PROPOSAL INTERDISCIPLINARY GRADUATE PROGRAM IN VACCINOLOGY & IMMUNOTHERAPEUTICS January 19, 2007 Executive Summary Title of proposal: Interdisciplinary Program in Vaccinology & Immunotherapeutics Degrees: MA, MSc and PhD Field of Specialization: Vaccinology & Immunotherapeutics Level of Concentration: graduate Option(s): N/A Degree College: Graduate Studies Department: N/A Home College: Graduate Studies Contact person(s) (name, telephone, fax, e-mail): Dr. Bernhard Juurlink PH: 306-966-2542 FX: 306-966-4298 Email: Bernhard.juurlink@usask.ca PROGRAM OBJECTIVES The objective of this program is to establish an exceptionally strong academic program, unlike any other in North America, to educate the brightest trainees in the concepts underlying the basic and applied sciences as well as social sciences aspects of vaccinology and immunotherapeutics. Once the students are introduced to these basic concepts they will enter one of three streams: 1) Vaccinology & Immunotherapeutics: Societal Issues. The research in this area will involve the complex social, health care, legal and ethical issues associated with vaccination and other immunotherapeutics. Students in this program will receive an MA or PhD. 2) Vaccinology & Immunotherapeutics: Design & Production. The research in this area will focus on the design and production of vaccines and other immunotherapeutics. Students in this program will receive an MSc or PhD. 3) Vaccinology and Immunotherapeutics: Scientific Bases. The major focus of research in this area would be the science that underlies vaccines and other immunotherapeutics. Students in this program will receive an MSc or PhD. RATIONALE 1 Immunization was one of the most cost-effective infectious disease health interventions of the 20th Century. Besides infectious diseases, vaccines and immunotherapeutics have great promise in treating diseases involving allergies, autoimmunity (e.g., type 1 diabetes, multiple sclerosis, lupus) and cancer. The University of Saskatchewan has externally-recognized strength in the science of vaccinology and immunotherapeutics with the presence of VIDO and the Immunology and Infectious Diseases Research Group. But without good vaccination and immunotherapeutic plans in place, without public acceptance of such therapeutic interventions and without adequate production capacity, it does not matter how good the science is and how efficacious the vaccines and other immunotherapeutics are. The successful use of vaccines and immunotherapeutics for public health needs an understanding of the risks (and perceived risks) and the ethical & legal issues involved with treatment, an understanding on how to design effective clinical trials, commercial aspects of the production of therapeutics. Although there is some strength at this University in the area of latter issues in the area of biotechnology and technology in general, this area needs strengthening. The V&I Graduate program will enhance the research on the basic science underlying Vaccinology and immunotherapeutics and will act as a great stimulus in the development of the areas of design and production of vaccines & other immunotherapeutics as well as the societal aspects (ethical, legal, sociological, economic, public health policies) of vaccinology & immunotherapeutics. It is anticipated that this program will be the impetus for the University of Saskatchewan becoming a centre of excellence for all aspects of vaccinology and immunotherapeutics DESCRIPTION OF PROGRAM CHARACTERISTICS The program includes MSc, MA and PhD degrees with a research project culminating in a thesis. There is no non-thesis option. Program Outline and Program Streams All students in the program, regardless of stream, will take two keystone multidisciplinary courses. These courses are: V&I 801.3 (A Multi-Disciplinary Introduction to Vaccinology & Immunotherapeutics) and V&I 990.0 (Seminars in Vaccinology & Immunotherapeutics). Both courses will deal with all facets of vaccinology and immunotherapeutics. In addition, to the mandatory courses of Vaccinology and Immunotherapeutics (V&I) 801.3 and V&I 990.0), students will complete their course requirements in the different streams by taking courses already offered at the University of Saskatchewan. One of these courses must deal with research methodology: such a course may be literature driven where the research questions, the addressing of research questions, the methodology and interpretation of data are critiqued or it may be a formal research methods course such as, for example, SOC 841.6 (Advanced Research Methods). The program is organized in such a way that different students follow different streams within the multidisciplinary Vaccinology and Immunotherapeutics Graduate Program. These streams are: 1) Vaccinology & Immunotherapeutics: Societal Issues, 2) Vaccinology &Immunotherapeutic: Design & Production, and 3) Vaccinology and Immunotherapeutics: Scientific Bases. 2 Since the degrees arising from this program are research thesis-based, students will also be enrolled in one of the following the research courses: V&I 994.0 – Research Students registered in a Master’s thesis program must register for this course annually throughout their entire MSc or MA program. V&I 996.6 – Research Students registered in PhD dissertation program must register for this course annually throughout their entire PhD program. VACCINOLOGY AND IMMUNOTHERAPEUTICS PROGRAM GOVERNANCE AND ADMINISTRATION The Vaccinology and Immunotherapeutics Program is a multidisciplinary graduate program under the umbrella of the College of Graduate Studies and Research. Governance and administration of the Vaccinology and Immunotherapeutics Program takes the following form. Vaccinology and Immunotherapeutics Group Includes all those on campus with interest and expertise in areas related to vaccinology and immunology. Members are registered for five-year periods, renewable. The Vaccinology and Immunotherapeutics Program is carried out by members of the Vaccinology and Immunotherapeutics Group. A General Meeting of the Vaccinology and Immunotherapeutics Group will be held once a year. Additional meetings can be held during the year if required. Vaccinology and Immunotherapeutics Executive Committee Oversight for the Vaccinology and Immunotherapeutics Program is the responsibility of a seven (or eight) member Vaccinology and Immunotherapeutics Executive Committee. The membership, initially appointed by the Dean of the CGSR, will be elected by the full members of Vaccinology & Immunotherapeutics Group. The Vaccinology and Immunotherapeutics Executive Committee is the main policy body for the Vaccinology and Immunotherapeutics Program. It sets the rules and regulations for the Vaccinology and Immunotherapeutics Program, and ensures that these rules and regulations are carried out. The Vaccinology and Immunotherapeutics Executive Committee is also responsible for communicating these rules and regulations to the members of the Vaccinology and Immunotherapeutics Group, as well as receiving feedback from the Vaccinology and Immunotherapeutics Group on the Vaccinology and Immunotherapeutics Program. Vaccinology and Immunotherapeutics Graduate Committee The Vaccinology and Immunotherapeutics Graduate Committee carries out the day-to-day operations of the Vaccinology and Immunotherapeutics Program. The Chair of the Graduate Committee (the Graduate Chair) has formal roles and responsibilities relating to the CGSR Graduate Council, including the College’s Executive, Awards, Nominations, Master’s and Ph.D. Committees. A complete description of the role of the Graduate Chair is provided in section 2.3 of the CGSR Policy and Procedure Manual. The Graduate Chair will be appointed by the Vaccinology and Immunotherapeutics Executive Committee. The Vaccinology Graduate 3 Committee and the Vaccinology Graduate Chair are of critical importance in ensuring the success of the Vaccinology Program and of individual students in the program. The Vaccinology Graduate Committee has four members that are appointed by the Executive. Given the large roles that VIDO and the University’s academic microbiology departments will have in the Vaccinology and Immunotherapeutics Program, one of the members will be from VIDO and one from an academic microbiology department RESOURCES Existing Resources The physical resources to mount this program are already in place or are part of the University plans (e.g., INTERVAC). The faculty resources are also in place, particularly in the sciences. There are faculty in place who are interested in the societal aspects of vaccinology and immunotherapeutics. It is expected that some academic departments will replace retiring members with faculty able to take full advantage of this Graduate Program New Resources & Budget Total New Financial Resources Requested are outlined in Table 5. A one-time $207,000 and an ongoing $33,000 are requested. The one-time support requested include graduate student support ($150,000) and program advertising ($20,000). Ongoing costs include Half-time Clerical Services Worker II ($17,000), program advertising, sessional relief costs, V&I 990 speaker costs, other administrative costs. Vaccinology Program Drafting Committee Dr. Bernhard Juurlink, College of Medicine Dr. John Gordon, Veterinary Microbiology Dr. Lorne Babiuk, VIDO Dr. Lou Qualtiere, College of Medicine Dr. Andy Potter, VIDO Dr. Michael Mehta, Sociology Dr. Allen Ross, Community Health & Epidemiology 4 Proposal for New Program to be approved by Academic Programs Committee and Council 1. PROPOSAL IDENTIFICATION Title of proposal: Interdisciplinary Program in Vaccinology & Immunotherapeutics Degrees: MA, MSc and PhD Field of Specialization: Vaccinology & Immunotherapeutics Level of Concentration: graduate Option(s): N/A Degree College: Graduate Studies Department: N/A Home College: Graduate Studies Contact person(s) (name, telephone, fax, e-mail): Dr. Bernhard Juurlink PH: 306-966-2542 FX: 306-966-4298 Email: Bernhard.juurlink@usask.ca Date: August 4, 2006 Approved by the degree college and/or home college: Approved by the Vaccinology & Immunotherapeutics Program Drafting Committee: Proposed date of implementation: September 2007 2. TYPE OF CHANGE Requiring approval by Council X A new Degree-Level program or template for program. 3. RATIONALE The formulation of this Interdisciplinary Academic Graduate Program in Vaccinology & Immunotherapeutics was in part driven by the recent and rather remarkable local, national and international successes realized within the University’s Vaccine and Infectious Diseases Organization (VIDO). Compounding these with parallel successes within other sectors of the University has led to the incorporation within the Strategic Plan of the University of Saskatchewan of a commitment of significant institutional resources to development around themes relating to these accomplishments. This program represents the realization of one such opportunity, an exciting one that will lead to the establishment of an exceptionally strong academic program at the University of Saskatchewan, unlike any other in North America, to educate the brightest trainees in the concepts underlying the basic and applied sciences as well as social sciences aspects of vaccinology and immunotherapeutics. We are proposing to have a Graduate Program with three streams: 1) Vaccinology & Immunotherapeutics: Societal Issues. The research in this area will involve the complex social, health care, legal and ethical issues associated with vaccination and other immunotherapeutics. Students in this program will receive an MA or PhD. 5 2) Vaccinology & Immunotherapeutics: Design & Production. The research in this area will focus on the design and production of vaccines and other immunotherapeutics. Students in this program will receive an MSc or PhD. 3) Vaccinology and Immunotherapeutics: Scientific Bases. The major focus of research in this area would be the science that underlies vaccines and other immunotherapeutics. Students in this program will receive an MSc or PhD. The current proposal is relevant to the University’s goals of biotechnology and health research as identified in the University’s strategic plan. This proposal will bridge both of these facets of the University’s aspirations. Indeed, the President of the University of Saskatchewan has stated on numerous occasions that infectious diseases will play a pre-eminent role in helping to achieve the University’s goal. It is anticipated that the Vaccinology & Immunotherapeutics Graduate Program will become internationally recognized attracting the top students from around the world. 3.A. Background 3.A.1. Overview 3.A.1.1. Scientific Aspects: Chronic diseases (e.g., cardiovascular disease and stroke, cancer, and respiratory diseases) are Canada’s leading cause of avoidable illness and death, but in the past three years a number of emerging infectious diseases have come to the forefront in the list of avoidable disease. For example, SARS has arisen only recently, yet its cost to the Toronto economy alone has been estimated to be two billion dollars (J. Skinner and I. Levy, Discussion paper prepared for the Canadian medical Association [http://www.wma.net/e/pdf/sars_discussion_paper.pdf.]. In addition, the spectre of a catastrophic influenza pandemic continues to pose a demonstrable risk to society. Cutting edge advances in immunology and biotechnology have allowed us to make great strides in developing effective vaccines and immunotherapeutics for some of our major diseases, and while we are on the edge of success in dealing with others, for many of our most prevalent challenges we simply do not have sufficient information regarding their biology to understand the best approaches to them. Nevertheless, we do know that vaccination will be the most effective way to control many infectious agents (and this is particularly true given the significant increases in antibioticresistant bacteria), and that successful immunotherapeutics will likely be our best approach to many autoimmune, allergic, respiratory, and cardiovascular diseases, as well as cancer. Immunization was one of the most cost-effective infectious disease health interventions of the 20th Century. Canada benefited greatly from the eradication of smallpox, elimination of polio and measles, diphtheria, tetanus, mumps, rubella, and childhood invasion of H. influenza B infection. The future even looks brighter with the recent licensure of new conjugated vaccines against bacterial meningitis, varicella, and adolescent and adult pertussis. Similarly, recent advances in immunotherapies for cancers, allergic and autoimmune diseases have brought successful treatments for some of these within our grasp. The advent of genomics has further enhanced our ability to understand the pathogenesis of such diseases, and this should dramatically increase our ability to develop more effective immunotherapeutic approaches and vaccines. Within five to ten years, additional new vaccines against infectious diseases, and immunotherapeutic approaches to certain cancers, autoimmune diseases, and Alzheimer’s 6 disease will undoubtedly be developed in Canada. This fits in well with the Executive Summary of the 1998 WHO World Health Report, that stated “the future of infectious disease control is likely to lie with vaccines rather than drugs.” Similarly, immunotherapy clinical trials are in progress now for tolerization of various autoimmunities (e.g., type 1 diabetes, SLE) and transplants, and proof of principle has been established recently by immunologists at the University of Saskatchewan for full tolerization of asthma and for induction of tumour immunity. Furthermore, inside pharmaceutical industry predictions forecast that immune and inflammatory disease immunotherapeutics will account for 40% of the global pharmaceutical market by 2010. 3.A.1.1.1. Current Areas of Strength: The University of Saskatchewan is currently training graduate students in the broad areas of vaccinology and immunotherapeutics, with approximately 48 graduate students enrolled in various departments. A strong genomics program in pathogenomics with researchers from the University of British Columbia, Simon Fraser University, University of Calgary, and the University of Manitoba is in place. Furthermore, the University of Saskatchewan Immunology and Infectious Diseases Research Group has solid links with the immunology research groups at the University of Calgary, the University of Alberta, the University of Manitoba, and Dalhousie University. This will provide a unique opportunity for our students to interact with researchers from other universities. Having visiting scientists spending significant amounts of time at the University of Saskatchewan is further evidence of the need for, and attraction of, such a program. This will be truly unique and expose our students to world-class experts in all aspects of immunotherapeutics and vaccinology. Similarly, the Immunology and Infectious Diseases Research Group has established a visiting speaker series that has in the past year attracted numerous Canada Research Chairs, some of Canada’s leading immunotherapeutics researchers, and a Nobel laureate. The University is also part of a new CIHR-sponsored training program in hepatitis C, as well as a new CIHR-sponsored National Centre of Excellence in Allergic Disease (AllerGen). The University officially opened a new $17.8 million addition to the Vaccine & Infectious Disease Organization (VIDO) and in January 2004 received an additional $1.14 million to fully equip the new facility. Both the College of Medicine ($60M) and the Western College of Veterinary Medicine ($10M) are building new research wings that will significantly add to our abilities and infrastructure in vaccinology and immunotherapeutics. Infectious diseases is one of the research priorities of the College of Medicine. Finally, the University was successful in a proposal to the Canadian Foundation for Innovation (CFI) to build a $110 million Level III biocontainment facility (InterVac) to facilitate work on infectious diseases. The Board of Governors has given approval to move forward with this facility. In addition to this space, the University has the staff to deliver this program. There are 21 PhD-level scientists and 23 post-doctoral fellows/research associates dedicated to vaccinology at VIDO and approximately 37 more MD-, DVM- or PhD-level clinician-scientists or basic researchers actively involved in biomedical aspects of vaccinology and immunotherapeutics research in the Saskatoon Cancer Centre, the College of Pharmacy and Nutrition, the Department of Microbiology and Immunology, and the Departments of Veterinary Biomedical Sciences, Veterinary Microbiology, Large Animal Clinical Sciences. In addition, there are a myriad of molecular biology, oncology, pathology and other research and support personnel in the faculties of medicine, veterinary medicine, agriculture, the Virtual College of Biotechnology, as well as the social sciences and humanities. Thus, the physical and scientific resources are in place to deliver a world-class program. 7 Finally, the Saskatchewan Research Council is working on the production of a Canadian Food Inspection Agency (CFIA)-regulated product and has had its employees trained in good manufacturing practice (GMP). The SRC is willing to assist in teaching students in the area of fermentation, product isolation and GMP (communication from Amy Friesen – see Appendix 1). 3.A.1.2. Societal Aspects: There are societal concerns about vaccination and immunotherapeutics. Students must also be attuned to societal concerns about the research they are performing. Thus, in addition to the basic sciences, a top-level graduate program in vaccinology and immunotherapeutics must involve the social sciences and the humanities. There are complicated social, health care, legal and ethical issues and other concerns, perhaps to a greater extent than was ever the case before. For example, there are issues around national/regional vaccination programs for public health purposes, cost-effectiveness of vaccines and their accessibility (cost issues). There are questions on how to plan for pandemics: what emergency measures should be in place, how is this to be coordinated, the stockpiling of drugs, who are essential workers? Because of public concerns about possible adverse effects of vaccination, there needs to be better communications on the risk/benefit aspects of immunization and immunotherapy. Should there be a national policy on vaccination for immigrants (or even visitors)? How to better explain the need for vaccination to Canadians who travel abroad to high risk areas? There are ethical issues regarding voluntary versus mandatory vaccination and how vaccines are manufactured (e.g., an issue for animal rights activists who may oppose the use of animals or eggs for vaccine production). Issues as to what constitutes legitimate consent. Finally, legal and economic issues, including management of intellectual property, need to be taken into consideration for effective delivery of these products into the marketplace. The market also requires strict attention to regulatory issues, such as good laboratory practices (GLP), etc. It is apparent then that a graduate training program that broadly addresses the issues and questions surrounding vaccinology and immunotherapeutics will need to be multidisciplinary in nature. Our science graduates in vaccinology and immunotherapeutics will need to be versed in more than the technical and commercial aspects of the technology they will be creating and deploying. Similarly, social scientists with interests in vaccinology and immunotherapeutics need some scientific grounding to effectively carry out their research. In recent years, Canada has faced several emerging risk issues (e.g., blood safety, SARS) that have strained our collective ability to respond to challenges to our health care system. Since modern-day risks are both global and local simultaneously, a failure to understand and manage such risks in a socially sensitive way creates a set of interconnected impacts on various kinds of actors (e.g., trust of patients, consumer confidence, etc). Protecting Canadians and the global community from the devastating effects of infectious diseases is contingent on the development of effective risk management strategies. In this domain, the making of effective policy choices is dependent upon, and constrained by, our understanding of relevant risk factors for infectious diseases, including the detailed estimation of both the probabilities and full consequences of potential harms. Risk science has emerged as an important new discipline over the last two decades, offering powerful qualitative and quantitative methodologies for the assessment and management of 8 health risks of concern to Canadians. A number of frameworks have been developed during this period by a variety of agencies, providing comprehensive structured approaches for assessing both the magnitude and consequences of risks falling within their mandates. Risk assessment has traditionally focused on the analysis of chemical, biological and radiological hazards, but more recently has expanded to consider the impact of the broad range of determinants of health on the levels of risk experienced by specific populations and subpopulations. Historically, there has been a heavy reliance on the statistical and epidemiological assessment of risk. More recently, however, the recognition of risk as a social construct and the development of implicit theories of perception of risk among the public, has emerged. This social perspective on risk takes into account how the public evaluates the acceptability of risk, and how individuals make personal risk management decisions. Risk management therefore requires an integration of risk decision making in which objective assessments of risk, risk communication strategies, and risk management policies are in congruence with subjective perceptions of risk, notions of risk acceptability, and risk decision behavior of the public. The active participation of faculty in the social sciences and humanities will assist students registered in this program to appreciate the social environment in which medical innovations get introduced and utilized. 3.A.1.2.1. Current Areas of Strength There is externally recognizable strength in the area of public health, ethical, legal and the sociological aspects of health and risk within the faculty in the Sociology of Biotechnology Program at the University of Saskatchewan, Department of Community Health & Epidemiology, the College of Law and the Department of Philosophy. This on-campus expertise will assist faculty and students in this proposed program to better understand how risk, ethics and the law play a central role in shaping public policy responses to infectious disease control. 3.A.2. The Challenges: 3.A.2.1. Science: Vaccinology and immunotherapeutics research today is extremely complex, such that it requires multidisciplinary approaches. Nevertheless, fundamental to both is an understanding of how pathogens work, as well as the host factors that drive acute or chronic disease processes, and those that protect us from these pathogens. The incredible successes in vaccine development realized at the University of Saskatchewan’s own Vaccine and Infectious Diseases Organization (VIDO) and elsewhere were based on knowledge gained, in each case, from years of dedicated investigative immunopathogenesis and pathogenomics studies, as attested to by the more than 600 basic and applied immunobiology and biotechnology research publications that have arisen from VIDO in the past 35 years. And this does not begin to mention the reports from all of the other University of Saskatchewan units studying basic disease pathogenesis and immunobiology, and pathogenomics. As we gain more information about the basic biology of our own immune responses, as well as that of our as yet still challenging diseases, we move closer to managing them effectively. The proposed V&I Graduate program will enhance the research on the basic science underlying Vaccinology and immunotherapeutics and will act as a great stimulus in the area of design and production of vaccines and other immunotherapeutics. 3.A.2.2. Societal Aspects: As noted above, immunotherapeutics and vaccines are important not only in disease control but becoming increasingly important in the context of social, economic, legal and political issues. In this context areas of study may include the following: 9 1) An effective ethical-legal framework for the conduct of immunotherapeutics and vaccines research. 2) Effective ethical-legal and policy-making structures that enforce and monitor legal rights of trials. 3) Immunization contestation about the relative risks/side effects - the role of uncertainty and trust. 4) Major social issues in cost for developing countries, and adequacy of supply. 5) Economic studies of vaccine development and delivery. 6) The reasons for limited number of vaccine manufacturers in the market. 7) National research agenda and policy framework in domestic and global immunotherapeutics and vaccines. 8) Developing a resource allocation model to support immunotherapeutic and vaccine program decisions in developing countries. 9) Strategies for optimizing the usefulness of immunotherapeutics and vaccines to maximize social equity. 10) Ethical-legal framework to promote the welfare of immunotherapeutics and vaccines trial participants. 11) Liability for vaccine-related harms and the impact of potential liability on development, marketing etc. 12) Consent issues in vaccination programs (legal and ethical perspectives) 13) Regulatory standards and controls on research and manufacturing; harmonization of regulation (legal and policy perspectives) The proposed V&I Graduate program will enhance research activities on campus on the societal aspects of vaccinology and immunotherapeutics. It is anticipated that these activities will grow such that the university of Saskatchewan will be a centre of excellence for such scholarly work. 3.A.2.3. Overall Comments: To maximize the potential for vaccines and immunotherapeutics for maintenance and improvement of health, Canada must have: (1) an excellent base of researchers with the funds and facilities to fully investigate the immunology, pathobiology and pathogenomics of our diseases and to develop new and improved products. Students must be able to access faculty expertise in a wide range of subject areas, and they must be exposed to a variety of approaches and techniques. The recent Sixth Report of the National Biotechnology Advisory Committee stated that “there will be a shortage of people with combined scientific specialties such as peptide chemistry, gene therapy, bio-informatics, production and scale-up, and formulation which is exacerbated by the emigration of key researchers.” By developing a multidisciplinary team environment, we hope to develop these collaborative and complementary skills in our trainees. (2) an effective clinical vaccine and immunotherapeutics trials network able to evaluate the safety and efficacy of candidate approaches. 10 (3) expert investigators working in areas of public health, epidemiology, and health services research to model the impact of proposed treatment programs and to determine their costeffectiveness; and, (4) social scientists studying the knowledge, attitudes, and behaviors of vaccine and immunotherapy recipients and providers, and the cultural determinants of vaccine and immunotherapy acceptability (e.g., risk perception). Thus, the development of these approaches involves much more than simply elucidating disease pathogenesis, the underlying protective immune mechanisms, or identifying antigens: students need to be exposed to a broader array of experiences. The current multidisciplinary program is designed for the potential development of all of these opportunities. 3.A.3 Summary Assessment of Strengths: In short, the University of Saskatchewan and partners have a presence in all the areas required to do state-of-the-art research in all aspects of vaccinology and immunotherapeutics. Due to their multidisciplinary nature, these are not the domain of a single department or organization, nor do they rely solely on the fundamentals of immunology, but rather require the integrated knowledge of people with expertise in pathogenomics, cell and molecular biology, fermentation technology, epidemiology, ethics, law, risk assessment, computational science, engineering, and pharmacy, as well as the disciplines of infectious disease. Indeed, given its broad base of programs in these areas, the University of Saskatchewan is ideally suited to be leader in graduate student training and research in the area of vaccinology and immunotherapeutics. We have had a significant historical impact in controlling infectious diseases by developing a vaccine against Western equine encephalitis in the 1950s; more recently, seven different vaccines have been developed by VIDO. Furthermore, investigators at the Saskatoon Cancer Centre have developed cutting edge immunotherapeutic approaches for the treatment of cancers (which are currently in clinical trials), and other sectors at the University of Saskatchewan have successfully developed effective trial immunotherapies for allergic and inflammatory diseases. There is also recognizable strength in the area of public health, ethical, legal and the sociological aspects of health and risk within the faculty in the Sociology of Biotechnology Program at the University of Saskatchewan, Department of Community Health & Epidemiology, the College of Law and the Department of Philosophy. This on-campus expertise will assist faculty and students in this proposed program to better understand how risk, ethics and the law play a central role in shaping public policy responses to infectious disease control. 3.B. Enrolment Projections 3.B.1.1. Scientific Bases and Design & Production Streams: The recent Sixth Report of the National Biotechnology Advisory Committee stated that “there will be a shortage of people with combined scientific specialties such as peptide chemistry, gene therapy, bio-informatics, production and scale-up, and formulation which is exacerbated by the emigration of key researchers.” By developing a multidisciplinary team environment, we hope to develop some of these collaborative and complementary skills in each of our trainees. 11 The number of graduate students and post-doctoral fellows/research associates pursuing their training directly in the area of the biomedical aspects of vaccinology and immunotherapeutics is given in Table 1. Employment prospects for past graduates have been very good, with a placement rate of 100%. Indeed, in some sectors, headhunters call on a regular basis to identify potential candidates for various positions nationally and internationally. A number of our graduates have gone on to be Canadian Foundation for Innovation awardees at other institutions. Based upon the number of graduate students currently carrying out research using VIDO facilities (15 MSc and 19 PhD students), it is anticipated that in five years there will be 45-50 students enrolled in the “Scientific Bases” stream. There is developing interest in Vaccine Design & Production and it is anticipated that in five years there will be at least 6 students in this stream and considerable growth of student numbers over the next five to ten years. 3.B.1.2. Societal Issues Stream: This interdisciplinary program will provide training for graduate students with interests in this area enrolled in the Departments of Economics, Philosophy, Political Studies, Sociology and Community Health & Epidemiology at the University of Saskatchewan. Such students are likely to have interests in areas such as the sociology of biotechnology, health policy, science, technology and society studies, and medical sociology. Components of this program will also be of interest for students doing an MBA in Biotechnology or graduate degrees through the School for Public Health. It is anticipated that within five years there will be at least 6 students in this stream with increased growth in subsequent years. Continued growth in student numbers is anticipated in the subsequent five to ten years because of increasing student awareness of this program and because of the relevance of vaccines and other immunotherapeutics to public health. 4. DESCRIPTION OF PROGRAM CHARACTERISTICS The program will follow the University template for MSc and PhD students with a requirement for course work for both degrees as well as a research project culminating in a thesis. There will not be a non-thesis option. Students will be able to take the program on a fulltime or part-time basis, though part-time students would likely not qualify for scholarships and research awards. 4. A. General Admission Procedures All students will need to meet the University of Saskatchewan’s Graduate Studies requirements with regards to entry into the program. Thus, students will need to have at least a 70% average in the last 60 credit units of their previous programs for entry into an MSc or MA program and at least an 80% for PhD program. Secondly, for non-English speaking students, a TOEFL score of 550 or an equivalent measure of English proficiency will be required. The Vaccinology & Immunotherapeutics Graduate Program will follow the guidelines of the College of Graduate Studies and Research. All students admitted to the Vaccinology and Immunotherapeutics Program will be provided with funding (minimum two years for MA/MSc students and three years for PhD students). In the short term this will come from CGSR Graduate Scholarships, external scholarships, research funding and a one-time funding from the Academic Priorities Fund. In the long term, this will come from CGSR Graduate Scholarships, external scholarships, research funding and, hopefully, CIHR Training grants. The Vaccinology and Immunotherapeutics Graduate Committee (see 12 below for further details on this Committee) will be responsible for making admission recommendations to the College of Graduate Studies and Research (CGSR). Admission recommendations will be based on the applicants’ academic record, letters of reference and on the ability to secure funding for the student from the proposed supervisor (and/or the supervisor’s unit, department/college or external scholarship support). Students will be required to select a Program of Study in consultation with their major supervisor and Advisory Committee members. These courses will be designed to make up any deficiencies they might have, as well as to provide them with the knowledge and expertise they require for their research program. MSc/MA students will normally take 9 CUs and PhD students will take 12 CUs of graduate courses. However, depending on each student’s background and needs, these credit unit requirements could be increased. Decisions on the elements of the Program of Study will be done on an individual basis, taking into consideration the student’s area of interest as well as their previous training. To meet their seminar (990) requirement, students will be required to attend the weekly Vaccinology and Immunotherapeutics seminars that are held throughout the year. Graduate students in their senior year will be required to give a seminar on their thesis research. Students will also be required to attend regularly-scheduled journal clubs for at least 1 year in the case of an MSc student and 2 years as a PhD student. The journal club discussions will focus on sociology of immunization, commercial aspects of vaccine production and distribution, applied clinical and epidemiology, public health, molecular biology, pathogenomics, and vaccinology/ immunotherapeutics, with each topic being covered consecutively. However, each session will try to incorporate all areas as much as possible so as to ensure that students are continually thinking about the broader implications of their research. As well as meeting with their immediate supervisors on a regular basis, students may be required to participate in regularly-scheduled team meetings of various programs in which experimental objectives and experimental design will be discussed. This experience will provide students with a stimulating environment of constructive criticism and more opportunities to collaborate on specific aspects of other projects where they have interest or expertise. Students gain an understanding of the importance of teamwork, as well as in helping understand experimental design for projects beyond their own single project. Furthermore, faculty and staff will provide input into presentation and communication skills. If students wish to transfer from an MSc to a PhD program, they will be required to pass a qualifying examination. This qualifying exam will be in the form of defense of a PhD thesis proposal. For a PhD candidate, an oral comprehensive exam will be required after coursework is completed. 4. B. Program Outline and Program Streams All students in the program, regardless of stream, will take two keystone multidisciplinary courses. These courses are: V&I 801.3 (A Multi-Disciplinary Introduction to Vaccinology & Immunotherapeutics) and V&I 990.0 (Seminars in Vaccinology & Immunotherapeutics). Both courses will deal with all facets of vaccinology and immunotherapeutics. Descriptions of these courses are presented in Table 2. 13 In addition, to the mandatory courses of Vaccinology and Immunotherapeutics (V&I) 801.3 and V&I 990.0), students will complete their course requirements in the different streams by taking courses already offered at the University of Saskatchewan. A list, although not complete, of possible courses is given in Table 3. One of these courses must deal with research methodology: such a course may be literature driven where the research questions, the addressing of research questions, the methodology and interpretation of data are critiqued or it may be a formal research methods course such as, for example, SOC 841.6 (Advanced Research Methods). The program will be organized in such a way that different students could follow different streams within the multidisciplinary Vaccinology and Immunotherapeutics Graduate Program. These streams are: 1) Vaccinology & Immunotherapeutics: Societal Issues, 2) Vaccinology & Immunotherapeutic: Design & Production, and 3) Vaccinology and Immunotherapeutics: Scientific Bases. Examples of course requirements for some of these streams are given in Table 4. In addition, as mentioned above, components of the Vaccinology & Immunotherapeutics Graduate Program will be of interest to students carrying out graduate programs in Business Administration in Biotechnology or in Public Health. Since the degrees arising from this program are research thesis-based, students will also be enrolled in one of the following research courses: VI 994.0 – Research Students registered in a Master’s thesis program must register for this course annually throughout their entire MSc or MA graduate program. VI 996.6 – Research Students registered in PhD dissertation program must register for this course annually throughout their entire PhD research graduate program. New Courses To Be Developed in the Future As the Vaccinology & Immunotherapeutics Graduate Program progresses we anticipate the development of several new courses. Within the biomedical sciences these could be: VI 830.3 – Vaccinology and Immunotherapeutics A course similar to the distance-learning course in vaccinology which was previously coordinated by the University of Nebraska (with lectures by experts from across North America, including the University of Saskatchewan) will be developed here at the University of Saskatchewan. This course had been approved as a Special Topics course at the University of Saskatchewan for a number of years. We propose to formalize it as a course in the Vaccinology and Immunotherapeutics program. VI 840.3 – Host and Pathogen Genetics Genetics of host resistance to pathogens Genetics of virulence of pathogens Genetics of susceptibility to cancer and allergies Genetics of transplant rejection 14 Mechanisms of resistance – innate and immune How effector molecules of pathogens interact with the host Evolution of resistance or susceptibility in host populations Some thoughts on delivery of course – guest lectures, combination of student seminars and guest lecturers VI 841.3 - Immunopathogenesis of disease What is known and not known about host-parasite relationships Immune responses vs protective immune responses Parameters that discriminate between protective and non-protective Immune responses 5. VACCINOLOGY AND IMMUNOTHERAPEUTICS PROGRAM GOVERNANCE AND ADMINISTRATION The Vaccinology and Immunotherapeutics Program is a multidisciplinary graduate program under the umbrella of the College of Graduate Studies and Research. Governance and administration of the Vaccinology and Immunotherapeutics Program takes the following form. 5. A. Vaccinology and Immunotherapeutics Group The Vaccinology and Immunotherapeutics Program is carried out by members of the Vaccinology and Immunotherapeutics Group. Faculty/Scientists with active research programs and with academic or research interests in vaccinology or immunotherapeutics who work at the University of Saskatchewan or any of the federal or provincial agencies or private sector laboratories on campus, are eligible to become members of the Vaccinology and Immunotherapeutics Group. More specifically, membership in the Vaccinology and Immunotherapeutics Group is open to anyone who: • Provides significant course instruction in the Vaccinology and Immunotherapeutics Program. • Has supervised a graduate student in the areas of interest to the vaccinology and immunotherapeutics program within the last 10 years. • Has made major contributions to areas of interest to the vaccinology and immunotherapeutics program on campus through their research efforts. • Contributes significantly to the vaccinology and immunotherapeutics program either through journal clubs, course development, or supervisory committee activity (i.e., new recruits are welcome). Two types of membership may be granted in the Vaccinology and Immunotherapeutics Group: 1. Associate Membership is granted to individuals who have a principal interest in vaccinology or immunotherapeutics, but are not presently engaged in active research or teaching in the field of vaccinology and immunotherapeutics. 2. Full Membership is granted to individuals who are currently involved in research or teaching specifically related to areas of interest to vaccinology or immunotherapeutics program. 3. Nominations, including self-nominations, to the Vaccinology and Immunotherapeutics Group will go to the Dean of Graduate Studies and Research and appointments will be made for five years, and will be renewable. Initially, terms will be staggered between one and four years to ensure continual membership. When a permanent governance and 15 administrative unit is in place nominations for this Group will go to the Director or equivalent. The mandate of the Vaccinology and Immunotherapeutics Group is to: • maintain the academic graduate program in vaccinology and immunotherapeutics at the University of Saskatchewan • promote and facilitate research in vaccinology and immunotherapeutics • promote public awareness and engage in community communications on important issues in vaccinology and immunotherapeutics • work cooperatively and collaboratively with all academic or other units participating in vaccinology and immunotherapeutics and address difficulties when they arise in matters involving shared resources. Qualified members of the Vaccinology and Immunotherapeutics Group who are members of the College of Graduate Studies and Research are eligible to serve as supervisors for students enrolled in the MA, MSc and PhD programs in Vaccinology and Immunotherapeutics. These members will be actively engaged in research across a broad spectrum of vaccinology and immunotherapeutics sub-disciplines. A list (still incomplete) of individuals interested in the Vaccinology and Immunotherapeutics Graduate Program is provided in Appendix 3. A General Meeting of the Vaccinology and Immunotherapeutics Group will be held once a year. Additional meetings can be held during the year if required. 5. B. Vaccinology and Immunotherapeutics Executive Committee Oversight for the Vaccinology and Immunotherapeutics Program is the responsibility of a seven (or eight) member Vaccinology and Immunotherapeutics Executive Committee. The Vaccinology and Immunotherapeutics Executive Committee is the main policy body for the Vaccinology and Immunotherapeutics Program. It sets the rules and regulations for the Vaccinology and Immunotherapeutics Program, and ensures that these rules and regulations are carried out. The Vaccinology and Immunotherapeutics Executive Committee is also responsible for communicating these rules and regulations to the members of the Vaccinology and Immunotherapeutics Group, as well as receiving feedback from the Vaccinology and Immunotherapeutics Group on the Vaccinology and Immunotherapeutics Program. The membership of the Executive Committee shall be drawn from the following academic areas: (1) one member from clinical sciences or epidemiology; (2) one member from law, commerce, economics, philosophy or sociology, 3) one member from an academic microbiology department, 4) one member designated by the Immunology and Infectious Diseases Research Group, and 5) one member from VIDO. In addition, if there are significant numbers of graduate students in the V&I program not from the five academic areas listed above, one member appointed by the Executive to represent that area. Finally, the Dean, CGSR (or his/her designate), and a leader from the University will also be appointed to the Vaccinology Executive Committee. The Executive initially will be appointed by the Dean of the College of Graduate Studies and Research but thereafter will be elected by the Full Members. Normally the members of the Executive will serve for a term of three years; however, an exception is made for the members of the first Executive. 16 Towards the end of the first year one of the academic members of the Executive will be chosen by lot for his/her term to end. The Executive will then call for nominations from the Vaccinology and Immunotherapeutics Group members in the area represented by this Executive member. The Vaccinology and Immunotherapeutics Group membership will then vote for the representative from that academic area who will serve for a period of three years. Towards the end of the second year, two of the members of the Executive will be chosen by lot for their terms to end. The Executive will then call as above for nominations in the area represented by these Executive members, and the membership will then vote for the representative from these academic areas who will serve for a period of three years. Towards the end of the third year the term of the remaining original members of the Executive will have come to an end and the Executive will call for nominations in the academic areas of these Executive members. The membership will then vote for the representative from these academic areas who will serve for a period of three years. Following this, during each year one or more members will have their term coming to an end. The Executive will call for nominations from the Vaccinology and Immunotherapeutics Group in the specific academic area(s) followed by a vote of the Vaccinology Group membership. 5.C. Vaccinology and Immunotherapeutics Graduate Committee The Vaccinology and Immunotherapeutics Graduate Committee carries out the day-to-day operations of the Vaccinology and Immunotherapeutics Program. The Chair of the Graduate Committee (the Graduate Chair) has formal roles and responsibilities relating to the CGSR Graduate Council, including the College’s Executive, Awards, Nominations, Master’s and Ph.D. Committees. A complete description of the role of the Graduate Chair is provided in section 2.3 of the CGSR Policy and Procedure Manual (available at http://www.usask.ca/cgsr/administration/index.html). The Graduate Chair will be appointed by the Vaccinology and Immunotherapeutics Executive Committee. The Vaccinology Graduate Committee and the Vaccinology Graduate Chair are of critical importance in ensuring the success of the Vaccinology Program and of individual students in the program. A key role of the Graduate Committee will be to match eligible students with supervisors and to ensure that funding is available for the students before an offer of acceptance into the Vaccinology and Immunotherapeutics Program is made. To enact this role, the Graduate Committee will need to work closely with the members of the Vaccinology and Immunotherapeutics Group to confirm the appropriate funding. The Vaccinology Graduate Committee has four members that are appointed by the Executive. Given the large roles that VIDO and the University’s academic microbiology departments will have in the Vaccinology and Immunotherapeutics Program, one of the members will be from VIDO and one from an academic microbiology department 6. RESOURCES Preamble: The University of Saskatchewan is strategically positioned to be able to develop a world-class program in vaccinology and immunotherapeutics with the presence of all the health science colleges plus engineering, agriculture, law, sociology, philosophy and commerce all on one campus. The University of Saskatchewan is home to VIDO, a very successful research 17 institute focusing primarily on vaccine development and delivery, and has multiple laboratories dedicated to cutting edge immunotherapeutic research. On the University campus is also the Saskatchewan Research Council that is interested in enhancing the area of vaccinology & immunotherapeutics. Furthermore, the interactions of the University’s researchers with national and international infectious disease and immunotherapeutics programs provides external support for exposure of our students to world leaders in vaccinology and immunotherapeutics. It is not the intent that the Vaccinology and Immunotherapeutics graduate program will replace any of the graduate programs already in place in our microbiology departments. However, some of the faculty in these departments will be involved in various aspects of the new program, including teaching, supervision, and management and, in this sense, there will be a redeployment of resources. There are faculty in the social sciences and humanities units on campus that have an interest in vaccinology and immunotherapeutics. These academic units include Law, Commerce, Sociology and Philosophy. Currently there are approximately 48 graduate students on campus that are working in the broad area of the science of vaccinology and immunotherapeutics. Many of these students are formally registered in the Department of Veterinary Microbiology. The creation of a Vaccinology and Immunotherapeutics Program may mean some loss of graduate students for Veterinary Microbiology and other departments on campus. However, given the expertise in Veterinary Microbiology and the other departments, it is clear that many students in the Vaccinology and Immunotherapeutics Program will end up working with faculty in these departments. This type of shift is also going on in other parts of campus, where faculty are increasingly supervising graduate students that are “outside” their department (the students are often in interdisciplinary programs). To recognize this trend, CGSR has indicated that departments that have faculty that supervise students in interdisciplinary programs will be given credit for this work. This credit takes the form of counting all students supervised by the department’s faculty (including those students that are in interdisciplinary programs) when determining the amount of devolved scholarship funds that the department will receive. 6.A. Existing Resources The physical resources to mount this program are, for the most part, already in place. The University of Saskatchewan has three distinct microbiology departments (Department of Microbiology and Immunology, Department of Applied Microbiology & Food Science, Department of Veterinary Microbiology), each with experienced and qualified faculty and wellequipped labs. In addition, expertise that is useful to a graduate program in vaccinology and immunotherapeutics is present in other units such as Chemical Engineering, Pharmacy & Nutrition, Saskatoon Cancer Centre, Saskatchewan Research Council, VIDO, etc. When the new research additions to the Western College of Veterinary Medicine and the College of Medicine are completed, and the level 3 facility, INTERVAC, becomes operational, the program would gain access to even more advanced facilities and equipment. The faculty resources are also in place, particularly in the sciences. It is expected that some of our academic departments will replace retiring members with faculty able to take full advantage of INTERVAC, and these new faculty will further strengthen the program. Indeed, Infectious disease is a research priority of the College of Medicine as well as the Department of Microbiology and Immunology. Furthermore, the most recent recruit (November, 2006) to the Department of Microbiology & Immunology carries out research in the area of infectious 18 disease. We have faculty in place who are interested in the societal aspects of Vaccinology and immunotherapeutics. 6.A.1. Graduate Teaching Facilities Many of the courses that will be included in the Vaccinology and Immunotherapeutics Program are being taught in numerous lecture theatres and teaching laboratories rooms across campus. In addition, VIDO has multiple new meeting/lecture rooms and a lecture theatre for 200; these facilities are equipped with state-of-the-art audiovisual equipment. 6.A.2. Infrastructure Currently, all departments and institutes that will participate in the Vaccinology and Immunotherapeutics Program have laboratories, offices, and equipment. Approximately 100,000 sq. ft. of research space is available at VIDO, and 1470 sq. ft. of new research space is under construction at the Western College of Veterinary Medicine, as well as 173,000 sq. ft. of new research space has been approved for construction within the College of Medicine. Thus, the equipment and laboratory space, as well as the support staff will be available to provide a very strong graduate program in Vaccinology and Immunotherapeutics. In addition, the University was successful in obtaining approval for a new $110 million level III biocontainment facility. Library and other resources are already in place. Thus, no new infrastructure will be required. 6.A.3. Visiting and Associate Faculty The Vaccinology and Immunotherapeutics program, by nature of its structure, does not directly appoint visiting faculty, clinical faculty, or associate faculty. These appointments, if they occur, are usually associated with home departments or colleges where the research facilities are located. VIDO is developing a program to encourage scientists on sabbatical to spend their year on campus. Facilities are available for hosting such visiting faculty. 6.A.4. Support Staff The University of Saskatchewan has numerous units, departments and colleges that can provide support for graduate student training. The classes to be offered within the Vaccinology and Immunotherapeutics program are currently being taught by these departments and colleges, and thus have support staff in place. 19 6.B. New Resources Total New Financial Resources Requested are outlined in Table 5. A one-time $207,000 and an ongoing $33,000 are requested. 6.B.1. Graduate Student Support As this is a multidisciplinary initiative, care must be taken to ensure its ongoing success. The University has an unfortunate history of inadequately supporting interdisciplinary and multidisciplinary programs, which then may flounder as the original enthusiasm of proponents wanes. CGSR has modified its own regulations to support this kind of initiative, but this will not be enough. Accordingly, a modest request of $150,000 (one-time) is made to initiate this program and to ensure that it fulfills its promise as one of those graduate programs for which the University of Saskatchewan is noteworthy. The source of funding is the Academic Priorities Fund and, since it is anticipated that the first cohort of students would be admitted in the fall of 2007, funds should be available in the 2007-08 budget year. 6.B.2. Half-Time Clerical Services Worker II - $17,000 Since this is to be an interdisciplinary program, some administrative assistance is required (much like that available to support the individual student interdisciplinary programs managed by the Interdisciplinary Committee of CGSR). PCIP will be approached to fund, through the Academic Priorities Fund, this half-time position on an ongoing basis. This position would be housed within CGSR if possible. 6.B.3. Course Development & Sessional Relief Costs for V&I 801.3& V&I 990.0 and Graduate Chair - $11,000 Only the Sessional relief will be ongoing. These monies will be used to buy teaching relief for faculty heavily committed to teaching components of V&I 801.3 and organizing V&I 990.0. One of the ongoing costs of the program will be the compensation offered to the academic unit from which the Graduate Chair/Program Coordinator is selected. Normally, these costs would be borne by the academic unit mounting the graduate program. Since this is an interdisciplinary program, PCIP is being asked to fund, through the Academic Priorities Fund, this cost on an ongoing basis. 6.B.4. Compensation to Director - $3,000 We propose to compensate the Director of the Multidisciplinary V&I Graduate Program by 0.5 CDI to base salary. 0.5 CDI as an administrative stipend and $1,000 increase to the Professional Allowance. 6.B.5. Multidisciplinary Seminar-$6,000 Most of these monies will be used to bring in visiting speakers for the V&I 990.0 course. Some of the monies will be used to supply coffee for V&I 990.0. Students in the Vaccinology and Immunotherapeutics graduate program will be working in departments and laboratories in various locations across campus. It is important that these students and the faculty who supervise them come together on a regular basis to present and discuss critical papers and their own work. Normally, these costs would be borne by the academic unit mounting the graduate program. Since this is an interdisciplinary program, an ongoing budget to organize and support 20 the seminar is essential. PCIP is being asked to fund this item through the Academic Priorities Fund. 6.B.6. Program Advertising Costs Funding of $20,000 has been budgeted in the first year for advertising and recruitment, and of $1,500 in continuing years for advertising and recruitment. 7. RELATIONSHIP AND IMPACT OF IMPLEMENTATION The greatest impact of this program will be on the graduate students who wish to pursue training in Vaccinology and Immunotherapeutics. The proposed graduate program in Vaccinology and Immunotherapeutics is unique in that it provides graduate students an opportunity to be exposed to a variety of different disciplines in one institution and to interact with top-level national and international scientists and experts through the linkages that have been and will be developed. As outlined at the beginning of this document, Vaccinology and Immunotherapeutics students increasingly require exposure and an understanding of a wide range of topics in science, medical science, social science and the humanities. The Vaccinology and Immunotherapeutics program will provide opportunities for increased interaction between the various groups of faculty and researchers on and off campus that are currently working on Vaccinology and Immunotherapeutics and their related issues. To date, much of the work in Vaccinology and Immunotherapeutics done at the University of Saskatchewan has been somewhat segmented. A greater deal of cross- and inter-disciplinary work is required to meet the challenges inherent in Vaccinology and Immunotherapeutics research. The structure of the Vaccinology and Immunotherapeutics Program should facilitate such cross-cutting work. As is often the case, graduate students and their thesis work become the mechanism by which faculty and researchers are brought together. Students in the proposed program will get an appreciation of the importance of academic excellence, as well as the linkages and teamwork critical in both academia and the commercial arena. The ability to work with a wide variety of people is important in today’s multidisciplinary environment and is increasingly being demanded by both academia and industry. Since all of our students will receive exposure to the commercial mindset or interact directly with commercial companies, they will become familiar with confidentiality agreements, research planning, Gantt charts, and the importance of achieving set milestones. Thus students choosing to enter academia will already have the tools to establish and maintain relationships with industry and to participate in university–industry-type programs supported by the Federal Government. By having alumni in industry, governments, and academia, the University is also able to establish strong partnerships with all sectors of the biotechnology industry. One of the reasons graduates from the University of Saskatchewan are so highly sought after is that they have been exposed to a collaborative research program in an entrepreneurial environment. This is considered to be critical for the success of the knowledge-based economy that Canada hopes to build in the 21st Century. 21 This proposal was developed by the Vaccinology and Immunotherapeutics Program Drafting Committee. This Committee is comprised of those researchers on campus that have an interest in vaccinology and immunotherapeutics and in the training of students in the area of vaccinology and immunotherapeutics. A list of the members of the Drafting Committee is provided in Appendix 3. The draft program was the result of numerous discussions that have taken place on campus over the last number of years about creating a vaccinology program. The draft program was revised and approved by the Vaccinology and Immunotherapeutics Program Drafting Committee. 8. BUDGET Because of a one-time major graduate student support request, the budget for the first year would be $207,000. The budget for the remaining years would be $33,000/annum. Graduate Student Support Year 1 $150,000 Continuing Unspecified-students considered as part of regular CGSR competitions Clerical Services Worker Phase II (half-time) $17,000 $17,000 Course Development Costs $5,500 Sessional Relief Costs $5,500 $5,500 Remuneration for extra duties of the Director $3,000 $3,000 Multidisciplinary V&I 990.0 $6,000 $6,000 Advertising $20,000 1,500 Total $207,000 $33,000 22 APPENDICES Attached: List of New Courses Memorandum of understanding between CGSR and VIDO Letters of Support: SRC, Provost & VP Academic, Dean of Veterinary Medicine, Dean of Arts & Science College Statement Additional appendices available from the Office of the University Secretary: Lists of faculty and scientists interested in participating Keystone courses Lists of courses which could be used in the program Vaccinology program drafting committee Some examples of program streams List of New Courses VI 801.3 A Multidisciplinary Introduction to Vaccinology and Immunotherapeutics Calendar description: This multidisciplinary course gives an overview of the science, commercial production including good laboratory and manufacturing procedures as well as regulations, sociology, public health, legal and ethical aspects of vaccines and immunotherapeutics development, production and administration. Rationale for introducing this course: This course will be a mandatory keystone course for the new Vaccinology and Immunotherapeutics Graduate program VI 990.0 Seminars in Vaccinology and Immunotherapeutics Calendar description: This seminar-based course will have weekly seminars and the occasional workshop during terms 1 and 2. Seminar will be given by invited speakers both local and from elsewhere. In addition, graduate students in their final year of study will present their research findings. This seminar series will be multidisciplinary dealing with commercial production including good laboratory and manufacturing procedures as well as regulations, sociology, public health, legal and ethical aspects of vaccines and immunotherapeutics development, production and administration. Rationale for introducing this course: This course will be a mandatory keystone course for the new Vaccinology and Immunotherapeutics Graduate program. 23 Letter from SRC From: "Friesen, Amy" <friesen@src.sk.ca> Date: November 5, 2006 12:28:11 PM GMT-06:00 To: Bernhard Juurlink <bernhard.juurlink@usask.ca> Subject: SRC contribution to Vaccinology program Hi Bernie, Thank you for the invitation for the Saskatchewan Research Council to participate in the Vaccinology & Immunotherapeutics Graduate program. SRC has experience in working with vaccines regulated by the Canadian Food Inspection Agency, and in the past, we have brought in GMP trainers for our employees. Using this expertise, SRC would be pleased to assist with the Vaccinology & Immunotherapeutics Graduate program, in collaboration with our University colleagues. The areas where we could best contribute are: vaccine development, microbial fermentations, mammalian cell culture process development, and protein purification. Sincerely, Amy Friesen Amy Friesen, M.Sc. Research Scientist Fermentation Technologies AgBiotechnology Branch Saskatchewan Research Council 15 Innovation Blvd. Saskatoon, SK S7N 2X8 Tel: (306) 933-7920 Fax: (306) 933-7299 24 University Secretary's Office Memorandum TO: Bernie Juurlink, Department of Anatomy & Cell Biology Associate Dean Trevor Gambell, College of Graduate Studies & Research FROM: John Rigby, Chair, Planning Committee of Council DATE: Jan 17, 2007 RE: Notice of Intent for graduate programs in Vaccinology and Immunotherapeutics The Planning Committee discussed the Notice of Intent for graduate programs in Vaccinology and Immunotherapeutics at its November 29, 2006 meeting. Thank you for attending this meeting to provide us with additional information about the notice. We have the following suggestions for additional information to be included in the final proposal document. 1. Linkages with departments in Medicine and in the Western College of Veterinary Medicine, with VIDO, and with the School of Public Health The Planning Committee wants to ensure that the linkages between these graduate programs and existing graduate programs, and with existing research centres, be identified and discussed. The consultation process for the development and coordination of the programs should be described. 2. Faculty resources The relationship between the College of Graduate Studies & Research and the researchers at VIDO should be clarified with respect to graduate student supervision and teaching. 3. Graduate program array The final version of the proposal should describe how the graduate programs in this area fit into the overall graduate program array at the University. ______________________________ cc: Dean William Albritton, College of Medicine Dean Charles Rhodes, Western College of Veterinary Medicine ASSOCIATE DEAN MEMORANDUM TO: Academic Programs Committee FROM: Trevor Gambell, Associate Dean, CGSR DATE: Tuesday, February 27, 2007 RE: Vaccinology and Immunotherapeutics Graduate Programs ____________________________________________________________________________________ The proposal for graduate programs in Vaccinology and Immunotherapeutics includes M.Sc., M.A. and Ph.D. degrees. They are interdisciplinary programs which, in the interim, will be administered through the College of Graduate Studies and Research. The proposal first came to the Joint Master’s and Ph.D. Committee on November 21, 2006. The Joint Committee considered the proposal to be well-prepared and could be recommended for approval with some suggestions to strengthen the proposal, as follows: 1. It was not clear whether students could take the program on a part-time basis or whether fulltime study was required. Response: both part-time and fulltime status is possible. 2. There is no course requirement in any of the programs for a research methods course. The Committee deemed this to be highly unusual for a research program. Response: It is quite common for science graduate programs not to specify of research methods course. Research methods are usually dealt with in a course that covers current literature. 3. There are MBA courses listed as electives, and these are subject to special tuition assessments. Recommendation that a statement appear beside these courses to the effect that “This course will incur an additional program cost of $1,300.” Response: This will be done. 4. There was concern expressed by the Committee whether students can enter the program directly from a Master’s degree and take just three additional credit units. Response: If a student has a M.Sc. from a recognized university, they can enter directly into the Ph.D. program, but if not or if entering from a B.Sc. program, the student will need to enter initially into a M.Sc. program and then the student can transfer into the Ph.D. program if certain academic standards are met. 5. A concern was expressed that the proposal was under-costed; that is, the request to PCIP was too low. Where would the funding come from to hire a Director? Response: The Director would be a person equivalent to a Department Head. There is only a small amount of reimbursement to Department Heads, and this should be budgeted for. With these changes, the Committee made and carried a motion to approve the Vaccinology and Immunotherapeutics program. The motion of approval then went to the Executive Committee on December 14, 2006. Members of this Committee were not persuaded by the rationale for there being no need for a required research methods or design course, and sent the proposal back to the Joint Committee with the motion “The Committee does not approve the proposal and is not persuaded by the rationale for there being no core research methods course.” The motion was sent back to Dr Bernard Juurlink for his response, and to the Chair of the Joint Committee for its re-consideration of the proposal. Response: Dr Juurlink indicated that the program can be revised to state that in addition to the two core courses, all students must take a graduate course that deals with research methodology. This satisfied the Joint Committee, which on January 17, 2007 reviewed the concerns of the Executive Committee and the responses from Dr Juurlink, and reaffirmed its previous motion to approve the programs with the added requirement for a graduate course in research methods or design. The Executive Committee then met on January 18, 2007 and made and carried a motion to approve the programs as per the added requirement noted by the Joint Committee and proposed by Dr Juurlink. Graduate Council then approved the Vaccinology and Immunotherapeutics programs on January 29, 2007 with no further changes or comment. The College of Graduate Studies and Research has awaited these program proposals for a long time, since these types of programs in vaccinology, immunology, and the social, public health and welfare, and sociological implications of such research and application offer great potential for graduate study and research, and also because the expertise exists on this campus for such programs, with the U of S in a potentially strong position to be a world leader in this field. The programs offer to fulfill the CGSR College plans in three ways: interdisciplinary programming; growth of graduate students and programs; and growth the doctoral studies and studies in particular. Trevor Gambell Associate Dean College of Graduate Studies and Research Office of the University Secretary 212 College Building 107 Admin Place Saskatoon, SK Canada S7N 5A2 Phone: (306) 966-4632 Fax (306) 966-4530 MEMORANDUM TO: John Rigby, Chair, Planning Committee of Council FROM: Trever Crowe, Chair, Academic Programs Committee of Council DATE: April 30, 2007 RE: Program proposal for graduate programs in Vaccinology and Immunotherapeutics At its April 13, 2007 meeting, the Academic Programs Committee discussed the Subcommittee Report on the proposal for new graduate programs in Vaccinology and Immunotherapeutics. The Subcommittee had discussed the program at several meetings and had met with the proponents. In conclusion, they endorsed the program as academically sound, noting that this will be a unique program in Canada. Professor Desautels provided information to APC about discussions on the following points: 1. Oversight of the program and its relationship of the program with the School of Public Health: Dean Wishart told the Subcommittee that the program will be a CGSR program until the School of Public Health is approved; at that time, it will become one of the three core programs of that school. 2. Handling of the graduate scholarships and other budget issues: The graduate scholarships fund requested is going to be used as a start-up fund over several years, and will be for new students. The School of Public Health will have funding for initial seminar presentations. VIDO has agreed to contribute funding toward a clerical position for CGSR to manage this interdisciplinary program. . The Committee approved the following motion: That the proposal of the College of Graduate Studies and Research for graduate programs in Vaccinology and Immunotherapeutics be recommended for approval. _______________________________ MEMORANDUM TO: John Rigby, Chair Planning Committee of Council FROM: Alison Renny, Chair Budget Committee of Council DATE: April 30, 2007 RE: Vaccinology and Immunotherapeutics Graduate Program Proposal ______________________________________________________________________________________ A joint subcommittee of the Academic Programs Committee and Budget Committee met on March 22, 2007, to consider the proposed graduate programs in Vaccinology and Immunotherapeutics, and subsequently met with program proponents on April 12th. The subcommittee considered the proposal to be academically sound and well developed. Budgetary issues considered related to graduate student funding, student recruitment, and program support. At the April 26, 2007, Budget Committee meeting, the following motion was carried: Motion: “That the Budget Committee receive the joint subcommittee report on the Vaccinology and Immunotherapeutics graduate program proposal, and recommend approval of the proposal to the Planning Committee. “ I would be pleased to answer any questions you may have regarding the committee’s deliberations. _______________________________________ Alison Renny, Chair, Budget Committee of Council c C. Fornssler Attach: Subcommittee Report JOINT SUBCOMMITTEE REPORT Academic Programs Committee and Budget Committee Vaccinology and Immunotherapeutics Program Proposal Members: Academic Programs Committee: Michel Desautels (Chair), Chary Rangacharyulu; Budget Committee: Ramji Khandelwal, Ed Kendall; Resource: Jim Spinney, Sandra Calver (Secretary) The joint subcommittee met on March 22, 2007, to consider the Vaccinology and Immunotherapeutics Graduate program proposal and subsequently on April 12, to review the proposal with the program proponents. The meeting on April 12th was attended by Bernie Juurlink, Acting Assoc. Dean, Basic Sciences, College of Medicine; Tom Wishart, Dean of the College of Graduate Studies and Research; and Bruce Reeder, Special Advisor to the Provost on the School of Public Health. The program was commended from an academic viewpoint; however, there were a number of questions regarding the program administration and budget. A summary of the discussion with the proponents on these points follows. The relationship of VIDO to the program was clarified by proponents. VIDO will be a major contributor to the program, in terms of both program content and instruction, but is not intended to have academic oversight over the program. The program is proposed as an interdisciplinary program to be administered and housed within the College of Graduate Studies and Research until the School of Public Health is created, at which time the program will then become one of the School’s core graduate programs. Presently, the CGSR manages several interdisciplinary programs. The subcommittee clarified that the $150,000 requested for graduate student funding would be start-up funds, to be deployed over the first years of the program, rather than just in year one. The intent is that by the fourth year of the program offering, the program would have enough students to become part of the devolved scholarship program within the CGSR. The program is meant to attract new students, particularly from the social sciences and in the area of vaccine design production. Current students in Veterinary Microbiology who are just starting their research work at VIDO could conceivably transfer into the program. Students that are far enough into their current program are unlikely to do so and will be encouraged to complete their program under their present arrangement. Proponents noted the program scope is unique and not replicated elsewhere in Canada. Difficulty in recruiting high-quality students is not foreseen, although with program approval coming late in the year, recruiting students for a fall start this year will be more challenging. Regardless of program quality and uniqueness, the subcommittee agreed an important component of student recruitment is advertising. In light of the intent to recruit new students to the program, rather than rely upon the transfer of an existing cohort, the subcommittee suggested the advertising budget of $20,000 may be inadequate, and suggested this figure be revised upwards. The subcommittee also considered the seminar budget to be low, but was informed the existing seminar series within VIDO will be made available to students within the program. The proposed clerical support provided by VIDO was clarified as an additional 0.5 fte graduate secretary to be housed within the College of Graduate Studies and Research, and eventually transferred to the School of Public Health. With respect to the sessional relief and stipend sought for the Director/Graduate Chair, this was clarified to be sessional relief meant to backfill any faculty member time to develop specialized courses within the program. The stipend to the Graduate Chair is not unique as far as interdisciplinary programs are concerned. It is meant to help recruit a Faculty member to that position in providing some funding for a graduate student to help the Graduate Chair carry his/her functions. …2 The Steering Committee for the School of Public Health has worked closely with the Vaccinology Program Drafting Committee over the past year. The fit of the program within the School of Public Health was outlined as a core program within the school, which would align well with the school’s other graduate program offerings and the infectious disease epidemiology courses available through the school. In general, it is envisioned the school will contribute towards rounding out the social science aspects within the program. The subcommittee noted that many of the budgetary concerns result from consideration of the program as a stand-alone program. With the planned integration of the program within the School of Public Health, many of the administrative and budgetary aspects of the program will be folded within the overall administrative structure for the school. Members supported this approach. With respect to the overall budget, the key point is that appropriate level of funding be provided to sufficiently resource the program, not only in its start-up phase, but on an ongoing basis.