Featured Articles
EXECUTIVE INTERVIEW – HERMES PHARMA: Reducing Risk, Speeding Development – A CDMO Model Including GCP-Sponsorship to Better Meet the Needs of Pharma Companies
Dr. Martin Koeberle, Head of Analytical Development & Stability Testing, and Dr. Bernice Wild, Head of Stability Testing and Senior QA Manager GCP, at HERMES PHARMA, discuss the challenges of developing innovative oral medicines, as well as how these new service offerings are helping meet a critical need among companies looking to bring portfolio-enhancing formulations to market.
PRIMARY CONTAINER CLOSURE SYSTEMS – In From the Cold: Realizing the Benefits of Primary Packaging Innovation for Lyophilized Drug Products
Neal Higgins discusses the benefits and challenges associated with lyophilization before reviewing some of the current macro influences, West’s design philosophy and QBD blueprint, and data to demonstrate the efficacy of the 4040 elastomer platform.
PLACENTA-ON-A-CHIP – The Future of Drug Discovery In Women’s Health
Hagar Labouta, PhD, presents how researchers continue to increase the complexity of their placenta-on-a-chip models and, as their research progresses, they are confident this technology will aid the development of novel therapies to treat a wide range of maternal and fetal conditions.
CLINICAL TRIALS – 2023 & Beyond: How Technology is Changing the Face of Clinical Trials
Betsy Wagner and Marie E. Lamont explain how before anyone can take full advantage of this opportunity, education about the technology and the practical benefits, viewed through the lens of understanding historical lessons learned, will be the critical next step.
NATURAL LANGUAGE PROCESSING – Mandatory IDMP Compliance is Almost Here – How NLP Can Help
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.
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.
EXCLUSIVE ONLINE CONTENT
Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 for the Prevention of Delayed Graft Function in Kidney Transplant Patients
Unicycive Therapeutics, Inc. recently announced the US FDA has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney….
2019 Analytical Testing in Drug Development eBook – Regulations Help Propel Testing Market
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.
LIPOPHILIC SALTS – Opportunities & Applications in Oral Drug Delivery
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.