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Reg Kelly presented Aijun Wang with the award. Wang nearly missed the ceremony because of bridge traffic.

Aijun Wang and Zhenyu Tang have won the 2012 Deloitte QB3 Award for Innovation, a $10,000 prize that recognizes life science research at UC Berkeley, UC Santa Cruz, and UCSF with the potential to improve human health.

Wang, an assistant professor of surgery at UC Davis, and formerly a postdoc in the lab of UC Berkeley professor Song Li for four years, accepted the award from QB3’s director Reg Kelly at a ceremony at UCSF Mission Bay on Thursday, October 18.

Wang barely made it to the ceremony, having driven from Davis and run into traffic on the Bay Bridge. Tang, according to Wang, is visiting hospitals in China to collect samples of arterial plaque for his ongoing work as a graduate student in Li’s lab.

Li nominated Wang and Tang for the award based on their discovery that stem cells, not smooth muscle cells as had previously been thought, are responsible for hardened arteries. Their work made national and international news earlier this year.

“The whole process of the award selection is fabulous and this award really means a lot to me,” Wang said. “It’s a great recognition of our research and it’s also going to be a booster for my new career as an assistant professor.”

Keynote speaker Laura Deming fired the ceremony with passion. She recalled how, as a 12-year-old in New Zealand, she had emailed UCSF professor Cynthia Kenyon, asking to visit her lab to learn about her research on aging. Deming’s family then moved to San Francisco so she could work in Kenyon’s lab. Now 18, and a Thiel Fellow, she has founded and runs a venture capital firm that backs companies creating cures for aging-related disease.

Deming said that scientists at UCSF and elsewhere in the Bay Area have an amazing opportunity right next door: Silicon Valley. The Valley is home to the world’s best coders, who are eager to make their names in world-changing ventures. UC scientists should partner with them, she said.

Michael Bassik, a postdoc in Jonathan Weissman’s lab at UCSF, had the unenviable task of following Deming. “I can’t bring a quarter of the energy you just saw,” he said. But he delivered a solid and accessible explanation of his joint work with postdoc Martin Kampmann (away at a conference in Germany) on mapping interactions in the human genome. Their work, he said, was already the basis for several efforts to develop multidrug therapies for challenging diseases.

Laura Deming spoke to finalists Rand Miller and Ville Paavilainen afterward.

The path to the award ceremony began back in June, when UC faculty nominated 29 students, postdocs, and staff—or teams, the largest a six-person group nominated by UCSF professor Charles Chiu. Over the summer a jury of experts from academia, industry, and venture capital narrowed the field to five. The campus community voted to choose the winner October 1-12 on the QB3 Facebook page. (An active UC email address was required.) Exactly who would come out on top was not clear until the very end of the Oct 18 ceremony, when Kelly opened an envelope and read out the name of the winner.

Just before the winner was announced, Matthew Hudes of Deloitte played a short video that QB3 had made about the finalists. Bursts of laughter came from the audience at various points when, in the film, Bassik and Kampmann high-fived, and when the five-person team from Jack Taunton’s lab at UCSF examined molecular structures on a computer screen while wearing protective laser goggles.

“We never wear those goggles,” said graduate student Rand Miller later. “We just thought it would be funny to put them on.”

Read the Daily Californian story

The five finalists for the award, and their work in their own words:

• Michael Bassik & Martin Kampmann, UCSF
  Research Topic: Genetic interactions in human cells
  Nominated By: Jonathan Weissman, UCSF
  The human genome sequence provides a “parts list” of the cell. Now, the challenge is to understand how these individual parts work together in health and disease. We have developed a technology platform that makes it possible for the first time to systematically explore the interactions between huge numbers of genes in human cells. This approach will reveal how the genetic background of patients determines whether a given drug will be effective or harmful. In addition, our approach will identify targets for combination therapies that synergize to kill cancer cells with minimal effects on healthy cells, and prevent drug resistance.

• Anjan Debnath, UCSF
  Research Topic: A new drug lead for global diarrheal parasite
  Nominated By: Jim McKerrow, UCSF
  50 million people suffer annually from amebiasis, a diarrheal disease caused by Entamoeba histolytica. Current therapy has adverse side effects. Because amebiasis is a “neglected disease,” new drug development is not a priority for pharmaceutical companies. We developed an automated screen to identify new drugs for amebiasis and found auranofin, an FDA-approved drug, more efficacious than current therapy. Auranofin has now received an orphan drug status from the FDA for the treatment of amebiasis. Since auranofin is off-patent and has been in clinical use for 27 years, the cost and development time for this “repurposed drug” can be significantly reduced.

• Shyam Krishnan, Jesse McFarland, Rand Miller, Ville Paavilainen & Iana Serafimova, UCSF
  Research Topic: Chemical technology for selective drug design
  Nominated By: Jack Taunton, UCSF
  Small molecule drugs are an invaluable part of nearly all human disease treatments. Unfortunately, the number of new drugs approved annually has stagnated despite increased investment. We have developed a new cysteine-targeting method that enables both the improvement of current small molecule therapeutics as well as the rapid development of novel drugs. Our approach can result in safer, more selective drugs that are active in vitro, in cells and in animal models. This technology is being used to develop cancer therapies, and we anticipate that it will be applied to the treatment of a wide range of other diseases.

• Michelle Maalouf, UC Santa Cruz
  Research Topic: Using nanopipettes to create artificial stem cells
  Nominated By: Nader Pourmand, UC Santa Cruz
  I have shown that nanopipette technology potentially can be used to inject molecules into human skin cells to induce pluripotent stem cells on the single-cell level. These artificial stem cells, made from patients’ skin cells, can be used for disease treatment in the field of regenerative medicine without immune response concerns for the patient or ethical issues connected with obtaining stem cells. This technique to generate artificial stem cells far improves present-day methods which have a success rate of only 1-5%. Regenerative medicine is the key in shifting human disease as we know it and alleviating pain in millions of patients.

• Zhenyu Tang and Aijun Wang, UC Berkeley
  Research Topic: Stem cells: the real culprit behind hardened arteries
  Nominated By: Song Li, UC Berkeley
  Cardiovascular diseases are a leading cause of death in many countries. In the past three decades, it is generally accepted that vascular diseases are mainly caused by smooth muscle cells. The work by this team challenges this dogma and found that a previously unknown type of stem cell is to blame for hardened arteries. It provides a brand new target for future vascular disease treatments and would revolutionize therapies for vascular diseases because stem cells rather than smooth muscle cells are the correct therapeutic target.

Mayor Lee with QB3 associate director Doug Crawford and QB3 director Reg Kelly.

San Francisco mayor Ed Lee makes it a point to meet innovative business leaders and workers in the city on what he calls “Tuesday Tours.” On Tuesday, July 31, Mayor Lee dropped in for a meet-and-greet at UCSF Mission Bay with ten or fifteen entrepreneurs in the QB3 incubator network.

“I’ve been working for the city for 22 years,” Lee said. “I was the city’s first whistleblower investigator…I got to investigate anything I wanted that smelled of corruption or inappropriate waste of government funds.”

“That’s not why you’re here,” QB3’s director Reg Kelly said, to general laughter.

In brief remarks and a Q&A, Lee focused on international investment and the payroll tax exemption for biotech companies in San Francisco.

“We made that as part of redevelopment of Mission Bay so we could invite incubators,” Lee said. “Thanks to Gavin Newsom, biotech and life sciences got a start here. It’s kind of taken over on its own and built success.”

“We’re the only city in state of California that taxes on payroll basis,” he said. “When you’re trying to create jobs, that kind of tax goes in the opposite direction. Today we enjoyed an 11-0 vote on the board to put on the November ballot a complete change, and eliminate payroll tax in exchange for a gross receipts tax. The theory behind it is not to unfairly tax job creators, but to give you a chance to succeed so we can have revenue based on your success. It’s a huge shift in dialogue in the city—one of the milestones to attract companies to be here, because they won’t be taxed on growth. We worked with all kinds of industries—hospitality, hotels, restaurants, the tech community, real estate—to make this agreement.”

Asked whether the gross receipts tax would tax investments in a startup, Lee said no; only “revenue based on selling a service or product.” Income from federal grants would also be exempted.

Deloitte’s Matthew Hudes with finalists Lily Huang and Daniel Zwilling at the 2011 award ceremony.

Twenty-nine candidates or teams are contending for the 2012 Deloitte QB3 Award for Innovation, a $10,000 prize to be awarded on October 18.

Last month we asked faculty at UC Berkeley, UC Santa Cruz, and UCSF to nominate students, postdocs, and staff scientists who have made scientific discoveries, or invented technologies, that could significantly improve human health.

We also encouraged those who had been nominated for last year’s award to enter this year’s cycle if they thought they had made progress in their work.

In the end, we received applications from 14 individuals, 12 duos, one 4-mer, one 5-mer, and one 6-mer. Most entries came from one of our three campuses, but we had one pair bridging Berkeley/UCSF and one group spanning Berkeley/Santa Cruz.

The topcis spanned the breadth of QB3 research, including tumor imaging, therapeutic stem cells, microfluidics for biomedical assays, and screening for parasite-killing drugs.

We stored information (summaries and publication pdfs) for all candidates on Dropbox, a file-sharing site that our jurors can access as they consider which ten entries are worthy of progressing to the next round.

The first “downselect,” as our Deloitte partners like to call it, will take place on July 20. The second downselect, from ten candidates to five finalists, will occur on August 20. Then our campus communities will vote for the ultimate winner. We expect vigorous campaigning! And we will do our best to involve the campus public affairs offices.

Last year a trio from Roger Linington’s lab at Santa Cruz won the award. It remains to be seen whether there is magic in team effort, or a lone nominee can capture the imagination—and the votes—of the community. We will get the word out via our Facebook page, where we will launch a custom app later in the summer, and we hope to see a lively discussion of the merits of the finalists. See you on Facebook!

How many of you, like me, remember the first time you heard of the acronym ADME?

“Add me to what?” I was perplexed as a neurobiologist uninitiated in pharmacological jargon. By now of course, I have learned ADME stands for Adsorption, Distribution, Metabolism, and Excretion. According to Luke Lightning, however, it’s not enough to just know the WHAT of ADME; you need to also know the WHEN, WHERE, and HOW. If you’re interested in pre-clinical drug development, you’d better make sure ADME is your BFF.

Lightning, Senior Director of Research at Alquest Therapeutics, spoke at the symposium “If only I’d known about preclinical drug development,” hosted by QB3 and co-sponsored by Patheon and Deloitte Consulting LLP. He argues that the importance of ADME cannot be overstated, because it allows you to learn more about your candidates, and informs go vs. no-go decisions.

Keep in mind that multiple in vitro and in vivo ADME approaches are available. In vitro studies include metabolic stability, drug-drug interaction, induction, permeability, and transporters. In vivo experiments investigate pharmacokinetics and dose formulation. In deciding whether to perform ADME studies in-house or through outsourcing, a myriad of factors need to be considered, including financial reasons, granting agencies, personnel, and equipment.

Conducting ADME studies in-house offers direct oversight, but the hefty price tag of hiring specialized personnel and purchasing equipment could be a deterrent. With flexibility, repeatability, and fast turnaround time, outsourcing to Contract Research Organizations (CROs) serves as an attractive alternative. Given the differentials on price and scope of service, finding the CRO that fits your need could be a daunting task. Dr. Lightning recommends two useful online databases to facilitate your search: Assay Depot and Science Exchange. Assay Depot contains a database of CROs worldwide with information on pricing and protocols. Science Exchange operates similarly but also includes a list of universities that can provide services.

Here is a simple example of ADME work plan provided by Lightning. He suggests initially starting with some exploratory, non-GLP experiments to get a quick idea of the ADME profile of your compounds and help select candidates for further studies. For example, select ten compounds for in vitro experiments in singlet instead of triplicate to drive down cost. These may include plasma protein binding and blood stability, as well as metabolic stability in liver microsomes. From there, you can select two to three compounds for rodent pharmacokinetics and CYP3A4 inhibition experiments, move them on to efficacy studies after evaluation, and then repeat the process. In the end, you will obtain two to three promising candidates for more in-depth ADME analysis run in triplicates.

Fast iteration is key to the lean startup model, he says.

Check out Lightning’s slides here for a wealth of tips and links. The pre-clinical drug development symposium, held last Friday at UCSF Mission Bay, also featured presentations and panel discussion by other industry leaders and academic experts, covering topics ranging from CMC, ADME, toxicology, to drug development partner selection and sources of funding. More slides are distributed via our podcast feed.

Doug Crawford warns the class that changing the stated aim of your SBIR at the last minute is not a good idea. He knows. He tried.

In the past few months, QB3 has offered life science entrepreneurs a spread of new services. Among them, QB3 Startup in a Box, which provides everything you need—except for inspiration, hard work, and luck!—to turn an idea into a company.
Read the SF Business Times story

A key component of the Box is the QB3 SBIR workshop, which teaches entrepreneurs how to apply for federal SBIR grants. Shauna Farr-Jones, a grant writer and QB3 Innolab consultant, led the first session of the latest SBIR workshop at UCSF Mission Bay on Wednesday, June 20. Over 60 people registered.

If your application is successful, a Phase I SBIR from the NIH can net your startup around $250,000. (A Phase II SBIR can bring in as much as $1 million.) SBIRs are offered by several federal agencies—the DOE, the NIH, the NSF—each of which has its own requirements.

“There are a lot of complicated rules. It’s like the tax code, so we’re hoping to make sure [course-takers] get, at the very least, an application which doesn’t have mistakes in it that will cause it to be rejected due to errors in forms,” Farr-Jones says. She gives them templates and lists; points them to instructions that they might not have found on their own; and directs them to people at the agencies who can help. “I highlight common mistakes because the instructions are often difficult to understand and some of the SBIR rules don’t make a lot of sense from the perspective of the company’s goals,” she says.

Nancy Mize, CEO and co-founder of GenoGen, a regenerative medicine startup, tried to write an SBIR application a few years ago. “It was such a frustrating experience I decided I would take the class,” she says, noting that last time she spent 30 days on the application, but didn’t find that was enough time to do it properly.

Ken Harrison, QB3’s entrepreneurship program manager, helped organize the workshop. “Everyone is really engaged,” he says. “We’re getting great value out of the Q&A. While it’s useful to have slides queued up and have an agenda, the shared knowledge from Q&A is probably of most value to everyone in the audience.”

This would be because each entrepreneur is encountering his or her own challenges. Steve Yannone, a biochemist at Lawrence Berkeley National Laboratory, and founder of Cinder Biological, a biofuels startup, found information about personnel the most useful. “There’s a lot of confusion on the different websites about who can be what at a company,” he says. “I’m fully employed at the Lab; I can’t be PI on an SBIR grant unless I quit my job. There are a lot of subtleties about how to position people who can do the work and either maintain employment or give it up. That’s a tricky business. Not everyone can quit their job.”

Farr-Jones advises that you can improve your chances of success by near-obsessive refinement. “Typos, inconsistencies, unclear methods or rationale, poor significance are not going to cut it,” she says. “It has to be really good. Write a draft early. Then have friends, colleagues, experts read it, poke holes in it, criticize it and just keep polishing it.”

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Janet Woodcock takes questions from the audience. Photo: Christine Fu

Clinical research and drug discovery in the United States are in need of a serious overhaul, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, told an audience of nearly 300 in Byers Auditorium at UCSF Mission Bay on Thursday.

Listen to the podcast or download her slides.

Perhaps the most interesting segment of her talk was the Q&A session at the end, which highlighted her deep knowledge of drug discovery and regulation. A lightly-edited version follows.

Read coverage of the event on the Burrill Report, Forbes, and the Nature Bioentrepreneur blog.

Audience member: You think about this as an incredibly capital intensive, risky, research-heavy enterprise, one that the private sector seems to be getting out of—is there a role for government?

Woodcock: The FDA—we’re supposed to be a regulatory agency…I believe the NIH is trying to address this problem with NCATS (the National Center for Advancing Translational Sciences). So they’re trying to do something but they haven’t received a lot of funding. I’m not sure they have a clear concept of what needs to be done… I think the NCATS concept will be advanced and that will be the federal government’s effort in this area.

Audience member: Do you personally think the “complete response” letter should be made public?

Woodcock: In the user fee program the industry submits a marketing application to the FDA…we have a certain amount of time to get it all reviewed and then we’ll send them back a complete response—or we’ll approve the drug. So a “complete response” means we didn’t approve the drug. A lot of people would like to hear about that transaction. Because the investors would like to hear where they’re being spun by the company; the public would like to hear; many of my staff would like to make it public because they want our side of the story to get out there; like, why did we turn this down? There are points on either side of this, and this would probably be for Congress to decide because it has to do with IP and confidential commercial information versus transparency of the process and investors’ rights. So I don’t know enough about economics to have an opinion. I usually favor transparency in all things because I think it eventually solves a lot of problems.

Audience member: Shouldn’t NCATS work closely with the FDA? Why does it seem from an outsider’s perspective that NCATS is stuck?

Woodcock: Well, they don’t have a director, they’re in the process of selecting a director and I think they’re waiting to get that leadership in place. Right now they’re merely an amalgam of other programs that were committed funds…so they don’t have a lot of freedom to operate. So it’s going to take a while for them to reveal the promise of what NCATS is going to be.

Jeff Bluestone, executive vice-chancellor and provost, UCSF: What’s the FDA doing in thinking about how we’re going to deal with some of the unique challenges that cell-based challenges provide?

Woodcock: I was involved in that a long time ago, but I’m not anymore, and the Center for Biologics regulates cell-based therapies. What I understand from them is what they’re concerned about is rigor, that there be some kind of characterization of what is the phenotype of the cell so you have some kind of reproducible manufacturing. That’s the level where they’re really focusing right now. But I don’t know all the other challenges. I think that therapies from regenerative medicine will really become prominent in the future, will create lots of struggles.

Laura Esserman, professor of surgery and radiology, and director of the Carol Franc Buck Breast Care Center, UCSF: Do you have a recommendation for how to engage the venture community in helping us build the new infrastructure that would allow us to make some of these transformational changes?

Woodcock: The venture community told me that they represent mainly pension funds. Old people’s money. And their job is to have a substantial return on investment within a four-year horizon. So they have a short time horizon and they need some predictable return after an investment is made, otherwise they’ll lose money for the pension fund. So they are not the entrepreneurial types that they may sell themselves as. They’re conservative. I’d be conservative too. That’s why they’re fleeing toward less risky investments.

Audience member: There are many competing agendas. How do you make it win-win for all the players? Could the FDA help?

Woodcock: I’ve found that our presence at the table is kind of validating. The FDA is really scary, so if we’re there it must really be important. And so we try to add our weight to the dialog. But we aren’t economists. That’s not our area of expertise. So how to make sure the system is altered in ways to provide a return on investment to everyone is not our expertise. But the problem is our problem too. We own the problem because if this enterprise fails…if we had no FDA standards, then lots of drugs could get on the market. But there might be reimbursement problems! So there is some relationship there that we have to own.

Audience member: Funding is flat. The cost is going up. So if academia has to take part in it, how is funding going to come to academia?

Woodcock: Academia is in charge of the study sections. You’re not completely helpless on what the research agenda might be, although you might feel totally helpless. In some ways there has to be more scholarly endeavor across the whole range of human biology, not just the very reductionistic level. That’s not a good answer, I know, but everyone has to own this problem.

Audience member: The flat portion of funding happens at the clinical research stage where the costs are very high. So how is the funding going to come?

Woodcock: I think we have to figure a way to make the cost lower and that’s what I’m working with Laura Esserman and other people on. It doesn’t have to cost that much. If you sat down and devised this, and you’re a systems engineer, they’d commit you. You put the sites where the patients aren’t, and you make huge barriers to initiating the enterprise, etcetera, and you do it over and over again, which is the definition of being crazy. So it isn’t like I expect academia to bear these costs. I think we have to work together to lower the cost. And improve the effectiveness and efficiency of clinical evaluation. Especially since now, if you’re going to do this right, you have to be iterative between the bench and the clinic.

Audience member: Is there a way that valuable data can be collected in randomized studies, post-marketing, while companies are collecting revenue to help pay for those studies? Before you get your first dollar in the door, it’s a billion dollars and ten or fifteen years out.

Woodcock: I’ve put before Congress with the Infectious Disease Society of America the concept of a limited population antibiotic drug —maybe a tiny development program, a couple hundred patients to test a drug to treat a drug-resistant organism. You get on the market and you have a logo and then you have instructions on the label saying ‘this is only to be used for this purpose’. And that would provide good antibiotic stewardship, and also if companies wanted it, they could continue developing the drug. Current drug trials are 5000 people, a major undertaking, which is why most companies have gotten out of the business

Audience member: So what’s the resistance to doing more of that in diabetes, cardiovascular?

Woodcock: We don’t have a tool. If I don’t get it in the statute, we’ll have to go to rulemaking, which would take forever. There are probably groups that would throw themselves bodily in front of it to prevent it from going into effect. Because people don’t like change, they feel threatened… Some of the companies are resisting. There’s a lack of trust among all the sectors. What you’re bringing up is staged approval mechanism. You can’t have staged unless, once it gets on the market, there’s some mechanism where people are willing to not use it. The previous paradigm was, you try to get it in as many people as possible, and that’s how things came to grief many times. Getting to some kind of staged mechanisms would be a good move.

Ken Kengatharan. Photo: Christine Fu

What does biotech development have in common with farming, poker, or automobile racing?

You are probably scratching your head now, if you missed Dr. M. (Ken) Kengatharan’s QED seminar on April 5 at UCSF Mission Bay. According to Kengatharan, president and CSO of Altheos, there are only a handful of factors that determine the failure of a biotech startup. He makes a reference to Freakonomics® in his seminar title, zooming in to the most unconventional factors among these.

The farming analogy is a recurring theme through this talk. Kengatharan compares biotech companies to farmers, obtaining seeds (IP), producing crops (R&D) and selling them to wholesalers (big pharma). If the farmer doesn’t get paid until the wholesaler sells a product, this whole industry is in danger of collapsing. He sees the current biotech industry as heading toward a hard landing, and in need of some audacious reform.

What is the number one reason contributing to the demise of biotech companies? Kengatharan believes it’s a faulty reward structure that fails to recognize and look after talents.

“The asset in the company is not patents and drugs; it’s people,” he says emphatically.

In an organization, leaders at the highest level get most of the reward, while neglecting people at the lower level who actually develop technologies to carry the company through successful exit. The resulting exodus of talents not only drains a company of innovation, but also gives competitors a leg up by capturing them.

To address this conundrum, Kengatharan proposes an alternative model, in which a percentage of every investment in a biotech trickled down to employees, previous investors, and founders. Such a strategy may boost morale and encourage people to reinvest for a tax break.

“Motivating employees is the key,” he argues. “Management of people is the reason for success but also the reason for failure.”

So where does the poker analogy come in? Kengatharan draws on the game’s low odds of winning to explain the technological risk associated with a biotech’s failure. A poker player can push opponents out of the pot before the game ends—not unlike a startup convincing big pharma it has the best drug by Phase II/III and selling itself. Which drugs have the best chance of winning? Nobody can predict that, as the cards are dealt at random. Some of the biggest blockbuster pharmaceuticals in history in fact met with much initial skepticism, including Lipitor, Viagra and Rituxan.

Another reason of failure is trying to revise the business model during the life of a biotech startup. Kengatharan points out that just like a car built for NASCAR can’t run on an Indy 500 circuit, you cannot expect to suddenly evolve your company into something that it is not. Although there are situations in which similar cars may ride on different tracks, you should decide on your business model from the outset, and focus on that until your exit.

Don’t miss out on the eyebrow-raising statistics, personal anecdotes, and cautionary tales in this talk. The podcast and slides are now posted.

Dennis Henner. Photo: Christine Fu

“It was like a kid in a candy store, and beyond that, the kids were running the candy store,” said Dr. Dennis Henner.

No, he was not telling a new adaptation of Charlie and the Chocolate Factory. Instead, Henner was describing the early days of Genentech, when he first joined the company in 1981.

Prior to his current position as Managing Director of Clarus Ventures, Dr. Henner was at Genentech from 1981 to 2001, holding various positions including Senior Vice President of Research. In a recent QED seminar at UCSF Mission Bay, he shared his experiences at Genentech, and provided some perspective on the current climate for investment in life sciences.

Henner had a strong background in Bacillus subtilis genetics from his Ph.D. and postdoc training in Microbiology. His scientific career at Genentech evolved from Bacillus subtilis to E. coli expression systems, and then to therapeutic antibodies. As the opening quote suggests, there was little supervision over research in the early 80’s. Innovation flourished, but commercial reality ultimately clashed with that free-willing culture. Henner outlined three crucial transitions Genentech went through in the mid 80’s to maintain creativity while expanding commercial success.

1. From technology company to pharmaceutical company. As David Packard, who sat on the board of Genentech, was quoted saying, “More companies die of indigestion than of starvation.” A decision was made to focus efforts on drug development and curtail other research programs.

2. From technology-driven to biology-driven company. As recombinant DNA technology became easier over time, Genentech was losing its competitive edge. The low-hanging fruits in pharmaceutical development were harvested relatively early. Genentech had to turn into a molecular biology company with more emphasis placed on “biology” than “molecular,” by reorganizing itself around different biological disciplines.

3. From bottoms-up and free-willing culture to more integrated and disciplined organization. Genentech went to academic institutions to find the “adults to supervise the candy store.” To encourage scientific innovation within an integrated framework, the company strived to maintain key interactions between its research and clinical arms, as well as organization-wide transparency.

New entrepreneurs may derive valuable lessons from Genentech’s success story. Just as Genentech had to do some soul-searching and focus, you need to carefully consider what your business model would be. What is your competitive edge and how long can you maintain it?

As an experienced venture capitalist, Henner also offered three observations about the current environment of investing in life sciences:

1. The amount of life science venture capital is shrinking, making capital harder to find.
2. The pharmaceutical and biotech industry is in a state of turmoil.
3. The FDA is a nightmare, and probably at a 30 year low.

So what can an entrepreneur do against these strong headwinds? Henner advised those trying to raise capital to understand the business of people who are making investments. A venture capitalist’s job is to make money for the limited partners who invest in him or her. You need to think about how your business can generate returns for that investment. Keep in mind that clocks are ticking in the VC world as soon as money is put into a company: A venture capital fund has a lifespan of ten to twelve years, and a new fund needs to be raised every four to five years.

Henner also suggested bringing experienced management to the table. Though you might be tempted by the genesis stories of Google or Facebook to take on management roles, Henner pointed out that the capital requirement is very different in biotech versus social media companies. Building a team with people who know the business and understand the regulatory processes could avoid blunders that you cannot afford.

To listen to the talk, stream online or subscribe to our podcast on iTunes.

Pat Scannon. Photo: Christine Fu

When you open a medication package insert, have you ever wondered how it comes into being during the drug development process? How is that little piece of paper packed with fine print relevant to you as a researcher with discoveries?

The package insert evolves from a document called the target product profile (TPP). According to the FDA, “a TPP is a format for a summary of a drug development program described in terms of labeling concepts.” Think of it as a list that defines the end goals and guides the development process. In a QED seminar held on March 1 at UCSF Mission Bay, Patrick Scannon, Executive Vice President and Chief Scientific Officer of XOMA, presented a primer on the TPP and how budding entrepreneurs may take advantage of this information.

Although TPP is used mostly in the industry setting, Scannon made a convincing case that it is adaptable as a communication tool between academic discoverers and investors. Incorporating the TPP format could impart a competitive edge to your discovery that differentiates it from others.

The informative presentation slides from this QED are available as a PDF file, along with the audio MP3. To download both files as well as future seminar recordings with one click, subscribe to the QB3 Bioentrepreneurship Podcast here.