When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results

When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results

“The first thing you feel when a trial fails is a sense of shame,” says physician Siddhartha Mukherjee. Then comes the “exhilarating — and dangerous” instinct to slice and dice the data to resurrect the drug’s potential.

Here Siddartha discusses the lure to make more of the science than is perhaps there, when stakes are high and we are desperate to find hope for patients who are out of treatment options. Continue reading “When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results”

1998 Shirov: Bishop to h3! Dubbed an all-time strategic chess move… How do future pharmacovigilance strategies compare?

1998 Shirov: Bishop to h3! Dubbed an all-time strategic chess move… How do future pharmacovigilance strategies compare?

Report: Pharmacovigilance Strategy Meeting, Boston, MA, USA November 2017

In less time than it took for me to travel to the meeting from New Zealand – the day was over! Hard to believe that within a short eight hours, 25 lively roundtables were conducted, two keynote speeches were delivered, and the panel discussed the learning of the day, including challenges of monitoring diverse sources, importance of real-world evidence in the context of risk benefit, and the game-changing impact of artificial intelligence. Continue reading “1998 Shirov: Bishop to h3! Dubbed an all-time strategic chess move… How do future pharmacovigilance strategies compare?”

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.