Quality by Design in the Development: Benefit or Bureaucratic Burden?

Jan 4, 2018

Petra Botzem and Dr Thomas Hille of LTS Lohmann answer this provoking question in their paper on the ICH guideline Q8, with focus on Transdermal Delivery Systems (TDS) development, providing insight on why it is beneficial. Due to its well-structured content, the referenced guideline ICH Q8 describes well-established development strategies, supplying a platform for controlled and organised development, not only for TDS. ...

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Accurate Protein Electrostatics Add a New Dimension to Structure-based Drug Design

Jan 4, 2018

The combination of advanced molecular force fields and improved visualisation capabilities has enabled chemists to expand their ligand-only view of the electrostatics of their system to include proteins, water and ligands. Important insights into the causes of ligand binding are now available on desktop computers and laptops, giving chemists unprecedented control over drug design. Dr Tim Cheeseright and Katriona Scoffin of Cresset look into electrostatic interactions, at the heart of drug discovery. ...

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Early Interventions to Reduce the Impact of Immunogenicity on the Development of Biopharmaceuticals

Jan 4, 2018

The development of biological therapeutics has led to remarkable clinical benefits in many indications. But, despite this success, the induction of anti-drug antibodies (ADAs) due to the potential immunogenicity of these therapeutics, remains a significant challenge to the successful development of biotherapeutics. In their paper, Dr Karen Hill and Dr Gary Bembridge of Abzena discuss the impact of immunogenicity and approaches that can be taken in pre-clinical development to reduce the effect on product success and patient experience. ...

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Needle-free Injection – Eradicating Diseases to Improve Global Health

Jan 4, 2018

Needle-free injection technology has evolved significantly over the last 50 years and is now accepted in many routine immunisation settings as a safe and effective vaccine delivery method. Disposable syringe jet injectors are now being used for the delivery of vaccines to eradicate polio, MMR, and influenza, and are showing promising results in vaccine clinical trials for the Zika virus and HPV. In her paper, Dr Erin Spiegel of PharmaJet shows that these devices are fast, safe, and easy to use, with most providers trained in less than 20 minutes. ...

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Automated Accountability: Maintaining a Chain of Custody from Release to Destruction

Jan 4, 2018

New solutions are proliferating to improve the efficiency of the clinical research function within pharmaceutical companies and CROs. In her article, Theodora Sarver of Almac reviews the challenges that sites and sponsors/ CROs face in complying with good practices and explains how accountability can be improved to reduce trial risks and all but eliminate the dreaded reconciliation process. ...

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