Root and Seidenberg: Fixing Cracks in the Medical Innovation Pipeline

For decades, the United States has enjoyed technological leadership in medicine thanks in large part to the robust pipeline of innovation that has flowed from our university labs through development, regulatory approval and commercialization to the American people.

The combination of the National Institutes of Health, outstanding university-based research, access to capital and sound regulation has enabled our country to build a thriving therapeutic medical device and biopharmaceutical industry, create millions of jobs and provide the most advanced health care for our citizens.

Yet, in recent years, an alarming crack has formed in this pipeline and, if left unaddressed, the flow of innovation that reaches American patients will slow to a trickle, putting our global technological and economic leadership in jeopardy.

Because the process of bringing medical innovation to patients is so time-intensive and high-risk, universities have relied largely on the venture capital system to translate our basic research into safe and effective drugs and devices. But this critical collaboration may now be compromised.

A new study published today by the National Venture Capital Association’s Medical Innovation and Competitiveness Coalition found that venture capital firms have been decreasing their investment in biopharmaceutical and medical device companies in the United States over the past three years and expect to curtail further such investment over the next three years, primarily because of challenges related to the Food and Drug Administration.

The resulting investment decline is anticipated to be in the billions of dollars, putting at risk the delivery of many of the promising discoveries currently in our country’s university labs and thousands of American jobs. Without venture investment, these discoveries have limited avenues to market and will wither on the vine.

Ironically, the promise of medical science has never been greater. Potential breakthrough treatments for prevalent and deadly conditions are being discovered at a faster pace than ever before.

Venture capitalists remain committed to shepherding these innovations through clinical trials despite the fact that today it requires 10 to 15 years and more than $1 billion to develop a new drug.

The venture industry has long understood and managed the scientific and business risks of investing in medical devices and biopharmaceuticals.

Many breakthrough technologies have been borne from this process including: MRIs, angioplasty and minimally invasive surgery for heart disease, blood glucose monitoring, implantable defibrillators and many lifesaving and life-sustaining new drugs for cancer, diabetes, heart disease, AIDS, multiple sclerosis, rheumatoid arthritis and orphan diseases of childhood and adults.

Yet, according to the survey, unpredictability and an imbalance in risk/benefit assessment at the FDA, and the difficult reimbursement and economic environment, are driving investment in innovative medical technology away from the United States and threatening our leadership position in the delivery of quality health care.

The time for FDA reform has come. The consequences of inaction are significant for our public health and economy. Faced with these regulatory and economic risks, venture investors — and the endowments and pension funds who fund them — believe they have no choice but to turn their attention and funding away from lifesaving and life-sustaining therapeutic products for highly prevalent diseases and into areas not regulated by the FDA such as health care information technology and services.

The report revealed significant investment decreases in companies fighting cardiovascular disease, diabetes, obesity and cancer as well as neurological, psychiatric, respiratory and gastrointestinal disorders. Additionally, venture investment is shifting away from the U.S. in favor of Europe and Asia, where American companies are expected increasingly to seek regulatory approval and commercialization of their products first.

The situation also jeopardizes our country’s economic health. According to IHS Global Insight, medical product companies founded and developed by  venture capitalists employed more than 1.7 million people in the United States in 2010. If venture capitalists are forced to abandon investment in American therapeutic medical product companies, these companies will be left with no funding alternatives.

The high-risk, long-term nature of the startup model does not suit lenders or other private equity investors.

Imagine the human and economic loss if Dr. Herbert Boyer, the founder of Genentech, had no funding sources available to him in 1976 to invent, develop and help commercialize recombinant human insulin for diabetics?

We must do all that we can to ensure that there is a predictable regulatory process and a balanced risk-reward system that will support the next Genentech, Amgen, Celgene and Gilead.

Risk capital is the driver of innovation, job creation and leadership. We must act now or lose our leadership position in medical innovation and access to lifesaving treatments in the United States.

The American medical innovation pipeline has indeed sprung a leak, but it is not beyond repair if we act quickly. In particular, we need a strong and well-resourced FDA that acts as a facilitator and not a gatekeeper of innovation.

FDA officials and lawmakers have acknowledged the need for reform and appear ready to identify and implement solutions. Proposed changes to the FDA approval process that do not compromise safety — specifically in the areas of predictability, transparency, efficiency and the benefit/risk balance — have been developed and should be considered in short order. Such work is required to restore the ability of venture capitalists to continue to invest enthusiastically in the most worthy ideas now being discovered in our labs.

At a time when our country is struggling with economic recovery and facing serious concerns about our ongoing global leadership, we must not forget that innovation has always been at the heart of our success. Without it, jobs will not be created and Americans’ health is at risk.

The venture industry stands ready to work with lawmakers and regulators to insure the flow continues. The ramifications of a medical innovation drought are too perilous to ignore.

Jonathan Root, M.D., is an investor with U.S. Venture Partners in Menlo Park, Calif. Beth Seidenberg, M.D., is an investor with Kleiner Perkins Caufield & Byers in Menlo Park, Calif.