Senior Consultant
Aclairo Pharmaceutical Development Group Inc
Emily is a Senior Consultant at Aclairo Pharmaceutical Development Group. She made a transition to consulting from her position as Senior Pharmacologist, at the FDA/CDER’s Office of Oncologic Diseases where she worked for over 8 years. At FDA, Emily worked on a team that supported a division reviewing applications in benign heme and hematological malignancies, and a team in a division reviewing applications in solid tumors. While in the oncology office she performed nonclinical review of Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologic License Applications (BLA), and Cross Center Consults. Emily has reviewed over 120 pre-INDs, 225 commercial and research INDs and 75 NDAs, BLAs and/or supplements. Emily has an expertise in oncology products and oligonucleotide therapeutics. She co-chaired the Pharmacology/Toxicology Subcommittee for Oligonucleotide Therapeutics for 7 years, for which she performed consults, provided education to review staff, developed internal regulatory practice, and oversaw the safety and activity of drug applications for Oligonucleotide Therapeutics in all therapeutic divisions across the Office of New Drugs. She is currently a member of the Oligonucleotide Safety Working Group and chairs their subcommittee on Carcinogenicity.
Emily has a bachelor’s in science in Biology from State University of New York at Binghamton, her PhD in Cell Biology from University of Connecticut, and an MPH in Epidemiology at the University of California at Berkeley. Following her PhD, she was an Associate Investigator at San Francisco VA Medical Center from where her research focused on miRNA dysregulation in prostate cancer. She completed a postdoctoral fellowship at Stanford School of Medicine testing chemotherapeutics in a translational model of NHL and was a Cancer Prevention Fellow at the National Cancer Institute in the Laboratory of Human Carcinogenesis where her research involved examining the role of extracellular plant small RNA communication in human carcinogenesis. Her research has culminated in several publications in peer-reviewed journals and book chapters. She is also currently Faculty at the University of California at Berkeley, School of Public Health, in the Division of Biostatistics and teaches Biostatistics in the Master’s in Public Program.
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Tuesday, September 10, 2024
3:30 PM – 5:00 PM ET
4 - Navigating the Regulatory Pathway of ASO Therapeutics
Tuesday, September 10, 2024
3:30 PM – 5:00 PM ET