DEVICE STUDY - Putting Auto-Injector Interchangeability to the Test
Alex Fong, MBA, says many factors need to be taken into account when deciding whether patients can successfully switch to a different drug delivery device because if patients struggle to cope with a new device, there is a risk they will miss out on vital doses of medication.
EXECUTIVE INTERVIEW - PCI Pharma Services: A Consultative Approach to High Potency Formulation Development
David O’Connell, Director of Scientific Affairs at PCI Pharma Services, explains how important it is to choose the right CDMO partner to accompany you throughout the drug product lifecycle.
THERAPEUTIC FOCUS - The Unmet Need of Agitation in Alzheimer’s Disease
Ram Mukunda, MS, and Evelyn Gutiérrez, and Claudia Grimaldi report on IGC-AD1, the first natural cannabinoid-based investigational drug to be tested in human FDA trials for the treatment of AD, which has shown promising results in treating agitation in Alzheimer’s patients.
CONTAINER PLATFORMS - Ready-to-Use Containers: Real Benefits, Important Challenges & Evolving Value
Gregor Deutschle and Gabriele Maier examine key benefits, dynamics driving the adoption of RTU container platforms, and several important areas of continuing evolution in the RTU market.
PFS MARKET TRENDS - Partnerships With Pharma Packaging Specialists Will be Key to PFS Product Success in 2024
Pieter Vercruysse says to overcome various challenges in 2024, pharma companies need to establish close partnerships with specialists focusing on PFS packaging.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Delivery: Next-Gen Injections Feature Technology & Reconstitution
Contributor Cindy H. Dubin highlights innovations from key players in parenteral delivery and prefilled syringes, with focuses on safety, meeting regulatory requirements, cost, fill/finish, and dosing.
SCALING MANUFACTURING - Collaboration Between a Device Supplier & Equipment Manufacturer to Meet the Needs of Patients, End-Users & Pharma Manufacturers
John Merhige and William (“Bill”) Jaworski present how their two companies have worked closely together, using creative manufacturing strategies to produce a wide array of problem-solving drug delivery systems.
EXECUTIVE INTERVIEW - Adare Pharma Solutions: Expanding Capabilities to Exceed Customer Expectations
Tom Sellig, CEO of Adare Pharma Solutions, discusses how he has realized various achievements and about the company’s focus on addressing special needs in the market, its global expansion, and where he expects to take the company in the future.
DRUG & DEVICE DEVELOPMENT - Integration of siRNA, Nanoparticles & Capsule Endoscopy for Treatment of Inflammatory Bowel Disease
Nila Murali, Leia Jiang, and Ravali Bhavaraju highlight a promising technology that can change the way IBD is treated. Current imaging technology can successfully identify inflammation, and current treatments can address active inflammation and manage symptoms.
CELL & GENE THERAPY - It’s Time to Build Infrastructure to Handle the Coming Surge
Fran Gregory says the complexities and innovations associated with the production of cell and gene therapies also necessitates a shift in infrastructure, which will affect manufacturers, distributors, and providers. From development, manufacturing, storage, and delivery to patients; each step in the process requires forging a new path.
FORMULATION FORUM - Prefilled Syringes: Overcoming the Challenges for Safe & Accurate Delivery of Drugs
Shaukat Ali, PhD, and Jim Huang, PhD, provide a better understanding about some of the advantages of prefilled syringes, methods for manufacturing, and the syringe types commercially available.
SUPPLY CHAIN SOLUTIONS - From Lab to Life: Strategies for Unwavering Resilience in the Clinical Supply Chain
Nina Vas says recent challenges underscore the need for specialty logistics teams to build a flexible, anti-fragile supply chain capable of withstanding global uncertainties, and the role of knowledgeable supply chain experts has never been more significant to ensure the uninterrupted flow of essential medicines worldwide.
FORMULATION DEVELOPMENT - The Rising Need for an Integrated Approach to Small Molecules Drug Development
Julian Northen, PhD, believes as the demands of a changing society evolve and continue to act as a driver for the identification of novel small molecules, the roles and diversity of the available medicines will also change.
EXECUTIVE INTERVIEW - Cocrystal Pharma: Utilizing Structure-Based Technologies to Provide First- & Best-In-Class Antiviral Drugs to Address Critically Unmet Medical Needs
Dr. Sam Lee, Cocrystal Pharma’s President and co-CEO, discusses the company’s latest achievements in antiviral drug development.
CLINICAL TRIALS - Enhancing Clinical Trials: A Strategic Framework for Positive Site-Sponsor Relationships
Matthew Jones and Julia Scanlon delve into the key elements of a framework designed to cultivate positive site-sponsor relationships. By examining shifts in trial strategy and execution, it can pave the way for a collaborative, mutually beneficial environment, and a sustainable competitive advantage.
DRY POWDER FORMULATION - Preparing to Deliver the Next Generation of Inhaled Therapeutics
Richard Johnson, PhD, outlines the trends and challenges within the inhaled drug delivery market. Specifically, DPI delivery will be explored, including how the challenges with dry powder formulation can be overcome and what the future holds for DPIs.
SPECIAL FEATURE - Excipients: Advanced Biologics Require Innovative Excipient Science
Contributor Cindy H. Dubin speaks with several leading companies to discuss novel and functional excipients being developed, the role they will play in reformulations and new formulations, and their versatility in drug delivery.
FORMULATION DEVELOPMENT - Solving Tough Solubility Issues With Fewer Compromises & Better Outcomes
Anshul Gupte, PhD, says fortunately, enhanced solubility can be achieved using a variety of approaches. For oral solid dosage forms, well-established approaches include micronization, nanoparticles, amorphous solid dispersions (ASDs), lipid-based formulations, salts, and co-crystals.
THERAPEUTIC FOCUS - Perspectives on Sigma-2 Modulation as a Therapeutic Modality for Slowing Age-Related Degenerative Disease
Anthony Caggiano, MD, PhD, believes there is evidence the sigma-2 receptor acts as a regulator of cellular processes, such as autophagy and protein trafficking, which are impaired in age-related degenerative diseases.
ORGANIZATIONAL CULTURE - Assessing Quality Culture: Five Key Elements
Londa Ritchey, MBA, believes there is sufficient passive endorsement of the idea that building and sustaining a strong quality culture is linked to enhanced business efficiency.
