January/February 2020

COVER

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.

FEATURES

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.

AUTOINJECTOR PLATFORM - Identifying New, Enhanced Device Delivery Solutions for Chronic Diseases

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.

PERSONALIZED MEDICINE - Personalizing Cancer Immunotherapy: Trends in Biomarker Discovery

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.

DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 1

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.

BIOPROCESSING - A New Era: Why the Time Has Come for Biopharma to Move to Continuous Bioprocessing

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.

EXECUTIVE INTERVIEW - Foamix Pharmaceuticals: Delivering Pharmaceuticals to the Skin Through a Foam

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.

MARKET BRIEF - Tumor-Infiltrating Lymphocytes: A New Frontier in Cancer Immunotherapy

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.