As coverage and reimbursement landscapes change, drug developers must assess how healthcare systems will handle the incoming wave of treatments for rare diseases that often carry a high list price, and they should prepare for restrictive practices that pass more of the costs along to patients. Developers can speed orphan medicines to patients through better communication of value to payers and other stakeholders.
An increasingly data-rich healthcare sector presents both opportunities and challenges for the MedTech industry, just as it does for the health systems and patients served by MedTech products.
Used intelligently and appropriately, the vast quantities of real-world data emanating from multiple healthcare sources, such as electronic medical records (EMRs), claims databases, products and disease registries, provide the raw material for real-world evidence (RWE) that can inform strategy and decision-making throughout the MedTech-product lifecycle.
Mike Ward, head of pharma content, sat down with Srinivasa Karri, a strategist with Oracle Health Sciences, to discuss the survey findings and highlight how companies can best manage the torrent of clinical data from multiple sources that will underpin their regulatory submissions.
US FDA is an ever-evolving organization, from recent changes to facility inspections under its so-called "Program Alignment" initiative, to plans to harmonize the agency's Quality System Regulation with international quality systems standard ISO 13485 – just to name two big-ticket reforms.
Adoptive Cellular Transfer (ACT): Novel Cancer Trials Demand That Participating Sites Act Differently
As more pharma and biotech companies bring their ACT platforms to the clinic, there is a need for the assistance of clinical research organisations (CROs) to support the conduct of clinical trials. Valued for their relationships with trial centres, CROs have been thrust into the forefront of operationalising ACT studies. So what can sites expect and commit to when participating in ACT trials?
Iron deficiency is a global public-health challenge in need of urgent attention. It affects more people than any other nutritional disorder, particularly in the developing world, but also with significant prevalence in industrialized countries
The history of stem cell research has been marked by a combination of great promise, disappointment and controversy. But progress is being made, with a number of stem cell therapies approved and many more in the late-stage pipeline. While the US has lagged behind other regions in stem cell therapy approvals, recent developments on the regulatory front are intended to provide a clearer path forward and accelerate development.
For more than 20 years – from the passage of the US Food and Drug Administration Modernization Act (FDAMA) in 1997 until just this year – the life sciences industry has had little to go on when deciding what health economic information about products could be shared with payers. This was especially true with regard to products or indications that had not yet been granted marketing approval; the boundaries of what was permissible were blurry at best.
Pharma has woken up to label optimization. Figuring out, in advance of your pivotal trial, what robust and compelling language you need in your label has become one of the most strategic issues in drug development.
mHealth device technology has evolved to the point where it is now possible to collect a vast array of physiological data including vital-signs such as heart rate, respiration rate, oxygen saturation, continuous glucose monitoring, sleep and activity data, and using advanced analytics to monitor patients in their own home outside of the hospital environment. There is a growing awareness in the healthcare sector of the benefit and value of a mHealth approach to healthcare.
As the costs of bringing drugs to market continue to rise and pricing pressure bites, pharma is looking for new ways to create value and drive efficiencies, including partnering with tech giants and agile start-ups to create technology solutions that lead to improved and diversified revenue streams. In doing so, pharma companies must self-disrupt to stay ahead in an increasingly competitive and demanding market.
Data sits at the heart of the pharmaceutical-product equation. The huge volume of data generated in drug discovery and development, and to provide support for regulatory approvals, is only the start. Increasingly, data flows from post-approval safety requirements, drug manufacturing, predicting and tracking health outcomes, or communicating with a wide range of stakeholders.
In today’s industry, data is arguably the product. Ensuring data integrity proactively at every stage of the product lifecycle is therefore paramount if pharmaceutical companies are to maintain their reputation, competitive edge and financial stability, as well as the safety and trust of patients. Compliance failures have a long tail in an environment where risks and benefits are always in delicate balance.
Download this Special Report, written by Mike Ward, Head of Content for Informa Pharma Intelligence Insights Portfolio, to learn how attrition rates in oncology drug discovery and development can be improved and why a multidisciplinary approach to R&D is needed. This report includes key coverage of the Bionow’s Accelerating Cancer Drug Development - From target to patients conference, which was hosted at Alderley Park in Cheshire where its Mereside life science campus is home to some 65 SMEs and 150 start-ups, many of which work in oncology.
Big data, real-world evidence and breakthrough technologies are expected to underpin a revolution in health care provision. The agents of this disruption, as is usually the case, are stakeholders not traditionally associated with health care but who are now converging with existing players. Participants at the IMPACTIV BIO CEO Summit Thought Leader Discussion panel, highlighting marquee deals such as the Amazon, Berkshire Hathaway and JPM three-way, considered how such convergences will be crucial to health care’s evolution.
In Life Sciences 4.0: securing value through platform-based businesses, EY’s latest edition of our Progressions series, we explore how health is being reimagined as a result of scientific and technological change and rising customer expectations. We also examine the ramifications for life sciences companies’ market offerings, business models and the new capabilities needed as the disciplines of health care and technology merge to become “health technology.”
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