• February 10, 2021

When repurposing oral or parenteral therapies for inhaled administration, there are a number of important factors to evaluate early in the drug development process. Considering these factors may increase chances that a repurposed product could be positioned for successful clinical studies and commercial adoption by patients. A key question is, “Why are we repurposing the […]

Current therapies for pulmonary arterial hypertension do not provide a cure and their use can be limited due to systemic side effects. Consequently, there is a critical need to discover and develop new drugs that target vascular remodeling and provide long-term disease reversal benefits. Drug repurposing can bypass common challenges of drug discovery and offer […]

  • February 4, 2020

It is inevitable that small- and medium-sized pharmaceutical companies outsource key research and chemistry, manufacturing and control (CMC) functions to contract research organizations (CROs) when it does not make financial sense to build internal capabilities for activities that are infrequent and/or require large capital or headcount investments to establish expertise. For inhalation product development, there […]

  • September 23, 2019

Because DPIs are a drug/device combination product, there are three critical components within the overall product that developers must select and evaluate: the device, the formulation and (when using a capsule-based inhaler) the capsule itself. These components form what may be called “the DPI interaction triangle.” Using a risk-based approach that ensures the appropriate technologies […]

  • December 15, 2017

The Lovelace Respiratory Research Institute, located in Albuquerque, New Mexico is one of the largest private, not-for-profit research organizations in the United States. Like other independent not-for-profit research institutes, LRRI conducts basic and applied science research and texting. According to the Association of Independent Research Institutes, all of the institutes in the US together receive […]

  • December 14, 2017

Over the past 20 years, contract research organizations (CROs) have evolved from simple analytical suppliers to companies providing full service activities across the product development continuum. This article presents a review of a collaboration between a sponsor and a contract research organizations. It describes the process for utilizing a dry powder inhaler for proof of […]

Until fairly recently, most large, fully integrated pharmaceutical and biotechnology companies liked to keep all aspects of product development and manufacturing in-house, under direct control of the company. Today, however, we estimate that the industry spends nearly one dollar out of every five on outsourced services, and Big Pharma has joined smaller companies in turning […]

  • November 29, 2017

Recently, regulatory agencies have put greater emphasis on the need to understand pharmaceutical process, product quality and risk management to ensure that patient needs continue to be met. The United States Food and Drug Administration (FDA) Quality by Design (QbD) initiative encompasses these considerations, building on previous concepts covered in the International Conference on Harmonization […]

Significant delays in product development can occur during the characterization process due to the need to solve scientific problems or because of resource limitations when staff or equipment requirements exceed what the sponsor site has available. As a result, a pharmaceutical company investigating a new orally inhaled drug (may benefit by integrating a contract research […]

Blockbuster MDI and DPI products have usually been brought to market by large pharmaceutical companies who have in-house capabilities in every aspect of product development, industrialization and supply. As these products approach the end of the exclusivity afforded them by intellectual property rights, smaller development companies (developers) have emerged. These companies focus on gaining a […]