Welcome to The Pipeline, filled with insights from our experts in the lab, clinical trials, and data science. In this issue you’ll find articles on:
- An exploration of the analytes and technologies driving the next phase of COVID-19 research and development (originally presented at the 28th Molecular Med Tri-Con)
- How to locate sites that are qualified for cell therapy studies—and have the bandwidth to handle your trial (originally published in Cell and Gene)
- The complex calculation that clarifies the “make vs. buy” decision regarding cell and gene therapy manufacturing (originally published in Cell and Gene)
- The Duncker Candle problem and what it teaches us about functional fixedness
You will also find links to two fascinating on-demand presentations. We hope you find this content helps you navigate challenges more easily and avoid potential roadblocks on the development pathway.
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.
Contributors
Megan Liles, Vice President, Operating Strategy
David Parker PhD, Senior Vice President, Diagnostics Solutions
Tony Khoury, Executive VP
Christian Hermanas, Senior Consultant
Salome Philip, Consultant
Deb Phippard, PhD, Global Head, Research
Dr. Al Blunt, MD, SVP, Medical
Leah Tasca, Vice President of Project Management
Accelerating Precision Oncology with a Novel NGS Screening Initiative
Cell therapies are advanced treatments that must be administered at accredited centers with experience and established quality processes, procedures, and practices to ensure patient safety. As of January 2021, 298 centers have been accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) in the United States.
Going Beyond Viral Detection: COVID-19 Diagnostics
The emergence of the COVID-19 pandemic spurred the development of nearly 300 diagnostics aimed at detecting exposure to the SARS-CoV-2 virus.1 Many of these tests are available for use in multiple settings of care to identify the presence of virus, assess viral load, and determine whether a patient has been infected. As we near the end of the acute epidemiology phase of COVID-19 diagnostics, the next generation of diagnostics will address COVID-19 as an endemic disease.
How To Calculate Viral Vector Yields: A Critical Component Of The “Make vs Buy” Analysis
Calculating viral vector yields is essential to determine how much drug product is needed for a specific gene therapy. This calculation will determine either how much internal manufacturing capacity is needed or how much it may cost to manufacture at an external contract development and manufacturing company (CDMO).
Duncker’s Candle Problem Shows Us the Risk of Functional Fixedness
Given a candle, a box of thumbtacks, and some matches, can you affix a candle to the wall and light it so that it doesn’t drip on the floor? Known as Duncker’s Candle Problem, this puzzle is actually a cognitive performance test, measuring the influence of functional fixedness—the cognitive bias that makes it difficult to use familiar objects in unfamiliar ways.
On-Demand Now: Operational Execution of Cell/Gene Therapy Programs: Challenges and Opportunities
This discussion will address the operational challenges in the cell and gene therapy space pertaining to supply chain operations and site activation.
On-Demand Now: Multiple Myeloma Insights from KOL Investigators
You will hear from two leading investigators on the lessons learned, current trends, and insights relevant to the Multiple Myeloma (MM) US and EU research community.
New Event
On Demand: Incorporating Tumor Spatial Biology and Hot/Cold Tumor Profiling in Oncology Clinical Trials (EU)
Understanding the immune system and biology in tumors is critical in oncology clinical trials. New methods have unlocked the ability to spatially profile immune cells in tumors, leading to a better understanding of the tumor microenvironment (TME) and hot/cold tumor status.
Points covered in this webinar include:
- Clinical and medical significance of the TME and hot/cold tumors
- Instrumentation, such as the Akoya Vectra® PolarisTM, and methods for tumor spatial profiling
- How to assess the TME via spatial analysis – defining hold vs cold tumors using spatial analysis, and assessing cell interactions between complex cell phenotypes