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.
ORAL SUSPENSIONS - A New Standard in Oral Suspensions: Leveraging Novel Excipients for FDA Approval
Mary Schuster introduces a new approach to perfecting oral suspension formulations, which is centered on the strategic use of a “novel” synthetic functional excipient, magnesium aluminometasilicate (MAS).
DRUG DELIVERY - PharmaShell®: Enabling Once-Monthly Therapeutics With Atomic Precision Coatings
Anders Johansson, PhD, Polla Rouf, PhD, and Joel Hellrup, PhD, review an innovative drug delivery system that uses nanometer-thin, inorganic coatings to turn short-acting drugs into long-acting injectables.
INJECTABLE DEVICES - Delivering Tomorrow’s Injectables to Patients Today: Responding to a New Era of Demand With Purpose-Built Capabilities
Tommy Schornak examines how evolving therapeutic modalities, delivery systems, and regulatory expectations are reshaping the fill finish landscape.
PLATFORM TECHNOLOGY - Developing Innovative Solutions to One of the Top Public Health Threats: Antibacterial Resistance
Jennifer Schneider, PhD, believes immunotherapy holds the potential to revolutionize the treatment of “hard to treat,” chronic, and often recalcitrant infections.
EXECUTIVE INTERVIEW - Plus Therapeutics: Advancing Targeted Radiotherapeutics for Rare & Difficult-to-Treat Cancers
Dr. Marc Hedrick, CEO of Plus Therapeutics, discusses the company’s targeted radiotherapeutic platform for central nervous system and solid tumor cancers and why internal radiation therapy offers patients a more advanced drug delivery solution compared to traditional external radiation therapy.
CGT MANUFACTURING - Scaling CGT Manufacturing Inside the US: The New Regulatory Paradigm
John Tomtishen says amid shifting FDA priorities as well as developing geopolitical considerations, US companies are entering a new regulatory era, one that will define how CGTs are scaled, distributed, and delivered domestically.
SPECIAL FEATURE - Excipients: Innovation in a Shifting Pharma Landscape
Cindy H. Dubin speaks with several companies and highlights this innovation and reveals how excipient suppliers are doing their part to ensure a reliable, resilient, and compliance-driven supply chain.
FORMULATION FORUM - Orally Disintegrating Tablets
Shaukat Ali, PhD, and Jim Huang, PhD, say as more NCEs are being discovered, the industry is weighing all options for evaluating those molecules in different dosages to improve solubility and oral bioavailability. With requirement for taste-masking of bitter drugs with commercially available ODT excipients, it poses additional challenges for improving taste-masking and performance of molecules for the intended usages.
PRECLINICAL SCREENING PLATFORM - From Preclinical Screening to Clinical Optimization: Accelerating Poorly Soluble Drug Development
Andrew Parker, PhD, John McDermott, and Sandeep Kumar, PhD, believe the development of poorly soluble drugs remains a significant challenge in pharmaceutical R&D. However, by adopting an adaptive approach that integrates services from preclinical screening to clinical optimization, developers can achieve significant time- and cost-saving benefits.
