Volv Global Blog

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Léon van Wouwe

Léon is the Clinical Innovation Director at Volv which is based in Lausanne, Switzerland. Volv is an applied data science company, that creates cutting-edge approaches to solving difficult problems in healthcare and life sciences. Throughout his career, he has taken a keen, creative interest in tackling the numerous challenges in developing healthcare solutions, by using a cross-functional and cross-disciplinary approach to drive forward the development of and access to innovative new treatment options for people living with disease. He has over 20 years of experience working for several different pharmaceutical and health technology companies in a variety of roles. Interested in: Creative, collaborative cross-disciplinary thinking, rare diseases, and next-generation healthcare.

From Mendel to genetic rare disease diagnosis: Two centuries of innovation.

Credit Photo by John Towner on Unsplash

Enlightened breakthroughs...

More than 350 million people live with rare disorders, that is, a condition with which fewer than 200,000 have been diagnosed. About 80 percent of these rare disorders are genetic in origin, and 95 percent have no treatment approved by the FDA.

Our ability to better understand, diagnose and potentially find treatments for these conditions was significantly advanced by the Human Genome Project (HGP). From October 1990 until its completion in April 2003, the HGP brought together a team of international researchers who collectively defined over 90% of the human genome [i].

However, it would be fair to argue that the journey to understanding the human genome began with Gregor Johann Mendel, who is now recognised as the father of genetics. Born 200 years ago, in 1822, Mendel put his interest in plant genetics into practice with pea plant experiments conducted between 1856 and 1863, which established many of the rules of heredity, now referred to as the laws of Mendelian inheritance [ii].

His work was published in 1866 but was then forgotten about until 1900, when three researchers, Hugo de Vries, Carl Correns, and Erich Tschermak, independently realised the meaning and importance of Mendel`s groundbreaking work.

Mendel’s theories were finally associated with human disease by Sir Archibald Edward Garrod, who published the first findings from a study on recessive inheritance in human beings in 1902 [iii]. In 1909, the term “gene” was introduced for Mendel’s “traits” [iv].

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Creating ripples

It’s time to rethink clinical trial protocols, and ensure inclusive designs through democratising our health data, in a privacy-preserving way

Credit Photo by Marc Zimmer on Unsplash

It’s time to rethink...

Throughout my career in the pharmaceutical industry managing clinical trials and study programs, I have been confronted with the same recurring problems. Trials struggle to recruit and retain enough patients, they fail to meet target timelines and the vast majority don’t conclude on time.

There are some staggering statistics in the industry, for example, 86% of clinical trials don’t reach recruitment targets in the specified time and 90% of clinical drug development fails.

One obvious reason for these shocking figures is that the pharmaceutical industry overestimates its ability to recruit. But, more troublingly, study design and protocol development seemingly fail to truly reflect patients’ lives or account for the reality in the clinic.

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