Founder & Managing Director

Maryam Hosseini, PhD, CLS (ASCP)™

Dr. Maryam Hosseini is a highly skilled, licensed, Clinical Laboratory Scientist with in-depth knowledge and expertise in high complexity CLIA/GLP laboratory operations.  She has over 20 years of experience in the clinical laboratory setting including 10+  years of leadership, operations, quality systems, and regulatory experience in industry-leading biotechnology start-ups. She also has over 10 years of research experience with strong analytical skills in a variety of molecular biology and genetics technologies.

Maryam has years of experience in building (from the ground up), scaling, and maintaining clinical laboratories operations, by building high performing teams and collaborating cross-functionally; launching novel high-complexity laboratory-developed tests (LDTs); relocating laboratories; participating in building regulatory programs, obtaining CLIA certification, CAP accreditation, California and New York state licenses, and PMA submission. Her passion is to implement long-term solutions by building efficient processes with strong foundations to support sustainable growth.

Medical Advisors

Russell Kerschmann, MD

Dr. Russell Kerschmann is an M.D. pathologist with over 30 years experience in executive management, clinical practice, biomedical device development, and the molecular pathology industries. During his career he has served on the faculties of Harvard Medical School, the University of Massachusetts, and the University of California at San Francisco. In 1997, he founded and served as CEO of a medical device company, Resolution Sciences, which produced an innovative award-winning digital microscopy technology and received financing from venture capital and Asian angel investors. From 2004 to 2009, he was Senior Executive Service manager of the Space Biosciences program at NASA Ames Research Center, where he initiated programs in radiation biology and toxicology and significantly increased the program’s funding. Subsequently, he served for a decade on the NASA Engineering and Safety Center and as an Ames Associate. Following his full-time tenure at NASA, he became the CLIA Medical Director of the San Francisco Bay business unit of Quest Diagnostics, the largest commercial clinical laboratory in the U.S. He currently holds CLIA/CAP medical directorships at several California laboratories, including Ascend Clinical, Octave Bioscience, Notable Labs, and Grail, Inc., and is the signing pathologist responsible for the medical quality of about 30 million laboratory tests annually. Dr. Kerschmann’s undergraduate education centered on electrical engineering and neurosciences. He earned his medical degree from the University of Massachusetts, and did his residency training at Massachusetts General Hospital.

Meredith Miller, MD

Dr. Meredith Halks Miller is a physician-scientist, Board Certified in Anatomic & Neuropathology. She started her career as an Assistant Professor at UCSF, doing research in neurotoxicology and brain injury models. She later joined Berlex Biosciences, a subsidiary of Schering AG, where she established the unit of Pharmacopathology to bring clarity and efficiency to analysis of histopathologic changes in early stage studies for drug development.  After Berlex, Meredith became the CLIA Laboratory Director at Pathwork Diagnostics, a cutting-edge molecular diagnostics company that analyzed RNA from cancer tissue samples to predict the tissue of origin for cancers of uncertain primary. From there, she joined Verinata (Illumina) as Laboratory Director.  Verinata had developed a test which used next generation sequencing to screen for fetal trisomies in maternal blood. At Verinata, she made the seminal observation that maternal malignancies could be detected from sequencing abnormalities in plasma cfDNA. That discovery led to the formation of GRAIL, where she served as the founding laboratory director.  After retiring from GRAIL, Dr. Halks Miller consulted for various CLIA laboratories. She currently serves on two Scientific Advisory Boards.

Dr Halks Miller did her residency training at Stanford and at UCSF. She received both her MD and AB (physics) degrees from Boston University. Before attending Boston University, she completed the Freshman Foundation program at the Rhode Island School of Design.

Ruben Gamez, MD

Dr. Ruben Gamez is an MD pathologist with over 20 years of experience. He is board certified in Anatomic and Clinical Pathology, as well as Hematopathology. He attended medical school at the University of Arizona College of Medicine in Tucson and completed his pathology residency at St. Joseph’s Hospital in Phoenix. After completing his hematopathology residency at Georgetown University in 2008, Dr. Gamez served as the assistant laboratory director at Quest Diagnostics in Valencia. He has also served as the Laboratory Director at several laboratories, including at Ascend Genomics in the Bay Area and Millennium Health in San Diego, California.

Rita Shaknovich, MD, PhD

Dr. Rita Shaknovich is a physician scientist with more than fifteen years of leadership experience in senior executive roles in the laboratory industry and academia. She directed strategy at Cancer Genetics Inc and established and oversaw Clinical Labs and Medical Affairs strategy at Grail LLC. Dr. Shaknovich has directed accreditation and overseen several CLIA/CAP laboratories nationally and has been a key contributor to the development and commercial launch of first-in-class Galleri™ Multi-Cancer Early Detection liquid biopsy test. She developed an NGS assay product portfolio, developed biomarker-based assays across multiple platforms, and established relationships with key opinion

leaders and pharmaceutical clients. Dr. Shaknovich has been published in more than forty scientific articles in the field of cancer biology, genomics and epigenetics, and has designed and executed NIH-funded research projects with a focus on cancer biology and genomics. She has excellent analytical and problem-solving skills, is effective in highly matrixed environments, and is a team player with high moral standards and integrity.

Stephen Cook, MD

Dr. Stephen Cook is a board certified anatomic and clinical pathologist, and is also board certified in hematopathology by the American Board of Pathology. Dr. Cook completed medical school at Vanderbilt University and his anatomic pathology / clinical pathology residency and hematopathology fellowship at the University of Virginia. He has worked at both UCSF and Stanford University as a hematopathologist, during which time he was responsible for signing out bone marrow biopsies, peripheral blood smears, coagulation studies, confirmatory consults, and lymph node biopsies. Dr. Cook has also practiced as a consultant for multiple commercial laboratories and has been involved in various aspects of laboratory medicine, including flow cytometry, FISH, immunohistochemistry, chemistry and molecular diagnostics. He is also an experienced CLIA medical director.

Business Advisors

Matt Watson, MBA

Matt is a veteran healthcare executive and entrepreneur with more than 37 years in the clinical diagnostics industry.  He has provided professional consulting services to some of the most prestigious healthcare companies and institutions in the U.S.  In 2019, he co-founded PathForce Technologies, Inc., a digital pathology workflow solutions company.  Prior to that he co-founded PathCentral, Inc., a national provider of integrated pathology business solutions, and served as their CEO until 2013.  He also served as CEO of Westox Labs, CEO of Pathology Business Services, and co-founded and served as CEO of Combimatrix Molecular Diagnostics after having been the COO of US Labs (now Labcorp/Integrated Oncology) for four years.

Matt received a Bachelor of Arts degree in Biology from Eastern Connecticut State University and an MBA from the University of Hartford, and completed an Executive Program in Leadership at Stanford University Graduate School of Business.

Behzad Hosseini, MBA

Behzad Hosseini, founder and president of Toba Consulting, is a dynamic leader with a proven history of delivering transformational change across a wide range of business and information technology. He is an expert consultant and client/stakeholder liaison, able to translate strategy into long-term plans with goals, outcomes and KPIs. Behzad is a seasoned transformational leader known for collaborating with business partners across organizations to discover the most efficient ways to run the business and optimize business functions and activities.

Operational Advisors

Rebecca Watson, CSPO®, DASM®

Rebecca has spent nearly 20 years in the clinical laboratory industry working with teams to simplify and streamline operations through laboratory informatics and software optimization. She has supported organizations in the commercial deployment of laboratory developed tests in the anatomic pathology and molecular diagnostics space, including high-complexity methodologies such as FISH, Flow, IHC, and PCR, and cutting-edge technologies used in multi-cancer early detection and glycoproteomic testing. She has also established customer call centers, managed biological sample storage and specimen logistics, and supported operations in multiple clinical studies domestically and internationally. Rebecca is a Certified Scrum Product OwnerⓇ and Disciplined AgileⓇ Scrum Master with experience in Agile software development lifecycles, as well as predictive / waterfall project management styles. She holds a Bachelor of Arts in English and a Bachelor of Fine Arts in Acting from the University of Connecticut.

Patti Hunsader, MT, CLS (ASCP)™

Laboratory Operations

Patti Hunsader has over 20 years of experience providing operational direction and oversight for laboratories. She has served in laboratory leadership roles for organizations of all sizes, from start-ups to large-volume reference labs. Patti completed her medical technology internship at San Jose State University and El Camino Hospital in Mountain View, CA. She is a licensed clinical laboratory scientist through the American Society of Clinical Pathologists (ASCP) and is a member of the California Clinical Laboratory Association (CCLA). Patti earned her bachelor’s degree in biological sciences from the University of California, Santa Barbara.

Michael Nketiah, MBA, RAC

Quality / Regulatory

Michael is a hands-on technologist and strategist implementing and enhancing regulatory affairs, quality systems and clinical affairs for medical devices (including in-vitro diagnostic tests and diagnostic systems). He has been a lead regulatory and quality liaison responsible for developing and implementing key quality and regulatory functional strategies including obtaining complex approvals and clearances from the US FDA and international agencies. He has harmonized key quality & regulatory strategies and processes and has worked for several successful companies in the past including Thoratec and Evalve (now part of Abbott Cardiovascular), Crux Biomedical, Procept BioRobotics, Siris Medical and InterVenn Biosciences. Michael holds two bachelor’s degrees in Chemistry (Midwestern State University) and Mechanical Engineering (San Jose State University). He earned his MBA from St Mary’s College of California.

Louis Apicella

Artificial Intelligence

Louis (Lou) is a dynamic Healthcare executive bringing more than 20 years of expertise steering enterprise-wide transformation and operational improvement programs leveraging industry-leading technology and business practices. His background includes aligning high performance teams with corporate vision, developing collaborative partnerships at all levels of the organization, and executing well-defined and prioritized program roadmaps to unlock business value. Throughout his career, Lou has been credited with driving laboratory programs and initiatives aimed at innovating and leveraging emerging technologies to deliver solutions that achieve desired outcomes. He has been credited with designing the Tech-Only FISH software platform at NeoGenomics Laboratories. In addition, Lou has provided executive level consulting to multiple billion dollar laboratories within the healthcare industry.

Lou received a Bachelor of Arts for Business with concentrations in Management Information Systems, Accounting, Finance, and a minor in Economics from the University of Buffalo.

Kelly Walton, MBA

Software

Kelly Walton is a product leader who is driven to improve people’s health and lives with an affinity for working with teams to innovate and launch high value solutions at the intersection of life sciences and technology. She has launched successful SaaS and embedded software products that aid lab automation / scale for metabolomics and glycoproteomics, in-patient care workflows, visualization of omic study results, and clinical trial strategy and operations. In her personal time, she volunteers to build stronger communities and enjoys travel and outdoor adventures such as hiking, skiing, and gardening.

Saniya Fayzullina, PhD, PMP®, PfMP®

Program Management & Project Management

Saniya Fayzullina offers consulting services in project and program management, program portfolio management, business process design, and technical writing. In addition to program and portfolio management certifications, Saniya holds a PhD in Pathobiology and has extensive experience working with bench scientists, bioinformatics scientists, and software engineers. She excels at bringing together development and regulatory, quality, and operations teams to achieve business objectives. Saniya’s guiding principle is that solutions should be fit for purpose: following common sense and avoiding over-engineering. She emphasizes easy-to-use tools, clearly defined processes, and consistent unambiguous communication. Saniya is based in the San Francisco Bay Area.

Avinash Peddi

Laboratory Automation & Engineering

Avinash Peddi is an accomplished professional with over 20 years of experience in the lab automation and engineering field. He has a track record of success in designing and developing custom automated solutions that meet customer-specific needs in the near term while providing flexibility to scale for the long term. Throughout his career, Avinash has held numerous leadership positions, including responsibility for the North America custom robotics business unit in meeting revenue and KPIs. His expertise in building automation solutions from the ground up that can scale to process millions of samples can help labs seeking to optimize their lab operations and drive positive change. Avinash is also experienced in identifying and building CLIA laboratories for commercial operations. He received his MS in Electrical and Computer Engineering from The Ohio State University.

Nima Shojaee, PhD

Bioinformatics & Data Science

Dr. Nima Shojaee is a data scientist leader at GRAIL, Inc., in Menlo Park, CA. He received his PhD in genetics from the University of Southern California and completed his postdoctoral training at University of California, San Francisco. He has more than fifteen years of experience in both translational and clinical aspects of oncology and neurodegenerative disease. Dr. Shojaee was one of the early members of the GRAIL team and played a key role in developing Galleri™ as the first multi-cancer test for early detection of cancer.

Maryam Yousefi, PhD

Science & Research

Dr. Maryam Yousefi is a cancer biologist and oncology biomarker researcher with over 10 years of experience in oncology and immuno-oncology in industry and academia. She has led research to discover molecular and cellular determinants of cancer initiation and progression, and identify biomarkers of response to targeted therapies and immunotherapies using the most innovative experimental and quantitative approaches. Dr. Yousefi received her bachelor’s and master’s degrees in Biotechnology from University of Tehran and a Ph.D. in Cell and Molecular Biology  from the University of Pennsylvania. She performed her postdoctoral research on cancer genetics at Stanford University.

Mahdis Shayan, PhD

Science & Research

Dr. Mahdis Shayan is a bioengineering scientist with more than 10 years experience in biomaterials, regenerative medicine, and tissue engineering fields. She received her Ph.D. in Industrial Engineering (Biomanufacturing) from the University of Pittsburgh, where she completed projects in developing different medical devices and investigating the surface modification techniques to enhance the biocompatibility of biomedical implants. She pursued postdoctoral training at Yale University and Stanford University, where her focus was on immunomodulatory implants for cardiovascular implants and the use of hydrogel biomaterials for stem cell therapy in cardiovascular diseases, respectively.

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