ABBOTT NUTRITION

Metabolomics Applied to Human Nutrition
Abbott Nutrition, based in Columbus, Ohio, is a leader in providing innovative and superior nutritional products that advance the quality of life for people of all ages. In the near future, individuals will be able to tailor their diets and health regimens to their genotypes or phenotypes. Such possibilities will be realized through nutrigenomics, the study of how genes and gene expression predetermine an individual's response to foods, and the converse; how nutrients and metabolites affect gene expression. The goal of nutrigenomics is to predict how food components affect health by using epigenetics and system biology tools, such as genomics (DNA), transcriptomics (RNA), proteomics (proteins), and metabolomics (metabolites). This innovative area of research holds promise to change the way nutrition is viewed in human health. However, the potential market impact is poorly defined.

The Abbott Nutrition TMP mission was to assess the market relative to the current state of nutrigenomics-related technologies and identify which disease states offer the greatest business potential for success. For the analysis of various nutrigenomics opportunities, the TMP utilized an evaluation matrix that the team created through conducting secondary and primary research with Abbott Nutrition internal members and key opinion leaders. As the final deliverable, the students facilitated Abbott Nutrition's Innovation Forum, a meeting that involved the company's top marketing and technical leaders. At the meeting, the team recommended a robust strategy to optimize the company's immediate and long term impact on nutrigenomicsrelated technologies.

▲ Top     

BIOMARIN
Global Development of Newborn Screening

BioMarin Pharmaceutical Inc. develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions, focusing on product candidates that address currently unmet medical needs. Currently commercialized products include several treatments for rare diseases, in particular Aldurazyme® for Mucopolysaccharidoses (MPS) I, Naglazyme® for MPS VI and Kuvan® for phenylketonuria (PKU).

The goal of the BioMarin Pharmaceutical Team Masters Project (TMP) is to develop strategies that are knowledge-driven and accepted by Key Opinion Leader (KOL) to implement newborn screening for Mucopolysaccharidoses (MPS) worldwide. Mucopolysaccharidoses which result from genetic deficiencies of one or more lysosomal enzymes, are a group of disorders classified by the inability to fully digest certain complex carbohydrates called glycosaminoglycans (GAG). GAGs accumulate and disrupt the cell functions and give rise to the physical manifestations of the disease. Without intervention, the average life expectancy is 17 years. Patients often have respiratory and cardiac complications, short stature and bone deformities, and may have debilitating motor and cognitive functions. Establishing newborn screening will help facilitate the early identification of patients and early treatment intervention, which may increase life-quality among those diagnosed with these rare diseases.

Our team has researched the various options available for assay design and commercialization, and has mapped the possible methods for expanding newborn screening panels in various priority countries. Our data was collected by attending relevant conferences, establishing discourse with appropriate KOLs and performing exhaustive literature searches. The feasibility and practicability of each strategy proposed were quantified in success matrices in terms of the resources required for full implementation. It is our mission to provide BioMarin with current and forward-looking information that will be valuable now and in the future. To ensure that these strategies remain viable post-TMP, a contact information database consisting of useful KOLs and organizations will be included in our deliverables in addition to a report and presentation delineating all of our references, thought-processes, and recommendations.

▲ Top     

BRISTOL-MYERS SQUIBB
Design of Small-scale, Parallel, Automated Experiments to Optimize Protein Purification
The integration of lab automation technologies with the optimization
of protein purification methodologies is an evolving
area within the field of protein purification. Most approaches
to date use automation for the simple purification of multiple
proteins in a short period of time. However, strategies that
provide the ability to run many experiments in parallel for
more rapid characterization of proteins need to be developed.

The goal of this project was to develop strategies to carry out
small-scale, parallel, automated experiments which enable the
most efficient use of materials and experimental conditions
to define and optimize protein purification processes at larger
scales. The approach uses statistically optimal experimental
design strategies to investigate the binding and elution characteristics
of proteins in a variety of modern chromatography media. The results were transformed into experimental templates that readily integrate with an automated process development workflow under development at Bristol-Myers Squibb (BMS). A secondary objective, a preliminary financial analysis comparing the BMS automated workflow with standard process development workflows, was also achieved. This allowed the team to define overall metrics for the efficient use of automation, which enables the development of future detailed cost-effectiveness models for the implementation of automated systems.
▲ Top     

CLEAR SPRINGS
Desalinization with Evaluation of Integrated Biofuels and Fresh Water Production
Clear Springs is a large land holder and eco-friendly development
company based in Florida between Tampa Bay and Orlando.
It is a wholly owned subsidiary of the investment bank
S.N. Phelps & Co. Clear Springs has sponsored the KGI TMP
to determine an optimal model for building a desalination plant
for a prospective community located in Polk County, Florida.
The model includes evaluations of desalination technology, fresh
water demand projections, cost effectiveness (developmental,
operational), environmental impact, regulatory issues, and sale
of byproducts. The TMP also required secondary research and
development of several scenarios. The team's final recommendation
justifies the economic feasibility of the desalination plant.

Secondary to the desalination plant assessment, the team also
evaluated the option of coproduction of biofuels and freshwater.
Cogeneration is a technique that has been employed in the
desalination industry to share costs between desalination and
energy production. Developing synergistic relationships between
energy resources and a brackish water source may prove a
unique process to benefit the growing planned green community
of Clear Springs.

▲ Top     

GENETECH
Study of Reactive Oxygen Species (ROS) in Biopharmaceutical Preparations and their Reactivity with Proteins
Genentech, founded in 1976 by Robert Swanson and Dr. Herbert Boyer, is considered to be the first biotechnology company. Currently, Genentech is one of the leading biotech companies in the world and possesses a broad portfolio of life-saving medicines along with many more drug candidates in its pipeline. This is Genentech's first Team Masters Project and it is centered on investigating the causes and effects of Reactive Oxygen Species (ROS) in protein therapeutic formulations.

Protein oxidation is a well known cause of structural modification, which in turn leads to a loss of effective potency. Various formulation chemicals and physical conditions contribute to the formation of ROS. Therefore understanding ROS formation and effects in vitro will allow for the formulation of more stable protein pharmaceuticals. This will provide Genentech with a competitive advantage in the manufacture and sale of low cost and high quality protein drugs.

The generation and effects of specific ROS have been extensively studied in vivo, however, there is a critical lack of study into the generation of these ROS from chemicals commonly used in the manufacture of biopharmaceuticals. The Genentech TMP group explored published literature in order to develop various assays that measure four different ROS in formulations. The group standardized and tested each assay's validity on several concentrations of Polysorbate 20 (or Tween 20), a commonly used surfactant in formulations. After the incubation of different preparations of Tween 20 at 5°C, 30°C, and 40°C over one week, the group measured the trend of ROS production at various time intervals. Next, assays and incubation times were adjusted to better capture individual ROS over a one month period. To conclude the TMP, the group arranged and prepared the results for future submission to a peer-reviewed scientific journal.

▲ Top     

GILEAD
Use of RAMAN Spectroscopy for Indentification Testing of Raw Materials and Active Drug Substances
The Gilead team has been working to implement an efficient method of using RAMAN spectrometry to identify raw materials and bulk tablets as they are received at Gilead Sciences. The group has been working on-site at Gilead throughout the spring semester. Using a RAMAN spectrometer from ThermoScientific, along with software such as TQ Analyst and OMNIC, the team has created databases of spectra for each compound/tablet of interest. These spectra are intended to verify the identity of a compound without opening the packaging, with the ultimate
goal of simplifying materials identification as samples are delivered to Gilead's facility in San Dimas.

▲ Top     

KCI
Product to Treat Disfigurement from Cancer Resections of Soft Tissue
Breast conserving therapy leaves lumpectomy patients with limited options for resolving any disfigurement. While thankful for the life-saving treatment, many women are profoundly unhappy with the physical results; this emotional dissatisfaction and can significantly impact their quality of life. Fear of these consequences also influences their treatment choices.

Our goal, therefore, was to develop a new technology that would provide patients with a better reconstruction option following lumpectomy. The project had two parts: the technical development of an implant to restore normal shape, and a market research project to analyze the market potential for such a device.

The goal of the technical project was to devise and investigate the feasibility of a device that could occupy the space to rebuild the breast for better physical appearance. Several biomaterials and methods were researched with some chosen for experimental testing. Testing took place in Dr. Phillip's laboratory at KGI.

For the market analysis project, we established a business case to explain the market need. We analyzed current competitors and alternative procedures, spoke with key opinion leaders and sought perspectives patients. We spoke with physicians to ask about current and future reconstruction options as well as assess their understanding of the degree of dissatisfaction of their patients, and with patients to get an insight into their choices and their experiences in treatment and reconstruction.
This primary research was combined with conventional market analyses to form the basis of our market opportunity analysis.

▲ Top     

KCI
Assessment of Current and Future Peripheral Nerve Regeneration Technologies to Determine the Market Landscape and Possible Entry Strategies
Kinetic Concepts Inc. (KCI) is a global medical device company with leadership positions in advanced wound care and therapeutic surfaces. The company is considering adding peripheral nerve regeneration to its portfolio, but a strong business case needs to be made to move forward to the concept stage. Evaluation of the technology landscape requires a thorough investigation of presently available peripheral regeneration technologies and determination of the direction of future research.

The focus of this TMP was to identify the most promising technologies and their adoption issues based on the market need for better regeneration products. Through a combination of literature review, key opinion leader interviews, and physician surveys, the team looked at the promise of peripheral nerve regeneration as a market opportunity. The results of the
primary and secondary research were combined in the form of a specific business recommendation. This project will help KCI make a strategic decision about how to focus their research efforts for developing this technology further.

▲ Top     

LIFE
Market Potential and Relative Vaue of Select Labeling and Detection Technologies
Life Technologies, is a global biotechnology firm that provides its customers with tools for bioscience research, personalized medicine, regenerative science, molecular diagnostics, agricultural and environmental research, and advanced forensics. With the acquisition of Quantum Dot Corporation in 2005, Life Technologies is now exploring the possibility of using quantum dots (QDs) as reagents in sentinel lymph node mapping (SLNM) procedures.

The overall goal of this TMP is to perform a market assessment of quantum dots for SLNM and formulate a strategy for commercializing the technology. The market assessment consists of determining the current market for SLNM, reviewing the current SLNM procedure and the drivers for pricing, conducting primary research to determine the factors most likely to encourage adoption of the new procedure, and determining the value added by this technology from a clinical standpoint. In addition, the project involves exploring the FDA barriers for launching such a technology.

The final deliverable is a business case for the potential value of incorporating the new technology into the SLNM procedure. In producing this final deliverable, we conducted detailed interviews with surgeons, radiologists, and pathologists currently involved with the SLNM procedure, and distributed a broad quantitative internet survey to a large list of oncology surgeons. In addition, we interacted with hospital administrators for cost and reimbursement data and with Life Technologies staff for general technological and marketing information. We used this data to create a foundation for Life Technologies to use as a
basis for assessing whether to proceed with development of this SLNM technology.

▲ Top     

LIFE
Trends in Life Research Tools
Life Technologies is the result of a merger that occurred in the fall of 2008 between two leading research tool companies; Applied Biosystems and Invitrogen. Life Technologies facilitates scientific exploration by providing researchers with the necessary tools to advance bioscience and technology. Life Technologies' customers do their work across the biological spectrum, from human disease research, to agricultural technology, to forensics. The company has historical annual sales of approximately $3.5 billion, employs 9,500 people, has a presence in more than 100 countries, and possesses a rapidly growing intellectual property estate of over 3,600 patents and exclusive licenses. This TMP, originally started by the Strategy & Business Development Group of Applied Biosystems, was charged with investigating trends in life science research.

The goal of the TMP was to identify trends in life science research and provide Life Technologies with specific information about customer needs related to these trends. The first phase of the TMP focused on trend identification through secondary research and discussions with the Life Technologies Corporate Development team. During the process of trend identification, research areas were segmented into different customer
groups based on research goals, methodologies, and techniques. The team identified trends in four research areas: epigenetic disease biomarkers, ex vivo biomarker discovery systems, rare cell detection and isolation, and synthetic biology applications for microbial consortia research. The final phase of the project focused on primary research via interviews with key opinion leaders in these research areas. These key opinion leaders provided information about specific barriers to progress that the team synthesized into customer requirements that Life Technologies can address in the future.

▲ Top     

SYNGENTA
Automation Design for Single Sample to Instrument Presentation

Syngenta is a world-leading agribusiness committed to sustainable agriculture through innovative research and technology. One of Syngenta's major divisions is the breeding of seeds for sale to farmers. One the tools the company uses to select specific phenotypic traits to advance the various Syngenta seed lines is near infrared spectroscopy. The machine that Syngenta currently uses to perform this spectroscopy must be attended continuously for several hours by a technician to sort a sample of appreciable volume. In order to reduce labor and increase throughput, Syngenta tasked our team with automating the seed sorting process. This involved the development of a mechanical apparatus capable of presenting a single seed from a bulk source to the machine, scanning the seed, and then removing it and placing it in the appropriate bin. The team successfully developed a prototype system accomplishing these goals. Further development will be required for the company to complete sorting of the seeds based on the spectroscopic results.

▲ Top     

VERACYTE
Characterization of a Molecular Diagnostics Opportunity in Europe and Japan
Veracyte, Inc. is an early stage personalized medicine company focused on the transformation of cancer diagnosis and staging through the application of molecular technologies. Veracyte is currently developing their molecular assays for the accurate diagnosis of certain cancers utilizing minimally invasive techniques to obtain cellular samples. Through Veracyte's solution, medical professionals will be provided better and more definitive diagnostic information, which should decrease
healthcare costs.

The objective of this TMP is to assess the viability of Veracyte's solution in the European and Japanese markets. Students investigated the clinical management and the payer models for patient care on a country-specific basis. Clinical and economic models were developed through secondary research of clinical guidelines and studies, and validated by primary research with on-site interviews of key opinion leaders in their specific clinical practices. The models were then used to project the market sizes in the respective countries to aid Veracyte in determining optimum market expansion.

▲ Top