Leading BioAgilytix to Exceed Expectations

Science-Minded, Integrity-Driven, Results-Focused

Meet Our Team

Mark Bethers

Chief of Staff

As Chief of Staff, Mark is involved in shaping the company’s overall corporate talent strategy, working closely with the entire leadership team to ensure human resources needs are met across the organization.

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.

Sean Blake

Chief Information Officer

Sean Blake has more than 20 years of IT leadership experience in technology operations, project management, systems implementation, and application support, with extensive expertise in regulatory compliance including 21 CFR Part 11, Sarbanes-Oxley, FISMA, and FDA regulations.

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).

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 35+ 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 Degree at The Wharton School at The University of Pennsylvania.

Christie Knittel Mabry, Ed.D, BCC

Chief People Officer

Dr. Christie Knittel Mabry has 20+ years of experience in Human Resources and Leadership Development. She has worked in six different industries in a variety of leadership roles including financial services (GE Capital), software (SciQuest), higher education (former Assistant Professor of HR and Director of Admissions at Peace College), supply chain management (GPI / CARQUEST), health care (Blue Cross Blue Shield of NC), and biotechnology (Biogen).

She spent the most recent 15 years of her career at Biogen, most recently as the HR Leader for Biogen’s Global Quality, Global Regulatory CMC, and Asset Development and Program Management organizations. Prior, she led Leadership Development efforts for Biogen where her team ran the corporate talent review process. Christie developed the Communities of Practice concept at Biogen which is now syndicated across the world.

She is a graduate of “Art and Practice of Leadership Development” at the Harvard Kennedy School of Government and earned her Executive and Business Coaching Certification from Duke University’s Executive Coaching Program. She holds three degrees from North Carolina State University including a BA in Communication, and MA in Organizational Development and a Doctorate in Adult Education / Human Resource Development.

Dominic Marasco, R.Ph.

Chief Commercial Officer

Dominic “Nick” Marasco has more than 22 years of executive experience in C-suite strategy development, commercial operations, strategic business development, alliance management, and financial resourcing within the Pharmaceutical, Biotech and Medical Device industries.

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.

Steven M. Michael, Ph.D.

Senior Vice President & Chief Operating Officer

Dr. Michael 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, 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.

Nathan Speicher

Chief Financial Officer

Nathan Speicher is the Chief Financial Officer for BioAgilytix and is responsible for the strategy, planning and execution of the enterprise’s financial and accounting operations. He is a seasoned leader with over 16 years of experience spanning a variety of roles with a particular focus on the biopharmaceutical and pharma services sectors.

Before joining BioAgilytix, Nathan was the Chief Financial Officer for NationsBenefits, a leading supplemental benefits provider serving the managed care space and recognized as one of the fastest growing scaled healthcare assets in the US.

Previously, Nathan worked at PPD (now Thermo Fisher Scientific) where most recently he served as Chief Commercial Officer for the laboratory services business and held several other roles including Senior Vice President of Finance, where he led the company’s FP&A, Treasury, Capital Markets, and Investor Relations functions. Nathan and his team were heavily involved in the company’s 2020 initial public offering, which represents one of the largest and most successful healthcare IPOs listed on Nasdaq in over a decade. Before PPD, Nathan was the Treasurer for Acelity, a medical device company now part of 3M and earlier in his career served as a Vice President at Morgan Stanley, where he focused on raising capital for clients in the healthcare and biopharmaceutical sectors.

He earned his bachelor’s degree in Finance from the University of Connecticut.

Dave Beyerlein

Vice President & General Manager, BioAgilytix San Diego

David F. Beyerlein has over 20 years of experience managing laboratory operations, is an experienced analytical chemist, and is highly skilled in the use of the mass spectrometer. David co-founded BioAgilytix San Diego with Gil in 1998. As General Manager, he is responsible for overseeing and managing all laboratory operations, project and sample management, and purchasing. Prior to co-founding BioAgilytix San Diego, David was part of the mass spectrometry group at Covance’s facility in Madison, Wisconsin. Before joining Covance, he was a Senior Research and Development Scientist the Madison facility of PPD where he started their Bioanalytical LC/MS/MS Department. David received his bachelor’s degree in Chemistry from the University of Wisconsin – Eau Claire.

Chad Briscoe, Ph.D.

Vice President, Business Development Europe

As Vice President of Business Development in Europe, Dr. Briscoe provides scientific and regulatory oversight to BioAgilytix’s European team with strategic guidance in line with emerging scientific developments. A seasoned scientific executive, he brings nearly 25 years of experience leading operational and scientific innovation in the bioanalytical and biomarker segments of the pharmaceutical industry.

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 chromatography. He also has a Master’s degree from the University of Michigan and Bachelor’s degree from Alma College in Michigan.

Kennon Broadhurst

Vice President, Global Marketing

Kennon joins BioAgilytix having more than 26 years of experience in sales, marketing and product commercialization experience within the Pharmaceutical and Biotech industries.

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.

Daniel Brooks, MBA

Vice President, Operational Excellence

Danny Brooks overseas the global team that manages the company’s pricing, strategy, proposals and project management. Since joining BioAgilytix in 2008, he has served on several key M&A integration teams, including when BioAgilytix purchased IPM, CBI, MicroConstants and 360biolabs®. He also led the team that launched the current BioAgilytix accounting system used by all locations today. Danny earned his MBA from Duke University and his bachelor’s in business from the University of North Carolina at Chapel Hill.

Jose V. Buenviaje

Vice President, Quality Assurance

Jose V. Buenviaje has over 27 years of research, analytical, and manufacturing experience in the biotechnology industry and more than 25 years of experience with Quality Assurance Compliance related to cGLP and cGMP regulations. As Vice President of Quality Assurance, Jose serves as the executive quality authority in all interactions with Regulatory representatives. He is also responsible for the creation, compliance, and deployment of BioAgilytix San Diego global quality system, including internal GLP policies and procedures consistent with internationally recognized standards. Prior to joining BioAgilytix San Diego in 1999, Jose was the Quality Assurance Supervisor at Syntron Bioresearch, a licensed Medical Device Establishment in Carlsbad, California. Before Syntron, Jose spent five years working in the field of forensic chemistry and has testified as an expert witness in the field of toxicology for numerous cases for the state of California. Jose received his bachelor’s degree in Biology/Psychology from the University of California, San Diego.

Alistair Draffan

Executive Vice President, Business Operations, 360biolabs

Jim Datin is a seasoned executive with significant experience in the Pharmaceutical, Life Sciences and Biotech industries. Over the course of his 35+ 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 Degree at The Wharton School at The University of Pennsylvania.

Kara Harrison

Vice President, Quality Assurance & Corporate Compliance

Kara Harrison is an experienced Quality Professional with more than 25 years of experience in Clinical Research, Quality Assurance, and Regulatory Compliance.

She started her career as a Field Investigator with the US Food and Drug Administration, concentrating in BIMO program audits and inspections, and has experience in nearly every type of development environment, including IRB and academia. To her, Quality is not just a job title, it is a collaboration between colleagues.

Beth Heinz

Vice President, Business Development

Beth has more than 18 years of commercial experience with a background in strategic pharma as well as several years of in-laboratory experience. She also has technical expertise in genomics and proteomics applications.

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.

Frank Horling, Ph.D.

General Manager, Europe

Dr. Frank Horling brings nearly 20 years of scientific and leadership experience in the pharmaceutical and biotechnology industry, specializing in bioanalytical strategy and regulatory support up to market authorization with a strong focus in the area of immunogenicity.

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.

David Johnson

Senior Director, DMPK

David A. Johnson has over 20 years of experience implementing and managing preclinical drug discovery contract research services. In 2000, he joined BioAgilytix San Diego, establishing the Drug Metabolism group which is responsible for preclinical drug metabolism research and non-GLP discovery bioanalytical research. Previously, David was the Drug Metabolism Product Development Manager for the Pharmazyme division of Immune Complex Corporation. Prior to Pharmazyme, David was a Research Assistant at Hybritech where he developed methods to automate the radiolabeling of monoclonal antibodies for use in medical diagnostic kits. He received his bachelor’s degree in Chemistry from the University of California, San Diego and his Ph.D. from the University of Minnesota, Twin Cities.

Kathryn Lindley

Vice President, Operations

Kathie has over 20 years of experience in academia and industry at UNC-Chapel Hill and GlaxoSmithKline. She has a wide range of experience in cell-based and immunoassay development by utilizing platforms, including ELISA, ELISpot, MSD, DELFIA, RIA, and FMAT.

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.

Angela Luttick

Executive Vice President, Commercial, 360biolabs

Co-founder of 360biolabs and Executive Director, Angela leads business development and future expansion activities. Angela has extensive drug discovery pharmaceutical experience and expertise in early phase drug discovery through to IND filing. With a background in virology and the combination of technical expertise and business acumen, Angela understands a client’s requirements from the initial engagement.

Melinda Pryor

Executive Vice President, Scientific Operations, 360biolabs

Co-founder of 360biolabs with a wealth of experience in the design and implementation of large multi-centre international clinical trials. Melinda has more than 25 years’ experience in molecular virology and immunology and leads our high performing clinical team. Melinda is focussed on delivering regulatory compliant data and providing expert clinical support to our clients.

Linda Robbie, Ph.D.

Vice President and General Manager, Boston Operations

Dr. Linda Robbie is Vice President and General Manager, Boston Operations, and responsible for leading all bioanalytical services at BioAgilytix’s Boston, MA laboratory. She directs all initiatives as they relate to science, technology, and laboratory operations.

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.

Afshin Safavi, Ph.D.

Founder & Board Member

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 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.

Dave Williams, Ph.D.

Vice President, Bioanalytical Operations

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.

Marianne Scheel Fjording, Ph.D.

Scientific Officer, Executive Director

Dr. Marianne Scheel Fjording has more than 25 years of experience within pharmaceutical and biotech companies, and brings extensive knowledge about bioanalytical assay development and regulated assay validation. Her previous role was at Novo Nordisk where she was Scientific Director implementing biomarkers in clinical trials and ensuring assays were validated for the intended use of data.

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. Dr. Fjording received her Ph.D. in intracellular signalling and MSc in biochemistry from the University of Copenhagen in Denmark.

Amanda Hays, Ph.D.

Scientific Officer, Senior Director

Dr. Amanda L. Hays offers more than a decade of lab experience in multiple fields, including pharmacology, drug metabolism, immunoassays, immunogenicity, biomarkers and flow cytometry. She has particular expertise leading clients from pre-clinical through phase III clinical trials and post-marketing studies.

Prior to joining BioAgilytix, she served as Director of Bioanalytical Science at PRA Health Sciences, where she provided global scientific leadership and technical guidance for PRA’s large molecule bioanalytical laboratory. Dr. Hays is the Vice Chair of the AAPS Biomarkers and Precision Medicine Community and has held several volunteer leadership positions through the AAPS in the last several years. She earned her Ph.D. in Pharmacology from the University of Kansas Medical Center in Kansas City, KS.

Lynn Kamen

Scientific Officer, Executive Director

Lynn Kamen earned her Ph.D. in Immunology at the University of Michigan and completed a postdoctoral fellowship at the University of California San Francisco. She has spent the past decade working in drug development supporting both large and small molecule formats from early target discovery through clinical development. Most recently, she was a principal scientist at Genentech where she supported large molecule and novel modality bioanalysis including PK, immunogenicity, and biomarker.

Jim McNally, Ph.D.

Chief Scientific Officer

Dr. McNally has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry.

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.

Michelle Miller, Ph.D. DABT

Scientific Officer, Director

Dr. Michelle Miller has over a decade of experience working in the fields of immunology and toxicology.  She has a strong background in project management, previously serving as a bioanalytical Associate Director at BioAgilytix.  Prior to BioAgilytix, Michelle worked as a study director leading GLP toxicology and immunotoxicology studies, as a lead investigator in the toxicology field developing high throughput screening assays, and as an R&D scientist in the pharmaceutical industry. She is a current Diplomate of the American Board of Toxicology.

In her prior role at BioAgilytix, Michelle worked closely with clients and operational staff to assure successful on-time execution of assays, validation, and sample analysis under GxP, supporting preclinical, clinical, and product release studies. Michelle earned a BA in Chemistry, BS in Zoology, and Ph.D. in Immunology with a minor in Biochemistry from North Carolina State University.