ConcePTION partners have united around a shared vision that we have a societal obligation to radically and rapidly reduce uncertainty about the safety of medication use in pregnancy and lactation. What do we deliver? ConcePTION aims to create a paradigm shift in how we study medication safety in pregnancy. We will establish (1) a successful, sustainable open-science based EU non-proprietary ecosystem of public and private stakeholders, pregnant women and researchers to generate and disseminate timely and reliable evidence on drugs across maternal, neonatal and long term outcomes of medication exposure in pregnancy and breastfeeding (2) a catalogue with fully characterized data sources for rapid selection of suitable data sources; 3) operational, business, network, information and data governance models, (4) quality assured and tested methodological approaches, analytical tools and data platforms allowing for distributed analyses, (5) procedures and tools for collection of digital data and samples directly from pregnant women, (6) In vitro, in silico and in vivo models for prediction of drug transfer in human milk, (7) a biobank and analytical network for quantification of drug in human milk, (8) best practice documents endorsed by regulators and health authorities and (9) a web-based drug information knowledge bank. How do we deliver? (1) Experienced leaders, able to manage challenging networks and public-public or public-private partnerships. (2) Defragmentation by connecting all key stakeholders and EU networks in this area. (3) Re-use of data, tools and foreground from prior European commission funded projects. (4) Connecting to leaders of similar initiatives in the USA, Canada, Asia and other parts of the world. (5) Systematic consensus & endorsement building. (6) Quality throughout as a precondition to trust the results and information by all users.

Beta-amyloid (β-amyloid) deposition is considered to be a necessary - but not sufficient - step on the path towards Alzheimer’s disease (AD). Depiction of brain β-amyloid in vivo can support an early diagnosis, and even provide an opportunity for consider secondary prevention of AD. Currently, however, the value of β-amyloid PET remains elusive, reason why this procedure is typically not reimbursed. Understanding the value of imaging of β-amyloid using positron emission tomography (PET) provides a unique opportunity to achieve 3 major goals: 1) improve the diagnostic workup of patients suspected of AD and their management; 2) stratify risk for AD and select homogenous groups for intervention; and 3) quantify treatment effects more accurately. AMYPAD will address the above objectives by studying the onset, dynamics, and clinical relevance of brain β-amyloid in the spectrum from normal aging to preclinical and prodromal AD. We will use β-amyloid-PET in an unprecedented large number of subjects (n=4000) from population studies, as well as memory clinics cohorts, with repeat imaging in up to 2000. In close collaboration with EPAD (www.ep-ad.org), the cohorts will be followed with to determine (surrogate) outcomes of cognitive decline and neurodegeneration. Lead from VU-VUmc, the Consortium brings together a word-class team of highly synergistic partners from across Europe constituting a highly experienced and efficient β-amyloid imaging network including the most active European PET sites, to ensure effective tracer delivery, access to patients and expertise to technical knowledge and disease modelling. AMYPAD will establish the true value of β-amyloid PET across the severity range of AD. Patients and clinicians will benefit from better and cost-effective diagnostic procedures and management, while academics and industry will benefit from better disease understanding, clear reimbursement strategy and more rationale and efficient clinical trial design.