U.S., EU Officials Provide Update on Parallel Scientific Advice Pilot
Representatives of FDA, EMEA and industry discussed their pilot program to provide parallel scientific advice to sponsors developing new drugs. The process aims to resolve critical clinical and safety issues early in the research process to avoid duplicative testing and regulatory delay.
Representatives of FDA, EMEA and industry discussed their pilot program to provide parallel scientific advice to sponsors developing new drugs. The process aims to resolve critical clinical and safety issues early in the research process to avoid duplicative testing and regulatory delay.
A U.S.- EU confidentiality agreement, which was finalized in 2003, provides a legal basis for the two regulatory agencies to discuss clinical protocols and development programs for investigational products. So far, the two agencies have held eight meetings to discuss specific scientific issues raised by industry sponsors, explained EMEA Executive Director Thomas Lonngren, Pharm, MSc. Although FDA and EMEA officials issue separate letters presenting their views on the issue raised, there has been little disagreement between the two agencies so far, commented Murray Lumpkin, MD, MSc, FDA deputy commission for international and special programs.
He noted that this pilot advisory program is most suitable for resolving specific issues involving new technologies that lack extensive guidance or regulatory experience. The two regulatory agencies agreed at a March 2006 meeting in Brussels to continue the pilot while evaluating its value and future development. While these joint meetings are highly resource intensive, they would like to overcome an apparent reluctance of sponsors to seek advice on highly controversial issues.
— Jill Wechsler
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
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.
