2014-09-14

In Richmond, biopharmaceutical researchers at Kaleo just won Food and Drug Administration approval on a treatment to rapidly reverse the effects of opioid overdose. In Vienna, scientists at CEL-SCI are working on a remarkable new cancer drug. In Charlottesville, ADial Pharmaceuticals is developing a medicine to reduce alcohol cravings.

These are just a few examples of extraordinary advances occurring in the commonwealth. Virginia lawmakers have been smart to support the bioscience industry through policies that encourage innovation.

The bioscience industry keeps our economy strong and our people healthy. But much more can be accomplished. This field is rapidly growing and changing, and our leadership - both in Virginia and the nation's capital - must ensure that government policy keeps pace.

Over the past few decades, medical breakthroughs have helped millions of Americans. Mortality rates for heart disease and cancer have fallen dramatically. New treatments are bringing relief to the chronically ill. Therapies for neurological diseases appear within grasp.

At the same time, the biopharmaceutical industry has boosted our nation's economy, supporting 3.4 million jobs nationwide and generating $789 billion in economic output.

That's the good news. The bad news is that as a nation we may be taking the biopharmaceutical sector's strength for granted.

In China, India and across Europe, governments are supporting companies to make huge research investments. A recent report by Battelle, a highly respected research organization, found that for the United States to maintain its leadership in biotech, the nation must support and improve policies that foster and reward innovation.

Biotech is a unique industry, both in its promise and its needs. It tends to grow in geographic clusters that offer a highly skilled workforce, access to research and capital, and effective government support.

Virginia is developing into one such cluster. Already, we have the sixth-highest concentration of technology workers in the nation.

In addition to established biotech companies, Virginia is home to numerous startups, many springing up from institutions like Eastern Virginia Medical School, Virginia Tech, the University of Virginia and George Mason, James Madison, Old Dominion and Virginia Commonwealth universities. Any one of these could deliver the next medical breakthrough.

In Virginia Beach, LifeNet Health Institute of Regenerative Medicine develops innovations including novel regenerative therapies. The Frank Reidy Research Center for Bioelectrics at ODU is pioneering the use of pulsed power technology in biomedicine, including new therapeutic delivery systems. EVMS research has contributed to the creation of at least 17 startups.

All of this development generates economic growth and jobs. Virginia's biopharmaceutical sector alone supports more than 76,000 jobs and $7.9 billion in annual economic output.

The rewards from biotech research can be huge. But developing a new drug isn't easy - it often takes 20 years and costs over $1 billion. Many promising ideas never pan out.

Thus, the biopharmaceutical sector spends more on research and development than any other manufacturing industry - including advanced sectors like semiconductors and aerospace.

Smart policies can narrow the gap between breakthrough discoveries and effective, commercially available treatments.

Policymakers need to maintain strong protections for intellectual property. Biotech innovators need to be able to recoup their enormous R&D investments before competitors can offer lookalike products.

A rigorous, transparent, but speedier regulatory approval process is also critical for patients and biotech innovators. The nation needs an environment free of delay unrelated to safety and efficacy.

Innovation depends on fair rules for the biggest single purchaser of medicines, the federal government. Some short-sighted cost-saving proposals, such as forcing pharmaceutical firms to rebate part of the sales price to government purchasers, would redirect much-needed investment dollars away from the industry, with the unintended consequence of hampering innovation.

With policy modernization, the United States could add more than 300,000 jobs in biotech by 2021.

Right now, the United States holds an edge in the innovation economy, and Virginia is on its way up. To keep moving, though, policymakers will need to be as innovative as the companies they're regulating.

Jeffrey M. Gallagher is CEO of the Virginia Biotechnology Association.

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