What struck me most about many of the presentations at the recent DIA Pharmacovigilance and Risk Management Strategies conference (27-29 January in Washington DC) was that the future is already here, because change is already happening. For the last 2-3 years, many sessions at PV conferences focused on the potential of game-changers such as artificial intelligence, real-world evidence, personalised medicine and social media: Can we utilise these? What role do they play? Are they effective? It seems that the time is now for such concepts to be embraced by the industry and regulators alike in the pharmacovigilance world. And all of this against the backdrop of Brexit coming to fruition. Continue reading “The future has arrived – report from the DIA PVRMS Conference 2020”
Economic Consequences of Major Depressive Disorder
PharmacoEconomics invites the submission of papers (original research, reviews, opinion and tutorial pieces) on the economic consequences of major depressive disorder (MDD) for a themed issue of the journal to be published in 2021 and guest edited by Paul Greenberg (Analysis Group). We encourage papers from the perspectives from a variety of stakeholders including payers, health technology assessment bodies, health economists, clinicians, pharmaceutical industry, policy makers, patients and caregivers, and advocacy groups. Special patient population perspectives (e.g. youth, comorbid populations, aged) and papers employing novel methods are particularly encouraged. Papers can be either methodological or applied.
Topics of interest include:
- Epidemiologic estimates of MDD and its treatment
- Economic and Humanistic Burden
- Direct and indirect costs
- Employment effects
- Spillover effects
- Quality of Life
- Cost Effectiveness of Treatment
- Models, trials or database analyses
- Stated Preferences
- Discrete choice experiments
- Utility estimation
- Methodological Challenges
- Special patient populations
- Impact of adherence
- Modelling (treatment sequences, combination treatment, defining health states)
- Challenges in conducting database analyses
- Estimating workplace burden
- Precision medicine
- Placebo effects
- Behavioural interventions
- Treatment adverse effects
- Distinguishing PRO and QALY data from data gathered using diagnostic instruments
Please submit an abstract describing your proposed paper by June 30th, 2020 to firstname.lastname@example.org. Full papers will be invited by July 31st 2020 and manuscripts due by November 30th 2020
From January 2020, Reactions Weekly (https://link.springer.com/journal/40278) – an Adis newsletter – will have a new focus and features.
Reactions Weekly provides readers with the latest and most important news and research relating to drug safety. It has published drug safety news for almost 40 years, producing over 1700 issues. It offers readers a significant saving in the time and effort required to research and keep up to date with the thousands of information sources reporting drug safety information. This information is provided in a concise and convenient weekly update.
Over time, it has become increasingly challenging to find relevant drug safety information in Reactions Weekly because of our focus on providing extensive coverage of the large volume of articles published in the biomedical literature. Therefore, we are introducing changes to the content of Reactions Weekly from 2020 to streamline the product and improve the reader experience.
The changes we are introducing will focus the content on the most clinically important adverse reaction news of significance to healthcare practitioners, researchers and regulators. The new features will increase our coverage of drug safety research, simplify the presentation of case report articles, and improve the ability to identify key data at a glance.
Specifically, the changes include:
- To increase our coverage of drug safety research, there will be a table of additional drug safety news articles relevant to our readers (see example 1).
- To streamline the presentation of case report articles, author comments and reporter country will be removed to focus on the most relevant information for our target readers.
- To make it easy to identify the key data at a glance, non-serious case reports will be presented in a table rather than as individual articles (see example 2).
We look forward to presenting the new features to you in 2020. If you have any questions, please contact Pauline.email@example.com.
Year after year our customer research has indicated that end users needed more information about the patent protection for the drugs they were analyzing with AdisInsight. They wanted to answer questions like when a generic version of a branded drug will be available, which countries are covered and not covered by patent protection, and what patent extension strategies are available to prolong market exclusivity. We studied the current user journeys of our users and found they almost always ended with an expert patent searcher or patent attorney searching one of the existing patent databases because these complex resources require special skill to use them correctly.
In 2017 we set out to enhance the patent information available in AdisInsight. We conceived of a simple and intuitive tool that would allow our users to discover patent information themselves in order to inform strategic decisions. This would translate into quicker answers and use fewer resources compared to their current approach involving patent attorneys directly. We had tried this many times before only to find the task of grouping the patents pertaining to a specific drug too difficult. This time our content development team identified and evaluated several potential partners who could provide drug-based patent information. Think BioTech rose to the top due to their ability to associate patents with the specific drugs they apply to. At the end of 2017 a partnership agreement was reached with Think BioTech (click here to read the press release) to supply AdisInsight with patent content for marketed drugs.
Once the agreement with Think BioTech was in place, stakeholders from product management, content development, IT&P, UX design, and IT developers came together to create the product vision for AdisInsight Patents, mock-up how patent information would be displayed to meet the needs of end users, and develop a plan to implement our MVP.
In March 2018 I went on the road with our lead UX designer, our business analyst, and one of my product manager for AdisInsight to conduct User Experience testing to validate the designs developed met customer needs. We conducted 13 end user interviews across pharma, biotech, and consulting. The results showed that our design placing an emphasis on displaying specific formulations of a drug missed the mark. In true agile form we rapidly arranged another stakeholder meeting to digest the UX findings and pivot our design.
The first iteration of the AdisInsight Patents module was made available to customers on August 31, 2018. It provided patent information for specific drugs organised in separate Drug Patent Profiles. Each Drug Patent Profile summarizes the key information from global patents and regional exclusivities protecting that specific drug and presents key information such as patent number, expiry date, claim type and country in easy to read tables allowing users to visualize the protection landscape globally. Subsequently enhancements were added to AdisInsight Patents to satisfy additional user needs. Adis Patent Detail Sheets were added to present key information about a specific patent such as title, abstract, inventors, assignee, application number, source, and claim details. This allowed users to drill down from the Drug Patent Profile to get more information about a specific patent protecting the drug they are investigating. Later link to the source document at the United States Patent and Trademark Office website or the World Intellectual Property Organization website were added to allow the user to click through to the source patent document.
The intuitive AdisInsight search interface makes identifying patent information easy for users. The new AdisInsight Patents module utilizes the same familiar search terms such as drug name, indication, mechanism of action, drug class, formulation, location and company used throughout all of the AdisInsight modules. These powerful search terms are enabled through manual indexing using controlled vocabularies and synonyms. This produces highly precise search results and minimal noise, especially when compared to free text or Google-like searching.
It has been a very interesting journey. One that ultimately led to a patent product that is proving valuable for our end users as they work to develop better drugs to treat disease. But this is just the start of the journey we will continue to add more content and more functionality to AdisInsight in the months to come.
Themed Issue – Patient and Public Involvement in
Health Economics Research (HEOR)
The disability movement first coined the phrase “Nothing about us without us” in the 1990s. Since then, the idea has widened and public and patient involvement (PPI) in health research has grown to be the norm. Patients and the public are no longer merely subjects or recipients of health economics and outcomes research (HEOR), we are now engaging with them as active research partners and collaborators, including as co-investigators and co-authors.
The Patient invites the submission of papers (original research, reviews and commentaries) on the role of patients and the general public in HEOR for a themed issue of the journal to be published in early 2020, guest edited by Paula Lorgelly (King’s College London).
We encourage papers that highlight innovative ways researchers have engaged patients and/or the public, projects that have trained patients/the public in order to increase their understanding of HEOR, and papers that have measured and quantified the value of patient/public engagement to their project. Country-specific perspectives are also encouraged particularly given that different funding bodies have varying requirements and standards regarding PPI. Papers can be either methodological or applied. Article types can be original research, thought pieces or reviews.
Topics of interest include:
- Patients and the public as collaborators, including generating research questions
- Patients and the public as trialists or modellers, i.e. designing methods
- Training patients and the public to increase/improve their value to projects
- Comparison of different engagement approaches, including PPI in HEOR projects vs other types of studies
- Comparisons of projects involving patients versus those involving the public
- Lay patients vs professional patients
- The role of patient groups and/or research charities
- PPI and conflicts of interest
- Risks and benefits of greater PPI in HEOR
Note we are specifically interested in the role of patients and the public in HEOR; papers either on PPI in funding decisions (for research funding or technology adoption) or on outcome measures that are not preference based or use patient values while of interest to the journal are outside of the scope of this themed issue.
Please submit an abstract describing your proposed paper by 31st August 2019 to firstname.lastname@example.org. Full papers will be invited by 30th September 2019 and manuscripts due early 2020.
This was the subject of many discussions at the recent World Drug Safety Congress Americas 2019 in Philadelphia. As has been the case at many pharmacovigilance meetings in the last few years, artificial intelligence, outsourcing solutions and automation were hot topics, with debates over the future use of such strategies to achieve operational efficiency whilst strengthening patient safety. Continue reading “Safety strategies and efficiencies – what is the best solution?”
In March 2019, the small molecule brexanolone was approved by the United States Food and Drug Administration (FDA) for the treatment of postpartum depression (PPD) in adult women. Brexanolone, developed by Sage Therapeutics under a license from the University of California, was granted priority review status and breakthrough therapy designation by the FDA. Continue reading “Brexanolone (Zulresso™): First Global Approval – First approved therapy for postpartum depression”
I recently attended the 7th DIA India Pharmacovigilance (PV) Conference in Mumbai. One of the sessions was dedicated to the Impact of Artificial Intelligence (AI) and Predictive Sciences in the world of PV. The session was moderated by Moin Don and Anju Agarwal; the panel comprised Mengesh Kulkarni, Saikat Biswas, Retesh Kumar and Saurahb Khurana.
The interaction between the panel of guest speakers and the open floor reminded me of the Mumbai traffic: it was frenetic, loud, comprised of many different thought vehicles and yet despite all this – it traveled in the same direction without any head-on collisions! Continue reading “Artificial Intelligence: organised chaos or chaos ordered?”
It is likely that in one’s lifetime a friend or family member will be diagnosed with Alzheimer’s disease. As of 2018, approximately 50 million people worldwide are living with dementia and this number is expected to triple to 152 million by 2050.
Despite the increasing prevalence of the disease, no new drugs have been approved for the treatment of Alzheimer’s since 2003. An article recently published on PharmaTimes proclaims, “The search for a cure for Alzheimer’s is far from over.”
This first session of the conference, chaired by J Vijay Venkatraman, gave the audience a broad overview of the state of flux in pharmacovigilance, essentially resulting from changes initiated in Europe – the impact of evolving Eudrovigilance, Brexit and E2B R3 were the focal points. Continue reading “DIA India 2019: Regulatory Trends in Clinical Safety & Pharmacovigilance (An EU perspective).”