Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
I often write – and you read – about those individuals at biopharma companies openly enthusiastic about outsourcing. Not too long ago, though, I ran into a person who seemed to outdo the others in absolute embrace of this model. But here’s the catch: Her company won’t allow her enthusiasm to be shared “on the record.”
There’s not much of a biotechnology industry in Japan. That doesn’t deter Shunichi Takahashi, head of Bayer's Open Innovation Center Japan (ICJ). He’s innovating the incubator to mine the abundant research at universities there.
Among the drumbeat of discussions at BIO 2015, three sounds reverberated above all: the first came from the bass drum of money; next was the razor-sharp tones of the nanotech snare drum; and hitting the cymbals for exclamation was “the whole digital field interacting with pharma and bio."
In this exclusive interview with Outsourced Pharma, Tae Han Kim, PhD, president and CEO of Samsung BioLogics, shares his story of how he selected the biologics contract-manufacturing industry, the building of his business, and his first customers.
At first blush, the BIO 2015 theme of “Super” doesn’t sound all that, well, super. But after meeting a super hero of the industry who warns of the need to prepare for super quality accidental collisions, the theme comes into full focus.
Biomarkers are becoming an industry unto themselves: they have their own FDA tables and World Congress, and have been before the Supreme Court. They also provide outsourcing companies with growing business opportunities. At the same time, it’s good practice to temper enthusiasm with a reality-check on the real-world status of the development and application of any science.
Sometimes one finds help in unusual places. This might be one of those times for Pharma, and the place could be AdverseEvents. And Pharma can turn to a more usual partner — CROs/CMOs — to positively influence what AdverseEvents measures.
As an applied economic theoretic, by driving out inefficiencies from the current model used by researchers to find and contract with CROs, the Science Exchange should improve the business model for drug discovery. But will all parties — Pharma/Bio, CROs and individual researchers — benefit equally?