What happens when a biotech company disappears? We think that the Web remembers everything. Do a search on Wikipedia for Immunex and you get Amgen, with little mention of Immunex at all. The results of over 500 publications and several thousand employees over 20 years are pretty much invisible on the largest collection of facts on the Internet.

One of the most successful stories in Seattle history and it is mostly gone from view. Ten years ago, Amgen announced it was buying Immunex. Xconomy will be commemorating this historic event in December.

Immunex may be gone from the Web but the lessons it taught still have impacts today. Before Immunex completely disappears from view, I wanted to discuss Five Lessons Immunex Taught Me.

• Get to decision points rapidly.

• Live in the gray.

• Size matters.

• Leverage insurrection.

• Vet in the open. And then vet again.

I was a researcher at Immunex for 16 years as it grew from a small community where everyone knew each other to a large, global undertaking with people spread out in multiple locations. While some of these lessons may be part of any good MBA program, there is nothing like dealing with the day-to-day reality to drive the lessons home.

I’ve used these lessons over the 10 years since leaving Immunex – as a Vice President in charge of research at a biotech startup, as a founder of my own organizations, as well as in collaborations with other organizations such as the Sustainable Path Foundation, the WBBA, Global Health Nexus and the Washington Global Health Alliance.

Caveat lector: These are my recollections about events – some of which are over 25 years old—so forgive me if I do not get the events exactly right. After all, these are the lessons Immunex taught me. Others may have learned something different.

1) Get to decision points rapidly. Immunex always worked towards a decision point, an action that would permit us to either kill the project, move forward or change direction. Simply delaying a decision was almost never a consideration.

Shortly after joining Immunex, I was a member of a presentation we gave to one of our collaborators – a company with lots of proprietary chemicals looking to find pharmacologically important ones. Steve Gillis was there along with several other Immunex scientists.

In contrast to the Immunex crew, the people we met seemed more interested in finding reasons to delay a decision for six months or so than in what we had to present. They kept nitpicking rather than moving forward. Any excuse to delay a decision was good enough.

For example, we produced a standard operating procedure for performing a biological assay we had developed to use with their chemicals. It described how to grow the particular cells at several specific temperatures such as 35°C, 37°C and 42°C.

The response from our collaborators? “What about 40°C or 39°C? Or 22°C? We want those in the SOP also. The entire thing needs to be redone to include these.”

Gillis exemplified the Immunex response to this – he simply told them not to run the procedure at those other temperatures. Decision made and we just moved on.

The large company seemed to be afraid to accept our protocol at all, perhaps because they might make a wrong choice. Being wrong was a greater transgression than delaying a decision.

Saying “yes” could be a mistake and so could saying “no.” Delay meant “maybe.” Who could make a mistake with “maybe?”

But delay itself is a decision and usually a poor one in a rapidly moving field, making it very hard to adapt as circumstances change.

That may be why our collaborator never became a big leader in the biotechnology arena. We created billion dollar therapies.

Get to those decision points as efficiently and as effectively as possible, then actually make a decision. This is critical for an innovative company.

Move forward, kill it or change directions. Delay actually can be the same as moving backwards.

2) Live in the gray. While seemingly contradicting the previous point, this actually follows from a key aspect of decision points – the need for as complete a set of data as possible.

Good data is critical for making a decision. Incomplete data can destroy any decision.

Like the Fog of War, the gray of the Fog of Science that often surrounds biomedical research can punish decisions made without proper supporting data. Do we have enough data to let us move forward, kill it or change directions? If not, can getting more … Next Page »

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We have many problems in biotechnology but I think Seattle is well positioned to overcome those barriers. Bear with me as I work to one possible approach.

I think there are two problems weighing on the biotechnology industry producing the current melancholy – lack of sustainable employment over a career and the inability to change the drug development paradigm.

On Monday, Luke wrote about the discontented winter the biotech industry finds itself in. The excitement that biotech once had not only came from its possible ability to create new therapeutics. It also came from its promise to sustain a large industry of scientists and their support personal.

A few weeks ago, Luke wrote another article about careers in biotechnology and Ed Lazowska had a comment with a wonderful link to a white paper just released by the President’s office.

It shows that we are training about 10 times as many people in the life sciences as are needed by the open positions.

What are we training all these people for? Academia cannot really take up the slack and for-profit corporations simply do not have the need.

This is not a new problem. In fact, my first column for Xconomy discussed the poor career paths for young researchers today. But these numbers are quite stark.

A company such as Dendreon or Amgen may hire lots of people in the life sciences and may produce some very important therapeutics.

But one single successful company does not make an exciting industry. Twenty might.

Biotech used to have the promise of that twenty.

When I started in the biotechnology industry, there was a clear career path for researchers who wanted to move in a different direction than academia. Biotechnology companies could be well funded based purely on the research from labs.

The goal of many companies was to become a fully integrated pharmaceutical company – a single entity translating their own research through clinical trials and product development to manufacturing and sales.

They could then play with the big boys – the major pharmaceutical companies. With lots of employees and many novel therapeutics on hand.

Immunex was one of the few that actually achieved that goal – thousands of employees with a wide portfolio of therapeutics. Of the multitude of hopeful organizations that started in the 80s, Amgen is perhaps the only one still standing that realized the dream of becoming a major, independent and fully integrated pharmaceutical company.

Biotech today cannot provide long term livelihoods for all the people who want to enter the industry. Many companies are simply looking for an exit strategy and will be gone from the landscape in a few years – whether they are successful or not.

Possibly exciting for investors but not for the general public and not for the people who make up the industry.

In addition, another promise – that biotech would change the paradigm of drug development – has simply not emerged, dampening the excitement further.

A paper in Nature Reviews discusses the ugly numbers. Almost all of … Next Page »

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I lived in Houston when the Oil Bust hit in the 1980s. With it came crushing unemployment. Yet Houston led the nation for the next several years in new business start-ups. Now large numbers of people work in a more diverse economy, including biotechnology, alternative energy, and information technology.

Seattle, where I live today, has a similar story with the Boeing Bust of the early 1970s. Michigan may be at the nadir of its fortunes now, but that could actually be the best time to reconfigure and explode in new directions.

Here are five things I observed at organizations in Houston and Seattle that could be applied today in positive way in Michigan.

1. Be adaptable. The best companies have the ability to change their course, often quite rapidly. In many cases, the ideas that get a company started are not the ones that actually create revenue. Follow the history of AMF, which changed from producing cigarette-making machines to producing recreational equipment, becoming one of the largest along the way.

2. Perseverance. Working at the cutting edge holds tremendous opportunities but also many pitfalls. There is a definite curve of excitement all companies follow—the initial rise is wonderful but the inevitable valley can be a brutal slog. It requires a special ability to overcome the inevitable disappointments almost all innovative companies must cross.

3. Destroy silos. Slow information flow kills companies. Never let silos develop and keep the organization flat. Encourage openness and transparency. You never know where the killer idea will come from.

4. Identify mediators. The biggest problem preventing innovation from becoming a commercial reality is the inability to identify and leverage the strengths of those few people who can translate great ideas into viable products. They mediate between the creativity of the lab and riches of the mass market. Find them and nurture them.

5. Learn to love constraints. Curiously, the best time for innovation is often when things are the most confining. Innovation can die if there is too much money to throw around. Some of the most creative works came about because of a lack of resources. Take advantage of this process, realizing that an emergent property of constraints can lead to incredible creativity.

[Editor's note: To help launch Xconomy Detroit, we've queried our network of Xconomists and other innovation leaders around the country for their list of the most important things that entrepreneurs and innovators in Michigan can do to reinvigorate their regional economy.]

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And so we embark on a new era of healthcare—one that may take many years to fully reach its potential for good or ill. But there are two small bits in the Patient Protection and Affordable Care Act that are immediately relevant and timely for the biotechnology industry. One provides tax breaks for smaller biotechnology companies, while the other simplifies some aspects of the regulatory landscape and adds some complicated wrinkles.

The Therapeutic Discovery Project Credit provides “an amount equal to 50 percent of the qualified investment for such taxable year with respect to any qualifying therapeutic discovery project,” permitting some of the costs for pre-clinical research, clinical trials and other research protocols to be reduced. It appears that it will be limited to organizations with fewer than 250 employees. The total amount of the credit is $1 billion.

A billion dollars is not chump change but could disappear pretty rapidly when clinical trials are included. This credit will be helpful for the right companies but it seems to be a one-time shot in the arm.

The noteworthy part of the legislation, Approval Pathway For Biosimilar Biological Products, provides real clarity on an important regulatory issue. This section permits biologics—the complex therapeutics produced by most biotechnology companies—to maintain 12 years of market exclusivity after FDA approval of the product.

The biotechnology industry breathed a sigh of relief with this section’s passage because this clearly delineated time frame could have been much different.

The Federal Trade Commission had felt that no additional period of exclusivity was required. The Generic Pharmaceutical Association (GPhA) wanted only a five year period. President Obama wanted seven years. The Biotechnology Industry Organization (BIO) wanted at least 12 years. In the end, BIO got exactly what it wanted.

This uncertainty has been eliminated. Biotechnology companies now have a known period of market exclusivity post-approval, one that is independent of patent time frames. This will provide investors with the predictability they crave when they project product sales far into the future for biotech drugs in development.

The generic companies may be happier with another part of this section, though. As the title suggests, it describes the approval process for follow-on biologics—biological copycat molecules that have similar activities to innovative therapeutics already on the market. Until this legislation, there was no practical way for a generic company to make a “biosimilar” drug without incurring many of the same costs as the original innovative biologic. This new route to the market could be very helpful to the generic makers, but only if they can navigate the treacherous pathway … Next Page »

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The most incredible things happen when scientists with a common interest have an opportunity to simply talk with one another. On a bone-chilling December night, 50 Seattle researchers from more than 10 different institutions with dramatically different backgrounds gathered to share drinks and conversation about their work. They discovered surprising connections, initiated new collaborations and found that many of them were exploring similar problems. The first Global Health Dialogues took place. The outcome may be groundbreaking new approaches to some of the world’s most pressing problems.

Serendipity, where one randomly stumbles on something critically useful while looking for something else, and synchronicity, where important ideas are ‘in the air’ at the same time, are two important aspects of research that are not often discussed. Sometimes researchers just lack the final piece of the puzzle needed for success. Or perhaps they need to alter their perspective slightly to see a way around a problem. Or maybe several scientists, working on very similar topics, just happen to randomly connect, to synchronize, resulting in a large flow of information that often solves very difficult problems.

In many ways, synchronicity is a major aspect of the work being undertaken at such organizations as Infectious Disease Research Institute, Seattle Biomedical Research Institute, PATH, Fred Hutchinson Cancer Research Center, Seattle Children’s Research Institute, Pacific Northwest National Labs, along with the major research universities in the state, UW and WSU. Their scientists may be researching different approaches to global health, but they often face similar hurdles getting a drug or therapy to the market.

But they are usually working inside their own silos, often unknowingly in parallel with other institutions. Scientific specialization creates increasingly narrow viewpoints separating researchers from others. Collaborations are critical but are hampered by these divisions.

One way to break silos and permit the flow of useful information is to exploit serendipity and synchronicity.

Let me provide some personal examples of this potent combination.

In an Xconomy article written in May, I showed, using only information that I could find online, that the Seattle area had more researchers with more funds working in more non-profit biomedical institutions than almost any other city in the U.S.

It turns out that this was an idea that was also … Next Page »

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Is it still possible to have a long, successful career doing research at a biotech company in the Seattle area? A young scientist today has only a slim chance of working for the next Immunex or Icos. Companies that last even 10 or 15 years are very rare. Yet a closer look at some of Seattle’s vigorous non-profit research organizations reveals some opportunities in surprising places.

Stewart Lyman wrote in February about the dismal picture regarding biotechnology in Puget Sound. Few companies are hiring. Most are not successful by almost any measure. Xconomy’s Luke Timmerman has reported in detail on the dire financial circumstances of so many biotech companies in the area, which has led to layoffs and other cutbacks in recent weeks.

It got me thinking about a very basic question.

Can a newly minted PhD spend their life working on fundamental research problems in biology here in the Puget Sound region? I’m focusing on basic research, which is the necessary driver for anything associated with biotechnology. A robust biotech environment cannot survive without a local nucleus of biomedical research.

Before the late 1970s, there were really only two career tracks for a young biologist interested in working on the critical problems affecting human health: get onto a tenure track path at a research university or go to work for a large pharmaceutical company.

However, there were only a limited number of tenure track positions available at universities. And pharmaceutical companies were much more interested in chemists than biologists for research.

The early biotechnology companies offered a third way, one where new technologies could be coupled with entrepreneurial spirit to create vertically integrated organizations that were involved in all aspects of therapeutic intervention in human health. There were lots of jobs available for researchers wanting to discover and develop products for medical purposes.

I moved to Seattle in the early 1980s to begin working at one of these early biotech companies, Immunex, as a research scientist. Since then, I have worked on a wide variety of basic science problems in corporate settings, helped create novel therapeutics, designed research protocols, written papers and submitted grants. Some of the molecules I worked on were developed into products that went through clinical trials and ended up being given to patients. I’ve worked at the bench as a staff scientist and as a vice-president in charge of research. My time here in Seattle has become a career.

How about research today in Seattle? The University of Washington is one of the top universities in the country, based on the amount of grants its scientists receive from the National Institutes of Health. According to numbers compiled by the Federation of American Societies for Experimental Biology (FASEB), in 2006 there were over 14,000 students just starting in a biomedical doctorate program. The total number of people attempting to get a PhD in biomedical science is over 70,000. About 7,000 new PhDs are awarded each year in biomedicine. Yet for the last 30 years, the number of tenured biomedical scientists in the US has been steady at about 20,000. The UW only has about 1,200 tenured professors total on the entire campus. Making a career in academia is still tough.

Are biotechnology companies a viable alternative for a research career? Biotech companies today are generally smaller and geared more towards development … Next Page »

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