NICE, France—The Global Alzheimer’s Platform (GAP) and the Innovative Medicines Initiative (IMI) announced recently that they would sign a memorandum of understanding to accelerate Alzheimer’s disease drug development by building a global, standing, trial-ready platform for such work. The collaboration represents a significant commitment to work together to recruit patients for clinical trials, to create a high-performing clinical trial system and to develop a standing adaptive protocol to test new molecules quickly—and move those with promise into later-stage development.
“This agreement represents an important commitment from major initiatives in Europe and the United States to expand and improve our capacity to conduct trials in Alzheimer’s in order to bring innovative medicines to patients faster,” said George Vradenburg, convener of the Global CEO Initiative on Alzheimer’s Disease, co-founder of USAgainstAlzheimer’s and a member of the World Dementia Council. “Through our collaborative efforts here in the U.S., organized through GAP, and with these consortia in Europe, we believe we can begin to design a truly global clinical trial system of speed, power and efficiency. No one company or one government can do this alone. We must have a global commitment, and it must come from government, industry and academia and be driven by the passion and urgency of the patient community.
“Currently, there is no global pool of persons with or at risk of Alzheimer’s who are standing ready, able and willing to participate in clinical trials of promising innovative Alzheimer’s medicines. The challenge of recruiting into the range of trials underway today and in the future stands as one of the single greatest barriers to increasing the pace of drug development in Alzheimer’s.”
The Global Alzheimer’s Platform, initiated by the Global CEO Initiative on Alzheimer’s Disease and the New York Academy of Sciences, is in advanced development with leadership and initial funding from Janssen Pharmaceuticals, the drug development division of Johnson & Johnson, Eli Lilly and Co., Lundbeck, Takeda and The Ray and Dagmar Dolby Family Fund. GAP’s objectives are to establish a global standing, trial-ready platform, projected to reduce clinical testing cycle times by two years or more; to achieve greater efficiency and uniformity in trial populations through large, well-characterized, trial-ready cohorts and certified clinical trial sites; and to more rapidly test the effectiveness of drugs through an adaptive proof-of-concept trial mechanism. This platform will enable the delivery of efficient and effective proof-of-concept and confirmatory trials, and ultimately the more rapid delivery of effective therapies to patients or those at risk.
The Innovative Medicines Initiative is a private-public partnership between the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations) that aims to improve clinical trials success rate and deliver clinical proof of concept, biomarkers and new medicines.
“This collaboration has the potential to be a game changer for Alzheimer’s drug development,” said Dr. Janet Woodcock, Director of the Center for Drug Evaluation at the U.S. Food and Drug Administration. “A global trial-ready platform will increase our prospects of finding important biomarkers, or discovering effective treatments for Alzheimer’s. If we don’t do this, we may be facing decades of uncoordinated, one-off efforts that fail to enhance our ability to accelerate learning and human testing and really move the field forward.”