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FAQ

Frequently Asked Questions

How can I work with you?
To set-up a project please review our Services page and submit the Project Request Form for one of our models that would be most appropriate for your study (i.e. primary cells, co-culture, cell lines). Once we receive the Project Request Form, we will set-up a call to discuss the details of your project. We will then provide a budget and timelines based on the study parameters.

How do I place an order for your services?
Step 1: Submit one of the Project Request Forms (primary cells, co-culture, cell lines)
Step 2: Set-up a meeting/call to discuss project specifications
Step 3: Review project budget
Step 4: Submit a purchase order
Step 5: Receive project deliverables

Do you also sell products? How can I bring zPREDICTA models to our lab?
Please see the Tech Integration page for detailed information on how to bring our technology to your lab.

I don’t see the system I need. Can I request a custom model?
Absolutely. We love to work on new models and welcome such requests. All custom models are developed by a dedicated team of scientists with expertise in a specific disease or site of interest.

I would like to build a custom model. How do I proceed?
Please reach out to us with your model specifications. We will set-up a call to discuss your requirements and model specifications. If necessary, we will put a non-disclosure agreement (NDA) in place to protect any sensitive information. We will then provide you timelines and a budget for the development of your custom model. As a general guideline, a custom model will take 6-9 months to develop and validate with primary cells. You will work with a team of scientists and will receive regular progress reports for each development milestone.

What do project deliverables look like?
For every project you will receive a report summarizing the key findings of the study. Additional deliverables are usually project specific and can include data tables, images, frozen cell pellets, and culture supernatants.

What is 3D culture?
3D culture is a method of culturing cells that promotes formation of 3-dimensional (3D) cellular structures (spheroids, networks, tubules, etc.). 3D culture format is preferable to the standard 2D culture, where cells are grown in a monolayer on the surface of cell culture plastic, because it provides a more physiological milieu.

How does zPREDICTA’s technology differ from other 3D culture platforms?
zPREDICTA’s technology is based on 1:1 reconstruction of human tissues comprising of our proprietary organ-specific extracellular matrix (ECM) formulations and disease-specific medium supplements. Our ECM formulations are assembled from natural components. We do not use synthetic hydrogels or plant material; all our matrices have >90% identity with human ECM.

Our models do not simply force cells to clump into 3D structures, they provide a physiologically-relevant milieu where cell-cell and cell-ECM interactions mirror the native architecture of human tissues.

What is zPREDICTA’s organ-specific ECM?
Each of our organ-specific extracellular matrices is a mixture of ECM components (collagens, laminins, fibronectin, hyaluronic acid, etc.) formulated to mimic the ECM of each human tissue. Once mixed with cells and placed in a well of a cell culture plate it polymerizes to form a semi-solid environment where cells form 3D structures and establish cell-cell and cell-ECM interactions consistent with the architecture of the native tissue.

What is the difference between various zPREDICTA platforms (i.e. r-Bone vs r-Lung)?
Each of zPREDICTA’s model systems is designed to mimic the organ and the disease of interest. For example, our r-Bone system for multiple myeloma is composed of the bone marrow-specific ECM and multiple myeloma-specific medium supplements. The ECM provides the scaffold mimicking the endosteum and central marrow and the medium supplements provide the multiple myeloma cytokine environment. The same general principle applies to all our model systems.

Are the cells mixed with the ECM or do they grow on top of it?
Both are possible. However, mixing cells with the ECM establishes a more physiologically relevant system. Prior to adding cells, the ECM is a viscous liquid, which polymerizes at room temperature allowing the cells to be suspended within the ECM layer. Growth medium with disease-specific supplements is then overlaid on top of the cell/ECM layer. Over time, cells proliferate and migrate throughout the ECM layer forming 3D structures (i.e. spheroids, tubes, networks).

ls the ECM integrity maintained in presence of proteases produced by the tumor cells?
ECM stays polymerized throughout the course of the culture. However, it’s stiffness is model dependent and can become looser when culturing highly aggressive migratory cells.

What is the thickness of your cultures?
The average thickness of the ECM in our models is 800?m-1mm and can be modulated depending on the study goals.

Do therapeutic agents penetrate zPREDICTA’s ECM after it has polymerized?
Yes. We have tested small molecules, antibodies, antibody-drug conjugates (ADC), and cellular therapies, such as CAR-Ts, and in all cases we observe targeted elimination of tumor cells at all depths within the culture.

How long can you maintain primary cells in culture?
Our systems are validated maintain viability for at least 21 days. However, most models can support primary cells for >30 days.

What type of therapeutic agents can be tested in reconstructed organ?
Any type of therapeutic agent can be used in reconstructed organ: small molecules, antibodies, antibody-drug conjugates, biologic agents, cell therapeutics (i.e. CAR-T cells).

Why do you wait 3-5 days prior adding treatment to your culture systems?
We do not add therapeutic compounds to our model systems immediately post set-up to avoid artificially skewing the results due to cellular stress and non-physiological cell organization. Culturing cells for 3-5 days gives them a chance to acclimate to the system and to form physiologically relevant cell-cell and cell-ECM interactions that drive the environmentally-mediated drug resistance (EMDR). Setting-up proper tissue architecture is crucial for the accurate prediction of drug response.

What should be the sample viability to obtain successful growth in the culture?
>70%

What is r-Bone?
Reconstructed Bone (r-Bone) is a 3D cell culture model system designed to reconstruct the bone marrow tissue for long-term culture of primary bone marrow cells. The first component of the r-Bone model is the ECM that provides the semi-solid scaffold reconstructing two distinct niches within the human bone: (1) the the endosteum, an interphase between the solid bone and the bone marrow, and (2) the central marrow. The second component is the medium supplement formulated to mimic the disease-specific circulatory environment.

What indications have you tested in r-Bone?
The r-Bone system has been tested with primary bone marrow cells from patients with AML, multiple myeloma, MGUS, plasma cell leukemia, amyloidosis, as well as non-malignant bone marrow from healthy donors.

Can you culture both fresh and cryopreserved bone marrow samples in r-Bone?
Yes, both fresh and viably cryopreserved bone marrow samples can be cultured in r-Bone. Fresh samples are first ran through a Ficoll gradient to isolate bone marrow mononuclear cells (BMMCs), which are then mixed with the r-Bone ECM and plated. Cryopreserved BMMCs are directly mixed with the r-Bone ECM without additional processing. For successful cultures, the cells must retain >70% viability after thaw.

Does r-Bone support both hematopoietic and stromal compartments of the bone marrow?
Yes. Lymphoid, myeloid, and stromal populations present in the patient sample prior to culture are present after 21 days of culturing in r-Bone.

Do malignant plasma cells from the BMMCs of multiple myeloma patients expand in r-Bone?
Yes. The primary malignant multiple myeloma plasma cells proliferate in r-Bone. The extent of the expansion is patient dependent, we routinely observe 2-10-fold expansion of the malignant clone.

Can I follow proliferating cells in r-Bone?
Yes, BMMCs can be labeled with CFSE prior to plating in the r-Bone ECM. Proliferation can then be observed by microscopy, flow cytometry, or fluorescence measurement on a plate reader.

How long can you maintain primary cells in culture?
We can maintain primary cells in our models for up to 35 days (maximum duration tested).

Do you enrich for multiple myeloma plasma cells before culturing in r-Bone?
No. To retain the heterogeneity of the ex vivo samples, we culture the mononuclear cells obtained from the bone marrow aspirates through Ficoll gradient.

Have you testing standard of care drugs against multiple myeloma in r-Bone?
Yes. Some of the drugs that have been tested in the r-Bone include: bortezomib, carfilzomib, lenalidomide, pomalidomide, daratumumab, dexamethasone and various combinations, such as RVD and CPD.

What readout is compatible with zPREDICTA’s technology?
Our technology is compatible with any standard readout techniques, including but not limited to, flow cytometry, microscopy, plate reader-based cell assays (CellTiter Glo, MTS, etc.), nucleic acid analysis (RNAseq, qPCR, arrays, etc.), proteomics, and in vivo studies.

Cells can be isolated from the organ-specific ECM using our proprietary non-enzymatic isolation solution that is compatible with flow cytometry and any other readout strategies that require intact surface receptors. Moreover, cells remain viable after isolation and can be subsequently used in both in vitro and in vivo studies.

What is the detection limit in zPREDICTA models?
The dynamic range of CellTiter Glo assay in zPREDICTA models is 10-80,000 cells per well in a 96-well plate.

Is it possible to image through the culture?
Yes, in-matrix imaging is possible. zPREDICTA systems have been tested with brightfield, fluorescence, confocal, and high content imaging methods.

What is the cell viability and yield post isolation?
We routinely obtain cells with >70% viability post isolation from untreated cultures. The yield is model dependent since different numbers of cells are plated per well depending on the tissue being reconstructed. For example, in rBone the yield from a single well of a 96-well plate is approximately 100,000 cells, but from r-Lung, it is ~20,000 as the plating densities and proliferation properties of the cells differ significantly between these models.

Do you get enough material for gene expression analysis?
Yes. The number of wells required to obtain enough material will depend on the model type and cell plating density.

Lawrence J. DeLucas, Ph.D

SVP, OPERATIONS,
Predictive Oncology
President, Soluble Biotech
At Predictive Oncology

Dr. DeLucas is the Vice president of Operations for Predictive Oncology and President and co-founder of Soluble Biotech, Inc. DeLucas is currently working to complete development of GMP facilities at Soluble Biotech and at TumorGenesis. In addition, he oversees Soluble Biotech’s solubility and stability contracts for numerous pharmaceutical/biotech companies.

Before Predictive Oncology

From 1981-2016 Dr. DeLucas was a faculty member at the University of Alabama at Birmingham (UAB) where he served as a Professor in the School of Optometry, Senior Scientist and Director of the Comprehensive Cancer Center X-ray Shared Facility, and Director of the Center for Structural Biology. Dr. DeLucas received five degrees from UAB culminating in a Doctor of Optometry degree and a Ph.D. degree in Biochemistry. He also received honorary Doctor of Science degrees from The Ohio State University, Ferris State University, the State University of New York (SUNY), and the Illinois College of Optometry. He has published 164 peer-reviewed research articles in various scientific journals, co-authored and edited several books on protein crystal growth and membrane proteins and is a co-inventor on 43 patents involving protein crystal growth, novel biotechnologies and structure-based drug design. DeLucas was a payload specialist NASA astronaut and member of the 7-person crew of Space Shuttle Columbia for Mission “STS-50”, called the United States Microgravity Laboratory-1 (USML-1) Spacelab mission. Columbia launched on June 25, 1992, returning on July 9.  In 1994 and 1995, Dr. DeLucas served as the Chief Scientist for the International Space Station at NASA Headquarters in Washington, D.C. In 1999, Dr. DeLucas was recognized as one of the scientists who could shape the 21st century in an article published by “The Sunday Times” of London titled “The Brains Behind the 21st Century.”  In 2004, he was recognized as a Top Ten Finalist for the Entrepreneur of the Year award from the Birmingham Business Journal. 

“ Soluble Biotech is continually demonstrating to pharmaceutical and biotech companies the significant value of its novel HSC technology for optimizing protein therapeutic formulations to treat a variety of chronic and infectious diseases. ”

Education
  • Five degrees from Univ. of Alabama at Birmingham (UAB): B.S. Chemistry, M.S. Chemistry, B.S. Physiological Optics, O.D. Optometry, Ph.D Biochemistry

  • Published 164 peer-reviewed research articles in various scientific journals

  • 1993-2016: Director of the UAB Comprehensive Cancer Center X-ray Shared Facility, and Director of the Center for Structural Biology

  • NASA Astronaut, flew on Columbia Space Shuttle

  • 1994-1995: Appointed Chief Scientist for the International Space Station at NASA HQ
  • Arlette Uihlein, MD, FCAP, FASCP

    Dr. Arlette Uihlein is Senior Vice President of Regulatory Affairs and Quality for Predictive Oncology and Site Leader of Helomics, serving as the Vice President of Operations, Pathology Services and Medical Director of Helomics® Clinical and Research Labs since 2011. Dr. Uihlein is Board Certified in Anatomic and Clinical Pathology, Cytopathology and Family Medicine. Dr. Uihlein completed her Pathology Residency at Allegheny General Hospital, where she served as Chief Resident in Pathology and completed Fellowships in Cytopathology and Surgical Pathology. During that time, she conducted extensive clinical research involving molecular pathology diagnostic and predictive markers, imaging of solid tumors, and novel applications of cellular tumor markers. While serving as Medical Director at Helomics, a CLIA and New York State certified lab, Dr. Uihlein has published research in molecular assay development, lab automation, and tissue and cell processing. She is a Designated Civil Surgeon for the U.S. Dept. of Justice and a certified Medical Review Officer for the Department of Transportation. She is a Fellow of the College of American Pathologists and the American Society of Clinical Pathology, NYSDOH Certificate Qualified, and a member of ASCO.

    “ At Helomics we’re delivering better-informed decision making saving pharma time and money, while providing cancer patients with appropriate therapies.”

     

     

    Education

    Medical College of Ohio
    Doctor of Medicine

    Baldwin-Wallace University
    BS, Biology

    Richard Gabriel, BS, MBA

    SVP, RESEARCH & DEVELOPMENT
    Predictive Oncology
    Site Leader, TumorGenesis
    At Predictive Oncology
    My role at Predictive Oncology is to bring the business sense to managing Research and Development programs at all our companies. To seek new ways and opportunities to commercialize exciting new technologies that we have built, licensed, acquired, or are developing through our own research and development. The success of any company is to get the research off the bench and to the customers. That is what I do at POAI and help the other companies as well.
    Before Predictive Oncology
    Prior to starting his first company in 1984 and registering with the FDA a pilot plant facility to make pharmaceutical actives, Mr. Gabriel managed a $50 million product line for W.R. Grace, developed new marketing and sales strategies for Ventron a Division of Morton Thiokol, research work at Ashland Chemical for pressure sensitive adhesives and plant scale-up. Since then, he ran a genetics company, built three GMP/Research facilities, and helped 5 drugs reach their markets in AIDS and cancer. Real expertise in cGMP process scale-up and compliance. Completely understand the needs of an API manufacturing facility and build processes that are scalable, environmentally acceptable, and safe. 3 FDA inspections with no 483’s, ISO certification, DEA registration, DoD compliance, NCI contractor and inventor. Has also broad-based experience in start-up companies and how to make them operational and profitable. 7 years of Team set-up, R&D management, and implementation for 165-person (85 PhD’s and Engineers) company (Pharm-Eco) and lecturer on cGMP and Teams within the Pharmaceutical Industry.

    “ Patients are always first, is our driving force. Oncology is a tough space, and we are determined to bring the best validated science to help cancer patients and as our CEO says, ‘Eliminate Cancer.’ That takes teamwork and a lot of smart hard-working people, our team members at POAI are up to the challenge. ”

     

     

    Education
    Suffolk University
    Executive MBA Program

    Ohio Dominican College
    BS, Chemistry

    Ohio State University
    Microbiology and Virology

    University of Cincinnati
    Associates Degree, Liberal Arts

    Mark A Collins, Ph.D

    SCIENTIFIC/CUSTOMER DEVELOPMENT
    Predictive Oncology
    Chief Technical Officer, Helomics
    At Predictive Oncology

    Mark is currently Chief Technical Officer at Predictive Oncology. Using the power of AI, Mark is responsible for leveraging Helomics’ vast repository of physical and digital tumor samples, to build multi-omic predictive models of tumor drug response and outcome. Such models can be applied to the discovery of new targeted therapies for cancer as well as used in clinical decision support to help oncologists individualize  treatment.

    Before Predictive Oncology

    Dr. Mark Collins embarked on a career in the pharmaceutical industry following his postdoctoral work. Pursuing a passion for both biology and computing, Mark has held multiple executive roles in a variety of discovery, informatics and bioinformatics functions within global pharma, and founded three startup software companies in the artificial intelligence (AI) machine learning (ML) and drug discovery space. Mark relocated to the USA in 2001 to work for Cellomics (now part of Thermo Fisher Scientific), where he played a pivotal role in establishing the High-Content cell analysis market, building, and commercializing several key informatics and bioinformatics products.

    Since leaving Thermo Fisher, Mark has focused on developing and commercializing informatics solutions for clinical and translational research, specifically in the specimen tracking, ‘omics data management and NGS analysis space, through key roles at BioFortis, Global Specimen Solutions and Genedata

    “ I have been pursuing a vision since the late 1990s that AI will help deliver better patient therapies. I firmly believe at POAI we will deliver on that vision. ”

    Education
    University of Surrey, UK
    Ph.D., Microbiology

    University of Wolverhampton, UK
    Undergraduate Degree, Applied Science

    Bob Myers, BBA, MBA

    CHIEF FINANCIAL OFFICER
    Predictive Oncology
    Site Leader, Skyline Medical
    At Predictive Oncology

    Executive Officer, Compliance Officer, Corporate Secretary, and member of the Senior Leadership Team. Responsible for Finance, Administration, Human Resources, Investor Relations, and IT. Skyline Medical Site Leader.

    Before Predictive Oncology

    Numerous years as CEO/Controller consultant including medical devices companies. Executive positions with CES Computer Solutions, Computer Accomplishments, Hi-Tech Stationary & Printing, Capital Distributors Corp, International Creative Management American Express, Showtime Entertainment and public accounting with Laventhol & Horwath, CPA’s.

    “ It’s a privilege to work with a highly talented team to pursue oncology advances, while protecting and increasing shareholder value. ”

    Education

    Adelphi University
    MBA, Finance

    Hofstra University
    BBA, Public Accounting 

    J. Melville (“Mel”) Engle, BS, MBA

    CHIEF EXECUTIVE OFFICER
    & CHAIRMAN OF THE BOARD
    Predictive Oncology
    At Predictive Oncology
    Mr. Engle became POAI’s CEO in 2021 and was appointed to the POAI Board of Directors in 2016. He was elected Chairman of the Board in 2020.
    Before Predictive Oncology

    Between 2012 and 2021, he was CEO of Engle Strategic Solutions, a consulting and coaching company focused on CEO issues. From 2009 to 2012, he was CEO and Chairman of Thermogenesis, a cell separation company. From 2002 to 2007, he was Regional Head/Director, North America at Merck Generics and CEO of Dey Laboratories, a respiratory company. From 1996 to 2001, he was CEO and Chairman of Anika Therapeutics, an orthobiologics company. From 1980 to 1995, he was with Allergan, Inc., an eye and skin care company, where he served as CFO, Managing Director (living in Toronto), and other positions with the firm.

    “ Eliminating cancer is our overall goal.  This is not an easy task.  We are working hard every day to make this happen, using our novel technology and talented team of employees. ”

    Education

    University of Southern California
    School of Business
    MBA, Finance

    University of Colorado Boulder
    BS, Accounting