Search Results for: DRUG DEVELOPMENT Human Challenge Studies
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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.
Roivant & Pfizer Form New Vant Company Focused on Developing TL1A Drug Candidate for Inflammatory & Fibrotic Diseases December 1, 2022
Roivant to develop PF-06480605 (now RVT-3101), a potential first in class, fully human monoclonal antibody that blocks tumor necrosis factor-like ligand 1A (TL1A), a cytokine believed to play a key role in inflammation and fibrosis ….
EXECUTIVE INTERVIEW - Credence MedSystems: Implementing a Flexible Manufacturing Line to Deliver Innovation in Drug Delivery to the Pharmaceutical Industry October 3, 2022
Jeffrey Tillack, Chief Operating Officer at Credence MedSystems, discusses the challenges being addressed by his innovative technology and the role its new Flex Line will play in the company’s scaling strategy.
SPECIAL FEATURE - Injection Devices: Three Trends Influencing Development & Delivery September 1, 2022
Contributor Cindy H. Dubin showcases in this annual feature how various innovative device manufacturers are addressing the current trends in their injection designs.
SOLUBILITY ENHANCEMENT - How Microparticles are Opening Doors to New Solutions for Oral Drug Delivery August 31, 2022
Jessica Mueller-Albers, PhD, Yiming Ma, PhD, Alexander Bernhardt, PhD, and Michael Damm review the use of microparticles for solubility enhancement of oral small molecules and how this approach can address the challenges in pharmaceutical formulations.
2022 Respiratory Drug Development eBook - Demand Accelerates Devices July 8, 2022
This fourth annual Drug Development & Delivery Respiratory eBook highlights the pMDI development path, as well as the importance of a holistic approach to that development that includes the patient and all stakeholders across the product’s life cycle.
Exavir Therapeutics Announces Preclinical Data for Ultra-Long-Acting Dolutegravir Prodrug XVIR-120 June 9, 2022
Exavir Therapeutics recently announced the publication of preclinical data for XVIR-120, an investigational agent being developed as a long-acting injectable antiviral for HIV….
SPECIAL ROUNDTABLE - Which Trends Will Have the Most Impact on Drug Development in 2022? June 6, 2022
Drug Development & Delivery posed this question to life science leaders during a recent roundtable discussion. While their responses are varied, a common theme is that COVID-19 has left a lasting impact on the industry….
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product June 1, 2022
Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.
AUTOINJECTOR TECHNOLOGY - De-risking Biosimilar Development With a Clinically Validated & Commercially Proven Disposable Autoinjector June 1, 2022
Victoria Meyer, MBA, explains how for many biopharmaceutical customers, BD and the BD Physioject™ Disposable Autoinjector have offered the appropriate combination of technology, documentation, and resources required for timely success.
CLINICAL TRIALS SOLUTIONS - Cracking Down on the Rising Costs of Drug Development: How Pinpointing the Complexity of Individual Patients Can Improve Success Rates June 1, 2022
Dominique Demolle, PhD, and Erica Smith, PhD, say taking a more holistic, patient-centric approach by considering patients’ individual psychology, perceptions, and beliefs provides drug developers the opportunity to quantify these interpersonal differences between patients and address this source of variability in data analysis and interpretation.
SPECIAL FEATURE - PFS & Parenteral Drug Delivery: Self-Injection is Very Much the “New Normal” May 2, 2022
Contributor Cindy H. Dubin showcases how leading CDMOs and drug delivery developers are responding to current market trends to create ergonomic technologies that are patient friendly, easy to use, reduce needle anxiety, and feature improved packaging materials.
Lonza Early Development Services & Integral Molecular to Offer Complementary Expertise to Enhance Early De-Risking of Biotherapeutics April 25, 2022
Lonza and Integral Molecular recently announced a strategy to offer complementary expertise to their respective customers to better assess the...FORMULATION FORUM - Oral Formulation Approaches for Different Stages of Clinical Studies April 4, 2022
Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.
DRUG DEVELOPMENT - The Promise of Cutting-Edge Microbiome-Based Therapeutics March 1, 2022
Andrew Thomson, Brian Carpenter, and Robert Broadnax focus on how developers must strategically address and overcome specific challenges to successfully drive development and eventual adoption of microbiome-based therapies.
NASAL DELIVERY - Improving Nasal Drug Delivery With Permeation Enhancing Technology March 1, 2022
Stuart Madden, PhD, focuses on the use of alkylsaccharides as absorption enhancers for nasal delivery of a wide range of drug types.
FORMULATION DEVELOPMENT - Impact of Excipients & Manufacturing Process on Solubility-Enhanced Ritonavir Tablet Size & Weight Reduction March 1, 2022
Gayatri Khanvilkar, MPharm, Ajit Bhagat, and Tejas Gunjikar, PhD, investigate bulking agents and disintegrants to develop efficacious Rotonavir tablets with improved in vitro release.
Gracell Doses First Patients in First-in-Human Clinical Trial of Dual-Targeting CAR-T Therapy February 17, 2022
Gracell Biotechnologies Inc. recently announced it has dosed multiple patients in a clinical trial evaluating GC012F, the company's autologous CAR-T...Berkshire Sterile to Offer Formulation, Lyophilization & Method Development Services February 9, 2022
Berkshire Sterile Manufacturing (BSM) MA, has recently added formulation, lyophilization, and method development capabilities to complement their clients’ drug productions…..