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In this episode we discuss with Lydia Ainsworth the global antibiotics crisis and the reasons for this crisis. In addition, we mention some of the drug development trends and some ideas how to encourage antibiotics development.

In this episode we review why we need women to participate in clinical research with medical devices. We also cover the FDA guidance on sex-specific data collection for medical devices and its main recommendations on the study design and data collection requirements.

This episode is a review of a white paper from Aug 2026 on dose optimisation for radiotherapeutics. In addition, Lydia Ainsworth reviews the FDA guidance covering the same topic and providing FDA recommendations. The episode contains recommendations on dose selection and study design for clinical trials with radiotherapeutics.

In this episode we review with Lydia Ainsworth an article discussing ethical challenges for clinical research with implantable neural devices. The overview provides valuable insights for ethics committees, researchers and manufacturers designing informed consents and investigational plans.

This episode is dedicated to psychedelics research. It covers the recommendations from the US FDA guidance from Jul 2026 which clarifies the agency's expectations regarding the drug development and clinical trials design for psychedelics. In addition, there is an overview of the study design of a clinical trial with psilocybin used in treatment-resistant depression.

This episode covers the upcoming changes in the clinical trial regulations in Canada based on information presented by Health Canada. It also contains global trends analysis and comparison to the regulatory changes in the USA and Europe.

This episode is an overview and analysis of the discussions from the 3rd day of the 5th FDA, MHRA and Health Canada Symposium in June 2026. It covers international initiatives for harmonisation of drug safety review among different regulatory agencies, and the use and challenges of AI in pharmacovigilance. In addition, Lydia Ainsworth provides practical perspective of the challenges of collecting drug safety information in clinical trials.

Our latest podcast is dedicated to bioequivalence studies and their specific challenges. We also cover what was discussed in terms of inspection findings, cases studies and expectations by FDA and Health Canada on their recent symposium in June 2026. In addition, Lydia Ainsworth, shares with us her practical experience from site level and monitoring level on common issues with blood sample collections.

This episode is review and analysis on the first day of the 5th FDA, MHRA and Health Canada Symposium in June 2026 which covered GCP, clinical trials and risk management.

Clinical trials GCP inspections are common but the expectations can vary between different inspectors and agencies. In this episode, we are discussing with my colleague Lydia Ainsworth, what we learnt during the GCP inspections that we had in Europe in 2025. We cover some key inspection preparation points for the sponsors but also for the hospitals.

This episode is a follow up on round table discussions during the ICR Conference on 13 and 14th of April 2026 in Birmingham. We discuss the common issues related to setting up clinical trials in the UK and also the challenges with adaptation of electronic site files and digital technologies in clinical research. We also provide some recommendations how the processes can be improved and streamlined.

In this episode we discuss with Lydia Ainsworth, our Senior Clinical Data Quality Manager, what we learnt from the Institute of Clinical Research (ICR) Conference, 13-14 Apr 2026. The conference covered the latest clinical trials regulatory changes which affect the pharma and biotech industry. There were representatives from UK regulators MHRA and HRA, but also from the industry, academia and NHS. You can learn about the clinical trials regulations changes; what is coming in the medical devices' field; the importance of patient engagement; the use of AI in clinical research; latest trends in drug development and other topics. You can read the transcript of the interview here: https://solutionsop.co.uk/2026/05/15/icr-conference-april-2026-the-latest-on-the-uk-clinical-trials-regulatory-changes/

This is a short overview of the current development of cell and gene therapies and their challenges. It discusses the different types of cell therapies; latest developments and the challenges of creating allogenic cell therapies. Terminology is avoided on purpose to present the information in accessible way for those without scientific background.

In this episode we decided to use a new approach in regulatory affairs and tell people how to fail their BLA (Biologics License Application) and piss off their FDA reviewers at the same time. In order to do that, Arvilla Trag, who is a Chemistry, Manufacturing and Controls (CMC) industry expert helped by walking us through the FDA CMC Hell where we met all kind of people from pharma companies and heard all kind of interesting ideas on how not to complete the CMC section. We would like to apologize to anyone who accidently learnt something from our entertaining discussion! You can read the transcript of our discussion here: https://solutionsop.co.uk/2026/04/17/visiting-the-9-circles-of-fda-cmc-hell-with-arvilla-trag/

In this episode we are discussing the clinical research opportunities in Japan. Our guest is Tetsu Yung who is a consultant with extensive experience in pharma and CRO industry in Japan. We cover the main requirements for setting up clinical trials in Japan and the timelines for obtaining approvals. We also talk about initiatives from the Japanese government to encourage pharma start-ups to set up in Japan and conduct their clinical research in the country. You can find the script for the interview here: https://solutionsop.co.uk/2026/04/10/clinical-research-opportunities-in-japan-interview-with-tetsu-yung/