Secretary Sebelius delivered a speech in California yesterday which recognized the potential of biotechnology to address unmet needs in human health, agriculture and industrial and environmental applications. In her remarks, Secretary Sebelius stated:
“[I]nvesting in each step of the process that starts with basic scientific discovery and ends with the development and provision of better diagnostics, treatments, and preventive strategies to significantly improve health care. I know I don’t have to tell you that because these steps are often very complex, promising scientific discoveries can move incredibly slowly toward practical application, encountering significant hurdles along the way.”
The Secretary also recognized the challenges faced by emerging companies in raising the funds necessary for research and development and the approval process:
“While many companies may have powerful new ideas, the fact is that when those companies are young and small, they may not have access to the capital they need to get those ideas off the ground.”
The Secretary’s stated objective to “accelerate the process of scientific discovery, and improve the health of the American people” requires a strong and predictable intellectual property system together with an efficient and flexible technology transfer system. It is equally important to foster partnerships and collaborations between the private and the public sector to translate basic research into new medical therapies and other products.
Without strong intellectual property protection and an efficient technology transfer system, biotech companies may have trouble attracting investment into cutting-edge products and technologies.”
Below is a transcript of the Secretary’s speech.
The Biotech Meeting
Laguna Beach, CA
October 12, 2010
Thank you Brook for that very kind introduction.
I want to thank both Brook and Steven Burrill for convening this important discussion today and for all the work you have done to advance the life sciences.
Thank you as well to my colleague and friend Congresswoman Anna Eshoo, a true champion of science and technology in the House of Representatives.
I am delighted to be here. As you know, I came to the Department of Health and Human Services as a governor where I saw firsthand the potential of biotechnology – not just to create jobs and drive growth, but also to solve some of our biggest problems: to improve health and eradicate disease, to reduce our dependence on foreign oil and keep our water clean.
When we look back over the last century, we see that biotechnology is responsible for some of our greatest progress in public health, from the discovery of penicillin to the development of effective therapies for HIV infection.
Diseases that had once been a death sentence have been eradicated or cured. Conditions that had once been disabling are now manageable.
Today, at the beginning of a new century, we can see even bigger opportunities ahead.
And our mission at HHS is to make good on those opportunities, accelerate the process of scientific discovery, and improve the health of the American people.
That means investing in each step of the process that starts with basic scientific discovery and ends with the development and provision of better diagnostics, treatments, and preventive strategies to significantly improve health care.
I know I don’t have to tell you that because these steps are often very complex, promising scientific discoveries can move incredibly slowly toward practical application, encountering significant hurdles along the way.
But with so much to gain, we can’t afford to let any good idea go to waste. We must be able to realize tomorrow’s opportunities. And that means being able to count on a robust and streamlined process to translate and carry promising ideas forward, from the microscope to the medicine chest, from initial investment to the global market.
As you may know, this very challenge was recently highlighted in an HHS report examining our nation’s medical countermeasure enterprise.
With the President’s support, we conducted a first-of-its-kind, comprehensive analysis, and its conclusions ultimately confirmed what some of you have been saying for some time: that the pipeline we rely on to provide those critical countermeasures – diagnostics, vaccines, antivirals, antibiotics – is full of leaks, choke points, and dead ends.
In an age of new threats and persistent challenges, where delays cost lives, we simply aren’t developing and manufacturing new medical countermeasures fast enough.
So, when the review was completed this August, HHS announced it would direct nearly $2 billion in preparedness funds to help us build a medical countermeasures enterprise that is modern, flexible, and equipped to respond quickly and effectively to any threats that arise.
What I want to share with you today is that:
One, we’re already moving forward on this plan.
And two, you need to be a part of it. We intend to call on your expertise and experience to make sure we get it right.
It was in this spirit last month that the Department’s Biomedical Advanced Research and Development Authority (BARDA) announced a solicitation for one or more new Centers of Innovation for Advanced Development and Manufacturing.
Despite tireless efforts on every front during the H1N1 influenza pandemic, we needed greater capacity and more flexibility to produce enough vaccine in a timely manner.
These new centers would serve as key platforms where flexible manufacturing can take place. They may be brand-new facilities, or existing facilities that are significantly refurbished. And they will have the potential to offer a dependable and robust domestic source of vaccines and other countermeasures for pandemic influenza, unknown pathogen outbreaks, and other evolving public health priorities.
But more than that, these Centers — established as public-private partnerships — will also serve as a resource so that small biotech companies with big ideas can get the regulatory, technical, and manufacturing know-how they need to demonstrate their product’s potential and bring it to market.
And they will provide manufacturing resources so those same small companies can produce these products without the heavy burden of capital investment into their own facilities.
Going forward, we are very interested in feedback and guidance from the community we hope these Centers will serve. Comments are due no later than October 29th, and will be used to develop a formal request for proposals that will potentially be awarded by the end of 2011. So please contribute your thoughts, so that we can make these facilities as responsive and effective as possible.
At the same time and in similar spirit, we are also initiating what we call the Concept Acceleration Program at the NIH, to ensure that discoveries with great potential do not die on the vine.
The program will create so-called “Sherpa” teams to guide these concepts through early stage development with partner agencies, academic researchers, biotechnology and pharmaceutical companies.
NIH is essentially scouting the emerging science that comes from its investments then leveraging its resources to take them further still.
Now, our comprehensive review identified another key challenge as well:
While many companies may have powerful new ideas, the fact is that when those companies are young and small, they may not have access to the capital they need to get those ideas off the ground.
Right now, there’s little financial incentive for private companies to explore rare conditions like the Ebola virus infection or exposure to non-medical radiation.
Yet in the event of an Ebola outbreak or a nuclear explosion, countermeasures for these conditions would be critical.
That’s why we’re exploring a strategic investment fund.
It may be a new entity entirely or a new initiative within an established government-sponsored fund.
But I can tell you it will be an independent, not-for-profit organization whose mission is to find and nurture those organizations that have the greatest chance of making good on the public’s early investment.
And we’re not just talking about money. A good venture capital organization does not just infuse capital into key projects; it brings in executive business expertise — the vision and the guidance to take something small with big potential and find the best path to reach the next level.
At the same time, we will continue, as always, to provide direct support for the advanced development of products that are important to the public health but often unattractive to investors in private industry. Let me give you some examples:
In 2005, the National Institutes of Health established the Centers for Countermeasures Against Radiation, where investigators developed innovative methods and tools to measure radiation exposure and evaluate potential drugs to treat radiation injury.
The program funded 130 pilot studies, and attracted many new scientists to the field, bringing with them new ideas and new perspectives.
So this summer, we announced an additional five years of funding to extend the program — $105 million in support of further research at seven institutions nationwide, building on the advances of the last five years.
On August 31, BARDA awarded a contract of up to $64.5 million for the continued development of a promising new antibiotic that may be used to fight drug-resistant organisms, including serious biothreat agents like the one that causes bubonic plague.
And late last week, we announced three new contracts that could reach $68 million focusing on a dengue vaccine delivered by a needle-free device, an anthrax vaccine delivered orally, and an anthrax vaccine delivered in conjunction with a compound that stimulates the immune system.
Clinical trials of all three vaccine products should begin within three years.
All of these investments, like many of the new initiatives highlighted in our medical countermeasure review, are about addressing risk.
By supporting facilities and resources at the new Centers of innovation, we’re addressing the technical risk that comes with taking on uncertain, but important public health projects.
By exploring a strategic investment fund, we are addressing the risk in terms of business development.
But there’s another kind of risk, and that’s regulatory risk.
So we’re addressing that too, by improving regulatory science at the FDA.
Last week, our terrific FDA Commissioner Margaret Hamburg unveiled the agency’s new Regulatory Science Initiative, laying out a strategic framework to modernize how we evaluate and regulate product development.
For too long, we’ve underinvested in the tools, models, methods and knowledge needed for making these assessments.
Because of this underinvestment, we’re often testing and producing cutting-edge products using science that’s decades-old.
We’re going to give our world-class FDA scientists the resources they need to create clear regulatory pathways, analyze promising new discoveries faster, and help identify and solve scientific problems as they occur. And we’re going to build capacity throughout the development process to support intensive and early interaction between FDA and sponsors as well as government partners.
In the end, if a product fails to make it into our national stockpiles, it should only be based on its failure to meet our stringent standards for safety, efficacy or quality, and not because we failed to provide the needed business, regulatory and technical support for success.
To achieve that goal we will have to work together.
Last year, less than an hour after being sworn in as Secretary, I was in the Situation Room being briefed on the H1N1 flu by John Brennan, the President’s Advisor for Homeland Security and Counterterrorism.
I was so new I didn’t even know where the Situation Room was. Someone had to show me how to get there.
During last year’s flu season, we turned to medical countermeasures, of course. But they were just one part of a much larger response.
That response depended on the strength of our health care workforce.
It depended on our ability to collaborate across the government and to execute a national strategy on the local level. And it depended on successful public-private communication and collaboration, as well as an informed and engaged public.
With so many factors in play at once, coordination was key.
It was a good reminder that to be ready for the next public health crisis, we need to focus on our entire end-to-end response, from how we assess and identify threats to how we distribute and administer products to counter those threats across the country.
This was one of the goals we had in mind when we passed the Affordable Care Act six months ago. And although it is not often referred to this way, it is one of the strongest public health bills our nation has ever seen.
The Treasury Department has already received over 5,000 applications and will soon announce recipients of the $1 billion therapeutic discovery grant and tax credit program as part of the new law, helping small businesses that are developing new and cost-saving therapies for patients suffering from serious diseases.
Investments like these create jobs and help us stay competitive as a nation.
So, too, will the new $15 billion Prevention and Public Health Fund that recently distributed nearly $43 million in grants to state, local, and tribal governments to improve their public health services.
And at the heart of so much of our prevention efforts is an understanding that vaccination is absolutely critical.
That’s why under the new consumer protections that took effect last month, Medicare and new private health plans will offer flu vaccine and other critical vaccine coverage – without co-pays or deductibles.
The elimination of cost as a barrier comes at a key moment: This is the first year in which health officials are recommending that every American older than six months get a flu shot. And there should be ample supply; over 100 million doses have already been distributed.
I want to thank you again for having me here today — and for your partnership. Together we’re going beyond scientific discovery, and bringing its possibilities to more people and more communities.
That is our shared responsibility — to make the very most of biotechnology’s great promise: to make it work for people’s families and communities, to strengthen our economy, and to improve our quality of life.
Francis Crick said that “Big questions get big answers.”
By pushing science in powerful new directions, we can continue to answer some of today’s biggest, toughest questions with confidence and real hope for a brighter tomorrow.
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