The Wellsmont Group is a consulting and educational services business that was founded by Douglas P. Malinowski, Ph.D. who currently serves as the founder and executive director of the business.
About Dr. Malinowski
Douglas P. Malinowski. Ph.D. is an experienced healthcare executive with extensive experience in the molecular technologies, biomarker research, IVD diagnostics and computational pathology industries. My career has focused on developing innovative products to address unmet needs in human healthcare which also create value for the healthcare system and stakeholders.
My professional career included the development and commercialization of diagnostic products in infectious disease testing, molecular diagnostics, oncology-based detection, oncology-based prognosis, molecular pathology, cytology, and histopathology.
During the past 27 years, I have worked in molecular oncology with the application of molecular diagnostic technologies to unmet needs in cancer-based detection, molecular characterization of disease, and improved options for patient management. This experience has been closely aligned with the concepts of individualized disease assessment and precision medicine.
Career Focus
My interest in personalized and precision medicine is to better align IVD diagnostic and molecular technologies with disease characterization and to create an actionable profile that aligns the individual’s disease status with the best treatment option available.
My background in technology development, IVD diagnostics, molecular profiling technologies, clinical applications, validation studies, communication and clinical evidence syntheses provides a unique perspective on the assessment of the opportunities and challenges within human healthcare and how new solutions in precision medicine can advance solutions in precision medicine to improve human healthcare.
I have applied my expertise, knowledge and passion about healthcare solutions to create The Wellsmont Group as a value-added consulting and educational services business.
The primary focus of the Wellsmont Group is to advance the applications, understanding and impact of personalized and precision medicine.
Career Profile
I have extensive executive leadership with 41 years experience in the creation of technologies, applications and innovations that have created significant value within the IVD diagnostics industry. My primary focus has been on advancing human healthcare and creating value for the healthcare system and stakeholders.
My career focused on the application of new technologies to address un-met needs and current problems in cancer detection, diagnosis, characterization, and treatment. Novel technology applications were aligned with key stakeholder feedback and early adopters in healthcare management.
These product solutions were integrated with state-of-the-science knowledge and clinical evidence synthesis to create compelling value propositions in cancer and infectious disease healthcare. This work was focused on improving the accuracy of disease detection, and the subsequent use of this information in the clinical management of disease.
I have experience in all phases of strategy development, innovation management, R&D portfolio management, technology development and product development. Specific R&D management includes biomarker research, translational research, assay prototype development, in vitro diagnostics product development and commercialization. Cancer-based product development includes assays for screening, early detection, diagnosis, and prognosis (both protein- and nucleic acid-based assays).
Value Creation:
My career has been focused on the value creation of technology solutions in human health spanning technology development, assay applications and clinical validation/commercial launch of products and technology to advance human healthcare.
• I successfully lead the development, application, and commercialization of the SDA technology at BD. Working with a talented group of scientists, this technology created BD’s infectious disease molecular testing business. The SDA amplification technology was utilized for 20 years in BD’s diagnostic business.
• Starting at BD in 1997, I was a founding member of an internal venture to partner with Millennium Predictive Medicine on biomarkers for cancer detection and prognosis. This program was transferred to TriPath Oncology in 2001, where I served as VP of Research and CSO for this biomarker program.
• The biomarker program at TriPath Oncology, along with the parent company TriPath Imaging, was acquired by BD in 2006. I rejoined BD as the VP of Research and CSO for the newly formed BD Women’s Health and Cancer business. In this role, I managed the R&D portfolio on cancer-based biomarkers for applications to molecular oncology applications, cervical cancer, ovarian cancer, breast cancer, prostate cancer and endometriosis.
• While at BD, I also worked in scientific affairs where my skills in communication and education helped stabilize BD’s cervical LBC global franchise and expanded the global franchise on HPV testing and the role of extended genotyping in cervical cancer screening program.
• At PreciseDx, I worked on the clinical utility of AI-based histopathology algorithms for the prediction of risk of recurrence in early-stage breast cancer. This work resulted in a number of external validations studies, scientific and medical conference abstracts, peer-reviewed publication on the analytical validation of the PreciseBreast algorithm, and a peer-reviewed publication on the cost-effectiveness analysis of the PreciseBreast algorithm in comparison to the current standard of care testing in breast cancer.
• I started the Wellsmont Group as a consulting and educational services business to help advance the understanding and application of new technologies in precision medicine and cancer-based healthcare. The Wellsmont Group has consulted on cervical cytology applications, provided webinars on cervical cytology applications and recently led the development and publication of a peer-reviewed paper describing a simplified liquid-based cytology preparation method applicable to low-resource settings.
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A complete list of the Douglas P. Malinowski peer-reviewed publications can be found here.