Though radiopharmaceuticals have been around for more than 70 years, interest in the diagnostic-centric pharma products is recently on the climb. Outsourcing-Pharma (OSP) spoke with Anwer Rizvi (AR), president of radiopharmaceuticals specialist SpectronRx, about the evolution of the technology and why interest in the specialized field is on the rise.
OSP: Could you please share a description of radiopharmaceuticals?
AR: Radiopharmaceuticals are a group of pharmaceutical drugs containing radioactive isotopes. Radiopharmaceuticals are being used for both diagnostic and therapeutic purposes. They are currently being developed primarily for the treatment and detection of certain types of cancers.
However, radiopharmaceuticals are also being used to detect cardiac disease as well. What makes radiopharmaceuticals so unique, as compared to nuclear medicine in general, is that they are able to be targeted to extremely precise areas in the human body, eliminating unnecessary damage to healthy tissue and organs by a significant margin.
Historically, radiopharmaceutical therapy began in the 1940’s with I-131, which has become an important agent for the treatment of benign and malignant thyroid disease. The development of Radiolabeled antibodies began in the 1970s, and Radium-223 dichloride was approved by the FDA in 2013 for treatment of castrate-resistant metastatic prostate cancer.
Industry experts predict that 30% of nuclear medicine procedures in 2030 will be radiopharmaceutical therapies. Lu-177 PSMA is being used in Germany and Australia, and it is expected to be approved in the US in the near future. There will be a huge demand for Lu-177, as there are currently more than 21 Lu-177 labeled drugs in clinical stage.
OSP: Please share your ‘elevator description’ of SpectronRx (i.e. who you are, what you do, key capabilities/accomplishments, and what makes your company particularly effective and innovative.
AR: SpectronRx is a US-based contract radiopharma development and manufacturing organization (cRDMO), and we are experiencing tremendous growth through our partnerships with pharmaceutical and diagnostics companies globally. Our partners trust in us because of our expertise, which ranges from Phase Zero through to commercialization, and because our roots in nuclear medicine go back nearly three decades, we understand the industry inside and out.
Partners choose us because of our expertise, our facilities and our ability to scale quickly. We provide early stage services ranging from pre-formulation studies to formulation development and pre-clinical testing, and can scale all the way through commercialization/full production, technology transfer and chemical and radioactive waste management.
Our facilities are FDA and NRC inspected, and compliant with 21 CFR Part 211 and Part 212. We are a registered nuclear pharmacy with multiple cleanrooms, shielded isolators and hot cells. And we can handle all the necessary logistical and compliance matters, and FDA filing necessary for Radiopharmaceuticals.
OSP: Can you share your thoughts on why interest in radiopharma is increasing (and why SpectronRx is growing)?
AR: As more radiopharmaceuticals make their way through clinical trials and FDA approval, more data is becoming available about their effectiveness. This data has helped boost the case for why radiopharmaceuticals are so much better for certain treatments, and this is why we are now starting to see more life sciences organizations committing real resources to Radiopharmaceuticals.
OSP: Why might companies that stand to benefit from radiopharma be not delving in yet? You mention “cost-prohibitive,” but are there other reasons?
AR: For life sciences companies to build a radiopharmaceutical operation from the ground up, the costs can be very prohibitive. Most life sciences organizations are not built to handle isotopes and all that comes with it.
In addition, building radiopharmaceutical teams and facilities from scratch can greatly impact time-to-market, and increases margin for error. Plus, most life sciences companies lack specialized staff, licensing and equipment for Radiopharmaceuticals.
All of these issues make the case for why organizations like SpectronRx are best for life sciences companies looking to take radiopharmaceuticals commercial. We have the equipment, facilities, staff, licensing, and experience needed to begin immediately, at little cost compared to building fulltime radiopharma operations.
OSP: You mention “regulatory compliance” as one of the areas in which the company can assist clients. Are there any notable challenges in getting radiopharma solutions through approval?
AR: Working with radioisotopes requires standards, oversights and licensing that traditional pharmaceutical companies are not familiar with. Not just anyone, or any facility can source, ship and work with radioisotopes. The environment in which we operate requires equipment validation and maintenance, SOPs, training, FDA filings and licencing that is truly unique.
Because of this, we maintain fully integrated quality and compliance management systems. Our facilities are FDA and NRC inspected, and compliant with 21 CFR Part 211 and Part 212. We are a registered nuclear pharmacy with multiple cleanrooms, shielded isolators and hot cells.
If you visited a traditional contract development and manufacturing organization and asked them if they had shielded isolators and hot cells, they would either give you a puzzled look, or send you to someone like us. At SpectronRx, we can handle all the necessary logistical and compliance matters, and FDA filing necessary for Radiopharmaceuticals.
OSP: Can you share any details on your projects?
AR: We are working with several organizations on various initiatives. But notably, in 2019, Y-mAbs came to us because they needed help in the development of Radiolabeling for brain cancer treatment in children. We are now assisting them with the early development and manufacturing of clinical trial and commercial supply for multiple products - and we are assisting with filings for FDA approval.
In addition, we are also working with a very large brand-name organization with a diverse health portfolio, with no experience developing radiopharmaceuticals. We are assisting them in early stage development and production of clinical trial supply for multiple radiopharmaceuticals for various cancer treatments.