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Snake Pit: Grant Me the Money!

The great advances in science come from innovative thinking, challenging the status quo, and proposing experiments to generate evidence to support or refute those ideas and to solve real world challenges facing our patients. At the ASCPT 2019 Annual Meeting you will have your opportunity to present your ideas for the next big thing in the Snake Pit: Grant Me the Money!

During this special session, 3 teams will present their research proposal to solve an actual real-world problem in front of a group of C-level executives in an effort to convince them that their proposal is viable. Do you have the drive, innovative thinking, and communication skills to survive the Snake Pit?

Here's how you can participate:

  1. Gather a team of scientists: We suggest 3-5 members with diverse skillsets and experiences.
  2. Prepare a grant proposal addressing 1 of the 5 challenges facing our patients today. Your team may choose which challenge you address from the list provided below.
  3. Submit the written grant proposal (maximum of 7 pages in length).
  4. The top 3 proposals will be selected by an independent review committee and those teams will be invited to present their proposal in the Snake Pit at the ASCPT 2019 Annual Meeting.
  5. If selected your team must submit this Conflict of Interest Form.

Key dates

January 2, 2019 Deadline for team sign up
February 7, 2019 Written proposals due
March 7, 2019 Top 3 proposals identified
March 15, 2019 Snake Pit at ASCPT 2019 Annual Meeting

Challenges

Full descriptions of the challenges will be provided to the registered teams.
Develop quantitative safety assessment tools for use in kidney transplant clinical trials 
Innovation in the development of maintenance immunosuppression drug (ISD) regimens for kidney transplant recipients has been stagnant over the last 20 years. The standard of care (SOC) ISD regimen is extremely efficacious at preventing graft loss in the first-year post transplant but is associated with a significant adverse events (AEs) profile. The anticipated rate of serious AEs and AEs, experienced in the context of a kidney transplant clinical trial, can be alarming to a biopharmaceutical industry sponsor, especially those new to the transplant field. This complex safety profile has impacted the willingness of the biopharmaceutical industry to evaluate ISD assets approved in other areas, such as psoriasis, lupus or rheumatoid arthritis, for potential use in kidney transplant. A quantitative development tool which can identify predictors of AEs occurring over the course of clinical trials in kidney transplant recipients exposed to SOC ISD regimens can enable sponsors to optimize the design of clinical trials from the safety perspective, achieve improved outcomes for patients who participate in such trials, and ultimately for patients in the real world.

Understand the continuum of predementia across key neurodegenerative diseases
How can biomarkers and disease models help identify candidate surrogate endpoints for cognitive decline? There is a need to understand commonalities in cognitive decline between specific diseases: Alzheimer disease, Parkinson disease, multiple sclerosis, huntington disease. Identifying datasets from each disease area and creating an interface that Snakeenables the interoperability of datasets to occur across data owners can inform a deeper  understanding of the dynamics of biomarker and clinical outcome assessments and can help design more optimal clinical trials.

Identify improved methods for translation of animal model efficacy data to predict clinical outcome in Tuberculosis
Tuberculosis (TB) remains a global health challenge which requires the development of novel regimens that are highly efficacious and shorter in duration than the 6-month standard of care regimen for drug susceptible pulmonary TB.  Several animal models of pulmonary TB exist and are used to guide regimen design (i.e., components, treatment duration) and prioritization for clinical studies.  However, despite the many animal models, their specific predictive and translational ability has not been systematically quantified, and there is no consensus on how best to extrapolate animal model findings to generate clinical response estimates.  Hence, there is a need to identify preferred approaches that enable the robust translation of animal model-derived efficacy data for established and novel regimens to predict response on clinically-relevant endpoints and therefore inform development decisions.

Develop a quantitative systems pharmacology model to describe micronutrient absorption that can be applied to early childhood stunting
There is a rich body of clinical trials investigating different micronutrient supplements to reduce the prevalence of early childhood stunting in low resource countries, with stunting generally defined as being 2 standard deviations or more below the median height for age and sex as per WHO growth standards.  However, the research approach has been largely empirical, investigating different combinations of micronutrients at different does levels in the absence of a model that would seek to explain how groups of micronutrients might interact with one another at different dose levels.  Understanding these interactions could be particularly important knowing that some key micronutrients compete with one another for absorption in the GI tract.

Develop a model-based individualized dosing tool for Direct Oral Anticoagulants in real world patients
In order to maximize the likelihood of trial success and also to provide information that can inform the product label, Phase III clinical trials will usually restrict patient enrollment based on age, body size, renal and hepatic function, disease severity, and comorbidities. By definition, the phase III clinical trial population sample represents only a fraction of the market population, and understandably cannot accurately capture the diversity of patient characteristics present in a heterogeneous patient population. For narrow therapeutic index drugs, like Direct Oral Anticoagulants (DOACs) where under-dosing or overdosing can result in treatment failure and death, investigating personalized dosing schemes is worthwhile.

Proposal requirements

Teams must submit a research proposal with a maximum of 7 pages. The detailed components of the research proposal are outlined in this document. Briefly, the proposal should outline the specific aims of the research, the significance of the work, innovations in the approach, a detailed scientific approach, a timeline for the work, and an estimated budget. Proposals will be scored based on the quality of the proposal, clarity of the communication, and likelihood for success. 

Team Entry Form

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Changes to team members should be sent to meetings@ascpt.org
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