Success Stories in Discovery Labs

 

Z-Sectioning Living Biological Specimens

Utilizing Human Genome Information

Optimizing Microarray Platforms and Chips to improve accuracy and lower cost

Microarray Data to Assist Selection of Compounds at the Early Screening Stage

Increasing productivity with ELN in Pharmaceutical R&D

Patent Portfolio Enhancement: A New Cell Testing Platform – Imaging Flow Cytometer

Patent Portfolio Enhancement: Gene Expression & Micro-fluidics Technologies


 
 

  1. Z-Sectioning Living Biological Specimens

 

Problem Confocal Microscopy had the potential to optically section and observe living biological samples, but laser illumination disturbed the physiology and destroyed the living biological sample.
Solution Coalesce gathered the input of multiple premier life science groups to develop the specifications of a confocal microscope that could work for both living and fixed tissue. A newly formed organization with video imaging technology, Noran, devoted their engineering team to the project and within one year had found and developed a highly workable solution. The new confocal microscope technology was able to see into living biological materials without perturbation of the physiology or destroying the specimens. Top microscopy groups immediately added this new confocal product to their inventory of confocal microscopes.
Result About 30% of new confocal purchases were for systems that could observe both living and fixed tissue. It offers a very important tool for the study of living systems. More recently, multiphoton excitation imaging uses similar principles to look even deeper into living tissue without alternating its normal functioning.

 

  1. Utilizing Human Genome Information

 

Problem Newly developed human genome information sometimes contained the Pharma organization’s genes of interest and sometime it did not. Also there were issues of security, the optimum ways to query such information and other critical questions. New and better ways of taking advantage of the wealth of information were desired.
Solution Coalesce worked with both Pharma organizations and genomic data providers to communicate and resolve issues and questions regarding the optimum ways they could work together. Also, Coalesce worked with Pharma organizations and genomic data providers to develop gateways and program definitions and to create powerful interfaces that Pharma organizations could use to better query their data, examine alternatives and choose the best solutions.
Result Successful interface protocols were facilitated between Pharma organizations and genomic data providers. Many new electronic portal gateways were developed and implemented to support rapid and successful querying of the human genomic data for discovery of new therapeutics.

 

  1. Optimizing Microarray Platforms and Chips to improve accuracy and lower cost.

 

Problem New Microarray Platforms were developed and offered amazing capabilities, but there were issues regarding the best platforms to use and the design of the chips themselves, especially regarding acceptable false negatives and false positives, footprint, number of features, security and other issues.
Solution Coalesce gathered the input of multiple premier life science groups to develop the specifications of the optimum microarray platforms and the optimum chips they needed to do their work. Coalesce then worked with Microarray platform and chip providers to develop and provide the most useful platforms and chips to the research organizations and for Pharma discovery.
Result Microarray platforms proliferated and were widely adopted. Initial costs were high, but gradually decreased to more acceptable levels. Far better chips were made with better accuracy and specificity and at lower costs. Chips were eventually designed with millions of features, ensuring greater coverage and better security and these custom designed chips could be made delivered in a matter of weeks and at low cost.

 

  1. Microarray Data to Assist Selection of Compounds at the Early Screening Stage

 

Problem Microarray Data provides a great resource at the discovery stage to identify new pathways and targets and to begin the initial target validation. However, its potential to screen active compound hits early in the screening process was mostly unrealized in industry. Therefore huge amounts of dollars often were spent on developing compounds that were ultimately found to be damaging in animal studies. Early microarray studies on promising compounds could eliminate many that would be later found to be unfit.
Solution Coalesce invited industrial BioPharma groups and government regulators to a well attended, intense and very beneficial set of talks about the success biopharma organizations were having in utilizing microarrays early in the screening process. This included discarding hits that showed any perturbation in the microarray profile, to selectively choosing compounds based on their microarray characteristics. FDA spoke to the issue of when and how they viewed microarray support as being beneficial. The conference was supported by ACS.
Result The sharing by the BioPharma organizations as to their success and failures in implementing microarray data upstream led to a more uniform understanding of how best to use microarray data in the selection of compounds to take downstream, saving millions and millions of potentially wasted development costs.

 

  1. Creating the optimum polymorph/crystal type for optimum solubility/stability

 

Problem The testing process for finding the optimum polymorph was painfully slow, extremely costly and often missed the optimum crystal type.
Solution Coalesce partnered pharmaceutical companies with a technology provider that had developed a new massively parallel testing platform that enabled Pharma/Biotech organizations to cut the time necessary to find the optimum polymorph and salt composition from months to 1-2 weeks, and cutting the material required to generate hundreds of crystallization experiments and thousands of data points down to as little as 0.5-2.0 grams of API.
Result $50 Million Dollars (USD) in Materials Savings, untold benefits in reaching market faster.

 

  1. Patent Portfolio Enhancement: A New Cell Testing Platform – Imaging Flow Cytometer

 

Problem A start-up company, Amnis, had new technology in search of applications needed by the intersecting communities of Flow Cytometry and Live Cell Imaging.
Solutions Coalesce Conducted Research, and the Interviews Uncovered the following Requirements Needed for Amnis to Produce an Ideal Instrument:

– “We would like to see more localization of drugs and sub-cellular disruption. We like multi-parameter analysis that uses less number of cells […] we also want to analyze a small population of cells within a large population and to distinguish small changes within that population […] I also want more sensitivity and quantification of multi-parameter, multicolor fluorescence.” – Abbott Laboratories

– “Would love to quantify the infected cells and the process of infection, but this might be too weak a complex” – CDC-Center for Infectious Diseases

– Since diagnostic assays will have to be FDA approved, it is advisable that blood based assays be tested against known assays – One of Coalesce’s Recommendations
Results Client Actions:
1) Developed several new patent families including:

– Multi-parameter analysis
– Increased sensitivity

2) Successful technology development / New applications for unmet needs

3) Accelerated adoption into the new markets

 

 

  1. Patent Portfolio Enhancement: Gene Expression & Micro-fluidics Technologies

 

Problems 1) Gene Expression & Micro-fluidics Technologies – Poor Sales at Nanogen
2) Needed to Determine Reasons for Lack of Market Demand of Current Products
3) Desire to Introduce “Probe” Products in Each Area to Develop New Preferred Embodiments
Solutions Coalesce Research
1) Gene Expression Technology

– Exposed Market Issues with Current Configurations: Assay Sensitivity, Samples Size Requirements, Workflow Issues, and Pricing

– Developed New Product Specifications to Resolve Issues

2) Micro-fluidics Technology

– Focused on Understanding Applications Required by Previously Unidentified Potential Markets
Results Client Advanced its Patent Families to Solve the Coalesce Identified Market Issues:

– Gene Expression Technology : Created New Preferred Embodiments Leading to Several Patents & Increased Sales

– Micro-fluidics Technology: Discovered New Applications in Assay Development & Screening which Led to Several Patents & Increased Sales