Emily Noonan Place, PhD, MPH
Senior Consultant
Former Senior FDA nonclinical reviewer in the Office of Hematology and Oncology Products. Emily has expertise in oncology products, oligonucleotide therapeutics (ONT) and biostatistics.
Background
Emily is a Senior Consultant at Aclairo Pharmaceutical Development Group. She was previously a Senior Pharmacologist, at the FDA/CDER’s Office of Oncologic Diseases for over 8 years. Emily has a BS in Biology from SUNY at Binghamton, a PhD in Cell Biology from University of Connecticut, and an MPH in Epidemiology from UC Berkeley. She completed postdoctoral fellowships at UCSF, Stanford University School of Medicine and the National Cancer Institute’s Cancer Prevention Fellowship Program. Her research has culminated in several publications in peer-reviewed journals and book chapters. She is also currently Faculty in the Division of Biostatistics, UC Berkeley, School of Public Health, in the Master’s in Public Program.
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 ONT. She co-chaired the Pharmacology/ Toxicology Subcommittee for ONT 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 ONT in all therapeutic divisions across the Office of New Drugs. She is currently a member of the ONT Safety Working Group and chairs their subcommittee on Carcinogenicity.
She has an 11-year-old son with neurofibromatosis type 1, who is in partial remission with brain gliomas; he is her biggest inspiration to always continue giving her best to public health service. She loves dogs and has a border collie/corgi mix, an English Shephard, a golden retriever and a pug/Jack Russell mix. In her spare time, she loves being outside, playing soccer, skiing, snowboarding, and snowshoeing. Fun fact, Emily is a certified wildlife rehabilitator for small mammals in New York and practices wildlife rehabilitation in part, to cross-train in toxicology.
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 ONT. She co-chaired the Pharmacology/ Toxicology Subcommittee for ONT 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 ONT in all therapeutic divisions across the Office of New Drugs. She is currently a member of the ONT Safety Working Group and chairs their subcommittee on Carcinogenicity.
She has an 11-year-old son with neurofibromatosis type 1, who is in partial remission with brain gliomas; he is her biggest inspiration to always continue giving her best to public health service. She loves dogs and has a border collie/corgi mix, an English Shephard, a golden retriever and a pug/Jack Russell mix. In her spare time, she loves being outside, playing soccer, skiing, snowboarding, and snowshoeing. Fun fact, Emily is a certified wildlife rehabilitator for small mammals in New York and practices wildlife rehabilitation in part, to cross-train in toxicology.
Practice Areas
- Oligonucleotide therapeutics
- Immune-activating products
- Hematology and Oncology products (Immune-activating, small molecules, Biologics, Biosimilars, ADCs, Novel molecules)
- Nonclinical Development Strategies
- Due Diligence
- Toxicological and Pharmacological evaluation of study data
- Statistical Analysis and Consultation (R, R Studio)
- Gap analysis for IND/NDA/BLA/505b2/Biosimilar
- Meeting package preparation
- PreIND/IND/NDA/BLA/505b2/Biosimilar writing/reviewing including the Oncology Office’s Integrated Assessment Aid Review Tool
- FDA interactions
- Nonclinical Weight of Evidence (WOE) for Reproductive Toxicity and Carcinogenicity