MEDTECH

A digital ecosystem for Clinical Trails

| July 30, 2021

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Clinical trials are complex, lengthy, and resource-inefficient. The clinical research industry is responsible for the delivery of medical solutions to society by systematically evaluating their safety and efficacy in humans during so-called clinical trials. As exemplified by the COVID-19 pandemic, a steady and efficient influx of vaccines, therapeutics, and other innovative medical solutions is critical for meeting society’s current and future medical needs. Unfortunately, the industry faces several persistent issues that make clinical trial operations overly complex, lengthy, and resource-inefficient.

Spotlight

Biothera Pharmaceuticals, Inc

Biothera Pharmaceuticals is a privately held biotechnology company developing Imprime PGG, a mid-clinical stage cancer immunotherapy that enhances the efficacy of tumor-targeting, anti-angiogenic, and immune checkpoint inhibitor antibodies. The Company has clinical research agreements with Merck to evaluate Imprime PGG and Merck’s KEYTRUDA (pembrolizumab) in Phase 2 studies in advanced melanoma, metastatic triple negative breast cancer, and head and neck squamous cell cancer.

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MEDICAL

Better Purification and Recovery in Bioprocessing

Article | August 2, 2021

In the downstream portion of any bioprocess, one must pick through the dross before one can seize the gold the biotherapeutic that the bioprocess was always meant to generate. Unfortunately, the dross is both voluminous and various. And the biotherapeutic gold, unlike real gold, is corruptible. That is, it can suffer structural damage and activity loss. When discarding the dross and collecting the gold, bioprocessors must be efficient and gentle. They must, to the extent possible, eliminate contaminants and organic debris while ensuring that biotherapeutics avoid aggregation-inducing stresses and retain their integrity during purification and recovery. Anything less compromises purity and reduces yield. To purify and recover biotherapeutics efficiently and gently, bioprocessors must avail themselves of the most appropriate tools and techniques. Here, we talk with several experts about which tools and techniques can help bioprocessors overcome persistent challenges. Some of these experts also touch on new approaches that can help bioprocessors address emerging challenges.

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DIAGNOSTICS

Making Predictions by Digitizing Bioprocessing

Article | April 20, 2021

With advances in data analytics and machine learning, the move from descriptive and diagnostic analytics to predictive and prescriptive analytics and controls—allowing us to better forecast and understand what will happen and thus optimize process outcomes—is not only feasible but inevitable, according to Bonnie Shum, principal engineer, pharma technical innovation, technology & manufacturing sciences and technology at Genentech. “Well-trained artificial intelligence systems can help drive better decision making and how data is analyzed from drug discovery to process development and to manufacturing processes,” she says. Those advances, though, only really matter when they improve the lives of patients. That’s exactly what Shum expects. “The convergence of digital transformation and operational/processing changes will be critical for the facilities of the future and meeting the needs of our patients,” she continues. “Digital solutions may one day provide fully automated bioprocessing, eliminating manual intervention and enabling us to anticipate potential process deviations to prevent process failures, leading to real-time release and thus faster access for patients.” To turn Bioprocessing 4.0 into a production line for precision healthcare, real-time release and quickly manufacturing personalized medicines will be critical. Adding digitization and advanced analytics wherever possible will drive those improvements. In fact, many of these improvements, especially moving from descriptive to predictive bioprocessing, depend on more digitization.

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Spotlight

Biothera Pharmaceuticals, Inc

Biothera Pharmaceuticals is a privately held biotechnology company developing Imprime PGG, a mid-clinical stage cancer immunotherapy that enhances the efficacy of tumor-targeting, anti-angiogenic, and immune checkpoint inhibitor antibodies. The Company has clinical research agreements with Merck to evaluate Imprime PGG and Merck’s KEYTRUDA (pembrolizumab) in Phase 2 studies in advanced melanoma, metastatic triple negative breast cancer, and head and neck squamous cell cancer.

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