonstrated the potential of our FRI technology to develop innovator drugs for lung diseases such as Lung Fibrosis, asthma and COPD. Now we also demonstrated the potential in the space of bio-equivalence trials. FLUIDDA is committed to help bring effective, safe and affordable to the patients and having the FDA’s support is of tremendous value.”

The full letter can be found here.

 

 

UCSF and FLUIDDA enter into a new research collaboration

Los Angeles, January 5th 2018 FLUIDDA Inc and the University of California, San Francisco (UCSF) are entering into a new research collaboration as of December 2017. Together with the team of Dr. John Fahy (Professor of Medicine in the Division of Pulmonary and Critical Care Medicine, Department of Medicine and investigator in the Cardiovascular Research… Continue Reading

FLUIDDA opens office in Los Angeles, CA

The opening of an office in Los Angeles (West Hollywood), California, marks the further expansion of FLUIDDA’s global presence. With an increasing number of clients located at the US West Coast, the California office allows FLUIDDA to provide an even better customer experience. “The high concentration of pharmaceuticals and medical device companies, as well as… Continue Reading

FLUIDDA’s IPF Catalyst Challenge Entry

FLUIDDA is excited to join the IPF Catalyst Challenge! Functional Respiratory Imaging (FRI) is a very promising tool for early diagnosis, disease staging and progression and as a sensitive biomarker in drug development trials. As part of the challenge we would like to build a framework to enhance patient care through FRI because we believe… Continue Reading

Introduction to Functional Respiratory Imaging (FRI) for Investors and Market Analysts

For those who cannot attend our event coming Thursday at Flanders House in New York, you are welcome to register for the Webcast via following link: https://attendee.gotowebinar.com/register/8186175617140384514       FLUIDDA is delighted to invite you to a dedicated session discussing her proprietary Functional Respiratory Imaging (FRI) technology and its application in drug and device… Continue Reading

CIRO and FLUIDDA join forces in pursuit of better patient care

At the recent European Respiratory Society conference in Milan a collaboration between CIRO and FLUIDDA materialized in an effort to enhance the rehabilitation of COPD patients. The care of COPD patients is challenging due to the vast heterogeneity of the disease. Especially the severe COPD patients are often difficult to manage and require intensive care… Continue Reading