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Translational Multi-Disciplinary Approach for the Drug and Gene Delivery Systems for Cancer Treatment
Rachna Nayak1, Igor Meerovich1, Alekha K Dash2
1Department of Pharmacy Sciences, School of Pharmacy and Health Professions, Creighton University, 2500 California Plaza, Omaha, Nebraska, 68178, USA.
Abstract:
Over the last several decades, nanoparticulate delivery systems have emerged as advanced drug and gene delivery tools for cancer therapy. However, their translation into clinical use still poses major challenges. Even though many innovative nanoparticulate approaches have shown very positive results both in vitro and in vivo, few of them have found a place in clinical practice. Possible factors responsible for the existing gap in the translation of nanomedicine to clinical practice may include oversimplification of enhanced permeability and retention effect, lack of correlation between the in vivo animal data vs their translation in human, and challenging multiple biological steps experienced during systemic delivery of nanomedicine. Understanding these challenges and coming up with solutions to overcome them is an important step in effective translation of nanomedicine into clinical practice. This review focuses on advancements in the field of nanomedicine used for anti-cancer therapy, including passive targeting, active targeting, and stimuli-controlled delivery. The review further reveals some of the challenges that are currently faced by pharmaceutical scientists in translation of nanomedicine; these include lack of adequate models for preclinical testing that can predict efficacy in humans, absence of appropriate regulatory guidelines for their approval processes, and difficulty in scale-up of the manufacturing of nanodrug delivery systems. A better understanding of these challenges will help us in filling the gap between the bench and bedside in cancer therapy.
Insights
Nanoparticulate delivery systems offer advanced cancer therapy, but clinical translation faces hurdles. Overcoming challenges in preclinical testing, regulatory approval, and manufacturing is key for nanomedicine to reach patients.
Area of Science:
- Nanomedicine
- Cancer Therapy
- Drug Delivery Systems
Background:
- Nanoparticulate systems are advanced tools for drug and gene delivery in cancer therapy.
- Despite promising in vitro and in vivo results, clinical translation of nanomedicine remains challenging.
- Existing gaps in translation are linked to oversimplified models, poor correlation of animal data with human outcomes, and complex systemic delivery.
Purpose of the Study:
- To review advancements in nanomedicine for anti-cancer therapy.
- To identify and discuss challenges hindering the clinical translation of nanomedicine.
- To highlight the importance of addressing these challenges for effective nanomedicine implementation.
Main Methods:
- Review of current nanomedicine approaches for cancer therapy.
- Analysis of passive targeting, active targeting, and stimuli-controlled delivery strategies.
- Identification of translational challenges in preclinical testing, regulatory processes, and manufacturing.
Main Results:
- Nanomedicine offers diverse strategies including passive, active, and stimuli-responsive targeting for cancer treatment.
- Significant barriers to clinical translation persist, including inadequate preclinical models and regulatory hurdles.
- Manufacturing scale-up presents difficulties for nanodrug delivery systems.
Conclusions:
- Addressing the identified challenges is crucial for bridging the gap between nanomedicine research and clinical application.
- Improved preclinical models, clear regulatory pathways, and scalable manufacturing are essential for successful nanomedicine translation.
- A comprehensive understanding of these translational issues will facilitate the effective use of nanomedicine in cancer therapy.
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