Q&A With Kevin O'Neill, president and CEO of GE HealthCare, Pharmaceutical Diagnostics

Kevin O'Neill
President and CEO
GE Healthcare, Pharmaceutical Diagnostics

For those who remember GE as a maker of appliances, air conditioners, and other items that require an electric plug-in to work, it might take a minute to switch gears and incorporate nuclear imaging fluids, contrast agents, and clinical trials into that mental picture. But in speaking with Kevin O’Neill, president and CEO, GE HealthCare, Pharmaceutical Diagnostics, what becomes clear is that it and its three sibling segments–imaging, patient care solutions and ultrasound–all independent of aviation and power-focused GE–have maintained their sense of scale. O’Neill, based in London, spoke with Medical Device & Technology.

(MDT:) What sort of reach does your segment of GE HealthCare have globally?

O’Neill: We operate in 130 countries with seven manufacturing sites and employ around 4,000 people worldwide. Our company has two divisions, one that manufactures contrast agents for X-rays, CT scans, MRIs and ultrasound, while the other is focused on molecular imaging products. These are designed for use in specific diseases. Around 100 million patients a year are imaged with our contrast agents. To give you an idea of the molecular imaging reach, we deliver, on a weekly basis, 3,000 units of loflupane I 123. We call it DaTscan. It’s used to measure neuron loss in the striatum in patients with suspected Parkinson’s and dementia with Lewy bodies.¹

(MDT:) How do the two divisions differ?

O’Neill: In the molecular imaging division, all agents are made to order because the agents’ half-lives can be measured in hours. Once we receive the order, we are literally counting minutes. For example, Cerianna ([18F]fluoroestradiol)¹ is used in PET imaging tests, in tandem with biopsy, to detect estrogen receptor positive lesions in patients with recurrent or metastatic breast cancer. It is radiolabeled with fluorine-18 which has a half-life of 110 minutes.

(MDT:) How does a nuclear imaging agent get to the prescriber’s location on time?

O’Neill: It depends on the half-life. DaTscan,² for example, takes about two hours to manufacture at our Arlington Heights (Illinois) facility. Once done, it is shipped by FedEx a few hours later. If the half-life is even shorter, we turn to a local specialty pharmacy for the dose’s manufacture.

(MDT:) How else are contrast media different from nuclear imaging agents?

O’Neill: Contrast agents take static photographs. The interesting science is on the molecular side. For example, how do you monitor activated T cells, so you know if immunotherapies are working? That is of real interest for us. Are the T cells expressing granzyme b (apoptosis mediators)?. How do you characterize disease space? How do you characterize tumor type with an in vivo image vs biopsy, instead of a photo? That is all the hard stuff that we are working on with clinical teams.

(MDT:) Because of your scale, do smaller companies ask GE for help regarding manufacturing, distribution, and so on?

O’Neill: Yes. We can make the products, manufacture the supply, and commercialize them. These are not easy products to make and scale. We have an evaluation group in our R&D team that looks at opportunities as they come to us. Some we in-license and they become part of our pipeline. That is how our relationship with Zionexa, the creator of Cerianna, started. The company didn't have the scale to commercialize its products and to invest and develop agents, so we brought Zionexa in-house.

(MDT:) How has this work improved patient experiences?

O’Neill: We can adapt clinical pathways for those patients in a way we couldn’t before. It is time to invest in this research, to bring these things forward. That is an exciting thing, because this work can lead to precision medicine and predictive health.

(MDT:) What work have you been doing with manganese?

O’Neill: We just announced recruitment completion of a Phase I trial³ looking at a manganese-based MRI agent that could be an alternative to gadolinium-based agents.* Unlike gadolinium, manganese is a trace element that is naturally occurring in and efficiently eliminated from the body. Manganese also has magnetic properties, making a manganese-based agent a viable alternative to gadolinium.

(MDT:) What partnerships has your company developed?

O’Neill: Pharma uses our imaging agents in their clinical trials. Also, we also have all the equipment – from the cyclotrons that make the isotopes to all the PET and imaging cameras. We also partner with universities, Vanderbilt⁵ for example, and other institutions that have data banks of cleaned-up data. Together we look for patterns in that data. As an example, we did a trial for Vizamyl ([18F] flutemetamol)⁶ for amyloid plaques. We looked at all records of trial participants who demonstrated amyloid plaque buildup during the trial and then built predictive analytics. We have a dedicated team looking at digital platforms, particularly for biomarkers that are applicable to more predictive analytics.

(MDT:) What else is going on at GE Healthcare Pharmaceutical Diagnostics?

O’Neill: We think demand for iodinated contrast media to double in the next 10 years. So, we’re investing across the contrast media lifecycle, securing reliable supplies of more raw material, investing in our manufacturing plants, and finding ways, at the point of injection, to: help reduce the contrast dose delivered to each patient; reduce volumes of unused leftovers; and recycle leftover contrast media.

(MDT:) You were once the financial controller for Eurostar, the London to Paris high speed train, back in the late 1990s. What do you prefer about your role now?

O’Neill: It is fantastic to work in life sciences. It is a great thing to do every day.

* Editor's note: The FDA⁴ has issued warnings that gadolinium, a heavy metal, can be retained in the body for long periods of time, but considers that for the vast number of patients, its benefits outweigh any potential risks.

References

1. FDA. Safety label. Cerianna (fluoroestradiol F 18) Injection https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212155s000lbl.pdf
2. FDA. Safety label. DaTscan. Ioflupane I 123 Injection https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022454Orig1s004lbl.pdf
3. GE HealthCare Announces Completion of Phase I Subject Recruitment in Early Clinical Development Program for a First-of-its-Kind Macrocyclic Manganese-Based MRI Contrast Agent. March 1, 2023.
4. FDA Drug Safety Podcast: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings. Jan. 20, 2022. FDA Drug Safety Podcast: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
5. GE Healthcare, Vanderbilt University Medical Center partner for safer, more precise immunotherapy cancer treatment Jan. 4, 2019.
6. Clinicaltrials.gov. Assess the prognostic usefulness of flutemetamol (18f) injection for identifying subjects with amnestic mild cognitive impairment who will convert to clinically probable Alzheimer’s disease. Trial record GE-067-005.