As Chief Medical Officer Dr. Ticho is responsible for Stoke’s efforts to develop first-in-class RNA based disease-modifying medicines to treat severe genetic diseases. He is also co-founder and former CEO of Verve Therapeutics which is developing therapies to edit the genome and confer protection from cardiovascular disease. Prior to joining Stoke Barry was Head of R&D for Cardiovascular and Metabolic Diseases at Moderna Therapeutics. He was previously Head of External R&D Innovation for Cardiovascular and Metabolic Diseases at Pfizer and was Vice President of Clinical Development at Biogen. Barry obtained his MD and PhD degrees from the University of Chicago. He was on staff at Harvard Medical School and Massachusetts General Hospital

Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office of New Drug Products (ONDP) at the FDA. Before FDA, Ben spent seven years in pharmaceutical R&D at Pfizer and Merck. Ben received a Ph. D. in Chemistry from the University of Pittsburgh, a M.P.H. from the Johns Hopkins and is a co-author of over 20 publications and patents.

Dr. Bart Rogers is a reviewer in the Division of Translational and Precision Medicine in the Office of Clinical Pharmacology (OCP) at the FDA. Dr. Rogers also serves as an active duty officer with the United States Public Health Service. He serves as the lead for OCPs review of all synthetic oligonucleotides. His research interests are focused on the pharmacology of synthetic oligonucleotides, orphan disease drug development, and pharmacogenomics. Dr. Rogers completed his Pharm.D. degree from the University of Maryland, School of Pharmacy in 2004. He went on to obtain his Ph.D. in Clinical Pharmaceutical Sciences with a focus on cardiovascular pharmacogenomics from the same institution.

Andrew began his career in industry over 20 years ago and has spent the last 17 years in Regulatory Affairs. He’s had the fortune of being a part of many great teams who have brought seven novel therapies to market for a variety of conditions. This includes the first four RNAi therapeutics. Andrew holds degrees from Bates College, Massachusetts College of Pharmacy and Health Sciences, and Babson College.

Dr. Sydney Stern is a clinical pharmacology reviewer in the Division of Translational and Precision Medicine (DTPM) in the Office of Clinical Pharmacology (OCP) at the FDA. She is a primary reviewer for oligonucleotide programs and rare diseases in OCP and she has extensive experience with in vitro/in vivo extrapolation. Dr. Stern has led several data projects in the rare disease space and research projects investigating strategies for selecting safe starting doses in oligonucleotide-based therapeutic. Her research interests are focused on the pharmacology of synthetic oligonucleotides and rare diseases. She received her Master of Science in Clinical Research and a Ph.D. in Pharmaceutical Sciences at University of Maryland Baltimore.

I received my PhD in toxicology from Karolinska Institutet, Stockholm in 2003. Joined AstraZeneca R&D in Gothenburg in 2004 as a toxicologist supporting Cardiovascular and Metabolic drug projects in the Discovery phase. Since 2012 focusing on nucleotide drugs, including oligonucleotides and mRNA therapeutics. Currently leading the preclinical safety activities for oligonucleotides and targeted drug delivery in AstraZeneca as well as different mRNA applications.

Dr. Elena Braithwaite is a toxicologist at the US Food and Drug Administration and a Diplomate of the American Board of Toxicology. She has a broad background in various aspects of basic research including DNA repair, mutagenesis and signal transduction.

Dr. Chi is a Supervisory Pharmacologist in the Office of Cardiology, Hematology, Endocrinology and Nephrology, CDER FDA. Prior to that, she was a senior consultant in the Federal Healthcare Practice at Deloitte Consulting LLP and her projects were focused on post-marketing drug safety, data warehouse and review modernization effort. She had also worked as a staff fellow at Office of Blood Review and Research, CBER FDA. She is specialized in analyzing data from toxicological, pharmacological and clinical studies of original NDAs, BLAs, INDs, and 510(k)s. She had Ph.D. in molecular genetics from Baylor College of Medicine and had postdoctoral training in molecular genetics and pathology at Columbia University Medical Center.

Ramin Darvari is a Research Fellow in Drug Product Design & Development group at Pfizer; contributing to the strategic and tactical planning for evaluation of external delivery technologies and internal delivery formulation & process development, with a focus on collaborative partner engagement. Ramin has lent his expertise in particle engineering and matrix-based drug delivery systems to evaluation and development of variety of applications, including his role as the drug product project lead for Pfizer-BioNTech Covid-19 Vaccine.

Dr. René Thürmer received his diploma in chemistry and his Ph.D. in biochemistry from the University of Tübingen. He joined the BfArM (Federal Institute for Drugs and Medical Devices, Bonn, Germany) in 2000. He currently serves as a CMC reviewer and is Deputy Head of the Unit Pharmaceutical Biotechnology. His experience is in the field of formulation, manufacture and control of medicinal products, in particular in the field of peptides, proteins, liposomes, sustained release polymer drug products, depot formulations, polymer-conjugated drug products, natural and synthetic surfactants, nanomedicine and others. His special focus lies on oligonucleotide preparations.

Dominik Altevogt is an experienced professional in the pharmaceutical industry, with over 15 years of experience leading regulatory submissions and health authority interactions for small molecule drugs, with a special focus on synthetic peptides and oligonucleotides. He started his career in CMC regulatory affairs at Bachem AG and has since worked for F. Hoffmann-La Roche AG and Novartis AG. Dominik holds a Ph.D. in organic chemistry from the University of Freiburg, Germany, and is an active member of the European Pharma Oligonucleotide Consortium (EPOC), where he currently leads the platform strategies subteam.

Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination products. As Assistant Director – Injection Devices at FDA, she managed reviewers and set technical and regulatory expectations for combination products and drug delivery devices. Before FDA, Rumi worked in R&D for a number of years at Genentech and AstraZeneca. She holds a Bachelor’s in Chemistry and Chemical Biology and a Masters in Material Science Engineering from Cornell University.

Dr. Katherine Windsor is a Senior Pharmaceutical Quality Assessor (Drug Substance Lead) in the Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER) at FDA. Katherine has 10 years of experience assessing CMC aspects of drugs in several therapeutic areas, particularly anti-infectives and antivirals, and a wide variety of APIs, including oligonucleotides, peptides, antibody-drug conjugates, and small molecules. Katherine conducted postdoctoral research at Vanderbilt University and obtained her Ph.D. in Organic Chemistry from the University of Wisconsin-Madison and her B.S. in Chemistry from the University of Notre Dame.

Dan trained on the MD PhD programme at UCL, completing a PhD in genetic epidemiology. Thereafter he worked in London as a clinical academic in internal medicine and clinical pharmacology. In his academic research he led international human genetics consortia for drug target discovery in cardiometabolic disease, with findings published in the Lancet and Nature Communications. Before joining GSK in 2022, Dan led oligonucleotide clinical development programmes and a computational genomics group at Silence Therapeutics, prior to which he worked in AI-enabled translational and precision medicine at BenevolentAI. At GSK, Dan is a clinical lead on translational and early clinical development projects. He is an honorary associate professor at UCL.

Dr. Henry received a PhD in Biochemistry form North Dakota State University. He was a post-doc fellow at Parke Davis, Ann Arbor MI, depart. of toxicology. He joined Isis Pharmaceuticals, Inc. as a Sr Scientist in toxicology. He helped characterized and studied mechanisms of various toxicities e.g. the effects of oligonucleotide treatment on clotting time prolongation, alternative complement pathway activation, proinflammatory effects in rodents, platelet alterations and the effects related to the accumulation of oligonucleotide in kidney. As VP of Non-Clinical Development he has participated in the development of ~8 different phosphorothioate oligodeoxynucleotides and 30+ different 2’-MOE modified phosphorothioate oligonucleotides.

James Wild received a MS and PhD in Pharmacology and Toxicology at the University of California, Davis. Areas of study included idiopathic pulmonary fibrosis and characterization of a novel, ryanodine-sensitive receptor in the lung. Subsequently he completed two postdoctoral fellowships specializing in asthma research. In later career positions, James conducted discovery pulmonary disease research at EpiGenesis Pharmaceuticals, Schering-Plough Research Institute, and Johnson and Johnson PRDUS. Currently, James is a Senior Pharmacologist at the FDA supporting the Division of Anti-Infectives. Areas of interest include anti-infective drugs, oligonucleotide therapies, pulmonary research, and drug regulation.