Michel Baelen, head of Regulatory Affairs at Advanced Oncotherapy plc (LON:AVO), talks to DirectorsTalk about the attraction of joining AVO, his past roles and how this experience benefits the company, work done to date and Michel’s plans for regulatory and quality control going forward.
Q: Michel, what attracted you to join AVO?
A: The development of the proton beam therapy system LIGHT, with its innovative and clinically superior approach to the treatment of cancer.
Q: So how does the position fit to what you have done previously?
A: I have a background in electronic engineering and was responsible for IBA’s regulatory and quality assurance affairs for 19 years.
Q: Can you tell us what IBA is?
A: IBA is the current market leader in proton beam therapy. As well as working at IBA, I was previously head of the European Commissions’ industry association for medical devices and worked in a regulatory/quality capacity assurance at the IAEA (International Atomic Energy Agency).
Q: So how does your experience benefit AVO and its investors?
A: Having worked on both sides of the regulatory fence I know exactly what AVO must do to meet all regulatory and quality control requirements.
Q: In that regard, what have you been doing so far?
A: We’ve been in dialogue with the major regulatory bodies and have been working through what we, AVO, must do to ensure we meet their requirements in as efficient and timely manner as possible.
Q: Can we expect any newsflow to that effect?
A: Absolutely, although timing is difficult to predict; we have been very busy in this regard and hope to make announcements to this end.
Q: On the LIGHT system itself, can you tell us some of the key features that will differentiate it from its competitors?
A: From a safety perspective, the ability to monitor the exact nature of the proton beam and completely control its transmission i.e. if the beam needs to be shut off, we will be able to ensure the patient receives no dose at all. Another is to vary the energy of the beam and, accordingly, the dose the target tumour receives at very high frequencies, for more accurate tumour targeting.
Q: For any new technology with the potential to disrupt a market, there must be risks associated with the realisation of that technology?
A: The development of LIGHT will be a process and there are challenges ahead. For example, the accelerating modules will contain a vacuum at much lower pressure than is present in existing radiotherapy systems. In addition, the ability to vary the energy of the proton beam with every pulse requires highly sophisticated and robust software control and management.
Q: Are there any other key safety USPs?
A: Yes, the LIGHT system will not suffer from comparable proton losses and, as a result, will not irradiate and physically/chemically alter, otherwise known as activate, the shielding and surrounding materials that any radiotherapy system is housed in. For example, the decommissioning costs of non-Linac proton accelerators can be up to three times as high as the initial cost. So that can be a major headache for hospitals and clinics; LIGHT is the only proton therapy system using a linear particle accelerator.
Q: And given the potential hurdles inherent in LIGHT’s development, what is AVO doing to manage and overcome those risks?
A: Two key approaches adopted by Advanced Oncotherapy have been to hire industry experts, in all relevant fields, and to partner market leading companies, such as Thales. For example, Thales, which will mass produce LIGHT for AVO, has already demonstrated its ability to create a vacuum at the required level that I previously referred to. We have also hired an expert in safety-critical software from Airbus, a market leader in another industry where it is absolutely essential that software, and the systems that that software controls, perform precisely as required.
Q: Is there anything else you’d like to highlight?
A: Just that we, AVO, are doing everything we can to ensure we clear all regulatory and quality control hurdles in all major markets and with all relevant bodies, globally.
Michel, thank you for your time.
