LESLIE DAN FACULTY OF PHARMACY UNIVERSITY OF TORONTO

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1 LESLIE DAN FACULTY OF PHARMACY UNIVERSITY OF TORONTO YEAR: 2010 COURSE NUMBER: PHM 454 COURSE TITLE: Selected Topics in the Pharmaceutical Industry REQUIRED: No ELECTIVE: Yes COURSE LENGTH: FALL ONLY Term 1 HOURS/WEEK: LECTURE 2 hours weekly COURSE COORDINATOR: Dr. Rami Batal Contact Information: rami.batal@utoronto.ca; Wireless: INSTRUCTORS: guest speakers from the industry (total 6) TEXTBOOK(S): (B) RECOMMENDED Name: Modern Pharmaceutical Industry (A Primer) Publisher: Jones and Bartlett Year: 2010 (Available in library) PREREQUISITES: None CALENDAR DESCRIPTION: 2 hour weekly; fall course COURSE GOALS & OBJECTIVES: The course is designed to introduce drug development and commercialization from the perspective of the pharmaceutical industry. It is intended to broaden the students understanding of: Page 1

2 1. key stages in the drug development process and important considerations pertaining to the commercialization process; 2. current issues facing these processes, and 3. potential role of the pharmacist in the industry. Specific course objectives include: Structure and Function Discuss the economic contribution of the Canadian pharmaceutical industry to the overall economy Identify external issues affecting the pharmaceutical industry Identify internal issues affecting the pharmaceutical industry Preclinical & Clinical Drug Development Outline key issues a pharmaceutical company considers when progressing from a pre-clinical research program to a clinical research program; Describe the key activities performed before, during and after a clinical trial Identify issues facing informed consent and patient recruitment in clinical trials Drug Safety Define an adverse event and an adverse reaction; Describe the sources and methods of collecting post-marketing safety data; Explain how the product monograph is a living document and why this is necessary Federal Regulatory Affairs Define regulatory affairs and discuss its role in the drug development process Describe the submission process Describe the submission review process and outline strategies versus tactics in regulatory submission Market Access Identify various cost containment policies and their intended and unintended impacts on health care Describe the difference between supply side and demand side cost containment Discuss the importance of market access above and beyond market approval Identify the stakeholders involved in the reimbursement/market access arena Pharmaceutical Sales and Marketing Discuss the current and changing role of a pharmaceutical sales rep; Describe the marketing planning process; Apply the market planning process to determine whether a new pharmaceutical product should be launched Professional Affairs Explain the role of a professional affairs department and the scope of their activities Page 2

3 Describe the various target audiences and target partnerships of a professional affairs department Pharmaceutical Advertising Read and critically analyze a pharmaceutical advertisement; Explain, in writing, to the marketing department how the advertisement infringes upon guidelines; Identify the risks and benefits of direct to consumer advertisements and nontraditional advertising such as advertising on the Internet Health Economics Overview of health economics and terms (jargon) Why important in launch of new drugs, as well as existing products (industry/ government/ private payer perspectives) Approaches /collaborations to conducting research Challenges/areas for development Requirements for employment in this area in pharmaceutical industry Business Development Discuss the business forces within the pharmaceutical industry and how the environment is influencing the Transformation of brand name companies Outline the types of and reasons for collaborations between pharmaceutical companies and discuss how companies evaluate various opportunities Intellectual Property Trace the evolution of IAP in Canada Explore the impact intellectual property protection has on investment in Canada Discuss the role of PMPRB and the framework of Canadian pharmaceutical pricing regulation Identify the interrelationship between Canadian IAP, pricing regulation and research and development investment by brand name companies Page 3

4 RATIONALE FOR INCLUSION IN CURRICULUM: This course provides a much needed exposure to the characteristics and works of the biopharmaceutical industry; imperative learning not only to pharmacy students seeking a career in industry but also future Pharmacists who are bound to interact with the industry independent of their chosen line of practice (e.g., community, hospital, etc.). Moreover, this course provides a global perspective on the industry vs. a local/canadian one, in alignment with the industry s global mindset and mode of operation. TEACHING METHOD/FORMAT: Didactic (lecture-based), with a considerable degree of interactivity with lecturer and fellow class participants. Lecturers include course coordinator (Dr. Batal) and senior pharmaceutical executives, who will cover a slew of interesting topics in a coordinated manner. STUDENT EVALUATION PROCEDURES: Student evaluation will consist of two written exams midterm and final, an assignment, and class participation. Midterm will evaluate student s grasp of fundamental principles covered in class, whereas final will primarily be real world case study-based open book exam. Assignment (written individually and culminating with a group presentation if time allows) will focus on a learning topic of interest. DETAILED COURSE OUTLINE : (Separate outline for lectures, seminars, tutorials, laboratories, etc.) Topic (2 hours each; interactive lecture format; order may be altered to reflect availability of guest speakers, etc.) Orientation and Course Overview: Why; What; How; When; Where (Dr. Batal and Class) Pharma Overview: Evolution and Trends; External Environment; Internal Environment; Strategies; Organizational Design (Dr. Batal and Class) Research and Development: Generating the Information Package (Regulatory Overview Included; Pharmaco-economics Included; Internal vs. External Pipelines) (Dr. Batal and Class) Global Supply Chain: Manufacturing the Physical Product (Dr. Batal and Class) Marketing and Sales: Disseminating the Information Package (Also Inclusive of Business Development Highlights) (Dr. Batal and Class) How a senior pharma executive thinks and acts: Learning from an Annual Report of a Pharma company (Dr. Batal and Class) Medical Affairs: Bridging Science and Business (Guest Speaker and Class) Strategic Marketing: How commercial considerations influence the clinical development path of the product (Guest Speaker and Class) Pharmaco-vigilance and Drug Safety (Guest Speaker and Class) Page 4

5 Extreme Pharma Manufacturing (Vaccines) (Guest Speakers and Class) Global Strategic Marketing: How R&D and Marketing Mutually Inform; How Country Affiliates Work Together (Guest Speaker and Class) The Pharma R&D Enterprise (Guest Speaker and Class) Summary of Concepts; Synthesis; Wrap Up; Preparation for Presentations and Final Exam (Dr. Batal and Class) DETAILED COURSE EVALUATION METHODS: COMPONENT CONTRIBUTION TO FINAL GRADE (%) Final 40% Assignment 20% Midterm 30% Class Participation 10% MISSED EXAM POLICY: Individual (repeat) exams are permitted when valid justification is provided and accepted by faculty s administration, in alignment with university and faculty set guidelines. Page 5