CRISPR Services & Case Studies
Comprehensive Services for Analytical Research Projects
Examples of Larger Projects We Have Tackled:
FDA regulatory filings and responses
for academic groups or companies filing INDs, responding to Clinical Holds or other responses and/or prepping for regulatory meetings.
Gene Editing Specificity, Off-Target Analysis and research plans
for academic groups and companies in preclinical development, derisking therapeutic development and wanting to speed progress to commercialization.
Bioinformatics and statistical review
Pipeline development or review of existing therapeutic pipelines and analysis plans. Examples include bioinformatics for off-target site nomination and NGS sequencing design and analysis.
Preclinical and Regulatory Safety Analysis
Developed preclinical assays for several key projects with plan for optimization, validation, and tech transfer to CMO. Guided data analysis, LOD determination, and risk mitigation. Advised on document preparation and strategy.
Research Plans
for companies hoping to secure investment. Enabled producing convincing data set, removing questions and allowing progression to funding round.
Reviewed business plans and assets
to identify high value opportunities for a company adding therapeutics to its current offerings.
Red Team Analysis
of regulatory failings to identify areas to address. Also advised on lexicon, submission strategy, assays, and release criteria.
Due Diligence
analysis for teams of investors. Analyzed individual data sets or full corporate data packages. Advised on patent portfolios. Instructed investors on missing data or controls required for thorough analysis. Advised on preclinical assays for several key projects with plan for optimization and tech transfer to CMO. Guided data analysis, LOD determination, and assay validation.
Competitive Analysis and Corporate Intelligence
of different gene editing technologies and companies.
Start-Up and New Company Development
Advised on research strategy as part of extended business plan. Identified possible BD and funding strategies, including grant opportunities.
Examples of Smaller Projects We Have Tackled:
Conference Reports
presented meeting highlights from recent conferences, analyzing the data presented and what was not revealed in the key presentations.
Data Analysis
of NGS and gene editing on- and off-target analysis.
Clinical Trial Data
analyzed data provided on advancing clinical trials to provide insights and what was not revealed in the key presentations.
Preclinical and Regulatory Safety Analysis
Developed preclinical assays for several key projects with plan for optimization, validation, and tech transfer to CMO. Guided data analysis, LOD determination, and risk mitigation. Advised on document preparation and strategy.
Research Plan
for a company hoping to secure investment. Enabled producing convincing data allowing progression to funding round.
Reviewed business plans and assets
to identify high value opportunities for a company adding therapeutics to its current offerings.
Red Team Analysis
of regulatory failings to identify areas to address. Also advised on lexicon, submission strategy, assays, and release criteria.
Due Diligence
analysis for teams of investors. Analyzed individual data sets or full corporate data packages. Advised on patent portfolios. Instructed investors on missing data or controls required for thorough analysis. Advised on preclinical.
Examples of Larger Projects We Have Tackled
Gene Editing Specificity and Off-Target and Research Plan for companies preparing for therapeutic development.
Preclinical and Regulatory Safety Analysis. Developed preclinical assays for several key projects with a plan for optimization, validation, and tech transfer to CMO. Guided data analysis, LOD determination, and risk mitigation. Advised on document preparation and strategy.
Research Plan for a company hoping to secure investment. Enabled producing convincing data, allowing progression to the funding round. Reviewed business plans and assets to identify high-value opportunities for a company adding therapeutics to its current offerings. Red Team Analysis of regulatory failings to identify areas to address. Also advised on the lexicon, submission strategy, assays, and release criteria.
Due Diligence analysis for teams of investors. Analyzed individual data sets or full corporate data packages. Advised on patent portfolios. Instructed investors on missing data or controls required for thorough analysis. Advised on preclinical assays for several key projects with a plan for optimization and tech transfer to CMO. Guided data analysis, LOD determination, and assay validation.
Competitive Analysis and Corporate Intelligence of different gene editing technologies and companies.
Start-Up and New Company Development. Advised on research strategy as part of extended business plan. Identified possible BD and funding strategies, including grant opportunities.
Examples of Smaller Projects We Have Tackled
Conference Reports: Presented meeting highlights from recent conferences, analyzing the data presented and what was not revealed in the key presentations. Data Analysis of NGS and gene editing on- and off-target analysis.
Clinical Trial Data: Analyzed data provided on advancing clinical trials to provide insights and what was not revealed in the key presentations.