Project Management

ProjMan1

 

HistoGeneX assigns a project manager and a scientific director to your project. Our lead project managers and scientific experts hold Ph.D. or M.D. degrees and carry deep research and clinical experience, both in the industry and the patient-serving sectors.

The project manager and scientific director work in tandem to ensure that your project stays on task, on target and on time. We clearly define points of contact and communication and we embrace regular and concise exchanges on your projects. The project manager will be your designated point of contact and this individual will ensure you have access to the relevant HistoGeneX resource.

Our project managers will initiate the project, facilitate interim progress reports, ensure data compliance with relevant regulations, and coordinate all day-to-day aspects to ensure study success.

Our scientific directors are available to confer over technical issues and provide consult and data interpretation.

Our project managers and scientific directors are committed to anticipating and resolving emerging issues with your project.

Collectively, HistoGeneX executives have participated in, or led the development and global commercialization of each oncology PMA-class companion diagnostics device in oncology. Embedded in this unique accumulation of experience are the industry's manufacturing, development and service perspectives, which will provide valuable insight to your development programs. We have defined operating, quality and project management processes that can anticipate and resolve emerging issues. 

  • Over a dozen PMA-class CDx trials
  • Leadership team that has been involved in, and in some cases, led PMA-class projects such as HercepTest(TM), EGFR pharmDx, KRAS real-time PCR, BRAF real-time PCR, ALK FISH and EGFR real-time PCR.
  • Facility and personnel that are experienced with FDA, EMA and other companion diagnostics class regulatory audits
  • Quality management process that is flexible yet uncompromising
  • Successful collaboration and familiarity with IHC, real-time PCR and FISH platforms
  • Participated at pre-IDE and FDA CDRH events

 

Development & Validation

We support your companion diagnostic objectives from the therapeutic asset’s earliest phases. In addition to our comprehensive set of development and validation services, we offer a companion diagnostic class package which offers additional documentation and project management features. With your development and validation programs, you can select the platform of choice (we offer multiple choices) and the entire assay can be developed using reagents, software and protocols that are a single system. This approach enables a straightforward transfer to the final diagnostics manufacturer.

HistoGeneX has established relationships with diagnostic manufacturing partners that will allow you select technology platforms and address distribution reach. These relationships pre-define development and work transfer responsibilities which will facilitate the development process.

HistoGeneX can develop de novo assays or collaborate on method transfers. For de novo assays, HistoGeneX has selected reliable IHC antibody or DNA probe manufacturers who can generate primary reagents that can then be screened and validated at HistoGeneX laboratories. 

Drug Trials

Our laboratory has extensive experience using companion diagnostic candidate assays in global registration trials. We collaborate with your appointed diagnostic manufacturer and CRO (if one is involved). Our team’s direct experience with diagnostic manufacturers and global CROs provides a platform for effective operations. We are familiar with the necessary training process, associated documentation, equipment transfer and sequestering, pathology scoring workshops, site audits and the many steps required to qualify as a laboratory for such trials. HistoGeneX has an excellent record of managing specimens expertly and maintaining required test turnaround times.

Diagnostic Device Trials

We routinely support diagnostic device clinical trials initiated by a diagnostic manufacturer. Our leadership has worked with each diagnostic manufacturer in a global setting and have developed strong and efficient collaboration models to optimize a successful clinical trial. In this setting, we support investigational and exploratory projects (e.g. definition of controls, expert pathologist survey of tumor types for the diagnostic target), function as a clinical site, operate as a training site or serve as an early launch site. For a detailed description of our services in this area, please contact us for a presentation overview.