Welcome to your February issue of The Pipeline from Precision for Medicine. This month, we offer insights into harnessing high-quality biospecimens for immuno-oncology R&D, a new paper on managing complexity in pediatric rare disease trials, tips to ensure an on-time EDC go-live date, 3 revealing on-demand webinars, and more. We hope you’ll find this information valuable as you conquer the complexity inherent to R&D innovation.

The Pipeline features timely insights from our experts in the lab, clinical trials, and data science, designed to help innovative researchers unwind complexity. It is published by Precision for Medicine.

February 2022 Contributors

Anuj Kalsy, Scientific Director, Precision for Medicine

Michelle Martell, Executive Director of Data Management, Precision for Medicine

Deb Phippard, PhD, Chief Scientific Officer, Precision for Medicine

Travis Harrison, PhD, Vice President, Bioassay Solutions, Precision for Medicine

Jo-Ann F. Gonzales, RAC, Director IVD Regulatory & Quality Control, Precision for Medicine 

Rare Disease Clinical Trials in Pediatric Populations: Lessons Learned

Rare disease trials are inherently complex. Pediatric rare disease trials compound it further. Having supported 150+ rare disease trials, many for pediatric indications, our Precision experts have detailed advice. Here, Traci Fulton, Executive Director, Project Management, addresses pediatric-specific hurdles and provides strategies to overcome them, including lessons learned during COVID-19.

Clinical Research EDC: Tips to Going Live on Time

Electronic data capture (EDC) systems are essential repositories for patient data in clinical trials. As such, their go-live date impacts trial-wide scheduling. In this article, Michelle Martell, Executive Director, Data Management at Precision for Medicine, shares the factors that drive EDC timelines, insights into key aspects of EDC design and build, and vital steps sponsors can take to optimize workflow.

On-Demand Webinar: NAb vs TAb Assays in Gene Therapy Development: Key Considerations For Assessing Immunogenicity

With pre-existing immunity to viral vectors presenting a major challenge to the delivery of life-changing gene therapies, developing an assay to assess humoral immunogenicity. But, how can you determine whether a NAb or Tab assay is best? Deb Phippard, PhD, Chief Science Officer, and Travis Harrison, PhD, Vice President, Bioassay Solutions, Precision for Medicine, offer guidance in this must-see webinar.

On-Demand Webinar: Emergency Use Authorization for COVID-19 Tests 20 Months Into the Pandemic

As the demand for COVID-19 diagnostic tests soar, the FDA guidelines around emergency-use authorization continue to shift. In this 30-minute webinar, Jo-Ann Gonzales, RAC, Director, IVD Regulatory & Quality Consulting, Precision for Medicine, shares what has changed, provides 2 example case studies, and offers 5 key takeaways for those seeking FDA approval.

On-Demand Webinar: Data Silos With a Translational Hub

When a network of specialty labs use individual data formats and annotations, the result is translational data chaos—and deep frustration for the researchers who have to manually curate and prepare data. In this 30-minute webinar, QuartzBio experts demonstrate how integrating exploratory biomarker, PK, and clinical data silos in a translational hub enables teams to interrogate trends and identify insights as data is generated on-study.

Contact us and let us connect you with the right expert.