Thank you This live web event has ended. Thank you for attending. Contributors Jim McNally, Ph.D. Jim McNally, Ph.D. is Chief Scientific Officer for BioAgilytix, a premier large molecule CRO. 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 led 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. 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. Rafiq Islam, MS Rafiq Islam is the Regional Vice President for the Pharmaceutical Development Services division responsible for scientific and operational leadership of bioanalytical operations in Gaithersburg, MD, and Ewing, NJ. Prior to joining Smithers, he was the Executive Director of small and large molecule bioanalytical services at Celerion Inc. He also serves as the chairman of the scientific advisory board for Somru Bioscience Inc. Previously, he served as the Scientific Director for Biopharma Services at EMD Millipore (MO, USA). He held similar positions as the head of a bioanalytical department at Covance Inc. (AZ, USA) and Huntingdon Life Sciences (NJ, USA). He also held several positions of increasing responsibility with Curagen Corporation. He has over 20 years of biotechnology and CRO industry experience. He has authored and contributed to more than 50 articles, industry whitepapers, and numerous posters on the topic of regulated bioanalysis, biomarker, immunogenicity, and biosimilars. Katy Matys Katie Matys has over 15 years of experience in the pharmaceutical industry. Prior to moving to PPD, she worked with several large pharma companies. In 2002, Katie started with Centocor in the core molecular and flow cytometry laboratories and transitioned to Merck in 2005. At Merck, Katie was part of the Vaccine Sciences Department, developing and validating ligand binding methods in support of Gardasil®. In 2009, she joined PPD and has held a variety of roles and titles, with the most recent as Senior Director, the General Manager of the Biomarker group. Katie earned a B.S. degree in Molecular Biology from Temple University, M.S. degree from St. Joseph in Cell and Molecular Biology and her EMBA from Drexel University. Amanda Hays, Ph.D. 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. Dave Williams, Ph.D. Dave Williams, Ph.D. is currently the Vice President of Bioanalytical Operations at BioAgilytix. He is responsible for the oversight of cell based and molecular assays at BioAgilytix's headquarters in Durham, NC. Dave has his Ph.D. in toxicology from the Univerisity of Kansas Medical Center. In Dave's 20+ year career he has worked at several CROs in the field of bioanalysis supporting preclinical and clinical studies.