Regulatory Affairs Personnel

Bruce Burnett

Director

Kunjan holds a Master of Science in Regulatory Science. She joined Stanford Laboratory for Cell and Gene Medicine (LCGM) as a Quality Assurance Associate in 2017. In her past roles in Quality Assurance, she has managed quality systems such as Deviations, CAPA, Internal Audit, and Supplier Qualification. She has also been responsible for Manufacturing Batch Record Review, Stability Program Review and Training. She has over 8 years of combined experience working in Pharmaceutical Marketing and Quality Assurance. 

Kunjan Kamdar

Associate Director

Kunjan holds a Master of Science in Regulatory Science. She joined Stanford Laboratory for Cell and Gene Medicine (LCGM) as a Quality Assurance Associate in 2017. In her past roles in Quality Assurance, she has managed quality systems such as Deviations, CAPA, Internal Audit, and Supplier Qualification. She has also been responsible for Manufacturing Batch Record Review, Stability Program Review and Training. She has over 8 years of combined experience working in Pharmaceutical Marketing and Quality Assurance. 

Azadeh Timnak, PhD

Regulatory Affairs Scientist

Azadeh received her Ph.D. in Bioengineering from Temple University, Philadelphia in 2017 where she developed a novel immunomodulatory wound healing patch and investigated polarization behavior of macrophages in skin wound healing. Over her postdoctoral training at University of Pennsylvania, department of Orthopedic Surgery she studied distribution profile of immune cells in tissues in which, due to a rare genetic disorder known as Fibrodysplasia Ossificans Progressiva, ectopic bone formation had occurred.

Prior to joining LCGM, Azadeh was a scientist at Liquid Biotech USA where she optimized a detection method for circulating tumor cells using a telomerase-specific adenovirus. When at Liquid Biotech she wore multiple hats of design of experiments, assay development and data analysis for downstream immunophenotyping of infected cells.

Selected Publications

A versatile system for neuromuscular stimulation and recording in the mouse model using a lightweight magnetically coupled headmount, Oct 2021

Annie Vahedipour, Matthew R Short, Azadeh Timnak, Omid Haji Maghsoudi, Thomas Hallowell, Jonathan Gerstenhaber, Ornella Cappellari, Michel Lemay, Andrew J Spence

https://pubmed.ncbi.nlm.nih.gov/34400212/

 

Detection of viable tumor cells from cryopreserved buffy coat using the VTX-1 Liquid Biopsy Platform, Jan 2020

Corinne Renier, Jamin Steffen, Azadeh Timnak, Clementine Lemaire, Elodie Sollier and Haiyan E. Liu

https://clincancerres.aacrjournals.org/content/26/11_Supplement/B31

Gradient porous fibrous scaffolds: a novel approach to improving cell penetration in electrospun scaffolds, Aug 2018

Azadeh Timnak, Jonathan A Gerstenhaber, Kang Dong, Yah-el Har-el and Peter I Lelkes

https://iopscience.iop.org/article/10.1088/1748-605X/aadbbe

Patents

Graded Porous Scaffolds as Immunomodulatory Wound Patches, PCT/US18/29519

https://patents.google.com/patent/WO2018200776A1/en

Negative Pressure Enhanced Cellular Infiltration into Electrospun Scaffolds, PCT/US17/55273

https://patents.google.com/patent/WO2018067782A1/en