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.
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.
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.
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.
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 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.
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.
Prior to joining BioAgilytix, Dr. Pine was Associate Director of Non-Clinical and Translational Sciences at Allergan, where he worked closely with drug safety scientists to develop novel protein therapeutics for ocular, neurologic, urologic, and dermatologic indications. He also garnered experience developing vaccines for a variety of infectious diseases through his previous positions with the Infectious Disease Research Institute, the HIV Vaccine Trial Network/Fred Hutchinson Cancer Research Center, and Novartis. Today Dr. Pine holds a patent as the co-inventor of “Composition and methods for stimulating an immune response against infectious agents”, has been published in numerous scientific journals, and actively contributes his insight to regulatory submission documents and peer-reviewed manuscripts.
Dr. Pine received his BA in Molecular, Cellular and Developmental Biology from the University of California at Santa Cruz, and his Ph.D. from the University of Washington, Department of Global Health.
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.
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