Featured Articles
EXECUTIVE INTERVIEW - Eloxx Pharmaceuticals: Developing Rare Disease Drugs for Nonsense Mutations
Bob Ward, Chairman and CEO at Eloxx Pharmaceuticals, discusses nonsense mutations and how his company’s goal is to bring safe and effective therapies to children and adults suffering from genetic diseases as quickly as possible.
2019 Respiratory Drug Development eBook - Increased Focus on Respiratory Drug & Device Development Makes Treatment More Personal
This e-Book highlights some of the innovators and innovations in the respiratory sector, addresses the importance of end users in the device development process, and presents recent advancements in improving patient adherence.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services
Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.
PARENTERAL DEVELOPMENT - Considerations in Developing Complex Parenteral Formulations
Iain MacGilp, PhD, says the path to delivering stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.
DEVICE DESIGN - Quality-by-Design Approach to Enable High-Dose Drug Delivery With Autoinjectors
Patrick Le Gal explains how his company deployed a quality by design approach to manage all the unavoidable competing requirements and to propose a solution that balances performance, robustness, and usability.
IN VITRO DDI STUDIES - 2017 FDA Guidance: Many In Vitro DDI Evaluations Should Precede FIH Studies
Brian Ogilvie, PhD, and Andrea Wolff explain the implications of the new timing requirements and best practices for negotiating them efficiently and effectively moving forward.
BIOSIMILAR DEVELOPMENT - Approval of Biosimilar Medicines Through Totality of the Evidence
Hillel Cohen, PhD, outlines the evolution of biosimilar approvals and describes the process of analytical and clinical testing followed in the development of a biosimilar, with use of data from the scientific literature.
MARKET BRIEF - Nothing Degrading About Saving Lives: E3 Ligands Recruiting New Drugs Into the Clinic
Marianna Tcherpakov, PhD, discusses underexploited strategies, traditional approaches that can be optimized, novel techniques beginning to emerge and pay dividends, and results propelling this field toward better clinical outcomes.
FORMULATION FORUM - Amorphous Formulations for Insoluble Drugs: Rational Design & Practical Approaches on Formulation Screening & Development
Jim Huang, PhD, discusses the issues associated with amorphous formulations, including solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, stability in aqueous solution, in vitro in vivo performance, and process and scale-up.
EXECUTIVE INTERVIEW - Synteract: Advances in Pediatric Clinical Research & the Promise for the Future
Dr. Martine Dehlinger-Kremer, Vice President, Pediatric Development at Synteract, reviews current and significant challenges in pediatric clinical research, advancement of regulations surrounding them, and where the industry is headed.
EXCLUSIVE ONLINE CONTENT
Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 for the Prevention of Delayed Graft Function in Kidney Transplant Patients
Unicycive Therapeutics, Inc. recently announced the US FDA has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney….
2019 Analytical Testing in Drug Development eBook - Regulations Help Propel Testing Market
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.
LIPOPHILIC SALTS - Opportunities & Applications in Oral Drug Delivery
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.