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.
VACCINE DEVELOPMENT - Therapeutic Vaccines Development: At the Edge of a New Revolution
Mario Davinelli, PhD, Narcisa Mesaros, MD, David Morland, and Judith Neville, PhD, say therapeutic vaccines are an exciting area of research that has the potential to revolutionize the way we treat diseases.
DRUG DELIVERY PLATFORM - VitalDose® EVA Implants for Systemic & Local Delivery of Therapeutics
Cyonna Holmes, PhD, Karen Chen, MS, and Brian Duke explain how systemic delivery approaches that leverage continuous dosing can address adherence issues and improve drug effectiveness while minimizing adverse reactions, and how a localized delivery approach can minimize total drug exposure, reduce off-target toxicities, and overcome targeting issues.
EXECUTIVE INTERVIEW - Petros Pharmaceuticals & Self-Care: Expanding Access to Rx Products Through a Tech-Powered OTC Pathway
Fady Boctor, President and Chief Commercial Officer at Petros Pharmaceuticals, discusses the process of taking a product from Rx-to-OTC, the benefits and challenges of the process, and the future of the marketplace.
ARTIFICIAL INTELLIGENCE - Embracing AI Requires Digital Literacy. How Will Your Organization Prepare?
Dave Watrous says a strong training roadmap for digital literacy begins at the top, and it begins far in advance of any major Artificial Intelligence or Machine Learning project rollouts.
PERSONALIZED MEDICINE - Exploring the Potential of the Aryl Hydrocarbon Receptor for Personalized Medicine
Pedro Moura Alves, PhD, reviews the intricacies of AhR immune sensing and signaling, and its potential for personalized treatment strategies to optimize therapeutic outcomes and minimize adverse effects. He also touches on some of the limitations hindering the advancement of knowledge in this crucial area of research, and the direction this emerging field may take in the coming years.
DRUG DISCOVERY - Addressing Challenges in Drug Discovery: DEL Screening Applications
Matt Clark, PhD, explores DEL’s application in three areas of drug discovery that have received much attention throughout the past 5 years: Induced Proximity, Covalent Drug Discovery, and Machine Learning.
