Protein Power - BioLab Business Magazine · 2012. 10. 26. · Canadian Publications Mail...

Alabama Innovation • National Biotech Week Calendar • Gene Therapy

Championing the Business of BioteChnology in Canada July/August 2012

Protein PowerProtein discoveries have the power to re-energize an ailing drug pipeline

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BioTalent Canada’s BioSkills Recognition Program addresses skillsshortages by identifying people who are ready to join Canada’sbio-economy workforce. We need industry experts like you tohelp us recognize individuals’ skills and experience in the contextof real-world biotechnology sector requirements.

Give your seal of approval: join our Competency Committeeand help shape the future of the bio-economy.

Who’s BioReady? Have your say.

Funded by the Government of Canada's Sector Council ProgramBioTalentCanadaisaregisteredtrademarkofBioTalentCanada.

We all have a role to play in strengthening Canada’s biotechnology sector. Share your insights.

Join our Competency Committee now by emailing [email protected] or learnmore aboutthe BioSkills Recognition Program on our website at www.biotalent.ca.

What’s in it for you?

• Learn to recognize the skills that meetyour organization’s HR needs

• Get early access to the best andbrightest talent

• Create your own personal BioTalent CanadaePortfolio—for free

• Leave your mark on the bio-economy

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Championing the Business of BioteChnology in Canada

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22 BuSiNESS lEadErShip

There is a large inertia in the biomedical research system that hasn’t yet come to grips that there are way more proteins and genes than we study. They’ve not developed real mechanisms to work hard into the unknown.

– Aled Edwards, Director of the Structural Genomics Consortium. Read more on page 20.”“

aled Edwards and his mission to cure disease

Aled Edwards, Director of the Structural Genomics Consortium, is an original thinker and a man on a mission to discover something new about the proteins living inside the human body.

8 National Biotech Week The best part of September is National Biotech Week, the one week of the year when bio businesses get to spotlight how they will change the world.

10 a roundtable on personalized medicine Gene sequencing offer the promise to personalize medicines to every patient. A panel of lawyers and experts discuss the ins and outs of personalized medicine and where this field is going.

14 regional profile: alabama Alabama, home to the Edge of Chaos, is a newly built innovation centre that hopes to bring new bio businesses and a new way of thinking to this sweet southern state.

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BioTalent Canada’s BioSkills Recognition Program addresses skillsshortages by identifying people who are ready to join Canada’sbio-economy workforce. We need industry experts like you tohelp us recognize individuals’ skills and experience in the contextof real-world biotechnology sector requirements.

Give your seal of approval: join our Competency Committeeand help shape the future of the bio-economy.

Who’s BioReady? Have your say.

Funded by the Government of Canada's Sector Council ProgramBioTalentCanadaisaregisteredtrademarkofBioTalentCanada.

We all have a role to play in strengthening Canada’s biotechnology sector. Share your insights.

Join our Competency Committee now by emailing [email protected] or learnmore aboutthe BioSkills Recognition Program on our website at www.biotalent.ca.

What’s in it for you?

• Learn to recognize the skills that meetyour organization’s HR needs

• Get early access to the best andbrightest talent

• Create your own personal BioTalent CanadaePortfolio—for free

• Leave your mark on the bio-economy

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2012

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November 12-13 2012, The Mandarin Oriental, Washington D.C.

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Join us to discuss recent advancements in upstream and downstream cell-culture processes - advancements that will help your business improve bio-processing efficiency, optimize R&D, reduce production time and minimize costs.

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& Technology OfficerBoehringer Ingelheim

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and PurificationTakeda Pharmaceutical

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DevelopmentUCB Pharma S.A.

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Editorial

Genomics in Canada has hurdles to leap. Nationally, we have had success, with Genome Canada helping to create national goals. Provincially, we’re finding success, with B.C. and Ontario helping to make Canada a reliable source for

foundational genetic research. No doubt, Canada does well, but we need to do better. The challenges facing companies working in genomics are well understood. In the development stages, it’s the old story: a lack of funds. But it’s down-the-road chal-lenges that depress a business’s ability to raise funds.

The first challenge is a lack of access to medically actionable genetic research. To know how genes affect particular drugs in particular patients, researchers need detailed clinical information on patients exposed to the drug. This data exists, but it’s scattered in medical records and databases across the country. And it is difficult to obtain.

The second problem is payment. The success of a bio business depends on whether the healthcare system approves and pays for products. Brad Popovich, President of Genome BC, explains the problem: “We have many examples in this country of products that can improve patient outcomes, but they are not reimbursed, and if something isn’t reimbursed, it isn’t used. Period.”

What to do about these problems? The obvious answer is to clear a path to com-mercialization. Give investors more incentive to take risks, speed the road to approv-als and connect researchers to the genetic data they need. These are obvious, not easy, solutions.

Here’s another solution: let’s do more to help the game-changers, people like Aled Edwards (p. 18), who create new avenues for drug discovery. Let’s reward originality. Let’s demand that schools teach rebellious creativity, not obedience to the standard. Let’s challenge what we think we know, what we think works. The work of bio busi-nesses is too important to make wait. Let’s act to change what we’ve known for a long time needs to change. The diseases we need to cure don’t stand still. So why do we?

Championing the Business of Biotechnology in Canada

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Alabama Innovation • National Biotech Week Calendar • Gene Therapy

Championing the Business of BioteChnology in Canada July/August 2012

Protein PowerProtein discoveries have the power to re-energize an ailing drug pipeline

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July/Aug 2012 www.labbusinessmag.com

The definitive source for lab products, news and developments

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Good PipettingTips for Purchasing

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6 Bio Business July/August 2012

For McKenzie, the changes in the budget are a step in the wrong direction when it comes to supporting research and devel-opment in Canada. “These changes involved lowering the general federal tax credit rate for Scientific Research and Experimental Development (SR&ED), and eliminating or reducing the credit for certain types of expenditures,” writes McKenzie in his report, The Big and

the Small of Tax Support for R&D in Canada.

“The proliferation and variation in effective subsidy rates for R&D offered through the tax system is distortionary, inefficient and lowers the overall efficacy of government support for R&D in Canada,” he writes.

McKenzie argues that the changes favour smaller businesses versus large

corporations and don’t show any evidence indicating that the economy will benefit from this. His analysis shows that, pre-budget, the subsidy rate for small corpo-rations was 1.47 times larger than that for large corporations, but this ratio increased to 1.72 post-budget.

McKenzie also questions the bias towards labour-intensive R&D versus capital-intensive R&D. He argues that the variation in subsidy rates across busi-ness inputs distorts firms’ production decisions and unjustifiably favours firms with higher labour-intensive R&D.

Budget 2012 a Step in Wrong Direction: Policy Researcher

The changes to R&D financing outlined in Budget 2012 don’t sit well with policy researcher Ken McKenzie, a researcher at the School of Public Policy and Department of Economics at the University of Calgary.

Feeling under the weather? Not for long.

There’s a growing interest in drug therapies to help regulate the immune system, and Canadian researchers are one step closer to a discovery. Researchers at the university of Calgary revealed the mechanism for how white blood cells move to infection or inflammation in the body.

Two human proteins—L-selectin and calmodulin—are involved in moving white blood cells to the site of inflammation or infection in the body. When the white blood cell reaches a site of infection or inflamma-tion, it “sheds” the L-selectin protein, which lets it leave the blood stream and enter the damaged tissue. Calmodulin controls this shedding process. “Cell biologists had figured out in 1998 that calmodulin was negatively regulating the shedding process of L-selectin,” says Jessica Gifford, a PhD student supervised by Hans Vogel. “They knew calmodulin did it, but they didn’t know how.”

using powerful magnets and a technique called nuclear magnetic reso-nance spectroscopy, Gifford and Vogel determined the molecular structure of the interaction between the two proteins, providing important insight at the molecular level into how calmodulin controls the shedding of L-selectin.

“understanding the molecular details of these processes will help us understand how our bodies respond to inflammation,” says Gifford, “and if we can understand that, that’s the first step of producing drug therapies to manipulate your immune system, to either turn it on, or turn it off.”

Worth Repeating“Scientists spend 25 per cent of their time trying to get the technology they work with to work.”

– Overheard at PerkinElmer’s INspiring INnovation 2012 Tour.

Canadian Bio-economy Grows 12%, 2007-2011Signs of a turnaround for biotech? New numbers suggest that investors are taking a greater interest in Canadian biotech.

Over the past four years, the Canadian bio-economy industry has steadily increased from $78 billion in 2007 to $87.3 billion in 2011. This translates to a growth of 12 per cent.

According to BIOTECanada, all levels of Canadian government are working to build a competitive environ-ment for technologies to thrive. In July, MaRS Discovery District in Toronto hosted a two-day conference called The Innovation City, with speakers from around the world. Members of various industries, levels of govern-ment and academia gathered to discuss how cities can thrive in an ever-changing global playground.

research Boosts Understanding of immune System

12%


News

Canadian Company Adopts Orphan Drugs

Medunik Canada, an orphan drug com-pany based in the greater Montreal area, announced an exclusive distribu-tion agreement with Orphan Europe Recordati Group, a pharmaceutical company that provides treatments for patients with rare diseases.

Under this agreement, Medunik Canada receives the exclusive Canadian rights to market and distrib-ute four therapies. “We are thrilled to enter into a new partnership with Orphan Europe Recordati Group,” says Éric Gervais, Executive Vice-President of Medunik Canada. “This new strate-gic collaboration complements our existing alliances and represents an important milestone in our endeavour to help patients with a rare disease in Canada to benefit from the best treat-ments available,” says Gervais.

The therapies will target the following medical conditions: acute hepatic por-phyria, hyperammonaema due to N-acetylglutamate synthase deficiency, or one of three organic acidurias (isova-leric, methylmalonic or propionic), pat-ent ductus arteriosus and vitamin E defi-ciency in chronic cholestasis.

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Pfizer Canada Injects $4.5 Million into Public Research on alzheimer’s

Pfizer Canada and the Fonds de recher-che du Québec—Santé (FRQS) announced the creation of the Pfizer-FRQS Innovation Fund for Alzheimer’s Disease and Related Disorders, thanks to $4.5 million in funding from Pfizer Canada.

“Setting up this fund for Alzheimer’s disease is part of a broader Pfizer strat-egy for partnering with the FRQS to meet health needs identified in the Quebec population and is therefore enabling Quebec’s life sciences sector to bolster its presence and global leader-ship,” says Allen Van der Wee, General Manager of Pfizer’s Primary Business Unit Canada.

The program will be available to Quebec’s research community and will create a consortium of Quebec research-ers as well as fund high-risk, high-spinoff-potential projects to allow researchers to explore new avenues of research.

“The purpose of creating this fund is to mobilize Quebec researchers, to pro-vide them with an infrastructure that will enable them, among other things, to set up an Alzheimer’s patient data registry,” says Claude Lazure, the FRQS’s acting scientific director.

“It will also make it possible to con-duct innovative research for better understanding the mechanisms underly-ing this disease by exploring research hypotheses that have so far never been investigated,” says Lazure.


Event Date Location Contact

Biotech Activities at the Science Centre

Sept 15 - 16, 2012 2:00pm

Saskatchewan Science Centre, Regina

www.lsam.com

Secondary School Biotechnology Awareness Campaign

Week of Sept 14-21, 2012 www.techalliance.com

PEI BioAlliance Kick-off Sept 14, 2012 BioCommons Research Park in Charlottetown

www.peibioalliance.com

Agriculture & AgriFood Canada Sept 17, 2012 Morden Research Centre, Morden, Manitoba

www. agwest.sk.ca/

In class experiments and webinars

Sept 17-20, 2012 Let’s Talk Science Food Development Centre (Portage la Prairie)

Composite Innovation Centre (Winnipeg)

www.lsam.com

Student Workshops at the Richardson Centre for Functional Foods and Nutraceuticals

Sept 17, 2012 Winnipeg www.lsam.com

Student Workshops at the Composites Innovation Centre

Sept 18, 2012

Winnipeg www.lsam.com

Advocacy Day on Parliament Hill - Ottawa

BIOTECanada leads an ongoing dialogue to create science-based policy and increase awareness of biotechnology.

Sept 18, 2012 Day event

Parliament Hill, Ottawa www.biotech.ca

National Biotech Week shows off all that biotech and life sciences do for Canadians. This week is a celebration, so get out and celebrate.

Celebrating Biotech Across the Country

Each year, Canada’s biotech sector celebrates its contributions to Canadian society with National Biotech Week. A showcase for innovation, National Biotech Week brings together business, community groups, academia and policymakers to learn about

how advances in cutting edge life science research translates into better health, better communities and a better economy. Regardless of where in the country you are, make sure you get out in September and see what biotech offers!


National Biotech Week

Student workshops at the Inner City Science Centre

Sept 18, 2012 Winnipeg Inner City Science Centre

www.LSAM.caJonathan Frate at [email protected]

Biotech Blast!Student Workshop

Sept 18, 2012 All day

University of Saskatchewan, Saskatoon

www.agwest.sk.ca/

Student Workshops at the Red River College

Sept 18, 2012 Winnipeg www.lsam.ca

Pharmaceutical and Medical Regulatory Affairs Conference

Sept 18, 2012 11:30 am – 2:00 pm

Grand Times Hotel, Sherbrooke

www.sherbrooke-innopole.org

Lab At The LegWith Let’s Talk Science

Sept 19, 2012 3:00 pm – 7:00 pm

Winnipeg Manitoba Legislative Building

www.lsam.com

Greater Charlottetown & Area Chamber of Commerce Business Networking Mixer

Sept 19, 2012 4:30 – 6:30 pm

The Holman Grand Hotel, Charlottetown, PEI

www.peibioalliance.com

Student Workshops at the Innovation Technology Centre

Sept 19, 2012 Winnipeg www.lsam.com

Community Collaboration ForumHosted by Pillar Nonprofit Network

Sept 19, 2012 www.techalliance.com

The Amazing Biotech Race Sept 20, 2012 1:00 pm - 4:00 pm

Innovation place and the University of Saskatchewan campus

Blaine Chartrand at SIAST

Biotech & Beer at Boffins –

Educators, post secondary students, researchers and business people in the biotech company. Music, fun and games

Sept 20, 2012 4:00 pm- 7:00 pm

Innovation Place Saskatoon, SK

Allison at Ag-West Bio.www.agwest.sk.ca/

BIOlympics Sept 20, 2012 www.techalliance.com

BioPort Atlantic eventTheme

Sept 26, 2012 (5:00PM) and

Sept 27, 2012 (all day)

Halifax Westin Hotel www.bionova.ca/

Event listings as of press time. For up-to-the-minute items, visit www.imagenenation.ca.


Personalized medicine offers another passageway to a treasure room of cures and therapies. The hope is that by personalizing medicine and tailoring therapies for

individual patients, science will finally deliver lasting cures that have so far evaded capture.

As participants in this legal roundtable on personalized medicine explain, realizing the potential of personalized medi-cine will take time. Smaller companies carrying out the work need stable funding and laws related to the patenting of person-alized medical technologies need greater certainty. With technol-ogy rapidly evolving and gene sequencing become ever more affordable, personalized medicine will change the industry when it does arrive.

What are the key roadblocks from an IP and patenting perspec-tive that are slowing down the translation of research into per-sonalized medical solutions? Norman: To get a patent you need four things: It needs to be new. It needs to be inventive. It needs to be useful. And the fourth one is the important one—it needs to be patentable sub-ject matter. That’s where we are with personalized medicines. Patentable subject matter refers to things that the government says are patentable and things that are not patentable. In Canada, you can’t get a patent for a method of medical treat-ment. You can in the u.S. In Europe there are some restrictions as well. What you generally find is that a lot of the claims that are directed at personalized medicines fall into that non-patent-able subject matter area.

By Robert Price

A roundtable discussion on IP, patenting and personalized medicine

Deep into the Genome

Kingwell: From my perspective, the primary difficulty is a degree of uncertainty about what kind of IP is available. At the moment that uncertainty is probably leading private sector innovators to be cautious about devoting resources to innovation in the field.

Gravelle: The patent system hasn’t been kind to biotechnology generally, but especially personalized medicine. The key decision was a recent u.S. Supreme Court decision, the Prometheus v. Mayo decision, which was directed to a personalized medicine claim. The court invalidated Prometheus’s patent on the basis that it does not containing patentable subject matter. This is unfortunate. Now the courts are saying that any claim to a diag-nostic method is just the law of nature so it’s not statutory sub-ject matter. These are very valuable inventions and now the validity of these claims are in question because of the Prometheus decision.

Heller: There’s a lot of concern that the Prometheus v. Mayo deci-sion will be detrimental to personalized medicine. Some people are even saying that it will effectively kill personalized medicine. Going back to fundamentals, if you don’t have patent rights there’s really no advantage for any company to do this work.

Agha: One of the issues is always trying to obtain the patents for these different inventions and the amount of time it takes. That can be a roadblock. There are provisions regarding clean technol-ogy that can expedite prosecutions of patents. Similar provisions for personalized medicine would help significantly.

Samuel Abraham Vice-President of Research and Vice-President of Strategic Relations at BC Cancer Agency

Kazim Agha Associate, Ridout & Maybee

R O u N D T A B L E P A R T I C I P A N T S :


Personalized Medicine

What kind of broader policy changes do we need to see in Canada before we see more personalized medical therapies in our hospi-tals and clinics?

Norman: We need greater respect for patent law. The Canadian governments are looking at this from a payer’s point of view and they don’t want to pay for methods for determining if you have a higher a risk for breast for cancer or prostate cancer. This creates a disincentive for people to develop those methods for Canada.

Gravelle: There needs to be work to make sure that people’s fears are alleviated. We’ve been through this with GMO crops. It’s still an area where people get incensed. In Canada, we’re one of the few countries that doesn’t allow patents on plants and animals because, I think, of the public outcry. There’s really no basis in law for the ban.

Heller: In Canada, with nationalized healthcare, I wonder at the policy level if somebody will have to make decisions about whether to spend $20,000 per treatment on a patient when we’re not sure about the efficacy of the treatment. I think the u.S. will have an easier time because in the u.S. it is more acceptable to have private clinics and for people rich enough to pay for those treatments themselves.

Agha: One of the things that slows down the process is the cost of obtaining patents. Policy changes that allow companies to use SR&ED credits to obtain patents may help get more companies going into more research.

On the subject of policy change, what would you like to see gov-ernment do regarding privacy laws to ensure that concerns around privacy and protecting data don›t hamstring personalized medicine?

Norman: I believe they go hand in glove. By increasing privacy of people’s genome sequences, you’re not hampering research. Privacy law and the research environment are closer together than people believe. I don’t see it as a wart on our ability to use and develop personalized medicine.

Kingwell: I think a significant part of adapting to a new technol-ogy is familiarity and public perception. Personalized medical approaches are new enough technologies that people are still left with pretty thorough uncertainty about how they are protected, in terms of privacy and discrimination.

Heller: I have some clients who are hospitals and from my dealing with them and their handling of data, they are in the infancy of collecting data and keeping it organized. For me, privacy con-cerns become really important when you have giant databases, and the bigger the database, the more people have to have access to it, so the easier it is to hack into them and the greater the consequences of a security breach. At some point we probably will get to a stage where information on people’s DNA is kept in huge databases and then privacy will be a huge concern.

Personalized medicine relies on data, interoperability between different medical systems and platforms, and collaboration between research and medical professionals and governments. What needs to happen to streamline the system to enable person-alized medicine?

Micheline Gravelle Partner and Head of Biotechnology & Pharmaceutical practice group at Bereskin & Parr

David Heller Partner, Ridout & Maybee



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Find these hiring tools and more to grow your bio-business at www.biotalent.ca.

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Personalized Medicine

Abraham: The platforms are still duking it out. It’s difficult to use results from one place to make decision at another place using another platform. Some standardization is going to have to occur for this to come into play. In the Canadian context, there’s a greater likelihood of coming to the table with standardization because we’re a single payer system.

Norman: My personal belief is that this has to be done by the company that is offering the kit or the technique or analysis method. I personally don’t believe the government is capable of setting up a system that allows hospitals, the researchers, and the companies to all talk together. It’s expensive and there is no financial incentive or real reason for the provinces to get into that game. I know a lot of companies already have these systems in place.

Heller: I think it has to go through a phase of organic growth. If the government tried to create a database, they’d discover the content isn’t there to integrate. So they’d be creating a way of handling content when they’re not certain what the content will be. I think we’re looking at quite a ways in the future before we’ll be looking at more centralized systems.

How do you envision the biotech business landscape shifting over the next 10 years if personalized medicine comes online in a big-ger way?

Norman: As these methods of gene screening get cheaper, I can envision over-the-counter tests for various things. What people do with the results afterward would be scary.

Gravelle: You just don’t know what’s going to happen next. I never would have predicted that Prometheus would have gone the way it did. My bigger fear is that it scares away the funders, and they’re the people biotechs really need. If a lot of research in Canada is going on in the universities, it becomes harder to get that research to the public because everybody’s afraid to give money because they think the patents are going to be weak, invalid. Patents are difficult to get on a good day. They’re expen-sive to get. And universities cannot afford to patent worldwide if they don’t get some help on patents.

Kingwell: One thing I’ve been fascinated by in the business land-

scape of pharmaceuticals, particularly biologics, is that there is whole bunch of smaller companies staying in business in an industry that they no business being in, in the sense that they don’t have the resources to bring a product to market. Nonetheless, that seems to be the complexion of the whole biotech market for a long time, and it seems to be permanent in the sense that there’s a widespread recognition that smaller companies are better places for pioneering innovation. I think the move to personalized medicine further cements that complexion for the industry. The guillotine that overhangs the pharma industry is the expiration of patent term on their latest blockbuster. A part of what may change with personalized medicine is that they become more diversified and less dependent on blockbusters and therefore less sensitive to that patent term expiration problem that they all have.

Abraham: We can probably change the term from personalized medicine to rational medicine. “Rational,” because at a molecular level it doesn’t matter if the drug was developed for a particular disease. As long as we understand the molecular basis of the disease, we can apply it to a number of areas where that molecu-lar basis still holds true. You’re going to find more applications for therapies in different arenas.

Heller: Ten years ago, a lot of the most important research was coming out of Big Pharma. Big Pharma seems to be giving up on that. They’re realizing that with personalized medicine, everything is smaller by nature. So things are moving from a world domi-nated by Big Pharma to a world in which we need to rely on start-ups and government funding and university funding to advance medicine. The other big barrier I see is regulatory approv-al. In the past five or 10 years, the FDA has been getting increas-ingly scared to approve anything partly because they get sued. I’ve actually seen a few examples of Health Canada approving drugs or treatments before the FDA does, which used to never happen.

Agha: A lot of it is going to be coming from smaller biotech companies. The challenge is that the lifecycle is such that it takes a while to go from research to IP protection to commercializa-tion. A lot of small biotech companies just don’t have the resources to last that time frame, so significant research is stalled, lost or picked up by another big company. More funding would be required to sustain these smaller industries so they can take it to the point of commercialization. BB

Brian Kingwell Partner, Smart & Biggar & Fetherstonhaugh & Co.

John Norman Partner and Vice-chair of Life Science Industry Group at Gowlings


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BioTalent BioBusiness May June 2012_Layout 1 12-03-19 12:10 PM Page 1

Engineering InnovationBirmingham steps closer to the edge

By Julia Teeluck

On the fourth floor of Lister Hill Library, university of Alabama at Birmingham campus, a room waits to be filled with the buzz that flows when creative people come

together. Called “The Edge of Chaos,” the space serves as a meet-ing point. Faculty, students or anyone in the community can use the space to work, collaborate, or simply meet interesting people who have interesting ideas. Sure there are cafeterias and coffee shops to do this, but The Edge of Chaos was designed specifi-cally to engineer innovation. The concept of engineering innova-tion plays out in other areas such as with companies who look to create novel solutions to problems.

More than 550 biotech companies call Alabama home. Among them is Soluble Therapeutics, a spinoff from uAB.

Soluble Therapeutics received an award of approximately $1 mil-lion from the National Institutes of Health Small Business Technology Transfer Program in June. The company’s technology can reduce the time and resources required to prepare protein-based drugs for clinical development.

Steven Ceulemans, vice president of Innovation and Technology at the Birmingham Business Alliance, says the grant demonstrates the level of work in biotechnology that is coming out of uAB and being fostered at Innovation Depot, a technology incubator located near the campus.

Those who believe and have seen that great ideas come from converging minds challenge the notion that isolation gives birth to great ideas. In fact, the trend toward collaboration is growing as seen by the emergence of social labs and collaborative work projects, and soon the scientist in his silo will be a thing of the past.

In Where Good Ideas Come from: the Natural History of Innovation, author Steven Johnson writes, “The trick to having good ideas is not to sit around in glorious isolation and try to think big thoughts. The trick is to get more parts on the table.” Sometimes people get stuck in a way of thinking. For scientists, that could mean asking the same research questions over and over and getting no closer to a solution.

The biotech artistArtists and philosophers have long embraced the tradition of coming together to discuss ideas and share opinions. Imagine the professor who takes his students outside on the lawn underneath a large tree to dissect existentialist thought, or the Ancient Greek philosophers gathered in an open square debating the meaning of life. These settings serve to congregate people from various fields of thought and expertise to explore infinite possibilities.

“Biotech scientists should spend time with artists and philoso-phers,” says Jason Silva, a filmmaker, philosopher and television personality. “They should exchange ideas. They should consider biology an ‘instrument’—just like the pen or the violin. They should also see biology as their canvas for new forms of human creativity—this is key.” Creative people, those who are open, will welcome this suggestion.

At Alabama’s Innovation Depot, members can attend regular


there are 557 agricultural and life science bio businessesoperating in alabama, many clustered around Birmingham.

the university of alabama at Birmingham is home to the uaB Comprehensive Cancer Center. More than 330 physicians and researchers conduct their

research at the Center, which ranks in the top 40 in the u.S. for competitive funding from the National Cancer institute.


Regional Profile

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training sessions, seminars and workshops. Members come from industries such as biotech, information technology, medical devices, mobile applications and engineering. By providing their companies with the opportunity to interact and engage, the Innovation Depot sets the stage for precisely that—innovation.

If gathering people of multiple disciplines in uncontrolled spaces and setting them loose to create and converse inspires good ideas, this is what Birmingham is doing right.

Meet me at the EdgeThe idea for The Edge of Chaos came from conversations that Max Michael, dean of the university of Alabama at Birmingham School of Public Health, had with faculty members—especially the younger ones. He found that those working in research-intensive institutions seemed to spend all their time writing grants and responding to requests for proposals. The opportunity to grab a cup of coffee with a colleague and discuss ideas was lost. “The original notion was, how do you create a space and time to let faculty members of different disciplines get together and talk about what’s on their minds and sort of see what emerges from that.”

The Edge is equipped with conference and media rooms, desks, sofas and work-stations. The Café amenities include a kitchen with a refrigerator and microwave. Inside the Café, which can hold about 30 people, there is Smart Wall with a digital, touch-screen whiteboard that has a variety of functions such as showing presentations, news and virtual interaction. What Michael makes clear is he doesn’t want a glorified coffee shop, but a place where people go to share ideas.

The area has been built, but will they come? And if they come, will they stay?

“You want to set the stage for what you want to have happen, so cinder blocks and drop ceilings, that’s the stage for a prison, not for an entrepreneur,” says Dr. Jordan B. Peterson, professor in the Department of Psychology at the university of Toronto and a clinical psychologist. Entrepreneurs are open, and open people respond well to esthetics. “You have to pay attention to the beauty of the surroundings. It’s important. It portrays a creative environment.” The spaces at The Edge of Chaos and the Innovation Depot project beauty and openness. In both spaces, natural light filters through large windows, and modern designs paired with bright colours invite you in.

Michael hopes the project evolves to where people say, “Meet me at the Edge.” During the 1920s, in New York City, people used to say, “Meet me under the clock.” In the lobby of the famous Biltmore Hotel there was a grand clock, immortalized in literature by F. Scott Fitzgerald and J.D. Salinger. “You didn’t

have to say anything else. People knew it was the Biltmore Hotel,” says Michael.

Infinite possibilities Steven Johnson, who will speak at The Edge’s grand opening in October, also inspired the project. Michael describes one of Johnson’s bodies of work—The Ghost Map, The Invention of Air and Where Good Ideas Come From—as a trilogy about innovation and the methods by which interesting ideas emerge. According to Michael, one of the key messages expressed in all of Johnson’s work is that you can’t multitask 24 hours a day and expect to come up with a unique idea.

In Where Good Ideas Come From, Johnson writes that people working in innovative environments are better able to explore what he calls “the adjacent possible.” The phrase, coined by scien-tist Stuart Kauffman, refers to the possibilities that emerge as you

explore and push boundaries. To illustrate the adjacent possible, Johnson paints an image of a person exploring rooms within an ever-expanding magical house. Imagine entering a room with four doors. You choose a door, turn the handle and step into a new room where more doors appear. You choose another door and enter the room where several doors appear again. You can con-tinue this infinitely. What’s significant about the process is you could not have reached the new rooms from your original starting point. You had to keep opening doors to get there. Stop roaming and the doors stop appearing.

The curiosity to venture to new realms and welcome the unknown sets the true innovators apart from those who romanti-cize innovation but fear where it could lead. According to Johnson, innovative environments expose their inhabitants to a wide and diverse sample of spare parts and encourage new ways of recombining those parts.

Today, in the digital age, Silva sees the rise of the digital poly-math, one who can put ideas together from various different fields and contexts and see new patterns. Famous polymaths (those

if alabama’s biotech scene has a nucleus, it’s the university of alabama at Birmingham, which receives $450 million in externally funded research each year, much of it in life sciences.


Regional Profile

whose fields of expertise span many disciplines) include Aristotle, Leonardo da Vinci, Galileo and Goethe. “Today, we can chase down ideas through such endless digital rabbit holes and hyper-link our way across so many unlikely idea-connections, and all with such efficacy, that I would say the chief characteristic of any successful creative is pattern recognition,” says Silva.

Johnson cautions that environments that “block or limit those new combinations” either by punishing or preventing experimen-tation will generate fewer innovations. Although companies and countries claim to want innovation—that next great idea that will rocket them ahead of the rest—Peterson says enterprises don’t actually like innovation. It’s too crazy, too out of the box. “Like I said, innovation is kind of frightening, so lots of people can’t handle it.”

A management style for the new agePlaces such as the Innovation Depot thrive because there is a degree of trust and freedom established between management and the entrepreneurs. “Hire the right people then leave them the hell alone,” says Peterson. Managers remove obstacles from the entrepreneur’s way. That’s it. “If you want to foster their perfor-mance, you want to allow them the freedom to generate the ideas and do practical problem solving for them, so that they don’t face any more structural impediments than necessary,” says Peterson.

Silva agrees with the approach. “The best manager is the one who manages least, in a way. He sets up the spaces, the contexts for creativity, the parameters so to speak, and then he lets them all loose,” says Silva. He’s fascinated by the way these new innovative companies encourage their employees to actually create time for passion projects. “They understand that creativity is fostered by occasional daydreaming, by removing yourself from context and the problem at hand and letting the mind wander,” says Silva.

Innovation Depot set up areas with chairs and tables away from the office and laboratory spaces for people to sit down and brainstorm or just get away from their work for awhile. There is also a fenced outdoor area with a similar arrangement. They recently integrated what they call a Think Room, which has a gym and recreational equipment such as a ping pong table and dartboards. Outdoors there is a volleyball and badminton net. Whenever an entrepreneur needs a break, he can use these facili-ties to unwind. Devon Laney, Chief Operating Officer at Innovation Depot, says these areas help foster interaction among different disciplines.

“We may have a biotech researcher or a medical device engi-neer who decided to leave the office and go play ping pong for 20 minutes just to get out of the office for 20 minutes, and when they go in there they may interact with someone who is totally outside their normal scope of business,” says Laney. This fosters the cre-ativity that companies crave. Laney says he’s seen companies col-laborate from these mini-breaks.

Managers should maintain flexibility and a sense of reality when dealing with entrepreneurs. “You have to challenge them, challenge their assumptions, challenge their projections, but aggressively be helpful and try to be as honest with them as you can about what you think the potential is for their business,” says Laney. He cautions that managers should not be overbearing. “You’re not going to get anywhere by forcing people to do things,” says Laney. “None of the companies here have to fill out forms or attend so many sessions per month or per quarter.” Laney only requires his companies to meet with him at least semi-annually and provide their financial statements and business plan.

These systems and styles may seem odd to some but com-pletely natural to others. The challenges faced by citizens, compa-nies and countries today require an interactive approach that rewards the creative process. A good business starts with a good idea. Businesses can thrive by giving entrepreneurs and scientists the space and the flexibility to interact, play and dream about the infinite possibilities their minds can create. BB p

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INNOvATION CITy: connecting to create

We know that companies with certain work environments and management styles have greater instances of inspiring creativity and producing good ideas. Coincidentally, great companies seem to emerge from certain cities and neighbourhoods (think Silicon Valley, Boston and Waterloo). While many factors contribute to a thriving city, great companies and great cities share an important trait: they are connected to each other and to the world.

In July, the MaRS Discovery District in Toronto hosted a two-day conference called Innovation City. Business and government leaders, as well as urban visionaries and thought leaders from Canada and abroad, gathered to discuss what makes a city innovative and how to make cities powerful catalysts for innovation, economic growth and sustainability. Topics included advanced infrastructure and transit systems, digital networks and technology, and the factors that promote an active start-up community.

Panelist Bill Hutchison, Chair i-CANADA and the Executive Director of the Centre for Smart Cities Innovation at Ernst &Young, received massive applause from the audience for his opening remark. He opted to tell the truth: Canada’s behind in terms of innovation. Even Romania is ahead of us. “It’s an entirely different world. We’re way behind,” he said in respect to communications and telecommunications technology. Hutchison put it this way: great cities run on paved roads and Canada still operates on a gravel road.


Into THE

Unknow

nAled Edwards and SGC take biotech into new areas of discovery

By Robert Price


Bio Profile

On paper, the Pf-ClpP molecule could pass for a Christmas ornament, a seven-pointed star with curling foil of red, gold, green and blue. It looks festive, ready to

hang on a tree. The image of the molecule comes from the Structural

Genomics Consortium, a non-profit organization that conducts research into structural and chemical biology and publishes pre-competitive research and structural images of proteins. With offices in Toronto and Oxford, more than 200 researchers at SGC uncover, expose, catalogue and publish molecules encoded by the human genome. It is frontier research, the kind of foundational work that might lead to new drugs and new thera-pies. And it’s a huge job, a job few other people are doing, mostly because nobody knows what kind of business opportunities exist on the frontier. And because the profitability of the unknown is unknown, not many investors fund the study of uncharted proteins.

As Aled Edwards, Director of SGC explains, the system for drug discovery is broken. It creates sameness in research, and the drying of the drug discovery pipeline is a direct result of a system that makes novel ideas and solutions difficult to fund and difficult to invent.

“The funding systems for academic research and for business research constrain people to work on proteins that are worked on by everybody. I can’t think of a nicer way to say that,” says Edwards.

Systemic inhibitionWhat happens when you do the same thing over and over again? You get good at it. Practice the Jitterbug Stroll all day and night and even if you have no soul, even if you can’t dance to save a marriage, you know the steps. But cover the same terrain over and over and something else happens: it gets old and nothing new comes out of it.

According to Edwards’ take on drug discovery, nobody should be surprised with the shortage of new drug discoveries. Researchers tend to focus their research on drug targets that have been thor-oughly researched. In effect, they have been dancing the same dance with the same partners for years.

More recently, drug development has courted a new dance partner—big data—with the hopes that this new avenue of research uncovers some as-yet unknown link between human genetics and diseases.

It’s not a bad idea. In fact, the sequencing of diseases and the collection of data sets can only benefit researchers on some level.

But the fact that researchers have known the genetic causes of many diseases for decades and they still can’t translate that knowl-edge into cures is what Edwards calls, “a more sobering view.” Datamining will flood researchers with new genetic links to dis-eases (a “super exciting” development), but the flood may only result in a trickle of translation into cures.

“There is a lot of data out there, from clinical trials to patient records, and there is no doubt that having access to that data can’t hurt. But at the end of the day, we still don’t understand human biology,” says Edwards.

How much of human biology is still open for discovery? How little do we know about how our bodies work? Edwards says we can’t know what we don’t know, but a steady record of failure in the clinic provides a clear picture of our ignorance.

“Functionally, the best evidence we have that we don’t know much is that when we develop medicines and go into human tri-als, often the whole project fails. And the project fails because of some unexpected biology.” It’s hard to quantify how little researchers know, but, says Edwards, “I can say that if nine out of 10 new ideas fail in the clinic, that’s a good proxy for telling us how little we know. When we try to do the experiment in people,

a scientist at the Structural Genomics Consortium.


hell, it doesn’t work.” Finding success in clinical trials means diving into the

unknown—because chances are slim that studying what we’ve studied will produce new results.

“More data about what we do know is obviously going to be valuable, but how is it going to help us study the 90 per cent of things that we don’t know? That’s one of the hypnotizing things about having more data. It looks fantastic. It sounds fantastic. But remember, we’re piling lots of data into the small part of the world we know about. What’s the value of all that data about a small section of the genome versus some relatively less depth of data about more proteins?”

The unknownDawn Richards laughs when she hears Aled Edwards’ name. She used to work for him, says he’s a friend, calls him “eclectic,” and on the subject of pharma’s dry pipe-line, says Edwards is one of the people who might find an answer for how to get more drugs into development.

“Al is a trailblazer,” says Richards, a business development officer at the Ontario Institute for Cancer Research. “He’s eclec-tic. He’s not afraid to speak his mind. He’s not afraid to go out on a limb that’s different from other people.”

Edwards, currently the Banbury Professor of Medical Research at the university of Toronto, has led the field of structural genom-ics since 1997 when he helped pilot a program in structural biol-ogy. He co-founded Affinium Pharmaceuticals and has since written about the need for collaborative approaches to scientific problem solving.

It’s Edwards’ advocacy of openness, a principle that underlies the SGC, that make him different from other leaders in genomics, Richards says. Funded by public and private sources, SGC gener-ates data on proteins that have largely been ignored. And there are thousands of proteins to which science is ignorant: more than 20,000 different proteins inhabit the human body, but so far, researchers only know the shapes of about 10 per cent of these proteins. That means for 90 per cent of proteins in the body, sci-ence has no idea how they look—we don’t know if they look like Christmas ornaments or chewing gum. Nor do scientists know how these proteins function or how to target them.

“I go to these meetings all of the time and people are saying that the drug discovery pipeline is broken or pharma is broken and we need to come up with new models to populate the pipe-line,” says Richards. “Al Edwards [has one of these models]—this public database.”

Inherent inertia Ask an English PhD why she’s writing a dissertation on Shakespeare, when a billion words (at least) have already been written on the Bard, and she’ll probably say, with some defensive-ness, that Shakespeare is “inexhaustible.” No doubt. But reading a billion words about Shakespeare has to be exhausting, for any

reader. It’s more likely that proposing to study Shakespeare earned the student a ticket into higher studies, because few English departments accept applications from PhD hopefuls wishing to make a study of Detective Comics.

We can ask the same questions to biologists. “Why are you studying that protein? Major work was done on that protein 20 years ago. What’s going on?” You might get the same answer the English scholar supplied—“it’s inexhaustible”—and that might be a fair answer. Ask Edwards and he offers other answers: funding and an inherent inertia.

On the subject of funding, Edwards says the system as its cur-rently designed doesn’t promote risky research, particularly research into the unknown. “The funding systems that we have put in place really inhibit innovation. As a result, it’s very difficult to get research funds to work on proteins in the unknown.”

That’s partly a problem with the bureaucracy of the system. Researchers know that when they apply for grants, they need an answer for when they’re asked what they expect to find. “I haven’t the faintest” doesn’t earn the trust of reviewers.

And then there is inherent inertia within the research estab-lishment: it appears unwilling to change to keep up with industry.

“I don’t think the genomics revolution has impacted biomedi-cal research as much as it should,” says Edwards. “There is a large inertia in the biomedical research systems that hasn’t yet come to grips that there are way more proteins and genes than we study. They’ve not developed real mechanisms to work hard into the unknown.”

One way out of establishment thinking is to train students differently. Those entering the system need to see the purpose of their field differently. According to Edwards, this means bringing more industry-minded research into life science curricula.

“If we’re going to have a more productive and innovative soci-ety in Canada, more students should be trained in industry-related projects. Engineers and chemists do it. There are definite advantages to working on real-world problems,” says Edwards. And there’s an advantage of bringing industry closer to biomedi-

the Structural Genomics Consortium has made public the details of more than 1,200 proteins.


Bio Profile

cal research: industry has a way of identifying practical problems to solve that academia doesn’t. “I think that the mistake that we make as academics is that [we are not innovative] in solving prac-tical problems.”

SGC, funded by several large pharma companies and public institutions, offers proof of what can happen when private enter-prises work with curiosity-driven academics. In the nine years SGC has operated, it has published the structures of more than 1,200 proteins—exactly the kind of information companies and academic researchers need, but might not study on their own.

“Companies in my organization have been part of the reason why we’ve been able to go into the unknown generating chemical tools. Business wants innovation. Academia has freedom to do it, but I think business can help drive us or work with us to move into new areas, more easily than academics could alone or business could do alone.”

An urgent needChange in how we fund and operate life sciences is long overdue. Rubbing our chins, conferencing, postulating about what a better system might look can’t take forever. The situation we’re in, Edwards says, requires urgent action.

“Our healthcare systems are being squeezed. We have an aging population. The demographics are frightening. We’re going to have to care for older people with a tax base that is shrinking. And

we’re not that productive a society. And in terms of industry, since 2000, the pharmaceutical industries have fired 300,000 people,” says Edwards. “We need to transform the industry rather than tweak it. Part of the transformation is finding new models to work at collectively to solve these very, very complicated problems.”

Edwards says he pushes his model of open science and ven-tures into the unknown because he wants to find a solution, not because he’s merely curious. When he speaks about what he does, he speaks with passion.

“This is a really important problem. Why can’t we work on the unknown proteins, why can’t we invent new medicines and how the hell are we going to find cures for diseases like Alzheimer’s? I’m not convinced that working in the area over and over and over again will provide the solution. We need to find a way to do a hell of a lot more research for the same dollar.” BB

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Business Leadership

how does a scientist go from the lab to the boardroom? In Dr. Robert Gundel’s case, it was by chance. In school, he gravitated toward science and completed a

masters and PhD in physiology. While in graduate school, he had a friend who was working at a pharmaceutical company. The company had an opening. Gundel applied. He landed the position and discovered his love for business.

“That was a great experience. I got to see how a pharmaceu-tical company works and how the whole process is from early discovery from actually having a drug on the market,” says Gundel. Although at the end of the day a business wants to make money, he says a company profits by pro-viding treatments that save lives and improve the quality of life for patients. “I really like that concept, and it’s been something that has been important to me for my entire career.”

Heading northGundel, an American based in San Francisco, joined Amorfix Life Sciences in January 2010 as the Vice President of Research and Development. At the time he joined, Amorfix wanted to shift its focus from diagnostics to therapeutics and felt he was the right person to help them make that transition. A few months later he was appointed CEO.

One of the challenges is, of course, finances. “We’re public, but we’re not late-stage, so we’re in an area where getting good funding is difficult until some of our programs mature a little bit more,” says Gundel. What’s the trick to maximizing your mile-age when you’re driving on empty? “You’ve really got to maxi-mize and be efficient on everything that you do, make good decisions about where you’re going to spend money and where you’re not going to spend money, and then keep the focus of the

organization towards achieving that goal,” says Gundel.

Addressing Alzheimer’s with A4In June 2012, Amorfix licensed its Amorfix Aggregated Abeta Assay (A4) to JSW Lifesciences, a full service contract research organization. “The utility of this assay is to facilitate and speed up preclinical research for new drugs for Alzheimer’s disease,” says Gundel. “This assay works is a biochemical assay that mea-sures something called aggregated Abeta, and aggregated Abeta

is a hallmark of Alzheimer’s disease,” says Gundel. “It’s the building block of the plaques that are formed in the brains of Alzheimer’s patients.”

So what’s preventing a cure for this dis-ease that’s expected to affect millions more by 2050? “It’s not just one simple thing that presents a problem. It’s everything—it’s the science and perhaps we don’t know as much as we need to know to come up with good drugs. For instance, President Obama just designated many millions of dollars to facilitate research in Alzheimer’s disease,

but it’s going to take billions not millions. This is a tough nut to crack. It’s going to take a lot of funding and a lot of people work-ing toward the common goal of trying to figure it out.”

Besides finances, another issue that makes it difficult to develop new therapeutics for Alzheimer’s disease is lack of a good diagnostic. “Believe it or not, today, the only definitive diagnostic for Alzheimer’s disease is a post mortem analysis of the brain.”

Gundel says the real utility of the test right now is facilitating better clinical trials for Alzheimer’s disease. Right now, there’s up to a 30 per cent misdiagnosis. “In other words, three in 10 that you enroll into your study might not have Alzheimer’s disease at all,” says Gundel. “We need to do that better, so our test will improve that dramatically.” BB

By Julia Teeluck

Business success achieved by maximizing resources and focusing on the goal, says CEO of Amorfix Life Sciences

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