Lisa Carlton, PhD
Senior Director, Regulatory Affairs Activity
Lisa D. Carlton brings to the Cote team nearly 20 years of experience in Regulatory and Scientific Affairs. The majority of her experience was gained at Otsuka Pharmaceutical Development & Commercialization where she spent over 11 years in Regulatory Affairs and Medical Writing roles. In those capacities she worked primarily with the CardioRenal and Metabolic & Endocrine review divisions at FDA. Most recently she has worked on infectious disease projects (TB and HIV) that required interactions with the Special Pathogens and Antivirals Divisions at FDA. In her most recent role prior to joining Cote Consulting, she was Director of Regulatory Affairs at International Partnership for Microbicides, where she worked on global regulatory strategy (US, EU and Africa) and submission implementation for HIV prevention technologies.
Dr. Carlton obtained from North Carolina State University a BS in Biochemistry and from the University of North Carolina at Chapel Hill an MS in Medicinal Chemistry and a PhD in Pharmaceutics (with a concentration in Pharmacokinetics). She then completed her post-doctoral training and initial Regulatory Affairs training at NIH (at NIAID and NCI respectively).
Senior Regulatory Affairs Specialist
Malia Segar joins Coté Orphan Consulting with eight years of regulatory affairs experience. Previously a Senior Regulatory Project Manager at Aclairo Pharmaceutical Development Group, Inc. her major responsibilities included writing orphan drug designations (US and EU), Pre-IND packages, INDs, NDAs, and literature reviews, as well as project management. Malia received her Master’s degree in Biotechnology and Biodefense from Johns Hopkins. Prior to that, she worked at Human Genome Sciences as a Bioprocessor and at Duke University Medical Center as a Research Technician in the Oncology department. She received her Bachelor’s degree from Elon University.
Lisa Nolan Wright, MS
Regulatory Affairs Specialist
Lisa Nolan Wright joins Coté Orphan Consulting with over ten years experience in pre-Clinical research. Previously a Biologist for the National Cancer Institute where her primary research direction was investigating the effects of activated Ras proto-oncogenes in different mouse/tumor model systems. Her research was focused in bioinformatics, to perform sequence analysis, analysis of gene expression, analysis of gene regulation, network analysis and mutational analysis of tumors. Lisa received her Master’s degree in Biotechnology and Bioinformatics from Johns Hopkins University. Prior to that she worked at Uniformed Services University of the Health Sciences researching the tumor suppressor activity of Annexin VII. She received her Bachelor’s degree in General Biology from the University of Maryland, College Park.
Susan Carter
Senior Regulatory Affairs Specialist
Susan Carter brings to the Coté team nearly 20 years of clinical research experience in the biopharmaceutical industry. Ms. Carter has extensive global clinical research experience in the strategic development of various therapeutic compounds including gene therapy products. During her career, Ms. Carter has worked at Pfizer, Abbott, Schering-Plough, and PPD where she held roles in clinical operations, regulatory, medical writing, and project management. Ms. Carter has written a variety of clinical documents including Phase I – III protocols, clinical study reports, investigator brochures, and integrated summaries of effectiveness and safety for various therapeutic compounds. Her regulatory experience includes IND, NDA submissions along with regulatory filings in Europe. She received her Bachelor’s degree from Indiana University and attended Emory University School of Law where she focused on Food and Drug law. Ms. Carter has led clinical programs for Phase I – II trials, pivotal Phase III trials, investigator-initiated trials, and National Cancer Institute (NCI) group cooperative trials. While at Abbott, Ms. Carter was based in England and managed the regulatory submissions for several European countries. Prior to joining Coté Orphan Consulting, she managed the regulatory activities at The George Washington University Biostatistics Center, which was the data coordinating center for clinical trials funded by the NIH National Institute of Child Health and Development (NICHD).
Regulatory Affairs Specialist
Prior to joining Cote Consulting, Arundhati Ghosh (Arun) worked as a Postdoctoral researcher at the University of Maryland (Baltimore) for over 12 years. A research scientist, Arun investigated molecular mechanisms of diseases such as sepsis, breast and brain cancers and embryonic heart development. Most recently, Arun managed a full-scale cardiology lab, taught students, trained postdocs and wrote manuscripts, SOPs and reports. Prior to that, Arun was also a technical consultant for a small start-up, and helped to establish the scientific infrastructure, provide technical knowledge for projects and train other scientists. She received her Bachelor’s degree (Hons.) in Biotechnology, as well her PhD in Microbiology from King’s College London (UK). Recently, she also completed her Postdoctoral Professional Masters (PPM) in Bioscience Management from the Keck Graduate Institute (KGI) in California. She is also a Chartered Biologist (CBiol) and member of the Institute of Biology (UK).
Sally Yang, MS
Regulatory Affairs Associate
Sally Yang graduated with her Masters of Science from the Keck Graduate Institute of Applied Life Sciences, where she focused her studies in clinical and regulatory affairs. She attended Pennsylvania State University where she received a BS in Biology and a minor in Spanish. A native of China, Sally speaks fluent Mandarin Chinese.