The Academy newsletter recently included a publication speaking to the importance of vaccination to eliminate infectious diseases as well as the report that polio was very close to its eradication. But what happened? The war in Pakistan and Afghanistan halted vaccination campaigns, and the virus took the opportunity to continue its spread, arriving in the UK and the United States.
The IFAPP Academy has inaugurated a Global Fellowship of experts and those experienced in the development of medicines with the aim to advance the disciplines involved in pharmaceutical medicine/medicines development to gain competence and professional identity amongst their membership. In 2020, 117 individuals from 24 countries received the Global Fellows in Medicines Development (GFMD) award.
It is well-known that the 2022 Nobel Prize was won by Dr. Svante Pääbo, a Swedish geneticist, for his studies on human evolution. But why are these studies so important, and how can his discoveries be put to practical use? This article from the Lancet includes some answers to these questions. Namely, Dr. Pääbo’s work examines a fundamental question of human physiology: what is it that makes us human?
The migraine landscape has evolved over the past 20 years, with refinements in classification and research design, a surge in new treatments developed with intent and not by chance, the emergence of 21st-century migraine genetics, and a refocusing on peripheral and central pain mechanisms (figure). One notable advancement has been the development of the International Classification of Headache Disorders (ICHD), presently in its third edition: the ICHD has provided standardized case definitions and nomenclature for migraine, including the first definitions of chronic migraine and medication overuse headache, as well as uniform criteria for patient selection in worldwide clinical research.
The climate of our planet is rapidly changing, and this may have serious global consequences. In particular, Africa seems to be the continent more seriously affected by climate change. A group of editors of African Medical journals composed an editorial and we have included some key insights from the editorial below.
The European Medicines Agency has launched a public consultation for the first release of the Data Quality Framework for the EU medicines regulation.
The draft Data Quality Framework document provides general considerations that can be applied to a wide range of data sources for the purpose of characterizing and assessing data quality for decision-making. It also outlines what data quality actions and metrics can be put in place in different regulatory decision-making scenarios and introduces maturity models for the characterization of data quality for regulatory purposes.
The IQVIA Institute recently published a report on biopharma companies. Important findings include.
There are nearly 4,000 products in clinical development by emerging biopharma companies, which does not include research programs where emerging biopharma companies may be partnering with larger companies.
Since 2011, the emerging biopharma pipeline more than doubled, growing 165% with much of that growth coming in the last five years.
The emerging biopharma R&D clinical pipeline has grown on average 18% annually over the last five years, compared to just 11% for the pipeline across all company sizes, highlighting the increasing important of emerging biopharma to the development of new therapies.
Larger companies have seen slower growth over the last five years with large pharma averaging 2% growth annually, mid-sized companies averaging less than 1% growth annually and small companies averaging 3% growth annually.
CIOMS (COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. The CIOMS mission is to advance public health through guidance on health research and policy including ethics, medical product development and safety. CIOMS is in official relations with WHO and is an associate partner of UNESCO.
Medical Affairs professionals are familiar with the importance of corroborating clinical evidence regarding new drugs from Phase II and III trials with results obtained from real-world evidence (RWE) studies. The included publication references RWE data related to oral antivirals in the treatment of COVID-19.
The EMA released its final favorable qualification opinion providing a regulatory framework for the application of the TwinRCT™ solution in Phase 2 and 3 clinical trials. The three-step PROCOVA™ procedure is the foundation for TwinRCTs and describes how to use patient-specific prognostic scores derived from digital twins to reduce clinical trial sizes while controlling Type-1 error rates. This qualification opinion represents the first time a regulatory body has formally supported a machine learning-based method for reducing sample size in pivotal trials.