Contact UsDiana Bartlett
Assistant Vice President,
Phone: (909) 607-9864
Email: diana_bartlett[at symbol]kgi.edu
TMP Presentations 2011
Intellectual property valuation project
The team is charged with developing metrics for valuing the potential range of intellectual property that might emerge from Abbott Nutrition's research & development activities. As part of this, the project should develop a set of strategic decision-making tools (e.g., a checklist of "patent route" or "product route") to enable Abbott Nutrition R&D leaders and business leaders decide whether to invest in an "IP" or "Product" route for a given set of research activities.
The KGI TMP team will need to benchmark other organizations, conduct necessary research, and deliver the outcomes of (a) set of metrics for valuing potential IP, and (b) decision-tools for deciding whether or not to conduct "patentable" research.
Optimizing development capacity
Currently, Allergan's biologics product pipeline is bottlenecked at the development phase of the product lifecycle. The company wishes to consider external development and manufacturing activities to further reduce the bottleneck, and needs a strategy for optimizing development throughput by finding the appropriate balance of internal vs. external sourcing. The optimization strategy would minimally consider the following parameters: time, cost, resources, complexity, location, competency/expertise, communication, intellectual property, regulatory risk, quality and safety.
The TMP team should generate a vetted list of external contract research organizations (CROs) and contract manufacturing organizations (CMOs) that are either currently being used and/or could be used. Additionally, a checklist or other process for evaluation, selection, and management of CROs/CMOs should be created as a recommended strategy for optimizing internal vs. external development activities with supportive capacity, financial, scientific and risk assessments.
Product Life Cycle Management analysis
Beckman Coulter, Inc. (BCI) currently has effective processes to assist in the development and launch of new products. However, once a product is launched, BCI has few formalized processes to sustain the growth and maturity of its products.
This TMP team is responsible for recommending new processes or modifications to existing processes to address growth/maturity product life cycle management (PLM) issues. The goal of the PLM process is to describe an idealized future state of the processes needed to effectively take a product through the life cycle. The process will be cross-functional and incorporate marketing, commercial operations, development, supply chain management, finance, quality, and regulatory.
The team also will be responsible for recommending a Master Plan which will describe the current phase, responsibilities, and goals for each chemistry system.
Cell growth optimization
This is an experimental project designed to optimize cell growth of Protein X. Work will involve numerous bioreactor runs and will require a fully functional and supported cell culture lab, with all analytical devices in good operating condition. KGI will need to send samples to BioMarin for product quality analysis and measurements of product concentrations (titers) under different culture conditions.
Celgene Cellular Therapeutics
Injectable Cellular Therapeutic
This project relates to the design and preparation of an injectable cellular therapeutic.
In the first phase, students will assess the current knowledge on delivery of cellular therapies for different disease indications, and develop criteria for selecting a route of administration (ROA). Students will perform an industry analysis to assess and understand the current delivery devices in the market and determine which delivery device/method and ROA is best suited for Celgene Cellular Therapeutics' (CCT) cellular product.
The second phase evaluates different designs, components, and parameters for injectable formulations. Students will be asked to provide an analysis of the various parameters in questions, and provide a recommendation and rationale for a specific formulation.
In the final phase, students will be asked to implement their recommendations for a sample indication. Frozen cells and reagents will be provided for laboratory experiments aimed at developing an injectable formulation, empirically evaluating the cell viability and stability, and evaluating the distribution and administration potential.
Based on the research and findings, students will provide CCT with recommendations for a delivery device, formulation of cells, and an indication(s).
Development and commercialization of a novel, disposable, integrated cartridge for the rapid detection of organisms associated with Hospital Acquired Infections.
Claremont BioSolutions has received a NIH Phase I Small Business Innovative Research (SBIR) grant to combat the growing problem of hospital acquired infections (HAI), more specifically Clostridium difficile.
The TMP effort will focus on performing research and feasibility testing related to the development of an easy-to-use integrated cartridge which would consist of the novel PureLyseTM technology at its heart. The sample preparation device will interface with a previously developed isothermal nucleic amplification assay so that sample preparation, amplification and detection are fully integrated.
In addition to the research, the TMP will aid in the development of a commercialization plan which will need to be submitted as part of the application process for the Phase 2 SBIR.
Scenario planning for tailored therapeutics
As pharmaceutical companies seek to develop tailored therapeutics, they will need to understand the future practice of personalized medicine and the use of such therapies.
How will health care providers, circa 2015 to 2020, practice personalized medicine? Will it differ by type of provider, by provider type, or by location?
How will pharmaceutical companies successfully commercialize novel, complex tailored therapeutics (with or without a companion diagnostic) given the marketing and sales force that might exist in these future time frames?
The team will create several personalized medicine scenarios in the US for the time periods 2010, 2015, and 2020. These will describe how personalized medicine is today and may in the future be practiced, defining and quantifying assumptions for each. The team should address what will be the key drivers that determine how personalized medicine will be practiced under each scenario.
After selecting one scenario for each future time period, the team should project how a major pharmaceutical company might market a tailored therapeutic in each time period. These scenarios should include the marketing, sales and health care provider educational components of the promotional program for the tailored therapeutic.
Use of near-IR spectroscopy for finished product release testing as an alternate to karl fischer testing for the determination of moisture at Gilead Sciences
The Karl Fischer assay for the measurement of small quantities of water has been in wide use since it was discovered in 1935. For freeze dried parenteral drug products, the test is the standard measurement of success of the drying process, and it forms an integral part of lot release testing of such products.
An alternate technology, utilizing near-infrared (IR) spectroscopy, is increasingly being used to study moisture in freeze dried products because it is much faster than Karl Fischer and because it is non-destructive.
Near-IR quantities for moisture are not determined a priori. A near-IR technology is instead implemented in this setting by 'training' the data analysis of the method with ostensibly real data for real vials of product for which both near-IR and Karl Fischer results are known.
The TMP team is charged with identification, creation, and testing of a complete "training" data set to account for variable moisture levels and, importantly, spatial/structural and other variations in lyocake and vial. They would evaluate precise methods of sample measurement.
The TMP team would also explore, develop, and validate a roadmap of the compendial and regulatory requirements for implementation with the two Gilead commercial products.
The final report would create a pathway for Gilead to use to go-live with this technology for commercial products.
Pathogens and biofilm in the healing process for chronic wounds and surgical reconstruction
The Center for Advanced Research and Technology (ART) of Kinetic Concepts Inc. would like to have a more focused picture of the role of pathogens and biofilm formation in the healing process for chronic wounds and in surgical reconstruction, specifically breast reconstruction, and in abdominal wall repair.
The KGI team will be tasked with conducting a global platform review to identify current and future technology innovations and biosurgical techniques that will impact how at-risk wounds and infected wounds are treated. This landscaping exercise should capture technologies aimed at preventative, management and treatment of microbial pathogens. Additionally the review should highlight antimicrobial technologies that were developed for or can be used in combination with medical devices. Technologies that are or could be directly applicable to medical devices that KCI currently has on the market (i.e. V.A.C.® dressings, tissue matrix products, support surfaces) should also be highlighted.
This information will then be compared to the current and planned product portfolios of the KCI divisions (Advanced Healing Solutions [AHS], Regenerative Medicine [LifeCell] and Therapeutic Support Systems [TSS]), to identify synergies and new product opportunities. These opportunities should be prioritized by a variety of criteria including regulatory considerations, novelty and differentiation, competitor environment, fit with KCI's current strategy, and more.
The output of the project will be a prioritized list of assessed product/service opportunities that KCI can then incorporate into technology development, business development strategy, and other functions.
Simplifying transgenic animal development - market opportunities for new stem cell lines and cloning technologies
Transgenic animals play a key role in helping life science researchers understand diverse biological phenomena. Yet, development of new transgenic animals is an expensive, slow, multi-step process that often yields lines that are not always genetically stable.
New tools, such as embryonic stem cells, coupled with new technologies, like Life Technologies' proprietary cloning platforms, make it possible to envision new transgenic animal platforms.
This project is designed to guide Life Technologies in the development of a multi-year plan to leverage its portfolio of cloning tools and stem cell lines for the development of such animals. The project team will contact key opinion leaders, and conduct primary research through interviews and surveys. The team will identify target market segments, desired products and organisms to develop, and the market potential associated with such segments for such products. It will additionally determine which channels to market might be most effective, including technology access licenses, and will financially model various possible outcomes.
Technology assessment of digital nucleic acid amplification
Quantitative Polymerase Chain Reaction (qPCR) is well established within the scientific community. Digital qPCR, on the other hand, is an emerging alternative that remains a niche technology. The need is to identify the technical characteristics of digital qPCR and other nucleic acid amplification methods that would disrupt conventional qPCR. What would digital qPCR have to look like in order to deliver meet the throughput requirements for various research, discovery, or screening programs with higher quality, at a comparable or lower price, than qPCR? Perhaps most importantly, what market and competitive dynamics would be necessary to move digital qPCR across the innovation adoption chasm to position it as a robust replacement for conventional PCR? Is there a compelling argument for the use of isothermal amplification methods in quantitative digital nucleic acid analytical products?
This Life Technologies TMP will focus on:
- Identify digital qPCR technologies globally and the applications for which they are used;
- Identify digital isothermal amplification methods such as LAMP, MDA, RCA, NASBA, NEAR and EXPAR that have been, or might be incorporated into a digital quantitative system;
- Assess these technologies utilizing criteria to be jointly agreed upon by the team and Life Technologies;
- Prioritize the technologies and their applicability to both existing PCR (Stokes, Biotrove) systems and new opportunities;
- Identify the intellectual property issues for top priority technologies;
- Characterize the competitive strength of the technology owners;
- Characterize the current PCR market and, on the basis of the highest priority technologies, describe how the market would need to change in order for adoption of digital qPCR or a digital isothermal amplification product to prove viable for particular markets.
Market analysis for select compounds
MediciNova has licensed-in eight compounds in many different therapeutic areas. The company's focus remains to develop its two core assets, but is looking for licensing partners to continue the development of its non-core assets.
The TMP team should conduct a thorough market analysis of each non-core asset. This analysis will consist of two phases: (1) ascertain the current value of the program by reviewing competitors, stage of development, NPV of development and potential revenue, etc.; and (2) identify a list of targeted companies to contact for which a partnership makes the most sense.
The KGI team will be asked to use databases and potentially conduct physician/KOL (Key Opinion Leader) interviews to thoroughly complete their market analysis. The final product would be very similar to something management and the board of directors would expect from a large consulting company.
Investigation of global alternative markets for new product
Tecan is developing a new diagnostic device for point of care (PoC) DNA testing. A specific DNA testing market has already been identified for initial launch of the device. However, the company is also interested in exploring additional market opportunities for DNA testing.
The goal of this project is to recommend alternative PoC testing markets in which Tecan could achieve at least a first or second global market leadership position in a time horizon to be defined by the company.
Opportunities in specific molecular diagnostic markets
For 2010-11, Veracyte plans to use a TMP to conduct two distinct projects by academic semester.
Develop a more detailed understanding of diagnostic and prognostic opportunities related to pulmonary nodules suspicious for lung cancer. This will include a granular understanding of current diagnosis and treatment of pulmonary nodules. The team will also explore and identify opportunities for molecular solutions to improve therapeutic treatment of lung cancer patients.
Develop a clinical model for pancreatic cancer looking at possibilities to improve diagnosis by applying molecular cytology solutions. Additionally, this project will look at the potential gains and limitations of partnering to develop a companion diagnostic for a specific cancer treatment requiring patient selection.