DRUG DEVELOPMENT - Understanding & Targeting the Mechanism of Action of Developmental Disorders March 1, 2021

Michael Snape, PhD, says when identifying promising therapeutic targets for any disease or condition, including developmental disorders such as Fragile X syndrome, PMS, CDM1, and Rett syndrome, it is critical researchers work to understand the mechanism of disease and disease pathways as well as the unmet need and patient experience.

SPECIAL FEATURE - Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis January 14, 2021

Contributor Cindy H. Dubin asked some of the key analytical testing providers to describe their offerings in several key areas and what advanced analytical testing techniques they can offer to pharma clients.

BIOSIMILAR DEVELOPMENT - Biosimilars: The Process & Quality System Approach to Clinical Applications January 13, 2021

Kaiser Aziz, PhD, addresses biosimilar developments and future innovations with an emphasis placed on quality system approaches to the development and availability of new biosimilar products.

FORMULATION FORUM - Age-Appropriate Pediatric Formulation Development November 23, 2020

Jim Huang, PhD, reviews how a pediatric formulation should consider the following factors: difference in physiological and pharmacokinetic of patient populations, dosage form selection, route of administration, dose accuracy, dose flexibility, drug and excipient tolerability (safety and toxicity), patient compliance (palatability/swallowability), stability, and drug accessibility.

PLATFORM TECHNOLOGY - Overcoming the Challenges of Drug Brain Delivery With a Novel Brain Delivery Vector November 23, 2020

Mei Mei Tian, PhD, explains how the xB3 platform has the potential to support development of treatments for CNS diseases that can treat thousands of patients in the years ahead.

VACCINE DEVELOPMENT - COVID-19 Vaccine Focusing on T Cells to Protect the Most Vulnerable November 23, 2020

Jeffrey Wolf, MBA, JD, says while most vaccines in development are targeted to protect healthy people, few are focusing on those who are most at risk – seniors and those with co-morbidities like heart failure, obesity, or type 2 diabetes.

CDMO CASE STUDY - AJILITY: Streamlining Drug Product Manufacturing October 1, 2020

Dustin Campbell says the AJILITY platform takes the burden off clients and allows his company to drive, manage, and support their drug product manufacturing, maximizing speed and success, while prioritizing these programs are driven to completion.

FORMULATION FORUM - Formulation Development Strategy for Early Phase Human Studies August 31, 2020

Jim Huang, PhD, says successful translation of discovery compounds into first-in-human and first-in-patient is one of the key challenges facing the pharmaceutical industry, and to achieve this, a rational formulation development strategy will be critical to avoid costly development failures, while speeding up the development timeline in a cost-effective manner.

DRUG DEVELOPMENT - Bringing New Drugs to Patients Faster by Integrating Traditionally Separate Pharma Development Functions August 31, 2020

Nutan Gangrade, PhD, says reducing R&D project timelines saves on overhead in development while increasing the likelihood of primacy in the marketplace (which engenders significantly more sales) and describes new approaches drug developers are taking to streamline drug development.

DEVICE DEVELOPMENT - Mapping the Regulatory Strategy to Better Navigate Electronic Drug Delivery Device Development for Patient Safety & Security August 31, 2020

Ahmed Mallek, Hadrien Gremillet, and Audrey Chandra say that along with technology advancement in the medical industry, the behaviors and needs of different stakeholders also evolve, resulting in a clear interest in electronic drug delivery devices for a variety of reasons.

COMBINATION PRODUCTS - Development Challenges & Solutions August 31, 2020

Tom McLean says combination drug development pipelines continue to rapidly expand and diversify with differentiated molecules and formulations, which can call for nuanced as well as significant packaging and delivery system requirements.

EXECUTIVE INTERVIEW - Nuritas Pharma: Life Changing Peptide Drug Discoveries for a Changing World August 31, 2020

Nora Khaldi, PhD, Founder and Chief Executive Officer of Nuritas, discusses the company’s innovative approach to accelerating the discovery of novel therapeutic peptides that address unmet patient needs in multiple disease areas.

BioAge Discovers Key Pathway & Identifies Promising Phase 2-Ready Drug to Treat & Reverse Immune Aging, a Root Cause of COVID-19 Morbidity & Mortality in Older Patients August 26, 2020

2020 Respiratory Drug Development eBook – Inhaled Medications for Treating Unconventional Respiratory Diseases June 30, 2020

This second annual Drug Development & Delivery Respiratory eBook focuses on a few companies that are taking inhalation devices to a new level in drug delivery.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules June 4, 2020

Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.

GENE THERAPY - The Role Viral Vectors Play in Current Gene Therapy Development June 4, 2020

Dieter Lingelbach, MBA, discusses the history and science of viral vectors, their current applications, and why they are a vital component in contemporary gene therapy development.

FORMULATION FORUM - Rational Design of Oral Nanosuspensions for Insoluble Drugs June 3, 2020

Jim Huang, PhD, explains how nanosuspensions are an important class of pharmaceutical dosage forms, particularly for pharmaceutical compounds with solubility and bioavailability challenges.

SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions May 5, 2020

Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.

BIOSIMILAR DEVELOPMENT - Biosimilar Biological Products: Development & Applications March 2, 2020

Kaiser J. Aziz, PhD, provides an in-depth overview of biosimilar products development and the evaluation criteria for FDA approval.

OLIGONUCLEOTIDE DELIVERY - Dectin-1 Receptor-Mediated Delivery of Oligonucleotide Drugs Complexed With Schizophyllan Dendritic Cells & Macrophages January 13, 2020

Kenji Arima, PhD, and Akihiko Watanabe, PhD, introduce NapaJen Pharma’s technology with a specific focus on solving some of the current challenges of oligonucleotide therapeutics.