Rafael Miñana, PhD, explores the benefits of preclinical outsourcing, the value of zebrafish as an alternative model, as well as the challenges and opportunities of managing a highly diversified portfolio and providing customized solutions.
GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 2, Notable Product Drug Delivery and Formulation Approvals of 2018
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on how the pharmaceutical industry has harnessed well validated drug delivery and formulation technologies to deliver important product approvals in 2018.
Contributor Cindy H. Dubin speaks with leading excipient companies to discuss the current role excipients are playing in continuous manufacturing, biopharma formulation, and controlled- and immediate-release delivery.
Ed Price, President and CEO of PCI Synthesis, reflects on the trends fostering the CDMO industry consolidation and the positive impact it augurs in addressing sponsors’ needs to enter the clinic more quickly and safely.
DRUG DEVELOPMENT – Rapid Preparation of Gadolinium & Protamine Complexes With Aurintricarboxylic Polysalicylates: Implications for Drug Development
Timothy J. Smith, RPh, PhD, reviews how derivatives of aurintricarboxylic acid (ATA), a commercial reagent for aluminum ion determination, are under consideration for drug development in view of ATA’s diverse pharmacological spectrum.
THERAPEUTIC FOCUS – Targeting the Novel LANCL2 Pathway Offers Potential for a Differentiated Treatment Paradigm for Autoimmune Diseases
Andrew Leber, PhD, Raquel Hontecillas, PhD, and Josep Bassaganya-Riera, PhD, say current IBD therapeutics have mediocre efficacy, poor maintenance of response, and damaging side effects, including cancer, infection, and death, resulting in an unmet clinical need for safer and more effective oral therapeutics.
Roger Humphrey, MBA, says as companies pursue various and unique collaborative platforms, their real estate needs are changing — with profound implications for how and where life sciences companies choose to operate.
Kaiser J. Aziz, PhD, explains how the FDA emphasizes the Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the use of new drug products by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use.
SPECIAL FEATURE – Improving Bioavailability & Solubility: Chemical & Physical Modification vs. Formulation Development
Contributor Cindy H. Dubin speaks with several leading companies to explore chemical and physical modification versus formulation development, and new technologies and techniques for improving bioavailability and solubility.
PRODRUG TECHNOLOGY – Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs
Travis Mickle, PhD, indicates key properties that prodrugs can potentially modify generally fall within one or more of the ADME categories, with the goal being the creation of an NCE that optimizes the performance, utility, and potential life-cycle management of the parent drug.
EXCLUSIVE ONLINE CONTENT
EXECUTIVE INTERVIEW – Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.