EU’s IMI Launces Effort to Improve Clinical Trials, Boost Exclusivity

A European public-private partnership is launching a new $4.5 billion decade-long effort to improve the success rate of clinical trials on certain drugs by 30 percent and boost exclusivity to make manufacturing treatments more enticing.

The Innovative Medicines Initiative (IMI), a partnership between the European Commission and European Federation of Pharmaceutical Industries, announced its new strategic research agenda. It outlines the priorities for the second phase of the partnership from 2014 to 2024, building on the first phase, which ran from 2008 to 2013.

The first phase resulted in numerous achievements such as new models to better predict drug toxicity and a greater understanding of the mechanisms behind chronic pain, according to a fact sheet from the European Commission (EC).

The European healthcare industry is under tremendous strain as an aging population creates a new demand for treatments, but patent cliffs don’t allow drugmakers enough time to recover their investments, the agenda says. To address this problem, over the next decade the IMI intends to use its $4.5 billion budget to fund research on:

• Innovative medicines. With the aging population, new incentives are needed to spur development of preventative medicines for diseases such as Alzheimer’s and osteoarthritis, the IMI said. Current patent protection lasts for 20 years. “For prevention medication, this will not provide sufficient time for companies to recoup their development costs,” the IMI said, but declined to propose any alternatives;
• Target identification and biomarker research (efficacy and safety). The IMI will work to gain a better understanding of disease mechanisms to help identify biomarkers that can predict a drug’s efficacy and serve as surrogate markers in a clinical trial. The partnership will also identify new methodologies for pharmacokinetic and pharmacodynamic studies to help drugmakers better understand adverse events;
• Adoption of innovative clinical trial designs. The IMI will explore using smartphones and tablets to develop new methods for collecting real-world effectiveness and risk data through patient-reported outcomes. However this also “brings with it the challenge of managing the collection, validation and analysis of data, cost-effectiveness of data collection, privacy laws and data security,” the agenda says; and
• Patient tailored adherence programs. The issue of patients failing to adhere to dosing regimens can compromise the effectiveness of products. The IMI will work to create adherence programs that include “the development of new drug delivery systems, and the development of portable monitoring devices,” the agenda says.

The IMI also identified 11 diseases and areas that are a high priority because they pose certain development challenges. The disease priorities are cancer, vaccines, antimicrobial resistance, osteoarthritis, cardiovascular disease, diabetes, neurodegenerative, respiratory, psychiatric, immune-mediated, aging-associated and rare/orphan diseases.

The EU tasked the IMI to improve the success rate of clinical trials for drugs treating the priority diseases by 30 percent. Other deliverables include creating at least two new therapies for antimicrobial resistance or Alzheimer’s disease, and creating diagnostic and treatment biomarkers for four diseases.

The EU will contribute $2.6 billion to the effort and the EFPIA will contribute up to $1.9 billion and $314 million if other life science industries decide to get involved, the EC said. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.