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.
Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 for the Prevention of Delayed Graft Function in Kidney Transplant Patients
Unicycive Therapeutics, Inc. recently announced the US FDA has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney….
SPECIAL FEATURE - Improving Bioavailability & Solubility: The Never-Ending Quest
Contributor Cindy H. Dubin speaks with several companies to review their innovative technologies in this annual report on bioavailability and solubility.
FORMULATION FORUM - Nanoparticle Technologies Used in Ocular Drug Delivery
Shaukat Ali, PhD, and Jim Huang, PhD, describe the basic understanding of eye diseases, challenges in ocular drug delivery, and the future trends in development of innovative drugs.
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.
DRUG DEVELOPMENT EXECUTIVE - Thermo Fisher Scientific: What to Expect From the Next Wave of RNA-Based Therapeutics
Dr. Dale Patterson, Vice President and General Manager, Molecular Biology at Thermo Fisher Scientific, delves into the world of RNA therapies and understand their next act beyond COVID-19.
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.
CLINICAL TRIALS - Digital Endpoint Integration in Clinical Trials: Key Considerations & Nuances Per Therapeutic Focus
Tapan Raval and Ganesh Gundi, MD, say enhancing the patient experience and reducing burden is key in today’s drug development landscape, and DHTs can certainly play a positive role in that.
DRUG DISCOVERY - Benefits of Acoustic Liquid Handling in Drug Discovery
John Fuller, PhD, believes automated acoustic liquid dispensing technology is a game changer – whether deployed as a stand-alone instrument, in a scaled-up workstation, or as part of fully integrated systems – when it comes to handling complexity in efficient and cost-effective ways.
DATA-SHARING PLATFORM - How to Overcome the Challenge of Differing Digital Maturity Levels in Biopharmaceutical Supply Chains
David Brick, MS, and Harlan Knapp, MS, review how the efficient and timely delivery of therapeutics with complex manufacturing needs cannot be achieved by simply unifying the entire pharmaceutical landscape within the most advanced digital maturity level. A better approach is to implement a flexible data-sharing platform that can accommodate partners with different data management capabilities.
VACCINE DEVELOPMENT - A Healthier Global Population Through a Universal Influenza & Multi-Virus Vaccine
Jeff Fischer, MBA, says we need to have an eye toward universal influenza or multi-virus vaccines that have the ability to provide broad coverage as viral strains continue to evolve.
THERAPEUTIC FOCUS - TTHX1114: Improving Outcomes for High-Risk Patients After Cataract Surgery
David Eveleth, PhD, says in many cases, high-risk patients have few options for complication-free treatment of cataracts or other degenerative eye disorders. By filling this unmet need, TTHX1114 has the potential to significantly improve vision health, enhance the well-being of high-risk individuals, and alleviate economic burden on healthcare systems and economies.
ENGINEERING BIOLOGY - Scaling Engineering Biology to Accelerate Advances in Healthcare
Raquel Sanches-Kuiper and Matthew Hayes, PhD, say the development of a benchtop synthesis platform has the potential to expedite the discovery and development time for drugs and biotherapeutics, greatly accelerating the rate at which engineering biology can shape the future of healthcare.
Dyadic Advances Collaboration With Israel Institute for Biological Research Targeting Bio-Threats & Emerging Disease Solutions
Dyadic International, Inc. and Israel Institute for Biological Research (IIBR) recently announced it has advanced its collaboration with IIBR and its commercial arm Life Science…
SPECIAL FEATURE - Outsourcing Analytical Testing: AI Could Transform Analytical Labs
Contributor Cindy H. Dubin presents how today’s leading analytical testing service providers are taking advantage of AI and other types of automation and innovative technologies.
EXECUTIVE INTERVIEW - How Resilience Is Bringing Forward Thinking to Disrupt the Biomanufacturing Landscape to Increase Access to Medicines
Syed T. Husain, Chief Commercial Officer of Resilience, discusses how the company became an industry-leading service provider in less than 4 years.
FORMULATION FORUM - Lipid Nanoparticles – Carriers for Nucleic Acids Delivery
Shaukat Ali, PhD, and Jim Huang, PhD, describe the role of individual components in aggregation, packing, stability, efficacy, and potency of nucleic acids, the understanding of which is important to achieve better designed and smarter formulations, and robust scale up and manufacturing of LNPs.
SPECIAL ROUNDTABLE - Leadership Panel: 4 Trends That Will Have the Most Impact on Drug Development in 2024
Contributor Cindy H. Dubin asked some of today’s life science leaders what they expect will have the greatest impact on drug development in 2024 and beyond.
