Contact UsDiana Bartlett
Assistant Vice President,
Phone: (909) 607-9864
Email: diana_bartlett[at symbol]kgi.edu
With the fall semester hurtling toward its inevitable conclusion, the 14 TMP teams were focused on satisfying both KGI curricular requirements (status presentations, written reports, TMP work week 2011 plans) and sponsor objectives.
Regarding the latter, projects may call for everything from final market characterizations to preliminary analysis of lab results.
In the case of first-time sponsor Celgene Cellular Therapeutics (CCT), the fall semester work focused on generation of a market landscape of stem cell therapeutics. A significant portion of this landscape was a decision rubric consisting of eleven variables. This rubric was created in order for the team and CCT to quantitatively assess which indication is most valuable for the company to pursue for its cellular therapeutics.
This spring, the team will complete a companion technology landscape of stem cell optimization.
Claremont BioSolutions was spun from KGI in 2006, with a mission of simplifying DNA extraction. Much of the fall semester effort for this first-time TMP sponsor involved training for and designing experiments to test limits of detection.
For the next phase of the project, the team will proceed to additional laboratory work to optimize and develop a protocol for a subsequent feasibility test. 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.
The Eli Lilly team has been charged with developing scenarios for personalized medicine over the next few decades. Personalized medicine is known by many names (for instance, "targeted therapeutics" and "predictive medicine") and, not surprisingly, has many definitions.
Thus, one of the team's first orders of business was to add specificity to the original project scope so that a viable project plan could be created.
It is not unusual for projects-those quite conceptual (such as the Lilly effort) as well as those quite tactical (such as many experimental ones)-to go through several weeks of project scope re-scoping. "We want students to learn and we want them to deliver value to sponsoring entities," explained TMP Director Craig Adams. "Thus, preliminary project scopes need to allow enough flexibility for students to test boundaries, but enough specificity so projects can be feasibly completed during the academic year. Because of this, considerable scope refinement is done early in the project life cycle."
The Lilly team successfully condensed this large scope into a concise definition. From this starting point, the students prepared a white paper of the baseline condition, identifying key stakeholders, forecast information flow and health economics implications. This paper, in turn, will enable the team to prepare commercially-oriented scenarios for this first-time sponsor between now and May 2011.
With its sponsor, Gilead Sciences, operating from a large manufacturing and distribution center in San Dimas CA, the Gilead Sciences' team is one of only two whose customer is within ten miles of the KGI campus. (The other is Claremont BioSolutions, in Upland CA.)
This project involves the investigation of near infrared (NIR) moisture analysis compared to the current "gold standard," Karl Fischer (KF). Over time, the team will look at requirements to develop and validate this technology for use with finished product.
From September through early December, the team tested over 1,200 samples (600 each for NIR and KF) during the pharmaceutical production process. From this data, they hope to construct the calibration model and assess its predictive ability.
MediciNova is a first-time TMP sponsor for 2010-11. The company approached KGI for assistance in identifying strategies for six in-licensed compounds that were no longer on MediciNova's internal development list.
Team strategy was to develop a methodology for evaluating the technical, financial, competitive, and other elements of the first compound. After refining the method, the team then determined to apply it to the other five compounds.