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Predictive Oncology Enters Biomarker Discovery Market After Successful Retrospective Ovarian Cancer Study Yields Compelling Results
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Predictive Oncology Launches Novel 3D Cell Technology to Accelerate Cancer Therapeutic Drug Discovery
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FAQs

Frequently asked questions about our solutions

Our wide range of solutions covers the oncology spectrum—from drug discovery to clinical treatment. Browse frequently asked questions about our solutions below. 

 

What is tumor drug-response testing

Drug-response profiling is a treatment selection marker. It determines how an individual cancer patient’s tumor is likely to respond to the various types of chemotherapy by testing the treatment options on that patient’s live cancer cells and measuring cell response. This provides valuable insights that help guide physicians’ treatment decisions, giving you an edge against cancer.

What is genomic testing?
Genomic testing is a group of clinically relevant cancer-related biomarker tests that look at your genetics to predict your cancer’s response to various types of chemotherapy and/or the course your disease is likely to take. The biomarkers included in genomic testing are well-validated and supported by current research and key opinion leaders.

Why have a tumor tested with us?
Your physician is using every advantage available to improve the odds in your fight against cancer. Combining drug-response profiling and genomic profiling of your tumor generates a more comprehensive picture to provide information to help your oncologist individualize your therapy. These tests are designed to reduce your risk of receiving therapies that are ineffective or to identify alternatives when the typical treatments recommended for your type of cancer cannot be tolerated.

How does a tumor get tested?

Tumor tissue is obtained during surgery and your oncologist will send that tissue to our CLIA-certified laboratory using our special collection kit. Two samples of your tumor tissue are obtained, fixed and live. The fixed tumor tissue is used for a panel of genomic biomarker tests. The live tumor tissue is grown in the lab and used to test the drug response of the tumor to a panel of standard-of-care (SOC) drugs. When testing is complete a report is provided back to your clinician with recommended SOC therapies based on the drug response and genomic profiles.

What is the value of having a tumor tested?

The data generated from testing the unique mutations of your tumor and from the drug response profiling, which essentially performs chemotherapy on your tumor outside of the body, provides information to your oncologist to improve the odds in your fight against cancer. In addition, and with your consent, de-identified data generated by testing your tumor is added to our cancer knowledgebase of existing tumor data. Deeper analysis of this data will improve the recommendations we give to clinicians to help patients like you, as well as provide insights to guide research into new cancer therapies.

How much will it cost?
We are committed to providing access to functional precision medicine to as many people as possible. Our panel of biomarker/genomic tests are covered by most insurers/Medicare. We have continued to offer tumor drug-response tests amidst reimbursement uncertainty from both commercial insurers and Medicare. Due to continued clinical demand and interest across the community, we remain committed to meeting the needs of patients. To keep this testing available to patients and their treating physicians, we offer our tumor drug-response profiling at a drastically reduced rate such that no patient will pay more than $615. We also provide a Compassionate Care Program for those patients who need further help with payment. Contact us for more information.

How can I work with 3D tumor models and what are the deliverables?
Contact us by filling out a form at the bottom of this page. We will be in touch to set up a call to discuss the details of your project. We will then provide a budget and timelines based on the study parameters.

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.

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. To get started, contact 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 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 our technology differ from other 3D culture platforms?
Our 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 our 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 our various platforms (i.e. r-Bone vs r-Lung)?
Each of our 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, its 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 our ECM after it has polymerized?

Yes. We have tested small molecules, antibodies, antibody-drug conjugates (ADC), and cellular therapies, such as CAR-Ts; 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 to maintain viability for at least 21 days. However, most models can support primary cells for >30 days. For r-Bone cell cultures we can maintain primary cells in our models for up to 35 days, the maximum duration tested.

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 to adding treatment to your culture systems?
We do not add therapeutic compounds to our model systems immediately post setup 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?
For successful cultures, the cells must retain >70% viability after thaw.

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 is 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 run 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, but 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.

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 tested 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 our 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 our models?
The dynamic range of CellTiter Glo assay in our 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. Our 3D tumor models 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.

Let’s discover and develop together.

Complete the form and we’ll be in touch to discuss customized solutions for your needs.

News & resources

Andrew Einhorn

Member

As a biopharmaceutical finance veteran and former investment banking and capital markets manager, Andrew Einhorn brings a wealth of senior financial leadership experience to the Business Advisory Board. Mr. Einhorn currently works with Danforth Advisors, builders of life science companies and leaders in healthcare innovation from strategy through execution, where he provides strategic and situational financial expertise to public and privately held life science companies.

Mr. Einhorn has served as interim chief financial officer of Cognition Therapeutics and chief financial officer of RVL Pharmaceuticals plc (formerly Osmotica Pharmaceuticals plc), Edge Therapeutics, Inc., co-founder and CFO of Oceana Therapeutics, Inc., Esprit Pharma, Inc. and ESP Pharma, Inc.

Earlier in his career, Mr. Einhorn was deeply engaged in investment banking and capital markets at PNC Bank, Chase Securities, and BT Securities, where he managed debt, equity and structured financing transactions with institutional investors. He is a graduate of The American University with a degree in finance and accounting.

Bernard A. Harris, Jr., MD, MBA

Member

Dr. Bernard A. Harris, Jr., brings a wealth of scientific, clinical, business, finance and operational expertise to Predictive Oncology and understands the vision, mission and enormous potential of applying artificial intelligence and machine learning to early drug discovery and development.

He currently serves as CEO and Managing Partner of Vesalius Ventures, a venture capital firm that invests in early to mid-stage healthcare technologies and companies. Harris is also Founder of the Harris Foundation, a non-profit organization that serves socially and economically disadvantaged communities, striving to reach the most underserved populations in the areas of education, health, and wealth. Dr. Harris is Board Director of Raytheon Technologies (NYSE: RTX), Massachusetts Mutual Life Insurance Company (MassMutual), and Chairman of the Texas Medical Center Board of Directors.

A former NASA astronaut, Dr. Harris has traveled more than 7.2 million miles in space and the first African American to walk in space in 1995.

He earned a Bachelor of Science in Biology from the University of Houston, a Master of Medical Science from the University of Texas Medical Branch at Galveston, an MBA from the University of Houston and a Doctorate of Medicine from Texas Tech University School of Medicine. Dr. Harris has held faculty positions at the University of Texas Medical Branch and Baylor College of Medicine and is the recipient of numerous awards, including nine honorary doctorates.

Christoph Reinhard, Ph.D., MBA

Member

Christoph Reinhard, Ph.D., MBA, is a leader in oncology translational research, new technologies in drug development and external innovation.

He currently serves as acting Chief Scientific Officer for CELLphenomics, where he is instrumental in determining what types of novel drugs and drug combinations might be beneficial to future cancer patients with solid tumors.

For more than a decade Dr. Reinhard worked at Eli Lilly (NYSE:LLY) where he was responsible for strategy development and implementation of translational research support for its oncology portfolio assets and spearheaded the company’s Innovative Medicine Initiative in Oncology.

Dr. Reinhard holds a Ph.D. from the Biocenter University, Basel, Switzerland; an MBA in Technology Management from Phoenix University; and a Bachelor of Science in Molecular Biology, Biochemistry and Microbiology from the University of Freiburg in Germany.

Robert F. Murphy, Ph.D.

Member

As a pioneer in the field of machine learning and analytics for biological data, Dr. Murphy is an expert in developing algorithms and models to understand biological systems and relationships. He was founding head of the Computational Biology Department at Carnegie Mellon University (CMU) and led the development of CORE™, the machine learning technology that is exclusive to and powers Predictive Oncology’s proprietary AI platform.

In addition to his role at CMU, Dr. Murphy has also served as Professor of Biological Sciences, Biomedical Engineering, and Machine Learning there. He is an Honorary Professor of Biology at the Albert Ludwig University of Freiburg, Germany, and was the recipient of an Alexander von Humboldt Foundation Senior Research Award.

He is a Fellow of the Institute of Electrical and Electronics Engineers and the American Institute for Medical and Biological Engineering, and served as President of the International Society for Advancement of Cytometry. He was the first full-term chair of the Biodata Management and Analysis Study Section of the National Institutes of Health and was a member of the National Advisory General Medical Sciences Council, and the National Institutes of Health Council of Councils.

Among his many accolades, Dr. Murphy has a patent for identifying location biomarkers, published more than 200 research papers and served on numerous editorial boards, committees, advisory panels, conference organizations and committee panels and professional societies. He received an A.B. in Biochemistry from Columbia College and a Ph.D. in Biochemistry from the California Institute of Technology. He was a Damon Runyon-Walter Winchell Cancer Foundation Postdoctoral Fellow with Dr. Charles Cantor at Columbia University

Marc Malandro, Ph.D., D.Sc. ​

Member

Dr. Malandro currently serves as the Vice President of Operations for Science at the Chan Zuckerberg Initiative, where he is part of the team that partners, supports and builds novel advances and tools to enable and accelerate biomedical research.

As an expert in genomics, molecular biology, biochemistry and bioengineering, Dr. Malandro has held roles in both business and corporate settings. Prior to Chan Zuckerberg Initiative, he was Vice Chancellor for Technology Management and Commercialization and the Founding Director of the Innovation Institute at the University of Pittsburgh.

Prior to that, Dr. Malandro co- founded Sagres Discovery, a systems biology company focused on the understanding of the molecular basis of cancer, where he served as Vice President of Technology and Strategic Alliances. There he was involved in all aspects of intellectual property, licensing and alliance management.

Dr. Malandro received his B.S. and M.S. in Biological Sciences and D.Sc. from Youngstown State University and his Ph.D. in Biochemistry and Molecular Biology from the University of Florida College of Medicine.

Gregory S. St. Clair, Sr.

Director

Mr. St. Clair has more than three decades of hands-on experience in building and growing companies across a diversity of markets. As an innovator and entrepreneur, his experience encompasses executive leadership, strategic planning, compliance, reimbursement and revenue integrity and cycle management. His professional and personal endeavors reflect his continuing commitment to the integration of the financial needs and market niche opportunities for health systems and related biomedical organizations.

He is Founder and a Managing Member of SunStone Consulting, LLC. Prior to that, Mr. St. Clair worked as a national vice president for CGI, ImrGlobal, and Orion Consulting and as a national director for Coopers & Lybrand.

Veena Rao, Ph.D., MBA​

Director

As a pharma, biotech and digital health veteran, Veena Rao, Ph.D., MBA, brings extensive experience launching products and building commercial organizations in the pre-launch and early launch phases.

Dr. Rao currently serves as Chief Business Officer of Portal Instruments, where she leads the identification, evaluation and negotiation of partnership opportunities. 

Before Portal, she served as Chief Commercial Officer and Head of Corporate Development & Strategy at Beta Bionics where she led the commercial team and was responsible for the go-to-market strategy. Dr. Rao also spent more than a decade working for Eli Lilly in a number of commercial and technical roles.

She has a Ph.D. in Chemical Engineering from Stanford University and an MBA from the University of Virginia Darden School of Business.

David S. Smith, J.D.

Director

David S. Smith, J.D., is a life sciences and intellectual property attorney, veteran biotech industry executive and leading authority on the legal issues surrounding the therapeutic use of human tissue and cells. He has extensive transactional experience, venture financings and regulatory matters for life sciences companies and investors.

Mr. Smith frequently speaks on matters related to the commercial development of tissue, cell and stem cell technologies, and has authored extensively on topics like human tissue therapies and tissue engineering research. He currently serves on the Board of Directors with Foundation for Cell and Gene Medicine; is a current fellow and past member of the executive committee of Tissue Engineering and Regenerative Medicine International Society; was a member of the Board of Directors of the Pennsylvania Biotechnology Association; and was a past officer of the Pittsburgh Tissue Engineering Initiative.

Chuck Nuzum, CPA

Director

Mr. Nuzum was appointed to the Board on July 9, 2020. He has extensive experience as a CFO that ranges from private start-ups to large publicly traded companies. Mr. Nuzum presently provides financial consulting services on a project basis to companies such as McKesson, BioMarin, AutoDesk and Squire Patton Boggs, mentors start-up companies and serves on the Board of Directors of several companies. Previously he was co-founder and CFO of the Tyburn Group, a financial services company that creates and delivers prepaid payroll and general-purpose card programs for customers. For the four years prior, Mr. Nuzum served as the Controller of Dey, L.P., a large pharmaceutical manufacturing subsidiary of Merck KGaA. Prior to that he was co-founder, Executive Vice President and CFO of SVC Financials Services, one of the first companies in the field to integrate a mobile money solution for global distribution, Vice President of Finance and Administration at Tiburon, Inc., a leader in public safety and justice information systems, and CFO of Winebid.com the world’s leading e-commerce wine auction company. 

For more than two decades, Mr. Nuzum was CFO of Loomis Fargo & Co., the well-known international provider of ATM systems, armored cars and other security services. Mr. Nuzum, a Certified Public Accountant, earned his BA at the University of Washington at Seattle.   He served with the U.S. Army Special Forces in Vietnam earning the Bronze Star and the Army Commendation Medal during combat operations, other international postings and served with distinction as an intelligence officer in Washington, D.C.

Matthew J. Hawryluk, Ph.D., MBA

Director

Dr. Hawryluk, Ph.D., MBA, currently serves as Executive Vice President and Chief Business Officer of Gritstone bio, Inc (Nasdaq: GRTS). Dr. Hawryluk was recognized by Pharmaceutical Executive magazine as a leading business executive in the pharma and biotech industries and has played key roles in bridging the gap between scientific discovery and the commercial application of scientific breakthroughs. As a named inventor on multiple patents and co-author on several peer-reviewed publications, he brings an instrumental awareness and insight to Predictive Oncology.

Before joining Gritstone, Dr. Hawryluk served as Vice President of Corporate and Business Development at Foundation Medicine, Inc., a public molecular information company—subsequently acquired by Roche—and before then assumed roles in business development, marketing and product management across multiple divisions of Thermo Fisher Scientific, Inc.

In addition to his Board role with Predictive Oncology, Dr. Hawryluk serves as an Advisory Board Member of PathAI, Inc. 

Dr. Hawryluk holds a Ph.D. in cell biology and protein biochemistry from the University of Pittsburgh School of Medicine, an M.B.A. from Carnegie Mellon University’s Tepper School of Business and B.S. from the University of Notre Dame. 

 

Dan Handley, M.S., Ph.D.

Director

Dr. Handley serves as a Professor and the Director of the Clinical and Translational Genome Research Institute of Southern California University of Health Sciences. Previously, he was the Chief Scientific Officer of the Clinical and Translational Genome Research Institute, a Florida 501(c)3 non-profit corporation. During that time, he also held a courtesy faculty appointment in the Department of Biological Sciences at Florida Gulf Coast University. He previously served as the Chief Scientific Officer for Advanced Healthcare Technology Solutions, Inc., Life-Seq, LLC, as a senior researcher at the Procter & Gamble Co., a senior administrator, researcher, and laboratory manager at the David Geffen UCLA School of Medicine, and as a founding biotechnology inventor for the National Genetics Institute.

He holds a B.A. in Biophysics from Johns Hopkins University, an M.S. in Logic and Computation from Carnegie Mellon University, a Ph.D. in Human Genetics from the University of Pittsburgh. He completed his post-doctoral training at Magee-Women’s Research Institute researching advanced genomic technologies applied to fetal and maternal health. He is a veteran of the U.S. Navy, having served as a nuclear propulsion instructor.

Nancy Chung-Welch, Ph.D.

Director

Dr. Chung-Welch is currently an independent consultant advising life science companies and their institutional investors on life science companies, technologies and industries with an emphasis on the research product/tools market. Previously she was a Director, Business Development at Cell Signaling Technology and was Director, Business Development at Thermo Fisher Scientific and Technical Marketing Manager for Fisher Scientific. She has over 25 years of marketing and business development experience in the life sciences market. Dr. Chung-Welch has a balanced blend of business and technical/analytical strengths to provide a sound foundation for technology/IP assessments and external partnerships.

She has a strong record of domestic and international experience in business and customer needs analysis, technology assessment, licensing, distribution deals, partnerships, strategic alliances, strategic customer relationships, mergers/acquisitions. She previously served as Instructor in Surgery and Assistant in Physiology at Harvard Medical School and the Massachusetts General Hospital with expertise in basic science research, including cell biology, tissue culture, vascular physiology, genomics, proteomics, and lab automation applications. She is also a hands-on marketing executive and has conceptualized, launched, and managed products and services in the laboratory, medical, biotech/pharma, academic and government markets. She received her Ph.D. in Vascular Physiology and Cell Biology from Boston University.

Arlette H. Uihlein, MD

SVP, Translational Medicine and Drug Discovery, Medical Director

Arlette H. Uihlein, MD, FCAP, FASCP, is Senior Vice President of Translational Medicine and Drug Discovery for Predictive Oncology and Site Leader of Helomics. She has also served as 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.

Larry DeLucas, Ph.D.

SVP, Biologics

Dr. DeLucas is the Senior Vice President of Biologics for Predictive Oncology. He oversees Predictive Oncology’s solubility and stability contracts for numerous pharmaceutical/biotech companies.

From 1981 to 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.

Pamela Bush, Ph.D., MBA

Chief Business Officer

Pamela Bush, Ph.D., MBA, leads all business development, partnering and growth strategies for Predictive Oncology.  As a key member of the executive team, she spearheads the company’s strategic, operational and financial planning initiatives for both existing customers and emerging new markets. This includes leveraging and expanding the company’s portfolio of proprietary solutions to advance drug discovery and enable oncology drug development for the company’s biopharma partners. She previously served as Senior Vice President of Strategic Sales and Business Development at Predictive Oncology.

Dr. Bush has more than twenty years of experience in venture creation, finance and business development in the life sciences industry. Prior to joining POAI Pamela worked at Eli Lilly & Company in various roles including Corporate Business Development, Finance and Patient Services. Throughout her career, Dr. Bush has supported the creation and growth of more than 100 life sciences start-ups.

She earned her Ph.D. in Biology from Carnegie Mellon University (CMU) and MBA from CMU’s Tepper School of Business.

Raymond F. Vennare

Chief Executive Officer and Chairman of the Board

Raymond F. Vennare became Predictive Oncology’s CEO and Chairman of the Board on November 1, 2022. He has served on the Board of Directors since September of 2021.

Mr. Vennare brings more than thirty years of experience as an accomplished senior executive, board director and biotechnology entrepreneur. As a seasoned professional who has founded, built and managed multiple companies on behalf of institutional investors, private foundations and research institutions, Mr. Vennare has a long history of leading companies that range from bioinformatics, diagnostics and therapeutic drug delivery to FDA-cleared medical devices. Throughout his career, Mr. Vennare has played a key role in the capitalization, development and commercialization of innovative and novel technologies.

Since 2015, Mr. Vennare has served as CEO and Chairman of Cvergenx, Inc., a genomic informatics company developing decision-support tools for radiation oncology, and is currently an Investment Partner in Inventeur, LLC, a holding company of medical technologies in anesthesiology. Mr. Vennare’s previous experience includes co-founding ThermalTherapeutic Systems, Inc., where he served as President and Chief Executive Officer, President and Chief Executive Officer of ImmunoSite, Inc., Senior Vice President and Chief Information Officer of TissueInformatics, Inc., and President of VS/Interactive.

Josh Blacher

Interim Chief Financial Officer

Josh Blacher is the Interim Chief Financial Officer for Predictive Oncology.  As a strategic and operational CFO with more than 20 years of experience in leadership for private and Nasdaq-listed companies, Mr. Blacher specializes in the life science and biotech sectors.

His background spans roles as Chief Financial Officer and Chief Business Officer for RNA Disease Diagnostics, InMed Pharmaceuticals, Therapix Biosciences, Galmed Pharmaceuticals. He has worked in corporate development for Columbus Circle Capital and Teva Pharmaceuticals, as well as in investment management for Deutsche Asset Management and Morgan Stanley.

With a focus on optimizing fiscal health and transforming business decision-making, Mr. Blacher’s expertise is in building finance functions from the ground up, pioneering new financial and establishing global initiatives. He possesses a track record of raising profitability, high-impact issues and transformational deal-making including IPOs, follow-on offerings, M&A, licensing and partnerships.

He earned his Bachelor of Arts in Economics from Yeshiva University and MBA in Finance from Columbia Business School.

David S. Smith

DIRECTOR

David S. Smith, JD, is a life sciences and intellectual property attorney, veteran biotech industry executive and leading authority on the legal issues surrounding the therapeutic use of human tissue and cells. He has extensive transactional experience, venture financings and regulatory matters for life sciences companies and investors.

Mr. Smith frequently speaks on matters related to the commercial development of tissue, cell and stem cell technologies, and has authored extensively on topics like human tissue therapies and tissue engineering research. He currently serves on the Board of Directors with Foundation for Cell and Gene Medicine; is a current fellow and past member of the executive committee of Tissue Engineering and Regenerative Medicine International Society; was a member of the Board of Directors of the Pennsylvania Biotechnology Association; and was a past officer of the Pittsburgh Tissue Engineering Initiative.

“ Having worked in the healthcare industry for over 30 years, helping the companies who deliver patient care utilize the best technology, improve their processes and receive all the revenue they can within all compliance standards;
I was excited to join Predictive Oncology’s Board of Directors in helping to guide this exciting company with all of their cutting edge capabilities for improving
the health care of patients
with cancer.”

Pamela Bush, Ph.D.

SVP, Strategic Sales and Business Development,

PREDICTIVE ONCOLOGY
At Predictive Oncology

Pamela Bush comes with more than twenty years of experience in venture creation, finance, and business development in the life sciences industry. At POAI, she leads the sales efforts and business development activities across the portfolio.

Before Predictive Oncology

Prior to joining POAI Pamela worked at Eli Lilly & Company in various roles including Corporate Business Development, Finance and Patient Services. In addition to her Lilly work experience, Pamela has worked in economic development, academia, and business consulting supporting the creation and growth of 80+ life sciences start-ups.

“ POAI has developed solutions to help biopharma partners increase the probability of success of their oncology pipeline.”

Education
Carnegie Mellon University

Ph.D., Molecular Biology
MBA, Tepper School of Business

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

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 

Raymond Vennare

CHIEF EXECUTIVE OFFICER
& CHAIRMAN OF THE BOARD
Predictive Oncology
At Predictive Oncology

Raymond F. Vennare became Predictive Oncology’s CEO and Chairman of the Board on November 1, 2022. He has served on the Board of Directors since September of 2021.

Mr. Vennare brings more than thirty years of experience as an accomplished senior executive, board director and biotechnology entrepreneur. As a seasoned professional who has founded, built and managed multiple companies on behalf of institutional investors, private foundations and research institutions, Mr. Vennare has a long history of leading companies that range from bioinformatics, diagnostics and therapeutic drug delivery to FDA-cleared medical devices. Throughout his career, Mr. Vennare has played a key role in the capitalization, development and commercialization of innovative and novel technologies.

Since 2015, Mr. Vennare has served as CEO and Chairman of Cvergenx, Inc., a genomic informatics company developing decision-support tools for radiation oncology, and is currently an Investment Partner in Inventeur, LLC, a holding company of medical technologies in anesthesiology. Mr. Vennare’s previous experience includes co-founding ThermalTherapeutic Systems, Inc., where he served as President and Chief Executive Officer, President and Chief Executive Officer of ImmunoSite, Inc., Senior Vice President and Chief Information Officer of TissueInformatics, Inc., and President of VS/Interactive.

 

Mr. Vennare earned his undergraduate degree from the University of Pittsburgh (BA) and holds graduate degrees from Duquesne University (MS) and Case Western Reserve University (MA).

What we do for our customers today will directly impact the lives of those patients who may benefit by these discoveries in the future.”