“In terms of adding value to society, [vaccines] are fantastic,” says Kornfeld, now general counsel for Vienna based vaccine-maker Intercell AG, and previously in-house counsel for Chiron Corp. and Novartis Vaccines and Diagnostics. The field allows her to work with an extraordinarily diverse group of talented people, she adds. “The diversity goes not just to cultural background, but to education, training, focus, and expertise — vaccines require expertise. I’ve had the opportunity to work with many outstanding scientists, physicians, and technicians.” On the business end, too, there is a “level of commitment” that isn’t found in all areas of the pharmaceutical industry, she says.
Legally, vaccine development stands apart from other pharmaceuticals because of vaccines’ distinctive use, Kornfeld explains. “It’s not the same as a drug that an ill person will take because they think it will do some good. This is taking a foreign substance and putting it into someone who, at that moment in time, doesn’t need it — so it had better not hurt them!”
Different cultural determinatives guide individual countries’ regulatory authorities and scientific communities, she says. “It’s based on what they have been exposed to historically and what has happened in their country with respect to their experiences with different vaccines.”
At one point, Kornfeld found herself negotiating, on Chiron’s behalf, for the supply of a pandemic influenza vaccine with the national health authorities of Germany, the United Kingdom, France, Italy, and the United States. “Those were separate negotiations for the very same product — an imaginary product that didn’t exist at the time, and for a use that might never occur. It was really fantastic to see the different countries’ approaches.”
She also supported the research and development of a vaccine tailor-made to control a meningitis B epidemic in New Zealand. “I supported that project from start to finish — from the initial response to the tender that was put out by the New Zealand Ministry of Health to getting the term sheet, negotiating the contract, and then seeing the product through the clinical studies,” she says. The key was the provision for an independent review of any issue that could cause the breakdown of the relationship.
At any time, a governmental entity “might throw its weight around” and make arbitrary, even politically-motivated decisions, notes Kornfeld. “The commercial entity in those circumstances can only be protected if they provided for an independent arbiter or expert of some kind to come in and advise both sides as to whether there is a resolution to the issue on the table.” Had such a provision not been inserted in the contract in question, “I’m not sure that New Zealand would have its epidemic under control the way it does today,” she says.
A Long Island native, Kornfeld credits her fluency in German with being a passport of sorts, first to a career in international business law with White and Case in New York, Frankfurt, Paris, Budapest, and London, and then to her vaccine-related work; Chiron was specifically looking for an American lawyer who had practiced internationally and was willing to live in Germany, where its vaccine division was located. It was an “easy fit” because it revisited issues Kornfeld had researched while pursuing a PhD in political science at Duke in the 1980s; her dissertation focused, in large part, on the West German vaccination program in Cameroon as a facet of its foreign aid initiatives.
“I didn’t join Chiron because I was looking for a vaccines position,” she says, “but I knew I would be more than willing to devote my time and energy to learning more about the industry. And I was right.”