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2(8): May 2008
Ontario Translational Research Network
Community News
In this Edition
 Editorial
 Welcome Message from OICR
 Community Events
 SOPs
 Our Partners
 Dear Community
 Member Profile
 Contacts
 OTRN Cancer Centers
Editorial
Welcome to the first OTRN newsletter. Ontario Translational
Research Network is a group of researchers across Ontario
working towards the same goal
“Make Ontario an epicenter of translational cancer research”.
Translational Research is the backbone of new drug
development for cancer. Ontario has a wealth of world renowned
researchers who are diligently working towards discovering new
drugs and treatments for various cancers. Our objective is to
integrate with various research groups across Ontario and work
collaboratively for more effective and efficient outcome.
To bridge clinical, translational and biomarker facilities we are
developing resources and links for both health professionals and
patients. We are in the process developing an extensive
catalogue of labs, their expertise and various biobanks as well as
links to these resources. We are also working towards
developing standard operating procedures that would aid in
infrastructure development of translational research. Another
very important initiative is our biobank repository. Archival and
blood samples will be collected on all consenting patients on
therapeutic clinical trials. This is being piloted at the Drug
Development Program (Princess Margaret Hospital).
We have developed a comprehensive website that will be one
stop for both patients and health professionals who are seeking
information on translational research.
Visit our website
www.otrn.ca
We are very excited about our upcoming OTRN forum. OTRN is
hosting a forum on biospecimen ethics, collection, and
biobanking. The purpose of the forum is to provide an
educational and networking opportunity to researchers across
Ontario. Our speakers as well as participants are key members
of organizations like UHN, CCO, OICR, Pharmaceutical Industry
and other Cancer Centers across Ontario.
For more information about the forum and other initiatives
please visit our website or drop us a line at:
[email protected]
2(8): May 2008
Ontario Translational Research Network
Community News
Welcome Message from OICR
The Ontario Institute for Cancer Research (OICR) is a centre of excellence dedicated to research on
prevention, early detection, diagnosis, treatment and control of cancer. Founded in 2005, OICR
combines the research funding and infrastructure programs of its predecessor, the Ontario Cancer
Research Network, with a broader strategy that includes in-house laboratories, partnerships with
researchers throughout Ontario, collaborations with other world-leading institutes and an extensive
commercialization program.
Translational research lies at the heart of OICR’s mandate. To make an impact in the fight against
cancer, it is not enough to focus on just the laboratory or the clinic. Our goal is to bring together basic
scientists, clinicians and the many other stakeholders who can help us accelerate the development of
new therapies and diagnostic tools.
OICR’s research strategy, outlined in our Strategic Plan and Blueprint (below), reflects our commitment
to translational research. Programs, platforms and commercialization initiatives are designed to interact
to move discoveries seamlessly from basic laboratory research through to fully-developed clinical
applications.
Some of our key initiatives include the Cancer Research Fund, which has funded dozens of
translational research projects and clinical trials; our Clinical Trials Programs, which provide funding and
training to clinical trials sites throughout the province; OntarioCancerTrials.ca, a user-friendly website
that allows Ontario patients to search for clinical trials for which they might be eligible; and our
commercialization team, which helps researchers find private-sector partners to develop their
discoveries and bring new therapies and diagnostic tools to market. Our in-house platforms, such as
bioinformatics and medicinal chemistry, will also put a strong emphasis on translation and support other
researchers throughout the province.
Key components of our strategy are the Ontario Translational Research Network and the High Impact
Clinical Trials Program, which OICR will launch this fall. We expect these two initiatives to interact with
each other and with the other OICR programs to greatly enhance the sophistication of the correlative
studies in clinical trials. We are optimistic that improved analysis of biological processes related to drug
response will greatly accelerate the development of new cancer therapies.
OICR is a young institute, and we will continue to grow rapidly over the next several years. Yet we are
already making an impact, and by the time we have grown to our full size of 50 principal investigators
and over 500 staff, some of our early investments could already be making a difference in the lives of
cancer patients. That is the power of translational research.
Dr. Bob Phillips
Deputy Director
Ontario Institute for Cancer Research
2(8): May 2008
Ontario Translational Research Network
Community News
Community Events
OTRN Forum:
Oct 3rd 2008. For details on
speakers and topics check
our website at: www.otrn.ca
The SAF-T-PAK Public
Compliance Training
Seminar for Shipping Class
6.2 is a one day symposiumstyle co Canada Tuition $339 CAN for the first
person, each additional
person from same
organization and at same
seminar, $220 CAN
For more information, please
call us at 800-814-7484, or
email us at
[email protected] or
check our website at
www.saftpak.com/
Regina, SK – sep 29
Edmonton, BC- 1-Oct
Calgary, AB 2-Oct
Vancouver, AB 3-Oct
Toronto, ON 13-Oct
Ottawa, ON 14-Oct
Montreal, QC 15-Oct
SoCRA conference:
17th Annual Conference
Clinical Research Quality and
Standards - Ensuring
National and International
Study Success
Sep 25-28
Vancouver BC
http://www.socra.org
Standard Operating Procedures
A Standard Operating Procedure (SOP) is “detailed, written
instructions to achieve uniformity of the performance of a specific
function” (ICH definition).
SOPs are necessary at every level of clinical research to ensure
maximum safety and efficiency of the performed clinical research
operations. All parties involved in clinical research, including a
pharmaceutical company, a sponsor, a Contract Research
Organization (CRO), an investigator site, a Research Ethics Board
(REB), should have an appropriate set of SOPs in place to operate
in compliance with current ICH-GCP regulations.
SOPs are required for assuring quality and consistency, ensuring
compliance with regulatory guidelines, defining roles of involved
parties, and providing guidance to current staff as well as a tool for
training new staff. All staff that performs the function of a particular
SOP must receive training on that SOP before it is considered
active.
The risk of GCP non-compliance is high when there is inaccessibility
to clinical research SOPs or when the staff are unaware of such
SOPs. During audits and inspections, lack of written SOPs and
failure to follow written SOPs are common reported deficiencies.
SOPs are an essential part of a Quality Management System and
therefore these documents must be properly maintained and made
available in the workplace. All SOPs should be created with an
activation date and a revision date. When changes occur in the
procedure, the SOP is revised to reflect the changes, given a new
revision date, and staff training must occur on the newly revised
SOP. If there are no changed to the procedure, the SOP should still
be revised at least every 2 years.
The body of the SOPs should include a title, a purpose, a scope,
and the procedure. The header should include a unique ID number,
the activated and revision dates, the names the people who issued
and approved the document. SOPs should be written in clear,
simple language (about Grade 7 reading level) to cater to all
audiences.
2(8): May 2008
Ontario Translational Research Network
Community News
8th Annual Princess Margaret
Hospital Conference – New
Developments in Cancer
Management
Toronto, Ontario
October 16-18, 2008
Contact Theresa Jones at 1-678242-0906 or email:
[email protected]
Advancing Cancer Research
Through Biospecimen Science
The 2nd Annual Biospecimen
Research Network Symposium
March 16-18, 2009
Bethesda North Marriott Hotel &
Conference Center
Bethesda, Maryland
biospecimens.cancer.gov
NCRI Cancer Conference
The NCRI Cancer Conference is
the major forum in the UK for
showcasing the best British and
international cancer research.
The Conference offers unique
opportunities for networking and
sharing knowledge by bringing
together the leading experts from
all cancer research disciplines.
The 2008 NCRI Cancer
Conference will be held on
5-8 October 2008.
http://www.ncri.org.uk/ncriconfere
nce/
Our Partners
The Ontario Cancer Biomarker Network
The Ontario Cancer Biomarker Network (OCBN) is a not-forprofit corporation that was established in 2005 with a grant from
the Ontario Institute for Cancer Research and the Ministry of
Research and Innovation for the purpose of advancing biomarker
research and development.
OCBN is a multidisciplinary network of biomarker research
laboratories, bioinformatics facilities, and biorepositories
throughout Ontario. At the core of the network is the OCBN
Central Research Facility located at the MaRS Incubator, in the
heart of the biomedical research community in Toronto. This
facility houses our comprehensive mass spectrometry platform,
multiplexed immunoassays and other advanced technologies. It
also serves as the central biorepository for the network, which
currently maintains samples collected in numerous institutions
under rigorous protocols.
In addition to providing the necessary infrastructure to support
research internal to the network, the OCBN also provides
management, technical expertise and resources to support
academic- and industry-sponsored research. We offer:
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Access to the leading biomarker and clinical researchers
from across the Province
Experienced personnel in “omic” methods and
technologies
Experienced drug and biomarker development personnel
Experienced, professional research management
Regulatory-compliant processes and state-of-the-art
facilities
Together with our experienced scientific management,
bioinformatics and supercomputing capabilities, and partnerships
with numerous complementary core laboratories, OCBN is truly a
world class biomarker discovery and development platform.
www.ocbn.ca
2(8): May 2008
Ontario Translational Research Network
Community News
Dear Community
I would like to get my lab Accredited, what should I do?
The Standard Council of Canada has a program for the Accreditation of Laboratories.
The Standards Council of Canada (SCC) was established by an Act of Parliament in 1970 to promote
“efficient and effective voluntary standardization in Canada”. The Council, consisting of members of
government and the private sector, has policies and operations that are independent of government,
although it is financed partially by Parliamentary appropriation.
The SCC Program for the Accreditation of Laboratories/Canada (PALCAN) recognizes the competence
and consistency of testing and calibration laboratory facilities. Facilities that conduct scientific testing in
a selection of areas, as well as those specialized in a particular field, such as medical laboratories, may
apply for accreditation from the PALCAN program.
PALCAN laboratory accreditation is an agreement between the SCC and the accredited laboratory. This
agreement specifies that the SCC recognize the ability of the laboratory to produce competent results
for the specific tests that are listed on its Scope of Accreditation. Recognition of competent results
relies on technically competent staff with the requisite skills and knowledge, the environment with the
requisite facilities and equipment, the requisite procedures, and the requisite quality control. The
accredited laboratory must formally agree to conform to specific program requirements outlined in the
CAN-P-1570 – PALCAN Handbook, as well as any Policies, Procedures, and Guidance documents.
The accredited lab must also agree to pay all fees associated with accreditation.
To start the accreditation process, an application form must be completed and submitted with all fees
($25-30000 + annual fee). Following approval of the application, an on-site review is conducted to
assess the laboratories, witness and review test procedures, and evaluate the Quality Management
System (QMS) and technical records in accordance with CAN-P-4E. After 1 year of the initial
accreditation, a complete reassessment is conducted and repeated biannually thereafter. Medical
laboratories are subject to regular self-assessments with full reassessment every 5 years.
Visit the PALCAN Website (www.palcan.scc.ca) for more information, such as reviewing the CAN-P1570 – PALCAN Handbook and the list of accredited laboratories and their scopes of accreditation
2(8): May 2008
Ontario Translational Research Network
Community News
Member Profile
Malcolm J. Moore, MD, FRCPC
Malcolm Moore is the Head of the Division of Hematology/Oncology in
the Department of Medicine, University Health Network and Mount Sinai
Hospital, Toronto, and Chief of Medical Services at Princess Margaret
Hospital. He is a Professor of Medicine and Pharmacology in the
Department of Medical Oncology, University of Toronto, and a Senior
Scientist in the Division of Experimental Therapeutics at the Ontario
Cancer Institute. In 2001, Dr Moore became the Director of the Robert
and Maggie Bras and Family New Drug Development Program at
Princess Margaret Hospital, and a principal investigator in the PMH
Phase II Consortium; a PMH based alliance cancer centre that won a
contract with NCI ensuring access to new NCI anti-cancer drugs. Dr
Moore received his MD from the University of Western Ontario in
London and carried out his postgraduate training in Internal Medicine
and Medical Oncology at the University of Toronto.
His major research interest over the past 12 years has been innovative drug development for cancer
therapy, and he has been a principal investigator for many phase I, II and III studies in gastrointestinal
and genitourinary cancer. He has been instrumental in the development of several agents that have
subsequently been approved for clinical usage, including both gemcitabine and erlotinib in pancreatic
cancer.
Dr. Moore is a member of the American Society of Clinical Oncology Program Committee (ASCO)
and most recently was appointed track leader of the Genitourinary Committee of ASCO for
2006/2007. He is the Chair of the GI committee for National Cancer Institute of Canada [NCIC] and
an Executive Member of the North American GI Intergroup, as well as an Executive Member of the
NCIC Investigational New Drug Committee. He was the Vivian Saykaly Visiting Professor in Medical
Oncology at McGill University, Montreal, March 2005. In 2002 he was granted the Ho Chair for New
Drug Development in Prostate Cancer at Princess Margaret Hospital, UHN.
Dr. Moore has authored over 150 peer reviewed publications, 19 book chapters and has given over
180 invited lectures worldwide.
2(8): May 2008
Ontario Translational Research Network
Community News
Contacts
OTRN:
OTRN Cancer Centers
Ontario Cancer Institute / Princess Margaret Hospital
Dr. Malcolm Moore (PI)
Azizunissa Irumnaz (Program
Manager) – 416 581 7893
PMH:
Dr. Eric Chen (Site PI)
Dr. Amit Oza (Site PI)
Dr. Lillian Siu (Site PI)
Dr. Ming Tsao (Site PI)
Dr. Geoff Liu (Site PI)
Juravinski Cancer Center
Anne Eisenhauer (Coordinator):
416 946 4501 X 5788
JCC:
Dr. Hal Hirte (Site PI)
London Regional Cancer Program
LRCP:
Dr. Eric Winquist (Site PI)
NCIC/Queen’s University:
Dr. Lois Shepherd (Site PI)
Dr. David LeBrun (Site PI)
National Cancer Institute of Canada, Queen’s University
OHRCC:
Dr. Glen Goss (Site PI)
Valerie Bates (Administrative
Assistant): 613 737 7700 X 70166
The Ottawa Hospital Regional Cancer Center