SPECIAL FEATURE - Artificial Intelligence in Drug Discovery, Development & Delivery
Contributor Cindy H. Dubin speaks with leading drug makers, device manufacturers, and contract organizations who dispel the myths around AI and Machine Learning in the pharma industry and share how they are using AI to streamline clinical trials, automate lab tests, optimize resource allocation, enhance development timelines, and improve patient-friendly dosage forms.
FORMULATION FORUM - Solid Oral Dosages: Controlled Release of Drugs
Shaukat Ali, PhD, and Jim Huang, PhD, review a few examples of controlled release excipients and their attributes from monolithic matrix tablets and polymeric coated tablets.
LEADERSHIP PANEL - Trends to Watch for in 2026
Contributor Cindy H. Dubin interviews life science leaders to discuss the role of AI in drug repurposing, the future of personalized medicine, the importance of sustainability, and how to keep pace with innovation amid real-time FDA reviews.
PREFILLABLE SYRINGE SYSTEM - Beyond Components: Designing Prefillable Syringe Systems to Streamline Success
Katie Falcone says prefillable syringes for biologics and vaccines can no longer be assembled as a set of parts; they must be treated as engineered systems with data, supply, and regulatory strategies built in from the start.
CONTROLLED RELEASE - Challenges in Consistent & Predictable Delivery of Drugs Using Oral Controlled Release Technologies
True Rogers, RPh, PhD, Matthias Knarr, PhD, and Mark Dreibelbis, PhD, say excipient selection is a key consideration within the QbD framework, particularly for CR technologies. Excipients must be chosen carefully to ensure they deliver the needed processability, quality, stability, and performance during and following the manufacture of dosage forms.
EXECUTIVE INTERVIEW - Incannex Healthcare: Pioneering the Future of Cannabinoid & Psychedelic Therapies
Joel Latham, CEO of Incannex Healthcare, shares how the company navigates complex global regulatory pathways, building strategic collaborations, and forging a path toward commercial success.
CELL & GENE THERAPY - What the Industry Can Learn From Baby KJ About Optimizing CRISPR Development
Venkata Indurthi, PhD, believes the success of Baby KJ provides a model that could be replicated many times over to treat people with ultra-rare genetic diseases.
PLATFORM TECHNOLOGY - How PolyPid’s PLEX Unlocks the Potential of Local & Prolonged Release
Dikla Czaczkes Akselbrad asks what if, instead of relying on systemic delivery, a platform could be created that anchors drugs directly at the site of need and controls its release over weeks or months?
MAB FORMULATION & FILL-FINISH - Obstacles in Monoclonal Antibody Formulation & Fill-Finish
Nandkumar Deorkar, PhD, explores some of the key challenges in mAb formulation and fill-finish, offering practical insights to help developers navigate complexity and ensure success.
EXECUTIVE INTERVIEW - CERo Therapeutics: A Novel Approach to Treating Cancer
Chris Ehrlich, CEO of CERo Therapeutics, discusses the company’s science, clinical program, the treatment landscape, and more.
MRNA THERAPEUTICS - Strategies for Enhanced Stability, Targeted Delivery & Safe Translation
Carsten Rudolph, PhD, explores many challenges and the solutions offered by novel technology platforms, providing insight into the evolving landscape of mRNA drug development and its potential as a future transformative modality.
2026 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
PURIFICATION STRATEGIES - Purification at Scale: Overcoming Chromatography Challenges for Advanced Modalities
William Sanders, PhD, explores the real-world challenges of scaling chromatography and highlights how contract development and manufacturing organizations (CDMOs) can help partners overcome them.
DRUG DEVELOPMENT - Common CMC Pitfalls in Orphan Drug Development
Hibreniguss Terefe, PhD, says although the unique challenges of orphan drug development are amplified by compressed timelines and limited patient populations, common pitfalls also serve as cautionary tales for other areas of drug development.
3D PRINTING - The Future of 3D Printing in Pharma: Aprecia’s Vision for Transformative Medicine
Kyle Smith, MBA, explains how his company, a pioneer in pharmaceutical 3D printing, has a vision for distributed, patient-centric manufacturing that could re-shape the future of medicine.
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.
Biocatalysis Without Barriers for Efficient Small Molecule Process Development
As the biocatalytic toolbox expands, chemists have gained access to a wider range of catalytic options, enabling improved stereo- and regioselectivity, simplified chemical synthesis routes, improved process mass intensity (PMI), reduced environmental impact and stronger process economics.
VIDEO - Built for the Clinic: Smart Drug Product Design for Accelerated Clinical Development
In this talk, Micah Tuttle demonstrates how intentional, forward-looking drug product design from day one can dramatically accelerate clinical development—eliminating the need for costly, time-consuming reformulations and bridging studies.
Atossa Therapeutics: Unlocking the Platform Potential of (Z)-Endoxifen Across Oncology & Rare Disease
Dr. Steven Quay explains how (Z)-endoxifen is being positioned as both an oncology backbone therapy and a potential treatment in rare diseases with substantial unmet need.
Drug Combination Screening in Oncology: Advancing Predictive Strategies for Precision Drug Development
Jinying Ning, PhD, reports combination therapy is no longer an optional strategy in oncology drug development. The biological complexity of cancer demands approaches that account for pathway redundancy, adaptive resistance, and tumor heterogeneity.
How Can a Stage-Based Program to Determine HME Applicability Benefit Your API?
Low bioavailability due to poor API solubility is one of the major challenges to be overcome when developing oral dosage form drug products. An effective way of addressing this problem is to transform low solubility APIs into amorphous solid dispersions (ASDs) and can often be achieved via hot melt extrusion (HME).
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EXCLUSIVE WHITEPAPERS
WHITE PAPER - Stop Guessing. Start Predicting: Rethinking Early Oral Drug Development
This article explores how AI-driven predictive insights reduce uncertainty in early oral drug development, enabling smarter decisions on solubility, dosing, stability, and scale-up while preserving API, accelerating timelines, and de-risking clinical success .
WHITE PAPER - Small Molecules: Choosing the Right Development Path
This white paper outlines a structured, risk-minimized approach to early CMC (Chemistry, Manufacturing, and Controls) development for small-molecule drugs—particularly for startups and virtual pharma companies with limited resources.
WHITE PAPER - How Advanced Containment Technology Is Reshaping High-Potency API Micronization
Harry Wade, Technical Associate, and Rosie Bird, EHS Lead, Catalent Dartford, review how for many high-potency APIs, micronization is not a downstream convenience but a critical performance step. Particle size distribution directly influences dissolution behavior, bioavailability, blend uniformity, and dose accuracy, particularly when therapeutic doses are measured in micrograms.
WHITE PAPER - Advancements in Intradermal Delivery: From Historic Techniques to Modern Innovations
This white paper explores the evolution of intradermal delivery methods, comparing historic methods of delivery such as the Mantoux technique with modern innovations such as the Terumo Immucise™ Intradermal Injection System.
WHITE PAPER - An Insoluble Problem? Overcoming Oral Drug Solubility Challenges With Functional Polymers
There are three key factors that need to be controlled when designing a drug product for solubility enhancement: the polymeric carrier; the manufacturing process; and the match to the desired API. By controlling these three factors bioavailability, drug release profile and manufacturability of your final drug product can be controlled.
EXCLUSIVE WEBINARS
ON-DEMAND WEBINAR: Drug Product Design for Delivery of Challenging Molecules
In this talk we illustrate several case studies demonstrating how a fundamental understanding of molecular properties combined with a strategic vision for drug product design can lead to effective and advanceable formulations for even the most challenging drug products.
WEBINAR - Vytal: The RTU Snap-Fit System for Container Closure Solutions – Setting the Standard for the Future
In recent decades, the landscape of parenteral drug production has undergone significant transformation, driven by the emergence of novel molecules and advanced therapies. The pharmaceutical industry has witnessed a notable shift towards biologics, mAbs, and cell-based therapies, which now represent some of the most successful pharmaceutical products globally.
WEBINAR ON DEMAND: Precision at Scale: Enabling Novel Therapeutics With Nanoparticle Manufacturing
Watch this on-demand webinar to learn about the key steps and considerations in bringing novel nanoparticle-based therapeutics from early R&D to commercial stages. Drawing from our 20 years of experience in the CDMO space, we cover critical topics unique to nanomaterials…..
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.
MARKET NEWS & TRENDS
Upperton Submits MHRA License Application for Annex 1 Sterile Manufacturing Facility Following APS Validation
Upperton has submitted its application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the approval of its new 7,000 sq. ft sterile…
Biologos Appoints New CEO, Celebrates 50 Years of Growth & Innovation
Biologos recently announced the appointment of Hetal Patel as Chief Executive Officer.
Medicus Pharma Reports Positive Phase 2 Topline Data Observing 73% Clinical Clearance & 40% Histological Clearance
Medicus Pharma Ltd. recently announced topline results from its Phase 2 clinical study (SKNJCT-003) evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to non-invasively…
LabVantage Solutions Introduces LabVantage CORTEX, Advancing its LIMS Platform for AI-Driven Laboratory Operations
LabVantage Solutions, Inc. recently announced the launch of LabVantage CORTEX, a next-generation artificial intelligence (AI), analytics, and automation platform. The launch represents a strategic evolution…
Codexis Signs Agreement to Manufacture 50 g siRNA Using its ECO Synthesis Manufacturing Platform
Codexis, Inc. recently announced it has entered into an agreement with an innovator pharmaceutical company to manufacture 50 grams of small interfering RNA (siRNA) using…
FUJIFILM Biotechnologies Unveils ShunzymeX Precision Purification Technology
FUJIFILM Biotechnologies recently unveiled ShunzymeX precision purification technology, which simplifies downstream processing for complex biologics. The technology will be presented this week at the Festival…
BioDuro & Cenra Launch Joint Venture to Expand Resilient Global API Manufacturing Capacity
BioDuro recently announced it has established a joint venture with Cenra API Solutions, also as known as Chunghwa Chemical Synthesis & Biotech Co., Ltd. (CCSB),…
NorthSea Therapeutics Announces Achievement of Key Regulatory Milestones for Orziloben
NorthSea Therapeutics B.V. recently announced the US FDA and the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) have granted Orphan Drug Designations…
ESTEVE CDMO Commences $15.5 Million Expansion of Chicago Small Molecule API Facility
ESTEVE CDMO recently announced it had commenced a $15.5-million investment to enhance production capabilities and associated space at its newly acquired North American facility in…
Bioxytran Reports Positive Study Results for a Broad-Range Antiviral Drug in Mild-to-Moderate COVID-19
Bioxytran, Inc. recently announced results from a randomized, double-blind, placebo-controlled Phase 1b/2a clinical study evaluating oral ProLectin-M in hospitalized patients with mild to moderate COVID-19 caused…
Quotient Sciences Extends Commercial Manufacturing Partnership for Ultra-Rare Disease Treatment
Quotient Sciences recently announced an extended commercial supply partnership with Ipsen, a global biopharmaceutical company, to manufacture a treatment for Fibrodysplasia Ossificans Progressiva (FOP), an…
Neurizon Initiates Dosing of NUZ-001 in HEALEY ALS Platform Trial
Neurizon Therapeutics Limited recently announced the first participant has been dosed in Regimen I of the HEALEY ALS Platform Trial evaluating Neurizon’s lead candidate, NUZ-001,…
MGS Acquires European-Based Medical Injection Molder Knudsen Plast A/S
MGS recently announced the acquisition of Knudsen Plast A/S, a premier Denmark-based injection molder with more than 40 years of dedicated healthcare manufacturing experience. With…
TARA-002 Demonstrates 68% Complete Response Rate at 6 Months in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Protara Therapeutics, Inc. recently announced updated interim results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company’s investigational cell-based therapy, in…
etherna´s Intratumoral mRNA/LNP Platform Advances to Clinical Testing in Nonmelanoma Skin Cancer Led by Almirall
etherna recently announced one of its key collaborators, Almirall, a leading medical dermatology company, nominated LAD116 as a novel therapy targeting non-melanoma skin cancer for…
SolasCure Completes Phase 2 Clinical Trial Demonstrating Accelerated Healing With Aurase Wound Gel
SOLASCURE Ltd recently announced the successful completion of its second Phase 2 clinical trial, CLEANVLU2. The study demonstrated that its investigational product, Aurase Wound Gel…
AC Immune Initiates Phase 1 Clinical Trial of NLRP3 Inhibitor
AC Immune SA recently announced that the first participant has been dosed in a Phase 1 clinical trial of ACI-19764, an orally administered small molecule…
Global Pain Market Presents Significant Opportunities for Novel Mechanisms & Modalities
There is a lack of diversity within the current pain market, with non-steroidal anti-inflammatory drugs (NSAIDs) and opioids dominating the market. With 98% of currently…
SGS Receives Regulatory Approval to Restart Human ¹⁴C ADME Trials
SGS recently announced it has received formal approval from the Belgian Federal Agency for Nuclear Control (FANC) to resume human ADME (Adsorption, Distribution, Metabolism and…
Lonza Strengthens Advanced Synthesis Capabilities to Lead Bioconjugates Innovation & Development
Lonza recently announced that it has strengthened its Advanced Synthesis offering to increase phase-appropriate support for the discovery and development of antibody-drug conjugates (ADCs) and…
