Contact UsDiana Bartlett
Assistant Vice President,
Phone: (909) 607-9864
Email: diana_bartlett[at symbol]kgi.edu
Abbott Medical Optics
Abbott Medical Optics Inc. (AMO) is interested in developing a next generation remote control device built around human use factors. To facilitate this effort, the AMO TMP Team collaborated with a multi-functional AMO Team to develop a working prototype of the remote control device. The KGI Team concentrated their efforts on the human factors required for this device. To accomplish this goal, the team examined the physical and functional characteristics desired by users. By establishing excellent lines of communication with AMO, the KGI students collaboratively interacted with AMO technical leads in design, electro-mechanical, and software aspects of the device.
The AMO TMP Team was tasked with redesigning AMO’s current remote control used with its phacoemulsification device. To accomplish this objective, the team utilized user feedback, focus groups, and marketing research to determine the appropriate look, feel and function of the remote. In addition, the team validated their design through materials testing using regulatory guidelines and marketing feedback. Upon completion of this project, the team will have produced a validated, working prototype of the next generation remote control device that will be used in over 30 countries worldwide.
Allergan, Inc. relies on microbial fermentation to produce various biologics, typically using large stainless steel fermenters. Allergan would like to test the production capability and economic feasibility of new disposable bioreactor technology that has been adapted for microbial expression systems. The use of a disposable system might create value by lowering costs and time associated with system validations in addition to improving safety and ergonomic outcomes.
The Allergan TMP Team was asked to evaluate the performance of a disposable bioreactor technology and develop a cost/benefit analysis which compares these systems to the typical stainless steel systems. To accomplish this goal, the team conducted cell-free testing which characterized the capabilities and limitations of a new, first of its kind, modified single use bioreactor and compared this system to a commercially available system. After analyzing the initial data and establishing optimal microbial fermentation parameters achieved with the new system, the Allergan TMP Team conducted several fermentation runs with E.coli and P.pastoris. Protein yields were analyzed and served as a basis for the economic evaluation of a disposable system. To develop an economic model, the Allergan TMP team analyzed the system productivity as well as variable and partial fixed costs in addition to safety and ergonomic issues. Upon completion of this project, Allergan will be able to assess the economic value and commercial potential of disposable fermentation technology in comparison to the stainless steel standard systems.
Amylin Pharmaceuticals is in the process of launching a new drug for the treatment of the ultra-rare disorder lipodystrophy. This disease is characterized by a lack of body fat and has severe metabolic consequences; one of the primary reasons for this is the loss of the neurohormone leptin which is produced by adipose cells. The drug Metreleptin is an analog of leptin and has been shown to significantly improve health outcomes relating to diabetes and hypertriglyceridemia in patients suffering from lipodystrophy. Due to the rarity of the disease and difficulty of diagnosis, Amylin is investigating strategies to discover undiagnosed patients who may benefit from Metreleptin.
The role of the Amylin TMP team was to assist in the launch of Metreleptin by investigating the genetic testing landscape and the use of genetic testing for diagnosis of lipodystrophy. Pursuant to this goal, the team performed exhaustive case studies into other rare diseases as a way of comparing current strategies, developed a database of labs performing genetic testing for lipodystrophy genes, and carried out extensive research into newborn screening, genetic counseling, genetic testing reimbursement, and regulatory issues. Finally, the Amylin TMP team provided a prioritized set of strategic alternatives for integrating genetic testing into the overall Metreleptin launch plan.
The goal of the AVI BioPharma TMP is to identify future targets for drug development within the rare genetic disease space by creating a comprehensive and interactive database with a set of defined criteria and parameters. To accomplish this goal, the AVI BioPharma TMP team defined two specific deliverables; a comprehensive database (designed using Microsoft® Access™) and a short list of 100-150 top diseases that would subscribe to the needs of AVI BioPharma’s drug discovery group. The short list would also be queriable through a Python script, which would allow AVI BioPharma to modify their target search by changing certain query variables.
To accomplish these goals, the AVI BioPharma TMP team examined and retrieved data pertaining to rare genetic diseases from several pre-existing publicly available databases and developed specific prioritization criteria to subsequently filter and thus generate a short-list of genetic diseases targetable by AVI’s technologies. The diseases on the short list were then scored using critical parameters such research feasibility and market potential. The scoring criteria were then combined with subjective assessment to provide a numerical value guided by requirements set by AVI. Weights assigned to each parameter were designed to be readily modified within the interactive program created using Python script.
Upon completion of this project, AVI BioPharma will be able to use the databases to generate prioritized lists of diseases to best meet their future research and business development goals.
As BioMarin’s pipeline grows, the company intends to expand their process development capabilities. In support of this goal, BioMarin intends to construct a pilot plant facility that can accommodate larger-scale process development activities and produce sufficient quantities of material for early product characterization and pre-IND studies. The pilot plant would also be used for large-scale process testing which currently takes place in BioMarin’s clinical and commercial manufacturing facilities. Shifting process development capabilities to a dedicated pilot facility would provide additional flexibility to evaluate and troubleshoot processes, and possibly create a longer-term cost savings for the company.
In three phases, the BioMarin TMP evaluated and designed a pilot plant facility to meet current and future process development needs. First, through discussions with functional leaders in BioMarin’s Process Sciences department, the team analyzed internal scale-up challenges in the department and identified the possible capabilities that would address these needs. Several necessities were recognized, such as the need for dedicated areas to perform process equipment testing, troubleshooting, and scale-up testing. Second, the BioMarin TMP team created a full layout of the potential pilot plant footprint based on a detailed analysis of all the required and desirable equipment for the facility. A range of scenarios and layouts were created to best analyze the opportunities for process development expansion. Finally, the team formed a business case for the implementation of a pilot plant. A Return on Investment (ROI) analysis was completed to present a preliminary financial justification for a pilot plant. Through these steps, the BioMarin TMP team was able to analyze how the benefits of these expanded capabilities might affect BioMarin’s process development strategy going forward.
Broadley-James is currently exploring the idea of potential variations of its BioNet system to reach a larger set of users. Their current full-featured industrial automation systems are expensive and limit the market size. Broadley-James would like an in-depth analysis of potential users’ needs in various markets to correctly guide a product redesign that is driven by well-defined market requirements. Saturation of the high-end market has driven Broadley-James to explore the design of a new control system with a smaller feature set at an affordable price point.
The Broadley-James TMP team was asked to take a two phased approach to develop a comprehensive analysis of market requirements. During the first phase, the team conducted primary and secondary market research. The goal of this effort was to assess the bioreactor market and understand the importance of various bioreactor features from the perspective of the end user. This market survey combined with interviews of knowledgeable users provided the team with valuable data which were used to create a market definition report assessing promising market segments. During the second phase, additional rounds of surveys were completed and competitor product analysis was used to create a product requirements specification for a mid-level product. Thus, the TMP team provided Broadley-James with actionable information that can be used to expand their product offering to a new market segment.
The City of Hope
Dr. Samuel Rahbar and colleagues at the City of Hope have developed a novel small molecular compound designated LR-90, which has been shown to inhibit the formation of Advanced Glycation End (AGE) products. AGE products are caused by high blood sugar levels found in both type 1 and type 2 diabetes and are considered to be one of the primary causes of the chronic diabetic complications such as nephropathy, neuropathy, retinopathy, and atherosclerosis. Based on preclinical studies performed at the City of Hope, LR-90 has demonstrated promise in mitigating these debilitating and deadly complications. In support of a commercialization strategy for LR-90, the City of Hope TMP team was tasked with drafting a detailed plan for the development of LR-90.
To fulfill this objective, the City of Hope team performed a two-phase analysis to characterize the commercial opportunities for LR-90. The first phase involved conducting a thorough examination of the U.S. diabetes market, as well as analyzing the competitive landscape for AGE inhibitors. This assessment yielded key lessons that have been used to formulate strategic options for the second part of this project. Subsequently, the City of Hope TMP team evaluated the LR-90 development timeline, development costs and strategic partnership opportunities to produce a detailed trade-off analysis. The City of Hope will consider this information as it develops a more complete commercialization plan for the LR-90 program.
The Clear Springs TMP team was hired to assess the value and the markets for co-products produced by the algal biofuel technology under consideration by the client. The team evaluated each step of the algal biofuel production process, and carried out a detailed cost analysis to estimate production costs. In addition, the Team researched both high volume and high value co-product markets to identify profitable opportunities in the foods, fuel, and chemical markets. The final report evaluated multiple scenarios for commercializing these byproducts and provided recommendations for the most profitable options.
Eli Lilly and Company was founded in 1876 with the purpose of producing high quality and effective drugs. It is the 10th largest pharmaceutical company in the world and is best known for development of innovative therapies to significantly improve the lives of patients.
For this project, innovation is defined as “something new that adds value to the company or consumers”. While innovations are the lifeblood of successful R&D companies, firms often have difficulty identifying, developing and bringing such innovations to market. The team’s research focused on the structural, cultural and behavioral elements that are necessary to sustain or inhibit successful innovation across several R&D intensive industries.
The Team analyzed organizations representing a wide range of industries including agricultural biotechnology, oil & gas, pharmaceuticals and government laboratories. To accomplish its goals, the Team partnered with the Industrial Research Institute (IRI) and its member companies to obtain essential data in support of the project. Additionally, the Team received training on qualitative research tools and techniques from IDEO, an innovation and design consulting firm. The Eli Lilly TMP Team ultimately conducted over 60 interviews with proven innovation leaders in these industries. Based on the data collected, the team developed frameworks that identify the cultural and behavioral elements that are seen across industries which drive and sustain innovation efforts.
One of Gilead Sciences’ development projects, a therapeutic antibody, is currently moving through the Gilead development pipeline toward product launch. In support of this product, Gilead has asked the Gilead TMP team to provide independent input into the primary packaging of this new therapeutic product. Of course, any change in primary packaging may result in an extended time to market caused by the impact of packaging changes on the developmental and regulatory timelines. However, the ultimate value of the final product will be tied to the medical efficacy and the “ease of use” needs of the consumer. The Gilead TMP team developed a competitive market analysis to establish the value of therapeutic antibody packaging choices. Finally, the Team cataloged and evaluated both the tactical and strategic tradeoffs involved in pursuing a change in therapeutic antibody packaging for this near term product.
The Gilead TMP produced a detailed assessment of the current marketplace for therapeutic antibody packaging. Further, the team made recommendations to Gilead which characterized the advantages of the team’s recommended packaging strategy. These recommendations were developed using primary and secondary marketing surveys focused on key stakeholders and their preferences as well as historical models for product packaging.
The KCI TMP team was asked to analyze rising innovation technologies within the orthobiologics market and explore their potential to leverage KCI’s technology and capabilities. Orthobiologics is a branch of orthopedics which focuses on the regeneration and restoration of normal function to damaged musculoskeletal tissues.
To accomplish this task, the team identified novel, noninvasive biophysical technologies using primary literature, patents and by conducting interviews with experts in the field. The collected information was evaluated using technical findings to establish feasibility, novelty, safety and efficacy. This information was ultimately summarized in a technology overview. Additionally, a market segmentation and competitive analysis was conducted based on areas of unmet need. The final deliverable was presented in the form of a recommendation for or against adoption of one or more noninvasive biophysical technologies in the chosen orthobiological market segments, including an analysis of the business and technical risks for KCI.
Life Technologies Corporation is a global biotechnology company dedicated to improving the human condition. The drug discovery and development process is expensive, lengthy, and risky. In preclinical studies, biologists attempt to predict how humans will Absorb, Distribute, Metabolize and Excrete a drug candidate, and also estimate the Toxicity (ADME/T testing). Scientists conduct experiments using animals, human cells, cell-surface receptor preparations and purified enzymes in order to predict the ADME/T properties of new drug candidates prior to initiating clinical trials in humans.
Scientists currently consider tests using animal models to be more predictive of clinical trial results than in vitro assays. Animal studies are costly, time consuming, and because of inter-species differences, may not correlate with human clinical results. In contrast, current in vitro methods are more convenient and cost-effective, but also limited in their ability to predict clinical outcomes. These limitations of both approaches create opportunities for new technologies that better predict clinical results while offering the advantages of in vitro studies.
The team explored the potential for novel in vitro methods to reduce animal testing in order to help Life Technologies investigate new commercial opportunities. In the first phase of the project, the team interviewed experts working in preclinical ADME/T testing to understand current practices, identify potential opportunities, and improve current tests. In the second phase, the team conducted a survey to quantify these findings. Finally, the team refined the survey results by conducting additional expert interviews. Through these processes, the team identified several pain points and unmet needs in the current ADME/T testing market. The team assessed the level of willingness of preclinical ADME/T customers to adopt new technologies and identified characteristics that could help drive their adoption.
Medco Health Solutions, Inc is in the process of evaluating how advancements in whole genome sequencing (WGS) technology will impact healthcare delivery within the next 3–5 years. Medco believes it can leverage its broad datasets and experience in genomics to become a leader in the integration of WGS into clinical care. However, significant hurdles exist to successfully gain physician adoption of WGS. Medco would like to understand these barriers and determine the best way to overcome them in order to successfully accelerate the integration of this evolving science into clinical practice.
The Medco TMP team was tasked with developing a decision framework by assessing how various dynamics will impact the development of WGS and how this technology might be integrated into Medco’s existing, and possible future, service offerings. The team investigated where Medco’s current infrastructure would need to be expanded and how the technological feasibility, legal and regulatory environment, and market factors would impact Medco’s decision to move into the WGS space. Through identification of key variables involved in WGS, the Medco TMP team identified several potential program offerings that Medco could implement. In addition, the team created a quantitative model to guide future decision-making as the field continues to evolve. Through this project, Medco has gained a clearer understanding of what role WGS plays in their existing business model and how this model can be expanded to provide maximum clinical and commercial value for its clients and their members.
The Monsanto Company utilizes genetic analysis extensively to augment the company's traditional breeding programs and to speed the development of its biotechnology trait pipeline. In support of these activities, Monsanto continually seeks to improve its methods by rapidly sampling tissues from seeds and plants with minimal damage to the sample source. Currently, Monsanto is looking to extend its time-, labor-, and space-saving non-destructive seed sampling technology from row crops to new plant species.
The Monsanto TMP team was assembled to demonstrate the proof-of-concept for non-destructive tissue micro sampling methods amenable to high-throughput automation and genetic analysis. During the fall semester, the team identified several promising minimally destructive sampling methods. Multiple iterations of refinement have yielded sampling methods that impair germination in fewer than 10% of the seeds for three high-value crops. The Monsanto TMP team has developed and characterized protocols for each of these species with validated germination rates and sample nucleic acid content.
The 1983 US Orphan Drug Act has facilitated the development of therapies for rare diseases. Orphan drugs are defined by the Orphan Drug Act to be drugs which target rare diseases affecting fewer than 200,000 people in the US. Drugs that have attained the orphan drug designation are eligible for grants to perform clinical trials, a 50% tax credit for clinical testing costs and, most importantly, a 7-year marketing exclusivity for the drug. The orphan drug manufacturers are also eligible for expedited review by the US Food and Drug Administration (FDA) and a fee waiver incentive for New Drug Applications (NDAs). The goal of this TMP was to present an objective comparison of the orphan and non-orphan drug development pathway which leads to regulatory approval. This analysis will provide the necessary information to evaluate rare disease drugs using the adjusted metrics required for the small rare disease patient population and the risk benefit profile for these diseases.
The Pfizer, Inc. team was asked to perform a systematic comparison of the regulatory pathways of orphan and non-orphan drugs and biologics first approved by the FDA from January 1, 2001 to December 31, 2011. To accomplish this objective, the team completed a detailed analysis of clinical trial characteristics extracted from package inserts for newly approved drugs. Ultimately, the Pfizer TMP compiled this information into a white paper which examined a number of clinical trial characteristics including: 1, number of trials performed; 2, largest trial size; 3, total number of patients enrolled; 4, randomization; 5, blinding; and 6, trial endpoint. Results showed that there was a statistically significant difference in a number of trial characteristics. In the therapeutic areas of specialty neuroscience (SNS), pulmonology, hematology, and endocrinology, we observed significant differences in: 1, the number of trials; 2, the largest trial size; and 3, the total number of patients enrolled.
Calorie Café is a new diet company that Prairie Ventures has been incubating. Built upon behavior modification, the Calorie Café diet is a proven weight-loss solution which facilitates weight management even after the program has been completed. With a diet program that is both sustainable and easy to follow, Calorie Café promises to be an improvement over the many diets currently on the market.
The Prairie Ventures TMP team was asked to identify market opportunities for Calorie Café and to develop a go-to-market strategy for bringing the company’s products to market. To accomplish this objective, the team spent the first semester performing an in-depth analysis of the diet industry. This included the analysis of both corporate and consumer markets, as well as related service industries such as food delivery, counseling, and on-line tools. Based on this work, the team identified corporate wellness as the best market opportunity for the new diet program. During the second semester, the team developed a product plan for the Calorie Café diet. To better understand consumer needs, the team performed a month long diet experiment which also served as an in-depth focus group. For the project’s final deliverable, the team developed a business plan that summarized all findings and provided a comprehensive go-to-market strategy for Calorie Café.
Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) is in the midst of Phase I development of a prophylactic for a rare disease called Necrotizing Enterocolitis (NEC). NEC is a devastating gastrointestinal disease which predominately affects prematurely born newborns. In order to demonstrate the value of the company’s therapeutic to the healthcare community, Sigma-Tau would like to investigate the entire lifetime costs associated with this rare disease. In undertaking this analysis, Sigma-Tau hopes to contribute to a more robust economic climate in which to introduce its NEC preventative therapy.
The Sigma-Tau TMP is aimed at developing a unique pharmacoeconomic cost analysis to assess the lifetime economic burden of NEC including direct, indirect and intangible costs associated with this disease and its complications. Given this goal, a “cost of illness” study was identified as an appropriate pharmacoeconomic model to guide the efforts of the project. The team gained an understanding of the clinical process influencing the direct costs of NEC and a subsequent direct cost model was constructed. The team also developed a framework for possible indirect and intangible costs associated with the long-term complications of NEC. To establish the indirect and intangible cost inputs, the team utilized an interactive marketing approach to target individuals affected by NEC, including survivors, caregivers and the families of patients. Interviews were conducted to develop case studies, through which the indirect cost model was created. Through the integration of all direct, indirect and intangible costs, the team has quantified the economic impact of NEC and its complications. These results provide Sigma-Tau and their key stakeholder’s with valuable insights into the costs of this disease and the overwhelming need for a cure.
Tecan Group Ltd. (Tecan) is a global provider of laboratory instruments and life science tools for the biopharmaceutical, forensics, and clinical diagnostics markets. The Tecan TMP Team was charged with profiling all point-of-care devices on the market and identifying product features that influenced market success or failure. Further exploration of certain products and markets of interest was carried out through interviews.
In the second phase of the project, the team was assigned a specific market for which its point of care device was being tailored. Focused on this market, the team was tasked with understanding the needs of its potential end users as well as writing product requirements to guide development activities. The Tecan TMP Team used a survey as well as interviews to accomplish this aim.
In the final phase, the team determined product requirements for an additional market. In this phase, the team yet again conducted both surveys and interviews to understand the needs of the end user. From this research, Tecan will be able to validate its business case and product features in order to accomplish successful product launches.
This year’s Veracyte TMP project was divided into two related portions focused on the diagnosis of Interstitial Lung Diseases (ILD). In the fall semester, the team developed a detailed clinical flow highlighting the role of pulmonologists from the time of initial diagnosis to treatment. The team focused on profiling pulmonologists, understanding their role(s) in the diagnosis and treatment of lung disease patients, and examining what potential improvements and cost savings could come from more accurate cytology diagnosis of ILDs. Interviews with key opinion leaders and a market survey provided the team with valuable data which was used to validate a clinical flow model.
In the second semester, the team performed a detailed analysis of the practice locations, habits, and billing procedures of pulmonologists diagnosing ILDs. The findings were interpreted to support a commercial strategy that will most effectively address the pulmonology disease market. The team also helped Veracyte create an economic model to estimate the value of a potential ILD diagnostic test.