Bringing a radiopharmaceutical therapy to market requires more than just scientific, clinical, and manufacturing breakthroughs.
Once your therapy is ready for patients, successful delivery and administration depends on a complex ecosystem of hospitals, treatment centers, logistics providers, and trained personnel, all of which must be equipped to handle the unique nature of your radiotherapy.
Understanding and planning for these challenges early can help streamline adoption, reduce delays, and improve patient outcomes. Here are five key considerations.
Which treatment center has the right infrastructure?
First, it is important to partner with a hospital or treatment center that has the infrastructure needed to administer therapy safely and effectively.
Radiotherapies require separate handling areas from chemotherapy infusion centers, and many hospitals are not designed to accommodate these needs. Obtaining the necessary licenses and regulatory approvals can be complex and time-consuming, particularly for sites new to nuclear medicine.
Financial planning is another critical factor, as they are often unprepared for the costs associated with updating their infrastructure, which may include:
- Establishing hot labs to receive and prepare radioactive materials.
- Investing in shielding equipment to ensure safe handling.
- Implementing radiation monitoring systems to meet compliance standards.
Collaborating with treatment sites early in the planning process and ensuring they have the necessary resources and support will set you up for success.
How will your doses get to the treatment center?
Radiotherapies’ short half-lives make timely and secure delivery one of the most pressing challenges—not only for patient scheduling but for maintaining dosing accuracy. Deliveries must account for radioactive decay over time and require real-time decay correction to ensure the dose received matches what was prescribed.
Managing these logistical hurdles requires a reliable transportation network and advanced tracking capabilities. However, several challenges continue to impact the efficiency and security of radiopharmaceutical deliveries:
- FedEx is the only major carrier currently equipped to transport radioactive materials.
- Other logistics providers, including UPS, DHL, and USPS, do not handle these shipments.
- Lost or delayed doses can result in serious patient care disruptions, including missed or rescheduled treatments.
- Without real-time visibility and integrated decay-adjusted dose tracking, treatment centers are left estimating potency upon arrival, which can impact treatment accuracy and scheduling.
That being said, new technologies, such as advanced GPS-enabled tracking, have the potential to significantly improve supply chain reliability.
What equipment will the treatment center use?
Therapeutic radiopharmaceuticals require precise administration, but the industry has yet to develop infusion pumps that meet these specific needs. So, hospitals frequently have to repurpose chemotherapy pumps that were never intended for nuclear medicine applications when administering radiotherapies.
The three primary methods used today each come with their own limitations:
- Syringe push: Provides manual control but requires skilled staff to ensure proper dosing.
- Gravity infusion: Often preferred in academic settings due to its simplicity, yet it requires continuous monitoring to maintain accuracy.
- Infusion pumps: The least commonly used option, though necessary for consistent and controlled administration over extended periods.
Without standardized equipment, selecting the best available method to avoid inefficiencies or safety concerns depends on a facility’s capabilities, staffing, and patient needs.
Who will administer the treatment?
Successfully administering radiopharmaceutical therapies requires specialized expertise, but many healthcare providers are still adapting to these new treatment methods. Infusion nurses from chemotherapy settings have been introduced into nuclear medicine workflows, yet they often lack experience in handling radioactive materials.
Certified nuclear medicine technologists (CNMTs) are the best-qualified personnel for these therapies, but their availability is limited. Plus, fewer training programs exist today than in the past, making it difficult for healthcare facilities to recruit and retain staff with the necessary expertise.
These challenges are even more pronounced in rural communities, where access to trained nuclear medicine specialists is limited. Many smaller hospitals and clinics lack the staff to safely administer these therapies, forcing patients to travel long distances to larger medical centers for treatment.
How will patients and staff stay safe?
Adherence to stringent safety protocols is another significant obstacle to consider, as many facilities lack the proper shielding, radiation monitoring, and the aforementioned specialized equipment required for handling radioactive materials.
Shielding is especially critical, as radiopharmaceuticals emit radiation that can pose risks to patients and healthcare workers. The infusion pumps used for radiopharmaceutical administration must also meet specific radiation safety requirements. Hospitals that attempt to repurpose standard infusion pumps used for chemotherapy may face challenges, such as contamination control and preventing residual radioactivity from affecting future use.
In addition to equipment concerns, regulations require precise dose calibration before administration, which many treatment sites are not fully prepared to manage. Unlike standard chemotherapy infusions, providers must measure and adjust the dosage of radiopharmaceutical therapies in real-time based on radioactive decay, meaning delays in administration can impact both dosing accuracy and treatment effectiveness.
Expertise to power your radiopharmaceutical journey
Make sure your radiopharmaceutical therapy reaches patients on time, intact, and is properly administered. Easier said than done, right?
That’s where we come in. As a full-service CDMO with deep expertise in radiotherapies, we provide the guidance, support, and solutions needed to navigate regulatory requirements, optimize manufacturing and logistics, and ensure seamless delivery.
Need help bringing your breakthrough to patients? Let’s talk.