October 2023

COVER

DELIVERY TECHNOLOGY - Topical NeuroDirect™ Ketamine in the Treatment of Neuropathic Pain Syndromes: Fibromyalgia, Neuropathy, Radiculopathy & Causalgia/Complex Regional Pain Syndrome

Ronald Aung-Din, MD, and Chantelle Martin, MBChB, explain how targeting such chronic pain with a fast-acting, non-systemic, convenient, and easy-to-use at-home NeuroDirect ketamine cream could be of significant benefit in patients with CRPS as well as other neuropathic pain states, including chronic neck and back pain.

FEATURES

DELIVERY TECHNOLOGY - Topical NeuroDirect™ Ketamine in the Treatment of Neuropathic Pain Syndromes: Fibromyalgia, Neuropathy, Radiculopathy & Causalgia/Complex Regional Pain Syndrome

Ronald Aung-Din, MD, and Chantelle Martin, MBChB, explain how targeting such chronic pain with a fast-acting, non-systemic, convenient, and easy-to-use at-home NeuroDirect ketamine cream could be of significant benefit in patients with CRPS as well as other neuropathic pain states, including chronic neck and back pain.

FORMULATION FORUM - CUBOSOMES – The Next Generation of Lipid Nanoparticles for Drug Delivery

Jim Huang, PhD, and Shaukat Ali, PhD, shed light on the design and formation of cubosomes with special focus on their applications for delivery of hydrophobic and hydrophilic small and large molecules, including oncology drugs and polynucleotides (DNA, mRNA, and siRNA).

PLATFORM TECHNOLOGY - The PTXΔLNP® Platform: On the Promise of Developing New LNPs for Tomorrow’s mRNA Therapies

Charlotte Dunne, PhD, Katrin Radloff, PhD, and Leonidas Gkionis, PhD, review the PTXΔLNP platform and how it offers a synergistic sister technology to the mRNA platform to obtain potent mRNA-LNPs for therapeutic applications.

SOLUBILIZING & STABILIZING TECHNOLOGY - CAPTISOL® - Part Perseverance & Part Serendipity

Vince Antle, PhD, James Pipkin, PhD, and Lian Rajewski, PhD, say with decades of experience, proven safety, and recent and forthcoming authorizations in several new routes of delivery, the Captisol Team is looking forward to the next 2 decades and more of new drug products, new applications, and continued improvement in the technology.

BIOLOGICS DEVELOPMENT - Five Steps to a Robust Cell Line Development Process

Robert Gustines reviews the critical steps for designing and implementing a robust cell line development process to help overcome the obstacles that often hinder biologic production.

FUNCTIONAL EXCIPIENTS - Much More Than Filler: Solving the Challenge of Patient Non-Compliance

Carin Siow, PhD, explains how the progress to tackle the root causes of medication mis-use has been frustratingly slow and believes the pharma industry’s secret weapon in the fight against non-compliance are functional excipients.

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.