Interview with James McBrayer

James McBrayer,

CEO, Cyclopharm Ltd

ePatient: You have been actively involved in the field of nuclear medicine for quite a while. Looking back at your career, what are the most significant changes that you have witnessed in the field over the past 10 years?

I have witnessed a great deal of change since starting in nuclear pharmacy as an intern in 1988. Following graduation from pharmacy school, I practiced nuclear pharmacy in the United States, Australia and New Zealand. Since taking on the role of CEO of Cyclopharm in 2008, given the numerous markets we distribute our products to, I have had the ability to view nuclear medicine from a global perspective.

In my opinion the top two changes in the past 10 years in nuclear medicine have been related to advancements in imaging technology and in Positron Emission Tomography (PET).

An example for advancement in imaging technology can be seen in diagnosing Pulmonary Embolism (PE). Nuclear medicine functional imaging with SPECT has reversed a previous trend toward anatomical imaging with CTPA. By replacing 2D Planar for 3D SPECT imaging and shifting from probabilistic outcomes, nuclear medicine physicians are delivering higher levels of sensitivity and accuracy in diagnosing PE at a fraction of the radiation dose compared to that of CTPA.

I believe the other area of major change in the past 10 years in nuclear medicine has been in molecular imaging with PET. In the past decade PET has grown from a few oncology studies primarily using FDG to a growing array of agents used diagnostically in oncology, neurology, cardiology and MSK.

PET continues to evolve rapidly by providing the platform for the development of Theragnostics. These diagnostic – therapeutic combinations acting on targeted biological pathways, predominantly used in oncology, are set to provide nuclear medicine its next major leap forward.

ePatient: What is Cyclomedica?

Cyclomedica is a wholly owned subsidiary of the Australian listed company Cyclopharm (ASX:CYC). Cyclomedica is best known for our proprietary functional lung ventilation imaging product Technegas. First used clinically in 1986, Technegas is now available in 57 countries around the world. Given Technegas’ unique properties, there are no contraindications for its use, it is ideally suited for 3D SPECT imaging and dramatically reduces the potential for hotspots often seen with competitive nuclear medicine products such as DTPA aerosols.

Our largest regional market is Europe where we are referenced in the EANM Guidelines 2009 as the preferred ventilation imaging agent in diagnosing PE. Our largest single country market is Canada. We are approved for use in China and will be looking forward in the coming years to expand the use of Technegas throughout Asia.

We are currently involved in a Phase 3 clinical trial with the USFDA and hope to bring Technegas to the United States very soon.

ePatient: Lung Ventilation studies for the diagnosis of pulmonary embolism have been successfully performed across the world for many decades with Technegas. Can Technegas play a role for the quantitative evaluation of the lungs function in other diseases?

4 million patients have been imaged with Technegas. Whilst best known for diagnosing PE, with the advancement of more sensitive imaging  technologies  to  include  SPECT-CT combined with newly developed analytical software, Technegas is more relevant today than it was when it was first introduced in 1986.

Given that Technegas can show true functional ventilation to the point of gas exchange at the alveoli, we are seeing strong global interest from respiratory physicians to apply Technegas to both quantify the extent of disease and measure response to therapy. We are working with both nuclear medicine and respiratory physicians around the world in clinical trials targeting severe asthma, chronic obstructive disease, lung volume reduction and lung transplant to name a few. An example of one of these initiatives can be found via the following link: https://hmri.org.au/news-article/nuclear- imaging-clear-airway-diagnosis.

What do you anticipate the role of artificial intelligence (AI) be in the field of lung imaging? Nuclear Medicine has always embraced advancements in technology. In lung imaging I have seen, where Technegas is available, that SPECT is replacing Planar imaging. Recent techniques using SPECT co-registered with low dose CT augmented with analytical software is providing another layer of information to clinicians not previously available.

In the September 2017 Lancet commissioned publication entitled “After Asthma: redefining airways disease” global leaders in the field of respiratory medicine call for tests that can incorporate “traits that can be measured” as well as measures “in the context of social and environmental factors and extrapulmonary comorbidities”. Rather than focusing on a singular image interpretation, I see that AI’s greatest contribution in patient outcomes will be in delivering personalized respiratory medicine by analyzing the numerous and complex inputs required to deliver on diagnostic, prognostic and therapeutic outcomes.

ePatient: You have had the opportunity to read the first two issues of the NM magazine Pangea- ePatient. What do you think of the magazine and what would your suggestions be to improve it?

 This publication is an important educational tool. Similar to AI, Pangea-ePatient is in its own way disruptive. I am entering my third decade

in nuclear medicine and have never known of a publication with such global support within the discipline of nuclear medicine combined with such broad reader potential.

I am enthusiastic to learn about the endorsement from so many of the global Societies of Nuclear Medicine and trust that this level of support will only expedite the messages being shared throughout the world to our referring physicians.

Thank you for the honour of contributing to Pangea-ePatient and congratulations on the important work that you are doing.