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.
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).
Prior to joining BioAgilytix, he was executive director of global bioanalytical science for a large contract research organization, where he was responsible for global laboratory scientific strategy including team leadership and key client relationship oversight.
Dr. Briscoe is a recognized global expert and thought leader in areas including regulated bioanalysis, analytical instrument qualification, and biomarker analysis with immunoassays, flow cytometry, and genomics techniques. He is also a sought-after speaker at industry events such as WRIB, the Global CRO Council, Land O’ Lakes, Global Bioanalysis Consortium, APA, APS, CPSA, and ASMS, and is often requested to participate in industry forums as a collaborator and mentor.
Dr. Briscoe holds a Ph.D. from the University of Nebraska where he studied protein binding interactions using immunoaffinity chromatograpy. He also has a Master’s degree from the University of Michigan and Bachelor’s degree from Alma College in Michigan.
Prior to joining BioAgilytix, he served as Managing Partner at the Bilgola Group, which specializes in marketing and product commercialization consulting for the life-science industry. He was also previously Global Marketing Lead for Oncology and Hematology Biosimilars at Amgen. As an accomplished pharmaceutical executive, he has extensive knowledge of global marketing, business development, alliance management and market access across multiple therapeutic areas. Kennon has demonstrated a record of commercial innovation, strategic insights and developing highly motivated teams at several top-tier pharmaceutical companies. Kennon holds a BA in Economics from Carleton College and an MBA in Marketing from the University of Michigan’s Ross School of Business.
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.
Dr. Fjording is an expert in regulated bioanalysis and brings project management and regulatory guidance to the team. Dr. Fjording is a member of the Expert Working Group (EWG) for ICH M10 Bioanalytical Method Development and has previously been on the steering committee for the European Bioanalysis Forum (EBF). At EBF she was the driver of several topic teams. Dr. Fjording received her Ph.D. in intracellular signalling and MSc in biochemistry from the University of Copenhagen in Denmark.
As Vice President of 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.
Just prior to joining BioAgilytix, Dr. Horling worked at IMC University of Applied Sciences Krems in Austria where he was Co-Head of the Research Institute for Applied Bioanalytics and Drug Development. Preceding that role he was the Associate Director of R&D at Shire and has also held senior scientific management positions at Baxalta and Baxter Healthcare.
As General Manager, Europe at BioAgilytix, Dr. Horling leads Operations, Finance, HR, and Facilities Management for BioAgilytix’s European business and its laboratory located in Hamburg, Germany. He also provides scientific leadership to our European team in progressing new drug candidates through all phases of development for multiple therapeutic areas including immunology, oncology, rare diseases, and gene therapy.
Dr. Horling received his Ph.D. from the University of Bielefeld in Physiology and Biochemistry and his MSc in Toxicology from the Medical University Vienna.
Since then, he has 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.
Kathie is also an expert in the use and interpretation of BIAcore technology due her extensive experience in developing high throughput primary antibody screens using the BIAcore A100. She has developed and holds patents on several monoclonal antibodies that are being progressed as therapeutic agents for sarcopenia, breast cancer, and osteoarthritis.
Since coming to BioAgilytix Labs, Kathie has developed and validated biomarker and immunogenicity assays, both cell-based and plate-based, under GLP regulations. Additionally, her work has been published in peer-reviewed journals, and she has been an invited speaker at national and international meetings. Kathie has a bachelor’s degree from Meredith College and a master’s degree in Microbiology and Immunology from UNC-Chapel Hill.
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.
Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he lead a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics.
Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance.
Dr. McNally obtained his B.S. in Biology from Mississippi State University, his Ph.D. Viral Immunology from Louisiana State University School of Medicine in Shreveport, and his Post-Doc in Viral Immunology from University of Massachusetts Medical School.
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, Dr. Michael 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.
Dr. Michael 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. Dr. Michael received his doctorate in analytical chemistry from the University of Michigan.
Prior to joining BioAgilytix, Dr. Nicholson spent nearly 13 years at Precision BioSciences where he held several leadership roles, including Executive Director of Scientific Operations, Vice President of R&D, and Senior Vice President of Research. Dr. Nicholson played a key role in developing Precision’s novel gene editing platform and led research teams focused on allogeneic CAR T therapies and gene editing-based gene therapies. Additionally, Dr. Nicholson led Human Resources for over 2 years as Chief People Officer.
Dr. Nicholson earned his BS in chemistry from SUNY Brockport, his PhD in molecular biology and genetics from the Johns Hopkins School of Medicine and carried out postdoctoral research at the University of North Carolina, Chapel Hill.
Dr. Robbie ensures operational efficiency inclusive of effective resource management and continuous process improvement, and leads the development and validation of biomarker/bioanalytical assays across a range of technologies, including immunoassay (single and multiplex), flow cytometry, cell-based assays and targeted genomics. She has more than 25 years of experience with biomarker assay technologies, including 20 years of experience in scientific leadership positions. She was previously Senior Vice President of Science and Laboratory Operations at Cambridge Biomedical, and joined our leadership team when the company was acquired by BioAgilytix in November 2019. Dr. Robbie has held prior roles at Quintiles, where she was responsible for establishing the Q2 Solutions/Quintiles global assay development business from the ground up, and with Immuncor, a biotechnology company engaged in the development and automation of new assays to benefit the blood transfusion industry.
Dr. Robbie held a post-doctoral research fellowship in Cardiovascular Science at Harvard Medical School as a member of the distinguished research team in Dr. Peter Libby’s laboratory, and has a Ph.D. in Immunology and Hematology from the University of Aberdeen and a BSc with Honors in Biochemistry from Heriot-Watt University in Edinburgh.
Prior to founding BioAgilytix in 2008, 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.
She has developed and implemented Quality Management Systems in compliance with domestic and international regulations and has had extensive Quality Assurance GxP experience in regard to the manufacturing of vaccines and bioanalytical analysis of small and large molecules. 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 on the North Carolina Chapter of the Society of Quality Assurance Executive Council.
Dave has over 15 years of experience in bioanalysis and drug safety.
Prior to joining the BioAgilytix team in 2017, he worked as an Associate Director of Science at PRA Health Sciences and as a Senior Scientist at Viracor-IBT Laboratories, Inc. Dave is an author of more than 25 peer-reviewed manuscripts and book chapters, and is also a committee member of the AAPS Flow Cytometry Action Planning Committee. Dave received his Bachelor’s Degree in Biochemistry from University of Kansas and his Ph.D. in Toxicology from the University of Kansas School of Medicine.
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.
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