May 2024

COVER

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.

FEATURES

EXECUTIVE INTERVIEW - Coya Therapeutics: Unlocking the Power of Tregs to Combat Inflammation & Fight Neurodegenerative Diseases

Dr. Howard Berman, Founder and CEO of Coya Therapeutics, discusses how the company is leveraging Tregs, its investigational products and the conditions targeted, Coya’s significant partnership with Dr. Reddy’s Laboratories, and his goals throughout the next 5 years.

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.