The latest advancements on the use of artificial intelligence in drug development

Approximately 50% of late-stage clinical trials fail due to ineffective drug targets, meaning only 15% of drugs advance from Phase II trials to approval. Artificial intelligence (AI) can help to enhance drug development by making more accurate predictions in novel areas of biology and chemistry. Read more “The latest advancements on the use of artificial intelligence in drug development”

How can drug development be augmented for the treatment of hepatitis D?

Hepatitis D (HDV) is a replication-defective viral infection that uses the hepatitis B (HBV) surface antigen as its envelope protein. HDV infection can be associated with severe liver disease which can lead to cirrhosis, hepatocellular carcinoma and liver failure. Presently, there are no drugs approved for the treatment of this life-threatening disease. Read more “How can drug development be augmented for the treatment of hepatitis D?”

MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit

In the event of a no-deal Brexit, reference medicinal products (RMP) for new generic medicines or abridged marketing authorisation applications will be required to comply with the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs). Comparator products (CP) used in these applications will need to be representative of the RMP. Read more “MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit”

How can novel, non-randomised analytic methods be validated for regulators? The EMA discusses

Real-world evidence (RWE) such as electronic health records (eHRs) can be combined with patient-level data from completed randomised controlled trials (RCTs) and new data sources such as social platforms, to potentially understand more about drugs’ benefits and risks. Read more “How can novel, non-randomised analytic methods be validated for regulators? The EMA discusses”

The Food and Drug Administration has finalised a guidance which will assist sponsors in designing and conducting non-clinical studies of investigational ERT products

Enzyme Replacement Therapy products are used to treat a wide range of metabolic disorders which have resulted from inherited defective genes (for example; Gaucher disease, Fabry disease or Pompe disease).

Read more “The Food and Drug Administration has finalised a guidance which will assist sponsors in designing and conducting non-clinical studies of investigational ERT products”

Did you know that the Enpr-EMA has published a draft framework regarding paediatric clinical trial preparedness?

The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has invited relevant stakeholders, and anyone involved in the preparation and conduct of paediatric clinical trials, to send comments on the draft framework released about paediatric clinical trial preparedness. Read more “Did you know that the Enpr-EMA has published a draft framework regarding paediatric clinical trial preparedness?”

MHRA updates guidance on substantial amendments to a clinical trial if there is a no-deal Brexit

The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their no-deal Brexit guidance which covers significant amendments to a clinical trial. This includes changes to the trial sponsor/legal representative, investigational medicinal product (IMP) certification and importation and amendments to the Research Ethics Committee (REC). Read more “MHRA updates guidance on substantial amendments to a clinical trial if there is a no-deal Brexit”

EMA study outlines how patient registries may prove valuable in regulatory decisions

Patient registries can be heterogeneous in their quality and design, however a new study in Drug Safety co-authored by a European Medicines Agency (EMA) official outlines how patient registries may provide valuable data for regulatory decisions. Such registries may be used when randomised controlled trials are not feasible, for example with some rare diseases, or to meet post-marketing commitments. Read more “EMA study outlines how patient registries may prove valuable in regulatory decisions”