Jim Greenwood Address at 2006 BIO CEO & Investor Conference

This morning at breakfast I noted that this year's conference is our most well-attended yet.

In just the past few hours, the numbers have continued to grow. We now have 1684 participants registered and still counting - even in the midst of a record-breaking snow storm.

And I think that is a sign - a signal that for biotechnology companies and investors, the sky is the limit with opportunities abounding in genomics, personalized medicine, diagnostics, biomarkers, cell therapies and vaccines - about which we will continue to learn today and tomorrow.

Our industry has reached a level of maturity during the past few years that is paying off in terms of stability. And stability leads to greater incentives for investment and partnering activities to fuel a steady stream of new and unique therapies.

Karen Bernstein, editor of BioCentury, reflected on this when she wrote at the beginning of the year that "dozens of metrics mark the coming of age of the biotech industry."

She ticked off a number of examples, including that at least 12 companies have drugs with more than $500 million in annual sales.

Our companies have attracted a flood of investment dollars, including more than $20 billion just in 2005.

Biotech companies have more than 300 biotech drug products and vaccines now in clinical trials addressing more than 200 diseases.

We expect, and the market points toward, a successful and strong year of growth for the industry.

We are featuring at this conference different forms and applications of biotechnology than we previously have. This means that there are new investors here today, and new companies that have not previously participated.

Industrial biotechnology is now achieving commercialization and growing rapidly.

The President's State of the Union speech singled out cellulosic ethanol as a viable and economic alternative to imported oil. This has prompted increased interest and investment in ethanol technology. Carmakers are exploring its use, major oil companies are exploring its development, and states are seeking ways to increase its availability.

Widely available and enormous supplies of agricultural waste material can now be turned into a low-cost renewable energy source that won't compete with precious food crops.

Combined with policy initiatives for renewable energy such as the President's, and exorbitant fossil fuel costs, ethanol produced with the help of biotechnology is poised to break into the marketplace for transportation fuel.

In addition, other products derived from these otherwise useless feedstocks are being developed with significant market potential - substitutes for certain plastics, for example.

Food and agricultural biotech is gaining increased acceptance among consumers throughout the world.

In 2005, farmers planted the 1 billionth cumulative acre of biotech crops.

The WTO last week found that European countries had imposed illegal moratoria on approvals of biotech crops and foods. And we hope that this will lead to an increased number of approvals in the future.

But our growth in all of these endeavors requires not only cutting-edge science and bullish investors, but it is dependent upon a stable, predictable regulatory environment as well.

Biotech companies need strong, clear guidance from all regulatory agencies, but most importantly the FDA must continue to fulfill its mission to deliver new and innovative therapies to patients.

Last year when i spoke at this conference I had just arrived at bio and I promised to build for you a world class advocacy team. That mission has been accomplished. We have the best policy and lobbying team in Washington and we are succeeding in meeting our goals on your behalf.

Last year we made sure that in the wake of a series of major safety episodes, the Congress did not overreact with draconian legislation that would bog down the approval process.

We ensured that proposed patent reform legislation did not undermine our companies' intellectual property rights.

We secured the passage of major new legislation to provide the incentives, legal protections and $3.7 billion in appropriations to protect our nation from pandemic.

We made significant progress in gaining protection for our smaller public companies from onerous Sarbanes-Oxley compliance.

And, just last week, we succeeded in moving from the FDA a set of regulations critical to our agricultural companies.

But we will not rest on our laurels.

Despite the established legislative and regulatory requirements and procedures, a lack of transparency and predictability as well as unnecessary delays continue to frustrate companies with products undergoing FDA review.

I met last week with Acting FDA Commissioner Andy von Eschenbach and shared with him BIO's commitment to work with him to enhance our members' ability to receive timely FDA review and approval and expand patient access to innovative, safe and effective biopharmaceuticals and therapies.

We aim to work with the agency to:

• Foster an efficient risk management and quality systems approach to medical product review;
• Enhance processes for inexperienced filers;
• Expand access to investigational drugs for treatment use;
• Accelerate approval for certain categories of products.

It is concerning that fewer new molecular entities are being submitted to FDA for review and product success rates have not improved over time.

Over the past twenty-four months, the FDA has endured periods of diminished public confidence in its ability to balance safety risks and possible adverse events with the benefits of broad patient access to life-enhancing medications.

Some have speculated that the FDA has become more conservative, with the net result of reducing patient access to new medical treatments and therapies.

We aim to increase public confidence in FDA regarding drug safety. To counter the effects of this reduced public confidence, BIO will work to achieve:

• More targeted resources for FDA for drug safety activities;
• An improved framework for post market commitments;
• Revamping of FDA's adverse event monitoring and reporting systems;
• Utilization of new technologies and genetic resources to identify and reduce adverse events;

As part of our efforts to increase public confidence at the FDA, we will also press for a strong, stable, senior leadership team at the agency.

FDA must be appropriately resourced to fulfill its mission of protecting the public health by assuring the safety, efficacy, and security of human drugs. This year marks the beginning of the reauthorization work for the Prescription Drug User Fee Act (PDUFA). It is imperative that this program, when ultimately considered by Congress next year, provide FDA appropriate resources for drug and new therapy reviews.

Today and tomorrow, as the BIO staff and I listen to CEOs and other scientists present their brilliant biotechnology break-throughs to record numbers of investors, we understand that our job is not just to bring you together, but it is also to create the policy environment at the federal, state and international levels that ensures that your therapies get to the patients on time.

As you thrive on your challenges, we thrive on ours, and we welcome the opportunity to play our part in bringing your dreams to reality.

Thank you.