September 2023

COVER

CELL & GENE THERAPY - Cell & Gene Therapy’s Everest – The Challenges & Opportunities That Will Shape Success

Samir Acharya, PhD, Rajiv Vaidya, PhD, Laura Kerepesi, PhD, and Cyrill Kellerhals, MBA, provide their unique insights as they explore the challenges cell and gene therapy developers and manufacturers are currently facing, those they can expect to see in the future, and more critically, how to overcome them.

FEATURES

DEVICE DEVELOPMENT - Connected Auto-Injector Development: How to Leverage Human Factors Engineering

Finola Austin examines the human factors process for such devices, including a detailed look at the recent development of the UniSafe® 1 mL auto-injector.

CELL & GENE THERAPY - Cell & Gene Therapy’s Everest – The Challenges & Opportunities That Will Shape Success

Samir Acharya, PhD, Rajiv Vaidya, PhD, Laura Kerepesi, PhD, and Cyrill Kellerhals, MBA, provide their unique insights as they explore the challenges cell and gene therapy developers and manufacturers are currently facing, those they can expect to see in the future, and more critically, how to overcome them.

SPECIAL FEATURE - Injection Devices: Designing in Sustainability, Usability & Digitization for Patient Compliance

Contributor Cindy H. Dubin, in this exclusive annual feature, highlights how leading device and drug companies are working to address the challenges of usability, sustainability, and technology to increase patient compliance.

EXECUTIVE INTERVIEW - Sever Pharma Solutions: Development & Manufacturing of High Potent Polymer-Based Dosage Forms

Tony Listro, Vice President of Technology and Site Lead for SPS’s North American site in Putnam, CT, discusses the company’s recent focus areas as well as current plans for expansion.

SUPPLY CHAIN SOLUTIONS - Steady Supply in Turbulent Times: The Importance of Secure Supply Chains & Drug Packaging Integrity

Peter Belden offers unique insight into strategies that can be applied to weather the turbulent times ahead and ensure a reliable supply of critical drug products to patients, and explores how sustainability and integrity can be attained with the right packaging and supply chain solutions.

THERAPEUTIC FOCUS - Effect of NE3107 on the Pharmacokinetics Profile of Carbidopa/Levodopa in Patients With Parkinson’s Disease

Joseph M. Palumbo, MD, says addressing Parkinson’s via the inflammatory pathway offers a unique perspective that was virtually unheard of only 10 years ago.

MEDICAL DEVICE TESTING - Breathing Component Biocompatibility: The Practical Application of ISO 18562

Luminita Moraru, MSc, explains how the medical devices industry has grown and is expanding daily and presents the key steps that need consideration when assessing breathing devices.

EXECUTIVE INTERVIEW - Tarsus Pharmaceuticals: A Journey to Establishing a New Disease Category in Eyecare & Transforming Treatment for Patients With Serious Diseases

Sesha Neervannan, PhD, Chief Operating Officer of Tarsus, discusses the company’s innovative approach to creating a new treatment category for eyelid disease and their strategic focus on advancing other treatments in their pipeline.