Biomedical-Innovation and Entrepreneurship Teachers: Professor Michael Wallach, School of Medical And Molecular Biosciences and i3, UTS Technion Visiting Professor, Department of Biotechnology & Food Engineering, room 317, Technion Michael.Wallach@uts.edu.au Prof. Uzi de Haan Office hours by appointment Tel: 04-8294459 Cell: 054-4630090 Bloomfield Room 523 uzid@ie.technion.ac.il Dr. Yoav Medan, Biomedical Engineering, Technion Pneumedicare, Voiceltt Ltd. Yoavm@bm.technion.ac.il Assistant Professor Ayelet Baram-Tsabari Department of Education in Science and Technology, Technion ayelet@technion.ac.il Teaching assistant: Mrs. Tali-Hadasa Blank, Faculty of Industrial Engineering and Management, Technion Cell: 052 3144546 Cooper Room 423 hadasa@tx.technion.ac.il Time: Lectures: Weekly on Thursday and on 2 Sundays, 15:00-16:30 Workshops: Weekly on Thursday and on 3 Sundays, 16:30-19:00 Venue Room 247 in Faculty of Biotechnology Open for registration for graduate students in the Faculties of Biology, Biotechnology & Food Engineering, Biomedical Engineering, Medicine and Industrial Engineering & Management. Course Overview & Objectives: To provide an understanding of how biotechnology projects (including medical devices, food science & general medical science) & companies are created, established, managed, advertised and funded in order to develop the students creative, innovative and entrepreneurial skills. Real life know-how and experience will be presented. The course includes a description of how the intellectual property for a new biotechnological invention is protected. In addition, students will learn how to write a business plan including financial planning, market analysis and financial projections. Finally, the presentation of new biotechnological products to potential interested parties (such as big Pharmaceutical companies) is described and students will test their ability to pitch their own ideas and projects. This can potentially lead to the formation of real start-up companies that can arise from this course. The course would be divided into lectures and student workshops as follows: Lectures: 8 lectures, 2 hours per lecture. Total of 16 hours Student workshops: 8 sessions: 2.5 hours per session, Total of 20 hours Grand total is 36 hours for the course Outline of the course: Lectures are given for 1.5 hours with a short break. Workshops are designed as follows. Students are divided into teams of 4. Each team is preassigned in order to include 1-2 students from each Faculty. Each group of students develop a new project/product. The exercises for development of the novel project will be carried out as follows: a. Design a virtual project/product using your creative imagination (keep in mind that there will be potential real funding). Describe and run the virtual project through proof of concept stage (assume the project will be run within an existing University or incubator). Design experiments/trials, work plan, and milestones that would need to be performed and achieved (exercise 1). Include a time schedule and estimated budget. This will take 3 sessions of 2.5 hours each with all teams jointly tutored by course teacher b. Exercise 2 will be a short description of your IP, 2-3 claims and a table of relevant patens and literature. This will take 1 session of 2.5 hours. c. Write a start-up biotechnology company business plan; give it a name, a vision and strategic goals, products and services, market analysis, financial backing, type of facilities and employees, etc. (exercise 3).This will take 4 sessions of 2.5 hours each. Each group of students will then present their company and product(s) to the class as if they were pitching it to a large multinational company or venture capital firm. The presentations will be 20 minutes in length with 10 minutes of questions. Course assessment and grading: Team presentations: a total of 3 exercises one of which is a complete business plan (see details at the end of this syllabus), and a final seminar (some of the team meetings and all oral presentations may be video recorded). The grades are based on the exercises (exercise 1 – 20%, exercise 2 – 10%, exercise 3 – 30%) and the final seminar (40%). Assessment of the seminars will be done by a panel consisting of the course instructors and some invited experts. Seminars will be assessed based on their content and quality of presentation. Submission of supporting material in appendices, which are expected to be submitted as part of the full business plan (exercise 3), e.g.: - financial assumptions including costs figures and supporting evidence market data data on competitors evidence for assumptions in R&D plan and risks involved evidence on possible distribution channels any other supporting material Team work will be assessed based on the ability of the team to recognize and manage the strengths and weaknesses of team members and to manage conflicts in a constructive way. There will be a group assessment sheet distributed at the end of the course that will be used to evaluate the contribution of each individual member. There will not be any assigned reading material for the course. Students will be asked to give feedback orally and in writing (feedback forms) during class and after completion of the course. Masters, PhD and MBA students from the Technion will be chosen from the Faculties of Biotechnology & Food Engineering, Biology, Medicine, Chemistry, Biomedical Engineering and Industrial Engineering & Management. Final year undergraduate students are also invited to attend. Teaching staff include Professor Michael Wallach, UTS, Dr. Yoav Medan from Technion (Electrical Engineering), Dr. Ayelet Baram-Tsabari, from the Department of Education in Technology and Science, Technion, Prof. Uzi de Haan and Mrs. Tali Hadasa-Blank from the Faculty of Industrial Design and Management, Technion. Dr. David Mencher, a patent expert from Erlich & Fenster, will provide a lecture and mentoring on IP. Course Readings (optional): 1. The new Business Road Test; what entrepreneurs and executives should do before writing a business plan. 2ed. 2006, John Mullins, Prentice Hall 2. New Venture Creation, 7th Ed. 2007, Jeffrey Timmons and Stephen Spinelli, McGraw-Hil 3. The business of healthcare innovation, 2005. L.R. Burns ed. Cambridge University Press 4. http://en.wikipedia.org/wiki/Biotechnology 5. Introduction to Bio-Technology, 2008, Thieman W.J. and Palladino,M.A. Pearson Week 1 (December 12, 2013) Lecture (15:00-16:30) Setting the Stage 1. An introduction to the business of biotechnology and a description of the course (Professor Michael Wallach). 2. Introducing tools for brainstorming and design thinking (Prof. Michael Wallach). Workshop (16:30-19:00) Divide into groups of 4-5 students, and start the process to describe your ideas and to choose a project. Design the project/product through a creative & design thinking approach. Design the Proof of Concept (PoC) to demonstrate that the concept/idea really works and can convince an investor to fund project commercialisation. Week 2 (December 19 and 22, 2013) Lecture (15:00-16:30) 1. The strategy and requirements for coming up with a good idea for a successful biotechnology project with an emphasis on medical devices (Dr. Yoav Medan, December 19). 2. Going from the bench to the marketplace; proof of concept, product development, preclinical trials, etc. (Prof. Michael Wallach and Dr. Yoav Medan, December 22) Workshop (16:30-19:00) Describe the experiment/trials and work plan needed for proof of concept (PoC). Describe the predicted experimental results in detail (assume that the PoC is a success). By the end of the second week, each team will be assigned a coach (either from course teaching staff, from within the Technion or through outside contacts) with appropriate expertise in their specific project area. Commence writing of Exercise 1 due on December 22nd. Week 3 (December 26 and 29, 2013) Lecture (15:00-16:30) IP, Drug Development 1. IP management and ways to protect your new invention. (December 26, Dr. David Mencher) 2. Drug development, licensing, clinical trials, regulatory authorities, etc. (December 29, Prof. Michael Wallach) Workshops (16:30-19:00) Decide on the strategy for protecting your IP- patent, trademark, tradesecret, etc. Work on exercise 2 due on January 5, 2014. Complete proof of concept, workplan, milestones and also decide on timetable & budget. Submit the project report (exercise 1) on December 22, 2013. Week 4 (January 2, 2014) Lecture (15:00-16:30) 1. Biotechnology, advertising and the media. How best to present your ideas to the public. This will include the student teams giving 3 minute pitches of their projects. (Dr. Ayelet Baram-Tsabari, August 21) Workshop (16:30-19:00) Prepare a 3 minute pitch and get feedback from Dr. Ayelet Baram-Tsabari. Submit exercise 2 on January 5, 2014. Week 5 (January 9, 2014) Lectures (15:00-16:30) Business planning and Finance 1. Business plan preparation. (Mrs. Tali Hadasa-Blank) 2. Establishment of start-up biotechnology & medical device companies; overview of the scientific and business plan, how to attract funding, etc. (August 28, Dr. Yoav Medan). 3. Financial analyses, marketing strategy & predictions, cash flow (Mrs. Tali Hadasa-Blank) Workshop (16:30-19:00). Prepare business plan including your final technical product description, financial analysis, production and marketing strategies, executive summary, etc. Plan is due by January 30. Week 6 (January 16, 2014) Prepare for seminar and work on business plan. Week 7 (January 19, 2014) Seminars will be rehearsed on January 19 (the whole day is available) Give Seminars Given on January 23 (each group 20 minutes + 10 minutes of questions from 10:0012:30) to a panel of Technion & industry experts Final Exercise Submission of final exercise (business plan, exercise 2) by January 30, 2013 Exercise reports: Exercise 1 (due on December 22, 2013): Project report – a brief description of the virtual idea, workplan & proof of concept and project results. Document should be around 2-3 pages and up to 1500 words in length. Exercise 2 (due on January 5, 2014)will describe your invention, 2 claims and a list of competing patents and prior art. Exercise 3: Business plan (due on January 30, 2014) – Consists of Executive summary, visions, strategic goals, products & services, SWOT analysis, market analysis and financial projections and budgets. Document should be 8-10 pages in length and about 5000-7500 words in length. Supporting material should be provided in back-up annexes.