Afleveringen
-
In this episode you can learn about the unique challenges that startups and small pharma companies face and how the regulators can help new products to reach the market. While many regulatory agencies have members coming from big pharma companies their experience may not be sufficient to understand the drug development issues that small pharma companies have to deal with.
-
This episode has some key advices for pharma and biotech startups which are looking to set up their first clinical trial. It discusses budget, selecting the right vendors, regulatory strategy, protocol design and the risk assessment that startups need to do before they start.
-
Zijn er afleveringen die ontbreken?
-
Our analysis on Eisai And Elly Lilly Alzheimer's Clinical Trials scandal. It involves 2 drugs -Leqembi, manufactured by Eisai and Kinsunla, manufactured by Eli Lilly. Both drugs are used to treat Alzheimer’s and they have known side effects of brain bleeding or swelling. It is also known that some patients have genetical predisposition to experience such brain injury. However, some patients died during the Eisai study and many had brain injury adverse events with different severity. There is a discussion on what could have been done to handle the situation better.
-
This episode of the podcast is providing an overview of METRIC Framework and practical advice on assessing the quality of medical data which is used to train AI. It covers common issues with medical data quality and how these could be tackled.
-
This episode is dedicated to clinical trials diversity plans. It discusses what are the current regulations in the USA and Europe, why do we need diversity plans and some recommendations how to improve diversity in clinical trials.
-
Sometimes clinical trials go wrong for various reasons and they need a study rescue. The study rescue requires experienced team who can step in and help bring back the clinical trial to compliance. In this episode you can learn what are the common issues with the clinical trials that end up needing rescue and some practical advices on how to avoid these issues.
-
The latest episode is about digital therapeutics and what can we expect from them in the future. There is also a discussion on the latest report from MHRA on mental health digital therapeutics and the feedback from users and specialists.
-
This episode is an analysis of the changing genomic data regulations and some upcoming biosecurity regulations and how they could affect clinical research. It covers the following regions: China, USA, UK and the EU.
-
This episode is dedicated to the budget and contract process for clinical trials in the UK. The main topic is what is the current process, what works and what doesn't and how we can improve it.
-
Can a clinical trial fail because of poor protocol design? You can learn the answer in this episode which reviews a real life case of a clinical trial which failed because of its protocol design.
-
This episode is about patients' involvement in clinical trials and the challenges and benefits for the industry of involving patients in the study design and review of patient facing materials. While it is easy to engage patients in academic and social research, there are some unique challenges for pharma and biotech companies.
-
This episode is about the Research Ethics Committees in Europe and some of the challenges that they will face in the future. It also covers some of the existing challenges that everyone in the biotech and drug development industry faces when dealing with Ethics Committees. At the end, as always, there will be some recommendations how to improve the current practices and address the challenges.
-
The extended access scheme allows patients to have early access to drugs which are not approved on the market but have shown potential in clinical trials. In the UK for the last 10 years were treated over 1,200 patients while in the USA just in 2022 were treated 2,417 patients. Why is that difference? You can learn more from this episode and what could be done to improve access to medications to more patients in the UK.
-
This episode is dedicated to some of the main challenges that small pharma and biotech companies face. While funding is a critical one there are other issues like selecting the right consultants and vendors and optimising your clinical trials protocols in order to reduce your costs. There is a discussion on some options to optimise the cost of clinical trials.
-
In this episode are summarised some of the main data protection challenges in artificial intelligence shared during the conference from Information Commissioner's Office.
-
In this episode I will share some insights from BIVDA mid year meeting and discuss the issues the industry faces in bringing their diagnostic devices to the NHS. I will also suggest on how some of these could be tackled successfully.
-
This episode is dedicated to IDEAL Framework and how it could be used to support surgical innovations. The episode is a brief overview of IDEAL and its classifications.
-
This episode is dedicated to using placebo in surgical clinical trials; the ethical aspects and what needs to be considered when setting up such clinical trials. Special attention is given to ASPIRE (Applying Surgical Placebo in Randomised Evaluations) guidelines.
-
This episode is dedicated on real work evidence (RWE) and the benefits and challenges of using such data in research and in support of marketing authorisations. I am also discussing how to improve the quality of real world data when designing your clinical trial.
-
In this episode I will be talking about placebo clinical trials. I will discuss why we have placebo clinical trials; if they are ethical and what needs to be considered when designing such trials.
- Laat meer zien
