The Premier Consulting Blog

JUNE 18, 2023

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.

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Drug Discovery World

NOVEMBER 9, 2023

These include: Samantha Bailey-Bucktrout, PhD, Senior Vice President, Akamis Bio, on: ‘Tumour specific immunogene therapy to deliver protein therapeutics to solid tumour microenvironments’. Jonathan Fisher, PhD, Group Leader, University College London, on: ‘Local secretion of immune active proteins for direct and bystander tumour killing’.

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Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.

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Drug Discovery World

AUGUST 15, 2023

Such techniques, if routinely deployed in drug discovery, may enable improved decision making in predicting serious adverse cardiovascular events. Cardiovascular diseases are the leading cause of death globally. Unexpected late-stage failures in drug development are, of course, the costliest.

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The Pharma Data

FEBRUARY 8, 2021

Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent of patients in the combination arm versus 56.2

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Of note: A government shutdown would likely delay or cancel some of the events listed below.

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Agency IQ

FEBRUARY 23, 2024

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. LILLIAN SIU, an oncologist and clinical trialist at Toronto’s Princess Margaret Cancer Centre, was a panelist on the day’s second session.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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