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/

In this episode we are talking with our Senior Clinical Data Quality Manager, Lydia Ainsworth, about animal testing in clinical research.

Join us to learn:

• What are the most common animals used in animal testing,
• The typical cost for using animals in clinical research,
• The ethical issues around using animals,
• When animal testing is needed in drug development
• What are the alternatives of animal testing.

This episode is an analysis of the latest investment trends in research and development in the pharma industry in 2026. You can learn what has changed in clinical research and the way companies invest in developing new drug products. It touches on investment risks, price pressure and the threat from biosimilars.

In this episode of the podcast, we discuss with Richard Vincins, medical device expert from MD Compliance, the medical device registration process in Europe and the challenges that the small and mid size manufacturers face. We also discuss what could be done to help medical device manufacturers to improve market access and innovations in Europe.

The script of this episode will be available soon.

In this episode we talk about clinical trials in primary care and the role of general practitioners (GPs) and family doctors in clinical research with the Dr Daphne Hazell who is a GP and CEO of the biggest GP network in the UK which is involved in clinical research. We discuss the challenges and the benefits of using primary care in clinical research.

You can read our transcript to the interview here: https://solutionsop.co.uk/2026/02/09/the-role-of-family-doctors-in-clinical-research-interview-with-daphne-hazell/

In this episode you can learn about the challenges of conducting clinical trials in Africa but also about some ongoing work which is aiming to create more opportunities for clinical research on the continent. In addition, there are some practical recommendations what could help African countries to establish better clinical research facilities and network.

There is a growing call for more wide-spread prostate cancer screening. In this episode you can learn about the methods used for prostate screening and some promising new research in the field. It will also answer the question why the medical bodies are against the roll out of the screening program to more men.