ReleaseWire Connect

The oncology therapeutic area has seen significant development and advances over the last decade. However, oncology has one of the lowest overall clinical success rates of all therapy areas with only a third of oncology drugs that get to Phase III proceeding to approval. There are a number of factors that will affect the likelihood of success in oncology drug development and these must be taken into consideration when designing the clinical development plan. Oncology clinical trials tend to be more complex than those in other therapy areas, largely due to the number of endpoints that can be utilized, the growing need for adaptive trial design and the types of patients that are eligible for the clinical studies. While overall survival is the gold standard endpoint, achieving this is challenging for many oncology trials and other endpoints such as progression-free survival are frequently used as surrogates.

The leading pharmaceutical players continue to face the combined threats of a difficult operating environment and patent losses while struggling to deliver on pipeline potential. Externalization strategies are a key means to boost future revenues and, indeed more imminently, to satisfy shareholder demands. However, the increasing size of the leading biopharmaceutical companies is necessitating their involvement in growing the numbers and size of deals year by year. This in itself, along with the rising financial firepower of the mid-tier players, has increased the level of competition for the most attractive targets.

Global Smart Glasses Market for Augmented Reality 2015-2019

Smart Card Market in North America 2015-2019

Smart Grid Equipment Market in Brazil 2015-2019

Used in Screening, monitoring, diagnosing and treating patients and can allow for stratification of patients to maximize efficacy and minimize risk.

As blockbusters go off patent and the pool of marketed products supporting pharmaceutical Research & Development (R&D) decline, questions about the future of R&D in the pharmaceutical and biotech industry arise. Where will funding come from? Is spend decreasing? If spend is decreasing, what impact is this having on R&D? What can be done to encourage innovation in the biotech and pharmaceutical industry? Is the biotech model of R&D better for innovation than the traditional pharmaceutical model?

Politics have a greater direct effect on the pharmaceutical industry than almost any other in the US, and correspondingly, pharma makes considerable investments in election campaigns. The November elections kept the face of Washington the same, with the re-election of President Obama, Democratic control of the Senate and Republican control of the House. However, the outcome of the elections will still impact the industry in a variety of ways.

Although immunotherapy was first recognized over 100 years ago, it has only become an important therapeutic tool in recent decades. The immune system can be harnessed in one of several ways to tackle various diseases such as cancer, infection, auto-immune disease and inflammatory diseases.

Adaptive Licensing (AL) is a flexible approach to drug development and regulation, with two live pilot schemes accepted by the European Medicines Agency (EMA). The system acknowledges that levels of uncertainty will always surround innovative treatments. An initial license is granted at an earlier stage than possible under the traditional system, with less clinical information from Randomized Controlled Trials (RCTs). After the initial license is granted, the entry to market is heavily restricted, and the patient population is carefully monitored through observational studies, electronic devices and registries. Data from ongoing RCTs, and the more robust data from post-license surveillance studies are used to determine full license permission. By improving the alignment of stakeholder needs in a fluid system, overall costs and patient access times can be reduced. However, uncertainty still exists around the approach, and it is clear that cultural and political changes will be necessary to realize the full potential of AL.