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A Dose of Pharma and Biotech News: December 12, 2019

With innovative research driving pharmaceutical and biotech breakthroughs, industry progress is accelerating at a rapid pace. It is important for us to stay on top of the latest developments in the biologics space to inform our own work in helping customers best address bioanalytical challenges and opportunities. Below are some recent industry articles we’ve found most interesting to share with you:

Gene Therapy R&D Accelerates
Pharma’s Almanac, December 6, 2019

Research efforts around gene therapy have expanded greatly in recent years. According to the Alliance for Regenerative Medicine, 366 gene therapy and 410 gene-modified cell therapy clinical trials were underway at the end of the first half of 2019. Recent product approvals like Novartis’ Zolgensma for the treatment of spinal muscular atrophy (SPA) and bluebird bio’s Zynteglo for the treatment of transfusion-dependent ß-thalassemia are proving out the potential of these classes of therapies to not only treat, but cure serious conditions that were previously intractable.

Continued development of safe, efficient gene delivery vectors and gene editing technologies will be necessary to continue to realize the full promise of these therapies to address significant unmet medical needs like rare diseases and cancer.

As the number of gene therapy products in development continues to increase, so too will the need for expert-level bioanalytical resources adept at understanding their unique complexities. Learn how BioAgilytix is supporting gene therapies today with specialized capabilities in immunogenicity assessments and expertise in the bioanalysis of modified and novel vehicles.


EU Report Highlights the Need for Biosimilars in Fostering Sustainable Health Systems
The Center for Biosimilars, December 2, 2019

In a recent report released by The European Commission, the role of biosimilars and generics was highlighted as having a large projected impact on the well-being of European healthcare systems in the years to come. According to the report, encouraging uptake of these medicines has the potential to help health systems across Europe deliver more efficient care while helping pharmaceutical companies control costs and achieve better value from resources spent. The findings reinforce the opportunities brought by biosimilars to improve equitable and sustainable access by patients in need.

The success of a biosimilar program centers on the ability to demonstrate that there are no clinically significant differences between the proposed biosimilar therapeutic and its reference product. BioAgilytix’s team is helping to shape industry best practices on bioanalytical assays to support biosimilar programs and the demonstration of biosimilarity – see how.


A ‘liquid health check’ – could blood proteins be used to predict disease risk?
Bioanalysis Zone, December 3, 2019

In a recently published study in Nature Medicine, an international team of scientists from the University of Cambridge and biotechnology company SomaLogic demonstrated that large-scale measurements of blood proteins from a single blood sample could be used to garner important health information and even predict risk factors for a number of different diseases.

The study highlights the potential for a “liquid health check” that analyzes specific blood proteins to predict disease risk, with the team of scientists developing predictive models reflecting a number of health states such as levels of liver fat, kidney function, alcohol consumption, and risk of developing cardiovascular disease and Type 2 diabetes.

Biomarkers will play a key role in the advancement of more personalized and predictive medicine, but because their uses are quite diverse, their study requires a breadth and depth of specialty bioanalytical expertise. Learn how BioAgilytix applies our world-leading biomarker testing capabilities to support drug development programs across a wide range of disease states.

Have you seen exciting industry news that you’d like to share with us? We would love to see your articles and hear your perspectives – we will even include them in our next round up! Submit your headlines here.

Scientific papers