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Diana BartlettAssistant Vice President,
Corporate Partnerships
Phone: (909) 607-9864
Email: diana_bartlett[at symbol]kgi.edu
TMP Presentations 2010
Project Summaries 2009-2010
| Students: Pratik Ahuja, Michael Esselman, Matthew Verbrugge, Brad Davis Corporate Liaisons: Dennis Huang Wajdie Ahmad Faculty Advisor: Prof. Daniel Byrd |
ALLERGAN Biologics Development Capacity Modeling and Analysis Allergan is a multi-specialty health care company sponsoring their first Team Master’s Project at KGI. This project serves their Biopharmaceutical Process Sciences Department. Currently, the biologics product pipeline is bottlenecked at the development phase of the product lifecycle. To help Allergan management strategize on how to best alleviate this bottleneck in the future, KGI students developed a dynamic process tool using Metastorm Provision® software. This tool serves as a capacity modeling tool for the Biopharmaceutical Process Science department at Allergan with the goal of analyzing potential capacity improvement opportunities. Using this modeling tool, the team ran different scenarios to provide recommendations on how to improve investing time and resources, maximizing capacity return for the next 5 years. Ultimately, this model will provide management with a flexible tool to make better informed business decisions in the future. ▲ Top |
| Students: Anna Carroll, Shefali Nagrani, Ivan Ban, Linda Soohoo Corporate Liaison: Ted Slocomb Faculty Advisor: Prof. Animesh Ray |
AMYLIN Orphan Drug Market Overview Amylin Pharmaceuticals, Inc., a San Diego based fully integrated pharmaceutical company, was founded with the goal of developing peptide hormone therapies for diabetes, obesity, and other metabolic conditions. Since its inception in 1987, and IPO in 1992, the company has brought two first-in-class diabetes drugs to market. Additionally, the company has several products in various stages of clinical development for both diabetes and obesity. Though Amylin is well regarded in the industry, and has attained a market cap of nearly $2.5 billion, the company has not yet achieved profitability. To continue to grow and establish the company within the upper ranks of the biotech sector while increasing their current cash flow, Amylin has identified a need to pursue additional growth opportunities. With this in mind, the Amylin TMP worked to evaluate opportunities for Amylin to pursue in the orphan drug market. This was for several strategic reasons. Orphan products present a lower risk to the company, and offer the quickest potential route to commercialization. If pursued, Amylin would like to see profits within five years. As many orphan diseases are lacking in treatment options, Amylin hopes that a new product will result in rapid sales to achieve this goal. The company has identified in-licensing as the desired route to commercialization within this time frame. Project deliverables included recommendations for how Amylin should proceed with this venture and the likelihood of success. By identifying success factors of companies that have pursued similar goals, this TMP worked to outline the best method of a successful licensure. Additionally, an overhead analysis of Amylin’s current capabilities helped the team properly assess areas of concern as the company moves forward. Overall the team made recommendations on whether partnering or purchasing is a better option and identified desirable compounds fitting these criteria. ▲ Top |
| Students: Prathuish Chander, Mike Hoang, Sana Moosa, Kelsey Rose, Adam Calvert, Tyson Fetzer Corporate Liasons Tina Song, Jeff Quint Faculty Advisor: Prof. Nancy Lam |
BECKMAN COULTER New Automation Products Beckman Coulter (BEC) is the global market leader in clinical diagnostic instruments, reagents and supplies. BEC clinical diagnostic instruments are routinely used throughout the hospital and reference laboratory settings to provide ˜90% of the answers to questions regarding patient health. They are also the first diagnostic company to provide fully integrated automation to the clinical laboratory thereby reducing costs and increasing reliability. BEC is creating the next generation automation system and needed a global marketing and commercialization plan for the launch of this system in to key target markets. The first semester task was to identify market drivers that affect the diagnostic industry, segment the target market and create a strategic marketing plan for 6 high-priority global markets. We successfully identified and prioritized launch targets as well as made strategic recommendations for BEC. The second semester task was to develop a commercialization timeline based on the work from first semester. For each of the launch targets, we developed unique marketing messages, prioritized key product features and developed the timeline based on customer base, market drivers, product lifecycles, and competitive product positioning. ▲ Top |
| Students: Vikashni Padmakuma, Delyan Rusev, Joshua Manohar, James Paliga, Mark Brown Corporate Liason: Nick Zecherle Faculty Advisors: Prof. Ali Nadim, Kirilynn Svay |
BiOMARIN Efficacy of Membrane Chromatography Sorbents for Removing Impurities from CHO Cell Line Delivered Enzyme Therapeutics BioMarin Pharmaceuticals Inc. develops and commercializes innovative enzyme replacement therapies for rare diseases. The company’s product portfolio is comprised of three FDA approved products (Kuvan®, Naglazyme®, Aldurazyme®) and several investigational product candidates. The focus of our project was to develop a quantification assay and purification strategy for reduction or removal of a trace protease impurity found in some of BioMarin’s purification process intermediates derived from mammalian cell culture. The BioMarin Team Masters Project (TMP) designed a two-phase plan to address the main goal of the project. During Phase I, the team worked on multiple proof-of-principle, sensitive blotting technique experiments for accurate quantification of the impurity. In Phase I the team developed an analytical assay which will be of significant importance to validate the effectiveness of Phase II methodology. During Phase II of the project, the BioMarin Team tested different membrane chromatography approaches to sufficiently reduce or eliminate the protease impurity without concomitant loss of the target therapeutic enzyme molecule. Additionally, we considered factors regarding the ease of implementation of a membrane chromatography step in an otherwise pre-defined purification process. ▲ Top |
| Students: Tyler Kibbee, Thomas Tredennick, Benjamin Haynes, Elizabeth Ward Corporate Liason: Fred Boling Faculty Advisor: Prof. Matthew Croughan |
CLEAR SPRINGS Economic Assessment of Biofuels Clear Springs is a large landholder and developer in Florida that has sponsored a Team Master’s Project (TMP) through the Keck Graduate Institute (KGI). The KGI TMP team has been given the objective of evaluating the potential of renewable power generation alternatives that could be developed on a 7,000 acre portion of a Clear Springs holding in Bartow, Florida, that was previously used for phosphate mining. The goal of the project was to evaluate if renewable energy can be produced on this land while being economically feasible. The renewable power alternatives to be evaluated included solar, wind, algae and switchgrass. This business development related project assessed the alternative power generation markets, confirmed key value propositions, negotiated and made recommendations to our client, Clear Springs. Upon completion of this project, our client should be able to make an informed decision on how to invest their resources in alternative energy. ▲ Top |
| Students: Hardeep Chiraya, Tiffany Wan, Anthony Hewitt, Lisa Baldini, Michelle Pesce Corporate Liasons: Robert Seemayer, Regan Shea Faculty Advisor: Prof. David Vetterlein |
GILEAD Due Diligence on Licensing Biologics and Fermentation Technologies Gilead Sciences Inc. was founded in Foster City, California over 20 years ago and has become a dominant force in the pharmaceutical industry with over 14 marketed products and more than $7 billion in revenues. Gilead’s product portfolio includes treatments for HIV/AIDS, liver disease, cardiovascular disease and respiratory conditions. All of their products are chemically derived small molecules, many of which were obtained through acquisitions. Gilead has extensive experience performing due diligence for small molecule product acquisitions. The team objective was to identify key challenges and risks Gilead is likely to encounter performing due diligence for a biologic product or involving biologic process components. As an approach, mock due diligence analyses were performed and documented for three existing products: Amoxicillin, Insulin and a recombinant MAb (LEB). The analysis relied on public information and interviews with experts. Due diligence is focused on: 1) Development and Manufacturing; 2) Regulatory; 3) Intellectual Property; and 4) Market Competition. Several challenges and risks were identified that result from the unique regulatory requirements for Biologics, the size and complexity of the molecules, and the increased manufacturing controls and facility design measures needed to produce a safe and consistent product and avoid microbial and viral contamination. ▲ Top |
| Students: Sarah Arlien, Maria George, Sri Ranga Yarlagadda, Brent Thompson, Sameer Sivaamnuaiphorn Corporate Liasons: Jay Flatley, Omead Ostadan Faculty Advisor Prof. Jim Osborne |
ILLUMINA Consumer Genomics Illumina (NASDAQ: ILMN) is a leading developer, manufacturer and marketer of integrated systems for large-scale genomic analysis. The company is headquartered in San Diego, CA and has a current market capitalization of $4.54 billion and 2009 revenues $647 million. The company’s product line caters primarily to genomic research institutions, academic institutions, and the pharmaceutical and biotechnology industry. In June 2009, Illumina forayed into the consumer sequencing market with their “Every Genome” offering. The primary objective of the project was to characterize the consumer genomics space and offer our client an independent perspective on how to move forward. To achieve this goal, the project was broken down into five key tasks that included market segmentation, identifying industry drivers and moderators, identifying international markets, evaluating the regulatory environment and suggesting an effective pricing and marketing strategy. To better understand the consumer genomics industry and to gain different perspectives of the various issues at hand, the team performed in-depth interviews with key opinion leaders. The final deliverable was a three-year strategic business plan incorporating each of these components. ▲ Top |
| Students: Ian McLaughlin, James Kwok, Corey Kuruma, Jennifer Woo, Biranchi Patra, Nithya Periasamy Corporate Liasons: Eric Tan, George Hutchinson Faculty Advisors: Anna Hickerson, Craig Adams |
KCI Wound Healing Diagnostic System Kinetic Concepts, Inc. (KCI), founded in 1976 by Dr. Jim Leininger, is a medical device company focused on the development and distribution of patient care systems. Though initially focused upon therapeutic support systems, KCI has since expanded into general active healing solutions—becoming the first company to commercialize Negative Pressure Wound Therapy upon the introduction of the ActiV.A.C.® System in 1995. KCI also has expanded recently into regenerative medicine, with the acquisition of LifeCell in 2008. The primary goal of this project was to enhance the clinical utility of the ActiV.A.C.® System (primarily used in the home care market) by first developing a method to sample wound fluid, and second, to achieve a time series collection of wound fluid. An engineering-driven effort was performed to explore different opportunities to automate sampling and to conceptualize potential models brainstormed by the team during the initial phase of the project. Additionally, laboratory-based experiments were performed to study the stability of biomarkers important for diagnosing wound healing status in the ActiV.A.C.® System. Finally, a condensed literature and patent review was performed which provided an analysis of potentially useful biomarkers and patents. Our prototype and the accompanying biomarker analysis provided KCI with options under evaluation for enhancing the ActiV.A.C.® System. Eventually, multi-sampling capabilities will increase the understanding of wound progression and drive better-informed therapeutic decisions. ▲ Top |
| Students: Chivas Wakuta, Purvi Lad, Sonali Talele, Michael Wang Corporate Liasons: Vicki Singer, Rodney Turner Faculty Advisor: Prof. Molly Schmid |
LIFE Maximizing Value for Life Technologies through Business Relationships with Contract Research Organizations in China and India Life Technologies was created through the merger of Invitrogen Corporation and Applied Biosystems Inc. in November 2008. The company provides premier products for life science researchers. Life Technologies provides reagent and consumable products for research applications under the Invitrogen brand, and systems-based solutions for DNA sequencing, genotyping, PCR, gene, and RNA analysis, under its Applied Biosystems brand. To maintain its strong presence, Life Technologies wishes to better understand the factors that are influencing the demand for its products. This Life Technologies-KGI TMP project analyzed trends in the outsourcing of preclinical drug discovery services to the Asia-Pacific region. Recently, there has been considerable restructuring of research and development in pharmaceutical organizations. Many preclinical drug discovery research activities, once conducted in-house, are now being outsourced to contract research organization in the Asia–Pacific region. Though the basic tools used for drug discovery remain the same, the users are changing. In phase one, we documented the outsourcing of specific preclinical drug discovery activities to the Asia-Pacific region. We interviewed KOLs from the top 10 pharmaceutical companies to better understand what specific activities are being outsourced, what is motivating the outsourcing, whether the outsourcing is increasing or decreasing, and to identify the decision-makers in this process. In the second phase of this project, we mapped the Asia-Pacific outsourcing activities of the pharmaceutical companies to Life Technologies products. ▲ Top |
| Students: Lane Bilbrey, Anisha Choudhury, Vincent Lam, Andrew Yunghans Corporate Liason: Brian Lee Faculty Advisor: Prof. Matthew Croughan Doctoral Student Assistant: Nate Freund |
PBS BIOTECH Single-use Bioreactor Systems PBS Biotech is a start up company that develops and manufactures single-use bioreactor systems, with a unique, pneumatic mixing technology. Their innovative bioreactor design can potentially impact the biotech manufacturing industry, not only with regard to biopharmaceutical production, but also in newer areas such as stem cell development, biodefense, and personalized medicine. Over the course of an academic year, the PBS TMP team has done an in depth technical characterization of the product by designing and carrying-out mixing, biological comparison, and scalability studies. Cell growth was compared for various cells between PBS bioreactors, at the 2-L and/or 50-L scale, versus 2-L stirred tank bioreactors and disposable wave-type bioreactors. Depending upon the cell line and culture conditions, cell growth in the PBS bioreactors was equal to or superior to growth in the other bioreactor designs. The team also performed a market assessment involving customer surveys and competitor analysis for the business segment of this project. Conference and academic databases were also built as extra resources for the company. ▲ Top |
| Students: Pierre-Alain Blosse, Solomon Iyasere, Claudia Lee, Spencer Trooboff Corporate Liason: Hillary Sullivan Faculty Advisor: Dr. Anna Hickerson |
PIONEER SNP Genotyping Via Continuous Flow PCR Pioneer-Hi Bred, a DuPont business, is the world’s leading source of customized solutions for farmers, livestock producers and grain and oilseed processors. With headquarters in Des Moines, Iowa, Pioneer provides access to advanced plant genetics in nearly 70 countries. This TMP was contracted by Pioneer to research and develop a prototype micro-fluidics platform capable of generating reproducible and concordant SNP genotyping data. An essential component of this project was a review of the current technology for PCR genotyping in a microfluidics environment, and subsequently the appropriate selection of material and design strategies from existing options. Multiple iterations of the microfluidics device and the channel patterns were then constructed and tested comparatively. It was found that the stability of such operation is highly dependent on preventing the evaporation of the micro-volume reagent. Droplet containment and elevated environmental humidity were shown to have positive effects. ▲ Top |
| Students: Ryan Carbone, Harsimranjit Kang, Aditya Kelkar, Rachelle Fryd, Alex Labby, Neelima Kumar Corporate Liasons: Yamil Hernandez, Vineeth Raja Faculty Advisor: Prof. Ian Phillips |
SIGMA-TAU New Product Opportunities in Rare Disease Therapy Sigma-Tau is one of the world’s leading pharmaceutical groups. The Group is headquartered in Rome, Italy. Founded in 1957, Sigma-Tau stands by their motto “Rare Dedication.” As a pharmaceutical company, it has focused its attention on the unmet medical needs of rare diseases. The United States wholly owned subsidiary, Sigma-Tau Pharmaceuticals (STPI), is based in Gaithersburg, Maryland. The company’s products address needs of patients suffering from various rare disorders related to metabolism, oncology, immunodeficiency disorders, invasive fungal infections, and renal failure. Recently, Sigma-Tau acquired Enzon Pharmaceuticals, Inc’s specialty pharmaceuticals business, expanding its orphan product portfolio in the market. As a part of its future expansion plans, Sigma-Tau Pharmaceuticals asked the TMP team to identify potential acquisition/in-licensing targets that fit within the company’s rare disease business model. The focus of the project was on products with orphan designation in the US and EU. Starting with over 2,500 products, the team developed a methodology to identify optimal targets for STPI. The team performed extensive research on these products and filtered them through stringent exclusion criteria, including over 20 parameters. As a final deliverable, the team produced a comprehensive report detailing product information on top candidates. In addition, the team developed a comprehensive database for Sigma-Tau to examine the US and EU orphan product market in future. ▲ Top |
| Students: Nicholas Jacenko, Rebecca Goldberg, Raunakk Advanie, Kankshit Bheda, Yvonne Klaue Corporate Liason: Bonnie Anderson Faculty Advisor: Prof. Steven Casper |
VERACYTE New Product Launch Strategy and Market Opportunities Veracyte is a private molecular diagnostics company committed to clarifying cancer diagnoses. The company’s goal is to use molecular cytology to develop diagnostic tools that may help physicians and patients make informed treatment decisions. The company is developing diagnostic tools intended to reduce the high rate of inconclusive test results associated with currently available technologies using fine needle aspirates (FNAs) and other cytology samples. This is the second TMP that Veracyte has sponsored. This year’s TMP was divided into two independent projects. In the fall semester the team focused on the development of a detailed commercialization strategy and Roll-out plan for Veracyte’s first commercial product in the US. The research gathered by the team was used to develop a strategic map showcasing regions with high probability of success and additionally proposed a long-term strategy. The second semester project involved the characterization of new market opportunities for a different indication. The team validated current diagnostic methods to evaluate the proposed clinical and economic models through secondary and primary research. Interviews with key opinion leaders provided the team with robust data which resulted in the validation of the clinical model for the targeted disease area. ▲ Top |
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