Don’t Extinguish Biotech’s Light

“Opportunity is missed by most people,” the great innovator Thomas Edison said, “because it is dressed in overalls and looks like work.”

Leave it to the inventor of the light bulb to ingenuously illuminate that dark corner of our collective character. The underlying contradiction is even less flattering. While we’ll blow an extravagant sum of words discussing our desire for a better future, we tend to spend considerably less in the deeds department.  In fact, we turn downright miserly in that section of life’s store where the legal tender is hard action rather than hot air.

I was reminded of Edison’s funny, spot-on observation by recent developments in Washington, and not for the reason that the cynics among you probably suspect.

Despite the enormity, complexity and gravity of our current economic situation, I am actually very encouraged and hopeful about our future. And that’s partly attributable to the fact that there are those in the Obama Administration and Congress who recognize opportunities amid the hardships and are doing the hard work necessary to seize them on our behalf. In other words, they’re thumbing their noses at Edison.

On issue after issue — from education to energy, home ownership to health care — they have rolled up their sleeves and gotten down to business. You may not agree with all, or even much, of what they’re doing, but at least they’re trying to do what is right by attending to both short-term pain relief and long-term
cures. That is as commendable as it is challenging, so I’m rooting for them.

As a scientist and researcher in biotechnology, I am particularly interested in — and optimistic about — the work underway on an issue that is obscure to many, but important to all.

The result of some of the most remarkable science we have ever seen, so-called biologics, drugs that actually include living cells or tissues. Although relatively new, biologics are producing extraordinary results in the treatment of cancer, Alzheimer’s, multiple sclerosis, HIV/AIDS and other debilitating diseases. And we have only just begun.  In fact, Biosimilars already have been
approved in Europe.

Excited by the great success and promise of these drugs, President Obama identified the introduction of less expensive generic alternatives as a top priority during a speech in March. Just days later, U.S. Representatives Henry Waxman (D-CA), Nathan Deal (R-GA), Frank Pallone (D-NJ), and Jo Ann Emerson (R-MO) introduced the “Promoting Access to Life-Saving Medicine Act,” which is intended to pave a safe regulatory path for what are known more technically as follow-on biologics.

Everybody at the negotiating table shares the same goal, which is more than a good start. It is a strong foundation for quality legislation. That said, there are details that need to be addressed, which isn’t at all surprising considering the almost futuristic sophistication of biologics.

One is safety. Unlike traditional drugs that are chemically synthesized, biologics are very hard — if not impossible — to duplicate exactly. Human cells and tissue, which biologics rely on, are a little like fingerprints. No two are precisely alike. So setting testing and surveillance guidelines is absolutely critical to ensure that follow-on biologics are close enough to deliver the desired benefit. The real barrier for biologics development is that full Chemistry, Manufacturing and Controls (CMC) development is, necessarily, required up front, which is a daunting investment before one even has a hint of
activity in humans.

A second issue is timing — the question of when generic producers may enter the market. Breakthrough drugs like biologics cost billions upon billions of dollars to develop. If generics are admitted before the groundbreakers are permitted to recoup their huge investments, then the incentive for this kind of innovative
work will be devastated, if not eliminated altogether.

If biotechs lose or merely break even, then investors will ultimately put their money to work elsewhere. And that will bring an end to this kind of innovation. Without these pioneers, there can be no followers. Denying the originators the support they need will, at some point, prove catastrophic.

The bill introduced by Congressman Waxman gives a scant seven years of intellectual-property protection or exclusivity to original developers, which is considerably less than the consensus of the scientific community considers necessary. What needs to be proposed is extended market exclusivity for biologics. Congresswoman Anna Eshoo has proposed a bi-partisan bill with over 50 co-sponsors that provides for 12 years, a far more reasonable timetable. This is necessary to safeguard the innovators working to find these amazing cures for us all.

I am confident that the parties will reach an agreement that makes these revolutionary new medications more widely available and gives our scientists the support they need to produce the next generation of medical treatments. To all involved, keep up the good work.

Jennie C. Hunter-Cevera, Ph.D., has served as President of the University of Maryland Biotechnology Institute since October 1999. She has given more than 70 invited lectures and keynote presentations and is the author of several papers, chapters, and books, as well as the holder of several patents in the area of natural products and biocatalysis.  

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