EXECUTIVE INTERVIEW - From Data Collection to Data Provenance: Building More Traceable Infrastructure for Decentralized Trials
Cecilia Xi, VP of Clinical and Scientific Affairs at Vivalink, explains why data provenance, vendor oversight, and long-term governance matter more than data collection as decentralized trials scale.
SPECIAL FEATURE - Excipients: Strategic Enablers of Innovation
Ahead of CPHI, Cindy H. Dubin learns from leading excipient suppliers how multi-functional and organic excipients are impacting novel formulations and how AI is becoming a valuable tool in formulation development.
SPECIAL REPORT - Excited About Excipients?
Kurt R. Sedo and Cindy H. Dubin take a deep dive into the excipient market, highlighting how new excipients enable advanced drug products and how AI and computation tools are helping match excipients to APIs.
FORMULATION FORUM - Oral Delivery of Nanocrystal Suspensions
Dr. Shaukat Ali and Dr. Jim Huang shed light on the challenges and opportunities to improve solubility and enhance oral bioavailability of molecules in nanocrystals or crystalline suspensions.
DRUG DELIVERY - Powder to Patient: Advancing Reconstitutable Injectables Through Integrated Aseptic Powder Filling & Next-Generation Dual Chamber Delivery
Laxman Halleppanavar and David Phasey offer a focused perspective on connecting formulation, particle engineering, aseptic manufacturing, device design, and patient use within one scalable development pathway.
SILICONE CHEMISTRY - Modification of Silicone Chemistry & Its Influence on Release Rates of APIs
Matthew Kihara explains how silicone lends itself to optimization, customization, and therapeutic performance, and that modifying silicone chemistry presents an opportunity to optimize drug release behavior and system performance.
VACCINE TECHNOLOGY - Delivering Better Global Vaccination Programs by Removing the Needle, Syringe & Fridge
Robin Cohen says that novel vaccine technology does not relate simply to the antigen, but also to method of administration and route of delivery, stressing that removing needle, syringe, and refrigerator are a step toward better vaccination programs.
EXECUTIVE INTERVIEW - Lonza: From Formulation to Scale-Up: Advancing Dry Powder Inhalation for Biologics
Dr. Kim Shepard and Dr. Beatriz Fernandes talk about the evolving respiratory delivery landscape, the technologies shaping the field, and development strategies for addressing formulation while initiating risk mitigation.
CONTROLLED RELEASE - Alginate Beads for Oral Drug Delivery: Formulation Strategies for Controlled Release & Enhanced Bioavailability
Vardan Ter-Antonyan, Casey Kikendall, and John Davis review the formulation principles governing calcium alginate bead performance and discuss the relationship between bead structure and controlled release.
ARTIFICIAL INTELLIGENCE - AI Has Transformed the Pharmacovigilence Landscape
Raj More surveys the field of AI tools and looks at some emerging trends as well as factors that will influence the development of these platforms.
EXECUTIVE INTERVIEW - Bone Biologics Corp.: Recombinant Protein Development in Engineering Active Orthobiologics & Targeted Bone Therapies
Jeffrey Frelick describes how Bone Biologics’ lead proprietary recombinant human protein is addressing the challenge of balancing strong bone growth with patient safety.
LIFE SCIENCE PERSPECTIVE - A Validated Modality Changes the Equation
Kelly Page shares her personal perspective on taking therapeutic modalities across the finish line and how she applies what she learns into future programs to turn scientific progress into improved patient outcomes.
SPECIAL FEATURE - Injection Devices: Advancements Converge to Expand Patient Possibilities
Cindy H. Dubin speaks with injection device developers about creating devices that are intelligent, intuitive, patient-centric systems that make advanced therapies easier, safer, and more accessible to use at home.
ARTIFICIAL INTELLIGENCE - AI/ML Supporting Biomarker & Target Discovery
William Whitford explains how Artificial Intelligence/Machine Learning provide new capabilities in analyzing the rapidly increasing type and amount of biological data employed in identifying potential biomarker and disease targets.
EXECUTIVE INTERVIEW - Portal Instruments: Beyond Springs – Portal Prime Nexus™ Autoinjector is a Versatile Solution for Biologics
As biologics become larger, more viscous, and more complex, software offers a fundamentally better way to control and optimize delivery.
Expert Insights Videos
Go beyond the written word with our new podcast series, featuring in-depth conversations with industry leaders shaping the future of drug development and delivery. Each episode explores real-world challenges, emerging technologies, and the insights driving innovation across the pharmaceutical landscape.
The Future of Excipients in Drug Development: AI, Lipids & Next-Generation Formulation Strategies
Excipients are playing an increasingly important role in solving some of today’s most complex drug formulation and delivery challenges. Explore the latest trends shaping excipient and formulation development.
Oral Peptide Drug Delivery: Overcoming Bioavailability & Formulation Challenges
The pharmaceutical industry is increasingly exploring oral delivery as an alternative to injections for peptides, proteins, oligonucleotides, and other complex molecules—but significant formulation and biological…
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.
Industry Education: Credence MedSystems - Insights on Solving Injectable Drug Delivery Challenges
As injectable therapies evolve, so do the challenges of delivering them. Credence MedSystems has launched the Industry Education home on our website where we share practical perspectives on important topics in injectable drug delivery, including larger-volume prefilled syringes, precision intravitreal dosing, dual chamber delivery and other emerging drug delivery challenges.
The New Consumer Health Landscape: High Growth, High Expectations
Over the past few years, several major pharmaceutical companies have carved out or spun off their consumer healthcare (CHC) divisions, creating standalone organizations with the scale and scientific heritage of pharma but the commercial ambitions of fast-moving consumer brands. High-profile examples include Kenvue from Johnson & Johnson, Haleon from GSK and Opella from Sanofi, moves intended to unlock greater focus, agility and capital efficiency in businesses that operate under different market dynamics from prescription pharmaceuticals.
Monoclonal vs Polyclonal Antibody Production
Antibody-based therapeutics have reshaped modern medicine. With demand soaring, choosing the appropriate production path can save months and millions.
Case study: Modeling polymor interactions to improve amorphous dispersion design
In this case study, OSDPredict™ narrowed formulation options early, focusing development on the most viable strategies which reduced experimental burden and conserved valuable materials.
The Last Mile of Digital Implementation: A Technical Framework for Turning Clinical Technology Adoption Into Measurable Value
As clinical trials become increasingly digitally enabled, organizations must look beyond successful technology deployment to determine whether new tools are delivering measurable value. This article presents a five-layer framework for evaluating technical fitness, workflow integration, adoption, data reliability, and operational outcomes to help translate clinical technology investments into better trial execution and evidence.
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WHITEPAPERS & WEBINARS
WEBINAR - Revolutionize API formulation with AEROPERL® 300 Pharma – Unlocking solubility challenges
Poor aqueous solubility is a key barrier for a growing share of new drug candidates, limiting their bioavailability and development potential. Evonik’s AEROPERL® 300 Pharma excipient helps formulators improve the solubility and bioavailability of poorly water-soluble APIs. Join presenter Carolina Mathias, Senior Applied Technical Manager at Evonik Smart Effects, on Thursday, November 26 at 9:00 a.m. CET for first-hand formulation guidance.
WHITEPAPER - Large-Scale LNP Process Conversions
Large-Scale LNP Process Conversions: The many hurdles of LNP scale-up and what to consider Lipid nanoparticle (LNP) formulation development begins on a small scale, often…
WEBINAR - Challenges of Sustained Release Drug Delivery Devices
Sustained release drug delivery is rapidly expanding across respiratory, ophthalmic, transdermal, and implantable applications, but translating products from development to manufacturing remains both complex and…
WHITEPAPER - Streamlined Product Development Leveraging Pharmaceutical Classification Models
A technology agnostic approach based on a fundamental understanding of API properties, a well-defined yet flexible target product profile, and a mindset for scalability and…
WEBINAR ON DEMAND - Heat Without Harm: The Reality of Hot Melt Extrusion Webinar
In a 2025 industry survey (1), 76% of respondents selected ‘risk of thermal degradation’ as a source of hesitation to pursue hot melt extrusion (HME). Concerns about heat-sensitive APIs frequently lead development teams to rule out HME early — often before conducting a thorough scientific evaluation of their formulation options.
But thermal risk is frequently overstated. In this on-demand webinar, Stefanie Hauck, Senior Director PDS&T Pharm. Tech. at AbbVie Contract Manufacturing, explains why many compounds initially considered unsuitable for HME can be successfully processed with the right expertise.
WHITEPAPER - Container Closure Integrity Issues in Cell & Gene Therapy Products
The cell and gene therapy (CGT) product market is expected to grow at a very high rate of around 20-30% per year over the next 10 years. Increasing number of approvals, expansion of target diseases, accelerated investment and innovation, and advent of aging population are the key factors for the growth.
WEBINAR ON DEMAND: Why early matters: Data-driven strategies to de-risk OSD development
This on-demand webinar focuses on how data-driven characterization, predictive modeling, and Quality by Design (QbD) approaches help teams identify and address risks earlier—when decisions are more flexible and impacts easier to manage, before scale-up begins.
eBook - An Introduction to PLG Polymers for Long‑Acting Drug Delivery
Bioabsorbable poly(lactide-co‑glycolide) (PLG) polymers and poly(lactic acid-co-glycolic acid) (PLGA) have become an essential part of modern healthcare. Over the past five decades, these polymers have…
MARKET NEWS & TRENDS
Shilpa CDMO Invests $50 Million to Expand Peptide Manufacturing Capacity in India
Shilpa CDMO is investing $50 million to expand peptide manufacturing capacity in India, adding SPPS reactors and a new commercial production line in Raichur.
Emvena Therapeutics Launches With Funding to Develop Placenta-Targeted Preeclampsia Treatment
Emvena Therapeutics has emerged from stealth to advance a placenta-targeted mRNA approach to treating preeclampsia, a serious pregnancy complication.
Phillips Medisize Expands UK Inhalation Operations With Chippenham Site Acquisition
Phillips Medisize is expanding its UK inhalation operations after acquiring the full Chippenham facility, adding capacity to its Global Inhalation Center of Excellence.
BioLife Advances Oral Peptide Delivery Platform Ahead of London Life Sciences Week
BioLife Products Limited plans to present its oral peptide delivery technology at London Life Sciences Week, as it advances an alternative approach to administering peptide-based medicines.
Biograil Raises Funds to Prepare Oral Drug Delivery Platform for Phase 1 Trials
Biograil has secured $22.4 million in new funding to advance its BIONDD oral drug delivery platform, designed to administer therapeutics typically given by injection, toward Phase 1 trials.
1nhaler Raises $3 Million to Advance Cardboard Inhaler Toward Clinical Trials
1nhaler has raised approximately $3 million in follow-on financing to advance its single-use cardboard dry powder inhaler, targeting its first regulatory approval in 2027.
AbbVie Commits $162 Million to Expand Research and Development Operations in Oxford
AbbVie is investing more than $161.7 million to expand its research and development presence in Oxford, England, adding a new facility focused on drug discovery in immunology, neuroscience and oncology.
AbbVie Licenses Nxera's Experimental IBD Drug in $1.47 Billion Global Deal
AbbVie has secured global rights to Nxera Pharma’s investigational oral IBD drug NXE0033744 in a deal worth up to $1.47 billion, including $100 million upfront.
MadeAi Introduces AI Platform to Streamline Pharmaceutical Dossier Development and Updates
MadeAi has launched Dossier Expert, an AI platform designed to help pharmaceutical and life sciences companies develop and maintain formulary and value dossiers. The platform links content to underlying evidence and can reduce authoring and update timelines by as much as 70%, according to the company.
FDA Issues Final Potency Guidance for Cell and Gene Therapy Manufacturers
The FDA has issued final guidance on potency assurance for cell and gene therapy products, replacing its 2011 guidance and outlining a lifecycle, risk-based strategy for manufacturers. A webinar is set for December 10, 2026.
Novartis Ends Collaboration With BioArctic on BrainTransporter-Based Drug Program
Novartis has terminated its August 2025 collaboration with BioArctic on a BrainTransporter-based therapy; BioArctic retains the $30 million upfront payment and continues developing the platform for CNS drug delivery.
3billion to Present AI-Driven Drug Discovery Platform at BIO-Europe 2026
3billion will present its Genetics-First AI drug discovery platform at BIO-Europe 2026 in Cologne, seeking pharmaceutical and biotech partners for joint research, licensing and commercialization.
Experimental Alzheimer’s Treatment Targets DNA Damage and Brain Inflammation
Scientists at King’s College London report KCL-286, an experimental oral drug, repaired DNA damage and reduced inflammation in a mouse model of Alzheimer’s and has already cleared Phase 1 human safety trials.
Karyopharm Files for Chapter 11 Restructuring, Reaches Merger Agreement With Ayrmid
Karyopharm Therapeutics has filed for Chapter 11 restructuring and reached a merger agreement with Ayrmid Ltd. The company secured up to $55 million in debtor-in-possession financing and targets completion in the first quarter of 2027.
Autoinjectors Market Forecast to Reach $5.52B this Year
The global autoinjectors market is projected to reach $5.52 billion by the end of this year. Rising chronic disease, biologic therapies and home healthcare are driving demand for patient-friendly self-injection devices.
Lonza to Acquire Five U.S. CDMO Sites From Merck KGaA, Broadening Manufacturing Network
Lonza has agreed to acquire five U.S. manufacturing sites from Merck KGaA, expanding its CDMO network to nine U.S. locations. The deal adds about 1,100 employees and new capabilities in bioconjugates, viral vectors and aseptic fill-finish.
FDA Revises Draft Guidance on Drug Delivery Device Performance Requirements
The FDA has released revised draft guidance on essential drug delivery performance characteristics for devices and combination products. The guidance replaces the July 2024 draft and aims to bring consistency and predictability to development and regulatory review.
Neuralink's Blindsight Vision Implant Faces Questions Over Clinical Readiness and Human Trials
Neuralink says its Blindsight brain implant could restore vision and is technically ready pending regulatory approval, but no vision-restoration study is registered and no human evidence has been released. The device’s FDA Breakthrough Device Designation is not an approval.
Fresenius Partners With WuXi Biologics to Add Up to 37 Biosimilar Candidates to Pipeline
Fresenius has signed an exclusive development agreement with WuXi Biologics that could add up to 37 biosimilar candidates to its pipeline, growing its portfolio from 29 to as many as 66 molecules.
Buccal Drug Delivery Market Set to Reach $6.48B by 2030
The global buccal drug delivery market is projected to grow from $3.89 billion in 2025 to $6.48 billion by 2030, as developers pursue faster, non-invasive alternatives to oral and injectable administration.
