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.
On-Demand Presentation: High Concentration Protein Suspensions: A Bevacizumab Case Study (>400 mg/mL)
Dr. Cindy Chung presents a case study demonstrating the development of high concentration bevacizumab suspension at up to 400 mg/mL for suitable subcutaneous delivery of the monoclonal antibody (mAb) therapy. Watch the presentation now to learn more.
DRUG-DEVICE DEVELOPMENT - Exploring the Complexities of Drug-Device Combination Products
Jeremy Guo, Senior Vice President at WuXi Biologics, and colleagues explain that many factors need to be taken into account when producing a Drug-Device Combination Product from development testing to fill/finish and assembly.
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….
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EXCLUSIVE WHITEPAPERS
Technical Brief: Mucoadhesive Polymers in Pharmaceutical Formulations
This technical brief will cover the use of polymers in a variety of dosage forms (buccal/sublingual tablets, liquid, semi-solid formulations, and oral care products) to impart mucoadhesion.
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….
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
Bespak & Orbia Fluor & Energy Materials Unite to Accelerate Transition to Climate-Friendly Inhalers
Bespak and Orbia Advance Corporation, S.A.B. de C.V. Fluor & Energy Materials recently announced a collaboration intended to accelerate the transition to climate-friendly inhalers utilising…
Lisata Therapeutics & Valo Therapeutics Announce Preclinical Research Collaboration
Lisata Therapeutics, Inc. and Valo Therapeutics Oy recently announce a preclinical research collaboration to investigate the benefits of combining Lisata's novel product candidate, certepetide, with…
SGS Expands Cutting-Edge Spray Drug Delivery Testing Capabilities in Belgium Health Science Laboratory
SGS has announced an expansion in its spray drug delivery testing capabilities at their laboratory in Wavre, Belgium. Utilizing the latest Malvern Spraytec system, SGS…
Rice Bioengineers Shed Light on Dosing Challenges for Cancer Immunotherapy
A team of Rice University bioengineers has developed a mathematical model that clarifies why interleukin-12 (IL-12) ⎯ a potent immune-boosting protein that holds promise for…
Sonnet BioTherapeutics Announces Patent Covering a Variant IL-18 Incorporated Into Two Novel Immunotherapeutic Candidates
Sonnet BioTherapeutics Holdings, Inc. recently announced the USPTO has issued US Patent No. 12,134,635 titled Interleukin 18 (IL-18) Variants and Fusion Proteins Comprising Same, covering two…
Transgene & ProBioGen Join Forces to Advance Individualized Cancer Vaccine Development
Transgene and ProBioGen recently announce they have entered into a license agreement for ProBioGen’s AGE1.CR.pIX suspension cell line. This partnership aims to add value by…
Nxera Pharma & Antiverse Enter Collaboration to Design Novel GPCR-Targeted Antibody Therapeutics Using Generative AI
Nxera Pharma and Antiverse recently announced a multi-target partnership and licensing agreement to design antibodies for G-protein coupled receptors (GPCRs). The collaboration combines Antiverse’s generative…
PrognomiQ Announces $34-Million Financing to Advance Development of Early Detection Test for Lung Cancer With Multi-Omics Platform
PrognomiQ recently announced its Series D financing of $34 million led by Seer, Inc., with participation from a new, large, strategic investor in the Diagnostics…
Nouscom’s Off-the-Shelf Neoantigen Immunotherapy Continues to Elicit Potent & Durable Immune Responses in Lynch Syndrome Carriers Highlighting its Potential to "Intercept" Cancer
Nouscom recently announced further promising data from the fully enrolled Phase 1b/2 study evaluating NOUS-209 for its potential to "intercept" cancer in Lynch Syndrome (LS)…
MannKind Successfully Completes Phase 1 Trial of Nintedanib DPI for Pulmonary Fibrotic Diseases
MannKind Corporation recently announced the successful completion of its first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF).…
EMA Confirms Acceptance of Marketing Authorization Application for a Proposed Biosimilar to Simponi
Alvotech and Advanz Pharma recently announced the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi (golimumab),…
Can-Fite Anti-Obesity Drug Received Patent Allowance in Australia
Can-Fite BioPharma Ltd. recently announced an update related to the intellectual property (IP) status of its lead drug candidate Namodenoson, currently being developed for the…
Conduit Pharmaceuticals Announces New Addition to its Autoimmune Pipeline
Conduit Pharmaceuticals Inc. recently announced the filing of two new patent applications relating to its lead clinical candidate, AZD1656, a HK-4 glucokinase activator licensed from…
SGS Announces Expansion of Biopharmaceutical Testing Capabilities
SGS recently announced it has added new capacity and capabilities at its center of excellence in Lincolnshire, IL. This expansion adds new instrumentation and expertise…
AbbVie to Acquire Aliada Therapeutics, Strengthening Focus in Alzheimer's Disease & Neuroscience Pipeline
AbbVie and Aliada Therapeutics recently announced a definitive agreement under which AbbVie will acquire Aliada, a biotechnology company advancing therapies using a novel blood-brain barrier…
Quotient Sciences & Medicines for Malaria Venture Announce Dosing of First-Ever Long-Acting Injectable for Malaria Prevention to Study Volunteers
Medicines for Malaria Venture (MMV) and Quotient Sciences have begun the first clinical trial for a long-acting injectable (LAI) preventive compound for malaria. The trial, conducted in healthy…
Intensity Therapeutics & The Swiss Group for Clinical Cancer Research SAKK Announce First Patient Dosed in the Randomized, Presurgical Triple Negative Breast Cancer Phase 2 Clinical Trial
Intensity Therapeutics, Inc. and The Swiss Group for Clinical Cancer Research SAKK are collaborating in the INVINCIBLE-4 Study, a Phase 2 trial to treat patients…
SGS Launches New Consultancy Services to Transform & Accelerate Clinical Trial Submissions
SGS, the world’s leading testing, inspection and certification company, recently launched its pioneering CDISC Open Rules Consultancy, a new service designed to transform and accelerate…
Curevo Presents Positive Shingles Vaccine Outcomes Data
Curevo Vaccine recently announced an upcoming oral presentation at the World Vaccine Congress in Barcelona of shingles case outcomes data from an 876-patient Phase 2…
Karyopharm Announces Favorable Change in Co-Primary Endpoint for Pivotal Phase 3 SENTRY Trial in Myelofibrosis
Karyopharm Therapeutics Inc. recently announced that, following feedback from the US FDA, it will be replacing TSS50, one of the co-primary endpoints in the Phase…
