Contact UsDiana Bartlett
Assistant Vice President,
Phone: (909) 607-9864
Email: diana_bartlett[at symbol]kgi.edu
TMP Presentations 2008
Students: Jennifer Boyd, Tyler Bradley-Hewitt (CMC), Zeynab Moradi, Ranjani Sundharam, Brian Watkins
Since the company is investigating leptin for use in a combination therapy, a crucial factor is to minimize the drug substance cost of goods manufactured (COGM). One way to keep COGM low is to find an efficient expression host that may also minimize downstream processing. The project helped Amylin determine whether P. pastoris can be a commercially acceptable alternative to the current system for producing the leptin protein. The technical assessment provided results for product titer, yield, and quality, as well as data that can be used to perform a matrix analysis to estimate cost of goods manufactured. The report also included an intellectual property analysis, a contract manufacturing assessment, evaluation of regulatory issues, and bioprocess models produced using SuperPro™. Combined, this information provides Amylin with the information necessary to begin assessing P. pastoris as an alternative expression system for the manufacture of human leptin.
Students: Naomi Arana, Shi Yu Chang, Tianhao Han, Sarah Moore (HMC), Kimberly Sevilla
Using a comprehensive, multidisciplinary approach, several implantable drug delivery systems were evaluated for potential inclusion as treatment options within the diabetes and obesity therapeutics market. Historically, implantable drug delivery devices have been developed for a variety of therapeutic areas including pain management, viral infection, delivery of hormones and cancer treatment. The drug delivery systems investigated for Amylin were generally small devices designed to be subcutaneously implanted in patients. The devices provide controlled and sustained delivery of drug for extended periods of time. To assess the market for implantable devices, the team evaluated the compatibility and feasibility of each type of implant with Amylin's compounds and also investigated the implants from a financial and market acceptance point of view. The implications of launching a drug delivery product of this nature for the diabetes and obesity markets were evaluated based on several factors including patient, physician and payer acceptance, along with the reimbursement landscape and product utility.
Other delivery technologies that prolong drug action were examined to explore changing the treatments for diabetics and obese patients. Summaries of the team's findings, including analysis of regulatory issues and development of a commercialization strategy, were organized into traditional marketing frameworks. Ultimately, a final recommendation detailing the most effective drug delivery systems was given.
Students: Sanket Acharya, Justin Custer, Krishnalekha Datta, Tezus Naidu, Jeremy Six, Alissa Sole (CMC)
The goals of this TMP were to provide Beckman Coulter with a background of mass spectrometry clinical diagnostic information, identify key customer practices and drivers for the adoption of clinical mass spectrometry technology, and evaluate the competitive landscape for this technology. Background information and an analysis of the competitive landscape were provided using summarized secondary web-site and Internet research. Background information included current uses of mass spectrometry in the lab, information on sample preparation, and current technologies available. Customer practices and requirements were identified through the use of an intricate on-line survey given to various hospitals across the United States. The survey was designed such that both hospitals that do and do not currently offer or perform mass spectrometry-based clinical tests were able to give meaningful input. All of the information gathered will be used to generate a report that answers the following questions regarding the use of mass spectrometry in the clinic: Why Mass Spectrometry? What tests are done? Where? Who is using it? Whose equipment is being used? What's next? ▲ Top
Students: AnGee Baldini (CMC), Victor Chiu, Anita Kurien, Jennifer Wong
Students worked with BrainScope to identify and characterize various markets for clinical use of BrainScope's revolutionary, proprietary and non-invasive technology. The students assessed neurological diseases for which Brainscope technology could prove most useful in diagnosis and they developed business models for a number of the diseases identified. The TMP effort provided analysis and recommendations that aid Brainscope in the mission to provide medical professionals with effective new tools to assist in the assessment of brain injuries and brain disorders and to provide appropriate and timely treatment
Students: Rajesh Chitta, Alex Clayton, Paul Schultz, Timothy Iafe (CMC)
The objective of this TMP was to analyze the renewable energy market and determine the optimal energy feedstock for this new community. Working directly with Clear Springs, the team identified algae and switchgrass as the two best suited energy feedstock options. For the analysis of the algae biofuels market, the team investigated all the companies currently involved in the field, conducted extensive interviews, created financial models, and developed detailed market reports. In addition, switchgrass strains and biofuel production technology were investigated and a final report and recommendation were provided.
The team also succeeded in developing a laboratory analysis of algae composition and growth characteristics. The algae and switchgrass financial valuations were supported by Crystal Ball risk and valuation software, which was utilized to forecast outcomes for the different investment proposals and provide reports to conduct a return on investment analysis.
The team successfully recommended several business proposals to Clear Springs with supporting marketing, financial, and laboratory information. The recommendations provided Clear Springs with the knowledge and resources necessary to make a final decision on how to proceed with their renewable energy venture.
Students: Matthew Grunseth, Pavan Kolli, Daniel Spurgin, Andrew Zepfel (CMC)
Average corn yield rarely matches the genetic potential because of stresses imposed by the environment. Drought stress is perceived to be the most common contributor to yield loss. With the majority of the crop reliant on rainfall, a drought resistant corn product would help farmers stabilize yields. The goal behind the Dow AgroSciences (DAS) Team Masters Project is to refine product definition and screening strategies for developing drought resistant corn traits for the United States and global marketplaces.
The DAS TMP approached product definition and screening development for drought tolerant traits in three ways: (1) established a database of competitive intelligence, (2) statistically assessed the non-irrigated corn market by correlating soil moisture to yield, and (3) designed an experimental proof-of-concept screening assay to identify drought resistance. In aggregate this tripartite assessment will refine DAS product discovery strategies for drought tolerance in corn, coupled with a high throughput means of identifying targeted traits.
Students: Joanna Kang, Theodore Nguyen, Jacqueline Rosselle, Satish Vammi
Incorporating dcLink, JDEdwards and Optio Software, we designed a software program that would barcode and automatically generate a WO. Our TMP also created a revised WO format using feedback received from user interviews and developed and tested test scripts which were used to validate the new system that was implemented. In addition, we developed several important scripting and verification documents including the User Requirements Specification (URS), Functional Requirements Specification (FRS), Validation Master Plan (VMP) and several Standard Operating Procedures (SOPs). Finally, we successfully validated the software system and transitioned this system into manufacturing and production processes within the San Dimas facility in April 2008, also known as our “Go Live” date.
Students: Sanket Borad, Aanchal Kamra, Jayasri Prabakaran, Parvin Rastegar, Tirso Alvarez Carrera (PTZ), Oliver Johnson (HMC), Autumn Petros-Good (HMC), Natt Supab (HMC)
Currently, there are two levels of inspection performed in the industry – 100% inspection of all incoming and final products by the manufacturing department, and a separate verification of batch quality by discrete sampling inspection by the quality assurance department.
This project was a joint effort between Harvey Mudd College and Keck Graduate Institute. There were two goals of this project. The first objective was to evaluate and make recommendations for the purchase of a manufacturing-scale automated inspection system for parenteral products. The scope of this evaluation included a risk assessment and an economic justification for the recommended system. The second objective was to design a system to detect and quantify cosmetic defects in pills for quality assurance purposes. The developed prototype is able to detect and classify cosmetic defects in pills using image analysis software and serves as a proof-of-concept for the development an automated inspection system for pill defect detection.
Students: Stephanie Brecheisen, Eureka Dias, Andrew Hopkins, Santosh Kuruvilla, Raghavan Vasudevan
The focus of this TMP was to assess the viability of various business strategies and approaches intended to expand and accelerate global market penetration of Mirasol beyond 2008. The team focused on determining a potential positioning strategy primarily based on white cell inactivation by Mirasol. The team investigated:
Students: Kristina Roskos, Marcia Soriano, Sean Tsai, Chris Warner
The team developed several methods for isolating and characterizing the enzyme-conjugate when it is aged on the analyzer. They compared the aged enzyme-conjugate to its native state using SDS-PAGE, Western Blots, and Size Exclusion Chromatography. A temperature gradient in the reagent storage carousel was characterized and a small device was subsequently built to replicate the gradient. Finally, using DOE studies, the addition of excipients to help mitigate the observed instability was examined. The team’s studies have increased knowledge of the biophysical properties of the enzyme-conjugate and the VALP assay, which may lead to more cost effective solutions for EMIT assays.
Students: Sebastien Brasseur, Ye-won Cho, Thi Nguyen, Peter Vandeventer
The team evaluated and tested different methods of heating and cooling that can be used to amplify the sample DNA much more rapidly than the current thermocycling times. Speed of amplification and cost were considered when designing and building a small scale prototype. The design was constantly modified and improved throughout the project based on results from extensive laboratory experiments. The final design provided Syngenta with a starting point to assess the feasibility of replacing their current system with a scaled up in-line PCR system based upon the results of our prototype. p>
Students: J.P. Doyle (CMC), Sunitha Jagannathan, James Lu, Isaac Middendorf, Brianna Schuetz
The assessment took the perspective of a mid-sized firm such as Theravance, Inc. which currently has one location in the United States. After gaining an understanding of the current Theravance approach to drug discovery and early development, the project team identified several alternative opportunities to use global resources to speed the R&D process. Through interviewing key opinion leaders and senior members at Theravance, the team quantified the potential benefits and risks associated with pursuing these opportunities. Using a structured decision analysis process, the team evaluated and ranked these options. The top three alternatives were developed into detailed strategic plans including key actions, timelines and budgets. These detailed strategic plans also highlighted the important success factors and associated risks (regulatory, operational, cultural, etc.). The results of the project and the detailed strategic plans were presented to the Theravance senior management.