INFLAMMASOME INHIBITORS - 21st Century Miracle Drugs: Spotlight on Clinical NLRP3 Inflammasome Inhibitors
Bryan Oronsky, PhD, says traditionally, pharmaceutical development is based on the “magic bullet” concept of “one drug, one target, one disease.” However, with the growing realization that chronic inflammation lies at the center of many, if not all, diseases, it is possible to envision inflammasome inhibitors, which reduce or prevent inflammation, as near-universal treatment panaceas.
SPECIAL FEATURE - Excipients: Their Future Could Lie in Generics
Contributor Cindy H. Dubin highlights the innovative work being done by several leading companies and exemplifies the importance of excipients to the future of drug development.
FORMULATION FORUM - Tackling Challenging Molecules by Spray Drying: Making the Impossible Possible
Jim Huang, PhD, and Shaukat Ali, PhD, focus on spray drying technology with special reference to polymers and solvents selection, processing conditions, and the challenges with downstream manufacturing, stability, and degradation of APIs in oral dosages.
EXECUTIVE INTERVIEW - PCI Pharma Services: The Global, Integrated CDMO Partner of Choice
John Ross, Senior Vice President of Development and Manufacturing at PCI Pharma Services, discusses what it means to be the partner of choice in a very dynamic industry.
MICROCRYSTALLINE CELLULOSE - N-nitrosamine Risk Assessments for Oral Dosage Forms
Takako Koyamatsu, Shohei Mikami, PharmD, Obata Kenji, and Julia Shmyrova show how Ceolus™ demonstrated a very low level of nitrite and nitrate that can allow mitigating nitrosamine formation in the drug products with secondary or tertiary amines.
DRUG-ELUTING IMPLANTS - Delivery of RNAi Therapeutics Through Drug-Eluting Implants
Cyonna Holmes, PhD, Karen Chen, MS, and Brian Wilson, PhD, review how localized therapeutic delivery of these therapies through an implant provides an innovative route of administration for chronic conditions that are difficult to dose adequately.
MARKET TRENDS - The Year of Resilience & Flexibility: Six Smart Ways CDMOs Are Preparing for 2023
Carsten Press says with biopharma businesses weathering one unexpected shift after another, it’s no surprise these organizations are looking to their partner networks for one thing above all: the flexibility they need to maximize their own business resilience.
LIPID-BASED EXCIPIENTS - Misconceptions About Lipid-Based Drug Delivery
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.
BIOAVAILABILITY ENHANCEMENT - Solving Low Solubility Challenges to Optimize Drug Delivery Platforms
David K. Lyon, PhD, discusses how low aqueous solubility NCEs have come to define the innovative pharmaceutical pipelines and how advanced technologies are often required to overcome this issue.
PLATFORM TECHNOLOGY - An Alternative Solution for Peptide Drug Formulation
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.
EXECUTIVE INTERVIEW - ICON: Transforming Clinical Trials in a Rapidly Shifting Landscape
Ute Berger, MD, President, Development & Commercialization Solutions at ICON plc, discusses how with the acquisition of PRA in 2021, it has enhanced its value proposition and how it is transforming clinical trials in a rapidly shifting landscape.
SPECIAL FEATURE - Solubility & Bioavailability: Difficult Beasts to Tame
Contributor Cindy H. Dubin highlights the services many of these outsourced providers offer to enhance solubility and bioavailability and get their clients’ projects to market faster and cost effectively – while maintaining critical quality attributes.
DELIVERY TECHNOLOGY - NeuroDirect™ Ketamine: Novel, Non-Systemic Topical Therapy for PTSD & Associated Intractable Depression
Ronald Aung-Din, MD, and Chantelle G. Martin, MBChB, present scientific data demonstrating how with NeuroDirect technology, the benefits of psychedelic compounds may be achieved without concern for their potential systemic effects.
EXECUTIVE INTERVIEW - Purple Biotech Ltd.: Developing First-In-Class Oncology Therapies
Gil Efron, Chief Executive Officer of Purple Biotech, discusses the company’s focus on identifying and developing promising molecules that may offer first-in-class approaches to treating devastating cancers with large unmet medical needs.
FORMULATION FORUM - Changing the Landscape of Nanoparticles for Long-Acting Injectable Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, say recently, there has been continued interest in parenteral NPs with sustained-release characteristics as more drugs discovered are poorly soluble and less bioavailable, and these challenges have led to enormous opportunities and launch of many drug products to market.
MARKET TRENDS - Emerging Trends in Injectable Drug Formulation & Delivery
Martin Gonzalez, PhD, details current trends in sterile injectable formulations and delivery devices and highlights the challenges pharma and its CDMO partners are facing bringing emerging parenteral breakthroughs to patients.
SUSTAINABILITY - Is the Pharmaceutical Industry Preparing Effectively for a Greener Future?
Michael Earl reviews 25 of the biggest pharma companies reporting environmental, social, and governance (ESG) scores to see how the industry is performing.
AUTOMATED SOLUTIONS - Automation & Shared Knowledge Pave the Way Into the Future
Luca Valeggia says by no means is automation a novel concept for most research labs, but its swift advancement and expansion into new fields such as synthetic biology have shown us that we are only witnessing the start of what is possible.
EXTRACTABLES & LEACHABLES - Detecting the Unknown With Extractables & Leachables Analysis
Derek Wood, Xiaochun Yu, PhD, and Aaron Lamb review how a new generation of extraction, identification, and quantification tools, now recognized as approved methods by regulatory bodies, are changing the E&L testing landscape.
CLINICAL TRIALS - New Technology & the Global COVID Pandemic Drive the Need for More Decentralized Trials
Suhas Gudihal, MS, MBA, explains how the COVID-19 pandemic has accelerated the ongoing shift to remote clinical trial monitoring, and remote site access and monitoring platforms are now an essential element of the clinical trial process and a vital connection between the sponsor, CRO, and research site.
