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.

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.

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 the increasingly complex world of biopharmaceutical commercialization, executives at emerging companies are often faced with the need to understand what levels of spend are appropriate for successfully launching a product. Many clinical-stage companies find themselves either underfunding launches and underperforming in the market, or overfunding launches and incurring costs that do not add incremental value to commercial success. And while every company is different, and every launch is different, all face the same question: What is the threshold of commercial spend needed to increase the probability of a successful product launch?