(Automated Immunoassays)
(MSD-Multiplex ECLIA)
(SPR Biomarker Interactions)
(ImmunoCAP)
(Western Blot Imager)
(Immune Cell Cytokine Release)
(Low Volume Automated ELISA)
(Multiplex Immunoassay)
SAN DIEGO LAB
~34,000 sq. ft.
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
~265,000 sq. ft.
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
~22,000 sq. ft.
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
~2,900 m2 (31,000 sq. ft.)
Assay Development
Validation
Sample Analysis
Global Disease Studies
MELBOURNE LAB
2,777 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
BRISBANE LAB
1,566 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
Explore the capabilities of each platform in more detail to learn which option will be best for your unique study. Our team is available for specific guidance on platform selection.
On this episode of Molecular Moments, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
Share This 
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
Share This 
In this article, Chief Scientific Officer at BioAgilytix, Jim McNally, Ph.D., explores why bioanalysts should prepare for the impending wave
Share This 
Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
Share This 
A3P Biomedical AB, a Swedish company specialized in advanced prostate cancer diagnostics, and BioAgilytix, a global bioanalytical services provider, have
Share This 
BioAgilytix Commits to United Nations Global Compact Leading bioanalytical services provider pledges to act in support of human rights
Share This The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
Share This 
An Overview of Cell Therapy: As we continue our blog series on cell and gene therapy, we will now dive
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An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of
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(Automated Immunoassays)
(MSD-Multiplex ECLIA)
(SPR Biomarker Interactions)
(ImmunoCAP)
(Western Blot Imager)
(Immune Cell Cytokine Release)
(Low Volume Automated ELISA)
(Multiplex Immunoassay)
SAN DIEGO LAB
~34,000 sq. ft.
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
~265,000 sq. ft.
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
~22,000 sq. ft.
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
~2,900 m2 (31,000 sq. ft.)
Assay Development
Validation
Sample Analysis
Global Disease Studies
MELBOURNE LAB
2,777 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
BRISBANE LAB
1,566 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
Explore the capabilities of each platform in more detail to learn which option will be best for your unique study. Our team is available for specific guidance on platform selection.
On this episode of Molecular Moments, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
Share This The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
Share This In this article, Chief Scientific Officer at BioAgilytix, Jim McNally, Ph.D., explores why bioanalysts should prepare for the impending wave
Share This Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
Share This A3P Biomedical AB, a Swedish company specialized in advanced prostate cancer diagnostics, and BioAgilytix, a global bioanalytical services provider, have
Share This BioAgilytix Commits to United Nations Global Compact Leading bioanalytical services provider pledges to act in support of human rights
Share This The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
Share This An Overview of Cell Therapy: As we continue our blog series on cell and gene therapy, we will now dive
Share This An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of
Share This
Vice President & General Manager, BioAgilytix San Diego
President, 360biolabs
Vice President, Business Development, BioAgilytix Europe
Vice President & General Manager, BioAgilytix Boston
Chief Technology Officer
Vice President, Business Development
General Manager, BioAgilytix Europe
Vice President & General Manager, BioAgilytix Durham
Executive Vice President, Commercial, 360biolabs
Chief Financial Officer
Chairman and Chief Executive Officer
Chief Scientific Officer
Executive Vice President, Scientific Operations, 360biolabs
Senior Vice President, Quality
Chief Operating Officer
Vice President & General Manager, BioAgilytix Durham
Scientific Officer,
Senior Director
Scientific Officer,
Executive Director
Chief Scientific Officer
Scientific Officer,
Director
Scientific Officer,
Senior Director
2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699
37 Kent St, Woolloongabba
Queensland, 4102, Australia
2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699
37 Kent St,Woolloongabba
Queensland, 4102, Australia
1320 Soldiers Field Road
Boston, MA, 02135
617-456-0700
Fax 617-456-0701
1320 Soldiers Field Road
Boston, MA, 02135
617-456-0700
Fax 617-456-0701
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
85 Commercial Road, Melbourne
Victoria, 3004, Australia
+61 3 9282 2184
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
85 Commercial Road, Melbourne
Victoria, 3004, Australia
+61 3 9282 2184
Copyright © 2023 BioAgilytix Labs.
All rights reserved.
2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
5927 S. Miami Blvd. Suite 100
Morrisville, NC 27560
919-381-6097
Fax 919-381-6099
1320 Soldiers Field Road
Boston, MA, 02135
Office 617-456-0700
Fax 617-456-0701
9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
37 Kent St, Woolloongabba
Queensland, 4102, Australia
85 Commercial Road, Melbourne
Victoria, 3004, Australia
03 9282 2184
Copyright © 2023 BioAgilytix Labs.
All rights reserved.
Terms of Use | Privacy Notice
2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
5927 S. Miami Blvd. Suite 100
Morrisville, NC 27703
919-381-6097
Fax 919-381-6099
1320 Soldiers Field Road
Boston, MA, 02135
617-456-0700
Fax 617-456-0701
9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
37 Kent St,Woolloongabba
Queensland, 4102, Australia
85 Commercial Road, Melbourne
Victoria, 3004, Australia
03 9282 2184
Copyright © 2023 BioAgilytix Labs.
All rights reserved.
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. 
Co-founder of 360biolabs with more than 20 years’ industry experience in collaborative pharmaceutical R&D and management, Alistair has a background in medicinal chemistry and a track record of leading teams that have successfully translated drug candidates into the clinic. Alistair ensures operational and quality management system best practice is applied to all studies we support. Vice President, Business Development, BioAgilytix Europe
Stephane oversees the commercial team in Europe and is instrumental in building BioAgilytix’s market presence in the region.
Stephane has over two decades of commercial experience in life sciences as a chemist and in Business Development. Most recently, he served at Nuvisan Pharma Services as Chief Sales Officer, managing the sales function across all business lines. Previously he worked for Citoxlab – Charles River, leading Business Development, supporting services expansion and growth, as well as creating strategic alliances with industry partners.
Stephane holds a Master of Business Administration from HEC Paris, France, and a Master of Sciences, in Analytical Chemistry from Birkbeck College, University College London, UK.
Franck leads the BioAgilytix Boston lab with a dedication to innovative bioanalytical testing and on-time delivery of regulatory-compliant data. Franck also oversees client engagement and satisfaction and manages the day-to-day operations of the business and facility.
Franck is a highly skilled scientist with nearly three decades of professional experience. His areas of scientific expertise include immunogenicity, biomarkers, cell-based assays, toxicology, and in-vitro GLP testing of pharmaceuticals and medical devices. For nearly nine years (1998 to 2007), he was an instructor and researcher at the Harvard Medical School teaching hospital, Beth Israel Deaconess Medical Center in Boston, investigating novel biomarkers and gene regulation.
Prior to joining BioAgilytix in 2019, Franck directed the scientific services and research efforts at Cambridge Biomedical and Toxikon Corporation. He earned his doctoral degrees in Pharmacy and in Molecular Biology at the Paris-Sud University in France.
Dave is responsible for the BioAgilytix strategic technology vision and overseeing the information technology (IT) team and structure that supports data integrity and business goals. He drives innovation while supporting current operational needs across the company’s entire portfolio of enterprise technology.
Dave has nearly 25 years of IT experience, most of it gained in regulated environments, specifically in the pharmaceutical manufacturing and lab services sectors. He has managed digital transformation, and has a depth of knowledge of electronic laboratory notebooks (ELNs), laboratory information management systems (LIMs), enterprise resource planning systems (ERPs), data security, risk mitigation, and business applications.
Before joining BioAgilytix, Dave was Vice President, Information Technology at Alcami Corporation, where he focused on operational excellence. Prior to that, he held IT leadership roles at BestCo, Endo Pharmaceuticals, Tandem Diabetes Care, and Johnson & Johnson.
Dave earned his master of business administration (MBA) degree at the University of North Carolina in Chapel Hill, and his bachelor of science (BS) degree in computer science at Arcadia University in Glenside, PA.
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. 
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. 
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. 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.
Chief Financial Officer
Maureen Marchek is the Chief Financial Officer for BioAgilytix and is responsible for the strategy, planning, and execution of the enterprise’s financial and accounting operations. She is a critical member of the team, ensuring strategic alignment with a focus on exceptional customer experience for our sponsors.
Maureen has over twenty years of experience in financial operations primarily in the biopharmaceutical and life sciences sectors. Maureen was most recently the Vice President of Finance for Clario (formed from the merger of ERT and Bioclinica). Previously, as Chief Financial Officer for Bioclinica, Maureen was instrumental in the success of the ERT and Bioclinica integration. She has supported transformative organic and inorganic growth while instituting financial disciplines and operational excellence across the broader enterprise. Earlier in her career, Maureen spent twelve years with PwC (PricewaterhouseCoopers) in Philadelphia, PA.
She is an alumnus of Villanova University, where she received her Bachelor of Science in Accounting and subsequently completed the work required to obtain the CPA qualification.
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. 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. 
Dr. Linda Robbie Is Chief Operating Officer And Leads All Global Operations Teams To Ensure Operational Efficiency Inclusive Of Effective Resource Management And Continuous Process Improvement.
She has more than 25 years of experience with biomarker assay technologies, including 20 years of experience in scientific leadership positions. She was previously Vice President and General Manager, Boston Operations and Senior Vice President of Science and Laboratory Operations at Cambridge Biomedical, joining the BioAgilytix leadership team when the company was acquired 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 Immucor, 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 earned 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.
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. 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. 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. 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. Scientific Officer, Senior Director
Robert provides scientific and regulatory consultation, focusing on our EU team and customers, to help guide bioanalysis supporting drug development.
Spending over fifteen years working in regulated (GLP/GCP) laboratory environments, Robert supports preclinical and clinical drug development programs, with broad experience in bioanalysis, immunogenicity, and biomarkers. He joined BioAgilytix from Labcorp Drug Development’s Scientific Affairs team, where he partnered with clients, operations, and other scientists to address science, technology, and regulatory challenges. Prior to this, Robert led the bioanalytical laboratory team at Swiss biotech company Novimmune.
Robert holds his Ph.D. in Molecular Physiology and B.Sc. with Honours in Pharmacology from the University of Edinburgh.
