ALS427 - Mammalian Cell Technology

ALS427 - Mammalian Cell Technology


This course is taught by Matt Croughan. Matt has a B.S. UC Berkeley in chemical engineering and a Ph.D. in chemical engineering from the Massachusetts Institute of Technology.  He worked for Genentech in South San Francisco as their expert in bioreactor design and scale up.  At Genentech, he developed the first licensed, high-density, fed-batch cell culture process. Before joining KGI, Matt worked as an independent consultant for biopharmaceutical process development and manufacturing to more than 50 firms. He served as a part-time as the Industrial Liaison Officer for the Biotechnology Process Engineering Center at MIT. 

This course requires a prerequisite which a PPM student  wouldn't be able to take before. Therefore, this course is suggested only to people who have prior experience in bioprocessing.

Description

Mammalian cell biotechnology has undergone explosive growth over the last 30 years.  Recombinant Chinese Hamster Ovary (CHO) cells now far surpass E Coli and all other expression systems for recombinant protein production.  Recombinant protein production levels have gone up 20,000-fold, are now often measured in grams per liter, and are expected to continue to increase.   Mammalian cell culture is not only the most common system for production of marketed recombinant proteins, but is also the most common production system for proteins undergoing clinical testing.  This leadership position, for both clinical and marketed products, also holds true for vaccines.  Stem cell and engineered tissue therapies will ultimately require many new cell culture and/or cell processing operations.  Persons skilled in mammalian cell biotechnology are in high demand.
The primary goal of this course is to provide students with an advanced background in mammalian cell biotechnology.   The scientific, engineering, and practical industrial aspects will be presented in a series of lectures.  This half-unit lecture course can be taken by itself, or in combination with a complimentary, full-unit laboratory course, Mammalian Cell Biotechnology Laboratory, ALS 421.  A student cannot take ALS 421 without taking this lecture course at the same time, or at a prior time.

Prerequisites

ALS 331 or permission of instructor.

Topics Covered

Learning Objectives:

- the history and status of mammalian cell biotechnology, including past, current and future products, as well as challenges faced
- the biology of cultured cells, including cell growth, death, metabolism, mortality, transformation, differentiation, and adaptation
- laboratory operations and design, sterile technique, containment, and safety
- cell culture kinetics and modeling
- cell line engineering techniques and common host cell lines for recombinant protein and vaccine production
- design of cell culture medium and control of cell metabolism
- cell culture bioreactor design and scale-up, including aeration, mixing, and hydrodynamic/sparging impacts on cells, as well as instrumentation and process control
- design and operation of high-density fed-batch and perfusion cultures
-  integration of cell culture processes with downstream product recovery and purification
- cell culture process characterization, validation, and troubleshooting
- manufacturing facility design and operations, from disposables to large-scale stainless steel, including cleaning and sterilization
-  vaccine process development and manufacturing
- stem cell biology and the current status of stem cell therapy
- engineered tissues as replacement body parts and as replacements for animal testing
- key issues and tools used in industrial cell culture operations, including economies of scale, operations management, control charts, and process flow diagrams

Grading

Homework assignments: 33%
Midterm:  33%
Final exam:  34%

Source: http://www.kgi.edu/faculty-and-research/profiles/matthew-s-croughan.html

ALS408 - In Vitro Diagnostics

ALS408 - In Vitro Diagnostics


This course is taught by Jim Osborne. Jim has a PhD in biochemistry from the University of Maryland Medical School in Baltimore.  From 1974 to 1985, he was a staff member of the National Heart, Lung and Blood Institute at NIH in Bethesda, Maryland.  He joined Beckman Instruments in 1985 as manager of Applications and Centrifuge Research.  He was named Director of Research and Applications in 1987 and was appointed Vice President in 1992.  From 1992 to 1996, he served as Vice President and Director of Advanced Chemistry and DNA Analysis and had responsibility for the Beckman Center of Advanced Capillary Electrophoresis, in addition to various analytical and specific chemistries.  In 1998, he became Corporate Vice President of Advanced Technology.  In 2008, Dr. Osborne transitioned back into academia by joining the faculty of KGI founding the Center for Biomarker Research. (excerpts from http://www.kgi.edu/faculty-and-research/profiles/james-c-osborne.html)

This fall Jim will be teaching ALS408. He's also involved in ALS320.
ALS408 covers emerging, high impact, and high growth rate areas of the in vitro diagnostics industry such as novel immunoassay formats, diagnostic applications of flow cytometry, molecular diagnostics and pharmaco-genomics, personalized medicine and drug diagnostic co-development, point of care diagnostics in developed countries and in global health / limited resource settings, as well as micro-fluidics and nano-technology in diagnostics. Students will acquire in depth knowledge of technical aspects as well as an overview of relevant FDA regulatory concerns and market barriers to the adoption of new technologies. The course consists of lectures supplemented by assigned readings and in class exercises. The last six lectures are dedicated to case studies on IVD applications to particular diseases with student presentations.

Prerequisites

First year MBS science/engineering curriculum, in particular ALS 320.

Topics Covered

Regulation of IVDs, Adoption of new diagnostic tests, Immunoassays, Particle-based assays, Liquid handling, Micro-fluidic technologies, Cytometry: applications, Cytometry: fluidics and optics, Cytometry: GLP guidelines, Histology, Cytology, Infectious diseases, Nucleic acid testing, Pharmaco-genomics
Multivariate index assays, Drug-diagnostic co-development, Point of care diagnostics, Global health: diagnostics in limited resource settings, IVD case studies

Learning Objectives

After completion of this course, students should:
1.)    Be familiar with recent technology developments in the established and emerging areas of the in vitro diagnostics industry.
2.)    Be able to evaluate the advantages and technical limitations of different IVD assay formats and devices.
3.)    Comprehend general approaches, standard parameters, and statistical methods used to characterize IVD assay and device performance.
4.)    Have in-depth knowledge acquired through independent investigation of one emerging, high growth or high impact area of the IVD industry, both from a technical and business perspective. Be able to present this knowledge in oral and written form.
5.)    Understand the regulatory framework governing the IVD industry, regulatory constrains and loop-holes that impact new product development, as well as recent changes in the regulation of novel assay formats.

Grading

Class participation and in-class exercises 20%
IVD Case Study - Written Report and Presentation 40% (identify unmet need and discuss how it can be filled; defend your position and present findings)
Current Topics in Clinical Chemistry - Written Report & Presentaion 40%

Source: http://www.kgi.edu/current-students/academic-affairs/course-catalog/courses/als-408.html

ALS360 - Professional Development

ALS360 - Professional Development 


This course has Craig Adams and me as instructors, however many topics will have guest speakers. When we  designed the course content we tried to include topics that we think are important for understanding corporate and general business culture and provide tools to understand personalities (oneself included) better and improve individual professional areas will be identified.

Description

This course is designed around four broad themes: effective writing, oral communications, teamwork and leadership. Classes will be a blend of interactive lectures, from faculty and industry executives, and workshops. Oral and written exercises will be coordinated with individual and team projects in ALS 320 and ALS 359, and students will participate in faculty and peer reviews to help each other improve professional skills.

Textbook
Hoffmann, Angelika H. Scientific Writing and Communication: Papers, Proposals, and Presentations. Oxford University Press. 2010.

Topics Covered

·        Finding and citing information - Pubmed and database searching, reference software, patent searches

·        Working with different personalities – Myers-Briggs personality analysis, interpersonal communication styles

·        Strategies for project success and adapting to reality – elements of team and project management

·        Interview Techniques – interview styles in different job areas

·        Writing skills workshop – elements of individual writing and plagiarism

·        Diversity, Harassment – diversity and harassment at KGI and in corporate culture setting

·        Corporate communication – professional report writing, email etiquette

·        Teamwork and Conflict Resolution

·        Critical Thinking and Analysis -

·        Professional Presentation Skills – organizing and presenting information in front of different stakeholders

Learning Objectives

After completion of this course students should:

1)      Effectively communicate technical concepts to executives, peers, employees and lay audiences.

2)      Understand team dynamics and be able to deal with conflicts and issues that arise during projects.

3)      Understand the different roles and responsibilities required for effective project management.

4)      Understand business etiquette and ethical practices necessary for a successful career in industry

5)      Understand the personal professional skills that need to be further developed to be an effective leader and team player.

ALS350 - Financial Accounting and ALS472 - Valuation in the Life Sciences

ALS350 - Financial Accounting and ALS472 - Valuation in the Life Sciences


These courses are taught by Luann Bangsund. Luann joined KGI in 2010 as a Professor of Practice and Director of the MBS program. She received her BA at the University of Redlands. She got a Masters in Education at Redlands and an MBA in finance and Marketing from UCLA. She spend 20 years in the financial sector working for Security Pacific National Bank (since merged into Bank of America), Wells Fargo, Citibank and Kleinwort Benson, Ltd. (now part of Dresdner Bank) in the Los Angeles, New York and London offices of the banks.  At Wells Fargo she was Senior Vice Presidents and Division Manager for the Structured Finance Group. In 2001 she enrolled in the doctoral program at Claremont Graduate University's Drucker Graduate School of Management. After completion in 2006, she accepted the position of Assistant Professor of Finance at the Eberhardt School of Business at the University of the Pacific in Stockton, CA.

Luann teaches a number of courses at KGI this Fall semester; ALS350 Finance and Accounting Principles and ALS472 Valuation in the Life Sciences.

ALS350 is a half course survey of Financial Accounting. Accounting is frequently referred to as the "language of business," and thus, is an essential tool for all managers who strive to be effective communicators.  ALS 350 involves the study of accounting from the perspective of the data user (an investor, manager, or lender), not the data provider (controller, CPA, etc.). Instead, the goal of the course is to gain an appreciation and understanding of the topics covered.  The educational goal of ALS 350 is for each student to become a competent user of accounting information. Students will learn how to interpret, understand, and use the basic financial statements.

Topics Covered

Basic accounting concepts
Balance sheet account categories
                        Current assets
                        Non-current and Intangible assets
                        Property, plant and equipment
                        Current liabilities
                        Long term liabilities
                        Off-balance sheet debt
                        Shareholder's equity
Income statement accounts including revenue and cost recognition
Cash Flow and Funds Flow statements (cash versus income)
Financial statement analysis
Financial ratios

Learning Objectives

After completing this course, students should be able to:
1.)     develop income statements, balance sheets and cash flow statements from raw data
2.)     use basic accounting concepts to evaluate a firm's financial strength
3.)     assess the impact of various business events on a firm's financial statements
4.)     correctly calculate and interpret financial ratios

Grading

Participation           15%
In-class exercises    15%
Final exam               45%
Final Statement Project    25%

 Sources: http://www.kgi.edu/current-students/academic-affairs/course-catalog/courses/als-350.html

Textbooks

       Financial Accounting for Executives & MBAs, Kenneth R. Ferris and James S. Wallace, ISBN 978-934319-62-8

      Fundamentals of Corporate Finance, Brealey, Myers & Marcus, ISBN 978-0-07-803464-0

"The second textbook will also be used for ALS 351 so they shouldn’t freak out about the cost." (quote Luann)

ALS472 - material covered will include the basics of valuation, including defining cash flow, estimating cost of capital and calculating terminal values.  It will also address the challenges of estimating value for technology firms in the early stages of development.  Firms in the life science industry hold particular challenges in valuation due to the long time to market and the significant capital needed to complete the lengthy approval process required by the US regulatory system.  Due to the nature of the discovery, development and commercialization process, it is likely that a project or firm valuation will be required at several stages of the process as ownership shifts from R&D firms, to development firms and on to firms that will market the products.  The involvement of venture capital in the capital raising process sharpens the need for understanding the appropriate methods of valuation in preparation for negotiation of ownership interests.
Most valuation courses focus on the valuation of a firm; however, in this course students will learn to address the issues of valuation, which are created by the limited exclusivity periods (patent protection) typical for intellectual property.  Students will learn to not only use the basic DCF methods used for firm valuation, but also the rNPV ("Risk Adjusted Net Present Value") method specific to the industry.  The course will address valuation of projects, intellectual property and licenses.

  Sources: http://www.kgi.edu/current-students/academic-affairs/course-catalog/courses/als-472.html

Please note, ALS350 is a first semester first year course and therefore doesn't require any prerequisites. However, ALS472 requires knowledge of finance, so unless you have some prior finance courses you will not be able to take this course (unless you're a part-time PPM and will take it in your 2nd year).

ALS341 - BioIndustry Ethics and Society

ALS 341: BioIndustry Ethics and Society

 

This course is taught by Jeffery Smith. Jeffery is an adjunct faculty at KGI and Associate Professor at the School of Business at the University of Redlands. He is the founding Director of the Banta Center for Business, Ethics and Society. He is a member of the Society for Business Ethics, the European Business Ethics Network and the American Philosophical Association.

Description:

As with other industries, the bioindustry has moved aggressively to assure that scientists, managers and employees conduct themselves ethically in in accordance with the law. This course provides students with an introduction to how the bioindustry has accomplished this, with special emphasis on ethical conduct related to biomedical research, use of genetic technologies, pricing of products, advertising, sales and human resource management. Students will not only be asked to critically examine the ethical problems that members of the bioindustry face through case studies, but also take time to consider how ethical conduct impacts their own professional identities and career trajectories.

 

Learning Objectives

This course is designed to have students understand and apply ethical theories, concepts and principles to problems that employees, managers and policy makers face in the bioindustry. This involves a critical examination of ethical problems that pertain to business generally and the bioindustry in particular. To that end, students will participate in classroom discussion and submit written work that demonstrates (a) the ability to critically examine and assess primary source material in the field of ethics, (b) novel argumentation, (c) attention to detail as presented in case studies and (d) a thoughtful integration of facts and values in defending recommendations when addressing ethical problems in the bioindustry. These efforts will be designed to get students to reflect upon their identities as researchers and managers within the bioindustry and to develop a more coherent sense of the ethical principles that shape their chosen profession.

Course Topics

 ·         Ethical Decision Making

·         Corporate Ethics Practices and Legal Compliance

·         Conflicts of Interest in the Bioindustry

·         Corporate Social Responsibility in the Bioindustry

·         Public Safety and Genetic Modification

·         Ethical Marketing and Information Disclosure

·         Intellectual Property in Genetic and Pharmacological Discoveries

·         Use of Human and Non-Human Research Subjects

Assessment

Students’ grades will be determined on the basis of two exams and classroom participation. Exams will be in a take home, essay format and comprised of short answer, concept application and integrative essay questions. The second exam will cover material from the entire course. All exam essays will be assessed relative to five criteria: clarity and organization in presentation, attention to detail, integration and comparison of assigned readings, effective argumentation, effective and proper research (if called for) and appropriate style and grammar. 

The relative weighting of each of these methods of assessment are as follows:

Midterm Exam                                     40%

Final Exam                                            50%

Classroom Participation                    10%

ALS434 - Clinical Biostatistics

ALS434 - Clinical Biostatistics

This course is taught by  Mark Ghamsary. Mark is the Director of the Biostatistics Program at the Department of Biostatistics and Epidemiology at Loma Linda University School of Public Health.

Description:

This half-course provides a basic primer in statistical methods commonly used in the design of clinical trials. Topics covered are expected include data reporting and descriptive statistics, probability, estimation, hypothesis testing (parametric, non-parametric, and categorical), multisample inference, regression and correlation. Sample size and power estimation methods will be developed for various hypothesis testing scenarios.

Prerequisites:

A basic knowledge of mathematical methods at the level of the Math ramp-up course is necessary. Additional exposure to concepts in probability and statistics is desirable but not a hard pre-requisite.

Objectives:

After completing this course students will be able to:

1.      Provide methods of presentation with numerical and graphical presentation on continuous and discrete data sets.

2.      Cover simple probability theory and provide examples of more common applications in clinical setting.

3.      Analyze discrete probability distributions (binomial, Poisson and Hyper geometric).

4.      Analyze continuous probability distributions (normal, chi-square and exponential).

5.      Construct the confidence intervals for the mean, proportion, and variance(One and two sample

6.      Construct the test of hypotheses about the mean, proportion, variance (one and two samples).

7.      Compute the measure of associations, odds ratio, hazard ratio, and the χ² statistics.

8.      Do analysis of variance for independent, as well as repeated measure data.

9.       Compute the sample size determination and power analysis.

10.   Compute the Bayesian probability and its application in medical field

11.   Analyze the simple and multiple linear regressions.

12.   Handle regression model building and examine the underlying assumptions.

13.   Perform survival data analysis for clinical trials.

14.   Understand to run Logistic regression, Poisson regression and Cox Regression

15.   Use SAS software in all clinical researches.

 Statistical Software: SAS will be used in all homework and labs

Homework: There will be about 10 sets of homework assignments. In order to succeed you need to review your notes, read the sections in our text on which we are working.

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.