Our Leadership

Leading BioAgilytix to Exceed Expectations.

Our integrity-driven leadership underpins and emphasizes a culture of commitment, collaboration, and scientific excellence – delighting customers with exceptional results.

Meet Our Leadership Team

Jim Datin

Jim Datin

President & Chief Executive Officer

Jim Datin is a seasoned executive with significant experience in the Pharmaceutical, Life Sciences and Biotech industries. Over the course of his 25+ year career, Jim has been a successful CEO, director, and executive in companies throughout the United States, Europe, and Asia. He is a proven leader and operator with deep experience leading emerging companies through periods of growth.  Jim was previously EVP and Managing Director at Safeguard Scientifics, Inc. (NYSE:SFE) where he led the team that invested capital into Life Sciences and Healthcare related companies.  He is a former Chairman of the Board of Clarient, a cancer diagnostics company that was acquired by General Electric for over $580M, the former Chairman of the board of Laureate Pharmaceuticals, a large molecule Contract Manufacturing firm that achieved great growth and had a strong exit, along with multiple other Life Sciences / Healthcare boards where he created significant value.  Jim was the former CEO of Touchpoint Solutions, CEO of Isuta, Group President at Dendrite International and was an executive with GlaxoSmithkline and Baxter Healthcare.  He received his BBA from Marshall University, his MBA from the University of New Haven; and completed the Advanced Management Program at The Wharton School at The University of Pennsylvania.

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Afshin Safavi, Ph.D.

Afshin Safavi, Ph.D.

Founder & Global Chief Scientific Officer

Dr. Afshin Safavi is a veteran biochemist with extensive experience establishing and leading bioanalytical teams in pharmaceutical, biotechnology, and manufacturing companies, as well as contract research organizations.  He and his teams have supported the development of a broad range of therapeutics in pre-clinical and clinical-trial laboratories.  Prior to founding BioAgilytix, he was the Director of Ligand Binding and Immunoassay, operating under GLP at AAIPharma.  At Talecris BioTherapeutics, he led the Preclinical and Clinical Assay Development team, building on his experience as a senior scientist at Nobex Corporation, GlaxoSmithKline and IGEN International.

Dr. Safavi is considered an expert in the area of immunoassays, with a wide working knowledge of various platforms.  He obtained his B.S. in Biochemistry from UCLA, his Ph.D. in Biochemistry from the University of Kentucky’s Medical School (Department of Biochemistry), and he completed a two-year postdoctoral assignment at Emory University’s Department of Pathology.

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Arno Kromminga, Ph.D.

PD Dr. Arno Kromminga

Senior Vice President & European Chief Scientific Officer

PD Dr. Arno Kromminga is a certified specialized immunologist with 20+ years expertise covering the entire cascade of assay strategy and characterization of immune responses against biological therapeutics. He co-founded IPM Biotech in 1996 for the research of chronic inflammatory diseases. Since then, he led the company to become a pioneer in the area of immunogenicity, and brought the first biosimilar EPO to approval in Europe, as well as supported the first biosimilar EPO submission in the U.S. IPM Biotech was acquired by BioAgilytix in 2016, becoming BioAgilytix’s European headquarters with Dr. Kromminga as Senior Vice President & European Chief Scientific Officer.

Dr. Kromminga is an esteemed senior expert in autoimmunity, allergy, and other immune mediated diseases, including assay development and clinical interpretation of laboratory parameters. He is also a co-founder and board member of the European Immunogenicity Platform (EIP), and member of multiple scientific societies including the American Association of Pharmaceutical Scientists (AAPS), German Society of Immunology (DGfI), German Society of Clinical Chemistry and Laboratory Medicine (DGKL). As a world-leading authority in the area of immunogenicity, he is invited to speak at numerous international scientific conferences and has authored multiple peer-reviewed scientific publications in journals and text books.

Dr. Kromminga has a Ph.D. in Biochemistry from the University of Münster, and is an Associate Professor at the Institute of Immunology, University of Kiel, Germany.

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Jeff Sailstad

Jeff Sailstad

USA Chief Scientific Officer

Jeff Sailstad has over 35 years of experience working with pharmaceutical and biotechnology organizations to develop, validate, and apply regulatory-compliant methods for biological and immunochemistry assays. He is a world-renowned thought leader in the development and application of bioanalytical methods used in regulatory submissions, and is specifically skilled in mentoring scientific teams on how to meet increased regulatory requirements as they move projects from research to full development.

Prior to his role at BioAgilytix, Jeff was a scientific consultant for both biotechnology and major pharmaceutical companies in the requirements for successful regulatory submissions of bioanalytical data related to immunogenicity, biomarkers, PK/PD, biosimilarity, and bioassays and potency testing. He was also formerly Manager of Bioanalytical Chemistry for Trimeris, Inc., and was the RTP Site Head for GlaxoSmithKline’s Pharmacodynamic Exploratory Research Lab (PERL). Jeff has a B.S. in Chemistry from North Carolina State University and is a frequent, sought-after contributor for industry whitepapers and publications.

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Todd Lynch, CPA

Todd Lynch, CPA

Senior Vice President & Chief Financial Officer

As Senior Vice President & Chief Financial Officer at BioAgilytix, Todd guides the company’s financial, IT, and HR strategies. He brings more than 23 years of experience in biotechnology, big pharma, clinical diagnostics and contract research organizations ranging from pre-revenue to Fortune 500 companies. Prior to joining BioAgilytix, he was Chief Financial Officer at Metabolon, the world leader in the field of metabolomics, where he helped successfully engineer the purchase of complimentary research technology company, Lipomics. He was also VP of Global Finance – Clinical Division at Inveresk Research, where he led due diligence and integration activities involved in several acquisition opportunities, and was responsible for financial oversight for the global clinical division related to the company’s IPO and sale to Charles River Laboratories.

Prior to Inveresk Research, Todd held six diversified roles during a 10-year tenure at GlaxoSmithKline. Key experiences included sales, marketing and global R&D finance support, licensing and strategic planning. Todd is also a Certified Public Accountant with Big 4 accounting experience. He graduated Magna Cum Laude from East Carolina University with a B.S. in Accounting.

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Steven M. Michael, Ph.D.

Steven M. Michael, Ph.D.

Senior Vice President and Chief Operating Officer

Steve is an accomplished executive with over 20 years of successful experience working in the Biotechnology and Pharmaceutical industries for companies focused on research and development.  He possesses a unique skill set including people leadership, scientific expertise, and business acumen. His pharmaceutical industry experience includes drug discovery, drug development, and research technology with a focus on bioanalytical research, translational research, biomarkers, and leadership development.

Before his role with BioAgilytix, Steve was an executive at Covance Inc. for 5 years where he served in a number of capacities, including Vice President, Global Drug Metabolism & Pharmacokinetics, DMPK. Previously, he served as an Executive Director of Bioanalytical Research & Compliance and Senior Director of Translation Research in Worldwide Pharmacokinetics, Dynamics & Metabolism at Pfizer Global Research and Development. He has been published in various scientific publications, including Analytical Chemistry, Journal of Pharmaceutical and Biomedical Analysis, and International Journal of Mass Spectrometry and Ion Process. He is a member of the American Society of Mass Spectrometry and the American Association of Pharmaceutical Scientists. Steve received a doctorate in analytical chemistry from the University of Michigan.

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Dominique Gouty, Ph.D.

Dominique Gouty, Ph.D.

Senior Vice President, Business Operations

Dr. Dominique Gouty is the Senior Vice President of Business Operations at BioAgilytix, where she holds key roles in both technical and commercial biopharmaceutical services.  She has over 20 years of industry experience and a career spanning R&D, clinical operation, and manufacturing in multiple multi-national pharmaceutical organizations such as Eli Lilly and J&J, as well as smaller biotech companies, and CROs.

Dr. Gouty is the leading expert in key subjects concerning preclinical and clinical bioanalysis for novel therapeutic biologics and biosimilars. Dr. Gouty is regularly invited to present at conferences and publishes key articles and ebooks concerning effective routes to robust and rigorous immunoassays.  She has extensive experience ensuring strict GLP compliance for bioanalytical assays and has expert knowledge on the evolving FDA, EMA, and other regulatory agencies.

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Anita Simkins

Anita Simkins

Vice President, Global Quality Assurance

Anita has a combination of 23 years of experience working within CLIA, ISO, GMP, GLP and GCP environments within pharmaceutical, diagnostic, biotechnology and Clinical Research Organizations. She has developed and implemented Quality Management Systems in compliance with US/EU regulations and has had extensive Quality Assurance GxP experience in regard to the manufacturing of vaccines and small molecules, and bioanalytical analysis. As a Quality Assurance Manager at previous companies (BioCryst, AlphaVax and Trimeris), Anita provided leadership and direction to ensure critical quality points were identified and monitored. She also has worked at two CROs, Kendle and Quintiles, as a clinical auditor, and at GlaxoSmithKline, where she provided practical and theoretical expertise for the development and validation of Immunogenicity testing. Anita has a BS in Clinical Laboratory Science from East Carolina University and maintains two certifications: American Society of Clinical Pathology and Register Quality Assurance Professional- GLP. She is also a member of the Society of Quality Assurance and currently a Director of Issues and Methods on the North Carolina Chapter of the Society of Quality Assurance.

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Craig Overton

Craig Overton

Director, IT & Facilities

Craig is a dedicated technology leader and Certified Lean Six Sigma Black Belt with over 15 years of successful experience leveraging industry leading IT technologies to drive, support, and deliver evolving business initiatives within a diverse range of industries such as Energy, Financial Services, Pharmaceutical, and Semiconductor. He is a team builder that champions change and provides innovative planning/implementation of business strategies. His key strengths include administration, lean architecture, and virtualization.

Prior to BioAgilytix, Craig was an IT Infrastructure Manager at Xerox for over 6 years where he was responsible for redesigning and architecting the infrastructure for the Commercial Vehicle and Revenue Services line of business, as well as, managing the infrastructure within 5 office locations and several different datacenters. Craig received his Bachelor of Science in Information Technology from the Rochester Institute of Technology (RIT).

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Monica Coleman

Monica Coleman

Senior Director, Finance

Monty Coleman is a licensed Certified Public Accountant in North Carolina with over 24 years of accounting and finance experience.  Monty began her career in public accounting with KPMG, LLP and progressed to roles of increasing responsibilities within a broad spectrum of industries.  As Financial Reporting Manager at Raleigh Federal Savings Bank, she was responsible for Regulatory and Securities and Exchange Commission reporting, as well as Shareholder Relations.  In Monty’s capacity as Business Analyst for Progress Energy, she was a member of a six-person Accounting Unit responsible for all external and internal financial reporting of the 7000+ employee company.  She was awarded the Company’s PACE and Key Performer awards for her efforts in leading various accounting project teams.  Monty also served as Accounting Manager for Investors Title Insurance Company, where she was responsible for all accounting operations, as well as Securities and Exchange Commission reporting.

Monty joined BioAgilytix after serving as the Company’s interim Controller on a consulting basis for over two years through Rankin McKenzie, LLC, a Financial Management firm.  While a consultant with Rankin McKenzie, Monty served as interim Controller for numerous entrepreneurial companies over a span of eight years.  Monty received a B.S. in Business Administration (emphasis in Accounting) with honors from Wingate University.  She is a member of the American Institute of CPAs and the North Carolina Association of CPAs.