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DEVICE DEVELOPMENT – Designing Devices for Inhaled Drugs
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.
OSD FORMULATIONS – Dissolving Bioavailability & Solubility Challenges in Formulation & Development
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.
IMMUNOGENICITY TESTING – Regulatory Updates for Immunogenicity Assessment of Therapeutic Proteins
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Jing Shi, PhD, provide a high-level analysis of the significant changes to the guidance compared to the immunogenicity draft guidance released in 2016, and the implications for drug development programs.
SPECIAL FEATURE – Injection Devices: Will COVID-19 Deliver Growth to the Market?
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.
COMBINATION PRODUCTS – Development Challenges & Solutions
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.
EXECUTIVE INTERVIEW – Nuritas Pharma: Life Changing Peptide Drug Discoveries for a Changing World
Nora Khaldi, PhD, Founder and Chief Executive Officer of Nuritas, discusses the company’s innovative approach to accelerating the discovery of novel therapeutic peptides that address unmet patient needs in multiple disease areas.
2020 Analytical Testing in Drug Development e-Book: A Critical Role in End-to-End Drug Development
This second annual Drug Development & Delivery Analytical Testing eBook shines a light on analytical outsourcing providers that are optimizing testing solutions to ensure more robust results, speed time to market, and characterize methods earlier in development.
EXCLUSIVE ONLINE CONTENT
Stevanato Group Launches Artificial Intelligence Platform
Stevanato Group has recently launched an Artificial Intelligence platform, based on Deep Learning (DL) models, that leverages the benefits of….
Catalent to Acquire Delphi Genetics & Launch US Plasmid Manufacturing Site to Establish Global pDNA Development & Manufacturing Capabilities
Catalent and Delphi Genetics recently announced they have entered into a final and definitive agreement whereby Catalent will acquire 100% of the shares of Delphi Genetics. Catalent is also….
Halberd Collaborates With GreenBioAZ for the Development of Radio Frequency Technology to Eliminate Disease Pathogens
Halberd Corporation has engaged GreenBioAZ, Inc. to conduct laboratory testing of Halberd’s patent pending Radio Frequency (RF) extracorporeal treatment to eliminate….
Samsung Biologics, National OncoVenture & Eutilex Obtains IND Approval From FDA
Samsung Biologics recently announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the….
Maravai LifeSciences Expands Its Intellectual Property Portfolio
Maravai LifeSciences, Inc. recently announced the United States Patent and Trademark Office has issued a new patent, United States Patent No. 10,913,768, to the company’s TriLink Biotechnologies subsidiary…..