• Testing Medicines

    Testing Medicines

    We are developing low-cost tests that can be used outside of the lab to detect low-quality medications.

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  • Undergraduate Research

    Undergraduate Research

    Undergraduates make important contributions to solving real-world problems.

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  • Working Globally

    Working Globally

    International partnerships enable us to create practical solutions for the developing world.

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A global problem

Many of the pharmaceuticals that are purchased in the developing world are substandard or outright fake drugs. Although there is no global system for monitoring the quality of medicine, study after study reveals pervasive poor quality and products that are worthless or even harmful to patients.  Many countries in the developing world do not have the technological infrastructure or regulatory resources to keep low quality medicines off the market shelves. And since the pharmaceutical trade is a lucrative global market, low quality medicine can cross borders and harm people anywhere in the world. 

Root causes:

Deliberate falsification by manufacturers or distributors

  • Fortune Magazine has a great investigatory report on Ranbaxy's contribution to this area.
  • Even secure supply chains fall victim;  see this WHO report on Semler Research faking bioequivalence studies.  

New ways to find fake medicines

Paper analytical devices (PADs) are test cards that can quickly determine whether a drug tablet contains the correct medicines. They are cheap and easy to use. They don't require power, chemicals, solvents, or any expensive instruments, so they can be deployed rapidly at large scale whereever a problem with pharmaceutical quality is suspected.

Partnering with regulatory agencies

By sharing our results directly with medical regulatory agencies, we help them quickly discover poor quality medicines in their markets.  This enables them to negotiate with manufacturers and distributors from a position of knowledge and to take other regulatory and legal actions to protect patients from poor quality products.

Bringing market forces to bear

In the developing world, most buyers have to trust what the seller tells them about the quality of the pharmaceuticals they purchase. Unscrupulous manufacturers and distributors know that there is little chance that their medicines will be screened in a lab. These paper test cards don't need a lab, and they will enable people all over the world to quickly detect low quality medicines and remove them from the market.  

 

News

PAD patent issued

Author: Marya Lieberman

US Patent 9,354,181, Analytical devices for detection of low-quality pharmaceuticals, was issued May 31, 2016, to Toni Barstis, Patrick Flynn, and Marya Lieberman.  

Toni, Pat, and Marya are grateful to Allan Fanucci at Winstrom & Strawn LLP, who acted for us and provided most valuable guidance through the patent maze, and to Karen Deak at Notre Dame who helped us understand the process.  …

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