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In response to the worldwide prevalence of type I and type II diabetes, the pharmaceutical industry has seen a record number of experimental anti-diabetic drugs go into development. However, the industry’s R&D productivity crisis does not spare this therapeutic area as failure rates of such drugs remain high due to the complexity of the disease, common side effects, and regulatory hurdles. A relatively recent challenge surrounds the design of drugs and planning of trials so they meet the FDA’s regulations on not only metabolic efficacy, but also cardiovascular safety. It has also been announced that the EMA is updating their guidance to address cardiovascular outcome studies in clinical investigations of diabetes products.
There remains a significant need for innovative anti-diabetic drugs to address unmet needs both effectively and safely. The benchmark for novel anti-diabetic drugs includes factors such as: a dual target of both diabetes and obesity; achieve long-term glycaemic control; reduce multiple cardio-metabolic risk factors; and capitalize on recent advances in pharmacogenomics. The success of these therapies hinges on careful drug candidate selection and careful early phase clinical trial planning. Target and biomarker validation, immunogenicity, drug compatibility, and delivery methods should also be carefully considered in demonstrating product value. An increasingly important consideration is also predicting how the therapies will translate into real-world practice. Too often clinical trials are performed on a highly selected patient population with a very specific treatment protocol. The robust clinical data that had originally satisfied the stakeholders can suddenly become irrelevant as clinicians find themselves treating a more diverse patient community. An early development program should also address the issues of external validity and the prediction of sustainability.
This interactive half-day webinar presents important perspectives from industry, institutes, and regulators as they take a detailed look at the current type 2 diabetes drug scene and give an analysis of the future outlook. Viewers can not only learn about the scientific, clinical, and regulatory challenges, but also how to implement strategies that apply to long-term success. The aim of this web-based seminar is to allow participants to gather up-to-date information necessary to make strategic decisions regarding developing early-phase anti-diabetic drugs while satisfying regulatory requirements.
04. Walter Janssens PhD - Preclinical aspects of bringing experimental diabetes drugs into first-in-human studies: A regulatory perspective
