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.
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.
EXCLUSIVE ONLINE CONTENT
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….
2019 Analytical Testing in Drug Development eBook - Regulations Help Propel Testing Market
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
EXECUTIVE INTERVIEW - Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
LIPOPHILIC SALTS - Opportunities & Applications in Oral Drug Delivery
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.