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.
PAN-VARIANT INHIBITORS - How Pan-Variant Inhibition Can Outsmart Cancer Treatment Resistance
Tim Clackson, PhD, says the goal in targeted oncology is to achieve pan-variant inhibition and, ideally, pan-variant inhibition should be accomplished with a single agent, avoiding the potential complications and toxicities of drug combinations.
(e-Book) Finally, a Complete Guide to Aseptic Manufacturing
Get ready to elevate your aseptic manufacturing game with this complete guide! All the info you need is within this must-have e-Book.
MARKET REPORT - Survey Suggests Global Innovation to Recover Much More Quickly Than Expected in 2023
After a brief fall in 2022 to a score of 6.5 – the first decline since its inception in 2018 – the index has surged to a record score of 7.4. This sudden recovery in scores over a little more than 8 months bodes extremely well for device and packaging manufacturers in the year ahead, suggesting a strong global recovery in industry outlook and confidence.
(e-Book) Lyophilization Trends in Pharma & Biopharma Drug Development
This 30-page eBook is exactly what you have been looking for. Find out what is driving the lyophilization market and how working with a CDMO will save time and money and help you comply with increasing regulatory requirements.
SPECIAL FEATURE - Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
FORMULATION FORUM - Sterile & Non-Sterile Formulation Capabilities - A CDMO Perspective
Jim Huang, PhD, and Shaukat Ali, PhD, explain how their company is expanding its footprints in sterile manufacturing to handle innovative molecules and leverage its services to emerging and specialty and biopharma companies requiring cGMP materials for preclinical tox and clinical studies.
DRUG-ELUTING IMPLANTS - Sustained-Release Implants - A Targeted Approach to Drug Delivery
Tom Quinci, MSc, believes oncology requires new treatment modalities that are better for patients, and it is time technologies like drug-eluting implants, offering real, achievable advantages, are more widely considered.
ROUNDTABLE DISCUSSION - Which Trends Will Have the Most Impact on Drug Development in 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.
FUNCTIONAL EXCIPIENTS - Improving the Water Solubility of Oral Drugs With Amorphous Solid Dispersions (ASDs)
Liliana Miinea, PhD, says with certain polymers, it is possible for drug formulators to take full advantage of the benefits of ASDs, enabling them to overcome formulation challenges to deliver more effective novel drug products capable of transforming the lives of patients.
CLINICAL TRIALS - Historical Controls in Rare Disease Drug Development: Using RWE to Overcome Key Challenges
William Maier, MD, PhD, says the utility of HCs based on RWE should be evaluated for potential applications to increase speed of product approval, reimbursement, and clinical practice adoption.
