The sharing of this knowledge is meant not merely to provide you wisdom, but hopefully inspire insight.
Chief Editor Rob Wright talks about the art of making predictions as compared to educated deduction. For this issue, we steer toward the latter.
The stunning Trump victory and the Republican hold in the Senate, giving the GOP full control over the executive and legislative branches, provides some breathing space for a pharmaceutical industry that increasingly felt under siege.
From a policy and political standpoint, the biosimilar industry promises to be anything but dull in the year ahead. Six biosimilar industry experts told us why.
Experts such as Andrew Skibo of MedImmune/AstraZeneca discuss everything from the current capacity crunch to biologics manufacturing issues.
The trouble is, sponsor-provider relationships in development and manufacturing haven’t been set up to accommodate innovation. While there are exceptions, CMOs were founded less around innovation and more on rigorous controls and process replication.
In 2013, the United States enacted pharmaceutical serialization and traceability requirements under the Drug Supply Chain Security Act (DSCSA). In the years preceding and following passage of the DSCSA, many other countries considered similar regulation for their own markets. Argentina, China, India, South Korea, and Turkey currently require the serialization of pharmaceutical products and the reporting of some type of serialization data. Approximately 40 additional countries — including the U.S., the European Union, Brazil, Russia, and multiple Persian Gulf states — have enacted requirements with future implementation dates or are actively working on requirements.
There is perhaps no riskier time in a product’s development cycle than during clinical trials. With the introduction of human research subjects, patient safety is paramount. Any failure to uphold rigorous standards not only leaves your company subject to the threat of costly litigation, it can cause irreparable damage to your reputation.
In the life sciences industry, a company’s anticorruption policy inevitably governs how employees engage with foreign healthcare professionals (HCPs) – who are considered foreign government officials (FGOs) under most global anticorruption laws.
Kaiser Associates’ second annual Hot Indications List is a global analysis of 13,000+ pharma R&D programs and investment trends.
What should the industry understand regarding the rules and practices that govern the communication of drug information to payers and formulary committees in light of evolving FDA policies on scientific exchange, First Amendment case law, and proposed legislative changes to FDAMA 114?
The executive-level participation for Life Science Leader magazine's signature 2017 Outlook issue had an overwhelming. This year’s feature article involved 13 executive life science leaders! In part four of this series, which is a supplement to the feature magazine article, we pose the question, “Looking even further ahead, what is your vision for how the global biopharmaceutical industry might look in the year 2027?”
The December 2016 issue of Life Science Leader magazine raised the bar in our 2017 Outlook feature article with participation from 13 trendsetters, including pharma leaders, payors, and a representative from the NIH. We hope you enjoy reading their thoughts in this supplement to the magazine’s December 2016 cover feature.
When Life Science Leader magazine asked for executive-level participation for the signature 2017 Outlook issue published in December 2016, we were overwhelmed with the response. This year’s feature article involved 13 executive thought leaders! In part two of this series, which is a supplement to the 2017 Outlook feature article, we pose the question, “What are you doing at your organization to address/capitalize on certain trends?”
Two weeks ago I went to the Partnering For Cures (Nov. 13 – 15) conference at the Grand Hyatt in New York. After the experience, it is almost painful to admit that this was my first time attending. Developed by Faster Cures and the Milken Institute, the conference (now in existence for over eight years) brings together nearly 1,000 leaders from across the research ecosystem. The event’s goal is to forge partnerships dedicated to reducing death and suffering. And while I have attended other conferences that preach partnering, this conference, for some reason, felt distinctly different.
On November 14, 2016, Carolyn Johnson posted “Trump just dropped a big hint to the pharmaceutical industry” in a wonkblog for The Washington Post. I shared the article on LinkedIn (receiving over 415 views) noting, “It is very early days, so let’s not get too excited or too concerned. But let’s be aware and strive to be part of the solution for helping patients.” This seemed like a natural fit to share considering a large percentage of my network have close ties to biopharma, and the industry seems to have always been pretty closely linked to politics. This fact was never more apparent than at the industry conference I recently attended.