issues

June 2019

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COVER

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.

FEATURES

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.

2018 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery & Formulation Pipeline

In conclusion of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, reviews and compares current Phase 3 and Registration-stage products with products first approved since 2014 in the United States, Japan, or Europe.

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