Find Out at the DIA Annual EuroMeeting
Twelve months ago (March 2005) the FDA launched its final Guidance for Industry Pharmacogenomic Data Submissions, designed to encourage the voluntary submission of genomic data as part of the approval process for new chemical entities.
Already some 25 voluntary submissions have been made, and Felix Frueh, Head of the Interdisciplinary Pharmacogenomic Review Group (and Associate Director for Genomics at the FDA's Center for Drug Evaluation and Research), believes that this, and the fact that several sponsors have made a second or even third submission, indicates that the program is "progressing well"¹.
But – are CROs ready to respond fully to requests from pharmaceutical companies to include a pharmacogenomics element in their trials?
There's the chance to find out by visiting the DxS stand (No 11) at this year's DIA Annual Euro Meeting in Paris on 6th – 8th March, and talking to their CEO, Dr Stephen Little.
As DxS is already providing pharmaceutical, biotechnology and clinical research companies with pharmacogenetic services, products and technologies to support their drug discovery, clinical development and personalised medicine, they are uniquely placed to offer comment. Furthermore, Dr Little attended many of the DIA / FDA consultation meetings that provided debate and input into the FDA guidance notes during their gestation.
To arrange an interview, please contact Kevin Payne at k.payne@defacto.com (00 44 207 861 3023) or Jo Cross of DxS at joanne.cross@dxsgenotyping.com (00 44 161 606 7201).
Ref 1: From interview in Pharmacogenomics Reporter – 8th February 2006.
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.