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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: 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