Fast-Track proposals will be accepted.
Direct-to-Phase II will not be accepted.
Number of anticipated awards: 2-4
Budget (total costs, per award):
Phase I: $300,000 for 9 months;
Phase II: $2,000,000 for 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Drug delivery systems are continually advancing and greatly assist the capabilities of cancer therapies and cancer survival. Yet, the pediatric population has not benefited, to the same extent as adult populations, from these advances in cancer therapy delivery device design and technology. A tailored dosage system for delivering cancer therapeutics to pediatrics is required. In addition to biological response differences, pediatrics vary anatomical with age and therefore require cancer therapy delivery devices and ports to be tailored for compatibility with anatomical dimensions of the patient. This topic is focused on drug delivery devices as opposed to drug delivery materials and vehicles. For example, in the case of central nervous system tumors—implantable drug delivery ports, pumps and ommaya reservoirs required for drug delivery to the cerebrospinal fluid often pose many issues for pediatric patients. Issues of device displacement, catheter migration and catheter fracture have all been reported and are primarily due to anatomical miss-compliance. Additionally, complications such as infection and insufficient wound healing are common because of devices with large profiles designed for use in adults. Furthermore, developmental and behavioral characteristics of young children should also be considered when designing a tailored device for pediatric patients – this includes changes in anatomy size for long-term implantable devices and mobility needs of children at different stages of development.
There is a need for versatile, efficient cancer therapy delivery devices that meet the needs of pediatric populations. This solicitation aims to aid the development of appropriate cancer therapy delivery devices that reflect pediatric patient specific designs and dosage parameters for pediatrics.
The purpose of this announcement is to assist the development of cancer drug delivery systems compatible to the needs of pediatric patients. This topic includes pediatric focused therapeutic targets within acceptable dosages suitable for pediatric patients and/or drug delivery systems designed to suit the needs of pediatric anatomical dimensions. Successful applicants will develop technologies to aid the administration of cancer therapies to pediatric patients, taking into account pediatric specific issues which include but are not limited to: dosage limitations, size restraints, comfort level and mobility. Adaption of currently available delivery devices for the pediatric population is also encouraged. One example is in the treatment of pediatric retinoblastoma where there have been some recent advances in the development of an episcleral device for delivering localized therapy to the retina and choroid, which has been tested in rabbits and is now proposed for testing in pediatric patients. This solicitation is not limited to cancer type or site, yet, justification of the need for pediatric-specific design parameters is encouraged. The offeror is required to outline and indicate the clinical question and unmet clinical need that the pediatric drug delivery device will address. This solicitation is not intended for drug formulation or nano-delivery systems; instead it is focused on delivery mechanisms and devices. In Phase I, offerors should demonstrate the proof of concept for the device proposed. Phase II projects will validate the device in the clinical setting.