Call for Papers – Drug Safety

Call for Papers – Drug Safety

Drug Safety invites the submission of original research articles (up to 6000 words) on the Role of Artificial Intelligence/Machine Learning in Pharmacovigilance for a themed issue of the journal to be published in 2021. The issue is guest edited by Dr. Andrew Bate (GSK) and Dr. Yuan Luo (Northwestern University). With a mix of invited review articles and original research articles, the theme issue will provide a comprehensive coverage of how emerging technologies can affect work tasks and further improve the field of pharmacovigilance.

We welcome proposals for original research articles on the following topics:

  • Methods for identifying safety signals in any or combinations of data source

Author Brief: The article will showcase novel research on how pharmacovigilance can benefit from the continuously increasing number and form of data sources, especially electronic health record data and patient self-tracked/self-collected data. In addition, the article will discuss how machine learning has helped improve identifying safety signals from these data sources for pharmacovigilance.

  • Prediction, in future numbers of adverse events or types of safety outcomes, or change in severity in RCT, PSPs, RWD or other data sources e.g. prospective surveys

Author Brief: The article will showcase novel machine learning methods for predicting outcomes such as future numbers of adverse events or types of safety events, or change in severity in randomized controlled trials (RCTs), patient support programs (PSPs), real world data (RWD) or other data sources e.g. prospective surveys. Of particular interests is how the methods will account for longitudinality and missing data from the above data sources for pharmacovigilance prediction.

  •  Visual pattern recognition in safety

Author Brief: This article will describe the novel application of visual pattern recognition to support signal detection in pharmacovigilance.

  • Developing test sets for assessing machine learning algorithmic performance

Author Brief: The article will showcase efforts for developing test datasets for assessing machine learning performance in pharmacovigilance tasks such as predicting future numbers of adverse events or types of safety events. The article will need to demonstrate rigorous annotation process e.g., inter-annotator agreement evaluation and quality control. Of particular interests is the actual release of a  dataset for pharmacovigilance prediction.

  • Developing frameworks for increasing transparency or explainability of machine learning outputs (including visualization) as well as assessing how to best implement into routine use

Author Brief: The article will showcase efforts for developing novel methods to assess and ideally increase the transparency of machine learning models in predicting pharmacovigilance outcomes either at systemic cohort level or at individual patient level. Adoption and/or implementation of such efforts in real world pharmacovigilance is a plus. Integration of multiple data sources to collate on each other and improve transparency is also a plus. Of particular interests is the open-source release of such a system.

  • Methods work in building capabilities to facilitate case processing and intake

Author Brief: Both regulators and pharmaceutical companies have very complex processes with many steps to get reports into their databases. The article will focus on robotic process automation and machine learning-based approaches to make report entry more efficient and effective.

  • Approaches for assessing quality, reliability, credibility and trust in machine learning outputs

Author Brief: The article will showcase efforts for evaluating quality and reproducibility of machine learning models in predicting pharmacovigilance outcomes either at systemic cohort level or at individual patient level. Evaluation on a large multi-institute dataset is ideal. Detailed error analysis on generalizability and reproducibility is a plus. Of particular interests is the open-source release of such a system to establish some “industrial standard”.

Please submit an abstract describing your proposed paper by 30 April 2021 to nitin.joshi@springer.com. Full papers will be invited by 30 May 2021 and manuscripts due by 31 August 2020.

Drug Safety is the official journal of the International Society of Pharmacovigilance (ISoP) and is indexed in all major databases. It is published by Springer Nature under the Adis imprint.

World Drug Safety Congress Americas 2020: my first virtual conference experience

World Drug Safety Congress Americas 2020: my first virtual conference experience

Last month I “virtually” attended the World Drug Safety Congress on September 2-3, 2020 on behalf of Adis Pharmacovigilance.   Originally scheduled as an in-person conference for March 24 – 25, 2020, due to COVID19, it was rescheduled as a virtual conference in September 2020. 

Continue reading “World Drug Safety Congress Americas 2020: my first virtual conference experience”

Pharmacovigilance in the Middle East: Adis PV attends the regional ISoP meeting

Pharmacovigilance in the Middle East: Adis PV attends the regional ISoP meeting

Springer Nature sponsored the annual meeting of the International Society of Pharmacovigilance (ISoP) Middle East Chapter under the Adis Pharmacovigilance brand, held on the 20th of September 2018 in Dubai. ISoP is an international non-profit organisation which aims to promote pharmacovigilance and enhance the safety and proper use of drugs worldwide. Continue reading “Pharmacovigilance in the Middle East: Adis PV attends the regional ISoP meeting”

The World Drug Safety Congress in Amsterdam addresses key challenges

The World Drug Safety Congress in Amsterdam addresses key challenges

Adis Pharmacovigilance attended the World Drug Safety Congress in Amsterdam on Sept 10th and 11th.

The event has been running for over a decade and is world renowned for its ability to connect key stakeholders in the drug safety field, as well as for leading the way in moving the sector forward.

Senior level drug safety professionals, as well as representatives from sponsors and service providers, met to discuss key topics and showcase solutions.

This year’s theme, Addressing Key Challenges for Safety Professionals, had us prepared for a series of interesting presentations and discussions on the ever growing importance of pharmacovigilance and the challenges connected with ensuring patient safety. Continue reading “The World Drug Safety Congress in Amsterdam addresses key challenges”

Call for papers: Special Issue – Family Spillover Effects of Illness

Call for papers: Special Issue – Family Spillover Effects of Illness

PharmacoEconomics invites the submission of manuscripts with a focus on family spillover effects of illness for a special issue of the journal to be published in 2018.

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Cover image of Pharmaco-Economics

The issue will focus on methods and applications for measuring spillover effects as well as conceptual papers discussing methodological and practical issues.

In a paper previously published in PharmacoEconomics, Guest Editors Eve Wittenberg and Lisa Prosser state:

Caring for an ill or disabled family member imposes a well-documented burden on the caregiver. The benefits of a health intervention may be underestimated if “spillover” effects on family members are not captured, resulting in inaccurate conclusions of economic evaluations.

For the context of this special issue, family spillover is defined as the effect on an individuals’ quality of life due to having a family member with a chronic illness. We consider spillover to include family caregivers as well as non-caregivers. Extensions to larger social networks may also be included with justification (e.g., classmates for children’s illnesses).

Topics of interest include:

  • Applications: Measurement of spillover for specific conditions or populations of interest, inclusion of spillover in cost-effectiveness analyses.
  • Methods: Conceptual frameworks, measurement tools or approaches, methodological or practical issues in measurement; challenges to application in CEA.

Please submit an abstract describing your proposed paper by July 31, 2017 to the Editor, Chris Carswell . Full papers will be invited by August 31, 2017 and manuscripts due in early 2018.

Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis

Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis

AdisInsightThe recent first global approval of sarilumab has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In February 2017, sarilumab (Kevzara™), developed by Sanofi and Regeneron Pharmaceuticals, received its first global approval in Canada for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Continue reading “Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis”

Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment

Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment

The recent first global approval of Baricitinib has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In February 2017, baricitinib (Olumiant™), developed by Eli Lily and Incyte Corporation, received its first global approval in the EU as monotherapy or in combination with methotrexate, for the treatment of moderate to severe rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Continue reading “Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment”

Plecanatide (Trulance™): First Global Approval –new treatment option for gastrointestinal disorders

Plecanatide (Trulance™): First Global Approval –new treatment option for gastrointestinal disorders

The recent first global approval of plecanatide has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

Late January 2017, plecanatide (Trulance™), developed by Synergy Pharmaceuticals, received its first global approval in the USA for the treatment of adult patients with chronic idiopathic constipation (CIC). Plecanatide is an oral guanylate cyclase-C (GC-C) agonist that regulates ion and fluid transport in the gastrointestinal tract. Continue reading “Plecanatide (Trulance™): First Global Approval –new treatment option for gastrointestinal disorders”

Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication

Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication

The recent first global approval of rucaparib has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In December 2016, Rucaparib (Rubraca™), developed by Clovis Oncology, Inc., received its first global approval in the USA for the treatment of ovarian cancer, specifically as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies.1 A marketing authorisation application for rucaparib for the same indication has been submitted to the European Medicines Agency. Continue reading “Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication”