In December 2014, Biogen got some huge news that sent its stock up nearly $19 — in just one day! The company had achieved positive Phase 1b clinical trial results for its experimental Alzheimer’s drug, BIIB037 (aducanumab). The data looked so good, in fact, that Biogen announced it would be fast-tracking the drug straight to Phase 3 clinical trials.
Early integration of delivery device expertise and methodologies – to create a true combination product team — will emerge as best practice in biopharma companies that succeed.
Given the choice, I would choose the combination of a mediocre asset and a great management team over a great asset and a mediocre management team. Simply put, management teams can create or destroy value.
Eileen Daniel, executive director of clinical operations at Nektar Therapeutics, always felt there were ways the clinical trial planning process could be improved.
In 2013, TransPoC, Inc. (Translational Proof of Concept) was formed to solve a serious problem: the diminishing number of new drug therapies resulting from oncology research. This problem has become more challenging given the overwhelming volume of genomic data available since the completion of the Human Genome Project in 2003.
Some biomanufacturing experts have recently begun referring to the expected growth of biologic therapeutics as an oncoming tidal wave or tsunami. Like the natural disasters these terms describe, there can be harmful repercussions — both to the industry’s reputation and the patients in need — if companies are not adequately prepared for the impending biologic manufacturing capacity crunch.
When the candidates in the Democratic presidential debate named their biggest enemies, Hillary Clinton placed drug companies next to Iran. Drug companies!
“My professional training is as a pediatrician,” says the FDA’s director of the Office of Biotechnology Products, Steven Kozlowski, M.D.
Leadership by walking around may sound like an antiquated philosophy, but for FDA’s Office of Biotechnology Products director, Steven Kozlowski, M.D. it's a best practice that is part of his exercise routine.
If you can say that you completely understand how immunotherapy works in cancer, please feel free to skip this small primer. But for the vast crowd that constitutes the rest of us, we include this basic explanation.
Stepping out of my hotel room on the last day of the 2015 International Society of Pharmaceutical Engineering (ISPE) annual meeting in Philadelphia (November 8 – 11), I reach down and pick up the USA Today that is blocking my egress. Flipping through the newspaper the headline “Allen Always Aimed High” catches my eye. As writer Nicole Auerbach relates how Duke University basketball standout Grayson Allen strived to achieve his childhood dream, I am struck by the similarity between the story and this year’s ISPE annual meeting. “I had so much joy,” recalls Allen of the sensation experienced the first time he successfully slam dunked a basketball on a 10 foot hoop — a goal that took years of persistent practice to finally achieve. It is important to remember that biopharma executives and engineers are not immune to deeply experiencing human emotions (e.g., joy, sorrow). And while attendees of ISPE were certainly treated to high-caliber networking and educational opportunities at this year’s show, they were also provided a strong dose of emotional reality to fuel their passionate pursuit of excellence. Like Duke’s Allen, to achieve beyond your expectations, sometimes it is important to be reminded of why it is you do what you do.
A news item on AZ’s new “crowdsourcing” approach to cancer-drug treatment. The report uncritically hailed the program as a veritable revolution in cancer therapy that could yield greatly improved results from combinations of traditional chemotherapeutics and, presumably, other approved drugs with different modalities such as molecular-pathway targeting.
Patients have become more empowered, better informed, and more financially invested in their health and well-being than ever before. As a result, we have seen the healthcare landscape evolve toward a patient-centric delivery model.