Dr. McNally brings with him an extensive background in bioanalytical assay development and program leadership working for almost 20 years in the pharmaceutical and biotechnology industry. His prior roles at Genzyme, Pfizer, EMD Serono, Shire and CRISPR Therapeutics have given him broad experience in the development of large molecule, gene therapy and cell therapy biotherapeutics. He is a 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. Dr. McNally has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue.
Dr. McNally’s role at BioAgilytix will be to advise on emerging scientific developments and provide scientific and regulatory guidance. He will continue to work across the industry to drive the development of regulations and guidance for bioanalytical testing representing BioAgilytix’s experience and expertise in these areas. “I am so excited to have the opportunity to join the amazing BioAgilytix team and to collaborate with so many scientists both internally and externally,” said Dr. McNally. “I look forward to continuing to drive exceptional science and compliance for all of our clients across the industry.”
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With US headquarters in North Carolina’s Research Triangle area, a laboratory in Boston, Massachusetts, and European headquarters in Hamburg, Germany, BioAgilytix provides global services for biomarkers, immunogenicity, PK, and cell-based assays supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e. product release testing, stability testing, etc.). We also offer diagnostic testing services through our Boston laboratory.
The Bioanalytical Laboratory Achieves Exclusive Ranking for a Seventh Time
OCTOBER 14, 2019—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has been named by Triangle Business Journal as a Fast 50 Award winner for 2019, marking the seventh time the organization has been recognized as one of the fastest growing privately held companies in the Triangle Park area. The Fast 50 Awards celebrate companies that have exhibited remarkable growth in the past three years and honor their contributions to creating new jobs and stimulating cash flow in their community. Previously included on the Fast 50 list in 2018, 2017, 2016, 2014, 2013, and 2011, BioAgilytix has continued to methodically grow its capacity and team to meet the rising demand for large molecule bioanalysis and efficiently serve the biologic development needs of pharmaceutical and biotechnology companies worldwide.
“I could not be happier for our team’s efforts to be recognized because they are the ones that have enabled BioAgilytix to become the premier bioanalytical services provider it is today,” said Jim Datin, President and Chief Executive Officer of BioAgilytix. “Our reputation for quality science and committed service have had a huge impact on our growth as both existing and new customers have the confidence to place more critical studies in our capable hands. In 2018, we supported 8 of the 18 large molecule drugs that were approved by the FDA – a huge testament to our team’s ability to meet our customers’ study demands efficiently and with the quality required to accelerate needed therapeutics to market.”
This past July, BioAgilytix completed a new expansion to its Durham, NC campus which grew the facility footprint an additional 21,173 square feet to accommodate its growing team and additional testing services for biologicals including cell and gene therapeutics. “We’re proud to have our US headquarters located in RTP and to have been a part of the Triangle’s growth for more than 10 years,” added Datin. “Its reputation as an innovation hub has been key in our recruitment efforts, giving us a great talent pool to source from as well as the ability to attract individuals outside of our region to join this vibrant scientific community.”
BioAgilytix will receive its list ranking with the other 2019 Fast 50 winners at an awards dinner to be held on November 20, 2019 at the Raleigh Convention Center in Raleigh, North Carolina.
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e. product release testing, stability testing, etc.).
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to many of the top global pharmaceutical and biotech companies. For more information, visit bioagilytix.com.