Management


Mamuro “Mark” Kubota - President and CEO

Sysmex Inostics GmbH | Sysmex Inostics Inc.

Executive Officer, Executive Vice President, Life Science Business | Sysmex Corporation

Over 30 years of experience leading Clinical Assay Development/ Regulatory Affairs and Business Development for Innovative Cancer Precision Medicines

  • Currently in charge of Global Clinical Development/ Marketing of lymph node metastatic IVD assay system, Laboratory Developed Testing Business expansion and a head of Life Science Business in Sysmex Corporation in Japan.
  • Basic Research, Assay Development, Clinical Development and Regulatory Affairs for bio-therapeutics in Kirin Brewery Company (now Kyowa-Hakko Kirin Pharma.) for 10 years.
  • Development of fully human antibody therapeutics with Abgenics (later acquired by Amgen) and Research and Development of lung cancer vaccines in Pharmaceutical Div. of JT Inc. for 10 years.
  • B.A. in Molecular Biochemistry from Kyoto University in Japan.

Dr. Frank Diehl - Senior Vice President, Development & Operations for Laboratory Developed Tests

Sysmex Inostics GmbH

Develop and implement proprietary and innovative biomarker testing services that are instrumental for the molecular analysis of human cancer.

  • Senior Vice President and responsible for Laboratory Test Development and Global Laboratory Operations.
  • Dr. Diehl and his former colleagues from The Johns Hopkins University founded Inostics, which is the first biotech company to focus on circulating tumor DNA-based liquid biopsy testing. During his PhD study at The Johns Hopkins University, he played a pivotal role in the development of the liquid biopsy field and DNA-based molecular technologies.
  • Graduate degree in Molecular Pathology from the University of Heidelberg and the German Cancer Research Center (DKFZ).
  • Received for his contributions several awards, including the 2017 AACR Team Science Award. He also authored several high impact publications in the liquid biopsy field.



Masaki Nishino - Executive Vice President

Sysmex Inostics Inc.

Focus on corporate strategy and planning for 15 years in healthcare industry

  • Business Strategy and Planning including Commercial Affairs at Sysmex Inostics, working on annual plan/ governance and management/ involvement in key business areas (e.g. Kit development, Business Development, etc.)
  • Corporate Business Planning at Sysmex Corporate with a focus on annual plan/ mid-term plan/ governance and management/ Post Merger Integration support (e.g. Partec and Inostics)
  • Corporate and business strategy, M&A/PMI, corporate governance at Takeda Pharmaceutical
  • Marketing strategy and product management at Novartis and investment banking at European financial firm
  • MA in International Affairs, Columbia University

Katie Gazdacka, CPA - Vice President, Finance & Administration

Sysmex Inostics Inc.

Accomplished financial professional with strong business acumen, most notably in the healthcare / life science industries

  • Global Finance and Administration responsibilities for Sysmex Inostics.
  • Knowledge and application of technical accounting topics under US GAAP and IFRS; legal entity board governance and compliance matters; consolidated reporting; short-term and long-range forecasting including financial modeling and product launch strategies; M&A; treasury and banking; tax areas such as corporate income tax, state tax and annual reporting, sales / use tax, and transfer pricing; cost accounting including inventory valuation and standard cost setting; internal auditing and S-Ox compliance assessments; risk management duties reviewing and setting entity risk policy and insurance needs.
  • Director of Finance, Sears Holdings
  • Controller, Motorola
  • Certified Public Accountant
  • Masters of Business Administration
  • Bachelor of Science in Accountancy

Jerzy Macioszek - Vice President, Product Development

Sysmex Inostics GmbH

30 years of experience in development of diagnostic assays, instrumentations, assay and system integration, microfluidics.

  • Responsible for multiple development projects which resulted in successful commercialization of 11 FDA approved diagnostic assays and a launch of 5 different instrumentation platforms, including class 3 devices.
  • Prior work experience in Abbott Laboratories, Gen-Probe, Qiagen and GenMark Dx.
  • Author of 9 patents and numerous publications.
  • MS in Chemical Engineering, Warsaw Polytechnic in Poland.
  • MS in Molecular Biology, University of Illinois in US.

Dr. Karen Rodriguez - Senior Director Production and Supply Chain Management

Sysmex Inostics Inc.

  • Oversee global manufacturing, quality control, procurement, warehousing and distribution operations as well as technical support for Laboratory Developed Test and IVD Kits at Sysmex Inostics.
  • Recruited engineering and advanced statistics skill sets to department.
  • Global lead for chemistry and manufacturing controls at Astellas Pharma with oversight for manufacturing process  development, transfer and approval, including extensive regulatory experience.
  • Group leader in different roles at Abbott Diagnostics for immunoassay business, including blood-screening products and cancer diagnostics (high-risk device classification).
  • BS in Biology (minor in genetic biology) from Purdue University.
  • PhD in Biochemistry, Molecular Biology and Cell Biology from Northwestern University.

Susan Petersen - Interim Director Quality Assurance, Regulatory and Clinical Affairs


Sysmex Inostics Inc.


Supports compliance of Sysmex Inostics Quality Management Systems for ISO 13485, ISO 9001, GCP and CLIA  at Hamburg, Germany; Baltimore, Maryland; and Mundelein, Illinois sites.

•    27 Years of cross functional experience supporting the life cycle of regulated invitro diagnostic tests including:
•    US 510(k) submissions
•    CE Mark, Technical File, Declaration of Conformity
•    Certified Auditor
•    Supplier and OEM Controls
•    World Wide Corrections and Removals, Risk Control
•    Manufacturing Process Development

•     BS Biochemistry, University of Wisconsin

•     MBA classes, Lake Forest Graduate School of Management

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