Bio Business January/February 2017

regional profile Exploring BC’s $14B life

sciences sector 13

ManagEment

Running online customer advisory boards 17

Feature

New developments in suicide gene therapy 21

january/february 2017

Championing the Business of Biotechnology in Canada

Hiring Fair Only 7% of Canadian biotechs employ persons with disabilities

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inside

feature

Squandering Talent

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The Opportunities Fund, which provides subsidies for Canadians with disabilities working in biotech, is not being utilized in an industry that is an avid consumer of wage subsidy programs. Why?

British Columbia

SUICIDe gENES

Suicide genes have long been used in the cell-based therapy realm, but now they are poised for huge growth as they enter the cancer and immunotherapy realm.

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Championing the Business of Biotechnology in Canada

Like all of Canada, B.C. biotechs struggles with capital investment but that doesn’t stop the growth of the sector.

17 Running Successful Online Customer Advisory Boards 5 tips for retrieving key insights and information.

standard regional profile

Exploring BC’s $14B life sciences sector 13

ManagMent

Running online customer advisory boards 17

feature

New developments in suicide gene therapy 21

One-StOp RepaiRS

jaNuaRy/fEBRuaRy 2017

DaviD Suzuki Learning from nature

Championing the Business of Biotechnology in Canada

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The DefiniTive Source for Lab ProDucTS, newS anD DeveLoPmenTS

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January/February 2017

Medical device manufacturers save time and money

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Mastering

Mentorship Sanofi Biogenius Canada finalist gains research experience at a Toronto lab while her mentors gain much more

Editor’s note 5 canadian news 6 worldwide news 7 moments in time 23

Hiring Fair Only 7% of Canadian biotechs employ persons with disabilities

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Meet an amazing 17-year-old.

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2017

CANADA’S NATIONAL BIOTECHNOLOGY AWARD PROGRAM – GOLD LEAF AWARDS

PROGRAMME NATIONAL DE PRIX DE BIOTECHNOLOGIE DU CANADA – LES FEUILLES D’OR

BIOTECanada’s Gold Leaf Awards program is an opportunity to recognize both companies and individuals who have contributed to the biotech industry.

Le programme des Feuilles d’or de BIOTECanada vous permet de rendre hommage aux entreprises et aux personnes qui ont accompli des réalisations importantes au sein de notre industrie.

AWARD CATEGORIES

CATEGORIES DE PRIX

NEW FOR 2017 – ECOSYSTEM BUILDER

NOUVEAU POUR 2017 – BÂTISSEUR DE L’ÉCOSYSTÈME

An ecosystem builder will be an organization or company who has distinguished itself through its contributions to Canadian communities beyond their respective business and economic impact. The respective nominee demonstrates leadership, showing significant contributions to the Canadian biotech ecosystem through their engagement and responsibility.

Une organisation ou société s’étant distinguée par ses apports aux collectivités canadiennes, au-delà de son impact commercial et économique naturel. Le candidat doit avoir fait preuve de leadership dans des initiatives locales, régionales ou nationales et avoir contribué de façon considérable, par ses activités et les responsabilités qu’il assume, à l’écosystème canadien des biotechnologies.

NEW FOR 2017 – INDUSTRY CATALYST An individual or group of individuals have challenged the status quo, broken down barriers, and re-written the rules for their biotech business.

Their dedication and everyday actions are leading the biotech revolution.

Respected by people inside and outside their organizations, these individuals are viewed as true innovators.

EMERGING COMPANY

NOUVEAU POUR 2017 – CATALYSEUR ÉCONOMIQUE Ce visionnaire a remis en cause le statu quo, éliminé des barrières et remanié les règles de son secteur d’affaires en biotechnologie. Son dévouement et ses actions de tous les jours font avancer la révolution des biotechs. Cette personne, respectée par les membres de son organisation comme par les intervenants externes, est vue comme réellement innovatrice.

ENTREPRISE EN DÉMARRAGE

(1 Health, 1 Agriculture/ Industrial)

(1 en santé et 1 dans le secteur agricole et industriel)

INNOVATION IN BIOTECH RESEARCH

INNOVATION DE LA RECHERCHE EN BIOTECHNOLOGIE

COMPANY OF THE YEAR

ENTREPRISE BIOTECHNOLOGIQUE DE L’ANNÉE

“We’re fiercely proud to be a Canadian company and we’re humbled to be recognized by BIOTECanada and our peers.

We’re looking forward to continuing the important work that has taken us to this point to make a difference for patients, for our team, and for the Canadian biotechnology industry. “ –Dr. Ali Tehrani, President and CEO of Zymeworks.

Winner Gold Leaf Award Company of the Year 2016

“Nous sommes farouchement fiers d’être une entreprise canadienne et nous sommes humbles d’être reconnus par BIOTECanada et nos pairs. Nous sommes impatients de poursuivre l’important travail qui nous a permis de faire une différence pour les patients, pour notre équipe et pour l’industrie canadienne de la biotechnologie.”

–Dr. Ali Tehrani, président et chef de la direction de Zymeworks.

Lauréat Les Feuilles d’Or, Entreprise Biotechnologie de l’année 2016

Nominations now being accepted | Candidatures maintenant acceptées Deadline for nominations is April 30, 2017

| La date limite pour la présentation des candidatures est le 30 avril 2017

goldleafawards.com

OPinion

Publisher & CEO Christopher J. Forbes cforbes@jesmar.com

Inadequate IP rights protections hurt patients, economy

By Kristina Lybecker

A

Bio Business is a proud member of BioteCanada and Life Sciences Ontario

s the old adage states, “You’ll be known by the company you keep.” As such, the implications for Canada’s biopharmaceutical sector are rather dismal.

While an extensive body of evidence demonstrates that patents and other intellectual property protections are critical to the future of innovation and the development of new treatments and cures, Canadian legislation fails to measure up.

For Canada, the legal architecture surrounding intellectual property rights (IPR) protection and the national regulatory regime helps shape the biopharmaceutical industry, its profitability, productivity and innovative future. And for Canadian patients, it affects the availability of medicines in Canada and access to future breakthrough innovations.

A recent study by the Fraser Institute describes existing IP policy in Canada, compares it to global norms and regimes, evaluates the strengths and weaknesses of the Canadian system, and recommends improvements and reform.

Overall, there are numerous deficiencies that weaken intellectual property protections within Canada relative to other industrialized countries. While Canada may aspire to join the ranks of industrial leaders, shortfalls in Canadian legislation prevent that from happening. Those shortfalls include: Onerous patentability requirements, specifically the patent utility doctrine, which creates significant uncertainty for innovative industries by requiring innovators to see into the future to “soundly predict” the usefulness of the innovation and demonstrate that the innovation will fulfill this promise.

Insufficient enforcement mechanisms, which make it difficult for biopharmaceutical companies to effectively appeal court decisions where a patent is ruled invalid.

And inadequate anti-counterfeiting measures, which increase risks of adulteration, counterfeiting and cargo theft.

Consequently, Canada sits in the middle of the pack in the global IP Index rankings.

These rankings matter to prospective investors and strongly signal Canada’s lack of support for knowledge-based industries. Fundamentally, Canada is a global outlier, providing inadequate intellectual property protection for the biopharmaceutical industry. The result has been a striking decrease in pharmaceutical research and development and a drastic drop in pharmaceutical innovation and patenting.

The Fraser Institute study proposes several recommendations for Canadian IP legislation. Specifically, Canada should provide innovative biopharmaceutical firms with patent term extensions in order to recover time lost due to mandatory governmental regulatory and marketing approvals.

In addition, Canada should remedy issues of weak enforcement by providing patent owners with an effective patent linkage right of appeal, to provide biopharmaceutical companies the ability to appeal court decisions where a patent is ruled invalid. Changes should be made to Canada’s IP laws to restore certainty to Canada’s distorted patent system and clarify the expectations of the patent utility doctrine. Canada should also extend data protection regulations and increase the scope of products that may be classified as “innovative drugs.”

Finally, Canadian policymakers should enact legislation to define rare diseases and encourage Canadian firms to intensify their research and development of new therapies.

These changes would help bring the Canadian regime in line with international standards, signal a commitment to knowledge-based industries, and foster a robust biopharmaceutical sector.

Publisher of Lab Business Magazine Bio Business Magazine

Kristina Lybecker is an associate professor of economics at Colorado College and a senior fellow at the Fraser Institute. See her latest study on intellectual property rights protection at www.fraserinstitute.org. ©2017 Distributed by Troy Media

Executive Editor Theresa Rogers trogers@jesmar.com staff writer Hermione Wilson hwilson@jesmar.com editorial intern

Michelle Chiu

CONTRIBUTORS BioTalent Canada

Kristina Lybecker Natalie Yeadon art director Katrina Teimo kteimo@dvtail.com Secretary/Treasurer Susan A. Browne marketing Stephanie Wilson manager swilson@jesmar.com vp of production Roberta Dick robertad@jesmar.com production Crystal Himes MANAGER chimes@jesmar.com

Bio Business is published 6 times per year by Jesmar Communications Inc., 30 East Beaver Creek Rd., Suite 202, Richmond Hill, Ontario L4B 1J2. 905.886.5040 Fax: 905.886.6615 www.biobusinessmag.com One year subscription: Canada $35.00, US $35.00 and foreign $95.

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Championing the Business of Biotechnology in Canada

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canadian news

Safety Concerns Over Fluoroquinolone Antibiotics

Health Canada’s recent safety review of oral and injectable fluoroquinolones, a class of antibiotics, found that the drug could have serious long-term side effects. This includes muscular issues such as tendonitis and Achilles tendon rupture, nerve damage such as peripheral neuropathy, and central nervous system issues such as anxiety, dizziness and confusion.

Fluoroquinolone antibiotics are used to treat several types of infections, including respiratory and urinary tract infections. As a result of its safety review, Health Canada is working with manufacturers to include information concerning this rare but serious risk in the product labelling of these drugs.

Study Suggests Strengthening Canadian IP Protection

LSO Breakfast Forum Discusses Medical Marijuana

Life Sciences Ontario recently held a Knowledge and Networking Breakfast Forum in Toronto. More than 100 members of the life sciences industry were in attendance at the event, which featured presentations on medicinal marijuana by Ken Clement, CEO of ABcann Medicinals Inc.; Christelle Gedeon, Associate at Fasken Martineau DuMoulin; and Nick Antoniadis, Principal at Nick Antoniadis Consulting. The speakers covered topics on everything from whether the medical benefits are quantifiable, organic versus synthetic products, legalization and dosing.

Dr. Kristina Lybecker, author of the Fraser Institute study, Intellectual Property Rights Protection and the Biopharmaceutical Industry: How Canada Measures Up.

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Anxiety, Depression Could Worsen Chances of Surviving Lung Cancer

A new study has shown that patients who experience anxiety and depression after being diagnosed with advanced lung cancer are more likely to die sooner.

The study, conducted by researchers at the University of British Columbia and the BC Cancer Agency, followed 684 recently diagnosed patients undergoing treatment at the BC Cancer Agency in Vancouver and Surrey, B.C. Although the research shows a link between anxiety and depression and lung cancer survival rates, the findings cannot assess whether high anxiety or depression directly caused these worse outcomes. The researchers are now looking at the long-term effect of psychosocial factors on survival rates for patients with prostate cancer.

A new study suggests that Canada could give its biopharmaceutical sector a much needed boost by strengthening protections of intellectual property rights for pharmaceutical drugs. The study, released by the non-partisan Canadian public policy think-tank Fraser Institute, found that Canada’s once-bustling biopharmaceutical sector has seen total research and development (R&D) investments fall below $1 billion since 2011. In fact, pharmaceutical R&D spending has declined by 20 per cent from 2001 to 2015.

While patent applications have been increasing around the world, they declined in Canada by 8.6 per cent between 2006 and 2012. Canada is now in the bottom five among G20 countries for biopharmaceutical patents filed by its own citizens. The reason for this, suggests the study, is that Canadian law does not provide a crucial patent restoration term to innovators to compensate for patent life lost due to regulatory requirements and administrative delay. Such patent restoration terms are offered in the U.S. and Europe, which provide a term of up to five years beyond a patent’s 20-year life.

Additionally, the data generated through clinical trials for new medicines – which can consume up to 60 per cent of the cost to develop a drug – is only protected for a maximum of 8.5 years in Canada, as opposed to 12 years in the U.S. and 11 years in the E.U. “Canada is a laggard when it comes to protecting pharmaceutical patents, which puts a chill on innovation and creates uncertainty as to whether the risky and costly investments to develop new medicines will be recovered,” says Kristina Lybecker, Fraser Institute senior fellow and author of the study. “Canada’s intellectual property rights regime should be strengthened to not only spur innovation, but bolster the economy as well.”

worldwide news

Merck Opens Fertility Treatment Training Centre

Bill Gates Launches End Malaria Council

Bill Gates, of the Bill & Melinda Gates Foundation, and Ray Chambers, the United Nations Secretary-General’s Special Envoy for Health in Agenda 2030 and for Malaria, recently announced the launch of the End Malaria Council. The council is comprised of influential public and private sector leaders who aim to ensure that malaria eradication remains a top global priority. The launch of the End Malaria Council comes just a month after the release of the World Health Organization’s 2016 World Malaria Report, which showed remarkable progress in reducing cases and deaths from malaria since 2000, but also underscored the urgent need for global leadership, new funding and innovation to stay on track to meet targets. “For the first time in history, we have a roadmap to a world without malaria,” Gates says. “With renewed focus, innovation and new commitments of leadership and funding, we can be the generation to end malaria once and for all.”

Microbiome Modulators Could Modify Human Microbiome for Improved Health

Merck has announced the opening of its first Centre of Excellence (CoE) for fertility in Bangkok, Thailand. In collaboration with Genea, a developer of innovative fertility technologies, Merck plans to offer fertility professionals an opportunity to learn concepts, processes and techniques that are undertaken in high quality clinics in order to address the unmet needs in assisted reproductive treatment (ART).

The CoE is a state-of-the-art facility that offers practical hands-on training through a training lab and the adjacent Genea clinic. The centre’s location in the Asia-Pacific (APAC) region was strategically aimed to attract participants from all over the world with a focus on APAC and China. The CoE aims to help optimize procedures to improve treatment outcomes for couples that want to conceive.

The centre is collaboration between Merck and Genea, also supported by the partners of the Global Fertility Alliance (GFA), which was founded in 2015.

The GFA is driving standardization in ART clinics for improved treatment outcomes. Therefore, the CoE also represents the The CoE is a state-of-the-art facility innovative technologies that offers practical hands-on training from the GFA partners through a training lab and the adjacent including Illumina, a leader in developing and Genea clinic. The centre’s location commercializing systems in the Asia-Pacific (APAC) region for analysis of genetic was strategically aimed to attract variation and function, participants from all over the world with ZEISS, an internationally a focus on APAC and China. leading technology enterprise operating in the optics as well as optoelectronics industries and the associated partner Chart MVE BioMedical, the world’s leading manufacturer of cryogenic freezer systems, as well as the latest technology in laser systems from Hamilton Thorne, Inc.

New Division Launched at American Laboratory Trading

American Laboratory Trading Inc. (ALT), the largest provider of premium refurbished lab equipment and asset management services in North America, has launched a new division designed to help life science companies monetize surplus assets and maximize their ROI. ALT’s Asset Management Solutions will streamline the company’s existing services, introduce new offerings, and extend ALT’s geographic reach. Services offered will include surplus asset disposition through outright purchase, consignment, or auction; turnkey move management including instrument decontamination, decommissioning, packing and shipping, and waste management; deinstallation, benchmark testing, and reinstallation of instruments; and asset management software for tracking inventory, service contracts and maintenance history.

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The Centre of Excellence in fertility officially opened with a ceremony in Bangkok on Jan. 16, 2017.

New research from OptiBiotix Health demonstrates that the company’s microbiome modulators have successfully increased the growth and biological effect of multiple species of microbe in human gut models, including their own cholesterol-reducing probiotic, LP-LDL. By using the microbiome modulator, LPGOS, to increase the growth of LP-LDL researchers reduced cholesterol as much as 27 per cent. This new research shows the potential for the development of species or genera-specific probiotics to selectively enhance the growth and health benefits of existing probiotics. In addition, there is the potential for microbiome modulators, which selectively modify an individual’s microbiome to improve health, to be added to a range of food products.

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Squandering talent Canada’s biotech sector missing out on opportunity to hire persons with disabilities

By BioTalent Canada

or an industry struggling with a shortage of skilled workers and insufficient capital to fill these shortages, wage subsidies seemed like the solution to kill two birds with one stone. For years, BioTalent Canada has worked with Canada’s federal government to provide wage subsidy funding to the biotechnology industry. However, the organization’s most recent wage subsidy project, The Opportunities Fund, which provides subsidies for Canadians with disabilities working in the bio-economy, is somehow failing to gain a foothold in an industry that is an avid consumer of wage subsidy programs.

Since 2005, for example, BioTalent Canada’s Career Focus Program has been offering wage subsidies as an incentive for biotech employers to hire new graduates.

This program has been wildly successful, injecting more than $2.5 million in the sector and placing 220 new graduates into jobs this past year alone. Historically, demand for wage subsidies in the biotechnology sector has exceeded the funding available, forcing BioTalent Canada to turn down applications.

Wage subsidy programs have proven to be critical, not just for the growth and development of Canada’s bioeconomy, but for employment of underutilized talent pools as well.

Wage subsidies for new graduates motivated employers to consider a talent pool which they might not have considered before. Seeing the impact on both industry and the underutilized talent pool of new graduates, in 2015 BioTalent Canada was ready to replicate this success with other underutilized talent pools.

Wage subsidy programs have proven to be critical, not just for the growth and development of Canada’s bio-economy, but for employment of underutilized talent pools as well.

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As a national non-profit organization, BioTalent Canada has a mandate to ensure that Canada’s bio92.5% Women economy has access to the skilled people it needs. The 81.0% organization welcomes funding initiatives to hire skilled talent, but also incentives for the biotech industry to 58.8% Internationally Educated look at strategically advantageous talent pools that 52.1% Professionals (IEPs) are currently underutilized such as new graduates, internationally educated professionals, persons with 49.4% Part-time disabilities, and women.

Workers n/a When the federal government introduced a new wage subsidy program at the end of 2015, BioTalent U.S.-Trained 45.9% Canada welcomed the opportunity to provide more Professionals 38.6% much-needed funding to Canada’s bio economy. The Opportunities Fund was to supply $1 million in wage People with subsidies as an incentive for biotech companies to hire 21.9% Disabilities 7.6% 90 persons with disabilities over a three-year span.

2008 With a little over a year into the Opportunities Fund Program, and only six persons with disabilities placed, 2013 20.9% Aboriginal BioTalent Canada is questioning the sector for its Peoples 7.7% reluctance to hire persons with disabilities. Anecdotally, BioTalent Canada was grappling with biotechnology 02 04 06 08 0 100 employers stating a preference to “wait for other wage subsidies to become available,” rather than utilizing the Percentage of Companies that Employ: (%) Opportunities Fund.

2008 and 2013 Rob Henderson, President and CEO of BioTalent Canada, has been vocal about hiring practices within BioTalent Canada, 2013 Canada’s biotechnology sector, particularly in the life sciences. “For an industry whose mission is to develop molecules and technology to improve the lives of persons with disabilities, it is ironic to see its unwillingness to hire the same individuals its science aims to benefit.”

The hiring statistics paint a disturbing picture. In BioTalent Canada’s 2013 labour market report Sequencing the Data, only 7.6% of biotech companies reported having persons with disabilities on staff, down 14.3% from 2008, when 21.9% of companies had persons with disabilities on staff.

Further research in BioTalent Canada’s Sequencing the Data, also shows companies with a diverse workforce reporting improvements in innovation, problem-solving and productivity. So, striving toward a diverse workforce is just good business practice.

BioTalent Canada wants the industry to keep its focus on attracting the best talent and recognizes innovation is the bread and butter of the biotechnology sector. “It is imperative to tap into strategic talent pools like persons with disabilities to remain competitive. The standpoint that hiring persons with disabilities is a charitable undertaking with potential detrimental consequences for the business could not be further away from the truth,” says Henderson.

Lisa Fraser, Founder and CIO of Wearable Therapeutics, agrees. Wearable Therapeutics, based in Vancouver, is the developer of Snug Vest, an inflatable vest that provides anxiety relief and sensory integration through a clinical method called deep

pressure therapy. The company is one of the employers utilizing the Opportunities Fund wage subsidy. “Hiring a diverse workforce strengthens our team and strengthens our products and services, so we can better serve and understand our diverse customer populations,” says Fraser. “We hire the right person for the job always, regardless of any mental, physical, sexual, and social differences.”

If recruiting within the same talent pool is not turning up the skilled and experienced workers Canada’s bio-economy needs, BioTalent Canada advocates it is time to look at underutilized talent pools. As a sector with challenges accessing capital and dependence on highly skilled talent to thrive, the biotechnology industry can ill afford to turn down capital and skilled talent.

The industry must focus on hiring For an industry whose mission is to develop molecules the best talent. and technology to improve the lives of persons with To reach organizations disabilities, it is ironic to see its unwillingness to hire the that understand the impact of same individuals its science aims to benefit. a diverse workforce on their bottom line and are already – Rob Henderson, President and CEO of BioTalent Canada hiring persons with disabilities, BioTalent Canada actively works with companies that are providing accommodation technology for persons with disabilities. The first partnership of its kind is with eSight, a Toronto-based company developing electronic glasses that let the legally blind see. Through this partnership, BioTalent Canada is expanding its reach to organizations that are already in the mindset of a diverse workforce and hiring persons with disabilities.

For eSight, joining BioTalent Canada as a project partner for the Opportunities Fund was a natural fit. “At eSight, we have a simple but profoundly fundamental belief: that everyone deserves to see,” says Brian Mech, President and CEO of eSight. “This mission extends to the workplace. We are proud to supply the technology that helps legally blind individuals build and grow a career which they are passionate about.”

BioTalent Canada is working to extend wage subsidies to more companies hiring persons with disabilities. Beyond opening the door to employment opportunities for persons with disabilities within biotechnology, it is about levering existing skills to grow Canada’s bio economy.

To continue driving innovation, it is the sector’s duty to seek the best and the brightest to work in Canada’s bio economy. “Albert Einstein and Sir Isaac Newton are just two of history’s geniuses who worked in science while managing a disability,” says Henderson. “In this day and age, a disability should not limit any talented Canadian from working in their field of expertise, especially where their work could benefit all Canadians.” BB

More information about the Opportunities Fund is available at biotalent.ca/wage-subsidies.

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British Columbia By hermione wilson

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regional profile

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regional profile

All Photos: City of Vancouver

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B.C. Facts & Figures T he life sciences sector in British Columbia employs almost 180,000 people and contributes $14.4 billion to the province’s GDP. L ifeSciences BC has a membership of more than 200 organizations and individuals with focuses on research, testing, and medical laboratories; drugs and pharmaceuticals; and medical devices and equipment.

T he total number of B.C. life sciences establishments comprises 17 per cent of the total number of life sciences establishments across Canada.

The largest standalone enrolment group at B.C.’s academic institutions are in the life sciences.

LifeSciences BC Sector Report, October 2015

T

he British Columbia life sciences sector, concentrated largely in Vancouver, is pretty typical of other major Canadian centres: it has no shortage of research institutions to draw innovation from, which gives rise to a lot of successful small and medium-sized biotech companies funded by venture capital from beyond our borders. Like the rest of the Canadian life sciences industry however, B.C. struggles to move past that stage.

“B.C., in general, is good at creating companies and moving them along into that past prototype, past proof of concept level and then, typical of all of Canada, it gets tricky when you’re getting to the point of commercialization,” says Doug Janzen, Founder and Managing Director of Northview LifeSciences, a private equity group that has seeded a number of biotech companies in both B.C. and Ontario. “Canada is getting better at it, but traditionally most companies have either sold or licensed their companies to bigger players south of the border or overseas to do that.”

The kinds of life science companies you see in B.C. are a mix of therapeutic development companies and “service providers who have a business model of generating revenue and doing contract, and then evolving... to developing their own products,” Janzen says.

Before he started Northview in 2010, Janzen (who has a background in both science and investment banking) took over a Vancouver-based cardiovascular company in 2003, built it up from $50

million to $1 billion and then licensed the technology to Merck for $800 million in 2008.

At STEMCELL Technologies, another Vancouver-based company, Chief Commercial Officer Andrew Booth says that over 95 per cent of business comes from outside of Canada.

STEMCELL is the largest biotechnology company in Canada and a major player in the province’s life sciences scene.

“We’re a company that provides tools to life sciences researchers to enable regenerative medicine or prospective regenerative medicine therapies,” Booth explains. “We provide the picks and shovels of the stem cell and regenerative medicine gold rush.”

The company was spun out of the Terry Fox Laboratory (TFL) at Vancouver’s BC Cancer Agency 24 years ago by Allen Eaves, former director of TFL and a head of Clinical Hematology at the University of British Columbia.

STEMCELL continues to hire researchers from UBC, Simon Fraser University and the BC Cancer Agency, Booth says. “We’re riding the wave of all the research being put into regenerative medicine.”

Due to a high concentration of academic institutions and research centres, B.C. has no shortage of innovative people to work with. The region has historically excelled and been a leader in fields such as virology, lipid drug delivery technology and antibodies.

A number of B.C. companies are in the antibody space, including STEMCELL.

Despite the region’s historical competency in life sciences, however, there are no GMP manufacturing facilities in Vancouver capable of producing clinical-grade antibodies.

“It’s really too bad that there isn’t, because at STEMCELL we could really use that facility right now, because for some products we have had to turn to contract manufacturers in the U.S.,” Booth says. “Although STEMCELL has the capability to manufacture products for research purposes, some clients are looking to get their own products to the clinic and are asking for all the inputs in the process to be manufactured under GMP.” Because of this, the company has to outsource approximately 20 per cent of production to third party manufacturers in the U.S. and expects that to grow in the coming years.

“It pains us because we would love to keep it here in B.C. and Canada,” Booth says. STEMCELL is currently trying to work out how it might be able to build the necessary infrastructure here and repatriate the manufacturing back to B.C., he says. The company would eventually like to build a GMP manufacturing facility in B.C. that would benefit both STEMCELL and the region’s biotech community at large.

Paul Terry is the President of PHEMI Systems, a company whose mandate is to facilitate access to data for those who work in life sciences, and improve patient outcomes and care. The company works with a diverse team of computer scientists, geneticists, mathematicians,

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regional profile

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regional profile

B.C., in general, is good at creating companies and moving them along into that past prototype, past proof of concept level and then, typical of all of Canada, it gets tricky when you’re getting to the point of commercialization.

– Doug Janzen, Founder and Managing Director, Northview LifeSciences

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physicists, and people with English degrees to sort through vast amounts of data that will be useful for researchers and clinicians alike. “PHEMI is to life sciences data what Google would be to web pages,” Terry says.

The data the PHEMI team combs through includes census information, discharge summaries, pharmacy records, electronic medical records, injection rates, and even Twitter feeds. PHEMI recently created a database of about a billion genomic key values and improved the search time for looking at drug interactions with genomic SNPs. The company is currently being sponsored

by Merck to look at diabetes data, a condition on which Terry estimates B.C. spends about $1.6 billion each year.

“Medicine and pharma want to be evidence-based,” Terry says. “They want to be able to look at the data and say, ‘yes, that drug worked,’ or ‘that drug didn’t’, and often that data is not available.

Terry has also sat on the board of LifeSciences BC, the industry association which supports and represents the province’s life sciences community, and notes the sector is a small, tight-knit group. “The degrees of contact are very strong,” he says. “Unlike other places in the world where you may know someone by reputation, here everybody knows everybody.”

It’s also a very supportive community, Terry says, especially of research and early-stage development. For example, the B.C. government has funded the Michael Smith Foundation for Health Research for the past 12 years, which has in turn funded a lot of health research at Genome BC. For an academic working in biotechnology at a place like UBC for example, “For every dollar of investor money, you can get three to four dollars of grant and in-kind funding,” Terry says.

There are also tax credits available to biotech start-ups, which Northview’s

Janzen praises. “Seed investors of these companies receive 30 per cent of their investment back in the current tax year, so if you put $500,000 into a biotech start-up January 1, you’re getting $100,000 back from the provincial government,” he says. “That’s one of the best tax plans in North America in terms of driving or creating innovative startup companies.”

B.C. is a very robust community, says Gordon McCauley, Interim President of the Centre for Drug Research and Discovery (CDRD). The industry generates around 14,000 jobs, about a billion dollars in GDP spending every year, and fairly significant support from local, national and overseas risk capital investors, he says. There are many advantages to operating in the province, not the least of which is the strong human infrastructure fed by teaching universities like UBC and SFU, McCauley adds.

Again, the problem is not at the early research and development stage, Terry says, but the translation of that innovation into commercial gains. “[B.C.] is strong, but slow in things like pharma and generating drugs and small molecules and so forth,” he says.

“Typically, companies that do that go for about 10 years. B.C. suffers, like most of Canada actually, from a lack of investment. The ability to raise venture capital in Canada is always a struggle compared to a U.S. company that can put $20, $30, $40 million down pretty quickly.”

“The appeal to sustainable risk capital, venture capital investment in particular, I think is important and that’s a space that has diminished a little bit over the course of the last eight or 10 years and is just starting to come back,” McCauley says. “That’s obviously the lifeblood of this industry so I think it’s important that we continue to attract them.” BB

ManagEment

5 Tips in Running Successful Online Customer Advisory Boards

By Natalie Yeadon

dvisory boards have become a staple in most pharmaceutical and biotech medical and marketing team’s brand strategies and is a key tactic for retrieving key insights and information.

If done well, teams can leverage their boards and the advice they receive to dramatically impact the decisions they make and the subsequent course that their brand will follow. When planning your next advisory board, here are some tips to consider:

1. Plan for an enduring board versus a single meeting

When most people think of an advisory board, it is often associated with a face to face consultancy meeting. Since they usually take place once a year, the agendas for these meetings are usually chock full of didactic presentations with little time left for real dialogue and discussion. In addition, issues don’t usually arise overnight nor are they solved overnight. More and more companies are moving in the direction of creating “enduring” or “authentic” advisory boards which they can tap into over the course of a six to 12-month period.

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Because face to face meetings can become expensive and also impractical to execute, these advisor “touchpoints” are often done online either as web meetings or asynchronous online assignments. Having an enduring board will allow a brand to quickly respond to marketplace changes as new data and competitor activity unfolds.

some still don’t!) and regularly read and respond to emails. Of course, a brand team should also consider other key elements when selecting who will participate including their level of expertise and influence, among other criteria.

2. Socialize the concept of “digital” with your team

When delving into the digital space for the first time, many brand teams’ first concern is that their advisors are “old school” and will prefer meeting in person and that they won’t use an online platform. The data, thankfully, disproves this concern. Eighty-six per cent of advisors who have participated in asynchronous online assignments through online advisory boards over the last six years have found this format to be more convenient than meeting face to face. In fact, Impetus has tracked that only 60 per cent of people invited to attend a live meeting actually attend while 85 to 90 per cent complete online asynchronous assignments. What’s the reason for this disparity? For live meetings, you are asking advisors to be available at the same place and at the same time which is not always possible due to schedule conflicts. Conversely, online asynchronous assignments are “live” on platforms for two to three weeks which advisors can access on any device and at any time that is convenient for them. This flexibility allows advisors to effectively participate and the ability to review and reply to their colleague’s responses asynchronously makes it a compelling and useful exercise.

It is both impractical and expensive to plan several face to face meetings over the course of a year. The only way to feasibly engage advisors in a consistent manner is to leverage an online platform. The system that you use should be intuitive and simple to use both for your internal team and your advisors. At the same time, it should be secure and have measures in place to ensure information safety. Reviewing the login procedure with your brand team and having them bookmark the site either on their iPad or computer will make it more habitual and easier to incorporate in busy routines. Advisor recruitment can also be greatly simplified by incorporating opt-ins and online versions of the company service agreement, however, this sometimes requires some internal discussion and education of the regulatory, legal and compliance divisions within organizations. Once compliance teams become familiar with the processes and appreciate the trackability of such systems and that it’s “work paid for work done” for advisors, they usually become diehard fans.

3. Choose advisors with “digital” in mind

I am often asked which demographics should be considered when selecting advisors to participate in an online advisory board. Over the past six years, Impetus has not found any specific trend as it relates to gender, age, geography or therapeutic specialty. What we have found, however, is that maximum advisory board engagement comes from advisors who have an email address (as

4. Trust that convenience is king and your advisors will participate

5. Be cognizant of your work obligations and plan accordingly

If you are a medical, marketing or market access professional, you are probably a pretty busy person who does not have a lot of time to waste. It is important when choosing the platform that you select for your online advisory board that it is not just software that you are buying. We

have often seen people getting trained on how to use these platforms and then life gets in the way, and these forums become digital ghost towns. We recommend you partner with a vendor who will not only provide the software but also help you to plan the number of advisor touchpoints you will have with your advisors, when these touchpoints will take place and what the content of these touchpoints will be. Finally, they can help to plan which modality will be best for each touchpoint, either as a live meeting, web meeting or an asynchronous online assignment. Most importantly, a good partner will help create the content for each touchpoint and, if an asynchronous online assignment, will completely project manage it for you. They should also be able to serve up your advisor responses in either a transcript report or a report with both advisor responses and analysis/ recommendations. It is important to consider, however easy it will be to forget you have an online board (out of sight, out of mind!) there is still work to be done on your part including preparing for content for each touchpoint and participating in planning discussions with the vendor.

The key is about trying something new—even if it is just a pilot. Concrete metrics such as costs savings (i.e. not having to pay face to face meeting costs), speed to accessing insights and the quantity and quality of insights shared can turn any naysayer around on the benefits of having an online advisory board. As Walt Disney once said, “The way to get started is to quit talking and begin doing.” BB Natalie Yeadon is Co-Owner/ Managing Director at Impetus, the Online Customer Advisory Board expert.

Impetus helps drive brand direction and strategies through the retrieval of timely insights with customer executives and key opinion leaders through a series of project managed online touchpoints.

She can be reached at nyeadon@ impetusdigital.com or (416) 992-8557.

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Genes

Suicide

feature story

S

uicide genes have long been used in the cell-based therapy realm as a kill switch, but now they are entering the cancer therapy and immunotherapy realm.

The idea behind suicide gene therapy is that when injecting cells into the body, you need a way to eliminate those cells once the therapy is complete or quickly kill them if something goes wrong. Through suicide genes, clinicians gain a measure of control over the cell therapy process.

Cells are modified to respond to certain drug before being transplanted. “The most typical approach involves the use of a pharmacological agent, a drug... that is normally not active, that would only be metabolised by those cells that expressed the suicide gene,” says Anton Neschadim, CEO of ImmunoBiochem Corporation in Toronto. “Basically, cells are rendered sensitive to a particular drug that otherwise does nothing.”

New Developments The traditional suicide gene approach is used with T-cells in a lot of hematopoietic transplantation procedures to combat Graft versus Host Disease (GvHD). With GvHD, the T-cells within the graft are activated against the patient’s body and start to attack the patient’s own cells. Suicide gene therapy can be used to combat this. The suicide gene HSVtk (herpes simplex virus thymidine kinase gene) is introduced in vitro in T-cells using a viral delivery method. The modified cells are then injected into the patient for treatment. If GvHD occurs then the T-cells can be eliminated by administering the drug Ganciclovir (an antiviral medication commonly used to treat cytomegalovirus eye infections) or one of its derivatives, which is then transformed into a toxic product by the HSVtk enzyme.

Neschadim has been involved in developing a number of human-derived suicide genes, which have the advantage of not being identified as foreign by the immune system. “Whereas the traditional... suicide gene systems are typically some sort of viral protein, what we are doing is taking human genes

and modifying them so they now have unique new productactivating abilities, new specificities, and putting them back in,” Neschadim says. “That way you have a minimally modified human enzyme that now becomes a suicide gene.”

These human-derived genes generate a more robust suicide gene system and more robust activation kinetics, he says. They could also be used for imaging purposes, allowing clinicians to mark gene-modified cells using the same process they used to deliver the suicide gene. “You’re not operating blind; you can actually visualize gene-modified cells using the same system,” Neschadim says.

Researchers have been working on the concept of suicide genes for decades, Neschadim says, but we’re only now starting to see clinical successes. One such success has come from Advantagene, a Boston-based company that is developing a number of treatments for cancers, the most prominent being a prostate cancer treatment called ProstAtak. It uses the traditional HSVtk-based suicide gene system, but instead of modifying cells to carry the HSVtk gene, it is delivered directly to the tumour, Neschadim says. What makes Advantagene’s approach unique is that it also acts as a vaccination of sorts.

“The damage induced as a result of the suicide gene therapy within the tumour is thought to have an immunotherapeutic effect,” Neschadim says. “It’s thought to stimulate the immune system to come in and respond to the tumour as well, so it’s a secondary after-effect.” Advantagene has rebranded the therapy and called it GMCI, or Gene Mediated Cytotoxic Immunotherapy.

“Immunotherapy is really hot right now,” Neschadim says.

“There is a crossover here from the traditional suicide gene therapy into the realm of immunotherapy.” ProstAtak is now in Phase III trials.

When injecting cells into the body, you need a way to eliminate those cells once the therapy is complete or quickly kill them if something goes wrong. Through suicide genes, clinicians gain a measure of control over the cell therapy process.

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Another application for suicide genes is to use them in concert with CAR (Chimeric Antigen Receptors) T-cell therapy, which involves retraining a patient’s own T-cells to target lymphomas and leukemia.

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There have been clinical trials in Europe and the U.S. that have looked at doing the same for incurable cancers like glioblastomas and pancreatic cancers, but none that have yet been successful, says Manuel Caruso, professor at the Centre de recherché en cancérologie at the University of Laval. “It’s difficult to target every single tumour cell,” he says. Even after the suicide gene has been introduced to the tumour, you also have to introduce the Ganciclovir, and there is no guarantee that the drug will be diffused throughout the tumour, since the tumour is not well irrigated with blood, and no guarantee that it will be in a high enough concentration to do any damage.

“That’s what limits the strategy,” Caruso says. “It’s difficult to target every single tumour cell.” Despite the difficulty of reaching the tumour with the viral delivery system, Caruso says preliminary clinical trials have found that these suicide gene therapies increase the patients’ chances of survival.

There have even been some long-term survivors.

“Of course, so far, there is really no Phase III trial that has shown that you could increase the survival,” he cautions.

“Preliminary trials, that’s what they show... but this needs to be confirmed in a larger trial.”

Solid tumours aren’t the only thing researchers are using suicide gene systems for, however. In treating leukemia with a graft of T-cells, clinicians attempt to mitigate the deadly risk of GvHD by introducing suicide genes into the T-cells before implanting them in the patient. If the patient develops GvHD, they can be treated with a drug to kill the T-cells before damage is done.

Two companies, MolMed in Italy and Bellicum Pharmaceuticals in the U.S., have proposed this strategy and are in Phase III trials, Caruso says. They should be commercialized soon, he says.

Another application for suicide genes is to use them in concert with CAR (Chimeric Antigen Receptors) T-cell therapy, which involves retraining a patient’s own T-cells to target lymphomas and leukemia. “Usually the T-cells are supposed to kill virus-infected cells or... cancer cells, but sometimes they don’t,” Caruso says. “What people have done is take the T-cells from a patient and introduce in these T-cells a CAR that will recognize the leukemic cells or the lymphoma cells. Then they inject them back in the patient.”

In preliminary trials this therapy has proved to have excellent responses, Caruso says, although the side effects caused by the reactive modified T-cells can sometimes cause the patient a lot of problems. Here again, the researchers plan to use suicide genes to control those adverse effects.

Meanwhile in Canada And as for Canada? “We’re behind on gene therapy,” Neschadim says. Although there are undoubtedly other Canadian researchers doing work in this space, they haven’t had the clinical success of their U.S. and European counterparts.

Canada was late to the suicide gene party.

“In these types of approaches, what you need to get is good intellectual properties,” Caruso says. “For example, for these [suicide gene] treatments of leukemia and lymphomas, we already have three or four companies that have all the IPs. It’s pretty crowded right now. The results are quite exceptional and when you have exceptional results, people want to invest.”

On the basis of this alone, Caruso says, there are companies that didn’t exist a few years ago that are now valued in the billions without having yet sold a single treatment.

Despite the fact that Canada has been slow out of the gate, there is some expertise in the cell therapy space. Caruso’s own lab in Laval developed a platform for delivering genes to cells, which is currently in use in clinical trials in the U.S. and England.

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moments in time

HAART I

n 1996, in the midst of the AIDS crisis, Vancouver’s life sciences community held the XI International Conference on AIDS (IAS). More than 15,000 advocates, researchers, health care workers and HIV/AIDS sufferers from around the world attended the conference to hear and participate in more than 5,000 presentations. In one of these presentations, Canadian virologist and AIDS clinician Julio Montaner and his fellow researchers debuted the highly active antiretroviral therapy (HAART).

It is estimated that HAART, through a therapeutic approach known as Treatment as Prevention, decreases the risk of HIV transmission by up to 96 per cent. The therapy has since been hailed for revolutionizing HIV treatment and transforming it from a death sentence into a chronic but manageable condition. Montaner has authored more than 450 scientific publications on HIV/AIDS and has become internationally recognized for his work in the field. BB

Sources http://3030.aidsvancouver.org/1996/ http://www.iasociety.org/Web/WebContent/File/IAS_20yearsIAS_book.pdf, http://www. marketwired.com/press-release/vancouver-hiv-pioneer-addresses-world-congress-ofdermatology-2027240.htm

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