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David Robinson Ligand Pharmaceuticals 2001-2003
In the 1980s, pharmaceutical companies tended to be stodgy-bureaucratic, slow to react-especially compared with the new wave of entrepreneurial biotechnology companies, which were risky to be sure, but also nimble, exciting and on the cutting edge of translating the revolution in molecular biology into new medicines. By the dawn of the 1990s, pharma veteran David Robinson knew that biotechnology was where he had to be.
"I'm not sure what attracted me more, the science or the excitement of small companies," he said. "But the appeal of small innovative companies was at the forefront of my interest."
Robinson joined Ligand Pharmaceuticals, then a small San Diego start-up, as president and CEO in 1991 and never looked back. His broader interest in the direction of the industry led him to join BIO's board of directors in 1994, and he accepted the chairmanship for 2001-2003. He is also the chairman of Ligand and a board member of BIOCOM, San Diego's regional biotechnology association.
Like most biotechs, his own company has had its share of ups and downs on Wall Street, but in early 1999, Ligand won its first two product approvals-both for cancer products-within one week. Today, the company has five products on the market.
Such success breeds new challenges, and for Ligand and the other 60-odd biotechnology companies with marketed products, ensuring patient access to medical breakthroughs is a critical one.
"Access is going to be a continuing issue over the next decade. On the one hand, we want these new technologies and products, and so every politician supports the biotech industry," said Robinson. "On the other hand, there has to be a funding mechanism that ensures fair and equal access and reimbursement, and that allows products in the market without price controls."
As the largest health plan in the United States, Medicare's coverage and reimbursement decisions can have a sweeping impact on access to innovative medicines and on the companies that develop those products. BIO supports expanded drug coverage under Medicare, alongside relief from recent deep cuts to drugs that are already covered.
"We want to weigh in as strongly as possible on behalf of the administration's efforts to bring a Medicare drug bill forward, but we would also like to see some redress for some very difficult policy decisions that were taken," Robinson said. "Those decisions clearly will inhibit the access of Medicare patients to virtually all of our member companies' products. Our goals in the U.S. should be to expand access and ensure equal access for Medicare patients, not to put up further obstacles."
Access begins with FDA approval of new drugs, and on that front, BIO in 2002 was a key player in successful negotiations to renew the Prescription Drug User Fee Act (PDUFA). Under PDUFA, developers of new drugs and biologics pay fees upon submitting applications for marketing approval, thereby providing the agency with the extra resources to conduct reviews faster. First passed in 1992 and renewed in 1997 and 2002, the act has helped cut average review times roughly in half.
"The extension of PDUFA sets the stage for continuation of the progress we saw under PDUFA I and II and expands the scope of the program to encompass best practices and issues of efficiency at the agency," Robinson said. "These are very important underpinnings for the next five years."
New Incentive Needed
For younger companies, said Robinson, the highest BIO priority is stabilizing the capital foundations for research and development.
"Here, there are two challenges," he said. "First, the public offering markets are severely curtailed, and that's followed in parallel by a severe curtailment of big pharmaceutical company investments in this area. The increasing consolidation of the big pharmaceutical companies is resulting in fewer and fewer strategic alliances."
To offset these trends, BIO has renewed its push for a refundable federal credit for net operating losses related to R&D.
"Right now, the federal government gives R&D tax credits," Robinson said, "but they're only useful for the handful of companies that are profitable and, therefore, have a tax bill against which to apply the credit. Those companies have already become successful and don't, therefore, have a capital fund-raising problem."
A biotech tax credit or other new incentive is especially critical in 2003, which Robinson described as "probably the most difficult environment for innovative companies-not just biotech companies-since I entered the business, and that's since 1991."
The reasons go beyond the biotech industry itself. "By and large the downturn in biotech mirrors the downturn in all the technology sectors," Robinson said, "and it is accompanied by a macro investor environment that is probably far uglier than the downturn in biotech itself. That macro environment, with some of the scandals coming out of the bubble and its bursting between 2000 and 2002, alongside some of the governance issues and scandals, has contributed a dimension to the downturn that, I believe, makes it more difficult.
"While biotech can turn around-and I believe it will, because the industry is far too rich in products not to emerge-it may take a little bit longer because there has to be confidence and trust rebuilt in that macro environment."
September 11
The shift in priorities wrought by the 2001 terrorist attacks "raises challenges for an industry to get its issues addressed," said Robinson. "America in the last 15 months has been clearly dominated by post-9/11 issues and increasingly dealing with the global environment and how that affects security at home."
BIO has responded by exploring how biotechnology companies can aid in the development of countermeasures against terrorist attacks, particularly those using biological agents.
"Since 9/11, BIO has really become a partner with the government to ensure the industry contributes in every way possible to antiterrorism efforts, and to be sure the technology is brought to bear in the most effective way in those initiatives," said Robinson.
Building Alliances
Both BIO's board and the organization's staff have grown and become more effective over the last few years, Robinson said.
"BIO's voice has never been stronger nor more frequently sought after," he said. "Every great industry needs a great industry organization with a strong ability to speak effectively. If we look back five years, I can remember that getting people to listen to BIO positions was not always easy. Today, they actively seek the BIO position. This has been a wonderful evolution for the organization, and it plays out in important debates about stem cell research, second-source biologics and dozens of other issues where BIO's position is actively sought, listened to and valued."
New alliances with organizations outside the industry have further strengthened BIO's impact, he added. "BIO is building strong alliances with patient groups, managed care, medical societies and others, so that when the macro environment improves for the biotech legislative agenda, we'll have a number of voices, and a more uniform series of voices, and that will make for good policy."
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