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Could grading finished-drug manufacturers on their quality and efficiency lead to greater transparency, improve quality and reduce drug shortages?
In June of this year, Martin Van Trieste, former chief quality officer at Amgen, Inc., retired from that company, but not from patient and industry advocacy. Seven years ago, VanTrieste founded the industry group Rx360, which has focused pharmaceutical company management attention on preventing counterfeit and substandard drugs from reaching the market. That organization, which now has over 100 members, went from a handful of volunteers to a group requiring full-time employees and a CEO, a post now held by Mark Paxton.
Van Trieste is now embarking on another project, which he gave attendees a glimpse of at September’s PDA/FDA joint regulatory conference. Working with software developers, he has developed a methodology that would grade individual suppliers of finished drug products on several essential metrics, including product quality and regulatory compliance, effectiveness of supply chain management (e.g., inventory levels and whether the company relies on more than one raw material supplier), and product/process understanding (based on process capability).
The goal is to hold pharmaceutical companies accountable to their customers and stakeholders, in the same way that other industries are accountable to theirs, and to offer key metrics at a glance.
The system’s underpinnings would be analogous to the credit-reporting methodology behind the FICO report, and would use both publicly available and proprietary data. Van Trieste and his team have developed a methodology and algorithms that would examine the effectiveness of each company’s quality systems and the probability that the company would experience a shortage in the future, assigning a letter grade for each key attribute.
The resulting analytics would allow users to compare products made by different companies, to compare companies, and products made at different facilities owned by the same companies, allowing consumers to choose the best product made by the supplier with the best product quality. The tool could help remove some of the factors that have insulated pharmaceutical manufacturing from real market forces.
A website, called medicine-i.com will launch in October 2016, and a smart-phone app is also being developed that would allow individuals to get information on their medications and the manufacturers of those products at the pharmacy.
Pharmaceutical Technology and Biopharm International will be publishing an interview with Van Trieste that will provide insights into the methodology and the website, and what it might enable manufacturers, the biopharma and pharmaceutical industry, and its stakeholders to do.
Stay tuned for Pharmaceutical Technology’s November eBook on Quality for more.