On this episode of Molecular Moments, Chad Briscoe speaks with Dr. David Berkowitz, Director of the Division of Chemistry at
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, Quality Assurance & Corporate 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.
Chief Scientific Officer
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.
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.
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.
Vice President & General Manager, BioAgilytix San Diego
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.
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.
Vice President, Business Development
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.
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.
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.
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.
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
Scientific Officer, Director
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.