A few weeks ago, Novartis became the latest Big Pharma company to depart the antibacterial field, joining Allergan and The Medicines Company, both of which — even though they manufacture the leading critical-need products — have soured on the lousy returns related to this therapeutic area.
Is the pharma industry ready to move beyond the buzz regarding terms like terms like AI, digital health, and machine learning (ML)?
Let’s see what unnecessary bureaucracy can be removed to further accelerate the drug-development process. In today’s electronic age, it seems unconscionable that it should take a month to get one’s testing results.
In this article, I reflect on how well the government of the people is doing “for the people,” and if our policies adequately promote good health and secure well-being, both determinants of happiness.
Here are some examples of why “soft skills,” such as those related to relationship building, leadership, and communication, are essential to today’s pharma and biotech leaders.
“We had to decide whether to spend a lot of money to bring on a sales force and marketing team, and expand manufacturing to meet demand, or take our resources and refocus them on these rare disorders.”
Tony Coles, M.D., chairman and CEO of Yumanity Therapeutics, talks about the loss of Susan Lindquist, one of the company’s cofounders.
Ameet Nathwani, M.D., EVP of Sanofi’s medical function, discusses digital health joint venture with Verily Life Sciences, and good places to look for digital health top talent.
In this preview of our July 2018 issue, the CEO of Sage Therapeutics, Jeff Jonas, M.D., elaborates on the company’s approach to developing small clinical trials.
The latest country that seems to be courting the U.S. life science public offering market is China, specifically, the Hong Kong Exchange. In particular, U.S.-based life sciences companies with Chinese management teams or some other connections to China seem to be the primary target.
At what stage of a biopharma’s growth does it makes sense to bring on an internal tax function? The answer, of course, varies significantly, but here are some factors to consider when making this important business decision.
The disconnect between increased investment/activity and output points to continuing significant challenges in the global clinical trials market. Here we examine three of the leading issues facing the biopharmaceutical industry today.
An employee already leading a department could someday be a candidate for the C-Suite. They just need the right educational tools to prepare them for the business and management-centered responsibilities future advancement will bring.
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.
The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This is the fourth article in a six-part series summarizing each of the draft guidance documents. It will discuss the guidance Human Gene Therapy for Rare Disease.
Are you ready to give the FDA more? “What?” you ask, as a manufacturer of API and finished goods. Are you ready to give them more data and information about your manufacturing process? You think, “Don’t they get all the necessary information from me during their inspections and from my filings?” Well, the answer is yes and no.
Patient-centricity has been defined in various ways, but we like to think of it as simply “to identify and seize the opportunity to create value for patients — and to do so with patients whenever it’s feasible.” Pharmaceutical and biotechnology companies have begun to embrace the concept relatively recently. However, the idea — and practice — has been around for a long time in other industries.
