Speaker Biographies

Bernardo is Halo Labs’ Founder and Chief Science Officer. He leads application and business development at Halo Labs. Bernardo received his Ph.D. in Mechanical Engineering from Cornell University where he also did his Postdoctoral work. He has a long history of developing a wide range of scientific instruments in the areas of includes particle detection and analysis, drug delivery devices, microfluidics, nanophotonics and bioenergy production.

Zuzana Demianova is a SCIEX Senior BioPharma Application Scientist since 2019. She join SCIEX in 2016 as Application Support Specialist to support Omics applications. in 2020, she was promoted to Global Proteomics Application Leader. Zuzana obtained PhD at the Helsinki University, Finland, her thesis was about development of miniaturize on-line 2-D gel electrophoresis. After her PhD,  she did post-doctorate work with Dr. Josef Cvacka, IOCH, Czech Republic, were she contributed to various proteomics projects at the institute that resulted in multiple publications. She then continue her scientific carrier with Karl Mechtler and his group, IMP, Austria. As part of this group she developed quantitative approach to understand kinetochore assembly during cell division.

 

Dr. Hanneman currently serves as a scientific advisor for the Biologics division at Charles River. He has over 20 years of experience in the pharmaceutical industry, with a focus on mass spectrometry and glycoprotein characterization.

Andrew joined Charles River with the acquisition of Blue Stream Laboratories. He previously served as Associate Director of Mass Spectrometry, overseeing the mass spectrometry laboratory characterizing AAV, mAbs, ADCs, Fc-fusions, enzymes, synthetic peptides, VLPs, and related biomolecules, HCP, and tissue/quantitative proteomics. 

I received my Masters degree in Organic chemistry in India. In addition, I obtained PhD degree in chemistry from University of Kentucky in 2010. Then I joined University of Minnesota for Postdoctoral training in the Department of Chemistry until 2012. I joined BioVision Inc where I built a team focused on designing, manufacturing and analytics for metabolic enzymes for commercial use. Then I pivoted to Gene Therapy when I joined Brammer Bio (now a part of Thermofisher Viral Vector Services) as principal scientist and led the team for developing analytical assays for viral vectors. Furthermore, in 2018, I joined Sangamo Therapeutics as a Senior Scientist for helping build analytical team on developing assays for viral vectors. I left Sangamo to join Asklepios Biopharmaceuticals (North Carolina) as the Director of Analytical Development but after a short duration, I rejoined Sangamo Therapeutics as an Associate Director where I am overseeing analytical development for early and late phase viral vectors.

Joseph Lee received his Doctorate in Biochemistry from McGill University (Montreal, QC, Canada). He further trained at the NIH (NCI and NIDDK). Collectively, Joe’s research background focused on signaling pathways leading to the dysregulation of cell growth – much of it centered on viral and cellular oncogenes. Following his post-doctoral fellowship, he led the Development Services/Molecular Biology group at BioReliance where he helped set up the Gene and Cell Therapy testing programs. Joe has held additional posts at Shire and Takeda supporting gene therapy and vaccine programs from both the CMC and Clinical perspectives. He was later recruited to build the Analytical Development (gene therapy) at group at PTC Therapeutics in New Jersey. Currently Joseph is leading the CMC Early Development Analytics group where his team is responsible for vectorology and assay development support for all of the cell therapy programs.

Dr. Camille Lombard-Banek received her PhD from the George Washington University. As part of her dissertation work, she developed micro-analytical tools for the analysis of single embryonic cells in Prof. Peter Nemes’ laboratory. She thereafter performed a one-year postdoc at the University of Maryland where she developed quantitative proteomic strategies for the analysis of small tissue samples and cell population. Dr. Lombard-Banek is now an NRC postdoctoral fellow at NIST/IBBR in the laboratory of Dr. John Schiel. There, she is developing SWATH™ liquid chromatography mass spectrometry-based proteomic approaches for the analysis of emerging cell and gene therapies.

Dr. Xiaohui Lu is the Executive Director of Analytical Development in Ultragenyx Gene Therapy, overseeing analytical activities for the development of Ultragenyx’s gene therapy products. Before join Ultragenyx, Dr. Lu was a Director of Analytical Development in CRISPR Therapeutics. Dr. Lu spent 8 and a half years in Analytical Development at Biogen from 2009 to 2018, leading bioassay development and process-related impurity assay development for biologics and gene therapy programs. Prior to joining Biogen Idec, he was Senior Research Scientist at Ariad Pharmaceuticals in Cambridge, MA from 2007 to 2009. Dr. Lu received his Ph.D. in Biochemistry from Dartmouth Medical School, and had post-doctoral training at the Whitehead Institute.

An experienced Associate Scientist in analytical development, Kathy has more than 20 years of industry experience in developing immunoassays (ELISA, MSD, Luminex, and AlphaLISA) to support preclinical to clinical development. She recently joined Bristol-Myers Squibb as part of the Juno / Celgene integration in 2018. Her current role is to develop, qualify, and transfer potency assays for QC release testing of cell therapy products. Prior to BMS, Kathy spent 18 years at Immunex/Amgen developing analytical methods to characterize the Pharmacokinetic and Pharmacodynamic properties of proteins and therapeutic monoclonal antibodies.

He Meng is a Senior Scientist of Analytical Development at Sanofi Biologics Development. He is responsible for the development, qualification and validation of physicochemical analytical methods using an aQbD approach to support the release and stability testing of biologics in preclinical and clinical development, including antibodies, enzyme replacement therapies and gene therapies. He also serves as an analytical team lead for an early stage program and contributes to the preparation of CTD analytical sections for a late stage program for global regulatory filing (EMA/FDA/PMDA).

Sahana Mollah currently manages technical marketing for capillary electrophoresis and biopharma scientific collaborations at SCIEX.  The past few years, she has been involved in gene therapy workflows development at SCIEX using capillary electrophoresis and mass spectrometric tools.  Sahana completed her PhD in bioanalytical chemistry from the University of Virginia. Her early work involved utilizing LC-MS for epigenetic and immunology studies including cancer research. She started as an application scientist at SCIEX focusing on LC-MS applications for proteomics, therapeutic protein characterization, and quantitation. Later, she led a team of application scientists for academics and biopharma focusing on various application development in proteomics, lipidomics, metabolomics, and biologics.   

An experienced Associate Scientist in analytical development, Maria has more than 10 years of experience in developing immunoassays (ELISA, AlphaLISA, AlphaScreen, and relative potency assays) to support Preclinical to Clinical development. She recently joined Bristol Myers Squibb as part of the Juno / Celgene integration in 2018. Her current role is to develop, qualify, and transfer vector potency assays for QC release testing of cell therapy products. Prior to BMS, Maria spent 8 years in both industry developing methods for analytical testing services and academia developing analytical methods to study epigenetic and transcriptional mechanisms contributing to leukemia.

Magalie Penaud-Budloo is currently a research scientist at INSERM UMR1089 (Nantes, France). She earned her PhD in Health and Biology at the University of Nantes and has acquired a 15-year expertise in the Gene therapy field through positions in the academic laboratory of Translational Gene Therapy for genetic disease (UMR1089, France) and at the University of Florida (Department of Molecular Genetics and Microbiology). Her expertise ranges from the fundamental virology, the production of AAV vectors to translational applications. Her previous research works concerned the molecular fate of AAV vector genomes in vivo, i.e. the relation between their epigenetics status and the transgene expression, as well as the determination of vector integration frequency in skeletal muscle and liver. She has also participated to the development of a novel QC method based on high-throughput sequencing for the assessment of AAV vector quality and purity. Her current research interest is the design of more potent AAV viral vectors.

Dr. Klaus Richter is the AUC group leader at Coriolis and dedicated to the biophysical characterization of drug products and substances ranging from peptides to viral particles and liposomes. He holds a Ph.D. from Technical University of Munich and worked in the area of structure-function & structure-activity relationships of pharmaceutically relevant proteins before joining Coriolis. Klaus obtained his Habilitation in 2012 and (co-) authored more than 70 publications in the field of protein characterization.

Nancy Sajjadi, M.Sc. is Founder and Principal Consultant of Sajjadi Consulting. She has over 30 years of experience in biopharmaceutical product development. She began her career as a bench scientist doing malaria vaccine research then joined a start-up company developing cell and gene-using therapies for infectious disease, cancer, and cell therapy applications. Her responsibilities included research, assay development, and quality control. In 2000, she left her position as Director of QC at Chiron Technologies Center for Gene Therapy to start her own consulting business. For over 20 years, Ms. Sajjadi has provided services to biopharmaceutical companies, contract laboratories, non-profit organizations, universities, and US government agencies. She has assisted clients in the development, implementation, and improvement of quality programs for a range of cutting-edge products and provides technical expertise in assay development, qualification, and validation. Ms. Sajjadi has authored several articles pertaining to bioassays and viral gene therapy and has served on 5 advisory panels for the United States Pharmacopeia (USP). She enjoys teaching introductory courses in bioassay design, development, and validation for non-statisticians. Her company has recently expanded services to include leadership development and executive coaching to guide organizations toward sustaining a culture of quality.

Ilya Shestopalov, PhD currently leads the analytical development group at bluebird bio. His research focuses on development of assays for lentiviral vectors and hematopoietic stem/progenitor products. Prior to bluebird bio, Dr. Shestopalov was a postdoctoral fellow in stem cell biology at Boston Children’s Hospital and Harvard University working with zebrafish hematopoietic stem cells. Dr. Shestopalov received his PhD in 2010 from the Chemical Biology program at Stanford University and a BS in Biological Chemistry from University of Chicago.

Kendal Studd is a Scientific Applications Specialist at Advanced Instruments. She has many years of experience as a scientist working in biotechnology industry specialised in sterile filtration validation. Kendal is responsible for advancing novel osmolality applications in the EMEA region.

Stephanie Whipple, PhD is a Scientist at Sanofi in Biologics Analytical Development. She recently completed an industry postdoctoral tenure on her Sanofi BioAnalytics team, training in AAV gene therapy and biologics cell-based potency assays. Stephanie is engineering reporter cell lines for gene therapy potency assays and is very interested in AAV structure-function analyses. Before Sanofi, Stephanie completed her Bachelors in Biochemistry and Biology/Biotechnology from Worcester Polytechnic Institute. She obtained her PhD in Molecular Biology, Cell Biology and Biochemistry from Brown University, where she studied the molecular mechanisms of insulin/IGF signaling in the biology of aging.