Biotechnology Focus October/November 2017

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

october/november 2017 VOLUME 20, NUMBER 5

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Anniversary

Taking the pulse of

Canada’s biotech workplace Our special report on the country’s biotechnology HR landscape

INSIDE : How to build a high performing team Regenerative medicine on the fast track Publication Mail Registration Number: 40052410

A rising 3D bio-printing startup

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FEATURES

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contents

Obtaining effective patent protection is critical to help position innovators and companies working on cell-based therapies for commercial success.

(By Herman Cheung and Laurence MacPhie)

OCTOBER/NOVEMBER 2017 – VOLUME 20 – NUMBER 2

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CANADA’S BIOTECH HR LANDSCAPE REVISITED: A NEW FORCE IN THE HORIZON The results of our 2017 Bio Employee survey were largely encouraging but our pollsters also detected some ripples of change which might bring about a wave of transformation in the future.

(By Nestor Arellano)

PATENT RIGHTS AND THE COMING OF AGE OF CELL-BASED IMMUNOTHERAPIES

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THE FAST TRACK FOR REGENERATIVE MEDICINE Canada is well positioned in a highly competitive global race to scale-up advanced cell manufacturing.

(By Brad Hussey)

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STEM CELL RESEARCH: WORKING TOWARDS A CURE AMID THE HYPE While unregulated and unapproved treatments are being peddled by unscrupulous clinics, Canadian researchers are working hard to make the country the hub of stem cell research.

(By Nestor Arellano)

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VANCOUVER BIOTECH START-UP BECOMES A LEADER IN 3D BIO-PRINTING MARKET The story of how one-time UBC spin-off, Aspect Biosystems evolved into a top contender in the lucrative global 3D bio-printing space.

(By Nestor Arellano)

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Anniversary

What employers can do to define, measure and lead their desired operating culture in today’s dynamic Canadian biotechnology and life sciences environment.

(By The Thrive Partnership Group and Environics Research)

BIOTECHNOLOGY 20TH ANNIVERSARY SPECIAL: We continue our celebration of Biotechnology Focus’ twentieth anniversary. This time, we look back at past issues from the years 2007 to 2009.

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RESEARCH NEWS

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BUSINESS CORNER

28 CALENDAR OF EVENTS www.biotechnologyfocus.ca

THE BEST DESIGNED TRIALS ARE ADAPTIVE-BY-DESIGN Adaptive design helps sponsors determine if a therapy is going to fail or not.

(By John Amrhein)

(Compiled by Shawn Lawrence)

DEPARTMENTS

CULTURE: THE SECRET WEAPON OF WINNING CORPORATIONS

IN EVERY ISSUE

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THE LAST WORD A deep dive into the 2017 Bio Employee survey to find out what is working well, what attributes of organizations are highly valued, and where practices are not meeting expectations.

(By Dean Fulford) October/November 2017 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S note PUBLISHER/ EDITOR-IN-CHIEF

Terri Pavelic

EDITOR

Nestor Arellano

WRITER

Michelle Currie

CONTRIBUTING WRITERS

Shawn Lawrence

Dean Fulford Brad Hussey Herman Cheung Laurence MacPhie

CANADA’S BIOTECH WORKFORCE SPEAKS OUT

John Amrhein Jon Rogers Glenn Busby Robert Seguin

Finally, we are able to share with you fully the results of our 2017 Bio Employee survey.

Congratulations to all those that participated in the poll. By providing us your thoughts and feelings regarding the operation of and the environment in your organization, you are playing a crucial role in the transformation – for the better – of the Canadian biotech and life sciences workplace.

In fact, this recent survey conducted by Stratford Managers, BioTalent Canada, and Biotechnology Focus indicates that the country’s biotech industry has been paying attention to the feedback we gain from you. The numbers show a notable uptick in positive responses towards what employers have been doing for their personnel.

Biotech employers, give yourselves a pat on the back!

But don’t forget there’s still work to be done. The survey has shown some interesting developments that need to be addressed if Canadian biotech companies want to attract and maintain the most promising talents in the industry.

You’ll find out more about this in our review of the survey findings in the article, Special Report - Canada’s biotech HR landscape revisited: A new force in the horizon.

Then, Dean Fulford, vice-president of HR consulting at Stratford Managers, rounds it all out perfectly in his Last Word, editorial. Dean’s piece, Surveying the Biotechnological HR Landscape, pulls out the survey highlights and explains what they mean to biotech employers.

The Thrive Partner group and Environics Research also worked together on an article which spells out how organizations can build a high-performing, winning team. Their article, Culture: The Secret Weapon of Winning Corporations outlines the three key strategies that businesses need to implement to build their competitive advantage.

Apart from tackling the topic of how to build a top performing team, this issue also focuses on stem cell research in Canada.

In his article, The Fast Track for Regenerative Medicine, Toronto journalist Brad Hussey reports on work being done by the Centre for Commercialization of Regenerative Medicine and the creation of the Centre for Advanced Therapeutic Cell Technologies (CATCT).

Herman Cheung and Laurence MacPhie of Bereskin & Parr LLP delve into patents and gene therapy in their article, Patent rights and the coming of age for cell-based immunotherapies.

For our Innovator series, we’re featuring Aspect Biosystems, a Vancouver-based company that employs a proprietary 3D bio-printing technology to print tissue cells that can be used to create structures that resemble human body parts such as a meniscus or an airway.

Whether you’re in the early stages of building your company or seeking to bring it to the next level, our story, Vancouver biotech start-up becomes a leader in 3D bio-printing market, is sure to offer some inspiration.

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Elena Pankova John R. Jones Melisa Sukhdeo

CIRCULATION DIRECTOR Mary Labao circulation@promotivemedia.ca Tel: 905-841-7389

EDITORIAL ADVISORY BOARD Christine Beyaert, Roche Canada; Pierre Bourassa, IRAP, Montréal; Murray McLaughlin, Sustainable Chemistry Alliance; Ulli Krull, UTM; John Kelly, KeliRo Company Inc.; Peter Pekos, Dalton Pharma Services; Robert Foldes, Viteava Pharmaceuticals Inc.; Gail Garland, OBIO; Barry Gee, CDRD; Bonnie Kuehl, Scientific Insights Consulting Group Inc.; Raphael Hofstein, MaRS Innovation; Roberto Bellini, Bellus Health; Peter van der Velden, Lumira Capital; Albert Friesen, Medicure Inc.; Ali Tehrani, Zymeworks Inc.; Dr. Jason Field, Life Sciences Ontario; Andrew Casey, BIOTECanada

Biotechnology Focus is published 6 times per year by Promotive Communications Inc. 1-226 Edward Street, Aurora, ON L4G 3S8, Phone 905-727-3875 Fax 905-727-4428 www.biotechnologyfocus.ca E-mail: biotechnology_focus@promotive.net Subscription rate in Canada $35/year; USA $60/year; other countries $100/year. All rights reserved. No part of this publication may be reproduced without written consent. Publications Mail Registration Number: 40052410 Return undeliverable Canadian addresses to: circulation department – 1-226 Edward Street, Aurora, ON L4G 3S8 National Library of Canada ISSN 1486-3138 All opinions expressed herein are those of the contributors and do not necessarily reflect the views of the publisher or any person or organization associated with the magazine.

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R&D news Promis announces humanized version of candidate antibody for Alzheimer’s

Promis Neurosciences Inc. is now gearing to kick off the cell line development of PMN310 – a humanized monoclonal antibody (mAb) targeting toxic forms of amyloid beta oligomers (AβO).

PMN310 is the lead candidate drug for Alzheimer’s disease (AD) of the Torontobased biotech company.

“We have now completed a significant

development milestone by producing a humanized version of PMN310 and, in the process, achieving a ten-fold increase in binding affinity for its conformational target on toxic AβO,” stated Dr. Neil Cashman, chief scientific officer of Promis. “This increased affinity of PMN310, along with its selective targeting of prion-like forms of AβO, continues to support the development of PMN310 as a potentially

impactful treatment for Alzheimer’s disease.”

The Promis mAbs for AD have all been created in the mouse (murine mAbs). Humanized antibodies are antibodies from nonhuman species that have been modified to increase their similarity to antibody variants produced naturally in humans.

Humanization (also called CDR-grafting) is a well-established technique for reducing the immunogenicity (rejection potential) of therapeutic mAbs from non-human sources.

PMN310 was designated Promis’ first lead product candidate in January 2017, based on its ability to selectively bind prion-like forms of AβO. AβOs are recognized as a root cause of AD. PMN310 displays an optimal binding profile, as it does not bind to amyloid beta monomer or plaque. Recent experimental and clinical evidence indicates that soluble toxic AβO, propagating in a prion-like manner, is actually the primary drivers of neurodegeneration and cognitive decline in AD patients and not plaque or amyloid beta monomer.

To see this story online visit http://biotechnologyfocus.ca/promis-announces-humanized-version-of-candidateantibody-for-alzheimers/

Using selfies to detect cancer Pose, snap, post. In the last few years, taking selfies has evolved from a curious social media-focused practice to a ubiquitous automatic reaction of global proportions. Now, researchers from the University of Washington believe they can turn the public’s prevailing penchant for self-portraits into something that could detect pancreatic cancer.

Pancreatic cancer is a very aggressive form of cancer. It is estimated to have caused the deaths of 411,600 individuals in 2015. It is the fourth most common cause of cancer deaths in North America. Pancreatic cancer has one of the worst survival rates because its symptoms manifest quite late into the progression of the disease.

Early detection of the disease can give patients a better chance at survival and researchers at UW are working on a mobile app that allows people to snap smartphone selfies which could aid in screening for pancreatic cancer and other diseases.

One of the symptoms of pancreatic cancer is jaundice.

“Jaundice is only recognizable to the naked eye in severe stages, but a ubiquitous test using computer vision and machine learning can detect milder forms of jaundice,” according to a study by researchers Alex Mariakakis, 6 BIOTECHNOLOGY FOCUS October/November 2017

Megan A. Banks, Lauren Phillipi, Lei Yu, James Taylor, and Shwetak Patel. “We propose BiliScreen, a smartphone app that captures pictures of the eye and produces an estimate of a person’s bilirubin level, even at levels normally undetectable by the human eye.”

Jaundice in the skin and eyes are caused by a buildup of bilirubin in the blood. Bilirubin is a substance found in bile. It is produced when the liver breaks down old red blood cells.

The researchers said the BiliScreen app is

able to snap pictures of the eye and produce an estimate of a person’s bilirubin level at levels that are not “normally undetectable by the human eye.”

The team hopes to continue building improved models of BiliScreen and conduct a longer-term study which will capture trends of bilirubin levels.

To see this story online visit http://biotechnologyfocus.ca/using-selfies-to-detect-cancer/

R&D news Culinary gelatin best for 3D printing artificial organs heat. The product can be applied in making cocktails and a host of modern dishes.

“The cold soluble GelMA showed a more reliable and stable droplet fabrication process,” according to the team’s findings which were published in Biofabrication. “Taken together, the cold soluble GelMA is a promising

Researchers at the University of British Columbia are working on a project that uses 3D printing techniques and gelatin-based biomaterials to create artificial organs in the laboratory.

Gelatin methacrylate (GelMA) hydrogel is a promising bio-ink for bio-fabrication applications, according to the findings by a research team made up of Zongie Wang, a research technician in mechanical engineering; Zhenlin Tian, PhD student in chemistry; Dr. Frederic Menard; and Dr. Keekyoung Kim, assistant professor, all from the UBC. “A big drawback of the conventional hydrogel is its thermal instability. Even small changes in temperature cause significant changes in its viscosity or thickness,” said Kim. “This makes it problematic for many room temperature bio-fabrication systems, which are compatible with only a narrow range of hydrogel viscosities and which must generate products that are as uniform as possible if they are to function properly.”

To determine which type of GelMa hydrogel was best suited for 3D organ printing, the researchers examined three different types of GelMa hydrogels – porcine skin, cold-water fish skin, and cold soluble gelatin.

The team found that the cold soluble GelMA could form healthy tissue scaffolds and enable cells to successfully grow. Cold soluble GelMa also had low viscosity and thermally stable at room temperature.

Being three times cheaper than porcine skin gelatin, cold-soluble gelatin is used primarily in culinary applications. It is used to make gels and foams that maintain the aromas of fruits and vegetables which would normally dissipate with the application of

bio-ink solution and may greatly benefit the research in bio-fabrication.

To see this story online visit http://biotechnologyfocus.ca/culinarygelatin-best-for-3d-printing-artificialorgans/

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October/November 2017 BIOTECHNOLOGY FOCUS 7

Spotlight | By Herman Cheung and Laurence MacPhie, Bereskin & Parr LLP

Patent rights and the coming of age

of cell-based immunotherapies

I

n August 2017, the U.S. Food and Drug Administration (FDA) approved Novartis’ Kymriah (tisagenlecleucel) for the treatment of certain pediatric and young adult patients with a specific form of leukemia. Kymriah is the first genetherapy to be approved by the FDA and represents a milestone for the treatment of cancer using Chimeric Antigen Receptor (CAR) T cells.

CAR-T cells hold a great promise for treating cancer and one estimate suggests that the sales of engineered T cells will reach $10 billion annually by 2021.1 Not surprisingly, a number of other companies are working on cell-based immunotherapies and it is likely that the use of CAR-T cells will expand beyond haematological malignancies to the treatment of other cancers and solid tumours. There is also a need for innovations regarding the manufacture and quality control of cell-based therapies, including methods for defining specific cell types and improving the purity of CAR-T cell products and dosing. Furthermore, advances in abrogating toxicities observed with the use of CAR-T cells (including cytokine release syndrome) may prove to be very valuable. Significant opportunities exist, however, the landscape is competitive. Obtaining effective patent protection is critical to help position innovators and companies working in this field for commercial success.

Patentability of cell-based therapies Patent rights are governed by the laws of each individual country or jurisdiction where a patent application is filed. While the specific requirements for obtaining a patent vary from country to country, most patent systems require that the invention defined by the claims be considered patentable subject matter, represent a novel and non-obvious (inventive) advance over the prior art, and have utility that is supported by the application.

Recently, whether certain inventions qualify as patentable subject-matter has been a concern particularly before the U.S. Patent Office. In general, cells that 8 BIOTECHNOLOGY FOCUS October/November 2017

are the product of genetic engineering such as CAR-T cells should qualify as they have “markedly different characteristics” from any naturally occurring counterpart. Furthermore, in the U.S., methods of medical treatment as well as methods for the production of genetically engineered cells should also qualify as patentable subject matter.

Inventions related to genetically engineered cells should also qualify as patentable subject matter in other jurisdictions.

Although method-of-treatment claims are generally not allowed outside of the U.S., corresponding use claims should be available. For example, a number of patents have been granted in Europe and Canada with claims directed to CAR-T cells, their use for treating disease, as well as methods for producing genetically engineered T cell receptors and T cells.2 A claimed invention must be novel and non-obvious over the prior art. The prior art includes public disclosures of information (such as research papers or published patent applications) made before a patent application is filed. While even minor differences are normally sufficient to establish novelty, proving that an invention is nonobvious can be challenging especially in a rapidly developing field such as cell-based immunotherapy. Carefully describing

features or elements that distinguish the invention or that are unexpected or surprising can often help establish that a claimed invention is non-obvious.

Clinical data demonstrating the utility of an invention in humans is rarely available at the time of filing a patent application, however other types of data can normally be used for support. For example, it may be possible to support claims to the use of genetically engineered cells in humans based solely on in vitro and/or animal data. Talking to a patent agent or lawyer at the outset of a research project can help clarify what data may be sufficient to support the utility of an invention and file a patent application.

Enforcement and licensing The amount of research and development required to launch a new therapy such as CAR-T cells is enormous and obtaining patent rights to protect commercial uses of the technology is paramount.

Prior to launching Kymriah, Novartis reached an agreement with Juno Therapeutics to settle a long-running patent dispute, allowing each to advance with their respective CAR-T cell therapies. According to the terms of the settlement, Novartis and its partner, the University of Pennsylvania, will pay $12.25 million, plus

Spotlight future milestone payments and royalties on CAR-T cell products to Juno and St. Jude Children’s Research Hospital.

Kite Pharma is another company engaged in the development of CAR-T cell therapies who amassed a significant patent portfolio.3 In August 2015, Kite filed for an inter partes review of U.S. Patent No. 7,446,190 (the ’190 Patent) of which Juno is the exclusive licensee, alleging that all of its claims were obvious. The U.S. Patent Office upheld the validity of the claims in the ‘190 Patent4 and Juno in turn filed a patent infringement lawsuit against Kite, seeking a declaration that one of Kite’s lead therapies infringes the ‘190 Patent.

On June 13, 2017, the District Court of Delaware granted Kite’s motion to dismiss the suit but it is unlikely that this will be the end of legal proceedings regarding patent rights between these competitors. In late

August 2017, Gilead Sciences announced that it was acquiring Kite for $11.9 billion.

In one swoop, Gilead acquired all of Kite’s patent assets and has become a major player in the development and commercialization of CAR-T cell therapies.

References: 1. Kitamura, M. 2015. GE Sees Cell Therapy Industry’s Sales at $10 Billion by 2021. Bloomberg. October 21, 2015. https://www.bloomberg.com/news/articles/2015-10-21/ge-sees-cell-therapyindustry-s-sales-at-10-billion-by-2021 2. See for example Canadian Patent Nos. 2,566,363 and 2,674,445 as well as European Patent No. EP2016102.

3. Kite Pharma states that the company has intellectual property portfolio that encompasses more than 150 patent assets, many of which relates to

T-cell therapies; see Kite Pharma, December 19, 2016, Press Release [Kite]: http://ir.kitepharma.com/releasedetail. cfm?ReleaseID=1004781.

4. Kite Pharma, Inc. vs. Sloan Kettering Institute for Cancer Research, 2016, United States Patent Trial and Appeals Board, Case IPR2015-01719, Patent 7,446,190 B2. Kite Pharma has appealed this decision.

Herman Cheung is an associate with Bereskin & Parr LLP and is a member of the Life Sciences practice group. Laurence MacPhie is a lawyer and partner with Bereskin & Parr LLP.

To see this story online visit www.biotechnologyfocus.ca/patentrights-and-the-coming-of-age-of-cellbased-immunotherapies/

Biotech start-ups get boost from new U of T entrepreneur hub ing. It has several flexible shared workspaces, meeting rooms, boardrooms and event spaces, including the RBC Innovation Hub. The facility is supported by U of T and RBC as part of a $4 million commitment by the bank to support the university’s innovation

Shire CFO says ‘no smoking gun’ in move to leave company One of the common challenges faced by start-up businesses and fledgling entrepreneurs is finding a place where they can hold meetings with potential funders, collaborate with partners and hold company events.

Now, for start-ups in Ontario, there is a facility that can serve this purpose. The U of T Entrepreneurship’s new ONRamp facility, a 15,000-square-foot collaboration and coworking space catering to entrepreneurs and their start-ups, was officially opened.

ONRamp will serve as a “home-away-fromhome” for entrepreneurs from other Ontario universities, according to an article written

by Chris Sorensen for the U of T News.

The facility is Located in the Banting building at the U of T. ONRamp will not only connect entrepreneurs and start-ups from across U of T’s extensive network of entrepreneurship hubs but throughout southern Ontario via partnerships with Hamilton’s McMaster University and London’s Western University, said Sorensen.

ONRamp occupies three floors of the build-

The decision in August by Jeff Poulton, chief financial officer Shire for the U.S.based agri-bio start-up Indigo AG, surprised investors of the global biotech firm.

However, Poulton quickly moved to ease investors’ worries by saying the move was a personal decision.

Poulton’s announcement follows the recent departure of Shire research and development Phil Vickers and the July announcement by the company that it was consolidating its U.S. operations into two main sites in Massachusetts – a move that could mean the closure of some facilities.

In an interview with the financial site Barrons, Poulton said that timing is “never good with these kinds of things.” He also added that there was “no smoking gun here.”

Poulton began working for Shire in 2003.

His stint as CFO of the company, which be-

BUSINESS corner

and entrepreneurship ecosystem.

To see this story online visit http://biotechnologyfocus.ca/biotechstartups-get-boost-from-new-u-of-tentrepreneur-hub/

gan in 2015, covers the period when Shire made its $32 billion acquisition of Baxalta last year.

David Steinberg, an analyst for the global investment banking firm Jeffries, told Fierce Bio that he believes Poulton’s explanation for this decision to leave.

“Our take is that his move is motivated by an interest in a more entrepreneurial professional opportunity,” said Steinberg. “…we have always found Mr. Poulton to be straightforward and honest.”

To see this story online visit http://biotechnologyfocus.ca/shirecfo-says-no-smoking-gun-in-move-toleave-company/

October/November 2017 BIOTECHNOLOGY FOCUS 9

REGENERATIVE MEDICINE

| By Brad Hussey

The Fast Track for Regenerative Medicine Canada is well positioned in a highly competitive global race to scale-up advanced cell manufacturing.

Can we keep up with the competition?

F

rom penicillin to the Tesla Model 3, every great modern invention that has solved a problem plaguing the human condition has faced a significant hurdle – scaling up from the lab bench to meet demand efficiently and cost-effectively, with no loss in quality.

As breakthroughs in regenerative medicine continue to make headlines worldwide, research communities are redoubling efforts to develop sustainable technologies and processes to usher potential cell therapies into the clinic. It is perhaps one of the most technically and logistically complex quests to date in the commercialization of scientific breakthroughs. Overcoming manufacturing challenges so that cell therapies scale out, and up, reliably into affordable and efficacious treatments will unlock a potentially astronomical return on investment in terms of economic activity and improvements in human health.

The good news is that Canada, despite having relatively smaller investments from funders compared with the U.K. or the U.S., is poised to make significant headway in advanced manufacturing thanks to a unique home-grown innovation model.

“On the commercialization side, there are very few people in the world who really understand what manufacturing a cell therapy at scale may look like – nobody’s done it yet,” explains Philip Vanek PhD, general manager of GE Healthcare’s cell therapy growth strategy.

“There is a lot of substantial process development work going on, new technologies that are evolving and new therapeutic indications being pursued [globally]. These things require a huge organizational ecosystem and industrialization effort, and this is where Canada stacks up in terms of the most competitive areas – understanding that industrialization and supply-chain thinking is required for these therapies to become mainstream.”

10 BIOTECHNOLOGY FOCUS October/November 2017

scalable cell and gene therapy manufacturing processes quickly and effectively. In 2015, the federal government of Canada’s First Research Excellence Fund also earmarked $114 million to create Medicine by Design at the University of Toronto. Its research program is devoted solely to research and clinical translation in regenerative medicine.

Culture of collaboration Even if the total investment in advanced manufacturing research pales in comparison to other international programs – the U.K.’s Cell and Gene Therapy Catapult program has invested over £100 million to date in R&D and commercialization efforts, with significant support for cell manufacturing – Canada maintains some advantages. Vanek credits Canada’s unique culture of collaboration and entrepreneurship for keeping the country ahead of the manufacturing curve.

He highlights the work of the Stem Cell Network, the Centre for Commercialization of Regenerative Medicine (CCRM, for which he serves as a board member), the Ontario Institute for Regenerative Medicine, the BC Regenerative Medicine Cluster and others for creating an ecosystem here that encourages collaboration within and across traditional disciplines and sectors, including industry.

This supportive environment has already borne significant fruit. Last year, GE Healthcare contributed $20 million to match federal funding via CCRM to create the Centre for Advanced Therapeutic Cell Technologies (CATCT), the world’s first cell therapy development facility to adopt a collaborative model of problem-solving between the research community and industry. The facility boasts unparalleled resources in terms of bioprocess technologies and analytical systems, along with a world-class staff, that will allow researchers to develop and optimize

Taping into the talent pool Perhaps the most significant testimonial to the value of Canada’s ecosystem is the creation of BlueRock Therapeutics, announced in December 2016. The result of a US$225 million deal between San Francisco-based venture capital firm Versant Ventures and pharmaceutical giant Bayer AG, BlueRock aims to rapidly develop cell therapies and bring them to market, with an initial focus on treatments for brain and heart ailments.

The ability to tap into the deep talent pool of Toronto’s stem cell research community topped the long list of advantages the city offered the start-up. Internationally renowned stem cell innovators Dr. Gordon Keller of the McEwen Centre for Regenerative Medicine, based at University Health Network (UHN) – North America’s largest research hospital – and Dr. Michael Laflamme of the Toronto General Hospital Research Institute have both signed on to BlueRock Therapeutics as cofounders. The new venture was also attracted to Canada thanks, in part, to efforts from the federal government to entice and retain talent in regenerative medicine, as well as CCRM’s unique plan to scale-up stem cell production through CATCT. There may be even more good news on the way for collaborative efforts in regenerative medicine. This past May, the federal government announced a $950 million supercluster funding initiative to stimulate job creation and

We need to create an ecosystem of regenerative medicine innovation in Canada that has a critical mass.

REGENERATIVE MEDICINE CCRM: Delivering Economic and Health Benefits for Canadians Regenerative medicine (RM), which aims to harness the power of stem cells, biomaterials and molecules to repair, regenerate or replace diseased cells, tissues and organs, has the promise to treat, manage and perhaps cure some of the most devastating and costly diseases in the world today.

Dr. John Dick, The Hospital for Sick Children and the University of Toronto, confirmed that brain tumours originate from cancer stem cells, which maintain and fuel tumour growth.

*Here are some of the major contributions

that Canadian researchers and institutions have made:

Researchers led by Dr. Michael Rudnicki, Ottawa Hospital Research Institute, discovered a trigger that turns muscle stem cells into brown fat.

2004

2013

Researchers led by Dr. Guy Sauvageau, University of Montreal, discovered a new molecule that allows for the 10-fold multiplication of stem cells in cord blood.

2015

*CANADA’S LEADERSHIP IN RM 1961

2008

Drs. James Till & Ernest McCulloch (left, illustrated) advanced medical research across the globe with the discovery of blood stem cells.

Dr. Gordon Keller, University Health Network, demonstrated cardiac specific differentiation of embryonic stem (ES) cells in culture.

2014

Dr. Tim Kieffer, University of British Columbia, published the discovery of a protocol that can turn stem cells into insulin-producing cells in a matter of weeks.

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global growth for Canadian companies. The program encourages consortiums of large and small companies, universities and non-profits to work together to turn ideas into marketable products and services in highly innovative industries, including biosciences and advanced manufacturing. Given the potential upside from the commercialization of cell therapies in a rapidly growing global market, and our strength in Canadian-grown companies such as STEMCELL Technologies (Vancouver, BC) that enable regenerative medicine research, supercluster investment in regenerative medicine would seem a natural fit.

“The supercluster approach is perfect for regenerative medicine; we need all sectors to come together to make a difference in human health, from the government to lay the framework, entrepreneurs to build the companies, and research to drive invention and innovation. Of course, ideas and people are critical,”

says Dr. Molly Shoichet, a Canada Research Chair in tissue engineering at the University of Toronto’s Donnelly Centre and an expert in science and engineering engagement. “The problems that we are trying to solve require careful, diligent and reproducible studies.

Regenerative medicine requires significant investment over long periods of time and long-term vision.”

Building critical mass Dr. Peter Zandstra, Canada Research Chair in stem cell bioengineering, director of UBC’s School of Biomedical Engineering and Michael Smith Laboratories, and co-founder and chief scientist at CCRM, stresses that despite recent advances it’s not the time for Canada to rest on its laurels. Even with significant leadership in regenerative medicine from organizations like CCRM and a robust and rapidly expanding ecosystem, opportunities

to commercialize cell therapies are being aggressively pursued worldwide. That has major implications for attracting and retaining highly qualified researchers, workers, and entrepreneurs with expertise in regenerative medicine and bioengineering.

“The next step is really to start building anchor companies in the cellular therapeutics space,” he says. “We don’t yet have one, but some of the opportunities we have are already in play in partnership with CCRM spinoffs such as ExCellThera, and associated companies; and that’s really exciting.”

Further industrialization will expand the ecosystem to the point where successful companies have the potential to compete for the best trainees, creating a sustainable knowledge base so that talent can move around in the same jurisdiction, he adds.

“We’re not quite there yet. We are at the exciting stage where there are just not enough people to fill the opportunities we are creating and seeing. We need to create an ecosystem of regenerative medicine innovation in Canada that has a critical mass. Training people for jobs, whether they are undergrads that work in the industry directly or graduates that lead it, is a really a great opportunity for Canada. Certainly, we are much better off than we were 10 years ago, and CCRM has really driven that.”

CCRM’s President and CEO, Michael May PhD, notes that Canada’s ability to punch above its weight in regenerative medicine is the result of a step-wise, strategic plan to build an industry by leveraging scientific excellence, key networks, infrastructure and academic institutions. The next critical step, he says, is to engage Canadian risk capital to achieve critical mass.

“It will be risk capital that will truly scale and drive the industry here, so we need to execute and build successes to drive investment,” he stated. “That’s how we are truly going to exploit our chances to win. We also need investors to be Canadian, so the companies they create are ‘sticky’ here.”

“When you tie that investor piece to CCRM’s focus on manufacturing, you get a doublebarrelled tool for stickiness. That’s been the heart of CCRM’s approach.”

While we’re not celebrating in the winner’s circle just yet, all signs suggest it’s a strategy that has shifted Canada into the fast lane toward producing cell therapies at scale — and on the road to a win-win for the health of Canadians and our economy.

To see this story online visit www.biotechnologyfocus.ca/the-fasttrack-for-regenerative-medicine/

October/November 2017 BIOTECHNOLOGY FOCUS 11

stem Cell

| By Nestor Arellano

Stem cell research: Working towards a cure amid the hype

A

cross Canada and the United States, scores of aging baby boomers, injured athletes and numerous other patients have been going to private clinics that promise a cure for arthritis, disc problems, joint injuries and skin conditions using stem cells.

Despite the warning from Health Canada and the U.S. Food and Drug Administration that almost all of these treatments are unproven and unsafe, the hype around the promise of a cure through stem cell therapy has driven many to embark on medical tourism trips to places like Arizona, Mexico and China.

However, unregulated and unapproved treatments pose significant dangers to patients. Earlier this year, The New England Journal of Medicine reported on the separate cases of three women in the U.S. who became blind after undergoing intravitreal injection of autologous stem cells for age-related macular degeneration (AMD) at private clinics that were offering such a procedure for a US$5,000 fee.

Some researchers have labeled such practices as pure “quackery” and the people peddling purported cures as “snake oil” salesmen.

“Virtually all of these so-called “stem cell therapies” are untested in clinical trials and there’s a huge amount of fraudulent stuff going on” said Dr. Allen Eaves president and chief executive officer of STEMCELL Technologies Inc. “Unfortunately, there are many seriously ill patients failing existing therapies who are prepared to try anything that holds out hope for them.”

Vancouver-based STEMCELL Technologies is the largest biotech in Canada with over a thousand employees. The company develops cell culture media, cell separation systems, instruments and other reagents for use in life sciences research. Only three per cent of sales are in Canada, with 60 per cent are in the U.S., 25 per cent are in Europe and the rest are in Asia Pacific.

“STEMCELL Technologies only supports legitimate stem cell and regenerative medicine

12 BIOTECHNOLOGY FOCUS October/November 2017

research in leading institutes and biopharma companies,” said Eaves. “We’re very careful to whom we sell our products. At present, all of our products are for research use only (RUO), not for use in patients, although a few of our products are in over thirty early phase clinical trials” If STEMCELL even suspects its products are going to used by a physician doing fraudulent work, he said, the company will not sell to that individual or organization.

The Canadian Stem Cell Foundation’s Web site lists the following areas where stem cell research is being done in Canada: ALS, arthritis, autism, blood disorders, breast cancer, cerebral palsy, Crohn’s disease, diabetes, eye disease, GVHD, heart failure, liver failure, multiple sclerosis, muscular dystrophy, Parkinson’s disease, solid tumour cancers, spinal cord injuries, stroke, and wound healing.

The routine availability of new stem cell therapies has been estimated to be anywhere from 10 to 30 years away.

New approaches to cell transplantation are among the most exciting areas of stem cell research these days, according to Professor Cindi Morshead, Chair of the Division of Anatomy, Faculty of Medicine at the University of Toronto.

The Morshead Lab is focused on understanding the fundamental questions regarding the behavior of neural stem cells. The lab’s researchers use in vivo and in vitro techniques, cell transplantation, imaging, genetic manipulations and animal models.

Morshead said her team is currently actively pursuing the role of stem cells in models of neurological disease such as stroke and spinal cord injury.

Considerable hurdles, however, continue to stymie Canadian stem cell research, according to Morshead.

“The federal government needs to put more money into stem cell research to make us truly competitive in this area,” she said. “We need to be able to move from basic scientific research to clinical applications.”

Eaves said the federal government has pro-

Human embryonic stem cells vided critical funding for stem cell research since the 1960s when Drs. James Till and Earnest McCulloch at the Ontario Cancer Institute first characterized stem cells; however, we have since fallen behind and Canada is now trying to play catch-up with our G7 counterparts.

“If we fail in funding fundamental research and clinical trials, we are going to lose even more researchers to countries like the United States where most of the stem cell research is occurring”, he said.

Still, there’s a lot of hope for Canada’s stem cell research environment.

Among the notable stem cell research being undertaken in Canada is that of Professor Timothy Kieffer of the University of British Columbia, Eaves said. Kieffer’s team believes that the best therapies for diabetes will come from stem cells that can be trained to produce daughter cells that make insulin.

Eaves also mentioned the world-recognized Edmonton Protocol developed by Dr. James Shapiro’s team at the University of Alberta some 17 years ago. Their treatment uses the insulin-secreting pancreatic islets from organ donors. The islets are injected into the liver where they function normally as long as rejection is prevented with immuno-suppressive drugs. However, over time, the immunosuppression causes problems. Thus, growing insulin-secreting cells from a patient’s own stem cells, as being researched by Kieffer.

Morshead said one of Canada’s promising new stem cell approaches is the breakthrough treatment for MS pioneered by Dr. Mark Freedman and Dr. Harry Atkins at the Ottawa Hospital and the University of Ottawa. The treatment involves disabling the patient’s immune system and then generating a new one using the patient’s own blood stem cells.

“Canada has become a hotbed of worldclass fundamental research in the last 25 years,” said Morshead. “…We can become the global hub of stem cell research.”

To see this story online visit www.biotechnologyfocus.ca/stem-cellresearch-working-towards-a-cure-amidthe-hype/

Special Report:

| by Nestor Arellano

Canada’s biotech HR landscape revisited: A new force in the horizon Are millennials poised to make an impact on Canada’s biotechnology sector?

October/November 2017 BIOTECHNOLOGY FOCUS 13

Special Report:

I

the Biotechnological HR landscape in Canada

Employee Opinion the Biotech EmployeeofOpinion of the Workplace Biotech Workplace Employee Opinion of the Biotech Workplace Participation and Geographic Participation andBreakdown Geographic Breakdown

ndustry benchmarks were created Participation and Geographic Breakdown when we first launched the first-ofits-kind employee survey of Canada’s Participation and Geographic Breakdown biotechnology industry in 2015.

• 148 responses from employees infrom 8 provinces/territories were received.were received.

• 148 responses employees • 148 responses from employeesinin88 provinces/territories provinces/territories were received.

Recently, Biotechnology Focus, Strat• Corporation, More than half of the survey respondents were from Ontario. ford Managers and BioTalent • More survey respondents werefrom from Ontario.

• than More half than of halfthe of the survey respondents were Ontario.

Canada sought to take another look at the Canadian biotech human resources landORGANIZATION TYPE LOCATION ORGANIZATION TYPE ORGANIZATION TYPE scape. The poll gathered responses from LOCATION LOCATION Nunavut 1% 13% employees in eight provinces and territories Northwest Territories Nunavut 0% 1% 19% Nunavut 1% 13% Yukon 0% 13% Territories 0% 19% Northwest Territories 0% Northwest across the country – more than half the re19% Newfoundland 0% Yukon 0% Yukon 0% Prince Edward Island 0% spondents were from Ontario.

5% Newfoundland 0% Nova Scotia 0% Newfoundland 0% Prince Edward Island 0% New Brunswick The results of our 2017 Bio Employee 1% 5% 6% Prince Edward Island 0% Nova Scotia Quebec 0% 16% 5% survey were largely encouraging but our Nova Scotia 0% Ontario 52% 6% New Brunswick 6% 1% Manitoba 4% 1% New Brunswick Biotech Quebec pollsters also detected some ripples of 6% 16% 1% 50% Saskatchewan 7% Quebec 16% Ontario Biopharma 6% Alberta 9% change which might bring about a wave of Ontario 52% 6% Medical Device Manitoba 4% 1% British Columbia Biotech 11% 50% transformation in the future.

Clinical Research Organization Manitoba Saskatchewan 4% 1% 0% 20% 7% 40% 60% Biotech Biopharma

Biopharma Clinical Manufacturer Organization

50%

Medical Device Other

Medical Device

Prefer not to say Clinical Research Organization

Clinical Research Organization

Clinical Manufacturer Organization

Clinical Manufacturer Organization Other Prefer not to say

Alberta 7% 9%British Columbia

Saskatchewan Alberta British Columbia

11% 20%

0%

©Stratford Managers 2017

52%

9%

0%

40%

11% 20%

40%

60%

60%

Other

Prefer not to say

Employee Opinion of the Biotech Workplace

©Stratford Managers 2017

©Stratford Managers 2017

Definitions

™

Definitions

Employee Opinion of the Biotech Workplace

Organizations are scored on four key Definitions indices.

• Organizations are scored on Performance four in keyeach indices.index is a score out• of 100 points.

Performance in each index is a score out of 100 points. is excellent

• 80-100 • 80-100 is excellent performance performance 60-79 isperformance strong performance • 60-79 is •strong • 40-59 is fair performance • 40-59 is •fair performance 39-0 is poor performance • 39-0 is performance • poor The relative performance of

each index should drive The relative performance organizational effort. of each index should drive organizational effort.

Job Clarity Understand job requirements and how employees contribute to organizational success.

Job Clarity Understand job requirements and how employees contribute to organizational success.

Organizational Climate Organizational Climate Design aspects of the organization and job that Design aspects of the organization and job that empower employees to be most effective. empower employees to be most effective.

Recognition and Reward Recognition and Reward Acknowledge employee dedication and contribution Acknowledge using availableemployee organizationaldedication resources. and contribution using available organizational resources.

Visionary Leadership Focus effort and develop commitment toward achieving theVisionary organization's Leadership mandate.

Focus effort and develop commitment toward achieving the organization's mandate.

©Stratford Managers 2017

©Stratford Managers 2017

14 BIOTECHNOLOGY FOCUS October/November 2017

™

™

Special Report:

the Biotechnological HR landscape in Canada

“When you look at the survey results at a high level, there was pretty good consistency between what we saw in 2015 and what we are seeing in 2017. But the one demographic whose responses showed more strongly than in 2015 — probably a reflection of the changing workforce — was from employees who have less than 10 years of tenure…” — Dean Fulford, Vice President of HR Consulting with Stratford Managers Corporation

Employee Opinion of the Biotech Workplace Response by Index Reward and Recognition Index 2017

Search for reward and recognition

Reward and Recognition Index Q21. This organization provides flexibility that enables me to balance between work and non‐work activities.

54%

Q20. I am satisfied with the benefit plans that are offered or available.

52%

18%

Q16. I am encouraged to continually develop my skills.

44%

Q17. This organization invests in my continuous learning and development.

43%

17%

Q19. I am compensated fairly based on my performance and contribution.

41%

23%

Q18. I feel that my hard work and contributions are recognized.

39%

28%

0% N=124

Strongly agree (6‐7)

5

4

15% 2% 9%

20%

26% 14% 11%

15%

7% 8%

15%

6% 8%

7%

19%

13%

12%

11% 9%

13%

10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 3

Strongly disagree (1‐2)

©Stratford Managers 2017

Reward and Recognition Index 2015

With birthdates bookmarked by the cultural and technological upheavals of the 1980s and early 2000s, millennials have been alternatively dismissed as a tech-immersed generation or savants of the future depending on who you speak to.

Disdained in some workplaces, embraced in others, it is an inevitability that millennials will be taking over the roost once held by exiting baby boomers in every sector.

Although millennials were not a specific focus of this year’s survey, there was a palpable sense of their presence in the feedback pollsters received, according to Dean Fulford, vice-president of HR consulting at ™ Stratford Managers.

“When you look at the survey results at a high level, there was pretty good consistency between what we saw in 2015 and what we are seeing in 2017,” said Fulford. “But the one demographic whose responses showed more strongly than in 2015 — probably a reflection of the changing workforce — was from employees who have less than 10 years of tenure…This group is seeking increased recognition, more responsive feedback from managers and supervisors, and a change in the reward practices of employers.”

This requirement of employers, he said, is generally associated with millennials.

October/November 2017 BIOTECHNOLOGY FOCUS 15

Special Report:

the Biotechnological HR landscape in Canada

Employee Employee Opinion of Opinion the Biotech of the Workplace Biotech Workpl mployee Employee Opinion Opinion of the Biotech of the Biotech Workplace Workplace Respondent Demographics Respondent Demographics Respondent Demographics Respondent Demographics

pondentRespondent Demographics Demographics GENDER

ORGANIZATION SIZE SIZE AGE GROUP AGE GROUP ORGANIZATION

GENDER

10% 0%

10% 0%

8%

5% 5%

3% 5%3% 5%

8% 29%

50% 40%

50% 39%

Female

Other

Male Prefer not Female to say

Other

1 to 9 employees 10 to 49 employees 50 to 99 employees 100 to 499 employees 25-34 18-24years yearsold old 500 employees or more 35-49years yearsold old 50-64 Don’t know 65+ years old Prefer not to say Prefer not to say

18-24 years old 35-49 years old 65+ years old

Prefer not to say

10%

In 2015, when asked to comment on the phrase “I feel that my hard work and contributions are recognized,” 41 per cent of respondents signified that they strongly agreed with the phrase. Twelve per cent said they strongly disagreed with it.

Two years later, there was a slight drop (down to 39 per cent) in the number of employees that felt their suggestions were wel-

18%

™

24%

©Stratford Managers 2017 ™

18%

16%

24%

2 to Less 5 years than 2 years

2 to 5 years

6 to 10 years

11 to615 years to 10 years

11 to 15 years

16 to 20 years

Over16 20toyears 20 years

Over 20 years

Prefer not to say

©Stratford Managers 2017

™

disagreed went down to 12 per cent.

Stratford Managers believe there is a substantial population of millennials in the biotech sector.

Fulford estimates that that about 13 per cent of survey respondents have less than two years of tenure on their workplace. Even accounting for other factors, he said, at least five to 10 per cent of the responses were from millennials.

EmployeeEmployee OpinionOpinion of theofBiotech Workplace the Biotech Workplace Respondent Demographics RespondentRespondent Demographics Demographics ROLE TYPE ROLE TYPE Prefer not to say Other Product and Customer Support Marketing and Sales MIS/IT Intellectual Property (IP) Management Manufacturing Quality Assurance Administration Business Development Regulatory Affairs Research Clinical Research

Prefer not to say Other 10% Support Product and Customer 4% Marketing and Sales MIS/IT 6% Intellectual Property (IP) 0% Management 3% Manufacturing Quality Assurance Administration 3% 1% Business Development Regulatory Affairs 8% Research 5% Clinical Research

5%

16%

JOB LEVEL JOB LEVEL

4% 6%

10%

22%

0% 3%

66% 16%

4% 10%

20%

30%

40%

4% 0%

10%

20%

16 BIOTECHNOLOGY FOCUS October/November 2017

22%

31%

3% 31% 1% 8% 5% 5%

0%

6%

6%

4%

4%

30%

66% Entry Level Intermediate Level Don’t know

40%

Junior Level Senior Level Prefer not to say

Entry Level Junior Level Intermediate Level Senior Level ©Stratford Managers 2017 Prefer not to say Don’t know

©Stratford Managers 2017

13%

Less than 2 years

Prefer not to say

comed. Thirteen per cent said they strongly disagreed with the phrase.

When asked in 2015 if they were “compensated fairly” based on their performance and contribution, 42 per cent on the respondents strongly agreed and 13 per cent strongly disagreed.

In 2017, the number of employees that strongly agreed went down a notch to 41 per cent. The number of those that strongly

3% 18% 18% 8%

16%

10%

19%

TENURE

13%

8%

18%

1 to 9 employees 10 to 49 employees 50 to 99 employees 100 to 499 employees 25-34 years old 500 employees or more 50-64 years old Don’t know Prefer not to say Prefer not to say

©Stratford Managers 2017©Stratford Managers 2017

Respondent Demographics

18%

39% 19%

Male

3%

29%

42%18%

42%

40%

3%3%

18%

TENURE

™

™

Special Report:

Employee Opinion of the Biotech Workplace the Biotechnological HR landscape in Canada

ToptoEmployee Commitment professional Engagement Drivers Top Employee Engagement Drivers development sought The number of people strongly agreeing that their organizations is committed to professional development also slipped.

Two years ago, 47 per cent of respon19 different dents strongly agreed that they were encouraged to continually develop their skills. organizational Forty-four per cent strongly agreed that their activities organization invested in their were continuous learning and development. reported as being In 2017, those numbers slid to 44 per cent to and 43 per centimportant respectively.

Employers need to do a better job of proemployees; the moting what they are doing for employees’ top 5 most development, Fulford said.

“This is a critical factor in talent retention and a very weighty important are factor when it comes to employee engageshown ment in any workplace.”

19 different organizational activities were reported as being important to employees; the top 5 most important are shown Opportunity for career advancement

23%

Professional development opportunities

24%

Challenge employees with greater responsibility or increasing variety of their tasks

28%

Strong leadership from senior management

30%

Flexible work schedules

31%

0%

10%

Employee Opinion of the Biotech Workplace Response by Index

Visionary Leadership Index 2017

Visionary Leadership Index

Q7. Our organization provides value to the public/community.

©Stratford Managers 2017

71%

Q1. I feel a strong sense of belonging to this organization.

17%

56%

23%

11% 2%

8% 6% 7%

Q2. I would recommend my company as an employer to a friend.

52%

22%

11% 6% 8%

Q4. I believe strongly in the organization’s vision and values.

51%

23%

11% 7% 8%

Q5. In this organization, senior management provides great leadership.

45%

Q6. I am confident that senior managerment strategies will help the organization achieve success.

44% 0%

N=142

Strongly agree (6‐7)

5

4

13%

13%

11%

22%

14% 9%

15% 14%

10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 3

Strongly disagree (1‐2)

©Stratford Managers 2017

Visionary Leadership Index 2015

20%

30%

There’s a perception that employers are not investing in professional development

Thumbs up on leadership Employers received positive feedback when it came to showing leadership.

“The responses showed an increase in the perception of leadership strength,” Fulford noted. “Whatever it was that leaders have taken on since 2015, they seem to be getting a positive reaction.” ™ Forty-five per cent of respondents in 2017 strongly believe that senior management “provides great leadership” in their organization. Two years ago, that number was only 43 per cent.

Forty-four per cent of respondents also said they were confident that senior management strategies will help the organization achieve success. That’s up one per cent from the 2015 survey results.

“Overall, we see an increased confidence in leaders because leaders are communicating sound plans for the organization and its goals,” according to Fulford. “What generally contributes to this sense is a stronger and more specific communication of business strategies, where the organization is headed, and how employee effort directly contributes to this success. Leaders, keep it up!”

October/November 2017 BIOTECHNOLOGY FOCUS 17

40%

™

Special Report:

the Biotechnological HR landscape in Canada

Employee Opinion of the Biotech Workplace Response by Index

Job Clarity Index

Job Clarity Index Q13. I can generally decide for myself the best way to get my work done.

83%

9%

4%

Q9. I understand how my work directly contributes to the overall success of the organization.

81%

12%

2%

Q8. I know what is expected of me at work.

74%

Q12. I have the information I need to make decisions about my work.

59%

Q10. We have indicators that measure the performance of my team.

46%

Q11. Information and knowledge are shared openly within this organization.

5

4

3

20%

8%

12%

23%

42% 0%

Strongly agree (6‐7)

12%

18%

24%

14%

20% 40% 60% Strongly disagree (1‐2)

2% 6%

5% 8%

8% 80%

12% 100%

bilities. Also significant, is that more than half of the respondents said they are encouraged to “openly and honestly” communicate their views at work.

Workplace flexibility and open, professional communication practices are elements of a workplace that drive employee engagement and motivation.

Sectoral growth anticipated “Overall, the survey demonstrates that working in biotech remains exciting,” said Janet LeClair, senior HR consultant with Stratford Managers. “It is a growing industry and in Canada, we need to focus on two key areas.”

These areas, according to LeClair are: • The continued encouragement of entry into the science, technology, engineering, and ™ math (STEM); and, • Preparing for growth in the sector.

Employee Opinion of the Biotech Workplace N=130

Response by IndexOrganizational Climate Index ©Stratford Managers 2017

Organizational Climate Index Q14. I am encouraged to make suggestions to improve our work processes.

62%

Q22. This organization cares about the health, safety and well being of its employees while at work.

61%

Q3. Knowing what I know now, I would apply to work here again.

16% 22%

53%

Q24. I am provided with the resources (tools, technology and processes) needed to fulfill the responsibilities of my…

22%

50%

Q23. I am encouraged to openly and honestly communicate my views at work.

50%

Q15. I receive constructive feedback from my manager that helps me improve my contribution at work.

43%

11% 2% 9% 6%2% 8% 11% 6% 8%

27% 19% 24%

8% 10% 5% 16% 15%

8% 7% 9%

9%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% N=143

Strongly agree (6‐7)

5

4

3

Strongly disagree (1‐2)

©Stratford Managers 2017

Job clarity and organizational climate

Job clarity was an important factor that came up in the 2015 survey.

This year, a majority of respondents continued to show overall awareness of the impact of their jobs to their organization’s success.

Additionally, a large number of respondents were also positive about different aspects of the organizational climate they encounter in the workplace.

Over 90 per cent of respondents said they generally can decide for themselves the best way to get their job done. Furthermore, 81 per cent strongly agreed that they are cognizant of how their work directly impacts the overall success of their organization. Another 74 per cent said they know what is expected of them at work.

Job clarity is a crucial driver of employees’ engagement in their organization. Being clear 18 BIOTECHNOLOGY FOCUS October/November 2017

on job and outcome expectations allows employees to keep their focus on tasks that are more relevant to success – both theirs as well as that of the organization.

Biotech employers are also showing that workers’ health and well-being are important to the organizations.

Nearly three-quarters of respondents agree that their organization provides the flexibility they need to integrate work and life responsi-

Boosting enrollment in STEM courses will ensure a solid pipeline of educated professionals for the local biotech sector. As the industry grows, LeClair said, employers need to prepare how they will transition from small start-ups to large-scale operations requiring a bigger pool of diverse skill sets.

As these developments unfold, it will become increasingly important to develop new leaders, she said.

“Leadership development, coaching and mentoring are necessary components in growing businesses and more especially so in the fast-growing biotech sector where it is common for technical experts to be placed in leadership positions often pre-maturely,” LeClair™ pointed out. “Continuous leadership training may foster increased confidence in the organization and increase buy-in to overall senior management strategies.”

Even start-ups should pay attention to employee rewards and recognition, she added.

“As competition heats up and employees have more choice of where to work, the most robust recognition and employee development programs will win the day,” according to LeClair.

“Boosting enrollment in STEM courses will ensure a solid pipeline of educated professionals for the local biotech sector. As the industry grows, employers need to prepare how they will transition from small start-ups to large-scale operations requiring a bigger pool of diverse skill sets.” — Janet LeClair, Senior HR Consultant with Stratford Managers Corporation

Special Report:

the Biotechnological HR landscape in Canada

For 2017, employees gave their employers high marks.

“Employers should be happy because employees are showing a high level of commitment to the organizations they work for,” according to Fulford. “Overall it’s a very positive set of results and employers should be heartened by that.”

However, while sectoral key indicators remained largely unchanged since 2015, Fulford said, this year’s survey contains several Performance key takeaways which Performance biotech employers onto.all indices should pay close attention

Index Performance

Employee Opinion the Biotech Workplace Performanceof on all indices remains strong, and virtually Employee Opinion of the Biotech Workplace unchanged since 2015 Index Performance

Organization Climate Index • This index is weaker for employees in the 6-15 year tenure range, indicating a point where employees are increasing their expectation of their organizations (more involvement, more feedback, better tools).

This is after years 1-5 where employees are still learning their role.

• Performance in this index weakens as organization size grows, driven by perceived organizational constraints on communicating openly and contributing toward ongoing improvement.

2015 2015 2017 2017

77% 77% 77%

-1 -1

67% 67% 66% 66%

2015 2015 2017 2017

©Stratford Managers 2017

Strong Strong Performance Performance

Recognition and Reward Recognition and Reward

0 0 77%

Organizational Climate Organizational Climate

Strong Strong Performance Performance

judgment to complete work at the expected level of contribution.

• Performance continues to be strongest in organizations with less than 100 employees alluding to increased access to relevant information for their work and more awareness of the direct impact of individual contribution to organization success.

Strong Strong Performance Performance

on all indices remains remains Top among them are: strong, and Job Clarity Index strong, and virtually • This index continues virtually to rise with organiunchanged zational tenure, indicating an improved unchanged awareness of job impact to organizational since 2015 since 2015 success and improved capability to use

Job Clarity Job Clarity

Strong Strong Performance Performance

Index Performance

Visionary Leadership Visionary Leadership

-1 -1

73% 73% 72% 72%

-1 -1

71% 71% 70% 70%

2015 2015 2017 2017

2015 2015 2017 2017

™

©Stratford Managers 2017

Recognition and Reward Index • Marginally weaker performance is fueled by perception about organizational commitment to professional development and recognition practices.

• Index performance is weakest among junior level employees (typically with less than 3 years of experience). This likely indicates the growing expectations of personal development and recognition in millennial group employees.

Visionary Leadership Index • The perception of employees in organizations with more than 50 workers of a decreased sense of belonging and lesser

™

confidence in senior leadership strategies, caused a slight dip in this index.

Employers should pay particular attention to the “slight dip” in scores pertaining employee perception of employers commitment to professional development.

“This is an important matter,” said Fulford.

“There’s a perception that employers are not investing in professional development.”

He pointed out that employer commitment to professional development is one of the key drivers of job satisfaction and talent retention.

Fulford suggests employers revisit and enhance the way they communicate their professional development strategies to employees, and directly influence that perception positively.

Employers should keep an eye on the rise of millennials in the workplace and develop strategies that would maximize the benefits gained from the strong points of this cohort.

“The numbers don’t lie, this is the group that will more and more be a part of all these organizations’ workforces going forward,” said Fulford.

To see this story online visit www.biotechnologyfocus.ca/ canadas-biotech-hr-landscaperevisited-a-new-force-in-the-horizon/ October/November 2017 BIOTECHNOLOGY FOCUS 19

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Innovator

| By Nestor Arellano

Vancouver biotech start-up becomes a leader in 3D bio-printing market One-time UBC spin-off, Aspect Biosystems charts the tissue engineering frontier with its Lab-on-a-Printer

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or as far back as he can remember, says Tamer Mohamed, he has always been intrigued by how things were built.

“When I think of engineering, I think of building things from the ground up. When I think of biology, on the other hand, I think of dissecting the human body down to its individual cells,” the young biomedical engineer told a very engaged crowd during a TEDx talk in Stanley Park in Vancouver this spring.

He might as well have been describing his team back at the Aspect Biosystems facility which is about a 25-minute drive away from where he was giving his talk. Tamer, who is the president and CEO of Aspect, leads a group of engineers, biologists, scientists, and clinicians. They work on a range of projects which primarily involve using a proprietary

3D bio-printing technology to print tissue cells which are then used to create structures that resemble human body parts such as a meniscus or an airway.

The first time I spoke with Tamer, was during an event in Toronto hosted by the Centre for Commercialization of Regenerative Medicine (CCRM). He was among the participants of a mock business pitch competition for biotech start-ups. They were not really competing for funding. The Dragons’ Den-style contest was meant to sharpen the business smarts of scientists.

Tamer didn’t win the top prize that day, but it probably shouldn’t be taken as an indication of his business acumen.

Some six months earlier, the company had just signed a deal with Johnson and Johnson Innovation that will see Aspect’s Lab-on-a-

Aspect Biosystems Team Left to right: Simon Beyer, Tamer Mohamed, Konrad Walus, Sam Wadsworth

October/November 2017 BIOTECHNOLOGY FOCUS 21

Innovator

Printer 3D bio-printing platform used to develop bio-printed knee meniscus tissue suitable for surgical therapy. The meniscus is the “shock absorber” of the knee. It is also one of the most commonly injured parts of the knee, especially among aging people.

Aspect is already making waves in the global tissue engineering space which is expected to be worth about US$11.53 billion by 2022. It had become pretty difficult not to run into the name of the company, whenever you made a Web search for 3D bio-printing.

This September, Tamer was selected by Business in Vancouver for their annual Forty Under 40 Awards. During the same month, Aspect was named one of the CIX’s (Canadian Innovation Exchange) Top 20 Most Innovative Canadian Technology Companies.

Before that, in June, Aspect won the Most Promising Start-up of 2017 award from Metabridge, an organization of technology CEO’s and founders that seeks to connect Silicon Valley tech start-ups with the counterparts from British Columbia.

Not too bad for a small biotech firm which was spun out of the University of British Columbia not more than four years ago.

UBC roots Aspect emerged from what Tamer calls as “a world-class collaboration” between a research group in UBC’s Faculty of Applied Science focused developing advanced printing technology for the creation of functional

Aspect Biosystems’ Lab-on-a-Printer technology is being developed to allow for the complex bio-fabrication of heterogeneous 3D tissues structures and a research group in the Faculty of Medicine focused on heart and lung disease research. To this day some members of that group remain with Aspect which is still pursuing the group’s fundamental mission.

Tamer, Ali Ahmadi, Simon Beyer, Anas Bsaul, Kelly He, and Shang Pan were conducting a bio-printing research in the Walus Lab which was founded by Dr. Konrad Walus within the Faculty of Applied Science and the Department of Electrical and Computer Engineering at UBC. The project involved “the design, fabrication, and characterization of inkjet printing technology that enables its integration with a common microfluidic module.”

“We have termed this concept as Lab-ona-Printer, an extension to the well-known Lab-on-a-Chip concept. Such a platform will enable on-chip processing of microfluids followed by their direct printing. Potential fields where this platform can be used include, but not limited to, combinatorial chemistry, tissue engineering, and printable electronics,” according to the Walus Lab research team.

They envisioned the technology helping cut down the number of drug candidates prior to clinical trial, thus drastically reducing the time of development and the cost of drugs. 3D

22 BIOTECHNOLOGY FOCUS October/November 2017

cell-based constructs could also reduce the need for animal testing in the drug development process.

Today, Tamer is president and CEO of Aspect, Walus is chief technology officer of the company, Beyer is chief product officer, and Sam Wadsworth, a former post-doctoral research fellow at the UBC Institute for Heart and Lung Innovation, is Aspects’ chief science officer.

Lab-in-a-Printer Aspect’s Lab-on-a-Printer technology is being developed to allow for the complex bio-fabrication of heterogeneous 3D tissues.

The platform integrates modular and disposable microfluidic print head cartridges. The print heads can accommodate various types of low and medium viscosity bioinks. This allows a range of cell type to be combined in a single print.

“We believe out Lab-on-a-Printer bio-printing technology has broad applicability and enables the production of common tissues for multiple applications in the life sciences, including pre-clinical disease modeling for drug development and clinical tissue therapies for regenerative medicines,” said Tamer. “By combining our platform expertise with the

Innovator One way of measuring a company’s true worth, is by obtaining third-party validation through partnerships with best-in-class pharma and biotech companies, thought leaders and top investors domain expertise in the field, we believe we could more quickly unlock the potential of bio-printing technology.”

Another key proprietary invention of Aspect is the 3DBioRin Airway. According to the company, the Airway the product is the world’s first 3D printed airway tissue that exhibits highly physiological contraction and relaxation responses in an in vitro setting.

The platform can be tailored for specific needs including modifying cell types, cell density, cellular micro environment, tissue architecture, and tissue stiffness.

The importance of collaborations Tamer’s advice to biotech start-ups is to cultivate an environment of collaboration” and “build your network before you need it.”

Collaborations are key to Aspect’s strategy for funding its R&D. In mid-September this year, the company

announced that it had completed its first institutionally led round of financing.

The private financing round was led by Pangaea Ventures and included investments

by Endure Capital, Pallasite Ventures, Relentless Pursuit Partners, and other new and existing investors.

Aspect will use the financing to fund ongoing technology and product development, expand its strategic partnerships and speed up the commercialization of its bio-printing platform.

A few days before that announcement, Aspect also sealed a collaboration deal with InSCREENeX GmbH of Germany and Fraunhofer ITEM (Institute for Toxicology and Experimental Medicine, Hannover, Germany).

The collaboration will expand the applications of Aspect’s 3DBioRing muscle tissue platform for use in developing models of other tissues including blood vessels, heart, and lung tissues.

“Personalized in vitro test systems that recreate the disease in a dish will take future drug development and regenerative medicine approaches to the next level,” according to Dr. Tobias May, CEO of InSCREENeX. “…we will join forces to develop unique personalized cell systems. These expandable and physiologically relevant cell systems will be used as building blocks to bio print contractile tissues with unparalleled physiology.”

One way of measuring a company’s true worth, according to Tamer is by obtaining third-party validation through partnerships with best-in-class pharma and biotech companies, thought leaders and top investors.

“Biotechnology companies are usually in the business of burning money for years and it is usually at least a decade until a company is able to demonstrate the meaningful value of patents,” Tamer explained. “Aspect has been fortunate to form collaborations with some of the biggest names in pharma and world-class academic researchers and bring on quality investors who believe in our bold vision.”

To see this story online visit www.biotechnologyfocus.ca/vancouverbiotech-start-up-becomes-a-leader-in-3dbio-printing-market/

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DOWNSTREAM October/November 2017 BIOTECHNOLOGY FOCUS 23

20th anniversary

| Compiled by Shawn Lawrence

Biotechnology 20th Anniversary Special: Years 10 to 12!

Biotechnology Focus in the years 2007 to 2009

We continue our celebration of Biotechnology Focus’ 20th anniversary with another look back at our past issues highlighting various moments in time that speak not just of then, but of today as well. This month we look back at past issues from the years 2007 to 2009, and while some issues are missing in our synopsis, you’ll see we’ve got most of the important ones covered.

January 2007

May 2007

Vol. 10, No. 1

Vol. 10, No. 5

On the cover, Shane Green delves into the science, ethical implications and politics of Stem Cell research in Canada. Next, John Sampali provides a practical guide to post-marketing observational studies, and rounding the issue out, MedBiogene’s Dr. T. Nathan Yoganathan is featured as our monthly innovator.

February 2007 Vol. 10, No. 2

Feature stories this month included a spotlight piece on the BC Cancer Agency and its unique bench-tobedside cancer research approach, an executive profile on then Neuromed CEO and president Christopher Gallen, and a technology piece on how to enhance the detection of phosphopeptides through electrospray mass spectrometry.

The massive 48-page issue marked our 10th anniversary and what a landmark edition it was! Inside you’ll find Pierre Bourassa and Dr. John Lawson offering up an in-depth look at Canada’s pharmaceutical history and its future, with Part 1 of HOW CAN CANADA SURVIVE IN A GLOBALLY-DRIVEN PHARMACEUTICAL MARKET. Next, Dr. Christian Burks covered the commercialization of genomics over the past 10 years.

June 2007 Vol. 10, No. 6

This issue not only features Part 2 in Pierre Bourassa and Dr. John Lawson’s series, Canada’s emerging biotechnology SMEs and how they can increase their value, but also an advice piece for sponsors to help them achieve a successful outsourcing relationship with their respective contract service providers.

September 2007 Vol. 10, No. 9

With an Alberta and Saskatchewan focus, this issue highlighted the work of the Alberta Research Council (which has evolved into the Alberta Innovates Corporations) , the Alberta Advanced Education and Technology group, Ag West Bio Inc. and the return of the Agricultural Biotechnology International Conference to Canada.

January 2008 Vol. 11, No. 1

October 2007

Vol. 11, No. 2

Hot topics from this issue include molecular diagnostic assays emergence as a new tool in physician’s arsenals, new biopharma methods for testing human specific biologics and McMaster University’s research on biosensors.

With MRSA on the rise in Canadian hospitals, we focus on a team of west coast Canadian researchers and their collaborative PREPARE project tackling infectious disease head on.

Next, Dr. Jim DeMesa of Migenix is our featured innovator, while in Across Canada, we look at shrinking VC investment and its impact on the Canadian medical device sector.

Rounding things out, the team at Gowlings list the top industry stories that made headlines in 2007, forecasting the opportunities and challenges to come for Canadian biotech.

2007

Vol. 1

Having just stepped into the Global HIV Vaccine Enterprise lead role, our featured innovator is Dr. Alan Bernstein. Other pieces in this edition cover translational research, personalized medicine, green fuels and biologics development.

February 2008 Vol. 10, No. 10

May

2007

prove just w comp its end the ris Mean tech”

June

Vol. 1

As pa Conv regula cusin plan, tre of and th in pla tive lo

2008

Biotechnology Focus in the years 2007 to 2009

2007 March 2007 Vol. 10, No. 3

On the cover, the Saskatchewan Research Council profiles its Biofuels Test Centre and ethanol-fuelled prototype vehicles, while inside Gord McCauley of Allon sheds light on what it takes to start up a biotech company and Michael Fenwick offers up his tips on how to attract VC money.

April 2007 Vol. 10, No. 4

In the spotlight, Bill Gates announces his retirement as head of Microsoft to focus on the biotechnology industry via the Gates Foundation, while also in this issue, we highlight the emergence of functional genomics, proteomics and personalized medicine as 21st century approaches to complex diseases.

July 2007

Vol. 10, No. 7 In our cover story, we look at protein overexpression in Escherichia coli with researchers engineering bugs to make them more productive and robust in protein synthesis as they are being cultured. Next, our Across Canada section spotlights the Sentinel Bioactive Paper Network’s efforts to tackle pathogens, communicable disease, dangerous bacteria and viruses such as E. Coli, salmonella and the SARS coronavirus. Finally, we review Agilent’s MAQC platform as a tool for gene expression measurements.

August 2007 Vol. 10, No. 8

As a follow up to the May media frenzy that came with then Governor of California Arnold Schwarzenegger’s visit and huge announcement of a joint research pact between his government and Ontario’s, we go oneon-one with OICR’s Dr. Tom Hudson to better understand how having the two jurisdictions working together will advance cancer research globally.

24 BIOTECHNOLOGY FOCUS October/November 2017

November 2007 Vol. 10, No. 11

On the cover is Dr. Brad Thompson of Oncolytics Biotech Inc. who talks about his company’s use of a reovirus, Reolysin, to treat cancer.

Next, experts weigh in on the pros and cons of conducting clinical development in Canada. Closing the issue out, we explore the impact of imaging fluorescent proteins to the life sciences.

December 2007 Vol. 10, No. 12

This month we review emerging biotechnologies that exploit alternative splicing, go one-on-one with innovator Greg Hines of Arctic Dx, and profile the Canadian Light Source Synchrotron.

March 2008 Vol. 11, No. 3

Inside, we talk about proteomics as an expensive science, pharma’s new worldview of transforming R&D through emerging markets and the eco-efficiency of green buildings.

April 2008 Vol.11, No. 4

This month, Shane Green looks at a number of key developments in stem cell research over the course of 2007/08, including the work of research teams in Japan and the U.S. showing for the first time that human dermal fibroblasts-skin cells-can be reprogrammed to a pluripotent state ( iPS cells). We also take an in-depth look at Canada’s leading public health infectious disease laboratory, the National Microbiology Laboratory, and the importance of a Canadian biotech patent strategy. In research news, McEwan Centre for Regenerative Medicine researcher Gordon Keller grows the earliest form of human heart cells from embryonic stem cells.

July

Vol. 1

As pa Peter Cana to Ch the b ment launc Stem

Aug Vol.

clinic drugs spotl Regu neuro

bal , n dition and

a’s R&D he .

20th anniversary We hope you enjoyed this retrospective look at Biotechnology Focus Years 10 to 12. Be sure to check back to see our next timeline piece for 2010 to 2012!

May 2008

Vol. 11, No. 5 Sometimes we guess right, sometimes we guess wrong. Our cover story suggesting Vasogen was on the road to commercialization proved the latter disappointingly, as just weeks after going to print, the company’s Phase 3 trial failed to reach its endpoint. A lesson learned on the risky business nature of biotech.

Meanwhile, in terms of trends, “Cleantech” becomes a biotech buzzword.

June 2008

Vol. 11, No. 6 As part of our annual special Bio Convention issue, we return to our regular Ontario spotlight format focusing on the province’s innovation plan, its reputation as a leading centre of stem cell and cancer research, and the programs and funding put in place that make Ontario an attractive location to set up shop.

September 2008 Vol. 11, No. 9

This marked our inaugural Hot Button issue edition, and among its highlights were the responses from our readership to our market analysis and industry trend surveys. The main take-away from your responses back then was that Canadian biotech companies would benefit from more business friendly government policies, and easier access to capital.

While Canada’s government has changed, the Canadian biotech wish list hasn’t.

October 2008 Vol. 11, No. 10

In this edition, David Young talks about the massive cash deal which brought his company (Arius Research) into the Roche family.

Meanwhile on a macro level, the effects of the 2008 financial crisis hit the Canadian biopharma industry hard.

January 2009

September 2009

Vol. 12, No. 1

Vol. 12, No. 9

Feature stories in this edition include: McMaster’s Dr. Sheila Singh’s quest to treat Medulloblastomas, Dr. Joseph Elliot’s choice to go the virtual company route, Peter Lambert explains the need for efficient, small batch, aseptic liquid processing and fill/finish operations, and finally, experts weigh in on ultraviolet light decontamination vs. high heat sterilization in cell culture. On the discovery front, McMaster’s Mick Bhatia finds a way tell the difference between normal and cancer stem cells.

This was the third in our Hot Button Issue series, and well known life science investor David Sable was the big name contributing an analysis piece. Inside we also reviewed BIOTECanada’s blueprint for a bio-based economy, Beyond Moose & Mountains, and previewed the first ever Canadian Science Policy Conference.

February 2009 Vol. 12, No. 2

Scott Cormack of OncoGenex is this month’s executive profile with the Cooley Godward Kronish LLP Canadian team contributing a piece on issues surrounding Section 116 and hypothesizing that its existence is a major reason for the lack of VC dollar crossing the border into Canada.

2008

October 2009 Vol. 12, No. 10

As a response to the success of our Bio International Convention Ontario editions, the folks in Quebec decided to work with us on a special issue showcasing their province’s strengths in the sector. Montreal InVivo took a lead in putting this issue together, profiling their world-class biotechnology city. Other key stories centered on CQDM, ICAV, and even big pharma companies Pfizer Canada Inc. and Merck has a part in this exceptional story lineup.

2009 2009

July 2008

Vol. 11, No. 7 As part of this outsourcing issue, Peter Pekos makes his case against Canadian companies outsourcing to China. We also look at some of the big Canadian biotech announcements from BIO 2008, including the launch of CQDM and the Cancer Stem Cell Consortium.

August 2008 Vol. 11, No. 8

The lead story this month is Jon Daniels’ and Geoff Goodfellow’s co-written piece on the regulatory harmonization of the nonclinical development of anticancer drugs, while other articles include spotlight pieces on the International Regulome Consortium and Canadian neurobiologist Dr. Samuel Weiss.

November 2008

April 2009

Vol. 11, No. 11

Vol. 12, No. 4

Inside this edition: Nansheng Chen talks Bioinformatics in the Era Of Genomics. Next, we take a closer look at the unique partnership between universities, hospitals, biotechnology companies and the pharmaceutical industry and the choice to launch CQDM to help stimulate pharmaceutical research and accelerate drug discovery.

Capping things off, our readers were first introduced to a rising industry star, Dr. Ali Tehrani of Zymeworks Inc.

Dr. Lincoln Kim takes the cover, and inside he discusses his involvement in one of the Ontario’s biggest biotech deals: an international collaboration between Toronto researchers and world renowned stem cell researcher Dr. Shinya Yamanaka, and also the creation of the Ontario iPS cell facility.

Next, staff writer Tonya Costoff answers the question where does Ontario’s future lie in cleantech; and in regulatory news, Health Canada approves its first subsequent entry biologic (SEB), a biosimilar for Ominitrope.

December 2008 Vol. 11, No. 12

Therapure Biopharma opened its doors and Mississuaga and we went one-on-one with the management team behind its launch. Also in this issue, Francois Lebarbenchon discussed the do’s and don’ts of deploying a well thought out outsourcing strategy and Jeff Doan dispells myths surrounding the Canadian pharmaceutical market.

November 2009 Vol. 12, No. 11

August 2009 Vol.12, No. 8

The second of a two-part series on China’s Drug Valley is our main feature from this issue.

Also, Annon Gonenne talks cancer specific antigens, and staying with the cancer theme, the team at OICR explain the ways to improve cancer clinical trial efficiency and effectiveness.

Michael Herman gets things going with his piece on the increase of merger and acquisition activity in Canada, seeing it as a possible solution to the funding/ financial crisis. We also looked at new therapeutic approaches for improving nerve growth and function following spinal cord injury.

While In industry news, Canadian biotech companies prepare to learn a new language of financial reporting with the International Financial Reporting Standard on the horizon. On the research front, BC scientists are the first in the world to decode the genetic evolution of breast cancer tumours.

October/November 2017 BIOTECHNOLOGY FOCUS 25

PERSPECTIVE

Culture:

Sponsored Content | By The Thrive Partnership Group (Glenn Busby, Jon Rogers, and Robert Seguin) and Environics Research (Dr. David Jamieson)

The secret weapon of winning corporations A guide to how culture plays a key part in building a high performing team

I

n the October/November 2015 issue of Biotechnology Focus, the results of an online survey of employees in the Canadian Biotechnology and Life Science sector were published and explored.

The results suggested an industry staffed by generally happy and engaged employees: • Employees rated their company as providing a “strong performance” on all four key aggregate indices: Job Clarity (77 per cent), Organization Climate (72 per cent), Visionary Leadership (71 per cent), and Recognition & Reward (67 per cent) • The number one thing organizations do well, is empowering employees to do their jobs in the best way they know how.

• Employees were most engaged by flexible work schedules, strong leadership from senior management, professional development opportunities, challenging employees with greater responsibility/variety, and rewards for performance The results, while good news overall, do raise several important questions: 1. In an industry where employees are generally satisfied, how can an individual company truly stand out to become the employer of choice in terms of recruitment, engagement, and retention?

2. How can a company deliver more than great employee engagement; how can it create a strategic culture that is a true “force multiplier” to improve business results over the long term?

realized that certain companies have no obvious technical, structural, or cost advantage, and yet they nonetheless consistently outperformed their peers. These successful companies were driven by people and culture.

Culture and employee engagement became the new, sought-after competitive advantages.

Unfortunately, the focus on engagement, while important and highly measurable, has led some companies to miss the mark on three key points: 1. Culture should be a strategic choice; 2. Measurement only works if you measure the “right” things; and 3. Actions speak louder than surveys.

This article will explore what employers can do to define, measure, and lead their desired operating culture in today’s dynamic Canadian biotechnology and life science environment.

People are typically the largest single corporate cost. Historically, this drove waves of costcutting and employee-shedding. While some leaning down was needed, most companies learned that over the long term, you cannot cut your way to growth. Successful leaders

In our experience, companies that understand these principles and undertake a carefully planned and executed approach to implementing them, can strengthen their organizational culture to further increase team productivity and sustainably accelerate business performance. In our Thrive Culture process, the path to successfully building a strategic culture has three deceptively simple but actually quite challenging steps:

26 BIOTECHNOLOGY FOCUS October/November 2017

1. Define Culture should be a strategic choice.

We view culture as the collection of values, beliefs, and behaviours that collectively define “who we are” and “how we do things around here”. Some suggest that culture is effectively an “accident of history” – something that comes to be over time based on leadership behaviours, personal experiences, etc. At Thrive, our belief is that we are products of our experiences, but effective leaders deliberately and actively plan and shape culture, evolving it over time. Importantly, leaders must avoid the pitfall of attempting to define their organization’s desired culture from only their perspective. Closed door executive team vision and values defining sessions tend to yield wonderful plaques for the wall, but often miss the mark, because they fail to take into account what internal and external stakeholders see, believe, and want. Therefore, the process must include careful stakeholder identification, stakeholder understanding, and structured data review, values definition and selection. “Typically, we engage all stakeholders and work with the executive

PERSPECTIVE

Sponsored Content

Table1: Common culture fallacies – The traps many leaders fall into versus the ideal approach Fallacy

Ideal

Culture just is. It is the accidental sum of history.

Culture is actively planned and crafted by leadership.

Leadership alone can define culture.

Stakeholders, both internal and external, are crucial inputters to the definition process.

Culture and business strategy are separate.

Culture is actively linked to and reinforcing of business strategy.

Engagement is the goal.

Engagement to the right, strategic culture is key.

(organizational) and at the individual or ‘micro’ level,” according to Glenn Busby of the Thrive Partnership Group. “In particular, companies need to identify the ‘game changers’; people who are the de-facto key influencers and leaders in the company and often set the tone on culture by nature of their role and/or charisma and personality, and help them see their impact on the culture, good and bad.

Then, most importantly, companies must help them adjust their behaviours to make a positive contribution, rather than a contamination, of the desired company culture”. To be successful, this process can require a great deal of coaching and facilitation. That’s because results flow not from theoretical understanding, but from self-awareness and specific, relevant behaviour changes.

Culture change and business results team to craft core values/behaviours. This is done through interviews, group discussions, work sessions, measurement tools and processes, and balance checks between global/ local issues and corporate/department differences”, according to Dr. David Jamieson, chief scientist at Environics Research, analytics partner of The Thrive Partnership Group.

Careful planning and defining of culture must also be actively linked to, and reinforcing of, business strategy. Culture cannot exist in a vacuum. The slow-moving, risk averse bureaucratic culture of a large bank would cripple a Silicone Valley start-up. At the same time, that start-up’s free-wheeling, innovative, non-hierarchical, risk-taking culture might bankrupt the large bank. Even within the same industry, companies pursue different strategies, and their cultures should reflect and align to the differences. This is also where employee engagement can be an inadequate measure. Being highly engaged to a strategically wrong and ineffective culture will not drive positive business results.

The culmination of this first step is typically a statement of the desired Operating Culture based on 1-3 Core Value drivers to optimize employee engagement and performance, and customer engagement.

2. Measure Measurement only works if you measure the “right” things Having defined their ideal strategic culture, companies must periodically measure and benchmark how they are performing versus their culture goals. As the saying goes, “you manage what you measure.” At this stage, we would suggest customized measurement.

If you have defined a unique culture, you

should measure the variable that you defined as important. That is not to say that you cannot also use more generic engagement surveys or similar tools. These can be valuable, particularly as they can often be benchmarked versus other organizations. That said, “We recommend seeking highly tangible and actionable data; taking regular pulse checks on both employee and stakeholder experience and perspective on your specific appropriate Values and Behaviours. This is achieved through the right blend of standard and customized measurement and research tools and includes the input of both internal and external stakeholders”, explains Robert Seguin, partner, Thrive Partnership Group.

3. Lead Actions speak louder than surveys To optimize their culture, organizations understand they must ensure the behaviours of their leaders and employees are aligned to the stated core values. Influence and results flow from individuals outward; they level and shape values, behaviours and culture, which drives employee and client engagement, which deliver results.

Crucially, many organizations drop the ball at this stage. After measuring where they stand versus their desired culture (or level or employee engagement, etc.), they fail to take a deliberate and planned approach to action. We often see that the best leaders and managers take measurement results to heart, seek to improve, and take action (even if they need to change the least), while the average and worse leaders often do not. In our experience, it is crucial to “develop action plans to optimize performance at the ‘macro-level’

In our experience, companies following these three steps rigorously have seen results that have been extremely meaningful. Here are two industry leaders who have lead their organizations through the Thrive Culture 3-step process describing their outcomes: • “Culture is a hallmark of Genentech’s corporate strategy. To ensure we maintain our competitive advantage, we are using the “Thrive Culture” process in our Franchise to augment our internal engagement data to really understand the root causes of our successes and to identify areas where our leaders can make adjustments. We really appreciate the depth of understanding we receive and the practical tools the “Thrive” process provides to help us to better role model the behaviors that have the most impact on employee performance and customer value.” — Warner Biddle, vicepresident and franchise head, Genentech.

• “We’ve used the “Thrive Culture” process to help us define, measure and lead the culture we want to have here at Otsuka Canada. Not only has it helped us achieve unsurpassed levels of employee engagement in the Canadian life science industry, but to achieve global best-in-class results”. — Joanie Michel, associate director, human resources, Otsuka Canada Pharmaceutical Inc. In a challenging competitive environment, with often limited ability to differentiate, life science leaders should look increasingly to building a strategic “thriving culture” to generate competitive advantage.

To see this story online visit www.biotechnologyfocus.ca/culture-thesecret-weapon-of-winning-corporations/ October/November 2017 BIOTECHNOLOGY FOCUS 27

CALENDAR November 2017

Phone: +49 89 2388 756 0 EmaiL: conferences@ebdgroup.com Web: https://ebdgroup.knect365.com/ bioeurope/about-bio-europe

November 6 – 7 1/31/2013 9:09 AM Page 1 WG Meeting 44th EEE-PT

United Kingdom Web: http://ilac.org/event/44th-eee-pt-wgmeeting/

November 13-14 19th World Congress on Biotechnology Osaka, Japan Phone: 1-650-889-4686 Email: biotechasia@conferencesworld.org Web: https://biotechnologycongress. conferenceseries.com/

November 6 – 8 BIO Europe Berlin, Germany

SRC101

November 13- 14 Pharmaceutical Microbiology East Coast Iselin, NJ Web: https://www.smi-online.co.uk/ pharmaceuticals/northamerica/PharmaceuticalMicrobiology-East-Coast/booknow

November 28-29 Pharmaceutical Serialisation and Traceability 2017 Vienna, Austria Phone: +44 (0)207 036 1300 Email: enquire@iqpc.co.uk Web: https://pharmaserialisation.iqpc. co.uk/?utm_medium=portal&mac=PMIQ_Events_ Title_Listing

November 30 – December 1 Lab-on-a-Chip, Microfluidics & Biosensors Asia Dayuan District, Taiwan Web: https://10times.com/lab-on-chipmicrofluidics-biosensors-asia

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C86 Buying Influence A Authorize

B Recommend

A B C D E F G

Analysis Instruments Basic Lab Equipment Chemicals/Biochemicals Chromatography – Gas Chromatography – Liquid Filtration, Water Purification LIMS

H I J K L M Y

Liquid Handling & Sample Prep Microscopes, Optics, Cameras Safety & Hygiene Spectroscopy Testing Systems/Equipment Vacuum Equipment None of the Above

C88 Product Development Stage (check all that apply)

COMPANYs PRIMARY BUSINESS ACTIVITY 50 50a 50b 50c

C87 Which products are used in your lab?

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A Research/Development B Pilot/Scaleup

C Production/Manufacturing D Tech Transfer E Not applicable

C89 Are you building a new lab?

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December 2017 December 1 2017 Annual Life Sciences Policy Forum Borden Ladner Gervais LLP, Toronto Phone: 416-426-7293 Email: admin@lifesciencesontario.ca Web: http://www.lifesciencesontario.ca/events/ eventsCalendar/PolicyForum2017.php

December 5 -8 Microbiology Havana, Cuba Web: https://10times.com/microbiology-ui

December 7 – 9 20th International Conference on Pharmaceutical Biotechnology Madrid, Spain Email: pharmabiotech@ pharmaceuticalconferences.org Web: http://biotech.pharmaceuticalconferences. com/

December 13- 15 IEEE Life Science Conference Sydney, Australia Web: http://lsc.ieee.org/2017/

January 7-11, 2018

C90 We have the following enewsletters: 1 2 3 4

Biotechnology Focus eBulletin Laboratory focus eBulletin BioPharma BioMedical

5 Health Care 6 Agri-Food 7 Clean Tech 8 Industry Inte

For a quick response please fax: 905-727-4428 or e-mail: circulation@promotive.net

28 BIOTECHNOLOGY FOCUS October/November 2017

BIO One-on-One Partnering San Francisco, California Web: https://www.bio.org/events/one-on-onepartnering-jpm

CLINICAL TRIALS

| BY JOHN AMRHEIN

THE BEST DESIGNED TRIALS ARE ADAPTIVE-BY-DESIGN Adaptive design helps sponsors determine if a therapy is going to fail or not.

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ood study design includes thoughtful planning and involves bringing subject matter experts, like statisticians, in early. Statisticians can take existing or historic trial data for a particular disease area and create hypothetical scenarios that can inform the shaping of a tighter, better designed trial. Good planning hones each aspect of a trial making it responsive, integrative of candidate data, and improves return on investment. Good design = good data.

So, how do we launch a trial that is good by design?

An approach to clinical trials popularized in the mid-1990’s, the concept of adaptive-bydesign allows for adjustments and modifications during the clinical trial, making the study responsive in real-time, particularly when paired with an eCRF - but that’s for another article.

Adaptive design helps sponsors determine if a therapy is going to fail – and if so, to help it fail early, to shorten timelines and reduce cost. We know that analysis is inextricably tied to the study of design; when you decide on a design, you are largely deciding on the

analysis. Bearing this in mind, let’s look at two scenarios that illustrate the benefits of adaptive trial design.

A look at two case studies In our first example, a biotech company developing a product to treat sexual dysfunction learned through a phase 2 study that the drug was showing high variability among patients due to the timing of medication, and that there was a placebo effect. They also did not have evidence to inform the optimal dose.

Solution: we designed a study that had a placebo run-in phase so that only patients that were placebo non-responders were brought in. Data was collected on different timing of medication from subject matter experts to deduce what timing to recommend in the phase 3 study. Then, stratified patients performed two interim analyses to confirm sample size.

Finally, computer models were created under different scenarios to inform decision-making and demonstrate how the sponsor would save a lot of time and money with the adaptive design model.

As an investigator or biotech start-up looking for funding, demonstrating a thoughtful approach to trial design moves the needle in your favour.

In a second example, we incorporated a biomarker into the study design for a cancer treatment. The results after a phase 2 trial indicated there were different endpoints for two different tumour types.

The product seemed to treat the tumours that remained by making them disappear.

For the ones resected, the outcome measured was the length of time to recurrence. The bio-

marker could predict failure in the first line of treatment, allowing researchers to randomize patient selection. The part that I thought was really cool was using adaptive design to address the question of optimal dose.

When this approach is applied to study design, each part of the study informs the next; such that something more is learned about the benefit-risk-value proposition and the unknowns. Safety, efficacy, and biology are lessened to know what your inputs are and what your outputs are likely to be. This predictive aspect also facilitates risk-based monitoring.

Really, the features that can be adapted are almost endless, including eligibility criteria, randomization, treatment regimens, medications that are allowed or disallowed, visit schedules, endpoints and the number of endpoints, and statistical methods.

By its very nature, our industry isn’t able to take three months of data and make a rapid shift - even a seemingly minimal one. Bringing subject matter experts to the table early and in meaningful ways always produces a better trial with optimal, reliable outcomes.

To take a deeper look at how to run trials that are adaptive-by-design and access the McDougall Learning Series, please visit mcdougallscientific.com/whitepapers John Amrhein is vice-president of McDougall Scientific, a provider of vital statistical strategy, trial design and analytics.

To see this story online visit www.biotechnologyfocus.ca/the-best-designed-trials-are-adaptive-by-design/ October/November 2017 BIOTECHNOLOGY FOCUS 29

LAST word

| By Dean Fulford, vice-president of human resources consulting, Stratford Managers Corporation

Surveying the biotechnology HR landscape

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or employers in every organization, in any sector, having a clear and focused understanding of the factors that drive employee motivation and commitment is pivotal to ensuring business success. Without an indication of what employee’s value from their workplace and employment experience, organizational effort and investment can be misaligned.

Stratford Managers, in collaboration with Biotechnology Focus and supported by BioTalent Canada, has just completed a follow-up study of our 2015 first-of-its-kind employee survey of Canada’s biotechnology industry. We asked 25 questions in an anonymous survey about different aspects of the work environment in biotech and life science workplaces. The goal was to build awareness of employee’s perception of their workplace and identify areas where improvement may promote a better overall experience.

Consistent with our goal in 2015, we wanted to provide a voice to employees in the biotechnology and life science sector, to gather opinions about the business and human resource practices in their organization’s – what is working well, what attributes of those organizations are highly valued, and where practices are not meeting their expectations.

Below are some of the highlights of the survey.

Employers are performing most strongly around job clarity which include defining job roles and responsibilities, and linking employee contribution to organizational success. Specific results indicate: • Employees with greater organization tenure have a stronger perception of this factor, noting an improved awareness of the impact of their individual job to organizational success, and being afforded greater opportunity to use their own judgment when completing their work.

• Employees in organizations with less than 100 employees have the strongest perception of this factor, indicating that they have 30 BIOTECHNOLOGY FOCUS October/November 2017

greater access to relevant information for their work, and again have increased awareness of the direct impact of their individual contribution to organization success.

Employers are performing well in the area of organizational climate: aspects of the organization that encourages individual performance.

Results indicate: • Employees with 1-5 years’ tenure have the strongest perception of this factor, at the stage in their career where they are still really ‘learning’ their role. Conversely, employees in the 6-15-year tenure range are less positive, indicating a point in their career where they have an increasing expectation of their organizations: more involvement, more feedback, and better tools.

• As organization size grows, the performance of this factor decreases. This appears to be driven by perceived organizational constraints on communicating openly and limits on opportunities to contribute toward ongoing improvement.

Employers are performing well around visionary leadership and developing commitment toward achieving the organization’s mandate.

We specifically noted that: • Employees in all categories have very strong alignment with the mission of the organization that they belong to and believe that their organization provides value to the communities in which they operate.

• Confidence in strategies of senior leadership decreases as organization size increases, inflecting at the 50-employee size.

Employers have the most room to improve in the area of recognition and rewards. Results indicate: • Employees have a weakening perception about their organiza-

LAST word

tion’s commitment to professional development and recognition practices.

• Recognition practices need to evolve. Younger and less tenured employees note that efforts of their organization to recognize their contribution and hard work is not meeting this expectation.

Using the data from 2015 as a baseline, we can see where change has taken place, both in positive and negative directions. Some of the most notable change in individual results across the employee experience factors include: • More than nine out of 10 employees agree that they can decide the best way to get their work accomplished, consistent from 2015 to 2017.

• Nearly seven out of 10 employees note that feedback from their manager helps them improve their ability to contribute to work, with there being a slight uptick in all positive response categories in 2017 compared to 2015.

• While six out of 10 employees believe that their organization invests in their continuous development, there has been a slight downward movement across all response categories in 2017 compared with 2015.

• Leadership strength of senior management has increased in 2017 compared with 2015, with nearly 6 out of 10 employees agreeing with this statement.

Our survey found that generally, employees are content with many organizational practices in their organizations. Employees rated the key indices, of Job Clarity, Organization Climate, Visionary Leadership and Recognition and Reward as providing a “string performance” in their sector.

But without question, there remains room to improve. As an example, nearly one-quarter of survey respondents list learning and development as one of their top factors of engagement, yet more than one in four don’t agree that their organization is investing in this area!

To us, one of the most powerful responses from this study is the level of job empowerment described by employees. Having control over the approach to their own work is both a strong driver of employee engagement and a sign of building a change-ready organization.

By continuing emphasis on this attribute, employers will build a critical core capability in their work teams: the ability to proactively adapt to change, and enable improved workforce performance.

To see this story online visit www.biotechnologyfocus.ca/ surveying-the-biotechnology-hr-landscape-2/ Got something to say? Please send your comments/letters to biotechnology_focus@promotive.net

October/November 2017 BIOTECHNOLOGY FOCUS 31

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