Report from BIO 2006

April 20, 2006
This article, adapted from our "On Pharma" weblog, summarizes a number of the key pharmaceutical-related presentations from the BIO 2006 show, which was in Chicago from April 9 through 12.

By Agnes Shanley, Editor in Chief

File 8, BIO `06 (Apr. 11):
Clinton receives standing ovation; stresses interdependence
and the need for a “world view”

About a half an hour before former President Bill Clinton was due to make his plenary address at BIO, thousands of people began to line up outside the convention center auditorium. Assuming we'd never all get in, and formulating a "Plan B" for the next hour, I started toward the end of this endless queue, but was soon whisked away by a BIO organizer to a well-hidden and (mercifully short) press line, and…miracle of miracles, a table fairly near the stage.

BIO's organizers and convention center staff deserve a huge amount of credit for pulling off this event, which went extremely smoothly.

There were two huge projection screens at either side of the stage. No doubt, the event organizers had developed material for the screens that would set the stage for a speech that would focus on philanthropy and good works (the focus of Clinton's Foundation), but having photos of the world's poor and medicine-deprived, and sobering facts flashing on the screen, rang a bit hollow. Although biomedicines and other new cures will eventually reach some of those who need them, seeing these images at an event like this was a bit like seeing an article about global famine sandwiched between ads for $10,000 Louis Vuitton purses and $5 million real estate in the New York Times Sunday magazine.

The former president looked very well, and his entrance on stage brought the audience [representing a wide spectrum of political views] to its feet.

Clinton discussed the interdependence in the world today, and the need for balance in global relationships. 9/11, he said, was the outcome of lack of this balance.

He took a not-so-gentle stab at those on the conservative right, emphasizing the need for science and evidence, and accusing them of attempting to muzzle findings on climate change.

Clinton compellingly argued for the need for all individuals everywhere today to have a true "world view," and to be able to distinguish between important and transient issues.

He did not shy away from reciting sobering statistics about the U.S. healthcare system, ranked 37th in the world, or, more disturbingly, the fact that one out of every four deaths on earth is that of a child, five years old or younger, from diseases that include AIDS, TB, malaria and cholera. (Not exactly at the top of the priority list for many pharma companies in the "developed" world today.)

He discussed the work that his Foundation is doing to reduce the costs of HIV treatments in developing nations, and his plans for addressing the obesity epidemic in the U.S.

The need for security was an undercurrent throughout his presentation; Clinton praised the Chinese government for its handling of the SARS outbreak, and reminded the audience of the Spanish flu pandemic, and the need for vigilance.

Clinton also voiced his support for agricultural and industrial bio, particularly the development of biofuels.

He didn't play to the audience, losing opportunities to bring it to its feet more than once, but his message was on target, and well worth the wait. He left the stage to a standing ovation.

As he said, human beings are 99.9% the same, genetically. Perhaps it's time to focus on what unites, rather than divides us.

File 7, BIO `06 (Apr.11):
Take Biocom’s survey on FDA or face the consequences
(Remember, there’s no “at will” employment at FDA)

Having a hard time getting through to FDA? Find that inspectors and field review people are singing completely different tunes? Or is working with the Agency pure pleasure? Please take this survey, as soon as possible, to let the Agency, your peers and all concerned parties know.

This morning, a group of experts including Eliot Parks, Managing Director of Life Sciences for Biocom, Karen Midthun of FDA, and lawyer John Manthei, discussed the 11-year-old survey, why it exists, and what it may achieve. The Agency’s working hard to improve its processes, yet a “real disconnect” continues to exist between the Agency and industry. Eliminating that disconnect is critical, if drug development and manufacturing are to improve — so take a few minutes. They may pay off hugely.

File 6, BIO `06 (Apr.10):
Puerto Rico’s committed to world-class R&D; governor wins BIO award

For the past few years, Puerto Rico has been moving beyond manufacturing, laying a foundation that will advance R&D innovation in pharma and biopharma. The island may not be able to devote the billions that Singapore is pouring into its recruitment and R&D efforts, but it is achieving significant results. Its exhibit at BIO illustrated its commitment and focus, and the professionalism and dedication of its workforce and educators.

The going has not been too easy, given the current economic climate, but the island's economic development board has restructured and fine-tuned its priorities, one of which, clearly, is biotech R&D. Driving these efforts is INDUNIV, which is strengthening ties between industry and academia.

The University of Puerto Rico is very strong in engineering and life sciences training, and is an active member of the National Institute for Pharmaceutical Technology and Education (NIPTE) which is advancing the science of drug manufacturing, and new NIPTE initiatives on the island are expected shortly. The island's biocluster is gaining momentum, and the government is clearly devoting its resources to advancing upstream R&D efforts. So much so that BIO named Puerto Rico governor Anibal Acevedo-Vila Governor of the Year at BIO `06.

At a celebratory dinner at Rumba Cafe, clearly one of Chicago's top restaurants, we saw a cross-section of the leaders of Puerto Rico's life sciences community, a diverse and cosmpolitan group. Seated at our table were trustees of the University of Puerto Rico: Ram Lamba, Chancellor of the University of Puerto Rico, Cayey; Hilda Colon-Plumey, Chancellor of UPR Humacao and Gladys Escalona de Motta, Chancellor of the UPR Rias Piedras. Dr. Lamba, a native of Delhi who has been living and teaching in Puerto Rico for years, described a deep affinity with the culture and the people of Puerto Rico, illustrating the fact that pharma and biopharma is global and should know no borders.

This global spirit was really the key message of BIO `06, although it was obscured at times by the appearance of competition — at one point, this competition became audible, as the strains of salsa from the Puerto Rican pavillion, of Irish music from Ireland's exhibit, and Chicago blues, from the Illinois pavillion, all competed for attention.

There's clearly room for all in the pharma/biopharma world of the future, and it will be interesting to see how each center of excellence carves out its own niche and makes a unique statement.

File 5, BIO `06 (Apr. 10):
On “Chindia;” Is Big Pharma a Dinosaur?

Today's luncheon session, and presentation on "the future of biotech" by G. Steven Burrill provided some food for thought on the issues shaping biotech — principal among them being the rise of personalized therapeutics, and all that go along with them. In the future, Burrill said, companies will need theranostic tools to go along with any new drug, allowing them to identify respondent subsets of the patient population.

He also pointed out the fact that pharmacovigilance is the top priority in the post-Vioxx era. "The biggest challenge is no longer getting products out to market, but keeping them on the market," he said.

Unfortunately, the presentation was marred by a discussion of China and India, in which the two were referred to, collectively, as "Chindia" … there's a way to lose half your audience.

Hype also entered the equation, with the statement that "Big Pharma are the dinosaurs of our generation." Burrill says they're "disintegrating" pieces of their operations, to emerge instead as powerful distributors of healthcare, globally. He is not the first to say this … and demand for outsourcing is clearly growing. But the statement seems just a bit exaggerated, and there are those who straddle both worlds, and find that each can complement/contribute to the other, as this article from Drug Discovery magazine makes plain.

File 4, BIO `06 (Apr.10):
Awe-inspiring nanotechnology sessions
New companies to commercialize technologies for life sciences

I've learned to "curb my enthusiasm" whenever I see the term "nano," given the hype that surrounds the term. A presentation at BIO, however, was awe-inspiring, and made me wonder why religious conservatives have issues with much of the medical research being done today. If the Bible says that man was created in the image of God, this work surely reflects the Divine, and promises to alleviate a great deal of human suffering all over the world.

The session summarized some of the results that nanotechnology-based drug delivery systems are already having in animal tests, and suggests what they might do in humans once approved and commercialized.

A video clip (this one from Johns Hopkins University — not sure it's the same one shown at the conference) of a paralyzed mouse before and after treatment with one stem-cell nanotherapy (using nanogel) bore witness to the potential power of nanotherapies.

Two highlights were presentations made by:

    • James R. Baker, director of the University of Michigan's Nanotech Institute for Medical and Biological Sciences, who discussed various projects, including work that has resulted in biocompatible dendrimers — work that will be carried on, outside the ivy-covered halls, by a new spin-off called Avidimer Therapeutics, based in Ann Arbor. His group received a grant from the Gates Foundation recently, and their work has repercussions for drug and vaccine delivery and development.
  • A presentation on nanotech's role in tissue "self-assembly" by Sam Stupp, Director of Northwestern University's Institute for Bio-nanotechnology in Medicine. Read a summary of a recent tutorial he gave on the subject here. It was he who showed the mouse videotape. A new company, Nanotope, is being set up in Illinois to focus on commercializing this work.

Also interesting was Nanosystem chairman Lawrence Bock's presentation, an overview of the potential forms available for life science applications, with an interesting aside on how nanofibers on the gecko's "toes" interact with weak Van der Waals attraction to the surfaces around them; the fibers function as a sort of "one-sided" velcro. He mentioned how nanofibers might be engineered to optimize drug transit time within the intestine. The gecko bonds at 10 N per square centimeter, but reportedly Nanosys has achieved "three Geckos" worth of adhesion, in testing so far.

File 3 from BIO `06 (Apr. 10):
Academic freedom is alive and well in Singapore

Singapore may be a beautiful and extremely well-run country, but is not known as a bastion of free thinking. Nevertheless, it is recruiting some of the world's top researchers and allowing them to do exactly what they want. What better gift could anyone dangle in front of a researcher than new laboratory facilities, excellently trained post-docs and grad students, and the opportunity to conduct open-ended research?

Dr. Beh Swan Gi, director of Biomedical Sciences for Singapore's Economic Development Board, explained the country's strategy and its commitment to the future of pharma and bio. (This report summarizes some of the background behind the government's strategy).

Pharma, biotech and medical devices currently account for 5% of Singapore's GDP, and the government has committed $12 billion to fund public sector research over the next 5 years.

Part of this funding is dedicated to training the next generation of scientists — for an elite group of students (with GPAs exceeding 3.8), the government will pay for their Ph.D. studies, wherever in the world they pursue them. (Providing that they spend some time working in government funded research programs after they graduate, a fair proposition).

Singapore is also recruiting some of the world's top biopharma researchers from Dundee, NCI and the Pasteur Institute, offering them laboratories and the ability to research whatever they want. Its institutes are also partnering with some of the leading academic institutions from around the world.

Sound interesting? Here are some academic job postings from Singapore U. Here are general job listings.

File 2 from BIO `06 (Apr. 9):
Indian pharma moving at the speed of light on innovation
and outsourcing tracks; Homer Simpson spotted in Bangalore

The first day of BIO 2006 also brought a press conference with Indian government officials, including Kapil Sibal, Minister for Science and Technology, Dr. M.K. Bhan, Secretary to the Government of India within the Ministry of Science and Technology's Department of Biotech, and delegation chair Dr. Swati Piramal, director of strategic alliances for the Indian drug company, Nicholas Piramal.

Also in attendance were Arun Kumar, the Consul General of India based in Chicago, Ramesh Adige, Ranbaxy Lab's corporate affairs director, Charles Caprariello, vice president for Ranbaxy's U.S. subsidiary, as well as Malathi Lakshmi Kumaran, a financial and legal consultant, one of whose specialties is "patent mapping."

[I'd asked her if she used computer programs such as Eureka to help with this daunting task — after all, the number of Indian patents filed has moved from 4,000 to 18,000 in three years. She says her staff use IT, but manual, bibliographic mapping tends to yield better results].

Both Ms. Piramal and Ms. Kumaran represent major change in India and the rise of female entrepreneurs and scientist/managers to top ranking positions. The fact that more women are achieving prominence in science and business in India is often lost in the media's incessant focus on the negatives.

Push to innovation

India's pharma industry is growing at a dizzying pace as it moves from a base in generics and process patents to developing new compounds. Bio is a small but growing part of the picture. Including industrial and ag bio, as well as biopharma, India's bio market is now worth over $1 billion, it should move to $3.5 billion in 2-3 years, and $5 billion in five years. The Patent Act of 2005 has brought with it tremendous change, with a growing number of individuals starting their own companies, filing patents and looking at new drugs. "They're not looking at reverse engineering or alternative delivery, but at developing new chemical entities, and this is a seminal change," Piramal said.

More global companies are taking part in India's market by setting up partnerships in which they share IP. Nicholas Piramal, which once operated exclusively in India, is expanding globally; currently 22 scientists from different countries are working on R&D projects with the company.

As Minister Sibal explained, biotech will be the key to addressing India's food productivity challenges as well as new, more virulent forms of diseases, and the government is fostering innovation through partnerships, incentives, incubators. Safety, and assuring highest safety standards will be one priority.

Taking stock of a rich heritage and Ayurvedic therapies

India is also beginning to leverage thousands of years of knowledge in traditional medicine, taking stock of its Ayurvedic healing tradition and exploring how it can be translated into new drugs.

At the heart of all this work, Minister Sibal said, is the human being, rather than any political agenda or national imperative. People working in a united world as members of a global community, are on a "global mission." "Drug discovery and development defy the laws of economics," he said, as science flows across borders.

Interdisciplinary research, on the super-fast Track

To accomplish its ambitious goals, India has realized that it needs to develop a new approach to research. A recent article in the American Chemical Society's Chemical and Engineering News highlighted the challenges ahead.

However, as Dr. Bahn explained, the government realizes the drawbacks and is developing a new approach based on "teamwork" rather than individual performance, and an interdisciplinary model that will bring together chemists, biologists, M.D.s, engineers and mathematicians. The government is also "retooling" its university programs to reflect this new approach.

"Modest" plans include:

    • Doubling the number of Ph.D.'s in life sciences over the next six years;
    • Enhancing the tech workforce through multidisciplinary training;
  • Most dramatic of all, the government will establish 50 centers of excellence over the next five years to advance the concept of interdisciplinary R&D.

Symptomatic of the change perhaps is the fact that the engineering powerhouse, India Institute of Technology (IIT) will now teach not just engineering but all the sciences and will establish new interdisciplinary programs, Bahn said.

[Outsourcing is also growing, of course. In the future, will companies be outsourcing to firms within India that they also compete with? It will be interesting to see how these two tracks play out… Speaking of outsourcing, ironically, I returned home that evening to find my children watching "The Simpsons," [while the cat's away…] and an episode in which Homer's facility is shut down and moved to India — and he is sent to "run" it. Masterfully written in some ways, the episode touched on several painful issues, on both sides of the outsourcing equation, using humor to criticize without offending anyone (or, at least not too much).]

For the curious, here a podcast of the program.

File 1 from BIO `06 (Apr. 9):
"It takes all the running you can do just to remain in the same place"

BIO 2006 opened to sunny, warmer weather and a conspicuous absence of animal rights, "Frankenfood," and anti-globalization protestors — I know they're here [here's what one group was up to] and some speakers have alluded to protestors outside their hotels, but they aren't demonstrating in front of the McCormick Center — at least not yet. Of course, they may be waiting until tomorrow, when former president Bill Clinton gives his plenary address (and offers them a much riper photo opp).

Chicago's taxi drivers are clearly loving BIO and the 18,000 visitors it has brought to the city. The choice of venue this year ("Hog Butcher to the World," as Carl Sandburg once called Chicago, an epithet that the city has been workig hard to distance itself from) underscores the growing importance of food and agricultural bio, which is often lost in the hoopla about new biotherapies.

EMEA and EC Initiatives

One of the best quotes of the day came from Georgette Lalis of the EC, Director of the Directorate for Consumer Goods, who summarized regulatory developments in Europe. In describing the state of the global biotech industry, she quoted the Red Queen from Lewis Carroll's "Alice in Wonderland": "It takes all the running you can do just to remain in the same place." She could easily have been talking about this conference as well, since many compelling presentations were scheduled at the same time.

Ms. Lalis' talk focused on how the EC is working with EMEA, and summarized EMEA's plans for biosimilars and orphan drug regulations.

John Purves, head of EMEA's Biologicals and Biotech sector, followed with an overview of EMEA, how it works, and what its priorities are. One interesting point from Purves' discussion: EMEA formally includes a presubmission stage designed for "front-end communication" a designated period where companies ask for advice on quality, safety and efficiency. Approval times average 210 days, he said.

On Wednesday, EMEA and FDA will give a side-by-side overview of "Critical Path" and EMEA's counterpart, which promises to be interesting.

Stephane Hogan of the EC's Unit for Biotech and Applied Genomics, described the research projects underway as part of the "Framework" program, including in vitro tests that will reduce the need for animal testing and generate results that are more specific to humans.

Representatives from Japan discussed that nation's biotech sector, the factors influencing its growth, and some critical focal points. Over the last six years, Japan's government has allocated $220 billion to R&D for biotech, and the country now has 464 biotech companies, and 55 startup companies in various biotech clusters throughout the country; its bio industry is roughly the size of Canada's.

Tsunehiko Yanagihara, VP of Mitsubishi's Life Sciences business, discussed the overall context. The nation spends $263 billion per year on medical costs, with cancer the number one cause of death. Its pharma and biopharma industry is the world's second largest based on revenues ($50 billion in 2004). Its biotech industry is the world's fifth largest by revenue, and fourth largest based on market cap, with $0.8 billion, following Australia.

Laura Francis, CFO of Promega Corp., a Madison, Wis.-based company, discussed her company's efforts in Japan — Promega now has Tokyo and Osaka offices with 35 employees and 10% of its sales come from Japan. Their collaboration began in 1990 after a trade mission. She had some good advice for U.S. companies:

    • Forget about your standard business model. Go there first and establish a relationship before investing. Don't go "direct" but develop and leverage a broad network of dealers and distributors, and work with organizations with which you can expect to have a long relationship.
    • Remember the importance of the journey and not just the results (a focus for most U.S. companies).
    • Remember the importance of ceremony.
  • And a few basics: domestic and international airports are at a great distance from each other; the Japanese drive on the left side, and don't be surprised by a 100,000-Yen dinner tab for any dinners that include Kobe beef.

Proposal would double Japan's biotech R&D budget

Michio Oishi, director of the Kazusa DNA Research Institute, then outlined the nation's biotech program and major focuses of today's research. Where Japan's government had been quick to recognize the importance of electronics and optics research, it took a bit longer for officials to recognize the importance of biotech. The first national strategy was launched in 2002, and Prime Minister Koizumi, with seven ministers and 12 industry, academic and other experts, devised the strategies as well as 200 action plans formulating targets timing and ministries. A current proposal would double the nation's budget for bioscience and biotech in five years.