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Improving Global Health with a Novel Handheld Counterfeit Drug Identifier

Description:

 

Improving Global Health with a Novel Handheld Counterfeit Drug Identifier

Phase I SBIR proposals will be accepted.

Fast-Track proposals will not be accepted.

Phase I clinical trials will not be accepted.

Number of anticipated awards: 1

Budget (total costs): Phase I: up to $150,000 for up to 6 months

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Background

The worldwide proliferation of poor quality medicines is an international health crisis, not only threatening the health security of people living abroad, but also in the United States. Poor quality medicines, which include falsified/counterfeit, substandard, and degraded products, are particularly rampant in developing countries lacking the proper resources to adequately deal with this public health threat. Poor quality medicines not only cause the deaths of hundreds of thousands of people worldwide, but also contribute to antimicrobial drug resistance, thus jeopardizing years of global public health accomplishments. Previous reports have shown that global estimates of drug counterfeiting range from 1% of sales in developed countries to >10% in developing countries. In specific regions in Africa, Asia, and Latin America, chances of purchasing a counterfeit drug may be >30%. Drug regulatory agencies (DRA) are vital in keeping this problem "in-check,"

but many of these DRAs do not have the resources to adequately monitor and enforce DRA regulations. A key component of maintaining good drug quality is the ability to detect sub-standard medicines rapidly and inexpensively, so that more samples can be tested and swift action can be taken. To address this need, an inexpensive, simple-to-use, hand-held device (Counterfeit Drug Identifier or CoDI) was developed at CDC. Unlike other commonly used field techniques, the CoDI requires no toxic or flammable chemicals and leaves the sample intact and available for further studies.

Project Goals

The goal of this project is to develop a new generation of portable, easy to use CoDIs with adjustable parameter to provide greater versatility for use with a wider variety of medicines. A CoDI Prototype I has been produced and tested on confirmed counterfeit antimalarial drugs collected in Africa. It was shown to be 100% accurate in discriminating genuine and counterfeit Coartem® and identifying products from specific manufacturers, and has successfully demonstrated "proof-of-concept" of the technique used to identify a counterfeited product. Based on experience from evaluating the CoDI Prototype I, improvements in user-friendliness and versatility can be made in order for the CoDI to be used for a wider variety of pharmaceuticals.

Activities and Expected Deliverables

The project research will produce a next generation portable, user-friendly, and affordable device with greater versatility (Prototype II) by incorporating adjustable parameters, such as laser output, detector sensitivity, sample compatibility and LED indicators. These improvements will provide easier and accurate interpretation of results, thus enhancing marketability of the device.

Impact

A CoDI Prototype II device can be used to help national regulatory agencies identify and interrupt illegal vendor and drug supply chains. Most importantly, by providing a quick and simple way to identify counterfeit or substandard drugs, many lives will ultimately be saved. Moreover, improving the availability of high-quality medicine may also lead to positive market pressure to decrease the overall number of counterfeit pharmaceuticals, boosting consumer confidence and raising the integrity and sustainability of national drug delivery systems.

Commercialization Potential

NGOs and non-profits distributing healthcare to individuals in developing countries would most benefit from the CoDI.

Other consumer segments with potential interest in the CoDI include:

• Drug Regulatory Agencies

• Customs officials

• Hospitals in Developing Countries

• Pharmacies

• Private individuals

At the end of the Phase I project period, but before a successful awardee moves to a Phase II, the awardee will be required by CDC to seek a license to the patent rights cited in this topic. Subject to mutual research interests, CDC and awardee may explore future collaborative research and development of CoDI by way of a Cooperative Research and Development Agreement (CRADA) or similar collaborative mechanism.

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