Quality Control Personnel

Bruce Burnett

Director

Dr. Burnett has over 20 years of pharmaceutical industry experience in quality control/assurance and regulatory affairs.

He recently served as the Acting Director of the Office of Research Support and Compliance (ORSC) at NIH within the Office of the Director and now continues at NIH as an advisor to ORSC.

At Duke, he supports translational research as the Director of the Regulatory Affairs and Quality group. Dr. Burnett came to Duke from Alpha Vax, a vaccine biotech company where he last served as Vice President of Regulatory Affairs and Quality.

Dr. Burnett joined LCGM in November 2018.

Aladdin Algaali

QC Specialist

Aladdin received his Bachelor of Science degree in Biological Sciences with a minor in Chemistry from California State University, San Jose, CA. Aladdin began his career with Becton and Dickenson & Company (BD Biosciences sector, San Jose, CA) gaining unparalleled 9 years’ experience in the Flow Cytometry space, while also establishing himself as a respected Quality Control Scientist.

In addition to Flow Cytometry experience while in BD, Aladdin gained experience in Next Generation Sequencing (NGS) space including preparing libraries, sequencing on Illumina platforms, and data analysis and interpretation.

At LCGM, Aladdin is responsible for supporting various QC flow assay development, improvement, validation, and testing different Phase I/II clinical trial products.

Jonathan Wong

QC Associate

Jonathan Wong received his Bachelor of Science degree in Neurobiology, Physiology, and Behavior from University of California, Davis.

Jonathan has 3 years of experience biotech and healthcare. In his most recent position with BioMarin Pharmaceutical, Jonathan worked as a QC analyst and supported the operations of the QC Microbiology group. He performed Quality Control procedure in environmental monitoring and analytical chemistry assays. Additionally, he supported facility qualification, method development and method validation projects.

With the Stanford LCGM, Jonathan supports the routine QC operations, from assay development and testing, to environmental monitoring.

Praful Bhusari

QC Manager

 

Praful joined the Laboratory for Cell and Gene Medicine as a Quality Control Manager in 2020. He has over 20 years of combined industry experience in Pharmaceutical development and Quality Control. His experience included the areas of vaccines, biologics and small molecule pharmaceuticals.

Praful has held several laboratories as well as supervisory/managerial positions. He has participated in method development, validation, tech transfers and analytical testing in support of preclinical development to post approval lifecycle management activities.  Additionally, he has been a subject matter expert in microbiological contamination control, environmental monitoring and adventitious agent testing.  He also made impactful contributions to Deviation management, CAPA, change control, quality risk assessments, regulatory inspection readiness and management of outsourced development and quality control testing.  Praful received his MS in Microbiology from the University of Wyoming and has an MBA from California State University - Hayward.

 

Publication:

Application of Flow Cytometry for Rapid Bioburden Screening in Vaccine Virus Production

Praful K. Bhusari, David E. Tabor, Ryan Yamagata, Mark S. Galinski

PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 445-452

Fariba Fazeli, MD

Senior Manager QC Analytical Scientist

Fariba received her M.D. degree from Marche Polytechnic University, Italy. She has more than 20 years of academic and industry experience in  immunology, oncology, microbiology, and molecular genetics. Prior to joining LCGM, Fariba was the senior development scientist at IncellDx, where she supported validation of cell based assays such as Fluorescent In Situ Hybridization and Multicolor Flow Cytometry for diagnosis  of  cervical, lung, breast, bladder cancer and various life-threatening infectious diseases. Her projects were from the earliest phases of research through process development and optimization of assays for IVD/CE-IVD prodcuts.

At LCGM, Fariba is responsible for supportting various QC assay qualifications and validations for clinical production of products at different phases according to ICH and FDA guidelines.

Publications and Abstracts

Cell by cell immuno- and cancer marker profiling for non-small cell lung cancer (NSCLC) tissue sample using non-enzymatic tissue dissociation and high-parameter flow cytometry.   AACR Annual Meeting 2018; April 14-18, 2018; Chicago, IL. 10.1158/1538-7445.AM2018-2112 Published July 2018

Characterizing PD-L1 expression in tumor-associated cells and CTC using IncellDx and Celsee molecular diagnostic technologies. 10.1158/1538-7445.AM2018-635 Published July 2018

Role of polyphosphate in thermophilic Synechococcus sp. from microbial mats. J Bacteriol. 2013 Aug; 195(15):3309-19. Doi: 10.1128/JB.00207-13. Epub 2013 May 17.

Responses of a thermophilic Synechococcus isolate from the microbial mat of Octopus Spring to light. Applied Environmental Microbiology, 2007 Jul; 73(13):4268-78. Epub 2007 May 4.

Phototaxis and Impaired Motility in Adenylyl Cyclase and Cyclase Receptor Protein Mutants of Synechocystis sp. Strain PCC 6803. Journal of Bacteriology, 2006 Oct; 188(20):7306-10.

Azadeh Timnak, PhD

QC Analytical 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 and abstracts:

Detection of viable tumor cells from cryo-preserved buffy coat using the VTX-1 liquid biopsy platform, American Association for Cancer Research, Advances in Liquid Biopsies, January 2020

  • Gradient Porous Fibrous Scaffolds: A Novel Approach to Improving Cell Penetration in Electrospun Scaffolds, J Biomed Mater. 2018. PMID: 30129563
  • Macrophage Infiltration into Macro-porous Electrospun Scaffolds Initiates a Reparative Inflammatory Response, Tissue Engineering and Regenerative Medicine Annual Conference, December 2017

Patents:

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

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