Rich Rogers: President
Dr. Rich Rogers received his Ph.D. from the Johns Hopkins University in 2003. His research focused on SUMO modification of transcription factors. As a post doc, Rich joined the Institute for Systems Biology. At the ISB, Rich expanded his research on post translational modification by applying mass spectrometry to detect phosphorylation and other ubiquitin-like modifications in macrophages. In 2012, Rich joined the Analytical Sciences group at Amgen. At Amgen, Rich developed a mass spectrometry based multi-attribute method (MAM) for biotherapeutic characterization and release from QC. In 2015, Rich joined Just Biotherapeutics where he continued his work on MAM and started the MAM Consortium. In 2019, Rich joined BMS, in Seattle, where he applied the principles of MAM for cell-based therapies. Recently, Rich joined Umoja Biopharma as the Head of Process Analytics.
Da Ren: Vice President
Dr. Da Ren is the founder and CEO of BioTherapeutics Solutions, an analytical solution provider for the biopharmaceutical industry. Prior to starting BioTherapeutics Solutions, he was a Scientific Director at Amgen in charge of analytical platforms and global strategy of the Multi-Attribute Method (MAM). In 2015, he led the first-in-industry implementation of MAM in the cGMP environment. Since then, MAM has been accepted by over 30 regulatory agencies around the world. Da is on the advisory board of several companies and serves multiple roles in industry-wide organizations including USP, CASSS, ASMS, and MAM Consortium. Prior to Amgen, Da was a Senior Applications Chemist at Waters Corporation. He received his Ph.D. in Analytical Chemistry from the University of Akron in 2002.
Carly Daniels: Secretary
Dr. Carly Daniels is a Senior Principal Scientist and Group Leader at Pfizer in St. Louis. She received her BS in chemistry, with a biochemistry focus, at the University of Florida in 2009. She received her PhD in biochemistry and molecular biology at UCLA in 2014. In 2014, Carly joined the US FDA as a postdoctoral fellow. During her time at UF, UCLA, and FDA she focused on development of mass spectrometry techniques to study proteins and medicines. Since 2015, Carly has been at Pfizer in the Biotherapeutics Pharmaceutical Sciences Analytical R&D division, focusing on method development for a variety of biotherapeutic modalities through all stages of development. She currently leads a team of scientists, co-leads the Pfizer Multi-Attribute Method (MAM) team, and leads analytical programs for conjugate and mRNA vaccines.
Doug Richardson: Treasurer
Dr. Douglas Richardson is a Distinguished Scientist in Analytical Research and Development (AR&D) within Merck Research Labs (MRL) located in West Point, PA. His current role focuses on providing scientific leadership across the AR&D organization at Merck. More specifically, Doug is responsible for developing scientific strategy and investments with pipeline impact, spanning a wide range of assets across all modalities, ranging from early discovery research to product development and commercialization. Additionally, Doug focuses on the development of the diverse organization talent to accelerate the progress of their development plans and career opportunities through scientific mentorship. Prior to his current role Doug was Director of Mass Spectrometry within AR&D. This role focused on leading the Mass Spectrometry teams across small molecule API, biologics, and vaccines characterization across MRL. This pipeline leadership has enabled progress for both the clinical pipeline from discovery through development as well as commercial product advancements. Research efforts within this team span a variety of disciplines including automation, two dimensional liquid chromatography (2D-LC), multi attribute method (MAM), hydrogen deuterium exchange (HDX), elemental speciation, and proteomics to enable Host Cell Protein (HCP) control strategy. Doug’s research interests have also included efforts to expand the large molecule Process Analytical Technology (PAT) toolkit to progress current and future biologics manufacturing platforms. As an extension of these research efforts Doug is an active contributor to a variety of external collaborations and consortia including the Indiana Center for Bioanalytical Metrology and NIIMBL. Doug earned his B.S. in Forensic Chemistry with a minor in Biological Sciences from Ohio University in 2003. In 2007 he received his Ph.D. in Analytical Chemistry from the University of Cincinnati in the lab of Dr. Joseph A. Caruso.
Chris Yu: Board Director
Dr. Christopher Yu is a Principal Scientist and Director in Protein Analytical Chemistry Quality Control department at Genentech, with 20+ years of biopharma industry experience. He has broad knowledge in analytical development in CMC setting, and is a recognized expert in applications of state-of-the-art mass spectrometry technologies in analysis of protein therapeutics. His current responsibilities include analytical method validation and transfer to support clinical product development and marketing authorization applications.
John Schiel: Board Director
Dr. John Schiel received his BS (2004) and Ph.D. (2009) in chemistry from the University of Nebraska-Lincoln, and is currently a research chemist in the NIST Biomolecular Measurement Division. Dr. Schiel coordinates the development of Reference Materials that support the biomanufacturing industry, including the recombinant IgG1κ NIST monoclonal antibody Reference Material 8671 (NISTmAB). He also leads an analytical research team developing innovative approaches toward production/characterization of next generation biotherapeutics (e.g. viral vectors, cell therapy products, and vaccines) and de-risking of innovative technologies for lifecycle appropriate implementation and regulatory assimilation. He is an author of over 30 publications, an editor of the ACS book series “State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization”, and recipient of numerous Awards including the Arthur S. Flemming Award, Department of Commerce Gold Medal, ACS Division of Analytical Chemistry Fellowship, Bioanalysis Young Investigator Award, and UNL Early Achiever Award.