Simon Johns says with the US scheduled to implement IDMP this year and the EU in the process of implementation, IDMP is no longer just a distant requirement. It is happening now, and all organizations should be prepared for mandatory use this year.
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.
In this fourth annual Analytical Testing e-book, learn more about Alcami, Stevanati Group, and West and their current contributions and offerings in the outsourcing analytical testing market, as it continues to be a time and money saver for bio/pharma companies.
EXCLUSIVE ONLINE CONTENT
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
EXECUTIVE INTERVIEW – Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.