DRUG DEVELOPMENT - Human Challenge Studies in Vaccine Development January 7, 2016

Bruno Speder and Adrian Wildfire, MS, describe how the concept is being applied to help develop vaccines against a number of common diseases, including influenza, rhinoviruses, respiratory syncytial virus, cholera, malaria, dengue, and Salmonella typhi.

DRUG DELIVERY - EUDRACAP® Select - Examining a Case From Development to Clinical Trial February 29, 2024

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 - Using a Novel Deep Cyclic Inhibition Mechanism to Treat Broad Range of RAS-Mutant Cancers January 26, 2024

Ben Zeskind, PhD, addresses the question: rather than targeting individual RAS mutations and treating chronically, is it possible to achieve broad therapeutic activity in a way that focuses on malignant cells while minimizing damage to healthy cells?

CLINICAL TRIALS - The Power of AI in Overcoming Patient Diversity Challenges January 26, 2024

Isaac Bentwich, PhD, explores why patient diversity is such a challenge for clinical trials, where that pain is often felt the most, some of the regulatory, technological, and industry changes already underway to solve the clinical trial gap, and where AI changes the future of patient diversity.

Biora Therapeutics Announces Initiation of Phase 1 Clinical Study for Drug-Device combination Program January 8, 2024

Biora Therapeutics, Inc. recently announced initiation of its Phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers. BT-600 is a drug-device combination program consisting of the orally….

Artelo Biosciences Announces Selection of Worldwide Clinical Trials as CRO to Support First-in-Human Study January 8, 2024

LIPOSOMAL PEPTIDE THERAPEUTICS - Revolutionizing Oncology: Unleashing Innovative Strategies to Tackle Challenging, High-Value Drug Targets December 4, 2023

Natalia Zisman, Krishna Allamneni, PhD, and Stacy W. Blain, PhD, explain how targeting downstream signaling proteins offers a promising approach to effectively mitigate the emergence of drug resistance that precision oncology therapies leave behind.

PLACENTA-ON-A-CHIP - The Future of Drug Discovery In Women’s Health September 29, 2023

Hagar Labouta, PhD, presents how researchers continue to increase the complexity of their placenta-on-a-chip models and, as their research progresses, they are confident this technology will aid the development of novel therapies to treat a wide range of maternal and fetal conditions.

DEVICE DEVELOPMENT - Connected Auto-Injector Development: How to Leverage Human Factors Engineering September 27, 2023

Finola Austin examines the human factors process for such devices, including a detailed look at the recent development of the UniSafe® 1 mL auto-injector.

Biora Therapeutics Announces Submission of IND Application for BT-600 Program Featuring NaviCap Ingestible Drug Delivery Device September 25, 2023

NodThera Announces Positive First-in-Human Data for Two Brain Penetrant NLRP3 Inflammasome Inhibitors June 20, 2023

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Putting Customers First June 5, 2023

Contributor Cindy H. Dubin speaks with several leading CDMOs from around the globe on their unique development and manufacturing capabilities and technologies, and presents real-world examples of how they have put these to use to produce innovative compounds, lower development costs, and shorten time to market.

DRUG DEVELOPMENT - Overcoming Challenges on the Path From Candidate Selection to First-in-Human Clinical Testing June 5, 2023

Eleanor Row, PhD, explores the current challenges drug developers face in transitioning their candidate molecules to first-in-human (FIH) clinical trials, including what the different drug development functions should be considering at this stage, and how an integrated approach can help to accelerate your molecule’s pathway to trial and beyond.

DEVICE DEVELOPMENT - How to Ensure pMDI Drug Products Are Fit for the Future Market Landscape June 5, 2023

Ross Errington explores the latest developments in the pMDI segment and explains the steps pharmaceutical companies need to take to ensure their pMDI drug products are ready to thrive in a very different market environment.

SPECIAL FEATURE - Parenteral Drug Delivery: Could a Dose of AI Improve Development? May 1, 2023

Contributor Cindy H. Dubin speaks with several innovative companies to highlight the strides they are currently making toward improving dose accuracy, integrating design safety, and accelerating time to market.

LIPID-BASED EXCIPIENTS - Misconceptions About Lipid-Based Drug Delivery April 3, 2023

Rollie Fuller and Ron Permutt provide formulators confidence in using LBDDS as part of formulation development programs, by demonstrating their benefits and key functional mechanisms when used and addressing commonly misrepresented, misinterpreted, and misunderstood LBDDS topics.

PLATFORM TECHNOLOGY - An Alternative Solution for Peptide Drug Formulation April 3, 2023

Michael Neely introduces a unique technology platform and provides examples of how it has solved difficult formulation problems while adding significant commercial value to the resulting drug products.

ROUNDTABLE DISCUSSION - Which Trends Will Have the Most Impact on Drug Development in 2023? January 16, 2023

Contributor Cindy H. Dubin posed this question to life science leaders during a recent roundtable discussion, and one common theme is the focus on sustainability in pharmaceutical development.

FORMULATION DEVELOPMENT - Understanding CBD Formulation Versus Dosage Format January 16, 2023

Gerry McNally, PhD, says there are many misconceptions when it comes to considering the best way or format to consume CBD and get the maximum benefit. Formulation scientists need to consider several factors when developing new formulations of nutraceutical ingredients, especially botanical ingredients and natural materials from various sources.

PATIENTS-ON-A-CHIP - Why Artificial Intelligence Will Be the Tipping Point to Remove the Faulty Reliance on Animal Testing in Drug Discovery January 16, 2023

Isaac Bentwich, MD, believes Advanced Bio-AI platforms that integrate artificial intelligence and machine learning with patients-on-a-chip, real-time nano-sensing, and stem cell genomic diversity technologies are the future of drug discovery and development.