Interview with Sergio Calvo, President, Radiopharmaceuticals Division at Jubilant Pharma

Sergio Calvo, President, Radiopharmaceuticals Division at Jubilant Pharma

Interview by Dr.Francois Lamoureux

Sergio, you are the president of the Radiopharmaceuticals Division of Jubilant Pharma. Can you give us a brief summary of your involvement in Nuclear Medicine and Jubilant?

First, I would like to thank e-Patient for this opportunity. My background is in engineering and I have worked in nuclear medicine since 1999, at Siemens, GE Healthcare and I joined the Jubilant Pharma family one and a half years ago. I am fortunate to have been a part of the development and market introduction of breakthrough technologies like digital PET/CT and the inception of Artificial Intelligence (AI) applications for medical imaging. I was attracted to Jubilant for the opportunity to work on the pharmaceuticals side of nuclear medicine, which is a fascinating field. It is a privilege to have both perspectives and one of my goals is to increase the synergy between radiopharmaceuticals and medical devices.

Jubilant Pharma has evolved into a global pharmaceutical company offering a wide range of products and services from radiopharmaceuticals to contract manufacturing, generics, complex generics and active pharmaceutical ingredients. The Radiopharmaceuticals Division of Jubilant Radiopharma has a similar heritage, being formed with the acquisition of DraxImage in 2008, which was founded 66 years ago, essentially at the birth of Nuclear Medicine.

We are based in Montréal, present in 22 countries and the North American market leaders in lung imaging and iodine therapies. We also have unique products like the RUBY-FILL Rb-82 Generator for Cardiac PET imaging and a large pipeline of breakthrough innovations. Being part of this larger organization gives us access to Jubilant peer companies, rich in R&D and innovation, which has significant application potential to both diagnostic and therapeutic Nuclear Medicine.

Jubilant Radiopharma is well established in the global nuclear medicine market. What are the biggest challenges of the nuclear medicine industry in the next five years?

Challenges bring opportunities and I am very positive about the opportunities we see, which will help propel the specialty to greater success and patient benefit; but there is work to do. Isotope supply is a concern as demands for new and existing isotopes increase with the adoption of novel imaging tracers and radiopharmaceutical therapies (RPTs). We need to grow capacity and need to transfer this capacity to industry. As you know, developing and approving radiopharmaceutical therapies requires multiple clinical trials of increasing size, complexity, cost and risk of success. Although big pharma is investing in RPTs, our industry consists of small and mid-sized companies with limited resources and expertise to conduct large clinical trials. We need to make the clinical development process more efficient. Logistics will get more complicated with radiotherapy isotopes for broad distribution on a global scale. Radioactive waste will also be a concern with long- lived isotopes, especially alpha emitters. We will have to train nuclear medicine workers to manage more complex isotopes and handling procedures to assure high level of safety to workers and staff. At the same time, there is a greater recognition of the value of RPTs by other medicine disciplines and they will be keen to get the training and capability to use these advances. This will require Nuclear Medicine Physicians to collaborate and keep their training relevant and robust. This will be good for the patients and the field as the best minds will be involved and identify further advances in therapy—especially about RPTs and non-radioactive therapies and/or RPT facilitators. Reimbursement will be a specific concern as more expensive therapies enter the market, and the healthcare systems will need education on the benefits of RPTs and may not be prepared for this increase in expense. Finally, with so many treatment options, we need to educate consumers so that the potential patients know that nuclear medicine treatment options are available, and how they compare to other methods, and what combination therapies might be better than either alone—as often seen in standard medical oncology.

As you mentioned in the previous question, the approval process of new radiopharmaceuticals is long and expensive worldwide. Is there a way for companies and the medical community to ease the process to the benefit of our patients?

It is true that the process is still long and expensive though it has improved in recent years. One example is the excellent work of the ICH (International Council for Harmonization), which has significantly improved interagency collaborations.

There is room for even more harmonization of requirements. With universal requirements, we will be able to collaborate more efficiently worldwide, and make the process cheaper by using the same clinical data across markets. This would accelerate the approval process and timelines, and coupled with timely education of healthcare community and patients about the product will ensure that new products are adopted faster into the practice of medicine and position it for expansion of indications and life cycle management.

On the industry side, we need to invest in and improve utilization of digital technologies to store and share clinical data safely and efficiently, which has the added benefit of providing a platform for development of AI applications. The key words are collaboration, simplification, trust and transparency. Jubilant believes that a key way to benefit patients is to have a well-designed product development roadmap with robust data, relevant medical indications and meticulous investigators.

Nuclear Medicine Theranostics is growing and already impacting patients. How will Jubilant contribute to this emerging field of Nuclear Medicine?

Theranostics is the opportunity of our lifetime and is at the core of Nuclear Medicine’s unique value and technology. Due to the complex biochemistry of humans, there are nearly unlimited possibilities in oncology and other specialties. The targeted nature of radiopharmaceutical therapies in particular, and Nuclear Medicine in general, means that each application will require a different and specific targeted molecule. There typically is no ‘one-size’ fits all, no silver-bullet, which has been the approach of big pharma, until recently. They too now see the need and value to provide more specific molecules for specific targets. The outcome is a lot of work for small, medium and large companies in the development of theranostics.

Jubilant is all in. We are leaders in Iodine-131, the first theranostic application developed 75 years ago that set the template for the long-awaited targeted therapies. We also have a clinical-stage MIBG program for neuroblastoma, which when approved, will improve lives of hundreds of sick children every year.

Our core competencies in R&D, Medical Affairs, Clinical Development, Regulatory, Quality, Marketing and Commercialization are fit for innovation and being shaped to develop new theranostic applications. We are also investing in strategic alliances and commercial partnerships to expand our portfolio, and working closely with drug discovery experts of our parent company, Jubilant Pharmova, with vast resources that include computational algorithms to discover and develop precision therapeutics.

We will not only play in theranostics; we will have a leading role in this field.

How do you see the future of Nuclear Medicine in the next five years?

The future is already happening. We are seeing the strongest momentum in nuclear medicine ever with radiopharmaceutical therapies coming into mainstream. More specifically, I have no doubt that we will see wide adoption of therapies targeting PSMA, with several recent approvals, and fibroblast-activated protein which is highly expressed in many cancer-associated fibroblasts. The data available on FAP inhibitors for imaging and therapy has been significant and consistent, and is so compelling that clinical success is self-evident.

I also expect nuclear medicine imaging to grow into whole new applications. Rheumatoid arthritis, for example, is biochemically complex and can be treated with different types of expensive biologics. There is an unmet need to predict and monitor treatment response; a clear opportunity for nuclear medicine.

Finally, and as mentioned at the beginning of this interview is the promise and now, developing, reality of AI applications which will undoubtedly be part of diagnostic imaging. This may be a concern for nuclear medicine as we are late to the AI applications. By harvesting more information from data, AI makes medical images more clinically insightful. We usually think about how AI will impact the work of imaging physicians. Another aspect is how AI will impact imaging modalities and how they compete against each other. Anatomical modalities powered by AI will be more capable of, for example, measuring function. Likewise, nuclear and molecular imaging powered by AI will be incredibly more insightful for disease evaluation and treatment strategy. However, our community must hurry to collaborate and develop AI applications. As of today, there is much more activity in AI developments for anatomical modalities; and given the inherent strengths of what Nuclear Medicine can uniquely provide we have strong AI potential.

Finally, what is your greatest wish for Jubilant, nuclear medicine and the patients you serve?

I have many wishes. One of them is that nuclear medicine will impact even more broadly than today the field of cardiology. Myocardial perfusion PET has proven itself to be the most powerful non-invasive test to assess coronary artery disease. Referring physicians embrace the Cardiac PET modality whenever available as it helps them make better treatment decisions. I strongly believe Cardiac PET can and should grow 10-fold or more in the US, and 100-fold in the rest of the world.

In a broader perspective, my wish is that nuclear medicine realizes its full potential to diagnose and treat disease, becoming one of the pillars of personalized medicine.

And for my company, I wish Jubilant Radiopharma to be an innovation leader, constantly renewing the mission statement set forth in 1955: to improve patients’ lives through nuclear medicine. Benefiting the patient is what we stand for along with the healthcare providers who use our products.