Thank you. It's GREAT to be in BOSTON!
MANY people think of BOSTON...as one of the world's GREATEST centers of excellence in EDUCATION...and it CERTAINLY IS.
With the Boston CELTICS...RED SOX...BRUINS...and New England PATRIOTS, many OTHER people think of BOSTON...as one of the world's greatest SPORTS TOWNS. Maybe it IS.
But in the convention center TODAY...we ALL think of BOSTON as one of the world's GREATEST BIOTECH communities!
So THANK you again, BOSTON...for being such WONDERFUL HOSTS of our industry's INTERNATIONAL convention.
As you've been HEARING...in the BIOTECHNOLOGY INDUSTRY...we DO...BIG THINGS.
Biotechnology can HELP our WORLD...achieve our SHARED GOALS...of developing CURES and BREAKTHROUGH new medicines for PATIENTS.
BIOTECHNOLOGY is KEY to REDUCING overall health care COSTS...DRIVING INNOVATION in CLEANER and safer ENERGY...COMBATING HUNGER...and PROTECTING against BIOTERRORISM.
We CLEARLY DO...BIG things.
Over the past year...I have had the PRIVILEGE of working CLOSELY with Jim GREENWOOD...his EXCEPTIONALLY FINE and HARD-WORKING BIO staff...and the OTHER members of the BIO Board of DIRECTORS...to represent ALL of YOU.
Under Jim's LEADERSHIP...last YEAR at BIO 2011...BIO introduced a NEW INITIATIVE...UNLEASHING the PROMISE of BIOTECHNOLOGY.
This INITIATIVE...is a FIVE-YEAR PLAN to RESHAPE the POLICY environment for biotech INNOVATION.
The THINKING is BIG...and what we are DETERMINED to ACCOMPLISH is EVEN BIGGER.
BIO has TRANSLATED...UNLEASHING the PROMISE of BIOTECHNOLOGY...into a series of very BOLD LEGISLATIVE PROPOSALS...and has ADVOCATED EXTREMELY effectively in this DIFFICULT political environment...to gain the SUPPORT of key STAKEHOLDERS...and key MEMBERS of the House and SENATE.
YOUR SUPPORT . . . of THESE efforts has helped MOVE the NEEDLE in a POSITIVE direction.
The AMERICA INVENTS ACT...signed by President Obama last SEPTEMBER...makes America's PATENT SYSTEM more TRANSPARENT...more OBJECTIVE...and more PREDICTABLE.
In April of THIS YEAR...the White House released AMERICA'S FIRST...NATIONAL...BIOECONOMY BLUEPRINT.
The BLUEPRINT recognizes the IMPORTANCE...of the EMERGING BIOECONOMY for the nation's future...and provides a FRAMEWORK...for federal policies to CLEAR the PATH for American INNOVATION...across ALL SECTORS of the biotechnology industry.
Both the AMERICA INVENTS ACT...and the National BIOECONOMY BLUEPRINT...are BIG BIO achievements.
BIO's MISSION is BROAD...and ENCOMPASSES...ALL areas of biotechnology...so I would like to FOCUS my remaining COMMENTS today...on examples of BIO's PROGRESS in ACHIEVING...a few of your SPECIFIC public POLICY OBJECTIVES.
- FIRST in HEALTH care...particularly on the REGULATORY front.
- SECOND in CAPITAL FORMATION.
- THIRD in the INDUSTRIAL and ENVIRONMENTAL arena.
- And FOURTH in FOOD and AGRICULTURE.
Let's BEGIN with HEALTH CARE.
EARLIER this morning...right HERE at BIO 2012...BIO released the RESULTS of several NEW OPINION surveys.
EIGHTY FIVE PERCENT of VOTERS in the United States...and NINETY PERCENT of our biotechnology industry LEADERS...are OPTIMISTIC that science and technology WILL FIND CURES . . . to help PATIENTS suffering from SERIOUS diseases such as CANCER...PARKINSON'S disease...ALZHEIMER'S...HIV/AIDS...and DIABETES.
U.S. voters RANK...FINDING CURES...second in IMPORTANCE to ONLY one NATIONAL priority.
I’m SURE it comes as NO SURPRISE that IMPROVING the economy is the only PRIORITY...that VOTERS believe is MORE important than finding CURES.
And nearly TWO THIRDS of the voters SURVEYED...SUPPORT CREATION of an ACCELERATED APPROVAL process...to SPEED the AVAILABILITY of CURES to patients with serious disease.
We need an FDA REGULATORY REVIEW process...that is MORE PREDICTABLE...MORE TRANSPARENT...and more SCIENCE-BASED.
We ALSO need a more APPROPRIATE BALANCE...between the NEED to SPEED new treatments to PATIENTS...and the DESIRE for ABSOLUTE safety...which we ALL KNOW is UNATTAINABLE.
Both of these needs are ADDRESSED in LEGISLATION that BIO has FOUGHT for...and that we expect the HOUSE and SENATE...to finalize SOON on a BIPARTISAN basis...and THEN SEND to the PRESIDENT for HIS signature.
We expect the final package to REAUTHORIZE...CRITICALLY needed FUNDING for the FDA.
And we believe the legislation WILL INCLUDE...an EXPANSION...and MODERNIZATION...of the ACCELERATED APPROVAL pathway...to SPEED safe and effective TREATMENTS...to PATIENTS with SERIOUS and LIFE-THREATENING conditions.
We also expect this legislation to INCREASE TRANSPARENCY and SCIENTIFIC DIALOGUE...between the FDA and SPONSOR COMPANIES.
It will also ENCOURAGE ADVANCES in regulatory SCIENCE...and REFORM the CONFLICT of INTEREST policies the FDA APPLIES...when SEATING FDA ADVISORY committees.
Another regulatory area of MAJOR focus for BIO...is BIOSIMILARS.
The FDA is now DEVELOPING the RULES and REGULATIONS that will DEFINE...the REVIEW PATHWAY for biosimilars.
BIO is DEEPLY ENGAGED to ENSURE that this PATHWAY includes BOTH...strong PATIENT SAFETY protections...and STRONG INCENTIVES for future innovation.
The CAPITAL FORMATION ENVIRONMENT...has BEEN INCREASINGLY DIFFICULT...over the past SEVERAL years...and small EMERGING companies have been the HARDEST hit.
Our industry is OVERWHELMINGLY made up of SMALL businesses...FOUNDED by ENTREPRENEURS...and supported LARGELY by PRIVATE CAPITAL.
THIS puts biotechnology companies at the MERCY of the FINANCIAL MARKETS.
Our companies NEED HELP...in an ENVIRONMENT... where CAPITAL has simply become UNAVAILABLE...and where INVESTORS have become INCREASINGLY RISK-ADVERSE.
For small VENTURE CAPITAL-BACKED...biotech companies...BIO WON RESTORED ELIGIBILITY for grants from the SBIR program...a CRITICAL source of FUNDS for many of our SMALL COMPANIES.
In April, the PRESIDENT signed the JOBS ACT. BIO fought VERY HARD for this bill.
The Jobs Act EASES the PROCESS of going PUBLIC for smaller companies.
It creates an IPO ON-RAMP...to give our NEWLY PUBLIC smaller companies RELIEF...from BURDENSOME regulatory requirements.
MOVING to our INDUSTRIAL and ENVIRONMENTAL section...as JIM mentioned in HIS comments YESTERDAY...advanced BIOFUELS THIS YEAR...will reach a HISTORIC milestone.
The WORLD'S VERY FIRST...COMMERCIAL-scale CELLULOSIC ETHANOL plant, will come ONLINE in Florida.
It took many YEARS...of SOLVING TOUGH SCIENTIFIC CHALLENGES to REACH this biofuels MILESTONE.
And it also took MANY YEARS...of BIO FIGHTING for the RIGHT PUBLIC POLICIES to make it POSSIBLE...INCLUDING encouraging CONGRESS to PASS...and then MAINTAIN...a strong RENEWABLE FUELS standard.
Despite biotech's POTENTIAL to revolutionize FOOD and AGRICULTURE TECHNOLOGY...and HELP FEED the WORLD'S HUNGRY...our FOOD and AGRICULTURE SECTION FACES...an EXTREMELY CHALLENGING environment.
AGRICULTURAL...biotechnology faces REGULATORY processes FRAUGHT with UNCERTAINTY...COSTLY...UNPRODUCTIVE...with requirements that are often ARBITRARY...OBSTRUCTIONIST...ANTI-SCIENCE...and ANTI-INNOVATION.
Even WITH these CHALLENGES...the ADVOCACY of BIO's FOOD and AGRICULTURE SECTION has led to a more STREAMLINED...and PREDICTABLE REVIEW for new BIOTECH CROPS.
The RESULT is a welcome ACCELERATION of new PLANT biotech PRODUCT APPROVALS in the LAST YEAR.
In addition...BIO CONTINUES to work to FEND OFF...ATTEMPTS to REQUIRE LABELING of GENETICALLY modified foods.
To highlight ONE example...BIO has WORKED with MEMBER COMPANIES to DEFEAT...each and every Congressional ATTEMPT over the last TWO YEARS...to DELAY APPROVAL of genetically engineered SALMON...including MOST RECENTLY an effort to ACCOMPLISH this through an AMENDMENT to the REAUTHORIZATION of DESPERATELY needed FDA FUNDING.
With ALL of BIO's IMPORTANT POLICY OBJECTIVES...NO TIME-OUT is permitted BETWEEN rounds.
Across EVERY field of biotechnology... the POLICY ENVIRONMENT is EVER-CHANGING...and BIO must be constantly INVOLVED...and EVER VIGILENT...to PROTECT and PROMOTE the environment for innovation.
By the end of this MONTH...the SUPREME COURT is expected to issue a RULING...on CHALLENGES to the AFFORDABLE CARE Act.
The court's RULING may STRIKE DOWN SOME...or ALL of the HEALTH CARE REFORM law passed in 2010.
We can't PREDICT what the Justices will DECIDE...but rest ASSURED that BIO HAS STUDIED...EACH POSSIBLE OUTCOME and HOW it COULD AFFECT the biotechnology industry...and we WILL BE READY...for WHATEVER happens.
BIO will also be ready for what is EXPECTED to be an EXTREMELY HIGH STAKES post-election...LAME DUCK session of CONGRESS at the END of this calendar year.
BIO will use the intervening time to ADVOCATE...for EXTENDING and EXPANDING...the THERAPEUTIC DISCOVERY PROJECT tax credit program...and to ADVOCATE AGAINST CUTS to drug REIMBURSEMENT under Medicare Part B...and AGAINST CREATION of a REBATE under Medicare Part D.
Beyond THESE EXAMPLES...there are ALWAYS SURPRISES we'll HAVE to HANDLE.
With your CONTINUING STRONG SUPPORT...the continuing COMMITMENT of BIO's Board of DIRECTORS and SECTION GOVERNING BODIES...and the HARD WORK and GREAT SKILL of the BIO STAFF under Jim GREENWOOD'S LEADERSHIP...I am FULLY CONFIDENT in our ABILITY to handle WHATEVER confronts us.
THANK you...and NOW let's get to work...doing THESE BIG THINGS!