PRECLINICAL/CLINICAL STUDIES - Preclinical Toxicology vs Clinical: Key Considerations in Using Lipid-Based Formulations
Anette Müllertz, PhD, Grace Furman, PhD, and Lisa Caralli say developers should first understand the developability challenges for their molecule, then a toolkit of enabling technologies can be identified to overcome those factors and individually leveraged to create fit for purpose formulations for use in preclinical and clinical studies.
PLATFORM TECHNOLOGY - Developing Novel Antisense Oligonucleotides for Neurodegenerative Diseases
Scott Schobel, MD, and Nicole Datson, PhD, are hopeful their novel platform for targeting disease-causing RNA with multiple modulating approaches will lead to major advances in treating genetic disease and improving the lives of patients and their families in the years ahead.
SPECIAL FEATURE - Injection Devices: From Pens & Autoinjectors to Pills, Sprays & Capsules, Injections Become More Efficient
Contributor Cindy H. Dubin reports on innovative and promising injection technologies that are ever more user friendly, versatile, precise, and life-saving.
ARTIFICIAL INTELLIGENCE - Accelerating Drug Discovery & Development: The AI Revolution is Here
Emilio Cordova delves into how AI is transforming the drug discovery sector by enhancing predictability and efficiency and explains her company’s unique approach.
FORMULATION DEVELOPMENT - Solubility-Enhancing Technologies in Pharmaceutical Development, a Mini-Review
Timothy Pas, PhD, and Vincent Levet, PhD, believe different solubility-enhancing technologies can be used by developers, and with different advantages and drawbacks, linked to payload, manufacturability, tolerability, and physical and chemical stability, effectively navigating solubility-enhancing solutions is multifaceted.
DRUG DELIVERY - Viewing Lipid Nanoparticle Delivery Technology Through the Lens of a CRDMO
Lu Tian, PhD, says the complexity of LNP formulations demands diverse and integrated capabilities for development – incorporating lipids, oligonucleotides, small molecules, and sometimes antibodies or ligands, and thus it requires a cohesive approach.
SILICON-STABILIZED HYBRID LNPS - Next-Generation Delivery of RNA Therapeutics
Suzanne Saffie-Siebert, PhD, Michael Welsh, PhD, Nissim Torabi-Pour, PhD, and Flavia M. Sutera, PhD, review current shortcomings, as well as some accompanying manufacturing challenges, and will show how they can be addressed by SiSaf’s silicon-stabilized hybrid LNPs.
CLINICAL TRIALS - Faithful Migration: Shifting Patient Reported Outcomes From Paper to Electronic
Melissa Mooney says by following certain steps to faithful migration, the shift to electronic measures is efficient and reliable, especially as there is an increasing body of evidence showing that when minor changes are made to an original measure, the resulting ePRO is likely to be considered equivalent.
EXECUTIVE INTERVIEW - Coya Therapeutics: Unlocking the Power of Tregs to Combat Inflammation & Fight Neurodegenerative Diseases
Dr. Howard Berman, Founder and CEO of Coya Therapeutics, discusses how the company is leveraging Tregs, its investigational products and the conditions targeted, Coya’s significant partnership with Dr. Reddy’s Laboratories, and his goals throughout the next 5 years.
2024 Analytical Testing eBook - Providers Offer Versatile, Advanced & Expanded Services
Learn more about Stevanato Group and LGM Pharma in this exclusive Drug Development & Delivery annual Analytical Testing eBook.
2024 Respiratory Drug Development eBook – CDMOs Will Become More Essential to Inhalation Device Programs
In this fifth annual Respiratory e-book, learn more about several companies and their contributions to inhalation drug delivery and device design.
PLATFORM TECHNOLOGY - Antibody Oligonucleotide Conjugates (AOCs™) - Revolutionizing a New Class of Targeted RNA Therapeutics
Arthur A. Levin, PhD, highlights the first-ever successful targeted delivery of RNA to muscle in humans, a revolutionary advancement for the field of RNA therapeutics that may help transform the opportunities to advance research targeting many previously untreatable diseases in the years ahead.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Going Beyond the Science to Become True Partners
Contributor Cindy H. Dubin speaks with leading CDMOs about how they are adapting to bio/pharma client needs, their capabilities in handling complex molecules, and how they are transforming from specialist contractors to true partners.
FORMULATION FORUM - Advances in Drug Delivery by Antibody Drug Conjugates (ADCs)
Shaukat Ali, PhD, and Jim Huang, PhD, focus on two aspects of drug delivery through ADCs. One, where an antibody is conjugated via a ligand with functionalized LNPs carrying cytotoxic drugs; and two, where an antibody is conjugated directly with drug through a linker at the specific site.
AMORPHOUS SOLID DISPERSION SPECIATION - Impact of Polymer Chemistry & Drug Properties
Wesley K. Tatum, PhD, focuses on the use of in vitro techniques for characterizing ASD performance and on how these techniques can be used to help better understand the role of polymer chemistry in ASD performance.
EXECUTIVE INTERVIEW - Lonza: Navigating Today’s Challenges in Drug Solubility & Bioavailability
Adi Kaushal, Director and Technology Head, Bioavailability Enhancement at Lonza, discusses solubility and bioavailability challenges and Lonza’s approach.
DEVICE STUDY - Putting Auto-Injector Interchangeability to the Test
Alex Fong, MBA, says many factors need to be taken into account when deciding whether patients can successfully switch to a different drug delivery device because if patients struggle to cope with a new device, there is a risk they will miss out on vital doses of medication.
EXECUTIVE INTERVIEW - PCI Pharma Services: A Consultative Approach to High Potency Formulation Development
David O’Connell, Director of Scientific Affairs at PCI Pharma Services, explains how important it is to choose the right CDMO partner to accompany you throughout the drug product lifecycle.
THERAPEUTIC FOCUS - The Unmet Need of Agitation in Alzheimer’s Disease
Ram Mukunda, MS, and Evelyn Gutiérrez, and Claudia Grimaldi report on IGC-AD1, the first natural cannabinoid-based investigational drug to be tested in human FDA trials for the treatment of AD, which has shown promising results in treating agitation in Alzheimer’s patients.
CONTAINER PLATFORMS - Ready-to-Use Containers: Real Benefits, Important Challenges & Evolving Value
Gregor Deutschle and Gabriele Maier examine key benefits, dynamics driving the adoption of RTU container platforms, and several important areas of continuing evolution in the RTU market.
