Fail Early, Fail Fast – and increase Likelihood of approval with biomarkers

Fail Early, Fail Fast – and increase Likelihood of approval with biomarkers

Our partners Amplion recently published an interesting blog post on the benefits of biomarkers in informing earlier decisions in the drug development process – “fail early, fail fast” to save time and money, and increase approval success. An interesting read, check it out! Continue reading “Fail Early, Fail Fast – and increase Likelihood of approval with biomarkers”

Date announced for next safety biomarkers webinar

Date announced for next safety biomarkers webinar

The second in a two-part series of live webinars on Pharmacovigilance and Safety Biomarkers is set to take place on Tuesday, March 21, 2017.

Joining forces with Amplion, the leading biomarker business intelligence company, we aim to provide useful insights for anyone involved in R&D, product strategy decisions, or working directly in a drug safety related role.

During the webinar, our speakers will cover: Continue reading “Date announced for next safety biomarkers webinar”

A brave new world: what does the future hold for pharmacovigilance?

A brave new world: what does the future hold for pharmacovigilance?

Report from the DIA Pharmacovigilance and Risk Management Strategies Conference, January 23-25, 2017, Washington, DC.

Written by Suzanne Berresford, Product Manager, Pharmacovigilance, Springer Nature

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Report author, Suzanne Berresford

The nature of medicinal products is in a rapidly shifting world, with therapeutic innovation becoming a major global trend that is here to stay. The precision medicine approach and use of targeted therapies such as biologicals, gene therapy and stem cell therapy is weaving its way into standard practice but questions still remain about monitoring the long-term safety and efficacy of such advanced therapies. The DIA Pharmacovigilance and Risk Management Strategies Conference set out to discuss some of the challenges and to provide an opportunity for pharmacovigilance professionals to share their experiences in these areas. Continue reading “A brave new world: what does the future hold for pharmacovigilance?”

Adis brings together expert speakers for special webinar on safety biomarkers

The team behind AdisInsight are working in collaboration with their latest partners, Amplion, to host a special live webinar on December 13, 2016, on the topic “Pharmacovigilance and Safety Biomarkers”.

Safety biomarkers offer potential benefits throughout the drug lifecycle. These range from the identification of drug candidates most likely to be tolerated in humans, through to predictive identification of patients most likely to benefit from, or not be harmed by, a treatment.

The webinar will provide an introduction to biomarkers, their characteristics, and current uses in drug safety. Information presented will be of interest to those working in pharmaceutical/biotechnology industries and adjacent markets – including those working in R&D, making strategic decisions, or directly involved in drug safety.

Guest speakers for the session include Nitin Joshi, Editor of Drug Safety – the official journal of the International Society of Pharmacovigilance (ISoP), which is published by Adis.

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Speaker profiles

Registration is free and open to all via the information page: http://www.springer.com/gp/adis/pharmacovigilance-and-safety-biomarkers

The December session will be the first in a two-part series on this topic, the second part of which will be held in late January 2017.

Meeting report: 3rd Annual Risk Management and Pharmacovigilance Summit, Vienna

Meeting report: 3rd Annual Risk Management and Pharmacovigilance Summit, Vienna

Colleagues from SpringerNature recently took part in the 3rd Annual Risk Management and Pharmacovigilance summit in Vienna, with the following meeting report provided by Daniela Ranzani, Adis Business Intelligence Product Manager.

Traditional topics as well as best practice and case-study presentations remain at the core of the meeting, allowing attendees to share knowledge and diverse experiences. Regulation revisions were also discussed, with a spotlight on the GVP Modules V and IX updates. Attention to patients with dedicated programs was highlighted, and a presentation on social media listening reminded us all of the great power represented by such tools when used for PV, which also brings great challenges in terms of carefully managing this type of information. Continue reading “Meeting report: 3rd Annual Risk Management and Pharmacovigilance Summit, Vienna”

Adis publishes white paper on the changing faces of device safety

Wendy McNeely, Product Development Specialist for Adis Business Intelligence, has recently authored a paper on the changing guidelines for medical device safety and the implications for manufacturers.

The paper acknowledges the increased workload related to gathering real-world performance data once a device is on the market, but stresses that there are many benefits to be attained from proactive literature monitoring throughout the lifecycle – from helping to cut costs and time to market to gaining a competitive advantage.

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Benefits of proactive literature monitoring for device safety

Some high-profile cases of safety issues with medical devices from the last decade are also highlighted, demonstrating the need for manufacturers to do all that they can to decrease the risk of devices causing harm once they get to market.

The full paper is available to download here .