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From Bench to
Business pg. 18
Down the Rabbit
Hole: How Much
Access to Your Medical
Information is Too
Much? pg. 22
The Complex Dynamic of Canada’s Laboratory Services pg. 27
features
TheBusiness
ofScience
FEATURES
18 CJMLS Winter 2015
The future’s bright with
emerging opportunities in
regenerative medicine and stem
cell businesses
From
Bench to
Business
W
hen she graduated from St. Lawrence College with her medical laboratory
technology diploma in 1984, Lianne Witt never imagined she would end up
working in one of Canada’s hottest scientific fields. Today, she is technical
director of laboratory and client services at Insception Lifebank, Canada’s largest private
cord blood bank.
“It’s an incredible opportunity to be involved in regenerative medicine, using cutting-
edge technology to work with stem cells from cord blood and cord tissue,” says Witt. Cord
blood stem cells are used to treat more than 80 life-threatening conditions such as cancers
genetic diseases, immune deficiencies and blood disorders. To date, there have been more
than 30,000 transplants of cord blood stem cells worldwide.1
Regenerative medicine involves the repair, regeneration or replacement of diseased cells,
tissues and organs, using stem cells, tissue engineering or biomaterials. Discoveries promise
to treat a wide variety of life-threatening illnesses and chronic conditions including heart
disease, diabetes, multiple sclerosis, spinal cord injury, cerebral palsy, vision impairment,
and severe burns. Globally, the regenerative medicine field is growing fast. The market
currently stands at USD$19.3 billion and is forecast to more than triple in size and reach
USD$67.6 billion by 2020. The global market for cell therapy is USD$5.1 billion, estimated
to reach more than USD$8 billion by 2018.2
Right now, there are more than 1,900
active cell therapy trials underway across
the globe, investigating new treatment
approaches that may one day become
commercial cell products or standard of care
therapies. One exciting example is the recent
addition of a human clinical study test site
in Edmonton, Alberta, for a breakthrough
long-term diabetes treatment. The VC-01TM
made by California-based ViaCyte Inc., is
an implantable pouch that holds pancreatic
progenitor cells derived from human
induced pluripotent stem cells (iPSCs),
(See Stem Cells 101 on next page). Once
implanted, the cells mature and secrete
insulin, promising to free people with
www.csmls.org 19
Type 1 diabetes from dangerous blood sugar
highs and lows and the need to monitor or
take insulin injections.3
As the cell therapy and regenerative
medicine fields grow quickly, new job
opportunities are emerging for medical lab
technologists looking for careers beyond
traditional hospital labs. Positions in these
organizationsare ideal forthosewhowantto
work with leading-edge technologies, thrive
in a fast-paced project-focused setting and
are motivated by unique leadership and
professional development opportunities.
Insception Lifebank is one of 46 member
organizations that belong to the Centre
for Commercialization of Regenerative
Medicine (CCRM), a Toronto-based, not-
for-profit organization launched in June
2011. CCRM operates as a global industry
consortium at the intersection of academia
and business, focusing on accelerating
the commercialization of stem cell and
biomaterials-based discoveries. Both
Insception and CCRM have medical lab
technologists on staff. All training happens
on-the-job since there are no formal education programs that offer instruction on how to
use the highly specialized and often proprietary equipment not seen in hospital labs.
At Insception, the eight technologists on staff are involved with the production of stem
cell products from cord blood and cord tissue from start to finish. They process units for
cryopreservation, conduct culture and sensitivity testing on samples with a BacT/ALERT
instrument, perform flow cytometry to analyze stem cells, and participate in product
releases when transplant requests are received. “We look for people with a track record of a
high level of accuracy, because with our samples, we have one chance to get it right: we can’t
go and get a repeat sample,” says Witt.
Technologists at CCRM are involved in all three of the organization’s areas of focus:
cell reprogramming and engineering, cell manufacturing and biomaterials. They keep
cells growing in culture, perform analyses and run experiments such as seeding cells on
biomaterials or inducing cell reprogramming. The Microsquisher, developed by CellScale
of Waterloo, Ontario, is one example of the highly specialized equipment operated by
technologists at CCRM. It is used to determine stress-strength properties of biomaterial
scaffolds, tissues and cells. Technologists also beta test new bioreactor equipment for stem
cell expansion and provide feedback to manufacturers. Emily Titus, BASc, PhD, hiring
manager, lab supervisor and project manager for CCRM’s product and process development
lab says, “Their feedback is always critical because they are often the ones doing the daily
hands-on manipulation of the equipment.” She leads a team of five scientists, one lab
manager and five technologists.
As the number of regenerative discoveries grows, medical lab technologists often work
Stem Cells 101
A stem cell is a cell that has the
ability to divide and differentiate
into any cell type. Induced
pluripotent stem cells (iPSCs)
are adult cells that have been
genetically reprogrammed to
revert back to an embryonic
state. Shinya Yamanaka, MD,
Ph.D., won the 2012 Nobel Prize
in Medicine for his discovery of
a way to reprogram mature skin
cells back to stem cells.
Discoveries promise to treat a wide variety of life-threatening
illnesses and chronic conditions including heart disease,
diabetes, multiple sclerosis, spinal cord injury, cerebral palsy,
vision impairment, and severe burns.
FEATURES
20 CJMLS Winter 2015
in teams on a changing roster of projects.
Titus says, “Something that defines the
technologist position here at CCRM is that
we have a diversity of projects and needs
change very quickly. We get exposure to new
ideas both from industry projects and from
exciting academic work that comes through
our lab. We have very defined expectations
in terms of project milestones and goal
setting.” Flexibility is key at Insception
too: “Things are always changing, even in
the space of a year. Our technologists now
process cord tissue, a technology we just
launched a year ago,” says Witt.
Gaining on-the-job specialized skills
means that medical lab technologists
become subject matter experts,
which leads to unique leadership and
professional development opportunities.
Lab technologists at Insception have the
opportunity to become accredited assessors
with the AABB (formerly known as the
American Association of Blood Banks)
and travel to other countries to assess the
quality and operational systems of other
cord blood programs. The AABB is the
accrediting body for cellular therapy labs
around the world. Witt participated in the
AABB’s rigorous Accreditation Assessor
Program and has travelled twice to different
parts of India, one of her technologists
recently went to Dubai, and she knows
others who have gone to Brazil, Poland,
Thailand, and China.
At CCRM, lab technologists lead the
Human Induced Pluripotent Stem Cell
(HiPSC) Workshop, providing essential
training to other technologists and scientists
in the community on how to produce and
maintain iPSCs. Participants gain a strong
foundation in standardized validation and
characterization methods to ensure quality
in the production of stem cell lines. “We
offer the program on a pay-per-service
basis. It is all run by the lead technologist
who provides hands-on training in a
teaching lab at the University of Toronto,
one of our partners. We have trained over
50 people in the past four years,” says
Titus. This year’s workshop was offered
in October, in conjunction with the 2015
Till & McCulloch Meetings, Canada’s only
annual stem cell conference. Technologists
attend together with leading stem cell
scientists, clinicians and bioengineers as
well as representatives from government,
health and non-governmental organization
(NGO) sectors from around the world.
CCRM, the Stem Cell Network and the
Ontario Institute for Regenerative Medicine
co-hosted the conference this year.
Both Witt and Titus say the ideal
candidate for a medical lab technologist
position with Insception is someone with
transferable skills and a keen interest to
learn and work in groups at the leading
edge of new discoveries. Witt says, “We look
for technologists that have been involved
in transfusion medicine. Experience with
Canadian Blood Services is a bonus because
they are familiar with blood manufacturing
and its regulations and standards, and
because they’re going to have knowledge
of some of the equipment we use here. We
have hired new grads and we also work with
The Michener Institute for Applied Sciences
to place students who have completed
their first year in our summer internship
program. They start as lab assistants and
can transition to casual labour and full
time,” says Witt.
At CCRM, all technologists currently on
staff have either a bachelor or masters degree
in science with a focus on cell biology,
molecular biology or bioengineering.
“Rather than looking for people with
specific skill sets, we are looking people
with a specific work ethic, a willingness and
Working in the regenerative medicine field
is a worthwhile career option for medical lab
technologists looking for a chance to work with
recent scientific discoveries and new treatments that
can help people dealing with devastating and costly
diseases and conditions.
Emily Titus
www.csmls.org 21
ReferenceS:
 1
Insception FAQs: Cord Blood. How can cord
blood help today? Found at http://www.
insception.com/frequently-asked-questions/
 2
CCRM: Quick Facts on Regenerative Medi-
cine  CCRM. August 2015. Found at http://
ccrm.ca/sites/default/files/QuickFacts_Au-
gust2015_Final.pdf
 3
JDRF news release. ViaCyte Announces
Highly Anticipated Encapsulation Clinical
Trial Site Expansion into Canada. July 29,
2015. Found at https://www.jdrf.ca/news-
and-media/in-the-news/viacyte-announces-
highly-anticipated-encapsulation-clinical-
trial-site-expansion-into-canada/
 4
National Institutes of Health: Stem Cell
Basics. VI. What are induced pluripotent stem
cells? Found at http://stemcells.nih.gov/info/
basics/pages/basics10.aspx
 5
University of California San Francisco press
release, October 9, 2012. Shinya Yamanaka
Wins 2012 Nobel Prize in Medicine. Found at
https://www.ucsf.edu/news/2012/10/12898/
shinya-yamanaka-wins-2012-nobel-prize-
medicine
Canada’s Legacy
Canadian doctors, James Till and Ernest McCulloch discovered
transplantable stem cells at the Ontario Cancer Institute in Toronto in 1961.
Since then, a number of Canadian scientists have been advancing the field.
Read more about Canada’s stem cell legacy of innovation at
http://stemcellfoundation.ca/en/about-stem-cells/canadas-contribution/.
Jane Langille
Health and Medical Writer
Special to CJMLS
excitement to learn new techniques and
work in collaborative team environments,”
says Titus, “We are open to all applications.
I haven’t seen someone with a medical
laboratory technology diploma applying
here yet but it would be very interesting to
interview someone with that background to
see how they would fit within the context of
our overall philosophy.”
The future is bright for career
opportunities for lab technologists in
the regenerative medicine sector. CCRM
anticipates tripling their workforce over
the next five years, spinning out more
companies that will provide novel stem
cell and biomaterials-based therapies.
Insception plans to introduce new
regenerative medicine technologies in the
future, technologies that are top secret right
now, but ones that technologists will also be
involved with.
Working in the regenerative medicine
field is a worthwhile career option for
medical lab technologists looking for
a chance to work with recent scientific
discoveriesandnewtreatmentsthatcanhelp
people dealing with devastating and costly
diseases and conditions. “Technologists
here truly embrace and love what they do.
There’s so much passion! They know that
the samples they’re working on are golden
and that this could be the difference in a
child’s life,” says Witt.
$
19.3
$
67.6
The regenerative medicine
field currently stands at
and forecast to more than
triple in size and reach
by 2020.2
1,900there are
more than
active cell therapy trials
underway across the globe
billion
USD
billion
USD

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From Bench to Business

  • 1. From Bench to Business pg. 18 Down the Rabbit Hole: How Much Access to Your Medical Information is Too Much? pg. 22 The Complex Dynamic of Canada’s Laboratory Services pg. 27 features TheBusiness ofScience
  • 2. FEATURES 18 CJMLS Winter 2015 The future’s bright with emerging opportunities in regenerative medicine and stem cell businesses From Bench to Business W hen she graduated from St. Lawrence College with her medical laboratory technology diploma in 1984, Lianne Witt never imagined she would end up working in one of Canada’s hottest scientific fields. Today, she is technical director of laboratory and client services at Insception Lifebank, Canada’s largest private cord blood bank. “It’s an incredible opportunity to be involved in regenerative medicine, using cutting- edge technology to work with stem cells from cord blood and cord tissue,” says Witt. Cord blood stem cells are used to treat more than 80 life-threatening conditions such as cancers genetic diseases, immune deficiencies and blood disorders. To date, there have been more than 30,000 transplants of cord blood stem cells worldwide.1 Regenerative medicine involves the repair, regeneration or replacement of diseased cells, tissues and organs, using stem cells, tissue engineering or biomaterials. Discoveries promise to treat a wide variety of life-threatening illnesses and chronic conditions including heart disease, diabetes, multiple sclerosis, spinal cord injury, cerebral palsy, vision impairment, and severe burns. Globally, the regenerative medicine field is growing fast. The market currently stands at USD$19.3 billion and is forecast to more than triple in size and reach USD$67.6 billion by 2020. The global market for cell therapy is USD$5.1 billion, estimated to reach more than USD$8 billion by 2018.2 Right now, there are more than 1,900 active cell therapy trials underway across the globe, investigating new treatment approaches that may one day become commercial cell products or standard of care therapies. One exciting example is the recent addition of a human clinical study test site in Edmonton, Alberta, for a breakthrough long-term diabetes treatment. The VC-01TM made by California-based ViaCyte Inc., is an implantable pouch that holds pancreatic progenitor cells derived from human induced pluripotent stem cells (iPSCs), (See Stem Cells 101 on next page). Once implanted, the cells mature and secrete insulin, promising to free people with
  • 3. www.csmls.org 19 Type 1 diabetes from dangerous blood sugar highs and lows and the need to monitor or take insulin injections.3 As the cell therapy and regenerative medicine fields grow quickly, new job opportunities are emerging for medical lab technologists looking for careers beyond traditional hospital labs. Positions in these organizationsare ideal forthosewhowantto work with leading-edge technologies, thrive in a fast-paced project-focused setting and are motivated by unique leadership and professional development opportunities. Insception Lifebank is one of 46 member organizations that belong to the Centre for Commercialization of Regenerative Medicine (CCRM), a Toronto-based, not- for-profit organization launched in June 2011. CCRM operates as a global industry consortium at the intersection of academia and business, focusing on accelerating the commercialization of stem cell and biomaterials-based discoveries. Both Insception and CCRM have medical lab technologists on staff. All training happens on-the-job since there are no formal education programs that offer instruction on how to use the highly specialized and often proprietary equipment not seen in hospital labs. At Insception, the eight technologists on staff are involved with the production of stem cell products from cord blood and cord tissue from start to finish. They process units for cryopreservation, conduct culture and sensitivity testing on samples with a BacT/ALERT instrument, perform flow cytometry to analyze stem cells, and participate in product releases when transplant requests are received. “We look for people with a track record of a high level of accuracy, because with our samples, we have one chance to get it right: we can’t go and get a repeat sample,” says Witt. Technologists at CCRM are involved in all three of the organization’s areas of focus: cell reprogramming and engineering, cell manufacturing and biomaterials. They keep cells growing in culture, perform analyses and run experiments such as seeding cells on biomaterials or inducing cell reprogramming. The Microsquisher, developed by CellScale of Waterloo, Ontario, is one example of the highly specialized equipment operated by technologists at CCRM. It is used to determine stress-strength properties of biomaterial scaffolds, tissues and cells. Technologists also beta test new bioreactor equipment for stem cell expansion and provide feedback to manufacturers. Emily Titus, BASc, PhD, hiring manager, lab supervisor and project manager for CCRM’s product and process development lab says, “Their feedback is always critical because they are often the ones doing the daily hands-on manipulation of the equipment.” She leads a team of five scientists, one lab manager and five technologists. As the number of regenerative discoveries grows, medical lab technologists often work Stem Cells 101 A stem cell is a cell that has the ability to divide and differentiate into any cell type. Induced pluripotent stem cells (iPSCs) are adult cells that have been genetically reprogrammed to revert back to an embryonic state. Shinya Yamanaka, MD, Ph.D., won the 2012 Nobel Prize in Medicine for his discovery of a way to reprogram mature skin cells back to stem cells. Discoveries promise to treat a wide variety of life-threatening illnesses and chronic conditions including heart disease, diabetes, multiple sclerosis, spinal cord injury, cerebral palsy, vision impairment, and severe burns.
  • 4. FEATURES 20 CJMLS Winter 2015 in teams on a changing roster of projects. Titus says, “Something that defines the technologist position here at CCRM is that we have a diversity of projects and needs change very quickly. We get exposure to new ideas both from industry projects and from exciting academic work that comes through our lab. We have very defined expectations in terms of project milestones and goal setting.” Flexibility is key at Insception too: “Things are always changing, even in the space of a year. Our technologists now process cord tissue, a technology we just launched a year ago,” says Witt. Gaining on-the-job specialized skills means that medical lab technologists become subject matter experts, which leads to unique leadership and professional development opportunities. Lab technologists at Insception have the opportunity to become accredited assessors with the AABB (formerly known as the American Association of Blood Banks) and travel to other countries to assess the quality and operational systems of other cord blood programs. The AABB is the accrediting body for cellular therapy labs around the world. Witt participated in the AABB’s rigorous Accreditation Assessor Program and has travelled twice to different parts of India, one of her technologists recently went to Dubai, and she knows others who have gone to Brazil, Poland, Thailand, and China. At CCRM, lab technologists lead the Human Induced Pluripotent Stem Cell (HiPSC) Workshop, providing essential training to other technologists and scientists in the community on how to produce and maintain iPSCs. Participants gain a strong foundation in standardized validation and characterization methods to ensure quality in the production of stem cell lines. “We offer the program on a pay-per-service basis. It is all run by the lead technologist who provides hands-on training in a teaching lab at the University of Toronto, one of our partners. We have trained over 50 people in the past four years,” says Titus. This year’s workshop was offered in October, in conjunction with the 2015 Till & McCulloch Meetings, Canada’s only annual stem cell conference. Technologists attend together with leading stem cell scientists, clinicians and bioengineers as well as representatives from government, health and non-governmental organization (NGO) sectors from around the world. CCRM, the Stem Cell Network and the Ontario Institute for Regenerative Medicine co-hosted the conference this year. Both Witt and Titus say the ideal candidate for a medical lab technologist position with Insception is someone with transferable skills and a keen interest to learn and work in groups at the leading edge of new discoveries. Witt says, “We look for technologists that have been involved in transfusion medicine. Experience with Canadian Blood Services is a bonus because they are familiar with blood manufacturing and its regulations and standards, and because they’re going to have knowledge of some of the equipment we use here. We have hired new grads and we also work with The Michener Institute for Applied Sciences to place students who have completed their first year in our summer internship program. They start as lab assistants and can transition to casual labour and full time,” says Witt. At CCRM, all technologists currently on staff have either a bachelor or masters degree in science with a focus on cell biology, molecular biology or bioengineering. “Rather than looking for people with specific skill sets, we are looking people with a specific work ethic, a willingness and Working in the regenerative medicine field is a worthwhile career option for medical lab technologists looking for a chance to work with recent scientific discoveries and new treatments that can help people dealing with devastating and costly diseases and conditions. Emily Titus
  • 5. www.csmls.org 21 ReferenceS:  1 Insception FAQs: Cord Blood. How can cord blood help today? Found at http://www. insception.com/frequently-asked-questions/  2 CCRM: Quick Facts on Regenerative Medi- cine CCRM. August 2015. Found at http:// ccrm.ca/sites/default/files/QuickFacts_Au- gust2015_Final.pdf  3 JDRF news release. ViaCyte Announces Highly Anticipated Encapsulation Clinical Trial Site Expansion into Canada. July 29, 2015. Found at https://www.jdrf.ca/news- and-media/in-the-news/viacyte-announces- highly-anticipated-encapsulation-clinical- trial-site-expansion-into-canada/  4 National Institutes of Health: Stem Cell Basics. VI. What are induced pluripotent stem cells? Found at http://stemcells.nih.gov/info/ basics/pages/basics10.aspx  5 University of California San Francisco press release, October 9, 2012. Shinya Yamanaka Wins 2012 Nobel Prize in Medicine. Found at https://www.ucsf.edu/news/2012/10/12898/ shinya-yamanaka-wins-2012-nobel-prize- medicine Canada’s Legacy Canadian doctors, James Till and Ernest McCulloch discovered transplantable stem cells at the Ontario Cancer Institute in Toronto in 1961. Since then, a number of Canadian scientists have been advancing the field. Read more about Canada’s stem cell legacy of innovation at http://stemcellfoundation.ca/en/about-stem-cells/canadas-contribution/. Jane Langille Health and Medical Writer Special to CJMLS excitement to learn new techniques and work in collaborative team environments,” says Titus, “We are open to all applications. I haven’t seen someone with a medical laboratory technology diploma applying here yet but it would be very interesting to interview someone with that background to see how they would fit within the context of our overall philosophy.” The future is bright for career opportunities for lab technologists in the regenerative medicine sector. CCRM anticipates tripling their workforce over the next five years, spinning out more companies that will provide novel stem cell and biomaterials-based therapies. Insception plans to introduce new regenerative medicine technologies in the future, technologies that are top secret right now, but ones that technologists will also be involved with. Working in the regenerative medicine field is a worthwhile career option for medical lab technologists looking for a chance to work with recent scientific discoveriesandnewtreatmentsthatcanhelp people dealing with devastating and costly diseases and conditions. “Technologists here truly embrace and love what they do. There’s so much passion! They know that the samples they’re working on are golden and that this could be the difference in a child’s life,” says Witt. $ 19.3 $ 67.6 The regenerative medicine field currently stands at and forecast to more than triple in size and reach by 2020.2 1,900there are more than active cell therapy trials underway across the globe billion USD billion USD