DRUG DELIVERY - Advancements in Transdermal Delivery Systems: A Focus on Invisicare® Technology for Obesity Treatment
James A. Roszell, PhD, and Doreen McMorran demonstrate how this technology has demonstrated potential in the transdermal administration of glucagon-like peptide-1 (GLP-1) agonists and cannabinoid receptor type 1 (CB-1) antagonists, primarily targeting obesity management and other conditions requiring glucose regulation.
FORMULATION FORUM - Lyophilization Technology - An Enabler for Stable Formulations of Small & Large Molecules
Shaukat Ali, PhD, and Jim Huang, PhD, explain how lyophilization or freeze-drying technology is one of the ideal methods that leads to immobilization of drug and other components that remain in solid or powder state for extended periods without concerns of degradation, and how it has also been applied to improve drug solubility by means of amorphous solid dispersions.
ARTIFICIAL INTELLIGENCE - Deciding Whether to Automate With AI? 6 Key Practices to Consider
Dan Milczarski believes before deciding if or how to use AI in life sciences, it’s critical to weigh the pros and cons. There is a vital need to customize constantly evolving AI applications and innovations to create tailored, effective technologies that reflect life science organizations’ regulatory and organizational frameworks.
THERAPEUTIC FOCUS - Pushing Boundaries in Idiopathic Pulmonary Fibrosis Clinical Research
Laura Iliescu, MSc, and Justin Herman, MD, explore the changing landscape of IPF and how biopharmaceutical companies developing novel treatments can effectively navigate the emerging challenges in a rapidly evolving IPF landscape.
CONTROLLED RELEASE - How Advanced Excipient Knowledge is Shaping the Future of Controlled-Release Formulations
Matthias Knarr, PhD, and True Rogers, PhD, review the latest insights behind CR formulations using HPMC excipients and how HPMC substitution specifically can assist formulators in developing cutting-edge CR delivery systems with differentiated performance.
EXECUTIVE INTERVIEW - Respiratory Drug Development: Lonza Experts Share Trends & Key Takeaways
Beatriz Fernandes, Principal Scientist for R&D, and Kim Shepard, Director, Technology Head Respiratory Delivery, at Lonza, discuss their presentations at RDD 2024, current trends, and the future of the inhalation space.
TOPICAL DELIVERY - Direct Effects™ Perampanel (FYCOMPA®): First Topical Anticonvulsant to Treat Seizures, Headache & Other Symptoms in Epilepsy
Ronald Aung-Din, MD, Sasha Feygin, and Daniele La Rosa say Direct Effects topical perampanel is effective in treating headache and other neurological symptoms commonly encountered in patients with seizures and other conditions in which neuronal instability and hyper-excitability exist.
LYOPHILIZATION - Lyo 101: Challenges & Solutions in Lyophilization Cycle Development
Matt Bourassa says as companies continue to pioneer new molecules and treatments, molecule stability has emerged as a persistent detriment to every iteration, and increasingly, lyophilization is an attractive path to a sustainable, repeatable solution.
FORMULATION DEVELOPMENT - Practical & Purposeful: Creating Novel Compounds Via Rediscovery R&D & Cannabinoid Molecules
Mark Bleackley, PhD, says as time goes on, more companies will discover the benefits of drug repurposing – and how to successfully use such strategies to develop new, patentable drug products. In fact, repurposing could be exactly what’s needed to enable pharmaceutical and biotechnology companies to more swiftly develop treatments for indications with significant unmet medical needs.
SMI TECHNOLOGY - How Soft Mist Inhalers Support Improved Biopharma Drug Delivery
Nicolas Buchmann, PhD, explores the opportunities and challenges of developing biologic formulations for delivery via SMIs and discusses the importance and impact of partnerships between inhalation device development experts when it comes to facilitating the innovation needed to expand the suitability of SMIs to a wider range of biopharma formulations.
PRECLINICAL/CLINICAL STUDIES - Preclinical Toxicology vs Clinical: Key Considerations in Using Lipid-Based Formulations
Anette Müllertz, PhD, Grace Furman, PhD, and Lisa Caralli say developers should first understand the developability challenges for their molecule, then a toolkit of enabling technologies can be identified to overcome those factors and individually leveraged to create fit for purpose formulations for use in preclinical and clinical studies.
PLATFORM TECHNOLOGY - Developing Novel Antisense Oligonucleotides for Neurodegenerative Diseases
Scott Schobel, MD, and Nicole Datson, PhD, are hopeful their novel platform for targeting disease-causing RNA with multiple modulating approaches will lead to major advances in treating genetic disease and improving the lives of patients and their families in the years ahead.
SPECIAL FEATURE - Injection Devices: From Pens & Autoinjectors to Pills, Sprays & Capsules, Injections Become More Efficient
Contributor Cindy H. Dubin reports on innovative and promising injection technologies that are ever more user friendly, versatile, precise, and life-saving.
ARTIFICIAL INTELLIGENCE - Accelerating Drug Discovery & Development: The AI Revolution is Here
Emilio Cordova delves into how AI is transforming the drug discovery sector by enhancing predictability and efficiency and explains her company’s unique approach.
FORMULATION DEVELOPMENT - Solubility-Enhancing Technologies in Pharmaceutical Development, a Mini-Review
Timothy Pas, PhD, and Vincent Levet, PhD, believe different solubility-enhancing technologies can be used by developers, and with different advantages and drawbacks, linked to payload, manufacturability, tolerability, and physical and chemical stability, effectively navigating solubility-enhancing solutions is multifaceted.
EXPERT CONTENT & RESOURCES
Whether you're a researcher, a pharmaceutical professional, or simply interested in the latest advancements in drug development and delivery technology, you'll find a wealth of insightful expertise and current resources here.
Lonza: Utilizing Analytical Tools & Predictive Models to De-Risk Drug Development
Drug Development & Delivery recently interviewed Josh Marsh, Bioavailability Enhancement and PBPK Lead Scientist at Lonza, to discuss the benefits of predictive tools and Lonza’s approach.
MediWound Ltd.: Developing a New Class of Biologic Enzymatic Therapeutic Products to Debride Wounds
Drug Development & Delivery recently interviewed Ofer Gonen, Chief Executive Officer of MediWound, to discuss the company’s innovative approach to debridement.
CPHI Annual Report 2024: Drug Delivery Trends & Insights From a Device Perspective
Significant growth in the drug delivery sector is predicted for many areas, with headliners including cell and gene therapies and the GLP-1 blockbusters. Small molecule-based formulations still dominate innovator pipelines, but advanced biologics are also….
Gelteq: A Breakthrough Ingestible Gel Drug & Nutrient Delivery System
Drug Development & Delivery recently interviewed Nathan Givoni, Co-Founder and CEO of Gelteq, to discuss challenges with traditional drug delivery and the company’s innovative ingestible gel platform designed for drug and nutrient delivery.
BASF Article - Should Developers Choose a Cosmetic or Pharmaceutical-Grade Excipient?
As regulations continue to change around cosmetic and pharmaceutical-grade excipients, the pharmaceutical industry has choices to make when investing in quality, risk, and public safety.
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EXCLUSIVE WHITEPAPERS
WHITEPAPER - Unlock the Secrets of Spray Drying for Sticky APIs
It is widely reported that 40% of New Chemical Entities (NCEs) in the pharmaceutical industry are poorly soluble, leading to inadequate bioavailablity. Spray drying is one of the most promising particle engineering technologies….
WHITEPAPER - Versatility of Geleol™ Mono- and Diglycerides NF
Geleol exerts different functional roles, depending on the drug, formulation, and the process applied. It may serve as carrier and release modifier for oral formulations and plasticizer in tablet film coating processes. It may be combined with polymers and/or other non-digestible lipids like Compritol®….
WHITEPAPER - Efficient Development of Miniature Drug-Loaded Implants
Drug-eluting implants offer a unique approach to overcoming challenges associated with traditional drug delivery methods. They can provide sustained, continuous release of a therapeutic at…
WHITEPAPER - A Holistic Approach to Getting the First Batch Right
Mark Rauckhorst, director of supply chain and project management at leading, global contract development and manufacturing organization (CDMO) Vetter, will share his expert insights on how an outsource….
WHITEPAPER - Continuous Flow - An Emerging Alternative
In the whitepaper Continuous Flow: An Emerging Alternative, Curia experts discuss how continuous flow chemistry and processing offer an alternative pathway. The paper explores its….
EXCLUSIVE WEBINARS
WEBINAR - Lipid Nanoparticle (LNP) Characterization: Leveraging HPLC-CAD for Lipid Quantification Assay
Whether you’re involved in research, development, or quality control, this webinar will equip you with the knowledge and tools you need to enhance your analytical processes and ensure success in your LNP projects.
WEBINAR ON DEMAND: Advantages of Carbopol® Polymers in Oral Formulations
In this video, the Lubrizol team together with the IMCD US team takes you through formulation aspects of Carbopol® polymers as well as the results of a case study on an Acetaminophen oral suspension formulation.
WEBINAR - ABISOL Emulsion Preconcentrate Kit & ABISORB-DC Excipient System for Tableting Lipids
ABITEC Technical Business Director, John Tillotson, RPh, PhD, discusses ABITEC’s latest products: The ABISOL Emulsion Preconcentrate kit for the easy formulation of emulsified drug delivery systems and the….
WEBINAR - Development of Orally Delivered GLP-1 Therapeutics…From Diabetes to Obesity and Beyond
Join Quotient Sciences’ experts on July 18 as we explore the latest developments in orally-delivered GLP-1 agonists, the potential for these therapeutics and overcoming the manufacturing challenges.
WEBINAR - 2024 Trends in Topical Drug Delivery: Insights & Innovation
This webinar will discuss some of the key trends from these leaders in the topical market on both a global and regional level, including the increased importance of sensory properties and the rise in non-conventional product formats, among others…..
MARKET NEWS & TRENDS
Novadip Reports Promising Interim Results From First-in-Human Proof-of-Concept Trial of New Game Changer in Bone Field
Novadip Biosciences recently announced positive interim results from its first-in-human clinical trial, NVDX3-CLN01, assessing the safety and efficacy of NVDX3 to heal distal radius fractures…
Avacta Expands its Pipeline with Two Novel Assets Developed Using its pre|CISION Platform
Avacta Group plc recently announced the addition of two novel preclinical oncology assets, AVA6103 and AVA7100, to its pipeline of pre|CISION-enabled drug conjugates. Avacta is…
Immutep Announces First-in-Human Phase 1 Study of IMP761 Progresses to Dose Escalation Portion of Trial
Immutep Limited recently announced the first part (Part A, single dose) of the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761 has been fully recruited…
BioAegis Therapeutics Enrolls First Patient in Phase 2 Clinical Trial of Immune Regulator for Treatment of Acute Respiratory Distress Syndrome
BioAegis Therapeutics recently announced the first patient has been enrolled in the company’s Phase 2 study of rhu-pGSN for the treatment of Acute Respiratory Distress…
Biognosys Presents Major Innovations Across the Spectrum of Proteomics Research Applications
Biognosys recently announced its participation in the 23rd Human Proteome Organization (HUPO) World Congress from October 20 to October 24 in Dresden, Germany. The company…
mRNA Licensing Agreements Surge 800% in Value as Confidence Grows Beyond Vaccines
Messenger ribonucleic acid (mRNA)-based innovator pharmaceuticals saw a staggering 800% increase in licensing agreement deal values from 2019 to 2024YTD, driven by the remarkable success…
Cullinan Therapeutics Receives IND Clearance for CLN-978 Administered Subcutaneously in Patients With Moderate-to-Severe Systemic Lupus Erythematosus
Cullinan Therapeutics, Inc. recently announced the US FDA cleared the Company’s Investigational New Drug (IND) Application for CLN-978 and its global Phase 1 clinical trial…
OKYO Pharma Announces Start of Phase 2 Clinical Trial to Treat Patients With Neuropathic Corneal Pain
OKYO Pharma Limited recently announced that screening and recruitment of patients has started for a Phase 2 trial of OK-101 to treat NCP. The Phase…
IgGenix Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating IGNX001 in Peanut Allergy
IgGenix, Inc. recently announced the first patient dosed in its ACCELERATE Peanut Phase 1 clinical trial. The trial aims to evaluate IGNX001, a novel therapeutic…
Wave Life Sciences Announces First-Ever Therapeutic RNA Editing in Humans Achieved in RestorAATion-2 Trial of WVE-006 in Alpha-1 Antitrypsin Deficiency
Wave Life Sciences Ltd. recently announced positive proof-of-mechanism data from the ongoing Phase 1b/2a RestorAATion-2 study of WVE-006 in alpha-1 antitrypsin deficiency (AATD). WVE-006 is…
Cellular Origins & Fresenius Kabi Sign Development Agreement for Scalable Automation of Cell & Gene Therapy Manufacturing
Cellular Origins and Fresenius Kabi, an operating company of Fresenius, recently announced they have signed a development agreement that leverages each company’s expertise in cell…
GRI Bio Presents Positive Preclinical Data Demonstrating GRI-0621’s Ability to Inhibit Invariant Natural Killer T Cell Activity & Reduce Important Inflammatory & Fibrotic Drivers in Idiopathic Pulmonary Fibrosis
GRI Bio, Inc. recently announced the presentation of positive preclinical data demonstrating its lead program GRI-0621 reduces important inflammatory and fibrotic drivers in Idiopathic Pulmonary…
ProductLife Group Acquires Halloran to Further Expand Its Global Reach & Capabilities to Support Development of New Therapies
ProductLife Group (PLG) recently announced the acquisition of Halloran Consulting Group, further positioning PLG as a leading global provider of comprehensive healthcare services. Utilizing its 1,900+…
Lonza Completes Expansion of New Drug Product Services Facility in Basel (CH)
Lonza recently announced it has enhanced its drug product services offering by adding a new facility for quality control and bioanalytics at its DPS site…
Lipella Pharmaceuticals Announces Patent Allowance for Innovative Liposomal Drug Delivery Platform
Lipella Pharmaceuticals Inc. recently announced the receipt of a notice of allowance from the US Patent and Trademark Office (USPTO) for its proprietary liposomal drug…
Bespak & H&T Presspart Announce Availability of GMP Pilot Line for Low GWP pMDIs
Bespak, a specialist inhalation contract development and manufacturing organization (CDMO), and H&T Presspart, a market leader in the development, manufacturing and supply of inhaled drug…
Impact BioMedical Inc. Announces Issuance of Patent for Linebacker Technology Targeting Inflammatory Disease
Impact BioMedical Inc. recently announced a significant milestone in its innovative Linebacker technology platform. The Canadian Intellectual Property Office has issued Canadian Patent #3,024,728 titled…
Molecure & Ocean Biomedical Sign Exclusive Licensing Agreement for Development & Commercialization of Selective YKL-40 Inhibitors
Molecure S.A. recently signed an exclusive licensing agreement with Ocean Biomedical Inc. concerning the development and commercialization of the selective YKL-40 inhibitor program, including the…
LGM Pharma Expands Analytical Testing Services With New Endotoxin & Rapid Sterility Testing Capabilities
LGM Pharma recently announced today expansion of its Analytical Testing Services (ATS) with the addition of endotoxin and rapid sterility testing capabilities. These new services,…
Ocular Therapeutix Announces Accelerated Timelines for SOL-1 Registrational Trial of AXPAXLI in Wet AMD
Ocular Therapeutix, Inc. recently announced accelerated timelines for the SOL-1 Phase 3 registrational clinical trial of AXPAXLI in wet age-related macular degeneration (wet AMD). The…
