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”

Improve your biomarker intelligence with Adis and Amplion

Adis will join forces with  new partners, Amplion, to deliver a series of expert webinars over the coming months. The first of these, taking place on October 25th 2016,  will explore how top organisations manage clinical information and, in particular, biomarker information.

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Ball curve image

During this live webinar, you will learn:

  • Why biomarkers are important at different points of the healthcare value chain
  • How highly-effective companies manage their clinical information
  • How the collaboration between Adis and Amplion can help to move you up the biomarker intelligence maturity model

The webinar is free and open to all. Please register here.

Free access to AdisInsight content on the Zika virus

AdisInsight profiles relating to the Zika virus are now available to access for free, as part of Springer Nature’s pledge to share data that can support public health emergencies.

Springer Nature is part of a group of leading global health bodies including academic journals, NGOs, research funders and institutes that published a joint statement earlier this year, committing to share data and results relevant to the current Zika crisis and future public health emergencies.

In line with this, Springer Nature is opening up its resources related to the Zika virus to help students, researchers, health care professionals, and other scientifically minded individuals to better understand the multidisciplinary approach to containing the virus and caring for patients.

We’ve included open-access links to drug profiles and clinical trial profiles from AdisInsight relevant to the Zika virus:

Drug profiles: 

Trial profiles:

Additional research has been organized into various disciplines and made freely available – this includes articles, commentaries, blog posts and news items. To view all of the content available, please visit the landing page.

If you are interested in learning more about AdisInsight, please complete your details in the form and one of our colleagues will be in touch

Complete the form

Adis partnership with Amplion delivers biomarker data to AdisInsight users

Adis, a leading global provider of drug information, has entered into a partnership with Amplion, market-leaders in biomarker information, to enrich drug and clinical trial content in the AdisInsight platform with curated biomarker data.

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Amplion logo

The new data is fully integrated into the AdisInsight platform meaning that users can perform quick or advanced searches across the data, view biomarker information within drug and trial profiles, and include it with exports and alerts. Existing customers will automatically benefit from the addition of biomarker data as part of their subscription.

Mirko Walter, Director of Product Management for Adis Business Intelligence states:

“It is very important for us to work with a partner that shares our commitment to providing scientifically accurate content. The work that Amplion does in this space with BiomarkerBase is unparalleled and we are proud to be working with them to deliver an even more valuable service to our customers.”

Established in 2012, Amplion have quickly grown to dominate the global biomarker business intelligence market. Their flagship product, BiomarkerBase is the leading source of information about biomarkers used in drug development and diagnostic tests, tracking almost 80,000 biomarker uses worldwide by over 800 companies across 20 therapeutic areas.

Amplion’s CEO, John Zicker, says:

“Working with Adis will allow us to distribute our information in a context that will help pharmaceutical and diagnostic companies better leverage biomarkers to triple clinical trial likelihood of approval and to improve top lines through improved product portfolio management. As a growing company we are ecstatic to be working with such a strong partner.”

This exclusive combination of data sets will support greater efficiency in R&D programs as users will be able to identify key biomarkers associated with a drug and understand how they were used in clinical trials to improve outcomes, and to reduce timelines. The enriched data will also provide greater insights into drug and disease landscapes, helping companies to identify new opportunities.

Biomarkers play a vital role in drug development and therapy. During the clinical phases, they can cut trial timelines through the use of progression and predictive markers and increase likelihood of approval by refining patient selection. In addition, they can be used to identify new drug targets for research and development.  In the clinic, biomarkers are critical to patient care with advanced diagnostic tools and the development of precision medicines tailored to individual patients.

Adis will also provide Amplion with granular drug information to enable more sophisticated analyses within BiomarkerBase. For example, users of BiomarkerBase will be able to organise their results by Drug Class, Mechanism of Action or Indication to assess how a biomarker fits within a therapy landscape. Users of AdisInsight will also have the option to follow links to BiomarkerBase to seek out further information.

Amplion is the leading biomarker business intelligence company, and its flagship product BiomarkerBase™, along with biomarker data mining and analytical services, deliver insights that inform key strategic decisions for drug and diagnostic test developers. Since 2012 Amplion has helped large and small companies alike make the best use of biomarkers in advancing precision therapeutics and next generation diagnostics.

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 .

Adis launches expanded range of services to support pharmacovigilance departments

Adis Pharmacovigilance will help pharmacovigilance teams to face the challenges of regulatory literature monitoring

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Under the name of Adis Pharmacovigilance, Adis, a leading global provider of drug information, has launched an expanded range of services to support pharmacovigilance departments. This new suite of services includes monitoring special situation Individual Case Safety Reports (ICSRs), local literature and customised source coverage, ongoing safety monitoring, and aggregate reports, PSURs and annual reports.

When Adis started out as an outsourcing partner for pharmacovigilance, its primary offering was centred on ICSR monitoring, which involves searching the literature to identify potential ICSRs related to a pharmaceutical company’s drugs.

Suzanne Berresford, Product Manager for Pharmacovigilance at Adis, explains:

“We work very closely with our customers to understand their unique situations, current set-up and requirements, and to design fully-customised solutions that make the most of our combined manpower and expertise. The expanded range of services we now offer reflects the success of this partnership approach – as our customers’ needs and regulatory requirements have changed, we have been able to adapt the way in which we support them”

Pharmacovigilance is concerned with identifying and reporting the adverse effects associated with the use of pharmaceutical products. Each company that has one or more drugs on the market has a regulatory requirement to conduct pharmacovigilance activities. A major part of this involves regularly monitoring the literature to identify and triage reports of adverse effects related to their products.

The European launch of Adis Pharmacovigilance will take place on 14 September 2016 at the World Drug Safety Europe congress in Munich. Mirko Walter, Director of Product Management for Adis Business Intelligence will deliver the plenary keynote speaking slot on the second day of the meeting, exploring the impact of the EMA MLM service and options for integration.

Mirko tells us:

“This is a great opportunity for us to meet with customers new and old to discuss some of the challenges they are facing. We know that the EMA MLM service has raised many questions within the industry and we look forward to sharing our experience to date of integrating this into workflows”

Adis Pharmacovigilance is the expert solution for regulatory literature monitoring offering a wide range of services and personal support every step of the way. Adis has been publishing pharmacovigilance and drug safety content for more than 30 years and for the last decade has applied this expertise to helping pharmaceutical companies with their global regulatory literature monitoring needs. More information can be found here.

Adis launches new open access pharmacoeconomics journal

PharmacoEconomics – Open will provide readers with the latest on health economics and outcomes

Adis, a leading global provider of drug information, is launching a new open access pharmacoeconomics journal, which will be added to their portfolio in 2017.

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Journal cover

Called PharmacoEconomics – Open, the new journal will focus on cost and health outcomes associated with drugs, devices and other healthcare interventions. PharmacoEconomics – Open has the same co-editors as Adis’s flagship subscription journal in the field, PharmacoEconomics. With 30 years of professional publishing experience between them, the co-editors will ensure that this new journal becomes an essential source of information.

Co-Editor Christopher Carswell at Adis says:

“I am delighted to be part of the editorial team of PharmacoEconomics – Open. There is an ever-increasing need to provide credible open access journals to help researchers disseminate their work. PharmacoEconomics – Open provides such a venue for the health economics and outcomes research community. It will allow researchers to maximize the reach of their work not only within the research community but also amongst the most important stakeholder of all – the patient.”

Co-Editor Timothy Wrightson, also at Adis, adds:

“We are excited to be providing this new publication which offers much-needed economic analyses and health outcomes research. This continues to be a rapidly growing field and is increasingly important as health budgets struggle to keep pace with medical innovations and population healthcare needs. Decision makers need access to these studies to inform optimal healthcare policy and practice.”

The new journal will be published under the AdisOpen program meaning that it will appear online only and will be entirely open access. This will make it accessible to readers globally without the need for a subscription. All articles published in the journal will undergo rigorous peer review to ensure that they meet the high standards expected from Adis.

Adis has more than 40 years’ experience in publishing, with a portfolio of more than 30 medical journals and newsletters. As part of Springer Nature, they are able to offer many benefits to authors including efficient article submission, tracking and review, expedited publication timelines, and high visibility through Springer Nature’s proprietary content platforms. Visit http://www.springer.com/gp/adis

Springer Nature is a leading global research, educational and professional publisher, home to an array of respected and trusted brands providing quality content through a range of innovative products and services. Springer Nature is the world’s largest academic book publisher, publisher of the world’s most influential journals and a pioneer in the field of open research. The company numbers almost 13,000 staff in over 50 countries. Springer Nature was formed in 2015 through the merger of Nature Publishing Group, Palgrave Macmillan, Macmillan Education and Springer Science+Business Media. Visit www.springernature.comand follow @SpringerNature.

Adis unveils a bold new look for pharmacovigilance at DIA

Two members of the Adis Product Management team have recently returned from the DIA Annual Meeting in Philadelphia where they officially launched Adis Pharmacovigilance to 7,000+ attendees.

For more than a decade, Adis has provided regulatory literature monitoring services under the name of Reactions Pharmacovigilance Service. This range of customizable outsourcing solutions includes ICSR monitoring, local literature monitoring and annual reports. The service has now been re-launched with a new name – Adis Pharmacovigilance .

A champagne reception was held during the DIA meeting to celebrate the official launch and the event attracted many visitors to the Springer Nature stand. The conference itself presented many opportunities for the team to speak to attendees about their current pharmacovigilance set-up and needs.

James DeFalco, Executive Licensing Manager, speaking with delegates during the champagne reception. 
Suzanne Berresford, Product Manager for Adis Pharmacovigilance, at the Springer Nature stand.

Over the coming weeks the Adis team will be preparing for a further three pharmacovigilance-related conferences– World Drug Safety Europe in Munich, the 3rd Annual Risk Management & Pharmacovigilance Summitin Vienna, and the ISoP Annual Meeting which will take place in Agra, India.

Further information about Adis Pharmacovigilance is available on the landing pageadis.com/pharmacovigilance.

More than half a million users trust AdisInsight

Adis announced recently that its drug development database, AdisInsight, has been visited by more than half a million users since it launched in 2015.

AdisInsight delivers the most compelling, current evidence on drug treatments being developed worldwide – how well they work, how safe they are, who is working on them, and how soon they will be available.

The platform brings together expertly-written content on drugs, deals, trials and safety. This content was previously offered through three separate databases – R&D Insight, Clinical Trials Insight and Pharmacovigilance Insight, but the launch of AdisInsight  saw this content come together in one place for the first time.

 

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What makes AdisInsight different is our scientific expertise

 

“I have completed more than 100 evaluations using AdisInsight. It is absolutely critical that the information I include is proven and trustworthy and it has been so every time.”

Business Development & Licensing Manager, top 50 pharma

The statistics, provided by Google Analytics, are a strong endorsement of the customer-driven development approach adopted by the AdisInsight team, which sees the platform continuously evolving in response to customer feedback.

The largest proportion of users to date are based in the United States, followed by India, the United Kingdom, Japan and Germany. AdisInsight has subscribers across multiple industries including pharma and biotech; finance, business and banking; hospitals and healthcare; and academia.

 

 

Adis to unveil a new-look service for pharmacovigilance

Adis will reveal a brand new look for its regulatory literature monitoring solution at the DIA Annual Meeting, taking place from June 26th to 30th in Philadelphia, USA.

For more than a decade, Adis has provided customized literature monitoring services to pharmacovigilance departments under the name of Reactions Pharmacovigilance Service. The outsourcing solutions offered include ICSR monitoring, local literature monitoring and annual reports. The service will be renamed as Adis Pharmacovigilance as part of the current rebranding initiative.

To celebrate the re-launch at DIA, a champagne reception will be held at the Springer Nature stand on the evening of Monday 27th June, immediately after the official conference opening ceremony. The event will be attended by Springer Nature colleagues including Director of Product Management for Adis Business Intelligence, Mirko Walter, and Product Manager for Pharmacovigilance, Suzanne Berresford, who will be on hand to speak to delegates about their literature monitoring needs.

Mirko explains:

“The Adis reactions portfolio has a very proud heritage and an enviable position as the industry leader in delivering pharmacovigilance content and solutions. The bold new branding reflects our ambitions in this area, in which we plan to continue growing and offering cutting edge, expert solutions for our customers.”

Adis is the industry leader with more than 30 years’ experience of delivering pharmacovigilance content and solutions to over 6,000 customers globally. Adis is a publishing imprint of Springer Nature, a scientific publishing company resulting from the May 2015 merger of Springer Science+Business Media and Georg von Holtzbrinck Publishing Group’s Nature Publishing Group, Palgrave Macmillan, and Macmillan Education.

Further information about Adis Pharmacovigilance can be found here.