Patient-Centered, Global Biotechnology


Hematogenix is a global biotechnology company providing reference laboratory services and answers for tomorrow’s medicine. Through our quality laboratory testing and data analysis, we help physician’s save lives.

We are fortunate to provide customized services from basic research and discovery to the movement of your therapeutic into the clinical setting. Together, we are at the forefront of precision medicine and ready to help you accelerate your cancer research and drug development efforts. We are an active part of many care teams for many patients fighting the brave battle of cancer. We understand the pathology of cancer, and we understand the clients we serve, and we know how to bridge that gap with our Pharma services to the patient’s bedside. We are strategically positioned to assist with novel drug launches, new drug indications and the validation of companion diagnostics.

Experience

The challenges in drug development require experience. Our personnel has a minimum of 10 years’ experience in both research and clinical applications. The following positions below will work closely with you and your team during the project or clinical trial.

Project Managment


Our project managers are highly skilled team members that employ best practices from past experiences. Our Project Managers manage a project from conception to completion, assembling teams, assigning tasks and determining target completion dates for the project’s different stages. We know it is your goal to make sure the drug or product you are taking to market is both safe and effective. Our project managers keep your need front and center through effective communications about each step of our collaborative project. Our seasoned project managers have direct experience with US and global clinical trials. The Project Manager will serve as a critical resource and your primary point of contact and is also responsible for handling the queries from clinical sites, CROs and third-party laboratories. The Project Manager will understand the management of tissue, development of molecular assays and the logistics of drug development. Our team members will monitor timelines, respect deadlines and proactively communicate emerging challenges. Our project managers have direct experience with US and global clinical trials. The Project Manager will serve as your point of contact and is also responsible for handling the queries from clinical sites, CROs and third-party laboratories. Our Study Directors have extensive experience with the development of morphological and molecular assays. This individual has addressed challenging parameters stemming from pre-analytical conditions through complex image analysis-based algorithms. Our Study Director’s understanding of multiple automated technologies and digital platforms are incorporated into the Scope of Work creation for each project. Both the Study Director and Project Manager will participate in interim updates and final summary presentations. Hematogenix board-certified pathologists are full-time employees. A Principal Pathologist and a backup pathologist will be assigned to your project. A Research Pathologist may also act as a consultant through the project. The Principal Pathologist will provide the reads for your project. Both the Principal Pathologist and the backup pathologist will be trained on the interpretation needs of the project. As required, these pathologists are available for consult and can participate in the interim updates and final presentations. Hematogenix Scientific Team is well published in biomarker research and will accommodate requests to support and contribute to manuscripts and conference presentations.

  • Project managers are allocated to studies based on their experiences, such as prior experience with a sponsor, study design and expertise in the methodologies utilized.
  • Methodology experts including support from Team Leads & Supervisors.
  • Sponsor liaisons.
  • Lead & back up Managers and Study Coordinators
  • Project managers coordinate all departments involved in study set-up, implementation, execution, and close-out activities,ensuring timeline deliverables.
  • Global studies will have project managers at each laboratory, as well as back-up project managers, to ensure timely response to queries and deliverables.
  • For early phase or validation projects, project managers organize milestone update (decision focused) meetings between the scientists and the sponsor team.
  • For later phase clinical trials, they lead scheduled operational calls between the laboratory and the sponsor team.
  • A strong foundation of scientific experts supports project managers
  • Supported by a Foundation of Scientific Experts response to queries and deliverables.
  • For early phase or validation projects, project managers organize milestone update (decision focused) meetings between the scientists and the sponsor team.
  • For later phase clinical trials, they lead scheduled operational calls between the laboratory and the sponsor team.
  • A strong foundation of scientific experts supports project managers
  • Supported by a Foundation of Scientific Experts

Discovery and Early Development


Hematogenix manages the full development of assays, from sourcing or generation of reagents, right through to verification and validation. The Hematogenix team brings over 30+ years of experience in assay development and market knowledge.

Full Development Capabilities

Hematogenix has broad capability across the full spectrum of platforms including both solid tissue and

hematologic disorders.

  • High sensitivity flow cytometry
  • IHC
  • RT PCR Sequencing
  • FISH/CISH
  • mRNA ISH

IMMUNOHISTOCHEMISTRY (IHC)
Hematogenix offers IHC automated instrumentation on platforms that are widely used. Multiple instruments are available to eliminate interruptions to patient recruitment that are being selected by your IHC assay.

FLUORESCENCE IN SITU HYBRIDIZATION (FISH)
Hematogenix offers FISH testing for solid tumor and hematology specimens. Automated slide preparation is available. We enjoy discussing custom probe design for novel targets.

MRNA IN SITU HYBRIDIZATION
mRNA ISH is an alternative to quantitative PCR, with the benefits of morphological detail and standard brightfield microscopy assessment. Hundreds of probes are commercially available, and Hematogenix can create custom probes for new targets or splice variants.

PCR
Hematogenix offers the industry-leading platforms and can validate kit-based mutation assays (BRAF, EGFR). We will work with you to design a validation plan that probes the required limits of assay sensitivity for a specific project or application.

IMAGE ANALYSIS
Hematogenix uses digital pathology and image analysis technologies extensively. Our suite of digital tools enables us to develop objective and reproducible IHC assays for your project and conduct Web conferences with access to biomarker images.

FLOW CYTOMETRY
Our flow cytometry platforms are routinely used to phenotype blood cells for the diagnosis of blood disorders. Consult with us to employ these platforms for biomarker detection for your research and clinical trial needs. Our technicians are experts at various applications including rare event detection.

CYTOGENETICS
Our team utilizes fluorescent in situ hybridization (FISH) and other molecular methodologies to rapidly identify targeted chromosomes with suspected abnormalities in interphase cells as well as in metaphases. Our highly trained technical team employs a state-of-the-art high-speed scanner system and networked workstations to provide you valuable images and analyses.

EARLY PHASE ASSAY DEVELOPMENT
Hematogenix offers a comprehensive set of assay development services addressing low to high complexity conditions on various platforms.

Development activity is performed according to GCP guidelines.

LATE PHASE DEVICE TRIAL
We provide a complete infrastructure to support conducting of a companion diagnostic device clinical trial.

  • Appointment of a Hematogenix device process trained principal investigator
  • On-site validated electronic document control process
  • Customizable electronic portals for specific data transfer according to client requirements
  • GCP-compliant logistics for specimen collection, study manuals and accessioning
  • Digital pathology conferencing platform to coordinate training between client pathologists and Hematogenix
    pathologists
  • Defined and customizable processes for reproducibility and proficiency testing
  • Audit prepared laboratory
  • Personnel trained and experienced in companion diagnostics devices clinical trials and adherence to Instructions
    for Use (IFUs)

POST APPROVAL & COMMERCIALIZATION SUPPORT

  • Contact us for customized support in the following areas.
  • Training of commercialization teams in the diagnostics and pathology related to the companion diagnostic
  • Hematogenix pathologist to pathologist consultation for implementation and workflow of the companion diagnostic
  • Training and confirmatory laboratory testing for reference and hospital laboratories

Custom Assays


Biomarker & Assay Development

The value of biomarkers in drug development programs is indisputable. The added interest by the FDA and insurance companies in biomarkers has placed further emphasis on the discovery, development, and use of biomarkers in drug development programs and ultimately, for matching patients with optimal therapeutics. Hematogenix Pharma Services excels at validation of biomarkers in a post-discovery setting when assays need to be transformed for translational and clinical stage deployment. Our biomarker programs are technology agnostic. The scientific experts in our organization and the processes we have developed enable us to assess and integrate novel technologies into our biomarker solutions rapidly. We rigorously maintain current know-how on validating technologies by consulting with academic groups, our network of pathologists and our extensive rapport with drug development teams globally. Hematogenix biomarker assay development services especially excel when you require a rapid turnaround with potential complexity. Our flexible infrastructure, deep assay development experience and emphasis on project communication allow us to respond decisively. At Hematogenix, we understand that assay development is the dynamic integration of core technologies with disciplined validation processes.

TECHNOLOGY
Our instrumentation and equipment are compliant with 21 CFR Part 11 requirements. Technologists are trained on GCP requirements.

OUR PROCESS
Our assay development and validation processes are the results of years of experience working with pharmaceutical partners. Hematogenix assay development and validation are comprised of discrete processes that allow for flexibility of assay design. Available options can span the full spectrum from specificity through reproducibility and analyte stability assessment, or a more limited scope that may include assay optimization and reproducibility. The former situation could be custom development of a reagent, and the latter could reflect a situation where the sponsor has specificity data on a reagent but requires additional optimization to ensure robust performance. Reagent, sample and operator information are recorded in worksheets that are associated with your specific project for ease in project review and sponsor audits.Hematogenix welcomes audits from our sponsors. We request advance notice to ensure the availability of relevant personnel.

PEOPLE
Assay development projects at Hematogenix will be managed by a Project Manager, a Study Director and supported by our board-certified Pathologists and our experienced Scientific Team. It is the goal of this team to provide comprehensive support to develop the assay you require.

Companion Diagnostics


We Understand. We execute. We Deliver.

Hematogenix works conjunction with our Pharma sponsors and IVD companies to streamline development to speed up the timely launch of your FDA-approved complimentary or companion diagnostic.

The selection of relevant patients as candidates for targeted therapies is an indispensable component for drug development in the oncology market. The Hematogenix leadership team has directly led or engaged in the development and subsequent regulatory approval of the industry’s prominent oncology companion diagnostics tests. The perspectives provided by the team come from years of experience in the diagnostic and contract manufacturing sectors. The Hematogenix team provides unique scientific development, regulatory, reimbursement, and market adoption insights and is well-positioned to anticipate and mitigate the challenges of companion diagnostics development and commercialization.

Hematogenix also serves as a test site supporting PMA clinical trials for companion diagnostics devices and is also able to commercialize both pilot and regulatory companion diagnostic tests through its reference laboratory arm.

Contact us for case study testimonials for companion diagnostics such as HercepTest™, RT PCR test for BRAF mutation and the development of a FISH gene amplification assay that is currently being used for patient inclusion in several global oncology trials.

Hematogenix offers the following Companion Diagnostics services to support the pharmaceutical company or the diagnostic manufacturer.

Clinical Trials Management


We believe that using the appropriate, timely planning will result in a higher quality experience for our clients. Our internal best practices as they relate to clinical trial management support all aspects of your early clinical trials cost-effectively with clear roles and responsibilities.

It takes more than a group of highly skilled scientists to monitor clinical trials, and it makes people who care. At Hematogenix, our caring team travels to you when they need to be on-site with you. Our experience with multiple studies and our experience the demands of our diagnostics clients, enable us to have a broad understanding of regulations and Good Clinical Practices.

CLINICAL TRIALS
Hematogenix offers a comprehensive array of services designed to navigate the complexities of human subject clinical trials. Our in-depth research and clinical laboratory experience enable us to resolve emerging challenges found in clinical trials. Hematogenix provides logistic management of tissue and sample procurement, distributes collection kits and contributes to standards and procedures required for initiating a clinical trial. Powered by a state-of-the-art laboratory information system, Hematogenix facilities and practices comply with a rigorous chain of custody and specimen management practices. We are a CAP, CLIA, and GCP compliant laboratory.

AUDITS
Hematogenix welcomes the opportunity to interact with your teams to customize and improve its quality processes and services. Contact our Director of Quality to schedule an audit.

PROJECT SETUP
The specimen gathering and testing requirements will be consolidated into a Scope of Work document. The Hematogenix Project Manager and System Administrator will translate these parameters into a project-specific database and validate it.

PROJECT MANAGERS
Our project managers have direct experience with US and global clinical trials. The Project Manager will serve as your point of contact and is also responsible for handling the queries from clinical sites, CROs and third-party laboratories.

SPECIMEN COLLECTION KITS
Hematogenix can receive collection kits from CROs or provide collection kits for fresh and archival material. Hematogenix can deliver collection kits to sites, monitor expiration dates and send replacement kits. Specimen collection kit inventory and its components are tracked remotely and automatically through Hematogenix LIMS.

CHAIN OF CUSTODY
Upon arrival at Hematogenix, all specimens will be tracked through our state of the art LIMs. The location of samples, whether in storage or mid-process, is available in real time. Hematogenix technicians scan specimens are utilizing barcoding stations at designated laboratory and storage areas.

REAL-TIME STATUS UPDATES
Sponsor project managers can query Hematogenix LIMs for project specific information such as the number of specimens received and testing status through a password protected and secure encrypted site. Hematogenix System Administrator can assign access rights per the instruction of sponsor project manager.

SPECIMEN STORAGE & MANAGEMENT (GET AN UPDATED IMAGE FOR THIS TOPIC)
The Hematogenix LIMs provides real-time chain of custody for your specimens. Specimen storage areas are humidity and temperature-controlled with three tiers of security access and video surveillance. The Hematogenix tissue bank and specimen storage areas meet ISBER standards.

Data Transfer & Security


We understand data. Technology is making precision medicine a reality. We partner with you to deliver accurate, actionable clinical trial data utilizing the latest security measures available from the moment your information is received, to the time your results are reported.

DATA TRANSFERS
Biomarker and testing data can be transferred through standardized electronic data protocols. Hematogenix System Administrator will configure data portals per sponsor specification and format.

DIGITAL IMAGE CAPTURE & RETRIEVAL
For security and convenience, Hematogenix captures and archives high-resolution images of specimens. These images are accessible via password protected and secure access and can be assembled for web conferences.

GDPR – NEED INFORMATION FROM BRIDGETTE

Training & Support


Our training is customized and built into each project from the beginning. Your team will receive end to end documents that explain our process so that you 3

**If you would like more details I would reach out to Renee so she can give you information from the operations standpoint and Bridgette from the QA standpoint.

USA
Hematogenix Laboratory Services

8150 W 185th St. Suite A, Tinley Park, IL 60487
Toll Free: +1 888.436.2861
Telephone: +1 708.444.0444
Fax: +1 708-444-0445

UK
Hematogenix Laboratory Services

BioHub, Mereside, Alderley Park
SK10 4TG, UK
Telephone: +44 1625 238817
Fax: +44 1625 238818
ClientServices@Hematogenix.com