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.
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.
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.
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.
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.
Just prior to joining BioAgilytix, he served as Executive Vice President, Global Business Development, Commercial at Syneos Health, where he led the overall strategic direction of the global business development team for the commercial division both in the U.S. and internationally. He was also previously Head of U.S. Sales for the Neuroscience Business Unit at Amgen, Inc. and prior to that Global Commercial Head, Amgen Biosimilars. Nick has also held executive-level commercial and business development positions at Sandoz Biopharmaceuticals (a Novartis company) and Quintiles Translational Corporation.
Nick is a member of the Health Policy and Management Executive Council at the Harvard T.H. Chan School of Public Health and is a University of Southern California Adjunct Associate Professor of Pharmaceuticals and Health Economics for the School of Pharmacy. He received his Bachelor of Science in Pharmacy from the Philadelphia College of Pharmacy and is a registered pharmacist with a current active licensure.
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.
Steve 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.
Just prior to joining BioAgilytix, he served as Senior Vice President, Finance & Treasurer at Syneos Health, a CRO/CCO based in Raleigh, North Carolina. He has also held senior-level finance positions at M*Modal, a medical transcription company, and Edwards Lifesciences, a medical device manufacturer, as well as with Fortune 500 companies. He has successfully participated in and completed numerous capital raising and M&A transactions, and possesses diverse management and leadership experience in the areas of corporate finance, treasury, tax, risk management, accounting, and financial planning and analysis. He is a CPA and holds an MBA with a concentration in International Business from the University of Toledo.
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.
Mark brings more than 20 years of experience as a senior HR professional in biopharma manufacturing and professional services. Prior to joining BioAgilytix, Mark held global HR and operational leadership roles in a wide variety of organizations, including WasteZero, inVentiv Health, Pfizer, and Quintiles. His core strengths include recruiting top industry talent and designing incentive compensation schemes, operational dashboards, and training curriculum.
Mark has a B.S. and MAcc in Accounting from Brigham Young University.
As Vice President of Global Business Development at BioAgilytix, Beth focuses on cultivating and managing both strong client relationships and strategic partnerships worldwide to ensure the company is able to continue to scale its growth in both USA and Europe. Since joining BioAgilytix in 2015, she has been instrumental in leading the business development team to achieve record growth backed by strong operational processes. Beth has a degree in Biology from Southern Illinois University.
Having led complex projects across various companies in the pharmaceutical and biotechnology industries, Sean has proven his capabilities in executing critical IT strategies and guiding international, cross-functional, and multi-organizational teams. He is the former Director of Information Systems at BioCryst Pharmaceuticals, where he led the strategic planning, execution, and oversight of innovative policies and procedures for all Information Services department functions in support of short- and long-term business goals and in compliance with all applicable federal regulations.
Sean has a BS in Information Systems Management from the University of Maryland Baltimore County, and he maintains three certificates: a Masters Certificate in Advanced Information Assurance and Security from Villanova University, and certificates in Risk and Information System Control ™ (CRISC) and Certified Information Systems Auditor® (CISA) from the Information Systems Audit and Control Association (ISACA).
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