SPECIAL FEATURE – Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results
Contributor Cindy H. Dubin, in her latest report, describes some novel analytical testing services aimed at ensuring quality and safety, and in some cases, speeding the process and saving money.
Karima Yadi, MSc, and Lionel Maritan, MSc, believe identifying enhanced needle solutions and offering integrated system solutions to serve the chronic disease market is a great step toward addressing improved patient outcomes and adherence.
Emile Youssef, MD, PhD, says due to tumor heterogeneity, the plasticity and diversity of cancer cells, and a multitude of other factors, biomarker development is a challenge, and thus explores four trends in cancer biomarker discovery.
Josef Bossart, PhD, explains how accurately estimating a product’s clinical development timelines is more than simply adding up the individual timelines, almost always optimistic. You need to “know” the numbers, not just calculate them.
IMAGE-BASED CHARACTERIZATION – Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using Three-Dimensional X-Ray Microscopy Analytics
Shawn Zhang, PhD, Johnathan Goldman, PhD, Xiaodong Chen, PhD, et al present a new method that not only characterizes quantitatively the microstructures of the lyophilized drug samples, but also presents the potential to correlate the microstructures with physical properties to optimize parameters in drug formulation, cycle development, process scale-up, stability control, and administration.
Dr. Martin Smith explains why the pharma industry must embrace continuous processing if it’s to survive and thrive in an era of global personalized medicine.
CYBERSECURITY – Why Pharmaceutical Companies Are Vulnerable to Cyberattacks & What You Can Do to Protect Your Company
Andrew Douthwaite says having a comprehensive cybersecurity strategy in place to safeguard digital assets has become an essential part of any company’s security protocols, and not doing so leaves valuable data vulnerable.
David Domzalski, Chief Executive Officer of Foamix, discusses his company’s innovative approach to drug delivery using foam to treat dermatological conditions, like acne and rosacea.
OLIGONUCLEOTIDE DELIVERY – Dectin-1 Receptor-Mediated Delivery of Oligonucleotide Drugs Complexed With Schizophyllan Dendritic Cells & Macrophages
Kenji Arima, PhD, and Akihiko Watanabe, PhD, introduce NapaJen Pharma’s technology with a specific focus on solving some of the current challenges of oligonucleotide therapeutics.
Cheryl L. Barton, PhD, and Bianca Piachaud-Moustakis, PhD, believe the role of TIL therapy as an anticancer therapy in melanoma and possibly other solid tumors holds great promise and could become a viable course of treatment in the future.
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
Stacey Treichler, PhD, believes the development process for new biologics is complex and requires a substantial amount of time and resources, and reviews some of the areas where careful choice of CDMO is key, including cell line development and cGMP manufacturing capabilities, and how an integrated approach can be beneficial.
EXCLUSIVE ONLINE CONTENT
Parexel, a leading provider of solutions to accelerate the development and delivery of innovative new therapies to improve world health recently announced…..
A Purdue team has received a $3.2-million grant from the National Institutes of Health for its work to treat antibiotic-resistant lower respiratory infections – the fourth-leading cause of…
Saama Technologies, Inc. recently announced it signed an agreement with Pfizer Inc. to develop and deploy an AI-powered analytics solution to reduce the….
TriSalus Life Sciences & Roger Williams Medical Center Announce Initiation of Phase 1 Clinical Trial for a Novel Delivery Technology
TriSalus Life Sciences recently announced the initiation of a new clinical trial assessing the safety and feasibility of an innovative new treatment that combines its…..
Alkahest, Inc. recently announced the initiation of a Phase 2b clinical trial of its orally administered small molecule CCR3 inhibitor, AKST4290. The company has dosed the first….
Credence MedSystems, an innovator in injectable drug delivery technology for the biopharmaceutical industry, has received the Pharmapack Award for its….
William Small, PhD, and Arsalan Khan say drug degradation can have toxicological effects in many instances, and it is imperative that this mechanism be minimized as much as possible. The best solution to this is to ensure that appropriate ingredients, both high in quality and purity, are chosen and used throughout the entire drug product lifecycle.
PharmaCyte Biotech recently announced it is about to embark upon a planned US FDA Phase 2b clinical trial to treat locally advanced, inoperable pancreatic cancer (LAPC) at trial sites all over the US, and with that journey comes the….
Two Labs recently announced it has acquired CEEK Enterprises, a management consultancy dedicated to supporting clients in the biopharma and MedTech industries with specialized expertise in….
Pelican BioThermal recently announced the acquisition of NanoCool, an Albuquerque, New Mexico-based manufacturer of temperature-controlled packaging solutions. This acquisition further…..