Yesterday, our friends at BIOtechNOW posted the following information about participating in a survey about the FDA.  We encourage you to check it out:

Posted by georgeatbio on February 1st, 2010

In an ideal world, everyone would have a strong and positive relationship with the FDA. With that as a goal, PricewaterhouseCoopers has launched its fifth survey –Improving America’s Health V Survey – to gauge the working relationship between the life sciences industry and the FDA. Your feedback is important to make this survey a success.

To participate, please send an email to PricewaterhouseCoopers.and.BIOCOM@us.pwc.com with “Life Sciences FDA Survey” in the subject line. A survey will then be forwarded to you. The survey should take only 15 to 20 minutes to complete. All responses to the survey will be kept confidential and private.

Those who participate in the survey will receive a preview copy of the results prior to their public release. The survey will close on Feb. 26. Please help foster improved relations between our industry and the FDA.

by:  David Welch

I left the office early Friday to catch the first showing at my local theater of “Extraordinary Measures.”  Although Hollywood altered a few names, places and institutions, the essential story is true. It is  about a dad determined to save his two children from the fatal certainty of the dreaded Pompe disease and a brilliant  medical scientist whose theory on how to develop a life-saving enzyme to treat  the disease leads to the two men launching a successful biotech start-up.  As the producer of many true-to-life  short-form films presenting biotech’s amazing potential and the emotional side of the patients who have been saved by biologics, I was natuurally excited about seeing the new flick on Day One.  It didn’t let me down.  I can only hope the millions of people with little or no awareness of biotechnology will come away with a greater appreciation for the potential of this healing science and the dedicated scientists who do “extraordinary” things every day. I also speak as a patient who receives a monthly biotech treatment for a crippling auto-immune disease that has allowed me to enjoy a normal and good life.

But my bigggest hope is that President Obama and the 535 Members of Congress understand one of the movie’s underlying messages:  if  companies are to continue developing drugs to improve and save the lives of millions of people — including children with unusual or “orphan” diseases — their  enormous monetary investment must be protected with strong patent laws and the inclusion of a sufficient period of data exclusivity rights to prevent generic companies from piggybacking on the biotech company’s safety and efficacy data.

As you might guess, this uplifting movie has an extraordinarily happy ending. First and most important, the lives of a brother and sister are saved and a loving family is preserved. But I am also struck by how intelligent and trained minds are fairly rewarded and how research jobs and careers are maintained. And yes, I am pleased risk-taking investors get a return on their belief and faith against all statistical odds that just maybe this will be a therapy that will work.

Two thumbs up for the inspiring story of a biotech executive and a biotech scientist.  ”Extraordinary Measures” is worth the watch for Members of Congress and all of us.

Check out this post from BIOtechNOW on biosimilars:

Biosimilars, also known as follow-on biologics, may eventually expand access and provide patients a more affordable alternative to innovative, lifesaving medicines. However, there are a few important safeguards that must be put into place before these “similar but not the same” versions of biologics can be safely introduced to the public.  Join Dr. Targan as he explains the complex nature of biologics and the steps that need to be taken by Congress and the FDA to ensure that biosimilars are safe and effective while ensuring the continued development of cutting-edge medicines.

In Governor McDonnell’s first “State of the Commonwealth” speech on January 18th, he spoke about the importance of investment in biotechnology. He noted that the biotech industry offers “high paying jobs and fast-growing career fields” and that “smart states look at this sector for future economic development.” Check out this video clip from the speech:

Today we heard the disappointing news that President Obama is speaking with Congressional leaders about reducing the number of years of data exclusivity for biotech drugs.  This is bad news for patients who are waiting for research to find cures for deadly diseases.  Researchers need funding from investors and investors need incentive to invest – like longer data exclusivity.

The House and the Senate have already overwhelmingly agreed to a 12 year data exclusivity for biotech companies, long enough for them to recoup their investments in research, development and production of biologics, a measure to which President Obama agreed as a U.S. Senator.

The potential consequences of reducing the length of data exclusivity could be debilitating for biotech companies and even worse for patients. Without a guarantee that investors will be able to recoup research costs, there will be little incentive for further innovation. This means the life saving and targeted therapeutics developed through biotechnology are at risk.

Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO) explains:

They are attacking a biosimilars provision  where a consensus and legislative solution has already been reached in the Senate and House, one that would encourage life-saving biomedical research while expanding access to powerful biologics, medicines that treat devastating diseases such as Alzheimer’s, HIV/AIDS and cancer.  It also preserves existing U.S. jobs and maintains the biotechnology sector’s ability to create high-wage, high-value jobs.

IAmBiotech will continue to cover these developments, so stay tuned for more information.

To learn more about biosimilars, check out this great post by Jonathan Sheffi.

You can also read more at  http://www.washingtonpost.com/wp-dyn/content/article/2010/01/14/AR2010011403612.html.

Reposted from BIOtech NOW:

Last summer, BIO joined with former Vermont Governor Howard Dean to advocate for biosimilar legislation that protects patient safety and promotes necessary incentives for continued innovation of biologics. The Governor, a trained physician, is a passionate supporter of the value of biotech products in treating disease and reducing healthcare costs.

To further familiarize him with the diversity of our member companies, I accompanied Governor Dean for a two-day tour of California biotech companies earlier this week.

We began our excursion Tuesday morning in the San Diego biotech hub accompanied by BIOCOM President & CEO Joe Panetta with a visit to Burnham Institute for Medical Research in La Jolla. The Institute is among the top four recipients of funding from the National Institutes of Health (NIH) and for the past decade has been ranked #1 for the impact of its research publications according to the Institute of Scientific Information. Dean was particularly impressed by the Institute’s high throughput screening robot and by the way patent royalty payments are plowed back into further research.

Next, we visited Conatus Pharmaceuticals where CEO Steve Mento, Ph.D., explained how a small virtual biotech company that has taken a drug “off the shelf” from another company is developing a novel clinical stage drug candidate for liver disease. The company employs just fourteen full-time staff and contracts out and collaborates with more than a hundred partners worldwide.

At Ceregene, President & CEO Jeff Ostrove, Ph.D., described the company’s work on delivering nervous system growth factors to treat Parkinson’s disease, Alzheimer’s disease and ALS. Jeff also explained how the restrictions on SBIR grants to majority VC backed companies as well as the on-going credit crunch had hampered emerging biotech companies. He emphasized the huge potential value of BIO’s effort to include a therapeutic discovery tax credit in health care reform legislation.

Our tour then took us to Phenomix where CEO Laura Shawver, Ph.D., reviewed the company’s work on an oral once-daily treatment for Type II diabetes and its protease inhibitor to treat HCV infection.

Next we travelled to Life Technologies where Chairman & CEO Greg Lucier led us on a tour of the multinational biotech tools company that supplies more than 50,000 products to 75,000 customers around the globe. We watched the manufacturing of protein gels and learned of Life Technologies’ expansion beyond the health market into biofuels.

The day ended with a lively dinner discussion with area CEOs, Governor Dean, Joe Panetta and California Healthcare Institute (CHI) President & CEO David Gollaher, Ph.D.

On Wednesday morning we left San Diego at 5:00 AM and flew to San Francisco for a tour of the Bay Area biotech hub.

We began the day at Geron Corporation where President and CEO Tom Okarma, Ph.D., M.D., gave his usual passionate and brilliant exposition of the company’s pioneering work on embryonic stem cell research including its first-in-the-world FDA-approved hESC-based therapy clinical study which will treat acute spinal cord injury. Tom also explained Geron’s work on telomerase inhibitor drugs attacking cancer stem cells. In the lab, we observed live differentiated cell types, including beating heart cells derived from embryonic stem cells.

At OncoMed Pharmaceuticals, President and CEO Paul Hastings led us on a tour of the company’s labs and walked us through a discussion of OncoMed’s anti-cancer stem cell antibody program aimed at attacking solid tumors.

Affymax President & CEO Arlene Morris and her leadership staff described for Governor Dean the company’s breakthrough development of Hematide now in Phase 3 trials for the treatment of anemia associated with chronic renal failure. The company’s unique approach of creating peptides was most impressive.

The final company visit was to Genentech where Governor Dean and I met with Head of Global Product Strategy and Chief Marketing Officer Ian Clark and Chairman Art Levinson, Ph.D. We toured the expansive campus where 8,000 Genentech employees continue to provide global leadership in biotech innovation.

As we did in San Diego, we ended the day with a broad dinner discussion with local CEOs.

After our two-day whirlwind tour, Governor Dean was awed and amazed at the incredible breadth and depth of biotech innovation and even more passionate about our mission to ensure policy makers and the public understand the critical importance and promise of our industry.

We read an article this morning written by Orville Schell that appeared in today’s Los Angeles Times.

In this article, Schell makes interesting observations about the sharp contrast between the U.S. and other countries like China, South Korea and Sweden who are pro-actively engaged in solving the challenges of today’s world. Toward the end of the piece, he lists the “aspects of U.S life that are still vigorous and filled with potential, aspects of U.S. life that still function but need help and aspects of U.S. life in need of drastic intervention.” Number one on his list of aspects that are vigorous and full of potential is biotechnology, which he says, “is delivering much of the world’s most innovative research and ideas.”

We  encourage each of you to post your comments voicing your support for biotech innovation on the Los Angeles Times site. Feel free  to post your comments to this entry as well.

America’s can’t-do list:  The list of what works in other countries, but no longer does in the U.S., is growing.

Lately, I’ve been studying the melting of glaciers in the greater Himalayas. Understanding the cascading effects of the slow-motion downsizing of one of the planet’s most magnificent landforms has, to put it politely, left me dispirited.

It is impossible to focus on those Himalayan highlands without realizing that something that once seemed immutable and eternal has become vulnerable, even perishable. Those magnificent glaciers are wasting away on an overheated planet, and no one knows what to do about it.

Another tipping point has also been on my mind lately, and it’s left me no less melancholy. In this case, the threat is to my own country, the United States. We Americans too seem to have passed a tipping point. Like the glaciers of the high Himalaya, long-familiar aspects of our nation are beginning to seem as if they are, in a sense, melting away.

In the last few months, as I’ve roamed the world from San Francisco to Copenhagen to Beijing to Dubai, I’ve taken to keeping a double- entry list of what works and what doesn’t, country by country. Unfortunately, it’s become largely a list of what works elsewhere but doesn’t work here. In places such as China, South Korea, Sweden, Holland, Switzerland and (until recently) the United Arab Emirates, you find people hard at work on the challenges of education, transportation, energy and the environment. In these places, one feels the kind of hopefulness and can-do optimism that used to abound in the United States.

China, a country I’ve visited more than 100 times since 1975, elicits an especially complicated set of feelings in me. Its Leninist government doesn’t always live up to Western ideals on such things as political transparency, the rule of law, human rights and democracy. And yet it has managed to conjure an economic miracle. In China today, you feel an unmistakable sense of energy and optimism in the air that, believe me, is bittersweet for an American pondering why the regenerative powers of his own country have gone missing.

As I’ve traveled from China’s gleaming, efficient airports to our often-chaotic and broken-down versions of the same, or ridden on Europe’s high-speed trains that so sharply contrast with our clunky, slowly vanishing passenger rail system, I keep expanding my list of what works here at home and what doesn’t.

Over time, the list’s entries have fallen into three categories. There are things that are robust and growing, replete with promise, the envy of the world. Then there are those things that are still alive and kicking but are precariously balanced between growth and decline. Finally, there are those things that are irredeemably broken.

Here is the score card as I see it.

Aspects of U.S. life that are still vigorous and filled with potential:

Biotechnology, which is delivering much of the world’s most innovative research and ideas.

Silicon Valley, which has enormous inventiveness, energy and capital at its disposal.

Civil society, which, despite the collapse of the economy, seems to be luring the best and brightest young people, and superbly performs the crucial function of goading government and other institutions.

American philanthropy, which is the most evolved, well funded and innovative in the world.

The U.S. military, the best-led, -trained and -equipped on the planet, despite being repeatedly thrust into hopeless wars by stupid politicians.

The spirit and cohesiveness of small-town American life.

The arts, including our film industry, which remains the globe’s sole superpower of entertainment, along with the requisite networks of orchestras, ballet companies, theaters, pop music groups and world-class museums.

Aspects of U.S. life that still function but need help:

Higher and secondary school education, in which America boasts some of the globe’s preeminent institutions. Increasingly, though, many of the best institutions are private, and jewel-in-the-crown public systems such as California’s continue to be hit with devastating budget cuts.

Environmental protection, which compares favorably with that in other countries despite being underfunded.

The national energy system, which still delivers but is overdependent on oil and coal, and depends on a grid badly in need of upgrading.

Aspects of U.S. life in need of drastic intervention.

Public elementary education, which in most states is desperately underfunded and fails to deliver on its promise to provide all children with high-quality schooling.

The federal government, which is essentially paralyzed by partisanship and incapable of delivering solutions to the country’s most pressing problems.

State governments, which are largely dysfunctional and nearly insolvent.

American infrastructure, including highways, docks, bridges and tunnels, dikes, waterworks and other essential systems we aren’t maintaining and upgrading as we should.

Airlines and the airports they service, which are almost Third World in equipment and service standards.

Passenger rail, which has not one mile of truly high-speed rail.

The financial system, whose over-paid executives and underregulated practices ran us off an economic cliff in 2008 and compromised the whole system in the eyes of the world.

The electronic media, which, except for public broadcasting and a vital and growing Internet, are an overly commercialized, broken-down mess that have let down the country in terms of keeping us informed.

Print media, which from newspaper publishing to book publishing are in crisis.

Basic manufacturing, which has fallen so far behind it seems headed for oblivion.

I started keeping these lists because I was searching for things that would banish that dispiriting sense that America is in decline. And yet the can-do list remains unbearably short and the can’t-do one grows each time I travel.

American prowess and promise, once seemingly as much a permanent part of the global landscape as glaciers, mountains and oceans, seems to be melting away by the day, just like the great Himalayan ice fields.

Schell is the director of the Asia Society’s Center on U.S.-China Relations. He is the former dean of the Graduate School of Journalism at UC Berkeley and the author of many books on China. A longer version of this article appears at tomdispatch.com.