ASSAY DEVELOPMENT – Case Study: How Custom Assay Development Helped Spur Precision Medicine Research in Multiple Myeloma
Steven Gross, MS, provides a behind-the-scenes look at the CMMC assay development process (from 2010 through today) to show how pharmaceutical companies can effectively partner with a laboratory to design customized assays that complement their drug discovery and development programs.
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.
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.
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.
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Jing Shi, PhD, provide a high-level analysis of the significant changes to the guidance compared to the immunogenicity draft guidance released in 2016, and the implications for drug development programs.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.
DRUG DEVELOPMENT – Bringing New Drugs to Patients Faster by Integrating Traditionally Separate Pharma Development Functions
Nutan Gangrade, PhD, says reducing R&D project timelines saves on overhead in development while increasing the likelihood of primacy in the marketplace (which engenders significantly more sales) and describes new approaches drug developers are taking to streamline drug development.
DEVICE DEVELOPMENT – Mapping the Regulatory Strategy to Better Navigate Electronic Drug Delivery Device Development for Patient Safety & Security
Ahmed Mallek, Hadrien Gremillet, and Audrey Chandra say that along with technology advancement in the medical industry, the behaviors and needs of different stakeholders also evolve, resulting in a clear interest in electronic drug delivery devices for a variety of reasons.
Tom McLean says combination drug development pipelines continue to rapidly expand and diversify with differentiated molecules and formulations, which can call for nuanced as well as significant packaging and delivery system requirements.
EXCLUSIVE ONLINE CONTENT
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