ALS454 - International Business and Global Health

ALS454 - International Business and Global Health

Another course taught by Steve Casper (see ALS359). 

This course will equip students with tools to effectively understand global marketplace issues within the life sciences.  The course has three broad aims.  First, students will learn how to assess bioscience market opportunities within different regions of the world, including advanced economies in East Asia and Europe and rapidly emerging marketplaces such as China and India.  Second, students will explore the causes and consequences of globalization, focusing on the increased ability of firms, both small and large, to develop global value chains that integrate research, development and other marketplace activities from regions around the world.  Finally, the course will explore global health issues, exploring a variety of policy perspectives oriented towards creating drugs for neglected diseases.  

Learning Objectives

1. Become familiar with analytic tools to assess bioscience related market opportunities within developed and emerging economies.
2. Evaluate how differences in the structure of national and regional economies impact how companies from different areas of the world develop competitive strategies.
3. Explore the development of global value chains in the pharmaceutical and other bioscience related industries and understand typical managerial problems they create.
4. Understand the causes of global health problems in different disease areas and different regions of the world, and become familiar with long-standing population-based and clinical approaches to combating global health problems.
5. Evaluate new approaches to drug development towards neglected diseases, including public-private partnerships, non-profit pharmaceutical companies, and company oriented approaches.
6. Development of professional skills – teamwork, project management, and both written and spoken forms of communication.

Course Assessment:

Short quizzes (3 x 5% each)                                                                  15%

Mid-term exam                                                                                     25%

Global health team project                                                                    25%

Class participation                                                                                35%

Short quizzes:  Three short quizzes (15 minutes) are designed to ensure that students have a firm grasp of core concepts surrounding national competitiveness and patterns of globalization. 

Final exam.  This will be a case-based exam, drawing primarily on international business issues examined during the second half of the course.  The exam will be open book.

Market assessment project:  Teams of 4-6 students will examine biotechnology investment opportunities within an emerging biotechnology country marketplace.  Students will assume the role of an analyst for a venture capital firm charged with evaluating new investment opportunities.  Teams must chose one country and explore relevant aspects of market and regulatory conditions in this country pertaining to a specific bioscience related investment opportunity in that country.  Project deliverables will include a written executive summary and 20 minute Powerpoint style presentation.  More detailed instructions will be distributed in class.

 

Course Materials

All Harvard Business School cases readings should be purchased in a reader available at the Huntley Bookstore.   Due to strict copyright enforcement by Harvard Business School, purchasing the casebook is mandatory for this class.  Unauthorized copying of HBS cases for use in this class will be treated as a KGI honor code violation.

Students should also buy the following book from the Huntley Bookstore (or order it on-line).

Pankaj Ghemawat, Redefining Global Strategy, Harvard Business School Press, 2007

All other readings, including several KGI case readings developed especially for this course, will be available on the Sakai system. 

ALS359 - Introduction to Market Assessment and Market Strategy

ALS359 - Introduction to Market Assessment and Market Strategy 

This course is a required class for all PPM students. It is taught by Steve Casper, one of KGI's business faculty. Steve has been with KGI since 2003. He has a PhD in Government from Cornell University and prior to KGI had a faculty position at Cambridge University in the UK.

The course will equip students with an understanding of conceptual frameworks in market strategy and market assessment with reference to bioscience industries. These topics will be explored with reference to the commercialization of academic science into commercial ventures.  We will examine industry dynamics within different segments of the life science industries, such as therapeutics, diagnostics, and medical devices. This includes evaluating common business models employed by entrepreneurial firms, and an introduction to analytical tools used to assess the attractiveness of a variety of life science marketplaces. Common tools used for market research, such as survey methods and qualitative interview based techniques, will be introduced.  Finally, the course will provide an overview to analytical tools firms use to design market strategies.

Learning Outcomes

1.      Describe basic industry dynamics within bioscience industries, and business models commonly employed by biotechnology firms.

2.      Demonstrate an understanding of technology commercialization processes, especially the translation of university science into entrepreneurial life science companies.

3.      Use quantitative and qualitative data to assess the attractiveness of life science marketplaces.

4.      Demonstrate the ability to analyze the strategic marketing strategies of companies in technology intensive industries. 

5.      Use market research and competitive intelligence techniques to conduct primary research on the commercial attractiveness of a novel life science technology.

6.      Demonstrate proficiency in the use of professional skills in the areas of teamwork, project management, and both written and spoken forms of communication.

  

Course Materials

There is a case reader that should be purchased from the Huntley Bookstore.  Due to the vigorous enforcement of copyrights by Harvard Business School, it is mandatory that students purchase the case reader.  Any unauthorized copying of Harvard Business School cases will be treated as a KGI honor code violation.

All other readings will be available on the on-line Sakai system within the ALS 359 course folder.

Grading

Class Participation                                                                                30%

Short Memo Assignments (5 x 7% each)                                               35%

Team Market Research Project                                                            35%

Market Research Analysis:  Teams of 3-5 students will conduct market research for a technology emerging from a university research lab or start-up biotechnology company.  For most projects your client will be a professional technology transfer officer working at a universitiy or research institute.  Most projects will combine market research and competitive analysis research.  Particular goals for each group will be negotiated between the sponsoring client, the course instructor, and students.  All groups must submit written report of findings (typically 15-20 pages plus appendices) and make a formal presentation to their client.  Most presentations will be scheduled during finals week.

ALS418 - Biopharmaceutical Quality Assurance and Control

This course is taught by Vince Anicetti. He's an adjunct professor at KGI and until recenlty was Vice President for Biologics Quality at Genentech. Currently he's a  Fellow, Science and Regulatory Affairs at the Parental Drug Association.
Here are parts of the course description.

The objective of ALS 418 is to provide students with a board understanding of the scientific and regulatory principles needed for quality assurance and quality control in the biopharmaceutical industry. ALS 418 will provide a through understanding of the following quality roles and responsibilities in the biopharmaceutical industry.

• Provide understanding of the structure of the quality unit and regulatory responsibilities of quality assurance and control organizations.
• Provide an understanding of relevant regulatory agencies and other organizations that set regulations and standards for the biopharmaceutical industry. Instruct students in the requirements and principles of the ICH Quality Guidelines and Good Manufacturing Practices.  
• Help students to develop the logic and critical thinking skills to make product quality and GMP decisions.
• Provide an understanding of best practices in developing and managing Pharmaceutical Quality Systems.
• Convey the expectations and responsibilities of Quality leadership in the Biopharmaceutical Industry based on regulations as well as case studies in management of product quality problems

LEARNING OBJECTIVES:

By the end of this course the student will understand the scientific and regulatory basis for quality assurance and quality control in the biopharmaceutical industry.

Students will be prepared for entry professional roles in biopharmaceutical quality control through instruction in specifications establishment, stability requirements, in-process control and microbial control of biopharmaceutical processes.

Students will also be prepared for roles in quality assurance through instruction in the ICH Quality Guidance and international GMP’s. Students will understand the fundamental concepts of product quality investigations, validation, and corrective/preventative actions.

Students will learn the authority of, and how to interact with, regulatory agencies; with particular emphasis on inspection management and resolution of product quality issues.

Last, student will be prepared for management positions in biopharmaceutical quality through instruction in regulatory expectations for management, industry best practices, and case studies of management failures in quality.

COURSE FORMAT:

The course is taught using lecture presentations of scientific principles, quality concepts, and relevant regulations. In addition most lectures will feature a case study highlighting quality failures in the biopharmaceutical industry and their consequences. These case studies will be used as learning opportunities to understand fundamental quality concepts and systems and where management lapsed.

Each class session will be 80 minutes. The first part of the class will be lecture followed by time for discussion. Reading assignments for each lecture will be reviewed the week before and will also be posted in your SAKAI folder. Reading assignments will consist of material found on assigned websites. There are no textbooks for this class.

There will be periodic homework assignments and a mid-semester group poster presentation.

COURSE MATERIALS:

Course reading materials will be found online. The course will be structured on the International Conference on Harmonization (ICH) Quality Guidelines, which can be found on www.ich.org. Additional reading assignments will be based on FDA, EMA, or other regulatory guidances and publications. Case study background research will be found in lecture preparation material.

ALS401 - Biotechnology-based Therapeutics

Today I'm starting the introduction of courses for the Fall semester. 
The first one is ALS401 - Biotechnology-based Therapeutics taught by Larry Grill.
More information on Larry click here.

Course Description taken from Syllabus:
Advances in genomics, proteomics, recombinant protein technology and structural biology have created opportunities and challenges for the biotech and pharmaceutical industries. This course will provide students with a background of the scientific basis of some key aspects of biotechnology-based drug, biologic and vaccine design, discovery and development process. Students will learn about therapeutic and vaccine targets, and how vaccines and drugs are designed, tested and produced to prevent and/or treat human diseases. They will also learn about development of new vaccines and how this differs from that of small molecules and other biologics, as well as real and perceived issues of safety. This course will consist of lectures, student presentations, and group discussions. Environmental, ethical, regulatory, patent, economic and social issues related to biotechnology-based therapeutics will also be discussed.
Course evaluation: quizzes and a final comprehensive exam, class participation, term paper, and group project (group of 3-4 will organize the plans to develop a biotech company that will produce a therapeutic product that may improve the human condition in some way. A 4 – 6 page group-produced paper will be required.)
The suggested textbook:
Biopharmaceuticals: Biochemistry and Biotechnology. 2nd Edition. 2003. Gary Walsh. Published by John Wiley & Sons, Ltd.