To imagine Genzyme when I joined in early 1984 you need to know our world headquarters occupied half of the 15th floor of an old textile building in Boston’s Combat Zone, so called because of the prevalence of drugs, prostitution and violence in this area. The neighborhood was dirty, dangerous, and disreputable. We had a research laboratory, a blood processing laboratory, and a small suite of executive offices. We initially shared our men’s room with a fur retailer and a gay book store. So generally I avoided using the bathroom. We were on the edge of Boston’s China Town so Chinese food was plentiful and cheap.
However Genzyme’s sales to biotech researchers of our line of interleukins raised some eyebrows shipping from such a location. Three months after beginning as Genzyme’s CFO my secretary nervously walked into my office to say we were the subject of a Food and Drug Administration (FDA) raid. Men in blue jackets with FDA in big letters started seizing all our financial records. Only after proving that 100% of our production was sold to legitimate research laboratories worldwide were they willing to release my staff and our documents.
The City of Boston was worried about the health impact of biotechnology’s genetic engineering, which eventually led many companies to relocate to Cambridge, but the FDA now was convinced we were legitimate suppliers of research materials. We were conducting leading edge research on a bootstrap budget. Senator Ted Kennedy had recently shepherded the Orphan Drug act through Congress to improve incentives to develop therapies for these often overlooked diseases. We were one of the first companies to focus on such diseases. Our enzyme processing lab collected and processed 150 human placentas a week from Boston’s hospitals. Our technicians ground the placentas up to extract a rare enzyme called glucocerebrosidase, an enzyme needed to treat a rare genetic disorder called Gaucher’s Disease.
This rare genetic disease leads to bruising, fatigue, anemia, low blood platelet counts, and eventually an enlarged spleen, liver malfunction, skeletal disorders, and a painful death. Our founding scientists were producing large research quantities of this enzyme for the National Institutes of Health (NIH) under contract. Searching to discover how to scale its manufacture and seek approval under the Orphan Drug Act for it as a therapeutic from the Food and Drug Administration (FDA). We would likely never have more than 10,000 patients a year for this therapy, which is why drug companies didn’t pursue it, but for these patients it would save their lives.
To commercialize Ceredase, our purified extracted enzyme, required massive quantities of human placentas and umilical cords. Cerezyme, our genetically created enzyme, required cloning the cell line for making glucocerebrisadase, scale it up to over 1000 times our current production levels, maintaining its purity and efficacy in transport, create a delivery mechanism to get it into all of the body’s cells that needed it, and then take it through three phases of FDA testing and approval. This would require $100 million spent over a decade just to develop and test it. This would be Genzyme’s first billion dollar product.
A computer CAD/CAM start-up was located on the 14th floor below our placenta processing lab. One Saturday morning, six months after beginning at Genzyme, I was returning with Sarah from breakfast, when I received an angry phone call from the CAD/CAM Company’s head of research. He wanted to know if the red goop dripping from his ceiling and mucking up his continuously operating computers was contagious or not. And how quickly I could be there to clean up the mess it was making. The Centers for Disease control and blood processing industry were only beginning to understand blood borne diseases and how to contain them. The emergence of gay cancer, increasingly called Acquired Immune Deficiency Syndrome (AIDS), which researchers later identified as coming from a Human Immune-deficiency Virus (HIV), had recently cast into doubt any certainty about the biological safety of blood derived products.
We were working in the dark. Most chemical purification techniques could damage the enzymes we were trying to preserve. So extracting and purifying involved a lot of calibrated heating and cooling, recirculating fluids between filters, and hoping we killed the things that could harm someone while preserving the enzymes they needed for survival. In 1984 this was very much a hit or miss proposition. It turned out in this case one of the recirculating lines in our processing lab had come loose and was spewing semi-processed blood products all over the floor of our lab which were now dripping down through the ceiling into his computer lab. It was impossible to know for sure, but I assured him that at this stage of the processing it probably wasn’t contagious, and of course we would clean it up. I called Scott our scientist who ran the processing lab and met him there to clean up the goopy red mess.