Evidera: Market Access Consulting Services

With rigorous, evolving, and heterogeneous payer evaluation criteria, challenging price negotiations, and a dynamic competitive environment, manufacturers need to prepare their market access strategy early in the product life cycle and assess often to ensure optimal access. Evidera is ideally positioned to help you create evidence-optimized value strategies to achieve your product access, price and reimbursement goals. Our team brings …

TCS Digital AI

AI in Pharmacovigilance — Re-imagining the ICSR processing

Over the last few decades, we have seen a spurt of medicines approved by regulatory authorities which have necessitated an increase in the need for monitoring drugs. Pharmacovigilance, is an arm of medical science which deals with gathering, monitoring and assessing the safety of drugs. It has gained increased focus and prominence, over the last decade. It’s thus not a …

Re-Imagining Drug Safety Powered by Genomics, Information Integration and Emerging Technologies

|| Whitepaper by Tata Consultancy Services. Pub. 17/08/2017 Abstract Scientific advancements, emerging technologies, and extensive information have created new opportunities for modernizing drug safety.  Simultaneously, the pharmacovigilance regulatory landscape is shifting to ensure improved safety for patients. This is the time to reimagine the  drug safety sector to transform it into an advanced, proactive and patient-centric practice. Introduction The global …

Machine Learning, Artificial Intelligence, and Systems Biology: A New Way to Interrogate ’Omics Data

This Precision white paper concisely illuminates how using machine learning and artificial intelligence fused with systems biology can harness the value in rich ‘omics data to provide novel insights. These insights can lead to the development of a diagnostic to monitor disease progression or guide treatment decisions. The white paper, “Machine Learning, Artificial Intelligence, and Systems Biology,” offers insights on …

HELM

Making Open Source Collaboration Work

Over the past few years the biopharmaceutical industry has deployed an arsenal of increasingly complex biomolecular entities in their search for effective therapeutic agents. Portfolios that were once comprised mainly of small molecules and antibodies have expanded to include modalities like antibody-drug conjugates (ADCs); proteins, peptides and antibodies with synthetic, unnatural amino acids; oligonucleotides with unnatural bases, etc. Investigators at …

HELM

HELM for Bioregistration

GSK will be making use of the Pistoia Alliance’s Hierarchical Editing Language for Macromolecules (HELM) notation to represent therapeutic large molecules in its bio-registration system, facilitated by the deployment of Dassault Systèmes BIOVIA’s Biological Registration solution. GSK scientists at sites around the world will use the system. Molecular Structure Exchange Across the industry there is a need for an advanced …

Pistoia Alliance

Ontologies Guidelines for Best Practice

By Pistoia Alliance Ontologies Mapping Project team Background These guidelines for best practice support the application and mapping of ontologies in the life sciences as part of the Pistoia Alliance Ontologies Mapping project which creates better tools and services for mapping ontologies to facilitate their exploitation. Ontologies can include hierarchical relationships; taxonomies; classifications and/or vocabularies which are becoming increasingly important for support of …

Parexel whitepaper

Three steps for filling the real- world evidence gaps

By Matthew Gordon and Kim Maguire-Wright, PAREXEL® INTERNATIONAL Today, payers and other stakeholders are demanding more (and more robust) real-world evidence (RWE) of a drug’s effectiveness and benefits. It’s understood that randomized clinical trials (RCTs), designed for regulatory approval, don’t provide a true picture of what happens in the real world. The Catch-22 is that payers would like RWE before they place a product on a formulary, …

Adis whitepaper

Whitepaper: The changing faces of device safety

The benefits of literature monitoring throughout the lifecycle Executive Summary One would be forgiven for thinking that the current changes to the guidelines for medical device safety meant just an increase in workload for the manufacturers. But look beyond the “overalls” and you will see that these changes present a golden opportunity for the device industry to demonstrate the real-world benefits it has on …