Biotechnology continues to hold the greatest promise to address many of the most critical issues facing our world. Continued innovation will lead to breakthrough new and improved cures and treatments for patients living with debilitating diseases such as cancer, HIV/AIDS, diabetes and Parkinson’s; enhanced agricultural products to feed a growing global population while protecting the environmental health of our planet; vaccines to protect against bioterrorism; and revolutionary biofuels. The ability of BIO members to continue our shared mission to heal, fuel, and feed the world depends on having an economic and public policy environment that supports research and development that leads to continued innovation.

Read the full article on BIO.org

There is widespread agreement among experts, policy makers and the public that the United States must overcome its addiction to fossil fuels to protect the environment and for reasons of national security. As in any addiction, interventions are necessary to break bad habits. Fortunately, in 2007 Congress expanded the Renewable Fuel Standard (RFS), requiring increased production and use of renewable fuels from multiple sources. American companies are making steady progress in creating advanced plant-based fuels. But this progress could be threatened by political uncertainty about continuing the RFS mandate.

Read the full post on The Hill’s Congress Blog

Small biotech companies continue to struggle to obtain funding as capital markets remain tight. The S&P downgrade may create even tighter credit markets and raise the cost of available credit, for small and large companies. To the extent that the downgrade leads capital flows out of the U.S., that hurts biotech.

Biotech’s contributions to the world are critically needed. Our industry holds great promise for curing and treating many prevalent diseases, such as Alzheimer’s, cancer, diabetes and Parkinson’s. Biotech can help to make the U.S. healthcare system more affordable, efficient, and of higher quality and foster the development of breakthrough technologies to provide alternative energy sources, combat hunger and protect against bio-terrorism.

Based on a recent survey of 800 registered voters, the majority of those surveyed place a high value on the industry’s contributions. Even in these fiscally focused times, finding cures to serious diseases ranks in the top tier of issues that matter to Americans.

In addition, continued funding for biotech research receives majority support in a second tier of priorities, far outpacing other areas of federal spending based on survey responses.

By Stephen Sherwin, Former Chairman of BIO

As Congress and the President work together to hammer out a new, national economic roadmap, it is important to point out to those working in, and interested in, our industry that we too have recently assembled a roadmap – one designed to fully realize the promise our industry holds for people everywhere.

Several weeks ago, at the 2011 BIO International Convention in Washington, DC, BIO unveiled its first ever 5 year strategic plan that will help guide the organization’s policy agenda for the near future.  The plan, crafted after consultation with industry experts, academics and BIO’s board, is designed to minimize the regulatory and legal burdens that hinder our ability to cure disease, feed the hungry and develop newer, cleaner forms of energy.  The plan seeks to accomplish this in two over-arching ways: incentivizing private and public investment in solving these problems, and enhancing the science-based regulation of our industry to ensure that new biotech therapies, cures and other bio-based products become available in a timely manner.

Much of the plan is focused on ways to improve the function of the U.S. Food and Drug Administration (FDA) – an agency many of us work with on a frequent basis.  Our experience suggests that the hard working and dedicated staff of the FDA would welcome the increased resources that we are advocate. Moreover, our proposals could help modernize the agency and enhance the transparency and predictability of its review processes and decision-making.

In the coming weeks and months, as BIO’s staff works with policymakers to craft the legislation that will deliver these changes needed to cure disease and save lives, BIO will continue to keep member companies apprised of actions they can take to help create the climate needed for passage of such measures.  In the meantime, we encourage everyone to review the following document to gain greater insight into this exciting new plan – http://www.bio.org/aboutbio/promiseofbiotech.pdf.

Mankind’s need to cure disease, combat hunger and discover new forms of energy has never been more urgent. Yet despite the extraordinary hope offered by biotechnology to solve these problems, government policies and the capital formation environment necessary to support these goals are insufficiently conducive to allowing us to meet these critical challenges.

During our 2011 BIO International Convention, we unveiled a strategic initiative to speed scientific breakthroughs, develop cures and grow the bio-economy. The policy proposals we presented will serve as BIO’s targeted advocacy plan for the next few years. Our comprehensive set of policy proposals address two vital needs for ensuring robust biotechnology innovation and industry growth: 1) the need to re-engineer the biotech economic model, and 2) the need to re-invent the idea-to-market pathway for biotech cures and other products. We will pursue these proposals by advocating for legislation, specifically by turning the relevant findings in to language that will be used to advocate for introduction and passage of legislation.

The process of putting together these proposals began last summer when interviewing thought leaders within and outside of our industry for the purpose of envisioning game-changing strategies. We contracted with Dr. Elias Zerhouni, former Director of the National Institutes of Health, to conduct an analysis of the challenges we face and a more comprehensive survey of medical experts, academic researchers and other life science leaders to suggest out-of-the-box, big ideas to significantly advance biotechnology’s chances to succeed. Additionally, during the past six months we worked with BIO Board members to review these ideas, debate their merits and create alternative and additional approaches to develop a comprehensive national policy strategy.

BIO has consistently succeeded in contributing to the development of important and effective policy at the federal, state and international levels. Our efforts notwithstanding, the legal and regulatory structures in place remain woefully insufficient to incentivize the magnitude of investment necessary in the biotechnology sector to translate the scientific potential that resides in the thousands of small, medium and large American biotech companies into products that save lives and fuel and feed the world in environmentally sustainable ways. Only by transforming the policy environment can we create a robust 21st century innovation economy, maintain our biotechnology global leadership, produce hundreds of thousands of high-paying jobs in the United States and prevent the tsunami of additional health care costs that will be associated with the aging baby-boomer population.

Stay tuned for more…

Couldn’t make this year’s 2011 BIO International Convention? Did you miss an interesting session? Do you want to hear an insider’s view of what happened or what you missed?

If so, you should check out these posts from members of BIO’s Official Blogger program:

BIO Convention 2011, Brady Huggett at Trade Secrets – follow Brady at @naturebiotech

Canada Kicks Off BIO, Mike Spear at Genome Alberta – follow Mike at @mikesgene

If Biotech Builds… Will Financers Come?, Angie Drakulich at PharmTech Talk

USAID: Global Health Efforts Tied to American Security, Angie Drakulich at PharmTech Talk

NIH Director Francis Collins: Broadening Our Vision of Global Health, Angie Drakulich at PharmTech Talk

That Elusive Factor, Brady Huggett at Trade Secrets – follow Brady at @naturebiotech

BIORadio, Mike Spear at Genome Alberta – follow Mike at @mikesgene

Third Annual Scientific American Worldview: Measuring Global Biotechnology, Yali Friedman at BiotechBlog – follow Yali at @thinkbiotech

A Conversation with NIH Director Francis S. Collins, PharmTech.com

Talent is Talent, Brady Huggett at Trade Secrets – follow Brady at @naturebiotech

Biotech and Emerging Markets: Perspectives from Brazil, India, Argentina, and South Africa, Angie Drakulich at PharmTech Talk

Boiling Things Down, Brady Huggett at Trade Secrets – follow Brady at @naturebiotech

Live from BIO: Transitioning to human models a big obstacle for DNA cancer vaccines, Erica Teichert at FierceBiotech

Getting Your Idea to Market – Crossing Death Valley, Betsy Raymond Stevenson at Snapshot – follow Betsy at @Betsy_RSHC

Docs at BIO: Steve Burrill’s State of the Biotechnology Industry Report 2011, Kevin Noonan at Patent Docs – follow Kevin at @patentdocs

By Stephen Sherwin, Former Chairman of BIO

All of us who have chosen careers in biotech began our journey because we passionately believe in the ability of our industry to improve the human condition. For many of us, this means devoting our career to improving the treatment of incurable diseases. For others, this means employing the power of biotech to provide high-quality and healthy food for everyone on this planet. And, for still others it means addressing the need to create new and environmentally friendly sources of energy and materials.  In short, we all began our journey in biotech with a set of goals and a moral compass to guide us towards achieving those goals.

My own path to biotech began at the National Cancer Institute as a practicing medical oncologist conducting clinical trials of new cancer therapies. I firmly believed that biotechnology could provide new ways to treat cancer and I have not been disappointed that my own compass pointed me in that direction. Recently, I have been fortunate to return to clinical work as a part-time volunteer physician in the oncology division at San Francisco General Hospital and see firsthand the impact of biotechnology on the treatment of patients with cancer.

San Francisco General is the hospital in our city where people without economic means, and sometimes even without a roof over their head, seek medical care. One of my fellow physicians put it very clearly, “Steve, we can never forget that cancer is the least of the problems that many of our patients face every day of their lives.”

When we read about human suffering every day, we must remember how very fortunate we are to have the opportunity to pursue our career in biotechnology. We spend our days working to heal, fuel and feed the world rather than waking up sick, cold or hungry.

All of us need to be sure that our moral compass is still pointing us in a direction that speaks to our hearts – a direction which includes giving back some of the good fortune we enjoy today.  We should do this so that our industry is always seen first and foremost as a group of dedicated and giving individuals, unified above all by our shared commitment to help heal, fuel and feed the world.

Read Stephen Sherwin’s full speech.

The other day I came across an article discussing vaccinations and the author mentioned his 15-year-old son asking him: “Dad, what’s polio?”

Many of us are old enough to remember a time when polio struck fear and caused suffering for millions.  Today, at least in the developed world, polio is something kids have to ask their parents to explain to them.

Imagine someday, our grandchildren asking us, “What was cancer?” How great would that be?

That is the future that we in biotechnology envision and work towards every day. To take cancer and aids and Alzheimer’s and malaria and all the other deadly and feared diseases that still end millions of lives each year—and move them from the medical books to the history books. Is there a reason that we shouldn’t envision a time when children will ask their parents what it was like back when people went hungry or worried about climate change?

This is the vision of the biotechnology industry, but we all know how much work it will take to get us there.

We at BIO are not the scientists. We’re not the entrepreneurs. We’re not the investors. But, we are your voice, your advocates to the policymakers and decision makers. We work to create the right conditions so your work can go forward.

Despite all of our progress, let’s face it: we are not getting the cures to patients, the crops to farmers and the fuels to consumers nearly as fast as we need to.

Imagine if it didn’t take 10 or 15 years to get a new medicine to patients. Imagine if we didn’t have companies laying off researchers and killing promising projects because investors just can’t afford the risk of funding early stage companies.

Instead, what if when you went on a road show, the investors couldn’t line up fast enough to give you money?

What if the FDA review of new product applications was actually coherent, transparent and predictable? What if you could get your new drug or device approved in a timely way? What a concept!

What if the EPA, the USDA and the FDA actually worked together to approve new biotech plant and animal products? What a concept!

Imagine the difference it would make if every country’s government made biotech innovation a national priority. Is that too much to ask?

Last year, after our convention ended in Chicago, I decided that to truly unleash the pace of biotech innovation, we had to think bigger, bolder and more outside the box. At BIO we started what we call our “big thinking project.” We asked biotech leaders, investors and patients across the country to give us their biggest and smartest ideas to radically change the policy environment. And we said, “don’t worry how controversial or how politically difficult it would be to accomplish—that’s our job.”

With those ideas in mind, BIO has been hard at work constructing a comprehensive legislative proposal—BIO’s first ever five year plan—that we’re confident will accelerate our progress.

Our plan includes: new capital formation proposals, regulatory reform provisions, a new progressive approval pathway, and more investment in biotech research.

We are telling Congress and the White House that to balance the budget, we need more high-wage, tax-paying jobs. Well, when you put biotechnology to work, you put people to work – lots of them.

We’ve also put together a comprehensive Biobased Economy Jobs and Development Act that would give a needed boost to dedicated energy crops, renewable chemicals, advanced biofuels and next generation bio-refineries.

We also need bold policy changes to advance agricultural biotechnology.

Unfortunately, the U.S. regulatory system for plant and animal biotechnology is fast becoming the greatest impediment to the development of safe and beneficial products. Our plan calls on Congress to provide clear direction to the regulatory agencies to fix this mess.

These are the kinds of policies that will enable us to achieve the dreams we’ve imagined. Every day, our products reduce suffering, save lives, and provide hope and healing.

But for us, that’s just not good enough.

If we really intend to leave our children a world with less disease, less hunger and less pollution, then we have to face the reality that our time is running out.

Download Jim’s full speech to the 2011 BIO International Convention.

In the age of new media, sharing information about a prescription drug is even more perilous than ever. Despite promises of guidelines in 2009, the FDA still has yet to issue clear guidance to pharmaceutical companies about how to remain in compliance with regulations while using the appealing and affordable medium of new media to disseminate information.

In their panel, “Talking About Your Product in the New Age: Social Media and the Internet,” moderator John Kamp, along with David Adams, Partner, Venable, LLP; Raymond Kerins, Vice President, External Affairs and WW Com., Pfizer; Michael Myer, President, Palio; George Ng, Partner, Co-Chair of Life Sciences Practice, Gordon & Rees LLP discussed current standards and policies and liability for companies in the new media age.

In short, all panelists agreed that companies needed to expect extreme vigilance by the FDA, and use caution when considering how, and how much, to  share and interact on social media, particularly when it came to off-label use of prescription drugs.

The panel had some practical tips for companies considering how, or if, to use new media to communicate information about products.

• Assume vigilant FDA
• Apply traditional standards on company sites
• Exercise caution when participating on third-party sites
• Consider product liability concerns regarding correction and adverse event reporting

George Ng advised creating a comprehensive social media strategy that included tactics to manage all of the above, and clearly defined how and where your company would participate in social media. The plan should answers to questions such as:

• Is this advertising and marketing?
• Who is the intended audience?
• What should I consider with this audience with respect to regulatory requirements?
• What mechanics will I use to regulate access to that audience?
• What is the sponsor’s tolerance for uncertainty and risk?
• How do I align the site with this tolerance level?
• What are the regulatory consequences of adding or linking other tools or content to my site?

Betsy Raymon, Founder and Principal, RaymondStevenson Healthcare Communications and one of our Official Bloggers, is attending the 2011 BIO International Convention and she is pretty excited about it (and she should!).