Author: GMDP Academy Editorial Board

Time to end the stigma of epilepsy

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An awareness campaign to dispel misconceptions about epilepsy was launched on International Epilepsy Day. In a joint statement on Feb 13, the organizations behind the campaign—the International Bureau for Epilepsy (IBE) and the International League Against Epilepsy (ILAE)—called for “greater understanding and intersectoral action to tackle the stigma and discrimination faced by people with epilepsy worldwide”. This campaign is timely because strengthening the public health response to epilepsy is one of the five strategic objectives of the Intersectoral Global Action Plan on Epilepsy and Other Neurological Disorders 2022–2031 (IGAP), and ending stigma and discriminatory legislation are key components of this strategic objective.

Benefits, Limits, and Risks of GPT-4 as an AI Chatbot for Medicine

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The uses of artificial intelligence (AI) in medicine have been growing in many areas, including in the analysis of medical images, the detection of drug interactions, the identification of high-risk patients, and the coding of medical notes. Several such uses of AI are the topics of the “AI in Medicine” review article series that debuts in this issue of the Journal. Here we describe another type of AI, the medical AI chatbot. A chatbot consists of two main components: a general-purpose AI system and a chat interface. This article considers specifically an AI system called GPT-4 (Generative Pretrained Transformer 4) with a chat interface; this system is widely available and in active development by Open AI, an AI research and deployment company.

Human medicines highlights from the EMA

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In 2022, EMA recommended 89 medicines for marketing authorization. Of these, 41 had a new active substance which had never been authorized in the European Union before. The overview of the 2022 key recommendations published today includes figures on the authorization of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.

The new shape of the Italian ethics committees

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The European Clinical Trials Regulation, approved in 2014, was implemented on January 31, 2022. The Italian Ethics Committees had still no indications how to operate, and this lack of directions caused delays. Finally, In February 2023, the Ministry of Health issued all necessary guidelines to make the new ECs fully operational. It is useful to underline that Italy has a good record for European clinical trials, running more than 21% of the total number of studies.

Curiosities about DNA discovery

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This year we celebrate the 80th anniversary of DNA discovery. The discovery in 1953 of the double helix, the twisted-ladder structure of deoxyribonucleic acid (DNA), by James Watson and Francis Crick marked a milestone in the history of science and gave rise to modern molecular biology, which is largely concerned with understanding how genes control the chemical processes within cells. In short order, their discovery yielded ground-breaking insights into the genetic code and protein synthesis. During the 1970s and 1980s, it helped to produce new and powerful scientific techniques, specifically recombinant DNA research, genetic engineering, rapid gene sequencing, and monoclonal antibodies, techniques on which today’s multi-billion dollar biotechnology industry is founded. Major current advances in science, namely genetic fingerprinting and modern forensics, the mapping of the human genome, and the hopes linked to gene therapy, all have their origins in Watson and Crick’s inspired work. The double helix has not only reshaped biology, but it has also become a cultural icon, represented in sculpture, visual art, jewelry, and toys.

Announcing the 2023 Global Fellows award ceremony & the Digital Capabilities in Medicines Development Symposium in London

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We have exciting news to share! After canceling our 2020 award ceremony due to Covid-19, we are thrilled to announce that the time has finally come for us to gather once again. On May 22, we will celebrate our first and second groups of Global Fellows in Medicines Development in London at King’s College facilities. This will be an amazing opportunity to network, learn and exchange ideas with some of the brightest minds in the field. The event will focus on Digital Capabilities in Medicines Development, a topic of great importance in today’s world. Whether you can join us in person or virtually, we invite you to come and be a part of this special celebration and hope to see you there!

Global trends in R&D in 2023

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There is now overwhelming evidence to support lowering LDL-c (low-density lipoprotein cholesterol) to reduce cardiovascular morbidity and mortality. Statins are a class of drugs frequently prescribed to lower cholesterol. However, in spite of their widespread use, discontinuation and nonadherence remains a major gap in both the primary and secondary prevention of atherosclerotic cardiovascular disease. The major reason for statin discontinuation is because of the development of statin-associated muscle symptoms, but a range of other statin-induced side effects also exist. Although the mechanisms behind these side effects have not been fully elucidated, there is an urgent need to identify those at increased risk of developing side effects as well as provide alternative treatment strategies.

Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients

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There is now overwhelming evidence to support lowering LDL-c (low-density lipoprotein cholesterol) to reduce cardiovascular morbidity and mortality. Statins are a class of drugs frequently prescribed to lower cholesterol. However, in spite of their widespread use, discontinuation and nonadherence remains a major gap in both the primary and secondary prevention of atherosclerotic cardiovascular disease. The major reason for statin discontinuation is because of the development of statin-associated muscle symptoms, but a range of other statin-induced side effects also exist. Although the mechanisms behind these side effects have not been fully elucidated, there is an urgent need to identify those at increased risk of developing side effects as well as provide alternative treatment strategies.

Clinical Trial Diversity Continues to Face Challenges

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Policymakers and biopharma companies acknowledge the importance of assessing drugs and medical products on a wide range of ethnic and racial populations to fully understand medical effects on patients. This has bolstered support for studies to enroll patients in proportion to the prevalence and burden of the disease in relevant subgroups, but achieving such equitable patient representation in clinical trials has been difficult and uneven, at best.

Quality control and childhood cancer medicines

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On Jan 25, 2023, the Bureau of Investigative Journalism published devastating evidence that at least 70000 children with cancer in 90 countries globally are at risk of being treated with contaminated and low-quality asparaginase, a chemotherapeutic drug used mostly in the treatment of childhood acute lymphoblastic leukemia. The investigation showed that at least seven manufacturers continue to sell their products despite being warned that they do not meet minimum quality assurance.

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