Johanna Mora, Ph.D., is a senior research investigator responsible for regulated bioanalysis of biotherapeutics in support of GLP and clinical studies in the Department of Bioanalytical Sciences Biologics at Bristol-Myers Squibb.
In today’s environment, companies are seeking to collect more data with smaller sample volumes, utilize multiplexing platforms to track more biomarkers within the same sample, apply high-throughput platforms to improve turnaround times, or apply automation to improve precision and reduce rework. Several technologies have emerged to address these needs, but many groups find it hard to prioritize new technology evaluations as they struggle to support the pipeline with minimal staff. Recognizing this gap, the American Association of Pharmaceutical Scientists (AAPS) chose to support the creation of an Emergent Technologies Action Program Committee (ETAPC) to evaluate new technology and provide the scientific community with practical recommendations on which technologies are worth exploring.
The ETAPC was established in the spring of 2012 in conjunction with the Ligand Binding Assay Bioanalytical focus group. The ETAPC gathers together North American and European experts from biopharmaceutical companies, contract research organizations (CROs), government institutions, and technologies developers. Its mission is to evaluate the potential of new emerging technologies for biologics quantification beyond the new technologies that are presently expanding in the pharmaceutical industry and/or technologies that represent progressive developments that offer a competitive advantage. This program committee provides a unique opportunity for the ligand binding assay (LBA) community to evaluate the scientific challenges of these technologies. Pivotal to the success of this committee will be critical technological evaluations and timely distribution of this information to the scientific community.
In an age of continuous improvement, it is of utmost importance to improve the respective bottom line, whether by increasing efficiency, reducing waste, or innovating to deliver what was not technologically feasible before. It is along these lines that the importance of the ETAPC becomes apparent; the ETAPC will collaboratively and openly evaluate the next level technology that just may provide an increase in efficiency, reduce our waste, or deliver a technology milestone. To facilitate the evaluation of emergent technologies across multiple fronts, the steering committee formed four working teams: Assay Tolerance; Assay Sensitivity; Throughput, Integration, and Multiplexing; and Real-time Measurement. Each team comprises two cochairs that sit on the steering committee and four to six team-specific members. Each team determines which technologies it will evaluate based on its own mission statement. The team information is then brought back to the steering committee for review by the team cochairs. To avoid duplication of effort, the ETAPC has clarified the teams’ scope with the Global Bioanalytical Consortium (GBC) and the 21st Century Laboratory Action Program Committee (APC).
Each team has assembled an initial list of technologies based on the team’s scope, and teams are working to prioritize the technology evaluations. The steering committee has agreed on a set of characteristics or user requirements, which will be used to evaluate the technologies and make recommendations to the industry. Because of the “emergent” quality of these technologies, they may be relatively unknown to most of the LBA industry, and a handful of technologies are described in the May AAPS Newsmagazine cover article, developed by the Biotechnology section. Read the article and then participate in the discussion question below.
Discussion Point: Are you evaluating technologies not listed in the cover article? Would you like to provide your feedback on a past or ongoing evaluation?