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Team Masters Project Presentations
The Team Masters Project (TMP) is the capstone activity
for students in the Master of Bioscience (MBS) and the
Postdoctoral Professional Master of Bioscience Management
(PPM) degree programs at KGI. In accordance with KGI’s
mission of translating the potential of the life sciences into
practice, the TMP offers a rigorous and experiential learning
opportunity which immerses students in the type of work
many will pursue after graduation. TMPs are supported
by interdisciplinary teams made up of three to six students
who work with sponsoring companies to address real world
company objectives.
Replacing the traditional Master’s thesis work found in
standard programs, these projects provide students with the
opportunity to apply their marketing, business, financial
and science training to state-of-the-art corporate challenges.
Importantly, our teams are advised by both KGI faculty
and expert industrial liaisons to assure that academic rigor
is paired with pragmatic focus. Our typical TMP Team is
composed of MBS, PPM, and senior undergraduate students
from The Claremont Colleges (Harvey Mudd, Claremont
McKenna and Scripps) resulting in a rich and diverse set of
skills, backgrounds and expertise.
TMP activities emphasize problem-solving, project
management, new business opportunity, productive
teamwork, and effective communications skills that will be
critically important to KGI graduates as they pursue careers in
the bioscience industries. Representing about 35 percent of a
student’s final year of academic work, these contract research
projects are designed to produce valuable deliverables for the
sponsoring companies.
2011 – 2012
Team Masters Projects
May 2, 2012
Program
7:00-8:00 a.m.
Continental Breakfast
Building 517 – Founders Room
8:00 a.m.
Introductions
◆ Sheldon Schuster, President
◆ Craig Adams, Director TMP Program
8:20 a.m.
Group Sessions
TMP – Group A
Bldg. 517, 137 Lecture Hall
TMP – Group B
Bldg. 535, 152 Classroom
8:30-9:00 a.m. PfizerKCI
9:00-9:30 a.m. Sigma-TauBroadley-James
9:30-10:00 a.m. Medco Abbott Medical Optics
10:00-10:15 a.m. BREAKBREAK
10:15-10:45 a.m. Clear Springs Gilead
10:45-11:15 a.m. AllerganVeracycte
11:15-11:45 a.m. Prairie Ventures BioMarin
11:45-12:45 p.m. LUNCH – Founders Room
12:45-1:30 p.m. Combined Corporate Liaisons’ Meeting
Building 517 – Room 147
◆ Diana Bartlett, Assistant VP, Corporate Partnerships
◆ Craig Adams, Director TMP Program
TMP – Group C
Bldg. 517, 137 Lecture Hall
1:30-2:00 p.m. City of Hope
2:00-2:30 p.m. Life Technologies
2:30-3:00 p.m. Amylin
3:00-3:30 p.m. Eli Lilly
3:30-3:45 p.m. BREAK
3:45-4:15 p.m. Monsanto
4:15- 4:45 p.m. Tecan
4:45- 5:15 p.m. AVI BioPharma
Project Summaries
Remote Control Device Prototyping
Sponsor Company
Corporate Liaisons:
Tim Hunter
Brian Eastman
Faculty Advisor:
Anna Hickerson
Students: Gloria Lin, Josh Miller, John Weaver,
Joy Wong
Abbott Medical Optics Inc. (AMO) is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver
optimal vision and lifestyle experiences to patients
of all ages. AMO does this by providing a Complete
Refractive Solution to address vision disorders at all
stages of life. They offer market-leading technologies
for myopia, hyperopia, astigmatism, contact lens care
and corneal health, as well as proven educational and
support programs that help eye care professionals master refractive technologies and grow their practices.
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.
Project Summaries
Performance Testing and Economic Feasibility
of Disposable Fermentation Technology for
Microbial Systems
Sponsor Company
Corporate Liaisons:
Jennifer Ton
Tom Kawata
Faculty Advisor:
Tina Etcheverry
Students: Sean Delfosse, Ying Lu, Wendy Milling,
Andy Nguyen, Thuy Truong, Rudy Tsay
Allergan, Inc. is a global multi-specialty health care
company focused on discovering, developing, and
commercializing innovative pharmaceuticals, biologics, and medical devices. Founded over 60 years ago in
1948 and headquartered in Irvine, Allergan’s portfolio
includes ophthalmic pharmaceuticals, neurological
therapeutics, and cosmetic products.
Allergan 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.
Defining the Genetic Diagnostic Space
for Lipodystrophy
Sponsor Company
Corporate Liaison:
Ted Slocomb
Faculty Advisor:
Larry Grill
Students: Kevin Baker, Jessica Cummings,
Aabha Khemani, Alex Lee
Amylin Pharmaceuticals is a world leader in providing
therapies for diabetes, obesity, and related metabolic
disorders. Founded in 1987 and based in San Diego,
Amylin currently has three drugs on the market.
Symlin® is a drug for patients with Type 1 and Type
2 diabetes while Byetta® is indicated to treat Type 2
diabetes. The recently approved drug Bydureon® is
also indicated for the treatment of Type 2 diabetes, and
has the novel advantage of only requiring once a week
dosing.
Amylin 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.
Project Summaries
Development of a Rare Genetic Disease Database
for Drug Pipeline
Sponsor Company
Corporate Liaison:
Brian Leppert
Faculty Advisor:
Animesh Ray
Students: Onofre Bacani, Milan Dalal, Robert
Davies, Ramya Kartikeyan, Risha Patel, Brent Wilson
AVI BioPharma is a Seattle-based biotechnology company focused on developing RNA-based therapeutics
against rare genetic diseases and certain viruses. With
their versatile RNA technology, AVI BioPharma has successfully been able to direct alternative splicing of certain
pre-mRNAs and inhibit translation of target mRNAs,
to eliminate or limit the extent of the disease phenotype.
This technology, known as Phosphorodiamidate Morpholino Oligomers (PMOs), can be used to create Splice
Switching Oligomers (SSO®s) and Translation Suppressing Oligomers (TSO®s), which regulate target genes at
the transcriptional and translational levels, respectively.
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.
Offering:
Master of Bioscience
Postdoctoral Professional Masters
Postbaccalaureate Premedical Certificate
PhD Programs
PharmD*
www.kgi.edu
*Through Chapman-KGI School of BioPharmacy, admitting its inaugural class in fall of 2014.
Project Summaries
Preliminary Design and Feasibility Study for a
Pilot Plant Facility
Sponsor Company
Corporate Liaison:
Kurt Yanagimachi
Faculty Advisor:
David Vetterlein
Students: Karthik Chandran, Marcus DeMaster,
Stephen Hsu, Jean Yeo, Jeffrey Welch
BioMarin Pharmaceutical Inc. is a leading innovator of
biopharmaceuticals for the treatment of rare diseases.
Since 1997, BioMarin has launched four products:
Naglazyme®, Aldurazyme®, Kuvan®, and Firdapse®.
These products treat mucopolysaccharidosis VI (MPS
VI), mucopolysaccharidosis I (MPS I), phenylketonuria (PKU) and Lambert Eaten Myasthenic Syndrome,
respectively. With commercial operations in over forty
countries and a robust clinical pipeline, BioMarin is a
key player in the orphan genetic disease market, providing fast access to treatments for patients with historically
unmet medical needs.
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.
Evaluating Market Opportunities and
Recommending a New Product
Sponsor Company
Corporate Liaisons:
Robert Garrahy
Bill Reynolds
Faculty Advisor:
Gail Baura
Students: Mukunda Krishna, Darin Shirakata,
Andrew Urazaki, Andrew Vo, Ari Wes
Broadley-James is a leading manufacturer of sensors,
bioreactors and automation systems for the bioprocessing industry. Established in 1967 by Leighton Broadley,
Marcile Broadley, and Richard James, Broadley-James
has become a trusted provider of high-end solutions
to bioprocessing and fermentation customers. The
company’s flagship product, the BioNet® system is a
highly regarded, full-featured industrial automation
system that can be configured to user needs. It has a
versatile controller that can manage up to 10 utility
towers, and in turn network and control entire suites of
bioreactors. Broadley-James works with customers to
continuously improve their product offerings with the
customer’s process needs in mind.
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.
Project Summaries
Commercialization Path for LR-90 and Treatment of
Diabetic Complications
Sponsor Company
Corporate Liaisons:
James Figarola
Matthew Grunseth
Samuel Rahbar
Faculty Advisor:
Craig Adams
Students: Matthew Avila, Thomas K. Bane,
James Y. Hasegawa, Janice Lee, Kyle Mak
The City of Hope is an independent research and
biomedical institution dedicated to the treatment and
prevention of cancer and life-threatening diseases.
With the support of humanitarian philanthropies and
collaborations worldwide, the City of Hope researches
innovative drugs and technologies to treat diseases such
as cancer and diabetes. In support of these efforts, the
City of Hope has become a recognized pioneer in bone
marrow transplantation. As a founding member of the
National Comprehensive Cancer Network, the City of
Hope has stayed true to their mission of healing the
whole person, nurturing the spiritual and social, as well
as physical well-being of those under its care.
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.
Investigation of Algal Biofuel Technologies and
Economic Analysis of their Derivative Products
Sponsor Company
Corporate Liaison:
Fred Boling
Faculty Advisor:
Joel West
Students: Pratyusha Ghoshal, Richard Head,
Paola Hernandez, Lauren Shaib
Clear Springs owns 18,000 acres of land in Bartow,
Florida. The company plans to expand its eco-friendly
community by venturing into new business opportunities
involving renewable energy. One option considered by
Clear Springs is algae cultivation for producing biofuels.
To support this option, Clear Springs is in the process
of evaluating an algal biofuel production technology
developed by one of its potential partners. Though
technologically feasible, Clear Springs is interested in an
economic analysis of the derived products to assess the
profitability of this potential investment.
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.
Project Summaries
Pharmaceutical R&D Transformation
through Innovation
Sponsor Company
Corporate Liaisons:
Jaime Dananberg
Carlos Garner
Faculty Advisor:
Joel West
Students: Cijian Feng, Selena Gunggavakin,
Ryan McComb, Durgalaxmi Ramachandhiramani
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.
Team Masters Projects range from highly technical to business-oriented.
KGI offers its students experiential learning opportunities that prepare
them to translate their education into practice in industry. Past project
categories have included:
• Therapeutic and diagnostic market opportunity evaluation
• Product launch model and go-to-market strategy development
• Pharmacoeconomic and cost-effectiveness analysis
• Bioprocessing technical feasibility assessment
• Medical device prototyping, including VOC input
Project Summaries
Competitive Analysis of Primary Packaging for
Therapeutic Antibodies
Sponsor Company
Corporate Liaison:
Scott Sellers
Faculty Advisor:
Vince Anicetti
Students: Andrew Jerome, Stephanie Sakamoto,
Jennifer Lee, Melissa Sathavipat, Eric Houghton
Since 1987, Gilead Sciences has worked to discover,
develop, and commercialize medications in order to
advance the care of patients suffering from life-threatening diseases in areas of unmet medical need. In just
over 20 years, Gilead has become a leading biopharmaceutical company with a portfolio of 14 marketed
products, a growing pipeline of investigational drugs
and approximately 4,500 employees in offices across
four continents. Gilead Science’s primary areas of focus
include HIV/AIDS, liver disease, and serious cardiovascular, metabolic, and respiratory conditions.
One of Gilead’s 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.
Assessment of Potential New Product Opportunities
in the Orthobiologics Market
Sponsor Company
Corporate Liaisons:
Michael Manwaring
Braden Leung
Eric Tan
Faculty Advisor:
Yvonne Klaue
Students: Daniel Burke, Eric Hsu, Gauri Jaju,
Hoang-Lan Tran, and Stephanie Wong
Kinetic Concepts, Inc. (KCI) is a medical technology
company focused on the development, manufacturing and marketing of innovative products for wound
healing, tissue regeneration, and therapeutic support
systems. Founded in 1976 and headquartered in San
Antonio, Texas, it initially focused on motion-based
therapy systems and has since become a global leader
in the wound healing and regenerative medicine
markets with the introduction of its negative pressure
wound healing platform and tissue matrix technologies.
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.
Project Summaries
In Search of In Vitro ADME/T Tools to Better Predict
In Vivo Outcomes
Sponsor Company
Corporate Liaisons:
Rodney Turner
Vicki Singer
Faculty Advisor:
Molly Schmid
Students: Shalini Chandrasekaran, Mohammad
Daremipouran, Sanjay Kumar, Sudhir Singh,
David Winternheimer
Life Technologies Corporation is a global biotechnology
company dedicated to improving the human condition.
Life Technologies’ industry-leading brands are found in
nearly every life science laboratory around the world and
include innovative instrument systems under the Applied
Biosystems® and Ion Torrent brands, as well as a broad
range of reagents under Invitrogen®, GIBCO®, Ambion®, Molecular Probes® and TaqMan® brands. Life
Technologies’ customers work across the biological spectrum in the fields of discovery and translational research,
molecular medicine, stem cell therapies, and many other
applications.
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.
Assessment of Incorporating Whole Genome
Sequencing into Future Program Offerings
Sponsor Company
Corporate Liaison:
Lon Castle
Faculty Advisor:
Luann Bangsund
Students: Ujval Kondragunta, Daniel Lee, Michael
Leibfried, Amrit Sareen, Laura Wilson, Jeff Young
Medco Health Solutions, Inc. is an American pharmacy
benefit manager (PBM) that provides pharmacy and
other healthcare services for private and public employers, health plans, labor unions, government agencies
and individuals served by Medicare Part D. Founded
in 1983, Medco covers approximately 65 million lives
and uses its expertise to provide mail order pharmacy
benefits, clinical services supporting appropriate
medication use, and evidence-based interventions to
improve the quality of healthcare. As a pharmacy,
Medco processes prescriptions and uses its size to
negotiate with drug manufacturers and pharmacies to
reduce the overall cost of medications for its clients and
their members.
Medco 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.
Project Summaries
Development of Laboratory-Based Methods
for Non-Destructive, High-Throughput Tissue
Microsampling
Sponsor Company
Corporate Liaisons:
Brad White
Edward Cargill
Faculty Advisor:
Jim Sterling
Students: Adam Brown, Stephen Kim, Erik King,
Brianna Posadas, Susan Tan, Ayyappa Vemulkar
The Monsanto Company is a leading global provider
of technology-based tools and agricultural products
which improve farm productivity and food quality.
Monsanto is dedicated to agriculture with products in
three key areas: agricultural and vegetable seeds, plant
biotechnology traits, and crop protection chemicals.
Through agricultural innovation, Monsanto is committed to meeting the world’s growing food needs,
conserving natural resources, and protecting the environment.
Monsanto 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.
“Anytime you get students who are learning, they ask questions and
draw unique conclusions. They raise ideas and bring up points you
may not have thought of otherwise. They're in a different paradigm,
than people who are in the company and heading down a certain path
just because that path was decided on.”
–Bonnie Anderson, CEO and co-founder, Veracyte, Inc.
“KGI makes the process easy, even the contracting, and its students
are coming from a different perspective, developing creative new ideas
we haven't thought of before.”
–Tom Lester, BioMarin
Project Summaries
Comparison of Key Elements of Drug Development
in Orphan vs. Non-Orphan Drugs in
Specialty Medicine
Sponsor Company
Corporate Liaisons:
May Orfali
Cara Cassino
Jack Mardekian
Faculty Advisor:
Tim Cote
Students: Victor Bhattacharjee, Patrick Harkins,
Supriya Kadam, Candice Lo, Manukiran Ravi,
Dipika Tuteja Shringarpure
Pfizer, Inc. is a research-based, global biopharmaceutical
company with a diversified portfolio spanning from human to animal biologics, small molecule entities, vaccines,
and nutritional products. The company has demonstrated
a long-standing commitment to rare disease drug development through its ongoing leadership in the orphan space,
resulting in 17 approved orphan drugs in the US market.
Pfizer is interested in expanding its focus in this area by
adopting innovative drug development strategies, public
health policies and patient-focused treatment designs.
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 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.
Developing a Market Strategy for a New Company
in the Diet Industry
Sponsor Company
Corporate Liaisons:
Rod Markin
Betsy Berentson
Faculty Advisor:
Diana Bartlett
Students: Elizabeth Harvey, Erik King,
Katie Redman, Jarred Yacob
Prairie Ventures is a private holding firm based in
Omaha, Nebraska. Its portfolio includes a wide range
of emerging technologies and companies in various
business sectors, but with a focus on the healthcare
industry. Prairie Ventures is dedicated to helping early
stage companies with high market potential navigate
the difficult process of establishing a business.
Calorie Café is a new diet company that Prairie
Ventures has been incubating. Built upon behavior
modification, the Calorie Café diet is a proven weightloss 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 Cafe.
Project Summaries
Lifetime Impact and Comprehensive Cost Analysis of
Necrotizing Enterocolitis (NEC) and its Complications
Sponsor Company
Corporate Liaisons:
Warren Holmes
Rebecca Moore
Brian Schreiber
Faculty Advisor:
Ian Phillips
Students: Lauren Breslin, Abimbola Onikoro,
Laurett Rivera, Hrishikesh Thakur
Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) is a
research-based, privately held pharmaceutical company
focused on the manufacturing and commercialization of novel medicines for patients with rare diseases.
Sigma-Tau Pharmaceuticals was founded in 1957 by an
entrepreneurial research chemist Claudio Cavazza, PhD.
Intent on becoming an international player, Sigma-Tau
began its US operations in 1980 by setting up a subsidiary located in Gaithersburg, Maryland. In 1984,
Sigma-Tau became the fourth company in the world to
obtain an Orphan Drug Designation in the US, signaling the company’s arrival as a major player in the rare
disease market.
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.
Point of Care Market Research for
Product Development
Sponsor Company
Corporate Liaisons:
Marc Feiglin
Tony Mamone
Faculty Advisors:
David Margolese
Jay Chok
Students: Susan Alfs, Abhishek Chandiramani,
Mimi Nguyen, Clare Xu
Tecan Group Ltd. (Tecan) is a global provider of
laboratory instruments and life science tools for the
biopharmaceutical, forensics, and clinical diagnostics
markets. Tecan produces and distributes advanced
automation and detection solutions, with two-thirds of
sales attributed to original equipment and the remaining supplied as OEM (Original Equipment Manufacturer) products.
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.
Project Summaries
New Product Launch and Market Opportunities
Sponsor Company
Corporate Liaison:
Brooke LeVasseur
Faculty Advisor:
Steve Casper
Students: Adefemi Adenuga, Megan Hill,
Swaroop Mallegari, Chitra Narayan
Veracyte is a private molecular diagnostics company
active in the emerging field of molecular cytology. The
company is developing molecular tests designed to
improve the diagnostic accuracy of cytology samples,
thereby helping to increase the utility of minimally
invasive procedures. In late 2010, Veracyte launched
the Afirma™ Thyroid FNA Analysis for thyroid nodule
assessment. Veracyte has sponsored 4 TMPs to date.
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.
Keck Graduate Institute
would like to thank all our
sponsors for their generous
support of the Team
Masters Project.
For more information
about TMPs contact
Diana Bartlett Assistant Vice President,
Corporate Partnerships
at [email protected]
Abbott Medical Optics
Abbott Nutrition
Allecure
Allergan
American Commercialization Institute
Amgen
Amylin
Applied Biosystems
Arterial Light Sciences
AVI Biopharma
Beckman Coulter
Biocatalytics
BioHelix
BioMarin
Bristol Myers-Squibb
Broadley-James
Ceres
Children’s Hospital of Los Angeles
City of Hope
Clear Springs Land Company
Dow Agrosciences
Eidogen
Eli Lilly and Company
Equigene Research
Genomatica
Genentech
Gilead Sciences
Health IQ
Illumina
Invitrogen
Ionian Technologies
Kinetic Concepts
KGI/Sun Micro Systems
Legendary Medical Information Systems
Life Technologies
Lnx Research
Medco
Monsanto
Nanostream
Navigant Biotechnologies
Northrup Grumman
Ortho Clinical Diagnostics
PBS Biotech
Pfizer
Pioneer Hi-Bred International
Prairie Ventures
Sigma-Tau
Syngenta Seeds
Tecan
Theravance
UVP
Veracyte
Waters
Zuyder
Mission
Keck Graduate Institute is
dedicated to education and
research aimed at translating into
practice, for the benefit of society,
the power and potential of the
life sciences.
Culture
KGI seeks to sustain an
interdisciplinary and entrepreneurial
culture, working in partnership with
industry to develop leaders for the
biosciences, while promoting
academic freedom and the highest
ethical standards.
Core Values
• Entrepreneurial and Reflective
• Ethical and Responsible
• Collaborative and Independent
• Interdisciplinary and Applied
535 Watson Dr.
Claremont, CA 91711
www.kgi.edu