The Biomarker(s) Assays Standards Dilemma: 510(K)s, PMAs, LDTs, and Beyond
August 18-19, 2013
The Royal Palms Resort and Spa
The NBDA is on a path to create a viable and productive organization dedicated to moving beyond discussion to implementation. Through these workshops, we are taking the time needed to ensure that we fully understand the critical barriers at each stage of biomarker development and identify viable (hopefully new and innovative) solutions that can be facilitated/implemented through the NBDA. The NBDA will focus on actions/solutions, be agnostic in terms of disease, and strive to be inclusive vs. exclusive of the affected stakeholders. Indeed the development of biomarkers from “discovery” to successful “products” is disconnected and often fraught with different definitions of success. Our goal is to address many of these challenges through the work of the NBDA and enable the realization of our shared vision of a new generation of personalized/precision medicine.
Thus far the NBDA workshops have focused on biomarker discovery, what constitutes a translatable discovery, and the development and analytical validation of the biomarker assay per se. The last workshop also defined criteria for decision making relative to moving from what seems to be a “good” biomarker assay to early clinical evaluation. We will pick up this conversation in NBDA Workshop IV where our intent is to “rethink” clinical trials “dogma,” analyze some new models that have merit, and brainstorm innovative approaches that might actually enable a paradigm shift toward more effectual biomarker-driven clinical trials.
There are numerous writings, meetings and initiatives in the field, ranging from efforts to define clinical trials that accommodate WGS/NGS to other advanced technologies to combinations of biomarkers and integrative algorithms. The NBDA will not re-invent good work but rather will embrace it. We will spend our time at this workshop thinking deeply about the clinical trials it will take to move a high-value biomarker from discovery to product (inclusive of the major classes of biomarkers we have defined). Our goal is not to “tweak” the classic clinical trials process but rather to learn from successful models, define real needs, and formulate concepts that the FDA and industry could collaboratively embrace through various mechanisms, including demonstration projects. The longer term intent of the NBDA is to engage appropriate stakeholders in action- oriented networks that create solutions (guidelines, standards, demonstration projects, common infrastructure, etc.) that no one community/sector can successfully develop on their own. The FDA is not our problem, as the Agency has repeatedly demonstrated their receptivity to new ideas and clinical trials models (e.g., ISPY-2, BATTLE). In that spirit we need new clinical trials ideas/concepts that are part of evidence-based end-to-end biomarker development models.
This information will be available in Spring 2016 to those individuals and organizations that join the NBDA as Partners, Collaborators or Members.