Regarding our current worldwide recession, cheap money and speculation not only hurt the investment and housing industries, but lead far too many organizations in the biotech industry to ignore their core businesses and focus on “growth through acquisition.” As we move into 2008, please help me encourage a return to the principles that built this biotech industry like: entrepreneurship, good science, strong relationships, and innovation. If your company wants to obtain a technology, make an investment or simply license the rights you want. But whatever you do, leave the small companies alone to do what they do best, and what made them attractive in the first place. The value of a company is seldom in its buildings, equipment, products, and IP. It’s in the goodwill that has been built through the value it offers, and the people who created this value…
Tag: <span>biotech industry</span>
There are some encouraging signs concerning the economy. We’ll know that things are improving when the big firms start to spin off companies. And the best deals will be those in which the new owners are the people who are closest to the products and technologies. As part of the deal, the divesting firm could retain certain rights or options for technologies, manufacturing, and marketing. They could also retain a certain amount of ownership in what would now be small innovative firms with people devoted to the technologies, and they could lease unused facilities to these firms instead of giving them away to people who would tear them down. And still better, would be if they returned to the very successful model of providing milestone payments when critical development goals were met…
First, I’m still dying to learn what the regulations are that are keeping American businesses from expanding their operations and hiring people. We keep hearing that the government has to illuminate regulations that are killing jobs, but I just can’t determine what these are. Surely the biopharmaceutical industry isn’t suggesting that it regulate itself while asking the government to protect it from litigation if something goes wrong. And I can’t believe that workplace safety or child labor laws must be abolished. So in this regard, I’ll just have to keep searching until things make sense, or I find they were never meant to…
There are many examples of efforts to make biosimilar products, such as every time a product is taken to a larger
scale, and when an established product is transferred to another facility, including a contract manufacturing site.
While most of these examples have resulted in products which were indistinguishable for all practical purposes,
others revealed troubling differences during product characterization or clinical administration…
“But why are they calling these products ‘drugs?’” I asked at the recent CMC Strategy meeting that CaSSS hosted in Gaithersburg. “Well it’s because they aren’t vaccines or blood products” said an old friend, who is an authority in the field. “But,” I said, “we’re really talking about therapeutic glyco-proteins produced by living organisms.” And just to make sure I was remembering things correctly, I searched Google and reviewed the definitions for a “biologic” and “biological” in several of the top technical references. Truly, a biologic or biological is a substance produced by a living organism, which would include glyco-proteins, non-glycosylated proteins, enzymes, viruses, and broken up proteins which could be used as poly-peptides or simple antigens…
Consistent with our well-established format, this issue contains a very interesting collection of technical articles. However, we have stepped outside our normal content with a manuscript on the successful implementation of a “spin-out” company that was formed to develop a highly specialized technology. I’m hoping that this article by Dr. Charlotte Dyring (ExpreS2ion Biotechnologies) will provide inspiration to others who have envisioned a similar business model, plus trace a roadmap for organizations which have discovered that mergers and acquisitions aren’t giving them the products or sustainable growth they really need…
