Simon Ducher, Chief Regulatory Officer at Seneque
July 28, 2021
Q1. You have been working for approximately 15 years in the healthcare industry (major pharma and biotech) with in-depth global expertise in Regulatory Affairs, Health Authority Policy and Business Development. How did you come to work in this field? What do you enjoy the most in your area of expertise?
Being in healthcare is likely a ‘family affair’ as many of my relatives are either physicians, pharmacists, or dentists! During my PharmD, I got to learn more about the pharmaceutical industry and then went on to complete a Master’s degree in Drug Development and Registration. I’d be the first to admit that the pharmaceutical industry is not perfect, however I do believe that the mission to help and hopefully cure patients is still at the cornerstone of our profession.
I chose the Regulatory Affairs field as I enjoy working with all the areas involved in Research & Development, e.g.
• Nonclinical to perform toxicology studies
• Clinical to design key studies required for a new drug
• Commercial to define the Target Product Profile (TPP) [i.e., an essential document outlining the desired drug labeling following regulatory approval]
• And, of course, the Quality department, who ultimately manufactures the product to be on the market!
I also particularly like the fact that Regulatory Affairs lead interactions with Health Authorities. Whilst guidelines exist to help prepare regulatory submissions, it does not mean that everything is set in stone! As an example, a brand-new primary endpoint for a pivotal phase 3 trial could be agreed upon with the FDA, thereby substantially decreasing the required number of patients and eventually enabling faster access of this drug by patients.
Q2. You have managed cross-functional projects to advance various products (small molecules/biologics/radiopharmaceuticals/medical devices) through drug development and up to commercialization. Can you tell us about the major differences between France and the United States in this process?
Prior to describing differences, it is important to underscore that Health Authorities around the globe ultimately share the same objective: to approve new drugs with an overall positive benefit/risk (or efficacy/safety) ratio.
Although national review procedures are sometimes utilized for new products in Europe, most of them are reviewed by the European Medicines Agency (EMA) which is now based in Amsterdam following Brexit. Overall, there is a high rate of convergence in the authorization of new medicines by the EMA and the Food and Drug Administration (FDA) in the US.
Two main factors can explain this convergence:
1) Owing to the globalization of the pharmaceutical industry, harmonizing the drug regulatory environment was very important to accelerate and facilitate the development of medicine. So, in 1990, the International Conference on Harmonization (ICH) was created aiming to issue guidelines for the standardization of (non)clinical practices and technical requirements for drugs, including the establishment and management of quality controls. At the inception, members of ICH were the US, the EU and Japan, but it has expanded over the years and now countries like Canada, Brazil, China, Singapore, Switzerland are also part of it.
2) Since the period 2000-2010, more and more information is being shared between the EMA and FDA in addition to the establishment of mutual agreements (e.g. for pharmacovigilance or inspections purposes). This has fostered alignment between the EU and the US with respect to decisions on marketing authorizations while both agencies keep evaluating applications independently of each other.
Such tight collaboration among countries is essential as nowadays to approve a new drug it takes an average 10+ years and costs more than $1B!
Notwithstanding, it is true that there could be, at times, divergence in approval decisions, types of approval, or approved indications. This can happen when there are differences in Health Authorities’ stances upon review of the efficacy data (more rarely about safety). Sometimes this could also be based on differences in required datasets submitted to the EMA or FDA.
Q3. You’re an investor/advisor to startups as well as a limited partner for an early-stage Venture Capital firm which also runs an accelerator program. As a French national, why do you think so many French startups leave France for the USA rather than staying in France?
I actually became a dual French-American citizen last year 🙂 Anyhow, it is true that in the past, startups often had to ‘flip’ and move to the US if they aimed at scaling further.
This could have been the case for a couple of reasons:
• the funding ecosystem was pretty good for the early stage (pre-Seed, Seed) but for larger rounds (Series A, B, C…) there was potentially a shortage of funds. This has changed though in the last couple of years and there is everything I believe now for startups to thrive in France/Europe. In addition, organizations like Business France, the BPI and initiatives such as ‘Choose France’ or the ‘Next 40 / French Tech 120’ have helped foster a new mindset and new perspectives for entrepreneurs as well as VCs;
• the approximately quintuple size of the US vs. French market (328M and 67M, respectively) likely played a role too but, nowadays, startups have very often a setup/strategy of looking global from the onset
• it was also sometimes difficult to find talent/hire new employees, but modern technologies and enhanced remote work are also changing that.
To illustrate this new dynamic with startups now staying/growing in France, it is worth highlighting the goal of President E. Macron to have 25 unicorns in 2025 which is likely in the offing (17 unicorns to this day!). This will create an even more prosperous environment and virtuous circle by having further resources for future funding.
Q4. Why did you decide to join the French-American Foundation’s Transatlantic Forum? What are the most attractive elements of this program and what do you get out of it? Would you recommend it to someone who doesn’t know the Foundation?
I was kindly introduced to the French American Foundation by Emeline (Foster), the former Executive Director. I immediately enjoyed it and I am truly delighted to be a member of the Transatlantic Forum.
This is a real privilege and I feel fortunate to be able to meet very interesting, dynamic, and thoughtful people from a wide array of fields/backgrounds. I highly appreciate the enlightening discussions on various topics and exchanges among its members as well as the guest speakers/experts who often join our monthly dinners. I am also fond of the friendly and warm atmosphere at our events. It has helped me deepen my understanding and knowledge of the French/American axis and beyond. This has become even more critical to me as I have recently started experiencing parenthood with a French-American-Belgian child!
I would definitely recommend the Foundation to anyone with an appreciation for global affairs, politics, life science, culture… and I have already done so! I cannot wait for the return of our monthly lively conversations over dinner… and a glass of French wine (well, American wines are great, too 🙂 )
Q5. According to you, how could the 2022 French presidential election impact the dynamics of transatlantic relations?
This is a fairly complex question to address as who could have known/anticipated a year ago that a pandemic would occur and transform our society (e.g., major health crisis, lockdowns, and a limited capacity to travel)
In any event, whoever wins the French presidential election next year, I would hope that the transatlantic relations remain very strong between the two countries. We have a rich and fruitful partnership which is crucial to preserve and, if possible, should be reinforced to best handle matters such as foreign policy, climate change, a potential new outbreak or economic downturn.