The general theme: The U.S. is slipping as a leader in global medical innovation, and something must be done, quickly. Among the “disturbing trends” that several speakers touched upon were the fact that U.S. patents from scientific researchers are on a serious decline vs. the rest of the world, and not enough young people are getting the science and math educations to propel them to be the innovators of tomorrow.
The forum had much discussion on the need for improved funding, better collaboration amongst researchers, savvier regulation, and protection of intellectual property rights (this latter topic was hammered home time and again). But it was Gephardt that really hit upon the key issue in spurring innovation and meeting the scientific challenges of today:
“I’ve thought a lot about this as a student of American history,” he said. “There are rare moments in our history when our country decides it wants to do something, and we do it. World War II and Sputnik were two cases.”
“What I’ve been struggling with is,” he continued, “what is our moon shot that would get medical science back into the fore?” Gephardt had no immediate answer. He was pleased that President Obama has as a goal to help eradicate cancer within his lifetime, but he says there has to be some crystallizing issue that will capture the attention of innovators, particularly those of tomorrow: “You’ve got to sell it to the people, especially the young people,” he said. “There has to be sizzle in it. It has to be cool to be a scientist!”
I had the chance to interview Gephardt, a longtime champion of manufacturing, about some of the issues we all face as companies and professionals in the life sciences. (And I had a chance to ponder the question, why did Gephardt’s presidential bid fail? He’s a smart, charismatic man of the people—must brush up on my 1980’s U.S. political history.)
I asked him what manufacturing workers should expect from their employers in these tough times. His message was unequivocal: transparency. Manufacturers must be held accountable for their quality and productivity, and must establish the necessary metrics to gauge them. Further, they owe it to their employees to share all of the data gleaned from those metrics.
What can professionals do for themselves? Demand accountability from their employers, and demand access to critical financial and operational data, and a share of profits.
Brennan also made himself accessible, and I spoke with him for a good 15 minutes about AstraZeneca’s responsibilities towards its employees and shareholders.(The videos of the Gephardt and Brennan interviews will be up on PharmaManufacturing.com shortly.) Brennan made it clear that his company maintains a commitment to manufacturing, contrary to the previous indications of executive VP David Smith that the company would seek to outsource most manufacturing-related activities (though Smith later backtracked on that statement). Brennan said that AZ would remain committed to late-stage and commercial manufacturing in small-molecule drugs(though outsourcing liberally in APIs and early-stage research and development), and would retain complete control of research and scaleup on the biological side.
Brennan also said AstraZeneca was committed to a local and regional flexibility regarding its global investments. The company has become a leader in the Chinese pharma industry, but Brennan insisted that this meant that it sought to capitalize upon the huge Chinese market to strengthen the companies position, and did not mean that the company would use China as a research and manufacturing base to export to the rest of the world.
The one instance in which he bristled slightly was when I suggested that the need for increased life sciences collaboration on a global stage would imply the opening and sharing of intellectual property between companies and countries. Protecting IP is the foundation of innovation, Brennan insisted, and we need to reverse course and further strengthen intellectual property and data protection rights. During the forum to follow, Brennan returned to the IP issue several times.
One amusing subtext: Brennan sat at the forum dais next to Bart Kamen, chief medical officer of the Leukemia & Lymphoma Society. During his talk, Kamen lamented the fact that drug manufacturers had neither the willingness nor financial incentive to pursue therapies for diseases affecting small portions of the population. The orphan drug dilemma was raised during the later Q and A. Said Brennan, “It’s an ongoing issue within the industry. One policy issue is the orphan drug laws, but by the same token there are a number of things that get put aside because they don’t represent any economic opportunity. . . .we’ll bring some [small-market oncology drugs] to market because we know that it’s an area that will have some opportunity . . . .I agree with you that it’s a big issue.” Missing was any statement about drug companies’ ethical responsibility to work with governments and non-profits to find creative ways to bring orphan products to market.
What follows are some of the best and brightest quotes from the forum:
“There is only one way out of our current economic crisis, and that is to innovate our way out.”
“We’re calling on lawmakers, the new administration, and the public to adopt a new philosophy of medical innovation, one that’s based on: a renewed emphasis on science, engineering, and math education; retaining the best minds in our country; encouraging risk-taking in the private and public sector; and ensuring we have the best research facilities in the world.”
“Other nations are putting together policies to try to expand their role. . . China in particular is trying to create an environment for innovation . . . it is developing infrastructure, attracting back scientists who left 30 years ago . . . they have a long-term perspective and a willingness to invest in it.”
“Our battle against cancer isn’t as much about spectacular breakthroughs . . . innovation is about steady incremental improvements and progress built upon failures and successes.”
Alicia Loffler, PhD, Director of the Kellogg Center for Biotechnology Management, Northwestern University:
“Knowledge is the new capital, and no other industry invests more in knowledge than the biomedical sector. . . . Knowledge is what separates wealthy nations from poor nations.”
“While the globalization of most industries offers low-cost locations to conduct activities previously innovated in the U.S., globalization in biomedical is a chance for countries around the world to compete head-to-head in creating innovation.”
“There is an opportunity for the U.S. to become a magnet for the emerging medical innovation clusters dispersed around the world.”
Bart Kamen, PhD, MD, Chief Medical Officer, Leukemia and Lymphoma Society
“We’re losing a whole generation of researchers. I can’t figure out how to replace myself and I’m old enough to be in AARP.”
“We have to figure out a way of getting the best and brightest into the field or we’re going to be a second-rate country.”
“FDA needs a big overhaul. . . . The people there are great, there’s just not enough of them. They’re overworked and outmanned.”
“The orphan product drug laws have been remarkably successful, and in some cases drugs have been approved for as few as 12 patients for trials. . . .We actually aim to partner with a small biotech and invest in them . . . we get our money back if they get bought out by big pharma. . . we try to pawn them off on the big guys with big money.”
“Kids are celebrating the wrong thing. If the football coach makes five times what the math teacher does, that’s sending the wrong message.”
David Miller, President and CEO of Illinois BIO:
“We need to provide a regulatory pathway for biosimilar medicines, one which protects patient safety and retains incentives for pioneer innovators. How this gets decided will be with us for a long time. There is a potentially huge impact on disease states for which there is now no available cure.”
“How much protection are you going to give the pioneer innovators? It’s a general and recurring theme that’s going to come up time and again.” --PWT