COMBINATION CORNER - How to Approach OTS Devices for Your Combination Product May 3, 2016

Lilli Zakarija, MSME, MBA, cautions that while OTS devices are already “developed” and on the market, they should still go through the device development design control process from the perspective of the combination product, and then let the design control process determine if the device meets the specific requirements of the CP.

COMBINATION CORNER - Keys to Avoiding Common Pitfalls in the Development of Product Requirements for Drug Combination Products February 28, 2017

Jerzy Wojcik says it is more important than ever to bring the right team together early in a project to capture product requirements correctly. The cost of missing needs or requirements goes up exponentially as development proceeds, and many of these requirements can be identified early in the project if the right individuals are at the table.

COMBINATION CORNER - Keys to a Robust Combination Product Design Verification & Validation June 30, 2016

Lilli Zakarija, MSME, MBA, explains that in order to conduct a successful V&V on the intended combination product, the key is to understand that the V&V testing is not an isolated activity and task.

SPECIAL REPORT - Outsourcing Formulation Development and Manufacturing: An Early Approach Saves Time and Money March 31, 2013

In this Special Report, Contributor Cindy H. Dubin asks many of the leading companies in this sector what challenges pharma currently faces in formulation and manufacturing and how they, as third-party providers, are helping to alleviate those burdens.

SPECIAL REPORT - Advancements in Respiratory Drug Delivery June 8, 2026

Advances in inhaled drug delivery are improving how therapies reach the lungs, with innovations in formulations, devices, biologics, and digital tools helping expand treatment options for respiratory diseases.

PREFILLABLE SYRINGE SYSTEM - Beyond Components: Designing Prefillable Syringe Systems to Streamline Success February 2, 2026

Katie Falcone says prefillable syringes for biologics and vaccines can no longer be assembled as a set of parts; they must be treated as engineered systems with data, supply, and regulatory strategies built in from the start.

Yatiri Bio Receives Grant to Advance Proteomics Interoperability in Cancer Research September 22, 2025

DRUG DELIVERY - Advancements in Transdermal Delivery Systems: A Focus on Invisicare® Technology for Obesity Treatment October 2, 2024

James A. Roszell, PhD, and Doreen McMorran demonstrate how this technology has demonstrated potential in the transdermal administration of glucagon-like peptide-1 (GLP-1) agonists and cannabinoid receptor type 1 (CB-1) antagonists, primarily targeting obesity management and other conditions requiring glucose regulation.

THERAPEUTIC FOCUS - Pushing Boundaries in Idiopathic Pulmonary Fibrosis Clinical Research October 1, 2024

Laura Iliescu, MSc, and Justin Herman, MD, explore the changing landscape of IPF and how biopharmaceutical companies developing novel treatments can effectively navigate the emerging challenges in a rapidly evolving IPF landscape.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Going Beyond the Science to Become True Partners June 3, 2024

Contributor Cindy H. Dubin speaks with leading CDMOs about how they are adapting to bio/pharma client needs, their capabilities in handling complex molecules, and how they are transforming from specialist contractors to true partners.

Processa Successfully Identifies Next-Generation Capecitabine Dosage Regimens for Phase 2B Trial November 1, 2022

PEPTIDE THERAPEUTICS - Oral Peptide Therapeutics – Opportunities Abound as Barriers Fall August 31, 2020

John S. Vrettos, PhD, says numerous technologies are currently in development that are designed to enable the oral delivery of peptides. Though each has its unique set of properties and capabilities, all must overcome key obstacles to successfully deliver peptides via the oral route.

TriSalus Life Sciences & Roger Williams Medical Center Announce Initiation of Phase 1 Clinical Trial for a Novel Delivery Technology February 14, 2020

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…..

MODIFIED RELEASE - Alternative Strategies for Development of Modified-Release Dosage Forms October 1, 2019

Andy Lewis, PhD, discusses a range of available formulation technologies, the challenges in MR formulation development, and the use of a design-space approach with on-demand manufacturing.

INTRATUMORAL DELIVERY - Arming the Immune System; Turning Cold Tumors Hot August 29, 2019

Daniel J. O’Connor believes a trigger mechanism that can turn cold tumors hot can help researchers set their focus on delivering potentially life-saving drugs directly to core of a cancerous tumor.

CHECKPOINT INHIBITORS - Novel Targets & Global Markets April 29, 2019

Laurie L. Sullivan and Cheryl L. Barton, PhD, say as manufacturers expand the clinical utility and healthcare professionals become more familiar with their efficacy and safety profiles, the checkpoint inhibitor market will continue to expand, becoming the cornerstone of many cancer treatment regimens.

ONCOLOGY DIAGNOSTICS - Advancements Paving the Way for More Tailored Drugs November 20, 2017

Divyaa Ravishankar, MS, says pharmaceutical companies have been subjected to a wide variety of external forces compelling them to get innovative about development of new platforms, liaise with new partners, leverage big data toward precision and predictive diagnosis, and identify new markers.

Allergan to Acquire Tobira Therapeutics, Expanding Global GI R&D Pipeline & Taking a Leading R&D Position in NASH September 25, 2016

SPECIAL FEATURE - Excipients: Manufacturers Look to Co-Processing as a Way of Improving Functionality June 2, 2016

Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.

ANTIGEN-SCREENING SYSTEM - Perfecting the Promise of T Cell Therapies for Infectious Disease & Cancer May 31, 2016