We can help you build your discovery organization to enable the seamless flow from one work stream to another. We know how to build in efficiencies and safeguards so that the discovery of your leads and their progression to the next stage gate happens without causing chaos within your teams.

Everything from concept to IND submission. Targets, discovery platforms, humanizations, multi-specific formatting, Fc engineering for effector functions and half-life modulation. Hit identification to lead optimization. Translation from POC to IND documentation.

Thorough practical understanding of the latest technologies and their applications in cell therapies and gene therapies, including delivery technologies. The latest technology platforms and which ones to use in your discovery program. Platform enabling and therapeutics.

Guidance and planning for the production of therapeutic proteins and cell therapy products (autologous and allogeneic including in-depth knowledge of iPSC platforms). Input on protein production methods, media development, and methods for monitoring product quality. Expertise in Tech Transfer from screening scale through manufacturing.

Design and planning of appropriate assays to support programs from early discovery through preclinical for any therapeutic area.

Communication with CROs to design and schedule preclinical studies, and study monitoring and report review. Site audits of CROs in preparation for GLP studies.

Review of and recommendations for nonclinical pharmacology and safety assays and studies. Recommendations on the placement of assays and studies within our network of trusted CROS.

Assistance in writing and review of regulatory documentation as it pertains to nonclinical modules in IND filing, including technical reports, study concept sheets, IND modules, and investigator brochures.