Dr. Eric Leire, MD, MBA is the CEO and Founder of GenFlow Biosciences. He has an impressive background in biotechnology and gene therapy sector. Furthermore, Eric has a plethora of impressive experience both in the pharmaceutical industry, having held posts at Pfizer, Schering Plough and Pharmacia. He also has found success in academic research, having held research position at Harvard University.
In addition, his career has soared throughout the biotechnology industry, being the CEO of several private and public biotech companies. He is also the inventor of several patents and serves on the board of several biotechnology companies, such as Pherecydes (ALPHE.PA), Immunethep, Inhatarget and BSIM. Academically, Eric holds an MD from Grenoble University and an MBA from HEC, Paris and Kellogg, Northwestern University.
In recent years, biotechnology startups have sprouted alongside computer technology companies in Silicon Valley. The aim of most is to use biotechnology processes to create breakthrough drugs. According to some experts’ projections, by 2026, medical biotechnology alone will hit $500 billion. Given the potential value and return on investment, research and clinical trials are extremely important.
We chatted to Eric about the key features of Clinical Trials for Gene therapies.
To summarise, Gene therapy is the delivery of working copies of a desirable gene to the cells that need it. However, our cells have evolved mechanisms to prevent such intrusion of foreign molecules. To overcome this barrier we use vectors to carry the new gene into the cell, whilst shielding it from the mechanisms designed to prevent this happening.
The number of clinical trials for gene therapies is increasing dramatically year on year, with the UK being somewhat of a hotspot. Almost 1,000 cell and gene therapy clinical trials are on-going today, most of them in early phase. The clinical trials conducted with gene therapies produce their own idiosyncrasies with very different challenges than the ones met in usual clinical trials. In general, clinical trials conducted to assess gene therapies are more difficult to justify, to design, to implement and to interpret.
First, because animals have similar but somewhat different sets of genes than humans, the animal models may not be fully predictive. Therefore, the investigators may face a more difficult task to document and justify the rationale for the human clinical trials.
The gene therapy clinical trials are also more difficult to design. The trial design has, for example, to take into account new issues such as the usually smaller size of the cohort of patients which forces the investigators to use different statistical methods to interpret the data. With the necessity of longer follow up for gene therapies, defining the duration of the trial may also become an issue. Old rules for clinical trials design no longer apply. For example, comparative, randomized double blind trials are now considered the gold standard.
But several factors render difficult the use of this gold standard in clinical trial for gene therapies. With gene therapies, comparators are often not available or not ethically justifiable. The use of a placebo as a comparator may be hard to implement in a gene therapy trial. Also, the blinding of patients and investigators may be unfeasible with gene therapies. In addition, the design of the dose finding part of the trial has to be more sophisticated with often more limited pharmacokinetic and pharmacodynamic data available due to the lack of trial in healthy volunteers.
Also, the investigators must pay extra attention to logistics feasibility and processes. Logistic issues may influence the gene product and therefore significantly impact the trial results.
Finally, Clinical trials for gene therapies are also more complex to interpret. In ‘classical’ clinical trials, investigators used to assess the relationship between doses and effects, but for gene therapies the investigators now have to evaluate the more complex correlation between gene expression, pharmacodynamic data, bio-distribution and functional parameters.
In spite of all these challenges, gene therapies hold promise as treatments for previously untreatable and high-burden diseases. And with such high expectations, the health authorities have offered high-quality guidance documents for the conduct of gene therapy clinical trials. In general, the regulators are open to discussion on new gene therapies as long as the approach has scientific merit, and does not improperly increase the risk to the patient.
Therefore, early and repeated engagements with regulatory authorities are key success factors for a gene therapy company such as Genflow Biosciences.
Navy Veteran Davis Chris Takes the Music Industry by storm
In life, you need to break down anything that might be holding you back and change course if need be...
5 Disruptive Leaders Paving the Way in 2021
Where there is uncertainty, lies a whirlwind of opportunity. 2020 was the year that had entrepreneurs learn a great deal...
Brock Pierce Wants To Disrupt The Two Party System And Be Your Next President
We don’t usually cover politics much here at Disrupt, but when Crypto billionaire and friend of the show, Brock Pierce...
John Mcafee – Predictions For The Future
John McAfee is a world-famous tech CEO, computer scientist, civil disobedience activist, privacy advocate, and pioneer of the commercial anti-virus...
Gaby Wall Street – Teaching Latinas to Thrive During The Crisis
It’s no secret we are facing one of the most challenging financial times of the last few decades as we...
Tony Delgado – The #1 Entrepreneurship Movement In Puerto Rico
Puerto Rican online market is in constant progress. With many entrepreneurs who are coming here to start a business, it...
Elena Cardone – The 10X Ladies Conference Is Declaring 2020 The Decade For Women
The next ten years are meant for women to continue growing their potential and succeeding in multiple areas, including business....
How Josh Elizetxe Built Snow Into a $40 Million Dollar Business
There is nothing quite like an entrepreneur’s determination when starting a business. That’s my original quote by the way (pun...
How Jason Capital Became A Self Made Millionaire By 24
Have you ever wanted to earn the respect of everyone who ever looked down on you at some point in...
Sam Bakhtiar On His Way To A Quarter Billion
Dr. Saman Bakhtiar, who prefers being referred as Sam, lives in an 8200 square foot $5.2 million house, Sam is...
Entrepreneurship2 weeks ago
Meet Ross Lee, CEO and Music Industry Disruptor
News2 weeks ago
Tony Lit is on the lead bombing every social media platform covering all the corners of the globe.
Executive Voice2 weeks ago
Lashiivo: The Lash Company Taking the Industry by Storm
Executive Voice2 weeks ago
How SafeTrip Token can help to cut costs in Financial Management?
Executive Voice7 days ago
PHOENIX MELVILLE – DOCUMENTARY DEMOCRACY
Executive Voice2 weeks ago
Hwood Group’s Poppy Nightclub hosts Ryan Chapell’s Anoma Artists for first House Music event in LA
Executive Voice6 days ago
How Feminine Leadership Mentor Gordana Jakopcevic Leans Into Her Sexuality
Entertainment1 week ago
Why Earl Chang, AKA Change, Believes That It’s Important To Grow As An Artist