Dustin Campbell says the AJILITY platform takes the burden off clients and allows his company to drive, manage, and support their drug product manufacturing, maximizing speed and success, while prioritizing these programs are driven to completion.
Sally Waterman, PhD, and Vasiliki Nikolaou, PhD, explain how transdermal drug delivery patches have the potential to significantly improve not only the outcome of treatments, but also the quality of life for those patients using them.
EXECUTIVE INTERVIEW – Immunic Therapeutics: Developing Next-Generation Oral Drugs in Chronic Inflammatory, Autoimmune & Infectious Diseases
Daniel Vitt, PhD, Immunic’s Chief Executive Officer and President, discusses his company’s pipeline of selective, small molecule therapies aimed at treating chronic inflammatory and autoimmune diseases, and its recent progress.
Andreas Meliniotis explains how there is plenty of opportunity for the development of new, improved devices to ensure inhaled drugs can be accessible for a wide range of patients and can treat various diseases and conditions effectively.
OVER-ENCAPSULATION CAPSULES – Double-Blind, Zero Bias: Over-Encapsulation — The Right Tool for Blinding Studies?
Julien Lamps believes that while many blinding options are available to drug sponsors and external clinical research partners, over-encapsulation remains a popular choice for its dosing simplicity, trial efficacy, patient accessibility, and cost-effectiveness.
Dr. Rajiv Khosla, CEO of Enteris BioPharma, discusses how his company’s innovative oral formulation technology is helping the pharmaceutical industry overcome the hurdle of low bioavailability to reshape treatment categories and expand market opportunities with minimal financial and regulatory risks.
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
CUSTOM DEVICE SOLUTIONS – Device Design Will Act as Competitive Distinguisher in a Post-Patent Expiry Biosimilar Market
George I’ons dissects the different factors that will determine biosimilars’ adoption and pace of advancement against their original counterparts, namely clinical confidence in the biosimilar and patient confidence in the drug delivery device.
Leon Shi, PhD, Lan Li, MS, and Jing Shi, PhD, provide a high-level analysis of the significant changes to the guidance compared to the immunogenicity draft guidance released in 2016, and the implications for drug development programs.
Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.
EXCLUSIVE ONLINE CONTENT
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
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.