As the number of RPs continues to grow, the drug development industry is struggling to keep up with a host of challenges: from adverse events to regulatory hurdles and supply chain complexities. This article will explore some of the most common obstacles RP innovators and developers currently face and how these issues may impact the future RP landscape.
Overview
RPs are critically important for diagnosing and treating diseases and the industry has many challenges. These include:
- To limit radiation exposure, RPs are subject to various regulatory restrictions regarding who can use, administer, and transport these drugs.
- When compounding RPs, like all drugs, specific FDA guidance must be followed so as not to affect quality.
- The nature of RPs themselves: their short half-lives (days, as opposed to years) mean they must be used promptly, making swift delivery essential.
Underscoring the need to get these products to patients as quickly as possible is the fact that, unlike nonnuclear drugs, RP developers don’t hold the drug substance itself. Instead, the drug substance is manufactured directly into the product—creating additional logistical complexities such as maintaining processing facilities and compliance with good manufacturing practices.
Considerations on the pathway to approval
RPs will always need to be handled with care, and they require a more rigorous system of safety measures. But the real challenges are faced during the development process.
- An appropriate carrier (vector) and capable radionuclide (an unstable nuclide due to excess nuclear energy) must be selected when developing and designing RPs. Straightforward decisions must be made in regard to the application desired, time constraints, and the variety and position of the molecule target.
- Dosimetry issues may arise. The possibility of unintended and untargeted radiation exposure must be carefully calculated, especially when determining the amount of RP product used in diagnostics vs therapeutics. Adjusting the dosage between children and adults also poses constraints.
Risk of adverse events
Due to the inherent nature of radiation exposure in RPs, the potential for adverse events (AEs) must be deliberately considered. Many AEs from RPs may go underreported, and while RP-related AEs usually resolve quickly, it’s important to be prepared for more serious issues should they arise. These can include skin rashes, tissue damage, or even life-threatening conditions.
Inconsistencies and regulatory hurdles
Many regulatory challenges exist within the clinical trial process, which impacts the commercial launch of new RPs. Radiation exposure studies with healthy trial volunteers are often most affected by regulatory hurdles, even though these are the studies most needed to successfully advance innovative RPs.
Throughout the approval process, navigating adherence to all guidelines and regulatory requirements can be difficult, especially when there are inconsistent standards and a lack of harmonization between guidelines. Developers must consider a number of stakeholders and organizations while progressing RPs through the approval process and into the market, including national and international atomic regulatory boards, the World Health Organization, RP manufacturers, and other nuclear medicine organizations.
Partnering with Pearl Pathways
Pearl helps clients achieve success throughout every phase of the product development life cycle. With so much at stake, working with an experienced consulting partner is essential to successfully navigating the RP development and regulatory processes.
Contact Pearl today to learn how we can help.