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Preparing the next generation of drug discovery scientists

Drug Discovery World

After just one cohort of students, the Clinical Pharmacology degree at St George’s University has been named the UK’s best pharmacology course. The ideas for the course began to germinate in 2016, when co-directors Professors Baker and Greenwood were asked to create a new degree. Providing a broad view.

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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

The drivers behind the demand for ADCs Providing more targeted therapeutic options in the oncology space has underpinned the rapid growth of the ADC market; between 2016 to 2020, the US ADC market grew by 45 percent to a value of nearly $1.5 Translational and Clinical Pharmacology [Internet]. 2022 [cited 2023 Feb 10];30(2):71.

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In Silico Modeling Unveils a New Era in Rare Disease Drug Development

The Premier Consulting Blog

This reflects the FDA’s long history of reviewing submissions that implement CM&S across a broad range of areas, including quantitative clinical pharmacology, dose-response modeling, benefit-risk assessment, complex innovative designs and disease modeling/trial simulation.

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Re-assessing the risks of drug-induced arrhythmias during drug discovery

Drug Discovery World

The pre-clinical pharmacological effects observed in such experimental model systems need to translate meaningfully into human clinical data to guide effective decision making in drug discovery. Journal of Cardiovascular Pharmacology, 20: S96-105 Aktas et al. Clinical Pharmacology & Therapeutics.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

In August 2016, the CHPA provided a lengthy comment asserting, essentially, that the petitioners had already sought relief in its earlier petition and that the Nonprescription Drugs Advisory Committee (NDAC) had addressed the concerns raised again in this latest petition. The two sides saw nearly every finding in a different light.

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Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.”

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Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. Whereas the prior workshops focused on certain types of therapies or the use of combination products, this newest workshop was designed to discuss “quantitative approaches to select dosages for clinical trials.”

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