Advances in Neuro-oncology

JEFF ZAGOUDIS | April 11, 2019

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Brain tumors are some of the most complicated forms of cancer to treat due to their extremely sensitive location. Surgery is the first choice when possible, as it guarantees removal of the tumor. Brain surgery is, however, an extremely invasive procedure and requires weeks to months of recovery time for the patient. Radiation therapy offers a minimally invasive alternative, but it comes with its own set of side effects and complications, including cognitive issues, fatigue, and hair and scalp problems, among others. According to the National Brain Tumor Society, however, only four drugs and one device have been U.S. Food and Drug Administration (FDA)-approved to treat brain tumors in the past 30 years.

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OTHER ARTICLES

Wisconsin biotech companies could play key roles in long-term economic recovery from COVID-19 pandemic

Article | April 19, 2020

Whether it’s called a modern “Manhattan Project” or a medical moon shot, the concept of long-term economic recovery rests on how confident people are they won’t risk serious illness by venturing forth in public again. Wisconsin stands to be a significant part of such an undertaking, whatever it’s called. The shorter-term debate is well under way over the gradual lifting of COVID-19 emergency rules, such as the now-extended “safer-at-home” order in Wisconsin. At least a dozen states, including regional coalitions on the East and West coasts, are exploring next steps as they seek to balance responses to the virus with calls for reopening the economy, at least, in part. Wisconsin’s ability to shape longer-term responses will come from private and public resources, which range from companies engaged in production of diagnostics.

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DIAGNOSTICS

Making Predictions by Digitizing Bioprocessing

Article | April 19, 2020

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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Ruminating on Bioprocessing 4.0

Article | April 19, 2020

The Bioprocessing 4.0 concept seeks to apply automation and technology to the digital transformation of biologics manufacturing. As the paradigm moves forward, it faces barriers to its adoption, according to Eric Langer, president of BioPlan Associates. “Perhaps the greatest challenges involve unsecured links and adapting the applications to areas where automation is critically needed today,” says Langer. “Unresolved security issues could seriously affect a company’s data in a regulated environment, so they will need to have iron-clad anti-hacking protection in place. Unfortunately, cyber security is not yet a top focus for the industry.”

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Pfizer, BioNTech Plan Clinical Trial for COVID-19 mRNA Vaccine Candidate

Article | April 19, 2020

Pfizer and BioNTech plan to begin human clinical trials on their lead COVID-19 therapeutic candidate, an mRNA vaccine, by the end of this month, the companies said today, through a collaboration that could generate up to $748 million for the German biotech. The companies announced plans last month to partner on BNT162, the first treatment to emerge from BioNTech’s accelerated COVID-19-focused development program, “Project Lightspeed.” BioNTech and Pfizer established collaboration intended to draw upon BioNTech’s proprietary mRNA vaccine platforms, and Pfizer’s expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network.

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Spero Therapeutics

Spero Therapeutics is a global multi-asset clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts dedicated to developing a novel and highly differentiated pipeline of antibacterials focused on unmet needs of patients with drug resistant bacterial infections.

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