Featured Articles
CLINICAL TRIALS - Enhancing Clinical Trials: A Strategic Framework for Positive Site-Sponsor Relationships
Matthew Jones and Julia Scanlon delve into the key elements of a framework designed to cultivate positive site-sponsor relationships. By examining shifts in trial strategy and execution, it can pave the way for a collaborative, mutually beneficial environment, and a sustainable competitive advantage.
DRY POWDER FORMULATION - Preparing to Deliver the Next Generation of Inhaled Therapeutics
Richard Johnson, PhD, outlines the trends and challenges within the inhaled drug delivery market. Specifically, DPI delivery will be explored, including how the challenges with dry powder formulation can be overcome and what the future holds for DPIs.
SPECIAL FEATURE - Excipients: Advanced Biologics Require Innovative Excipient Science
Contributor Cindy H. Dubin speaks with several leading companies to discuss novel and functional excipients being developed, the role they will play in reformulations and new formulations, and their versatility in drug delivery.
FORMULATION DEVELOPMENT - Solving Tough Solubility Issues With Fewer Compromises & Better Outcomes
Anshul Gupte, PhD, says fortunately, enhanced solubility can be achieved using a variety of approaches. For oral solid dosage forms, well-established approaches include micronization, nanoparticles, amorphous solid dispersions (ASDs), lipid-based formulations, salts, and co-crystals.
THERAPEUTIC FOCUS - Perspectives on Sigma-2 Modulation as a Therapeutic Modality for Slowing Age-Related Degenerative Disease
Anthony Caggiano, MD, PhD, believes there is evidence the sigma-2 receptor acts as a regulator of cellular processes, such as autophagy and protein trafficking, which are impaired in age-related degenerative diseases.
ORGANIZATIONAL CULTURE - Assessing Quality Culture: Five Key Elements
Londa Ritchey, MBA, believes there is sufficient passive endorsement of the idea that building and sustaining a strong quality culture is linked to enhanced business efficiency.
VACCINE DEVELOPMENT - Therapeutic Vaccines Development: At the Edge of a New Revolution
Mario Davinelli, PhD, Narcisa Mesaros, MD, David Morland, and Judith Neville, PhD, say therapeutic vaccines are an exciting area of research that has the potential to revolutionize the way we treat diseases.
DRUG DELIVERY PLATFORM - VitalDose® EVA Implants for Systemic & Local Delivery of Therapeutics
Cyonna Holmes, PhD, Karen Chen, MS, and Brian Duke explain how systemic delivery approaches that leverage continuous dosing can address adherence issues and improve drug effectiveness while minimizing adverse reactions, and how a localized delivery approach can minimize total drug exposure, reduce off-target toxicities, and overcome targeting issues.
EXECUTIVE INTERVIEW - Petros Pharmaceuticals & Self-Care: Expanding Access to Rx Products Through a Tech-Powered OTC Pathway
Fady Boctor, President and Chief Commercial Officer at Petros Pharmaceuticals, discusses the process of taking a product from Rx-to-OTC, the benefits and challenges of the process, and the future of the marketplace.
ARTIFICIAL INTELLIGENCE - Embracing AI Requires Digital Literacy. How Will Your Organization Prepare?
Dave Watrous says a strong training roadmap for digital literacy begins at the top, and it begins far in advance of any major Artificial Intelligence or Machine Learning project rollouts.
PERSONALIZED MEDICINE - Exploring the Potential of the Aryl Hydrocarbon Receptor for Personalized Medicine
Pedro Moura Alves, PhD, reviews the intricacies of AhR immune sensing and signaling, and its potential for personalized treatment strategies to optimize therapeutic outcomes and minimize adverse effects. He also touches on some of the limitations hindering the advancement of knowledge in this crucial area of research, and the direction this emerging field may take in the coming years.
DRUG DISCOVERY - Addressing Challenges in Drug Discovery: DEL Screening Applications
Matt Clark, PhD, explores DEL’s application in three areas of drug discovery that have received much attention throughout the past 5 years: Induced Proximity, Covalent Drug Discovery, and Machine Learning.
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.
