pharmaphorum

FEBRUARY 10, 2021

As these solutions are further developed, the consortium will produce data collections for validation, regulatory pathways and technical standards. One the partners involved in the project is InSilicoTrials Technologies , a health tech company founded in 2018 by a team of life sciences, cybersecurity, and digital innovation experts.

Drug Development 76

Drug Development Packaging Documentation Hospitals 76

pharmaphorum

APRIL 27, 2021

Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.

Chemotherapy 90

Chemotherapy Documentation Drug Development 90

pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Building relevance. The patient centricity movement has been building momentum in recent years.

Drug Development 98

Drug Development Documentation 98

pharmaphorum

AUGUST 31, 2021

However, like many other emerging healthcare technologies, they have been slow to gain traction and there is still confusion and scepticism around ECAs, stemming from a lack of precedence, step-by-step guidance and data to quantify their impact on drug development costs and clinical outcomes.

Insurance Coverage and Processing 89

Insurance Coverage and Processing Drug Development Documentation Labelling 89

pharmaphorum

SEPTEMBER 11, 2020

In a recent analysis, the Tufts Center for the Study for Drug Development reported that more than two-thirds of all sponsors are using at least four different data sources. Their pool of 155 respondents comes from large pharma companies, biotech companies, device developers, and contract research organisations worldwide.

Data Entry 98

Data Entry Documentation Drug Development 98

pharmaphorum

OCTOBER 29, 2020

The service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE. For PRIMA, the agency quotes Peter Wheatley-Price, market access and pricing director at Takeda UK, who said : “The Takeda team highly regarded the quality of the PRIMA reports and model review documentation.

Documentation 101

Documentation Drug Development 101

European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. Available from: [link] Botanical Drug Development Guidance for Industry [Internet].

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103