Message from EMA’s Outgoing Executive Director
Professor Guido Rasi’s last day as Executive Director of EMA comes in the middle of one of the biggest public health emergencies of the past century. “We are seeing an unprecedented effort…to tackle the pandemic. The number of therapeutics and vaccines that are currently under development is encouraging, and information on the initial results from clinical trials on vaccines is starting to be reported by the pharmaceutical industry. In the words of one developer, ‘we are a significant step closer’ to a vaccine.”
He emphasized the importance of the role that regulators would be playing in reviewing the available data packages. “EMA will ensure that the scientific review is conducted as rapidly as possible. This is a vitally important step as the time spent in conducting the review will not only ensure that our stringent regulatory standards are met but will also serve to reinforce public confidence in the vaccines.”
His successor, Emer Cooke, he describes as, “a strong leader who is committed to steering EMA during this very challenging period and ensuring that the Agency’s work on COVID-19-related activities continues uninterrupted.” And that What is needed now is, “a reinforcement of EMA’s resources so that it can continue to deliver on its core business, deliver on the joint EMA/Heads of Medicines Agencies strategy…to address future challenges and undertake the additional activities to fulfil its new mandate.”
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
