New Guidelines Aim to Accelerate Nanomedicine Advancement and approval

Nanomedicines, offering targeted drug delivery with the potential to save lives, often face meaningful obstacles in reaching the market and patients. To address this critical issue, a team of international researchers has collaborated to develop comprehensive guidelines designed to accelerate and improve nanomedicine advancement.These guidelines, known as “DELIVER,” aim to streamline the process from initial research to practical application, ensuring more life-saving treatments become available sooner. The development of these guidelines marks a significant step forward in the field.

Nanomedicines utilize tiny particles to transport active substances directly to the site of disease, offering a more targeted and effective approach compared to customary drug delivery methods. The collaborative effort has resulted in a practical list of considerations for researchers and developers. The frist nanomedicine was approved in 1995 and is used to treat various types of cancer.

According to Ruth Schmid, a researcher at the Norwegian science institute SINTEF, the guidelines are a flexible framework, not a rigid set of instructions. ItS not a recipe book; it’s a guide, Schmid stated, emphasizing the adaptability of the DELIVER framework to various nanomedicine projects.

The Challenge: Bridging the gap from Idea to Lifesaver

Ruth Schmid, a researcher with a career focused on nanoparticles and their properties, contributed her expertise to this endeavor. Her background, including her tenure as president of the global research organization CRS, made her uniquely qualified to address the challenges facing nanomedicine development.

The core problem lies in the lengthy and complex process required to bring new nanomedicines to practical use. While these medicines have the potential to save countless lives, too few promising ideas successfully navigate the regulatory and logistical hurdles to reach patients in need.

Nanomedicines offer a distinct advantage by delivering drugs precisely where they are needed. this pioneering treatment encapsulates chemotherapy drugs within fat particles, which then target cancerous tumors, releasing the medication directly at the affected site.

The Precision Advantage: Targeting Treatment, minimizing side Effects

The ability to target specific areas of the body is a key benefit of nanomedicines. Traditional methods, such as injecting cancer medicine into a vein, result in the drug spreading throughout the body, affecting both healthy and diseased tissues.

When a patient is given an ordinary cancer medicine, just 0.01 percent of it will actually reach the tumour itself. The rest goes to the liver, the kidneys and healthy tissue throughout the body. It can cause side effects in these parts of the body, because such medicines are usually toxic to many types of cells.

Ruth Schmid, SINTEF

Schmid further explained that with nanomedicine, you have the ability to control where it goes in the body. This targeted approach minimizes the exposure of healthy tissues to toxic drugs, reducing the severity of side effects and improving the patient’s overall quality of life.

nanomedicines can also solve the problem of administering multiple drugs in precise ratios. Some therapies require a specific balance of different medications to achieve optimal results.

Schmid highlighted an example: A new product that came to market a few years ago encapsulates two chemotherapy drugs that act synergistically. Synergistic drugs amplify each other’s effects, working best when administered together in a specific ratio.

In the case mentioned, the ideal ratio is five to one. Injecting the drugs separately into the bloodstream makes it arduous to ensure they reach the tumor together and in the correct proportion. Nanotechnology allows for the encapsulation of these drugs in the precise ratio,ensuring they are delivered together directly to the cancer cells.

DELIVER: A Checklist for Success

While nanomedicines have already demonstrated their life-saving potential, the approval process for new medicines remains a significant hurdle. You need the analyses to determine: Do they have the desired effect? Does the medicine have any side effects? Is it safe to use? Schmid noted, emphasizing the importance of rigorous testing and evaluation.

The “DELIVER” guidelines are designed to facilitate this process, providing a checklist of key considerations for drug researchers. The acronym “DELIVER” represents the seven critical points that must be addressed to successfully bring a nanomedicine from the research laboratory to the healthcare system.

The Seven Pillars of DELIVER

The seven letters of “DELIVER” serve as a mnemonic for the following essential considerations:

• D is for ‘defined product profile’. The nanomedicine must address a specific need and fulfill a clear purpose.
• E is for ‘essential characterisation’. A thorough description of the chemical composition,physical and chemical properties,and behavior of the fluids relevant to the application is crucial.
• L is for the ‘lead candidate’ that is developed to its optimal state. From possibly thousands of initial possibilities, one must be selected for further development and refinement.
• I is for ‘intellectual property’.Securing a patent and ensuring the freedom to develop without infringing on existing patents are essential.
• V is for ‘validated efficacy and safety’.The nanomedicine must consistently produce the desired effect and demonstrate safety throughout the testing process, from laboratory studies to animal and human trials.
• E is for ‘economical and scalable production’. the manufacturing process must be feasible at the required scale, whether for mass production or personalized medicine.
• R is for ‘regulatory and clinical pathway’. All regulatory requirements must be addressed before applying for permission to conduct clinical trials.

Thinking Ahead: Essential for Success

We’re trying to guide you through what you need to think about right from the start. It will help you make sure you don’t develop anything that will never reach the market, for example as it’s too expensive, because it can’t be produced in a controlled manner, or because you can’t protect the rights to the product, schmid explained.

Other potential obstacles include the inability to produce the product in sufficiently large or small quantities. Standard medicines require large-scale, consistent production, while personalized medicines may onyl need a few milliliters per dose. Both types of production must be carefully controlled.

We have created a table of points to consider for each topic to get the product to market. This is something that academics in particular don’t think about very much from the start, said Ruth Schmid. by addressing these considerations early in the development process, researchers can significantly increase the likelihood of successfully bringing their nanomedicines to market and, ultimately, to the patients who need them.