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.
CELL SEPARATION TECHNOLOGY - Breaking Down Barriers to Unlock a New Era of Cell Therapy
Dr. Liping Yu believes revolutionary cell separation technologies are crucial for enabling these rapid advancements, and will continue to play a growing role in establishing the decentralized, rapid, and cost-effective large-scale manufacture of potentially life-saving cell-based drugs well into the future.
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.
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EXCLUSIVE WHITEPAPERS
CASE STUDY - Overcoming Barriers to Patient Adherence With A Novel Dosage Form
In this CPHI Award-winning case study, learn how Adare scientists took the alternative sprinkle version out of the lab and into the hands of patients.
ARTICLE - A New Framework for Identifying Nitrosamine Risks & Efficiently Derisking Products
Adare’s team of nitrosamine experts have developed a straightforward framework that simplifies the identification of at-risk APIs.
WHITEPAPER - Concept to Commercialization: The Role of CDMOs in Driving Innovation Through Phase-Appropriate Technology Transfers
This whitepaper explores the various types of technology transfer from preclinical to commercial stages and successful strategies to foster innovation.
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. The basic mechanism of mucoadhesion and methods to evaluate it in the context of…
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….
EXCLUSIVE WEBINARS
WEBINAR: Introducing Key Concepts in Tableting Research: Unleashing Essential Concepts and Strategies for Enhanced Formulation Development
Tableting can present a series of challenges, particularly when dealing with formulations that have poor flowability, low compressibility, or high cohesivity. These issues can lead to manufacturing inefficiencies….
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
CERo Therapeutics Appoints Chris Ehrlich CEO
CERo Therapeutics Holdings, Inc. recently announced its Board of Directors has appointed Chris Ehrlich as CEO. Previously he held the position of Interim CEO. Mr.…
Exclusive UniSafe Distribution Agreement Between Owen Mumford & NIPRO Exceeds Expectations in Japan With New Biosimilar Launch
Owen Mumford, a global leader in medical devices, recently announce its exclusive agreement with Osaka-based NIPRO CORPORATION (NIPRO) to distribute drug delivery device UniSafe® has…
World’s First Zero-Off-Target Base-Edited NK Cell Therapy Receives IND Approval in Both China & US
Base Therapeutics recently announced its NK510 cell injection, the world’s first zero-off-target base-edited NK cell product, has received IND approvals from both the US FDA…
TILT Biotherapeutics Provides Update on International Clinical Trial Progress With Intravenous Delivery Regimen for Cancer Immunotherapies
TILT Biotherapeutics (TILT) recently announced it will be presenting data at the European Society of Medical Oncology Immuno-Oncology Congress (ESMO-IO) 2024. The oral presentation discloses…
Groundbreaking Cretostimogene Grenadenorepvec Monotherapy Data Demonstrates Sustained, Durable Complete Responses in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
CG Oncology, Inc. recently announced topline data from the Phase 3 BOND-003 trial in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus…
Denali Therapeutics Announces First Participant Dosed in Phase 2a Study of LRRK2 Inhibitor, BIIB122, in LRRK2-Associated Parkinson’s Disease
Denali Therapeutics Inc. recently announced initiation of dosing in a global Phase 2a clinical study, BEACON, of the investigational drug leucine-rich repeat kinase 2 (LRRK2)…
Samabriva Accelerates its Growth With New State-of-the-Art Biomanufacturing Facility
Samabriva recently announced the opening of a new 1,400 m² biomanufacturing facility in Liege, Belgium, at the heart of European’s biotech valley. This strategic investment…
Tiziana Life Sciences Expands Phase 2 Clinical Trial for Non-Active Secondary Progressive Multiple Sclerosis to Additional Prestigious US Medical Centers
Tiziana Life Sciences, Ltd. recently announced the expansion of its Phase 2 clinical trial evaluating intranasal foralumab for non-active secondary progressive multiple sclerosis (SPMS). The…
8 Years Survival With Complete Cure for a Patient With Advanced Liver Cancer Being Treated With Namodenoson Drug
Can-Fite BioPharma Ltd. recently announced a patient currently treated with Namodenoson in a compassionate use program in Can-Fite’s Phase 2 Liver Cancer Study has an…
Amarna Therapeutics Partners With NorthX Biologics to Advance Gene Therapy Development
Amarna Therapeutics recently announced its strategic collaboration with NorthX Biologics, a leading biologics manufacturing partner. This partnership represents a major step in advancing the clinical…
SGS Laboratory in Ireland Gains Platinum My Green Lab Certification
SGS, the world’s leading testing, inspection and certification company, is proud to announce that its laboratory in Ringaskiddy, Cork, Ireland, has received platinum certification under…
Medigene Receives Milestone Payment from Regeneron Pharmaceuticals
Medigene AG recently announced a $1 million milestone payment from Regeneron Pharmaceuticals, Inc. was triggered. Regeneron purchased the MAGE-A4-TCR program as part of its acquisition…
Roivant Announces Topline Results From Phase 2 RESOLVE-Lung Study of Namilumab in Chronic Active Pulmonary Sarcoidosis
Kinevant Sciences recently announced its Phase 2 study failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. The Phase 2 RESOLVE-Lung study…
Coherus Announces Agreement to Divest UDENYCA Franchise for up to $558 Million to Intas Pharmaceuticals Ltd.
Coherus BioSciences, Inc. recently announced it has entered into an asset purchase agreement (the Agreement) dated December 2, 2024, with Intas Pharmaceuticals Ltd. (Intas) for…
Palisade Bio Announces Preliminary Data From Phase 1 Clinical Study for the Treatment of Moderate-to-Severe Ulcerative Colitis Appears to be Safe & Well Tolerated
Palisade Bio, Inc recently announced preliminary results from its first three single ascending dose (SAD) cohorts in its ongoing Phase 1 human clinical study for…
Kairos Pharma Adds City of Hope Cancer Center for Phase 2 Clinical Trial
Kairos Pharma Ltd. recently announced the addition of City of Hope Cancer Center in Duarte, California to the Phase 2 clinical trial for ENV105 for…
Recursion Announces First Patient Dosed in Phase 1/2 Clinical Study of a Potential First-in-Class RBM39 Degrader for Biomarker-Enriched Solid Tumors & Lymphoma
Recursion recently announced the first patient has been dosed in its Phase 1/2 clinical trial of REC-1245, a new chemical entity for the treatment of…
Lonza Launches Tailored Offering for Smart Capsules Companies Developing Oral Delivery Solutions for Biologic Drugs
Lonza, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, recently announced an expansion of its service offering for orally delivered biologic therapies…
Veranova Recognized as One of SOCMA’s 25 Companies for Industry-Leading Safety Programs
Veranova recently announced it has been recognized by The Society of Chemical Manufacturers & Affiliates, Inc. (SOCMA) as a recipient of its prestigious 2024 Safety…
Olema Oncology Announces New Clinical Trial Collaboration & Supply Agreement
Olema Pharmaceuticals, Inc. recently announced a new clinical trial collaboration and supply agreement with Novartis in frontline metastatic breast cancer. Olema has also entered into…
