Featured Articles

THERAPEUTIC FOCUS – Sarilumab Approval for Polymyalgia Rheumatica Highlights Enduring Unmet Medical Needs

David A. Katz, PhD, and Robert Jacks, MBA, MSE, say a new, effective treatment option is now available, promotion of the drug will increase disease awareness, and the success encourages others in the industry to continue and expand their PMR research. However, the proportion of patients who can benefit from the drug is limited, and significant unmet needs remain for all persons suffering from PMR.

CANCER BIOMARKERS – Co-Analysis of CTCs & ctDNA: Gaining Multi-Dimensional Insights Into Cancer Heterogeneity

Yoon-Tae Kang, PhD, Abiodun Bodunrin, PhD, and Joby Chesnick, PhD, MBA, believe co-analysis of CTC abundance and phenotypic changes together with ctDNA concentration could allow for real-time monitoring of disease progression and reoccurrence, while genetic and epigenetic changes in CTCs and ctDNA mutations over time could provide valuable insights into the effectiveness of therapeutic interventions, as the presence of different somatic mutations may indicate cancer susceptibility or resistance to certain treatments.

DRUG DELIVERY – EUDRACAP® Select – Examining a Case From Development to Clinical Trial

Lucas Paulo Cusin, Kamlesh Oza, PhD, and Steven Smith, et al focus on the development of a customized functional coated capsule for the delivery of live biotherapeutics and demonstrate its effectiveness in the oral delivery of a sensitive proprietary microbiome ecosystem while simplifying the drug development process.

PBPK MODELING – Critical Parameters for Simulating Oral Absorption Using PBPK Models

Deanna Mudie, PhD, says with an increasing number of drugs posing absorption challenges, the ability to predict how a new molecule will behave in vivo is important, and being able to predict and mitigate absorption problems before they arise should help the project progress with fewer delays.

PREFILLED SYRINGES – Making a Prefilled Syringe Smart: Technological Solutions to Advance Patient Care & Clinical Trial Outcomes

Salvatore Forte, MS, believes adherence to the dosing regimen, as well as compliance to the injection protocol, are essential for treatment success in both these use-cases. Hence, the request for a connected, smart PFS is growing just as much to tackle poor medication adherence and compliance issues.

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