Course Outline and Syllabus for Students

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1 Course Outline and Syllabus for Students Name: Monica Gautam Course Number: PHM321 Course Title: Selected Topics in Pharmaceutical Industry Course Description: This course is designed to expose students to the pharmaceutical & biopharmaceutical industries, its environment, inner workings, and approach to engaging customers and stakeholders. The course outlines the business model of the and covers both drug development and commercialization, from international and Canadian perspectives. The course is intended to broaden the students understanding of the, introduce critical concepts and terminology, build confidence and prepare students who may seek a career in the. Required: No Elective: Yes Semester: Fall Enrollment: 240 maximum 1. Course Learning Objectives: Upon completion of this course, students will have achieved the following level of learning objectives: Introductory = knowledge and comprehension of concepts, definitions, Intermediate = application of concepts to simple situations Advanced = application of concepts to more complex situations with ability to synthesize and evaluate Knowledge Introductory Level: 1. List and distinguish the rolls of the various stakeholders in industrial pharmacy 2. Explain the role of firms in industrial pharmacy 3. Recognize the need for a financial return on investment for corporate investors in industrial pharmacy 4. List all steps of drug development and commercialization 5. Describe the drug discovery process with a focus on the entrepreneurship and business development 6. Describe the drug development process: bench work, animal testing and clinical development 7. Describe the regulatory environment that governs the pharmaceutical 8. Describe modern market access and drug promotion including the functions of the following departments: health outcomes and economics, medical and scientific affairs, as well as, sales and marketing Intermediate Level: 1. Analyze drug discovery and development strategies and plans 2. Analyze regulatory strategies and plans 3. Analyze market access strategies and plans

2 4. Analyze marketing strategies and plans 5. Discuss the rationale behind major regulations that have shaped the pharmaceutical 6. Differentiate between on-label and off-label promotion and cite the legal implications of off-label promotion 7. Assess when it is appropriate to engage in an off-label discussion Advanced Level: 1. Appraise a drug candidate s potential for commercial success 2. Appraise the success of marketed drugs in the face of emerging competition and other environmental changes 3. Debate controversial regulations and standards governing the such as drug development regulations and new regulations emerging in the field of post licensure market access and health technology assessment Skills Introductory Level: Intermediate Level: 1. Design a simple drug development plan 2. Design a simple market access plan 3. Design a simple marketing plan Advanced Level: Attitudes/Values Introductory Level: 1. Students will gain sufficient knowledge to be able to consider the pharmaceutical as they draw up their career plans Intermediate Level: 1. Develop an appreciation for the history of ethical, legal and regulatory forces that have shaped the pharmaceutical 2. Plan a career with in the pharmaceutical Advanced Level: 1. Formulate a point of view on future trends and opportunities with in the pharmaceutical 2. Rationale for Inclusion in the Curriculum: The industrial pharmacy course will prepare students for interaction with the pharmaceutical. Students will be provided with sufficient background on the s function, structure, stakeholders, incentives and code of conduct. The course will also build on this knowledge base to develop skills and competencies through interaction with actual senior professionals and through in-class discussions of current high profile and controversial topics. As a result, students will be able analyze and understand actions and decisions, appreciate the complexity and limitations imposed on drug development and commercialization, as well as, develop foresight into how the field of industrial pharmacy will develop in the future. In this manner pharmacy students will be able to better define their role while interacting with the and their potential role within

3 the. Further, students will be able to think about how to leverage the pharmaceutical as they progress their careers and profession. 3. Pre-requisites: None 4. Statement of agreement from course coordinators of courses for which this course is a pre-requisite: Not applicable 5. Co-requisites: (for the current and subsequent year) None 6. Statement of agreement from coordinators of courses for which this course is a co-requisite: Not applicable 7. Course Contact Hours and Teaching Methodologies: Didactic (lecture) Large group problem-based or case-based learning Large Group Size (eg 30, 60, 120, 240) Laboratory or Simulation Tutorial/Seminar/Workshop/Small Group Small Group Size (eg 5, 10, 15, 20, 25) Experiential On-line Other (please specify)* * Other specific information: Total course contact hours 26 hours hours persons hours hours persons hours hours hours 26 hours 8. Estimate and description of student's weekly out-of-class preparation time excluding exam preparation: This is estimated at around 2-4 hours per week necessary to work through assigned readings and slides when they are available. 9. Course Coordinator and contact information: Monica Gautam, BScPharm, PharmD Phone: W 10. Course Instructors and contact information: Monica Gautam, BScPharm, PharmD Phone: W

4 11. Required Resources/Textbooks/Readings: Text book Modern Pharmaceutical Industry (A Primer) Jacobsen & Wertheimer Jones and Bartlett publishing 2010 Select publications, see below. 12. Recommended Resources/Textbooks/Readings: None 13. Topic Outline/Schedule: For each, indicate level of knowledge, skills and attitudes learning objectives Week 1 Course overview (Monica Gautam) Review course structure and requirements Overview of pharmaceutical companies and the Knowledge: Introductory List and distinguish the rolls of the various stakeholders in industrial pharmacy Recognize the need for a financial return on investment for corporate investors in industrial pharmacy Skills: Not applicable Attitudes: Introductory Students will gain knowledge to be able to consider the pharmaceutical as they draw up their career plans None Week 2 Honorary Lecture/Panel Discussion/Workshop Roles and Value of the Pharmacist in the Pharmaceutical Industry A facilitated discussion with a panel of at least half a dozen established pharmacists with diverse careers in various aspects of the pharmaceutical.. The discussion will provide a bird s eye view of the and will discuss the s history, current challenges,future trends and how pharmacists provide value. Appraise a drug candidate s potential for commercial success Appraise the success of marketed drugs in the face of emerging competition and other environmental changes

5 Debate controversial regulations and standards governing the such as drug development regulations and new regulations emerging in the field of post licensure market access and health technology assessment Design a simple drug development plan Design a simple market access plan Design a simple marketing plan Attitudes: Advanced Students will gain sufficient knowledge to be able to consider the pharmaceutical as they draw up their career plans Develop an appreciation for the history of ethical, legal and regulatory forces that have shaped the pharmaceutical Plan a career with in the pharmaceutical Formulate a point of view on future trends and opportunities with in the pharmaceutical Review all course material Week 3 Discovery & Innovation 1 ( Industry guest speaker Ayman Chit, MBiotech, PhD) Bench side R&D Startup companies Academic-industrial partnerships Entrepreneurship Cost of R&D Knowledge: Introductory Recognize the need for a financial return on investment for corporate investors in industrial pharmacy List all steps of drug development and commercialization Describe the drug discovery process with a focus on the entrepreneurship and business development Describe the drug development process: bench work, animal testing and clinical development Design a simple drug development plan Attitudes: Introductory Students will gain sufficient knowledge to be able to consider drug discovery and development as they draw up their career plans 1. Jacobsen & Wertheimer CH 1 2. Edwards AM. Too many roads not taken. Nature 470 (2011) ; DIO:1038/470163a

6 3. Koff WC. Accelerating Next-Generation Vaccine Development for Global Disease Prevention. Science 340, (2013); DOI /science Adams CP. Estimating the cost of new drug development: is it really $802 million? Health Affairs, 25, no.2 (2006): Witty A. New strategies for innovation in global health: A Pharmaceutical Industry Perspective. Health Affairs, 30, no.1 (2011): Week 4 Discovery & Innovation 2 and Clinical Development (Industry guest speaker - Michele Caveen, BScPhm, MSc + Monica Gautam) Modern trends in drug discover Overview of the clinical development process Globalization of clinical research Knowledge: Introductory Describe the drug development process: bench work, animal testing and clinical development Design a simple drug development plan Attitudes: Introductory Students will gain sufficient knowledge to be able to consider drug discovery and development as they draw up their career plans 1. Jacobsen & Wertheimer CH 5 & 6 2. Glickman et al. Ethical and Scientific Implications of Globalization of Clinical Research. The New England Journal of Medicine. (2009) 360; 8: Week 5 Pharmaceutical regulation (Industry guest speaker + Monica Gautam) Regulating Research and Development Regulating promotional activities History and future challenges of modern regulation Knowledge: Intermediate Describe the regulatory environment that governs the pharmaceutical

7 Analyze drug discovery and development strategies and plans Analyze regulatory strategies and plans Analyze market access strategies and plans Attitudes: Intermediate Students will gain sufficient knowledge to be able to consider regulatory affairs as they draw up their career plans Develop an appreciation for the history of ethical, legal and regulatory forces that have shaped the pharmaceutical 1. Jacobsen & Wertheimer CH 7 2. Hamburg. Innovation, Regulation and the FDA. The New England Journal of Medicine. (2010) 363: Week 6 Medical and Scientific Affairs I (Safety & Medical Information) (Industry guest speaker, Maureen Bot BScPhm + Monica Gautam) Ensuring that marketing strategy is grounded in scientific and medical principles Compliance in the pharmaceutical Managing off label discussions Describe modern market access and drug promotion including the functions of the following departments: health outcomes and economics, medical and scientific affairs, as well as, sales and marketing Discuss the rationale behind major regulations that have shaped the pharmaceutical Differentiate between on-label and off-label promotion and cite the legal implications of off-label promotion Assess when it is appropriate to engage in an off-label discussion Debate controversial regulations and standards governing the such as drug development regulations and new regulations emerging in the field of post licensure market access and health technology assessment Design a simple marketing plan Design a simple market access plan Attitudes: Intermediate Students will gain sufficient knowledge to be able to consider medical and scientific affairs as they draw up their career plans Develop an appreciation for the history of ethical, legal and regulatory forces that have shaped the pharmaceutical 1. Jacobsen & Wertheimer CH Van Buynder et al. Marketing Pediatric influenza vaccination: results of a major metropolitan trial. Influenza and Other Respiratory Viruses. (2011) 5(1), Kesselheim et al. FDA Regulation of Off-label Drug Promotion Under Attack. Journal of the American Medical Association. (2013) 309(5),

8 Week 7 Medical and Scientific Affairs II (Medical Education & MSLs) (Industry guest speakers, Michele Caveen BScPhm, MSc, Willena Talbot BScPharm, PhD, Natalie Meyer BSc, MSc + Monica Gautam) Ensuring that marketing strategy is grounded in scientific and medical principles Compliance in the pharmaceutical Managing off label discussions Describe modern market access and drug promotion including the functions of the following departments: health outcomes and economics, medical and scientific affairs, as well as, sales and marketing Discuss the rationale behind major regulations that have shaped the pharmaceutical Differentiate between on-label and off-label promotion and cite the legal implications of off-label promotion Assess when it is appropriate to engage in an off-label discussion Debate controversial regulations and standards governing the such as drug development regulations and new regulations emerging in the field of post licensure market access and health technology assessment Design a simple marketing plan Design a simple market access plan Attitudes: Intermediate Students will gain sufficient knowledge to be able to consider medical and scientific affairs as they draw up their career plans Develop an appreciation for the history of ethical, legal and regulatory forces that have shaped the pharmaceutical 1. Jacobsen & Wertheimer CH Van Buynder et al. Marketing Pediatric influenza vaccination: results of a major metropolitan trial. Influenza and Other Respiratory Viruses. (2011) 5(1), Kesselheim et al. FDA Regulation of Off-label Drug Promotion Under Attack. Journal of the American Medical Association. (2013) 309(5), Week 8 Recommending bodies and payers 1 (Industry guest speaker, Ayman Chit+ Monica Gautam) Cost effectiveness thresholds Cost effectiveness analysis in Canada and the US Describe modern market access

9 Analyze market access strategies and plans Appraise a drug candidate s potential for commercial success Appraise the success of marketed drugs in the face of emerging competition and other environmental changes Debate controversial regulations and standards governing the such as drug development regulations and new regulations emerging in the field of post licensure market access and health technology assessment Design a simple market access plan Attitudes: Intermediate Students will gain sufficient knowledge to be able to consider market access and health economics as they draw up their career plans Develop an appreciation for the history of ethical, legal and regulatory forces that have shaped the pharmaceutical 1. Jacobsen & Wertheimer CH Neumann PJ. Legislation against use of cost-effectiveness information. New England Journal of Medicine. (2010) 363; 16: Towse A. Should NICE's threshold range for cost per QALY be raised? British Medical Journal. (2009) v.338: : b181 Week 9 Class assignments and Facilitated Discussions (Monica Gautam) Attitudes: Advanced Review class assignment Week 10 Pharmaceutical Marketing (Industry guest speakers Mirjana Chionglo BScPhm, PharmD, Taffik Choudhury BScPhm + Monica Gautam) Developing a marketing plans for all phases of a drug s life cycle Assessing the impact of marketing campaign Describe the marketing process Analyze a marketing plan Appraise a drug candidate s potential for commercial success Appraise the success of marketed drugs in the face of emerging competition and other environmental changes Debate controversial regulations and standards governing the such as drug development regulations and new regulations emerging in the field of post licensure market access and health technology assessment

10 Develop a simple marketing plan Attitudes: Intermediate Students will gain sufficient knowledge to be able to consider marketing as they draw up their career plans Develop an appreciation for the history of ethical, legal and regulatory forces that have shaped the pharmaceutical 1. Jacobsen & Wertheimer CH Van Buynder et al. Marketing Pediatric influenza vaccination: results of a major metropolitan trial. Influenza and Other Respiratory Viruses. (2011) 5(1), Kesselheim et al. FDA Regulation of Off-label Drug Promotion Under Attack. Journal of the American Medical Association. (2013) 309(5), Week 11 Recommending bodies and payers 2 (Industry guest speaker, Manny Papadimitropoulos + Monica Gautam) Overview of recommending bodies and post-licensure market access Global industrial perspective on reimbursement, health outcomes and economics Knowledge: Introductory Describe modern market access Design a simple market access plan Attitudes: Introductory Students will gain sufficient knowledge to be able to consider market access and health economics as they draw up their career plans 1. Jacobsen & Wertheimer CH Neumann PJ. Legislation against use of cost-effectiveness information. New England Journal of Medicine. (2010) 363; 16: Towse A. Should NICE's threshold range for cost per QALY be raised? British Medical Journal. (2009) v.338: : b181

11 Week 12 Vaccines (Industry guest speaker) Overview of the vaccines in Canada and around the world Overview of the market place for vaccines How vaccines are different from medicines in terms of R&D, manufacturing, regulatory environment, as well as, payers and recommendations Describe the vaccine discovery, development, manufacturing and commercialization process Recognize the differences and similarities between the vaccine and pharmaceutical industries Appraise a vaccine candidate s potential for commercial success Appraise the success of marketed vaccines in the face of emerging competition and other environmental changes Debate controversial regulations and standards governing the such as vaccine development regulations and new regulations emerging in the field of post licensure market access and health technology assessment Design a simple vaccine development plan Design a simple vaccine market access plan Design a simple vaccine marketing plan Attitudes: Intermediate Students will gain sufficient knowledge to be able to consider the vaccine as they draw up their career plans Develop an appreciation for the history of ethical, legal and regulatory forces that have shaped the vaccine Koff WC. Accelerating Next-Generation Vaccine Development for Global Disease Prevention. Science 340, (2013); DOI /science Week 13 Course and exam review (Monica Gautam) Attitudes: Advanced Review all course material 14. Assessment Methodologies Used:

12 Multiple Choice questions (MCQs) Short essay Class participation Learning Objectives Addressed Assessment 1: Midterm examination: covering lectures 1 to 5 inclusive of assigned readings Assessment 2: Short essay assessing intermediate and advanced learning objectives Assessment 3: Class participation Assessment 4: Final exam: covering all lectures and assigned readings Assessment Method Used Assessment 1: Multiple Choice questions (MCQs) Assessment 2: Short essay Assessment 3: Students will be graded based on in-class participation. Comment/question can be made either verbally in class or on a comment card submitted at the end of class. Marks are assigned for simply making/asking comments/questions, as well as, the quality of the participation. Assessment 4: Multiple Choice questions (MCQs) When Administered Assessment 1: During midterm period Assessment 2: Due at start of lecture 13 Assessment 3: Throughout the course, ends after the final lecture Assessment 4: During final exam period Percentage of Course Grade Assessment 1: 30% Assessment 2: 20% Assessment 3: 10% Assessment 4: 40% For Group Work (maximum 10% of course grade) indicate how marks within groups are allocated: Individualized or Same for all Group Members Assessment 1: Assessment 2: Assessment 3: Assessment 4: Remediation Opportunities? Assessment 1: As per university policy see section 15 below Assessment 2: As per university policy see section 15 below Assessment 3: No Assessment 4: As per university policy see section 15 below Expectation for pass grades for all Pharmacy courses is 60%. 15. Policy and procedure regarding make-up assignments/examinations/laboratories:

13 Missed Exam/Test Policy: Students who miss an examination or a test and who have a valid petition filed with the Registrar s office will be eligible to complete a make-up examination or test. This will be an oral examination. Missed Assignment Policy: Students who fail to submit an assignment by the specified due date, and who have a valid petition filed with the Registrar s office will be eligible to submit the completed assignment with no academic penalty. Late Assignment Policy: Students who fail to submit an assignment by the specified due date will receive a deduction of 10% for each day beyond the due date (including weekends/holidays), to a maximum of 50%. Assignments will not be accepted for grading after 7 late calendar days.

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