Policymakers recently have focused on the 340B program as its size increased. Whole cottage industries have been created that instruct how hospitals and contract pharmacies can profit from the loose regulations, to the point that the drug industry can no longer overlook the market inefficiencies Yet despite several oversight hearings by the House Energy & Commerce Committee, Congress could not come to a consensus on how to reform it.
We reached out to eight experts from biosimilar companies and consulting firms to see which topics they’ve been watching closely throughout 2017 and how they expect these trends will evolve and challenge the industry in 2018.
Deborah Dunsire, CEO of XTuit Pharmaceuticals; and Robert Discordia, executive director, global product development & supply procurement for Bristol-Myers Squibb discuss new approaches to external partnerships in pharma.
In 2017, real-world evidence (RWE) became the topic everyone wanted to discuss. Several executives I have spoken to recently believe it will continue to grow in importance as we move into 2018 and beyond. But why the sudden interest in RWE?
Seven industry experts answer questions related to the med device funding climate, which device segment will be getting all of the attention in 2018, and upcoming M&A activity related to med devices.
Three top biopharmaceutical executives share their ideas on what bio clusters biopharmaceutical executives should be paying attention to for 2018. In addition, insights are provided on other future potential bio hot spots.
Five top biopharmaceutical executives share their thoughts on Big Data, industry trends, personalized medicine, and more in preparing you for what to expect in 2018 – and beyond.
Five female biopharmaceutical industry CEOs share exclusive insights on what to expect for 2018 and beyond.
Daniel Skovronsky, M.D., Ph.D., former CEO of Avid Radiopharmaceuticals, sold his company to Eli Lilly and Company in 2010 for $300 million -- $850 million if you add in all the milestones achieved. This successful biopharmaceutical entrepreneur shares personal insights on the process of valuing his company prior to acquisition, his philosophy on optionality, and what if anything he’d do differently.
Would a standardized approach to orphan drug development result in more and better therapies being made available to patients? We think so.
The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.
The current situation in biopharma is exciting, with new technologies, biosimilars, cellular and gene therapies, and opportunities in emerging markets. And these innovative platforms are going to continue to need improved manufacturing technologies in the future.
The biosimilars market is going to heat up considerably over the next three years, but is the NHS ready for the biosimilars boom?
As a leader, your job is to make decisions that help your team navigate the endless demands on their time – and to protect energy and resources for the actions that matter most. Here are some suggestions on how to do that.
A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.
Kymriah and Yescarta have overcome the first hurdle to commercialization by receiving the FDA’s stamp of approval. Now, Gilead and Novartis must prove they can handle the supply chain complexities involved with manufacturing and distributing these personalized, time-sensitive therapies to wider patient populations.
Pharmaceutical reimbursement historically has largely been a process of first determining the efficacy and safety profile of a therapy and then deciding its ultimate coverage level based on its price. But now, payers are taking a cue from their European peers and beginning to do the sophisticated number-crunching and cost-effectiveness studies to take a more holistic approach to drug coverage.