Post-Doctorate: University of North Carolina at Chapel Hill (Ranked #1)
Fellowship: University of California, Irvine, School of Medicine
Ph.D.: Louisiana State University
MBA: State University of New York
Affiliated with American Association for Cancer Research, American Biomedical Engineering Society, American Association of Clinical Chemistry, American Association for the Advancement of Science, American Chemical Society, National Postdoctoral Association, etc.
Biotech, IVD, Medical Device & Life Science Professional
Orange County &
San Diego, CA
USA
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Recognized for 17+ years of hands-on industry experience, focused on new product and technology development, services, and operations under FDA, ISO, CE, EMA, MDR, ICH, IEC, and cGMP regulations for diagnostic, medical device, biotech, pharma, and life science applications.
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Served 12+ years in management roles with P&L responsibilities, building and leading global multi-site cross-functional teams of 5 to 60+ engineers, scientists, operators, and managers with diverse backgrounds and managing budgets ranging from $1M to $100M+ in both fast-paced, matrix structured startups and large corporations with $60B+ in revenue.
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Developed and launched over 170 innovative products, 50+ FDA-approved and award-winners, covering a wide range of equipment and consumables with supporting assay integrations, reagents, and software/apps ,as well as $10B+ production lines; led these projects from concept through development, launch, manufacturing, and full product life cycle management.
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Honored with the U.S. Medical Design Excellence Award for leading the development and launch of ePlex at GenMark Diagnostics, which became an industry benchmark and contributed to a $1.8B acquisition by Roche, world’s #1 provider of diagnostics.
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Functioned as startups founder and executive, responsible for making key decisions, influencing executives and KOLs, driving more than $500M in executed services, spinoffs, and M&As, and raising over $200M for fundraising, grants and technology transfers.
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Distinguished subject matter expert affiliated with professional organizations, with a strong network and over 100 patents, publications, prestigious awards, and invited scientific and business lectures.
In response to Covid-19 pandemic, I am so proud to see FDA clearance on addition of the Covid test to my ePlex work at GenMark Diagnostics (Roche)! This brings great impact to health and safety of our community and humankind all around the globe.
17+
Years
Experience
$10B+
Product
Lines
30+
Awards &
Honors
50+
FDA or CE
Approvals
170+
Launched Products
70+
Patents & Publications
BACKGROUND
ePlex System developed at GenMark Dx
After completing his post-doctorate, Hamed focused his efforts on transferring his knowledge and expertise to the biotech and diagnostic industry. He worked in Orange County and San Diego, two hot spots in this field, and dedicated himself to inventing state-of-the-art technologies that have a significant impact on saving lives through early diagnosis and modern treatment methods. He successfully developed and launched over 150 products, many of which comply with FDA and CE/ISO regulations and continue to have a significant impact on patients' lives and healthcare needs to this day.
Following his graduation with a Ph.D., Hamed completed a fellowship at the School of Medicine at the University of California, Irvine (UCI) in 2007. During his fellowship at UCI, he collaborated with several institutions, including the Beckman Laser Institute and Medical Clinic in Irvine. In 2010, he completed his post-doctorate at the University of North Carolina (UNC) at Chapel Hill, the highest ranked institution in his field. He also received multiple post-doctoral offers from Stanford University and UC-Berkeley. At UNC, he worked on several collaborative projects between the Department of Chemistry (Analytical Division, Professor Nancy Allbritton's group), Biomedical Engineering, Pharmacology, Radiation Oncology, Pathology, Genetics, the Carolina Center of Cancer Nanotechnology Excellence, the NC Cancer Hospital, and the Lineberger Comprehensive Cancer Center. In collaboration with world leaders in Microfluidics at UNC, such as Professor Michael Ramsey in Microfluidics, Professor Klaus Hahn in Pharmacology, and Professor Oliver Smithies, the 2007 Nobel Laureate in Medicine, Hamed developed cutting-edge devices, new technologies, and microfluidic-based systems and consumables for a variety of in-vitro diagnostics, point-of-care, clinical, and biotech applications.
Lab-on-a-Chip Concept
Professor Oliver Smithies, 2007 Nobel Laureate in Medicine (Postdoctoral Study)
Sean O'Keefe, former NASA Chief & LSU Chancellor (Doctoral Study)
In 2002, Hamed joined Professor Steve Soper’s group (now a Distinguished Professor at the University of North Carolina at Chapel Hill), a world leader in microfluidics technology, at Louisiana State University in Baton Rouge. He began his doctoral work on developing microfluidic systems and consumables for proteomic and genomic analyses of clinical and biological samples. His Ph.D. work involved active participation in several institutions, including the Center for Advanced Microstructures and Devices (CAMD), the world's largest synchrotron radiation research center, and the Center of Bio-Modular Multiscale Systems (CBM2). In 2006, Hamed was selected as one of three honorable Ph.D. candidates in North America by the American Chemical Society and received several prestigious national and international awards for his doctoral research and presentations. He completed his Ph.D. in 2006, and his publications have been highly cited (2000+) and acknowledged and featured by other leaders and professionals in the field.
Hamed was also a national champion for the World Chemistry Olympiad in 1991. He graduated as the top student of the Class of 1997 with a bachelor's degree with highest honors from the Chemistry Department of the University of Guilan. In the same year, he began his master's education at Polytechnic University and graduated as the top student of the Class of 2000 with a master's degree with highest honors from the Department of Chemical Engineering. In 2000, he founded Arya Chem, Inc., which he managed and expanded as CEO for a few years.
MEDIA
Representatives of products that Hamed has been involved with their development, launch and commercialization
SELECTED PATENTS, PUBLICATIONS & AWARDS
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Hamed Shadpour, Alex Smith, et al. "Auto-calibration pH sensor", U.S. Patent 18/224878, 2023.
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Hamed Shadpour, George Wu, et al. "Microfluidic determination of low abundance events", U.S. Patent 11,059,044, 2021.
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Hamed Shadpour, Sean Ford, et al. “Devices and methods for monitoring and controlling temperature in a microfluidic environment”, U.S. Patent 11,156,508, 2021.
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Hamed Shadpour, George Wu, et al. "Microfluidic determination of low abundance events", U.S. Patent 10,960,394, 2021.
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Single cell microfluidics system enables direct functional screening of therapeutic antibodies, Yonglei Shang, Hamed Shadpour, George Wu, et al. 15th Annual PEGS Summit, Boston, MA, April 2019.
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Functional screening of immunotherapeutics using innovative AmberFlow single cell platform technology, George Wu, Hamed Shadpour, Weian Zhao, et al. 15th Annual PEGS Summit, Boston, MA, April 2019.
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Hamed Shadpour, Sean Ford, et al. “Devices and methods for monitoring and controlling temperature in a microfluidic environment”, U.S. Patent 9,945,738, 2018.
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Hamed Shadpour, Steven A. Soper, et al. “Polymeric nanopillars and nanotubes: their manufacture and uses”, U.S. Patent 9,718,676, 2017.
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Hamed Shadpour, Nancy L. Allbritton, et al. “Systems and methods for isolating cells in cell colonies in culture ”, U.S. Patent and Trademark Office, PCT Int. Appl., WO 2010-068743.
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Hamed Shadpour, Jon Zawistowski, Annadele Herman, Klaus Hahn and Nancy L. Allbritton, “Patterning micropallet surfaces for cell selection based on high-resolution measurements of fluorescence biosensors”, Analytica Chimica Acta, 696 (2011) 101-107.
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Hamed Shadpour and Nancy L. Allbritton, “In-situ roughening of polymeric microstructures”, ACS Applied Materials and Interfaces, 2 (2010) 1086-1093.
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Hamed Shadpour, Christopher E. Sims and Nancy L. Allbritton, “Enrichment and expansion of cells using antibody-coated micropallet arrays”, Cytometry A, 75 (2009) 609-618.
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Hamed Shadpour, Christopher E. Sims, Randy J. Thresher and Nancy L. Allbritton, “Sorting and expansion of murine embryonic stem cell colonies using micropallet arrays”, Cytometry A, 75 (2009) 121-129, Special Issue, Invited.
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Yuli Wang, Georgina To’a Salazar, Jeng-Hao Pai, Hamed Shadpour, Christopher Sims and Nancy L. Allbritton, “Micropallet arrays with poly(ethylene glycol) walls”, Lab-on-a-Chip 8 (2008) 734-740.
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Hamed Shadpour and John K. Osiri, “Toward point-of-care microchip profiling of proteins,” Bioanalysis, 2 (2010) 1745-1754, Special Issue/Invited Review, (recommended by the Editorial Board as Best Articles of the Year), also served as the Corresponding Author.
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John Osiri, Hamed Shadpour and Steven A Soper, “Ultra-fast two-dimensional microchip electrophoresis using SDS µ-CGE and microemulsion electrokinetic chromatography for protein profiling”, Analytical and Bioanalytical Chemistry, 398 (2010), 489-498.
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John Osiri, Hamed Shadpour, Sunjung Park, Brandy Snowden, Zhi Chen and Steven A Soper, “Generating high peak capacity 2-dimensional maps of complex proteomes using poly(methyl methacrylate) microchip electrophoresis”, Electrophoresis, 29 (2008), 4984-4992, Cover Article.
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Annie Obubuafo, Subramanian Balamurugan, Hamed Shadpour, David Spivak and Steve Soper, “Poly(methyl methacrylate) microchip affinity capillary gel electrophoresis of aptamer-protein complexes for the analysis of thrombin in plasma”, Electrophoresis 29 (2008), 3436-3445, Special Issue, Invited.
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Hamed Shadpour, Mateusz L. Hupert, Changgeng Liu, Donald Patterson, Michelle Galloway, Wieslaw Stryjewski, Jost Goettert and Steven A Soper, “Multichannel microchip electrophoresis device fabricated in polycarbonate with an integrated contact conductivity sensor array”, Analytical Chemistry, 79 (2007) 870-878, Reported as one of Most Accessed Articles.
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Hamed Shadpour and Steven A. Soper, “Two-dimensional electrophoretic separation of proteins using poly(methyl methacrylate) microchip”, Analytical Chemistry, 78 (2006) 3519-3527, Hot Article, Featured in: Analytical Chemistry’s A-Pages, June 1, 2006, p.3489, and Journal of Proteome Research, 5(7), 2006, p.1521.
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Hamed Shadpour, Harrison Musyimi, Jifeng Chen and Steven A. Soper, “Physiochemical properties of various polymer substrates and their effects on microchip electrophoresis performance”, Journal of Chromatography A, 1111 (2006) 238-251, Special Issue, Invited.
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Mateusz Hupert, Jason Guy, Shown Llopis, Hamed Shadpour, Sudeer Rahni, Dimitris Nikitopoulos and Steven Soper, “Evaluation of micromilled metal mold masters for the replication of microchip electrophoresis devices”, Microfluidics and Nanofluidics, 3 (2007) 1-11.
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Hong Wang, Jifeng Chen, Li Zhu, Hamed Shadpour, Mateusz L. Hupert and Steven A. Soper, “Continues flow thermal cycler microchip for DNA cycle sequencing”, Analytical Chemistry, 78 (2006) 6223-6231.
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Jifeng Chen, Musundi Wabuyele, Hengwu Chen, Donald Patterson, Mateusz Hupert, Down Patterson, Hamed Shadpour, Dimitris Nikitopoulos and Steven A. Soper, “Electrokinetically-synchronized polymerase chain reaction microchip fabricated in polycarbonate”, Analytical Chemistry, 77 (2005) 658-666.
Complete list of over 100 patents, publications, and lectures is available upon request.
SELECTED AWARDS & HONORS
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Newly launched products globally ranked as Top Sellers and Featured Products, 2022-2024
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Achieved the Best Fiscal Year in company's 50-year history as Head of R&D, Halma plc, 2022
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Small Business Innovation Research (SBIR) Phase II Award, NSF, 2020
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Small Business Innovation Research (SBIR) Phase I Award, NSF, 2019
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U.S. Medical Design Excellence Award for design and development of ePlex, 2017
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Innovation Award, GenMark Diagnostics, 2014
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Best Articles of the Year, Bioanalysis (Editorial Board), 2010
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Referee for multiple Grant Review Panels and Peer-Reviewed Journals, 2006-2010
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Chair, Gordon Conference Organization, Featured in Science Magazine, 319, 2008, p.5863, 2007-2008
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Nobel Prize in Medicine awarded to Professor Oliver Smithies, while performing collaborative research in his lab at UNC, 2007
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Multiple major NIH Grants Awarded in support of Postdoctoral Fellowship, 2007-2010
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Several Publications featured in top journals and selected as Hot Article, Cover Article and Most Cited Article, 2006-2010
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Honorable Ph.D. Candidate of the year in U.S. and Canada, 2006
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Rohm and Haas Award for Excellence in Research and Development, 2006
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Multiple major NIH and NSF Grants Awarded in support of Doctoral Study, 2003-2006
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Travel Awards in support of Presenting Doctoral Research, 2004-2006
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Best Presentation Awards at International Conferences, 2004-2006
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Graduate Research Fellowship, 2002-2006
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Tuition Waiver Award, 2002-2006
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Production of Magnetic Recording Materials for the First Time in the Country (Featured by several Newspapers and Public Media), 2000
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Young Entrepreneurs of the Year, 2000
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Top Graduate of the Class in MS Degree (Polytechnic University, Ranked #1 Program in the Country), 1999
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Top Graduate of the Class in BS Degree (University of Guilan, Ranked Top 10 Programs in the Country), 1997
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National Champion for World Chemistry Olympiad, 1991
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High School Diploma with Highest Honor received at age 16​
EXPERTISE
New Product, Technology &
Business Development
Benchtop, Portable, Wearable &
Implant Systems
Systems & Consumable Engineering,
Assay & Device Integration
Advanced MEMS/NEMS &
Electro-Mechanical & Optical Systems
Design Control & Regulatory
(FDA, EMA, MDR, ISO, CE, IEC, ICH, GMP)
Strategic Planning, Roadmap,
Tech. Transfer & M&A