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Why are biomarkers particularly critical in the context of rare diseases? Developing novel therapeutic approaches for rare diseases poses inherent challenges due to the limited populations available for testing. How do AI-enhanced approaches accelerate the drug development process for rare diseases?
I am a pharmacist by training and continued with a PhD in ClinicalPharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as ClinicalResearch Manager at AstraHässle, a mid-size Swedish pharma company.
One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.
Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, rheumatoid arthritis , lupus and inflammatory bowel disease.
Dr Nurbhai has more than 25 years of experience and a strong track record in the strategic and operational leadership of all phases of clinicalresearch and development at companies across Europe and the US. The Company is managed by a team with broad international, commercial and clinical-science experience.
In the therapeutic study in patients with recurrent and/or metastatic disease (n=12), treatment was shown to be tolerable but there was no signal of efficacy, with median PFS less than two months in 9 evaluable patients. Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of ClinicalResearch at the Anticancer Fund.
12/29/2023 FDORA, Section 3607 Clinical Trials Modernization : FDA must issue or revise draft guidance regarding “the use of seamless, concurrent, and other innovative clinical trial designs.” The content will include both goals for enrollment of populations and rationales for those goals.
District Court March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.
EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.
Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinicalresearch. For example, elderly individuals are more prone to comorbidities, dementia, and functional decline.
Basket Trials and the Evolution of Clinical Trial Design in an Era of Genomic Medicine. Journal of Clinical Oncology, 33 (9), 975977. Adaptive Clinical Trial Design in Oncology: An Overview. ClinicalPharmacology & Therapeutics, 86 (1), 97100. Barker, A. Food and Drug Administration. FDA.gov biotx.ai
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