Speaker Biographies

Senior Scientist

Chloé Ackaert is a senior scientist on the immunogenicity team at ImmunXperts. She is a pharmacist by training (Catholic University of Leuven) with a PhD from the University of Salzburg (Austria). She has researched the impact of nitration on the immunogenicity of birch pollen allergens and the immunogenicity of nanobodies.

Chloé Ackaert

ImmunXperts

Senior Scientist

Barry J Byrne

Univ of Florida

Dir & Prof & Assoc Chair

Dr. Barry Byrne is a clinician scientist who is studying a variety of rare diseases with the specific goal of developing therapies for inherited muscle disease. As a pediatric cardiologist, his focus is on conditions that lead to skeletal muscle weakness and abnormalities in heart and respiratory function. His group has made significant contributions to the understanding and treatment of Pompe disease, a type of neuromuscular disease due to glycogen storage in motor units. The research team has been developing new therapies using AAV-mediated gene therapy to restore cardiac and skeletal muscle function in DMD, Friedreich’s ataxia, Pompe, and other inherited neuromuscular diseases. His group at the Powell Center has also established a series of new methods for large-scale AAV clinical manufacturing. The work is supported by several NIH and foundation awards. Dr. Byrne is the Associate Chair of Pediatrics, Director of the University of Florida Powell Center and Child Health Research Institute and the Earl and Christy Powell University Chair in Genetics.

Etienne Caron

University of Montreal

Assistant Professor

Etienne Caron is a Canadian scientist trained at the Institute for Research in Immunology and Cancer at the University of Montreal, Canada. He completed his education at EMBL-CRG in Spain and at ETH-Zürich in Switzerland. He is Assistant Professor at the University of Montreal and Principal Investigator at the CHU Sainte-Justine Research Center (www.caronlab.org). The research focus of his group is the immunopeptidome. He is the co-founder of the Human Immuno-Peptidome Project and the leading scientist of the SysteMHC Atlas project. His research group is interested in the development and application of mass spectrometry technologies to advance the field of immunology, vaccine and immunotherapy.

Saso Cemerski

Cue Biopharma

VP and Head of Discovery and Translational Immunology

Saso Cemerski is a VP and Head of Discovery and Translational Immunology and leads the company’s Immuno-Oncology Discovery and Translational Immunology team. His focus is on early pipeline development, building preclinical packages for assets in the immuno-oncology pipeline and developing adequate translational biomarker strategies to test key hypotheses in the clinic. Prior to joining Cue Biopharma, Dr. Cemerski held positions at Xencor, BMS and most recently, Merck where he led the STING agonist programs and participated as a core-team member of the anti-LAG-3 program, both of which are currently in the clinic. Dr. Cemerski did his postdoctoral training at Washington University in St Louis, Missouri where he worked to elucidate how immune synapses control T cell activation.

John Chappell

Gyros Protein Technologies

Application & Service Director EMEA and Asia Pacific

John Chappell has approximately 25 years of experience in the Contract Research industry supporting both preclinical and clinical drug development. He is a Fellow of the Royal Society of Chemistry and was involved in the American Association of Pharmaceutical Scientists (AAPS) Biosimilar Committee that has prepared papers on Pharmacokinetic and anti-drug antibody assays. John now leads the Application Support and Service teams for Gyros where he is responsible for customer service and technical support in Europe and the Asia Pacific regions. He has been a user of the Gyros system for over 10 years and uses this experience to help customers.

Lukasz Chlewicki

Eli Lilly & Co.

SC1: Mechanism of Action and Risk-Based Approach for Developing Neutralizing Ab Assays

Principal Research Scientist

Luke earned his Ph.D. in Cell and Structural Biology at the University of Illinois at Urbana-Champaign, where he engineered NK and T cell receptors for Class I MHC. Luke did his postdoctoral work studying NK receptor signaling for Vinay Kumar in the Pathology department at the University of Chicago. Luke then took a position as Assistant Professor for Yang-Xin Fu at the University of Chicago, where he worked on engineering immuno-cytokines to treat metastatic breast cancer. Luke then joined the Lead Optimization group at Boehringer Ingelheim in 2010. At BI, Luke engineered and de-immunized various biotherapeutic compounds. Luke joined the Investigative BioTDR ADME group at Eli Lilly in 2014, where he works on optimizing the ADME properties of different biologic modalities, as well as serving as a member of Lilly’s Immunogenicity risk strategy teams.

Shan Chung

Genentech Inc

Assoc Dir & Principal Scientist

Dr. Shan Chung is currently an Associate Director and Principal Scientist in the Department of BioAnalytical Sciences (BAS) at Genentech. Shan received his Ph.D. in Molecular Biology from University of Pennsylvania and completed his postdoctoral training in Protein Engineering at Harvard University. Shan has more than 20 years’ experience in research and development of pharmaceutical products, specifically in the areas of preclinical and clinical development of therapeutic antibodies. An expert on Fc effector functions, bioanalytical assays, and immunogenicity of biotherapeutics, Shan serves on the USP Fc Function Expert Panel, and is an active member of the AAPS Working Group on Immunogenicity Risk Assessment and Mitigation. Shan joined Genentech in 2006, and currently leads the Effector Function and Cell Biology group in BAS. The responsibilities of his group include biological characterization of clinical candidates, development and validation of bioanalytical assays, and evaluation of immunogenicity potential of antibody products.

Sivan Cohen

Genentech Inc

Scientist

Dr. Sivan Cohen is a scientist in the Department of BioAnalytical Sciences (BAS) at Genentech. A trained immunologist, She received her Ph.D. in Immunology from the Weizmann Institute of Science and conducted her post-doctoral training in Duke University. Sivan joined Genentech in 2017, and currently leads the development and implementation of in silico and in vitro bioanalytical assays to support evaluation of immunogenicity potential of Genentech’s biotherapeutic products.

Manuela Corti

Univ of Florida Gainesville

Asst Prof

Dr. Manuela Corti is currently an Assistant Professor at the University of Florida in the Child Health Research Institute and Powell Gene Therapy Center. Dr. Corti is a clinical scientist engaged in translational research focusing on understanding the contribution of neurological impairment in neuromuscular disorders by combining expertise in clinical assessment with novel therapies that rely on correcting the fundamental genetic defect. Her specific research is dedicated at developing AAV gene therapy programs for neuromuscular diseases and immunomodulation strategies to: a) prevent immune responses against the AAV capsid and the transgene; and b) allow for AAV administration in pre-existing immunity. Her research interests also include outcome measures and clinical trial readiness for neuromuscular diseases, such as Pompe disease, Friedreich’s Ataxia, Canavan disease and Duchenne Muscular Dystrophy.

Brandon J DeKosky

Univ of Kansas

Asst Prof

Dr. Brandon DeKosky is an Assistant Professor at the University of Kansas Departments of Chemical Engineering and Pharmaceutical Chemistry, where his laboratory leverages recent advances in next-generation DNA sequencing technologies to achieve a more comprehensive understanding of immune function and accelerate the development of new vaccines and therapeutics. During his graduate research, Dr. DeKosky invented the very first technology for sequencing the antibody proteins encoded by B cells at the single-cell level, at a massive scale (for example, over 5 million single B cells in a one-day experiment), which reduced cost and enhanced throughput for antibody sequencing by multiple orders of magnitude compared to traditional antibody discovery platforms. Dr. DeKosky also pioneered the associated bioinformatic methods for rapid statistical analysis of the very large datasets generated by this approach. Ongoing efforts in the DeKosky lab, supported by an NIH Director’s Early Independence Award and a United States Department of Defense Career Development Award, and focus on expanding our ability to determine the mechanisms of protection for human vaccines and to develop novel and improved targeted human therapeutics.

Bo Feng

Merck & Co., Inc.

Assoc Principal Scientist

Bo Feng is currently working in the Process Research & Development Department at Merck Research Laboratory and mainly responsible for development of immunoassays for potency measurement, cell screening and impurity testing in support of biological product process development. He has also engaged in related method transfer, assay lifecycle management as well as critical reagents control strategy development. Prior to the current position, he was with Boehringer Ingelheim and worked on biological product candidate screening and characterization. Bo Feng has a Ph.D. in Pharmaceutical Science from University of Maryland at Baltimore and did his post-doctoral research at Medical School of Columbia University.

Andrea Ferrante

Eli Lilly & Co

Principal Research Scientist

Andrea Ferrante attained his M.D. at the University of Genoa (Italy) School of Medicine in 2003 and his M.B.A. in 2017 at the University of Alaska Fairbanks. His postdoctoral training includes 3 years of residency in Clinical Pathology (Italy) and 7 years of research at the Blood Research Institute, Milwaukee (WI). In April 2012 he joined the faculty at the University of Alaska Fairbanks as an Assistant Professor in the Department of Biology and Wildlife and the Institute of Arctic Biology. His research activity has focused primarily on the molecular basis of antigen processing and presentation by MHC class II molecules. He has been the recipient of several grants as PI and co-PI, including a 5-year NIH R01 award and a 3-year Aspire Pfizer Award, and has authored about 20 publications including original research, review articles and conference proceedings. He joined Lilly in May 2017 to support the effort in developing an integrated group aimed at assessing and mitigating immunogenicity risk of biotherapeutics.

Daron Forman

Bristol-Myers Squibb

Principal Scientist

Daron has been at Bristol-Myers Squibb for 10 years focusing on both in silico and in vitro pre-clinical immunogenicity risk assessment and mitigation. He received his Ph.D training at the University of Massachusetts in Worcester and conducted his post-doctoral studies at Massachusetts General Hospital. Prior to BMS, he worked on understanding mechanism of action of several immune-modulating biologics including anti-CD3 and anti-GITR mAbs.

Daniel H Fowler

RAPA Therapeutics

Chief Medical Officer

Dr. Fowler, who was a resident in Internal Medicine and Pediatrics at Wayne State University, completed the Medical Oncology Fellowship at the National Cancer Institute, NIH in Bethesda, MD. After fellowship, he worked in the NCI to study the role of Th1/Th2 regulation of transplantation responses, including graft rejection, GVHD, and graft-versus-tumor (GVT) responses. As a tenured Senior Investigator at the NCI in the Experimental Transplantation and Immunology Branch, he maintained both a laboratory effort and a clinical translational effort, where he served as Principal Investigator on clinical trials evaluating various autologous and allogeneic immune therapies. Dr. Fowler’s lab pioneered the use of ex vivo rapamycin to generate rapamycin-resistant T cells, which in a phase II clinical trial performed in the allogeneic stem cell transplantation setting were found to be safe and associate with a low rate of GVHD, stable mixed chimerism, and GVT effects in patients with refractory hematologic malignancy. After a 27-year career at the NIH, Dr. Fowler started a T cell therapy company in Rockville, MD, RAPA Therapeutics, LLC. RAPA Therapeutics is a clinical-stage biotechnology company with two main foci: first, the use of rapamycin-resistant Th1/Tc1 cells for the therapy of cancer, with the initial clinical trial being a phase II study in relapsed, refractory multiple myeloma (clinicaltrials.gov; NCT04176380); and second, the use of rapamycin-resistant hybrid TREG/Th2 cells for the therapy of neuro-degenerative and auto-immune diseases, with the initial clinical trial being a phase I study in patients with amyotrophic lateral sclerosis (clinicaltrials.gov; NCT04220190).

Theresa Goletz

Theresa Goletz Consulting

President

Theresa received a B.A. from the College of Wooster (Wooster, Ohio) and a Ph.D. from Baylor College of Medicine (Houston, Texas). After post-graduate studies at the National Cancer Institute/National Institutes of Health (Bethesda, Maryland) which focused on vaccines and cellular therapies, Theresa joined the Abramson Family Cancer Research Institute at the University of Pennsylvania. Dr. Goletz left academia for industry where she has held positions of increasing responsibility in R&D at Centocor, a Johnson and Johnson company, Amgen and EMD Serono, a Merck KGaA company. Her expertise in immunology and oncology, as well as her experience in the discovery, development and registration of biologics, including molecule selection, bioanalytical assessment and immunogenicity led her to found her consulting business, which she currently leads.

Boris Gorovits

Sana Biotechnology

SC4: Recent Advances with Gene and Cell Therapy

VP, In Vitro Pharmacology, Biomarker Discovery and Bioanalysis

Boris Gorovits is a VP of In Vitro Pharmacology, Biomarker Discovery and Bioanalysis at Sana Biotechnology. Boris earned a Ph.D. in Enzymology from the Moscow State University and later completed postdoctoral research studies in Protein biophysics at the Medical Center, U of Texas at San Antonio, TX. In 2000 Boris joined Wyeth Research (later Pfizer Inc.) to lead a Bioanalytical group responsible for many aspects of the Regulated and Non-Regulated Bioanalytical support for pan-Pfizer Biotherapeutic portfolio. Boris co-chaired Pfizer internal Immunogenicity Expert Working Group responsible for review of the biotherapeutic immunogenicity risk assessment and mitigation strategies. Later, Boris transitioned to Sana Biotechnology where he continues to be involved in development of various gene therapy and cell therapy modalities. Boris has been actively involved in industry discussions focusing on PK and immunogenicity assessment bioanalytical support of various modalities, including mAbs, bi-specific antibodies, antibody drug conjugates, gene therapy and CAR-Ts

Soumi Gupta

BioMarin Pharmaceutical Inc

Director

Soumi Gupta received her Ph.D. in Microbiology from University of California, Davis in 2003, where the focus of her research was aimed at furthering our understanding of the immune correlates of protection towards a successful AIDS vaccine. She pursued post-doctoral training in Immunology at Chiron Corporation where she investigated anti-HIV T and B cell-mediated responses following mucosal immunization with alphavirus-based replicon particles encoding for HIV-Gag, Pol and Env. Following her post-doctoral training, she worked at Monogram Biosciences as a scientist in research and development, developing assays to characterize genotypic and phenotypic resistance to HIV antivirals. Soumi joined BioMarin in February of 2015 as a Director in Immunogenicity Assessment where she provides immunologic expertise to drug programs across developmental stages and develops immunogenicity and safety strategies for novel biologic therapeutics, including enzyme substitution therapies and AAV-mediated gene therapies.

Mohamed Hassanein

Pfizer

Associate Director, Clinical Assay Lead (Biologics)

Mohamed Hassanein has a combined academic and in industry experience of more than 10 years in oncology, translational medicine and regulated bioanalysis. Dr. Hassanein received his Masers in Biological Sciences from Delaware State University and PhD in Molecular Biology and Genetics from University of Delaware. He completed his post-doctoral training at Vanderbilt Ingram Cancer Center where he later became a Research Assistant Professor. At Vanderbilt his research focused on developing and validating blood-based biomarkers for early detection of lung cancer. He then moved to Covance Laboratories where he served as a Principal Investigator, overseeing the bioanalytical development and validation of PK, immunogenicity and biomarker assays in support of preclinical and clinical development of biologics from pharma and biotech clients. After Covance, he joined Regeneron Pharmaceuticals to serve as a Senior Staff Scientist overseeing the bioanalytical strategy in support of clinical development of IO therapeutics. At Regeneron, he directly contributed to the approval of the company’s first immuno-checkpoint inhibitor, cemiplimab in skin cancer which is also the third overall approved anti-PD1 in the market as well as the successful IND approval for more than 10 biologics. He recently joined Pfizer Global Product Development (GPD) team as an Associate Director and clinical assay lead to support the clinical development of the company growing biotherapeutics portfolio.

Timothy Hickling

Roche

Head of Immunosafety

Tim recently joined Roche as Head of Immunosafety to focus on quantitative assessment of immunosafety risks. Tim previously lead Pfizer's Immunogenicity sciences team, where he contributed to better by design processes for minimizing immunogenicity risk, and spearheaded the industry's efforts to predict immunogenicity through quantitative systems pharmacology modeling of immune responses to biotherapeutics.

Wojciech Jankowski

FDA CBER

SC2: Overcoming Drug and Target Interference in ADA Assays

Commissioners Fellow & Biologist

Dr. Jankowski is a research reviewer with the US Food and Drug Administration in the Office of Tissues and Advanced Therapies. He is part of an active research laboratory and his research interests lie in the regulatory-science associated with the licensure of the next generation of therapeutic proteins. A key focus of his research activities has been to understand the immune response to protein therapeutics, which can significantly affect the efficacy and safety of these drugs. He uses a combination of computational, in vitro and ex vivo approaches in his work. Dr. Jankowski received his Ph.D. from Rutgers University, NJ and was subsequently selected for the highly competitive Commissioner’s Fellowship program at the FDA. His research has been published in high impact journals such as Nature and Nature Chemical Biology.

Lynn A Kamen

Genentech Inc

Sr Scientist

Lynn Kamen is a Senior Scientist in the BioAnalytical Sciences department at Genentech. She earned her Ph.D. in Immunology at the University of Michigan and completed a postdoctoral fellowship in immunology at the University of California San Francisco. Following her postdoctoral fellowship, Lynn transitioned into industry working in early drug discovery of both small and large molecules at several biotech companies including Portola Pharmaceuticals and Alector. Since joining Genentech, Lynn has supported the in vitro biological characterization of large molecules and lead the development of immunogenicity assays including ADA, NAb and immunogenicity risk ranking assays. She is co-lead of the AAPS NAber working group and member of the AAPS NAb drug tolerance sub-team.

Emilee Knowlton

ProImmune

Senior Immunology Sales Specialist

Emilee gained her PhD in Infectious Diseases and Microbiology from the University of Pittsburgh under the direction of Prof. Charles Rinaldo, identifying immune responses to lytic infection with Human Herpes Virus-8. She joined ProImmune in 2013 after completing her Post Doc in Rinaldo’s lab. She works on the ProImmune team providing innovative solutions for clients that radically improve our understanding of both desired and unwanted immune responses.

Emilee Knowlton

ProImmune

Senior Immunology Sales Specialist

No bio available.

Daniel LaGasse

FDA CBER

Research Regulator

Daniel Lagassé conducts research and CMC review as a Biologist in the Division of Plasma Protein Therapeutics within the Center of Biologics Evaluation and Research at the U.S. Food and Drug Administration. Dr. Lagassé received his PhD in Molecular Microbiology and Immunology from Johns Hopkins Bloomberg School of Public Health.

David M Lansky

Precision Bioassay Inc

President

David Lansky has been practicing statistics on bioassays (and other non-clinical applications in Pharma) for 30 years. This includes 10 years at Searle/Monsanto/Pharmacia and 16 years as the owner of Precision Bioassay, Inc. David has been and is still an active participant in the work to revise the USP bioassay chapters. His education includes a year of Electrical and Computer Engineering (University of Michigan), a BS in Botany (San Francisco State), an MS in Entomology (Cornell) and finally both an MS and Ph.D. in Biometry (both Cornell).

Catherine Liloia

PPD Inc

Assoc Dir Cell Lab

I have nineteen years of experience in the biotechnology industry across manufacturing, quality control, and process development functions. Most of my experience is working in GMP laboratories supporting release and stability testing with cell-based, immunoassay, PCR, and gel methods. As an analytical scientist, I supported the optimization of these methods to ensure commercial readiness with focus on mitigating sources of variation and bias, while exploring efficiency gains. I have been a leader in laboratories for 10 years and in my most recent role. have transitioned to contract testing where my team of 80 supports method development and routine testing associated with monoclonal antibodies, proteins, and gene therapies in Phase 1 – commercial testing for over 50 clients. Most recently, I have joined the USP Bioassay General Chapters Expert Panel where we are actively revising the bioassay chapters for improved clarity and guidance.

Chang Liu

Genentech Inc

Assoc Scientist

Dr. Liu is currently an Associate Scientist in the department of BioAnalytical Sciences at Genentech. She received her Ph.D. in Neuroscience from Johns Hopkins University, where her research concentrated on pathways and molecular mechanism of pain. She joined Genentech as a postdoctoral fellow in the department of Biochemical and Cellular Pharmacology, where she characterized structure-function relationship of a number of drug targets. Currently, she conducts research and works on functional cell-based assays to support biotherapeutics development.

Bernard Maillere

CEA Saclay

Dir Research & Head

B. Maillere. He is currently head of the laboratory of cellular immunology and biotechnology at Commissariat à l'Energie Atomique (CEA) a French Governmental research Institute and head of the pole of immunology of the doctoral school “therapeutic innovation” of the university of Paris-Saclay. His current research focuses on the prediction of immunogenicity and the identification of T cell epitopes in humans with the perspectives of developing safe therapeutic proteins and new vaccines. He was co-leader of the workpackage immunogenicity prediction of the European project ABIRISK.

Ronit J Mazor

FDA CBER

SC2: Overcoming Drug and Target Interference in ADA Assays

Principal Investigator

Ronit Mazor did her undergraduate studies in Tel Aviv University in Israel. She performed her PhD in the NIH’s International Graduate Partnership Program, in collaboration with Tel Aviv University. Ronit continued her Post doctoral training in the national cancel institute working on the immunogenicity of recombinant immunotoxins for cancer therapy with Ira Pastan. She then joined the antibody discovery and protein engineering in Medimmune/AstraZeneca in Gaithersburg where she established their cellular and in silico pre-clinical immunogenicity prediction platform. In 2019, Ronit joined the Gene Transfer and Immunogenicity Branch in the FDA as a principle investigator. She is leading a research group studying the interaction between the immune system and gene therapy viral vectors.

Jim McNally

BioAgilytix

SC1: Mechanism of Action and Risk-Based Approach for Developing Neutralizing Ab Assays

SC4: Recent Advances with Gene and Cell Therapy

Chief Scientific Officer

Dr. McNally has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he lead a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics. Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance. Dr. McNally obtained his B.S. in Biology from Mississippi State University, his Ph.D. Viral Immunology from Louisiana State University School of Medicine in Shreveport, and his Post-Doc in Viral Immunology from University of Massachusetts Medical School.

Jos Melenhorst

University of Pennsylvania

Director

Dr. J. Joseph Melenhorst is the Director of Product Development & Correlative Sciences (PDCS) at the Center for Cellular Immunotherapies (CCI), and Adjunct Associate Professor of Pathology and Laboratory Medicine, University of Pennsylvania (U Penn). After he obtained is MSc degree at the University of Nijmegen, Netherlands, and PhD degree at the University of Leiden, Netherlands, he did his post-doctoral research at the National Institutes of Health in Bethesda, Maryland, studying the biology of bone marrow failure syndromes, leukemia and graft-versus host immunology, and adoptive cell therapy. Dr. Melenhorst was recruited to the University of Pennsylvania in 2012. The focus of his laboratory is to understand and improve the efficacy and safety of cellular immunotherapy through biomarker, mechanistic, and product development studies. His laboratory has uncovered key biomarkers of a chimeric antigen receptor (CAR) T cell therapy-associated toxicity, cytokine release syndrome (CRS), and developed predictive monitoring tools for CRS in leukemia 1. He furthermore identified the critical parameters determining success in CAR T cell therapies in leukemia 2 (and manuscripts under revision). Lastly, his efforts include the development of a universal, streamlined, cost-effective and potent manufacturing process for T cell engineering and some of his insight has already been translated into clinical practice.

Stephen D Miller

Northwestern Univ

Prof Microbiology & Immunology & Dir

Dr. Stephen Miller is the Judy E. Gugenheim Research Professor of Microbiology-Immunology at Northwestern University Feinberg School of Medicine in Chicago. He received his Ph.D. in 1975 from the Pennsylvania State University and did postdoctoral training at the University of Colorado Health Sciences Center before joining the faculty at Northwestern in 1981 where he currently serves as Director of the Northwestern University Interdepartmental Immunobiology Center. Dr. Miller is internationally recognized for his research on pathogenesis and regulation of autoimmune diseases. He has published over 410 journal articles, reviews and book chapters and has trained multiple generations of scientists. His work has significantly enhanced understanding of immune inflammatory processes underlying chronic autoimmune disease employing animal models of multiple sclerosis (MS), Type 1 diabetes (T1D) and celiac disease (CD). His work has focused on the study of the cellular and molecular mechanisms underlying treatment of established T cell-mediated autoimmune diseases using antigen-specific immune tolerance. His current work is geared to translating the use of antigen-encapsulating biodegradable PLG nanoparticles for the treatment of human immune-mediated diseases including autoimmunity, allergy, anti-drug antibody responses and tissue/organ transplantation. Dr. Miller is also co-founder of Cour Pharmaceutical Development Company which is partnering with Takeda Pharmaceuticals in testing tolerance therapy of CD using gliadin-encapsulating tolerogenic immune-modifying nanoparticles (TIMPs).

Paul A Moore

MacroGenics, Inc

SC3: Validation of ADA Assays and Cut Point Calculations

VP Cell Biology & Immunology

Over 20 years of experience working in biotech, coordinating efforts focused on the discovery and development of novel biologic-based therapies. Began biotechnology career at Human Genome Sciences, where directed genomic-based target discovery programs and the preclinical development of various protein and mAb-based therapeutics for the treatment of cancer, metabolic, and autoimmune diseases. Notably these efforts led to the discovery of BLyS as a B-cell survival factor providing the basis for the development of Benlysta for the treatment for lupus. At MacroGenics, leads a research group dedicated to the discovery, preclinical development and clinical translational biology of antibody-based therapeutics including Fc-optimized mAbs and bispecifics for cancer or autoimmune disease through harnessing of the host immune system. Obtained PhD from University of Glasgow and performed post-doctoral work at the Roche Institute of Molecular Biology; co-authored over 70 peer-reviewed manuscripts and 40 issued US patents.

Johanna Mora

Bristol-Myers Squibb

Associate Director

Dr. Mora is currently an Associate Director in the Non-clinical Disposition and Bioanalysis Group at Bristol-Myers Squibb (BMS). She received a Bachelor of Science degree in Chemistry from the University of Costa Rica in 1999 and a Ph.D. in Analytical Chemistry from the University of Kansas in 2004. At BMS she is the PK and immunogenicity Lead for innovative medicines development (IMD) assets and leads a team of scientists in the development of methods to support bioanalysis and bioanalytical strategy of small, macromolecular, and new modality therapeutics. She is a mentor to her team, is an author of over 15 scientific publications and has served in several cross functional teams within BMS. She is an active member of AAPS, has served in the Emerging Technology and the Therapeutic Product Immunogenicity Focus groups and is a member of Applied Pharmaceutical Analysis Regulated Bioanalysis Committee.

Kannan Natarajan

NIH NIAID

Staff Scientist

Dr Kannan Natarajan obtained his Ph.D. in Immunology from India and trained as a postdoctoral fellow at the Biozentrum, University of Basel, Switzerland, and at the University of Rochester, New York. Following a 2-year stint on the faculty of the Forsyth Research Institute in Boston, he joined the Laboratory of Immunology at the NIAID/NIH. Kannan’s research interests are the structural basis of ligand recognition by receptors of the immune system, especially receptors found on T cells and natural killer cells, and the molecular aspects of antigen presentation.

Simone Nicholson

AstraZeneca

Discovery Safety Specialist

Simone is a Toxicologist at MedImmune/AstraZeneca, she supports the safety assessment of multiple biologics modalities at all stages of development. Prior to her time at MedImmune, Simone performed in vivo pharmacology and safety studies at Dyax, the antibody library company. She also established a suite of in vitro toxicology assessments to evaluate the toxicity of Epix Pharmaceuticals’ innovative imaging compounds. She came to the field of toxicology, serendipitously, when asked to conduct the studies that were the foundation of the DrugMatrix toxicogenomics database at Iconix Biosciences. She has a Ph.D. in Immunology from Northwestern University and is board certified in Toxicology.

Morten Nielsen

Technical University of Denmark

Professor

Morten Nielsen holds a shared position as Professor of Immunoinformatics and machine learning at the Department of Health Technology, Technical University of Denmark, and the Universidad Nacional de San Martin, Argentina. He graduated with a master in physics from the University of Copenhagen. Obtained his PhD (also in physics) from the University of McGill, Canada. The core of Morten Nielsen’s research deals with the development of novel and advanced data-driven prediction methods for pattern recognition in biological systems. Morten Nielsen is a pioneer in the field of immunoinformatics and a key inventor of several state-of-the-art methods for T and B cell epitope discovery including the NetMHC-suite currently used worldwide for rational epitope discovery. He has published more than 200 articles, books, and book chapters within the fields of immunology, immunoinformatics, computational biology, data mining and machine learning.

Michael Partridge

Regeneron Pharmaceuticals Inc

Associate Director

Born and raised in Australia, Michael received his Ph.D. from Sydney University (CSIRO). He moved to the US for a post doc at Columbia University where he investigated integrin-mediated cell signaling, tumorigenesis and biomarkers of radiation exposure. Michael left academia to work at Regeneron where he led a group of scientists developing and validating PK, ADA, NAb and biomarker immunoassays. He has subsequently taken a role interacting with clinical teams as the bioanalytical strategic lead for multiple therapeutic areas.

Sofie Pattijn

ImmunXperts SA

Founder & CTO

Sofie Pattijn, CTO and founder of ImmunXperts, has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development with a focus on functional assays for immunogenicity, immune oncology, and cell and gene therapy products. She has extensive hands-on lab experience and has managed and coached several in vitro teams over the last decade. From 2008 until 2013, she was Head of the in vitro Immunogenicity group at AlgoNomics (Ghent, Belgium) and Lonza Applied Protein Services (Cambridge, UK). Prior to that, she worked at Innogenetics in Belgium for over 15 years.

Cheryl Pickett

NIH NCI

Associate Research Physician, Cancer Therapy Evaluation Program

Dr. Pickett recently joined the Investigational Drug Branch and CTEP to focus on early clinical trials of immunotherapy agents. Before coming to IDB, she was a Clinical Research Medical Director in Oncology at Amgen; prior to that, she held a similar appointment at Merck. She has over 15 years of broad oncology clinical trial expertise developing and conducting trials across Phase 1-3, covering a wide range of compounds, mechanisms of action, and tumor indications in both company-sponsored and in collaborative projects. Her work at Amgen included leading multiple clinical trials for the oncolytic virus, talimogene laherparepvec (T-VEC), as well as several combination trials incorporating checkpoint inhibitors. Dr. Pickett earned her Ph. D. in biochemistry at the University of California (UC) Davis and her M.D. at the University of Colorado. After residency at UC Davis and a clinical and research fellowship at the University of Colorado, she held faculty appointments at the University of Colorado and then at the University of Washington Medical Centers before moving from academia to oncology clinical development positions in the biotech/pharma sector.

Sandra Prior

NIBSC

Sr Scientist

Sandra Prior joined the National Institute for Biological Standards and Control (NIBSC, Potters Bar, UK) as a Senior Scientist in 2015. She works on the investigation of structure-function in relation to the safety and efficacy of monoclonal antibody products and on the development of bioassay standards for therapeutic monoclonal antibodies. She is a member of the European Directorate for the Quality of Medicines and HealthCare (EDQM) monoclonal antibody expert committee and the Official Medicines Control Laboratory (OMCL) monoclonal antibody testing group. She obtained her Ph.D. from the University of Navarra (Spain) and moved to the UK, where she initially worked at NIBSC investigating safety and protective mechanisms of bacterial combination vaccines. In 2010, she joined Lonza Biologics (Cambridge, UK) working on bioactivity and immunogenicity assessment of biotherapeutics. Sandra has over 15 years of experience in applied immunology and in vitro cell-based assay development.

Qiang Qu

EMD Serono

Principal Scientist

Qiang Qu is the Head of Clinical Assay Development lab in the DMPK department at EMD Serono, a Merck KGaA company. In this role, he is responsible for the clinical bioanalytical assay strategy and clinical pharmacokinetic and immunogenicity assay development for the large molecule portfolio, including scientific oversight of externalized assays. Previously, Qiang was a senior scientist at Pfizer (Andover, MA) in the PDM department which was responsible for both preclinical and clinical pharmacokinetic and immunogenicity assay development, validation and sample analysis supporting large molecules. Qiang has a B.S. degree in Biochemistry from Nankai University and a M.S. degree in genetics from Chinese Academy of Sciences.

Theodore Rispens

Sanquin

Head of Lab/PI

Theo Rispens studied chemistry in Groningen, The Netherlands. He received his PhD in 2004 following research of chemical reactivity in biological models systems. Since 2006 he has worked at Sanquin, where is staff member at the department of Immunopathology of Sanquin Research. Current research activities focus on the structure and function of immunoglobulins and the mutual interactions between the immune system and therapeutic antibodies. One research line involves mechanisms of humoral tolerance, in particular the biology of IgG4 antibody responses in health and disease. Furthermore, he studies the immune response to biologicals in autoimmune patients, particularly in rheumatology, and is responsible for the development of novel immunoassays to support this research line, and to implement for world-wide service testing at Sanquin Diagnostic Services, to support the optimization of treatment strategies with biologicals.

Bonnie J Rup

Bonnie Rup Consulting LLC

SC5: Advice on Putting Together an Integrated Summary of Immunogenicity

Biotechnology Consultant

Bonita Rup is a biopharmaceutical development consultant, providing expert advice on bioanalysis, immunogenicity risk assessment, and related regulatory strategy aspects of biopharmaceutical development. Previously she was Research Fellow and lead for the Immunogenicity Discipline at Pfizer, Assistant Vice President of Protein Bioanalytics in Wyeth, and held various positions directing development and application of immuno-ligand binding assay technologies for PK, immunogenicity and protein impurity analysis, and other aspects of biopharmaceutical development. During her career, she has been involved in multiple regulatory filings during preclinical, clinical development and marketing approval of biopharmaceutical products. She has been a member of AAPS, EIP, European IMI ABIRISK consortium, and Biosafe; with these organizations, she has been a co-author for multiple publications related to monitoring immunogenicity and bioanalysis of therapeutic proteins. Bonnie received her B.S. from University of Massachusetts, Amherst, Ph.D. from University of Texas, Austin, and conducted postdoctoral research at Duke University and University of Rochester, NY.

Nancy C Sajjadi

Quality Consultant

Independent

Nancy Sajjadi, M.Sc. is an independent quality consultant with over 30 years of experience in biopharmaceutical product development. She began her career as a bench scientist doing malaria vaccine research before turning to development of cell and gene using therapy retroviral vectors for infectious disease, cancer and cell therapy applications. Her responsibilities there included research, development, and quality control. She left her position as Director of QC at Chiron Technologies Center for Gene Therapy, in 2000 and to start a consulting business. She 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 biopharmaceutical products in early phase development. She also has provided technical expertise in assay development, qualification and validation. Ms. Sajjadi has authored several articles pertaining to bioassays and viral gene therapy, has served on 5 advisory panels for the United States Pharmacopeia (USP) and teaches introductory courses in bioassay design, development and validation for non-statisticians.

Sumona Sarkar

NIST

Biomedical Engineer

Sumona Sarkar is a Biomedical Engineer at the National Institute of Standards and Technology in Gaithersburg MD. She has been at NIST for 8 years with a focus on cell material interactions for tissue engineering and regenerative medicine, and analytical methods for cell and gene therapy. She serves as a subject matter expert and project leader in ISO TC 276: Biotechnology with particular expertise in cell count, viability, and characterization. Prior to joining NIST Sumona received her Ph.D in biomedical engineering from Drexel University, and her M.S. from Boston University.

Timothy L Schofield

CMC Sciences LLC

Owner & Consultant

Timothy Schofield is Owner & Consultant at CMC Sciences, LLC. Prior to joining this Tim worked at a Senior Advisor in Global Vaccines Technical R&D at GlaxoSmithKline, at MedImmune as Senior Fellow in Analytical Biotechnology, Arlenda, Inc. as Managing Director and Head of Nonclinical Statistics, at GSK in US Regulatory Affairs, and at the Merck Research Laboratories heading the Nonclinical Statistics unit, supporting research, development and manufacture of Merck pharmaceuticals, biologics and vaccines. Tim received a Bachelor of Science degree in Mathematics from Lafayette College, and a Master of Arts degree in Statistics and Operations Research in 1976 from the Wharton School of the University of Pennsylvania. Tim is a member of the USP Statistics Expert Committee and has participated in industry initiatives related to Quality by Design, analytical method development and validation, stability and specifications. He is the Chairman of the IABS Publications Committee where he is responsible for business and strategy related to the journal Biologicals.

Ethan M Shevach

NIH NIAID

Senior Investigator

Dr. Shevach received his A.B. and M.D. degrees from Boston University. He is presently Chief, Cellular Immunology Section, Laboratory of Immunology. Dr. Shevach is the author of over 450 papers in the field of Immunology and his research interests over the years have included antigen presentation and processing, T lymphocyte activation, pathogenesis of autoimmunity, and most recently the role of regulatory T cells in immune responses. He served as Editor-in-Chief of the Journal of Immunology from 1987 to 1992 and as Editor-in-Chief of Cellular Immunology from 1996 to 2007. He is a member of the editorial boards of several journals including Immunity, Journal of Experimental Medicine, and Human Immunology.

Basile Siewe

The Jackson Laboratory

Director, Business Development

Basile is a trained viral immunologist with a Ph.D. from the TU Munich, Germany. After a brief antibody engineering related stint at Roche Diagnostics, he pursued a post-doctoral fellowship at LUMC in Chicago, followed by a five year infectious diseases junior faculty tenure at RUMC also in Chicago. Over the last 6 years, Basile held various field positions as Field Application Scientist, Market Development Scientist and in Business Development.

Renu Singh

GSK

Scientific Leader

Renu Singh is a Scientific Leader in Global DMPK at GSK; prior to joining GSK, she held positions at Bristol Myers Squibb. She has more than 12 years of diversified experience in drug discovery and development in various therapeutic areas. Her expertise is in translation of ADME, safety and efficacy of therapeutics to human. She holds a Ph.D. in Pharmaceutical Sciences from University of Montreal.

Perceval Sondag

Merck & Co Inc

Assoc Principal Quantitative Scientist

Percy Sondag holds a Bachelor’s Degree in Physical Therapy and a Master’s Degree in Biostatistics, both obtained from the Catholic University of Louvain-la-Neuve in Belgium. He is a Statistician at Merck Sharp & Dohme. Prior to joining Merck Sharp & Dohme in 2019, he was working at Pharmalex (formerly Arlenda) as a Statistical Consultant. He specializes in Bayesian modelling and statistics applied to bioassays and process manufacturing. Since 2017, he is also a member of the Bioassay Expert Panel at the U.S. Pharmacopeia.

Daniela I Verthelyi

FDA CDER

Supervisory Biologist

Dr. Verthelyi received her MD from the University of Buenos Aires and a PhD from the Virginia Tech in USA, and then completed a fellowship training in Immunology at the Section in Retroviral Immunology in the Center for Biologics Evaluation and Research of the FDA before joining the Office of Biotechnology Products in CDER, FDA as a principal investigator. She currently heads the Laboratory of Innate Immunity and chairs CDER’s newly formed Center for Excellence in Infectious Diseases and Inflammation. She directs a lab focused on developing tools to monitor and control innate immune and inflammatory responses including potential impurities in therapeutic products that may foster unwanted immune responses therapeutic proteins reducing their life-saving potential. In addition, she has Chaired the FDA-NIH Immunology Interest Group, the NIH-FDA Cytokine Interest Group, and served on the Advisory Boards for the NIH Human Immunology Group. She has authored over 80 peer-reviewed articles, holds several patents, and has received FDA's, CBER’s, and CDER’s “Excellence in Laboratory Sciences” awards, among other honors.

Eric Wakshull

Eric Wakshull Consulting

CEO

Eric has been a scientist in the BioPharm industry since 1986 as a drug discovery scientist at Pfizer and AlphaBeta Technology and for over 20 years as a bioanalytical scientist at Biogen and Genentech. As a bioanalytical scientist, Eric led groups that specialized in the development, validation, and implementation of pharmacokinetic, immunogenicity, and biomarker asssays for multiple drug candidates. As an active participant in broad cross-functional project teams from early pre-IND phases through BLA submissions and post-marketing support, Eric has acquired a broad understanding of the drug development process. He has also interacted with Health Authorities via direct face-to-face interactions, as well as teleconferences and written query responses. Currently, Eric is a self-employed consultant to support bioanalytical strategies and review of assays development and data interpretation for a number of small companies.

Steven L Walfish

USP

Principal Scientific Liaison

Mr. Walfish is Principal Science & Standards Liaison at United States Pharmacopeia (USP) responsible for the Statistics Expert Committee. Prior to this role Mr. Walfish was Principal Statistician at Becton Dickinson in Franklin Lakes, NJ responsible for supporting continuous improvement efforts and process development for worldwide operations. Mr. Walfish has held roles at GE Healthcare, Human Genome Sciences and Chiron. Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries. Mr. Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification and validation and stability analysis. Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

Wen Jin Wu

FDA CDER

SC2: Overcoming Drug and Target Interference in ADA Assays

Sr Investigator

Dr. Wu is currently a Senior Investigator in the Division of Biotechnology Review and Research I (DBRR1), Office of Biotechnology Products (OBP), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), FDA. He earned his M.D. from Wannan Medical College in China. In 2002, he received his Ph.D. from Cornell University. After two years as a Research Associate supervised by Dr. Richard Cerione at Cornell University, he obtained the position of a Principal Investigator (PI) in OBP at FDA in 2004. In addition to his regulatory duty as a Product Quality Reviewer, Dr. Wu’s laboratory at FDA investigates the roles of ErbB/HER family receptors in breast cancer progression, conducts physiochemical and biological characterization of HER2-targeted antibody therapeutics, including monoclonal antibodies, antibody-drug conjugates, and bispecific antibodies, and antibody engineering generating novel bispecific antibodies for the treatment of breast cancer. His laboratory also carries out the development of cell-based bioassays for bispecific antibodies. He has published many research papers in highly reputed journals, including mAbs, Scientific Reports, Journal of Biological Chemistry, Nature, Cell, Molecular Cancer Therapeutics, and Cancer Research, and has been invited to give talks at many national and international conferences.

Weifeng Xu

Merck Research Labs

Principal Scientist & Group Leader

Weifeng has been in the field of immunogenicity for biologics for about 10 years. He had developed cell-based neutralization Ab assays for multiple key product at BMS including Opdivo and Yervoy. He is an active member in AAPS NAb work group as well as EBA NAb team; he is also co-leading the NAb assay drug tolerance subteam at AAPS. After join Merck at the end of 2018, Weifeng is now leading Cell Assay group within PPDM Regulated Immunogenicity to develop neutralizing assays for both biologics and vaccines.

Qi Yang

Regeneron Pharmaceuticals Inc

SC3: Validation of ADA Assays and Cut Point Calculations

Scientist

Angela Yang is a Scientist in the Bioanalytical Sciences department at Regeneron. She received a Ph.D. from the University of North Carolina at Chapel Hill, where she studied interactions between PEGylated nanoparticles and the immune system. At Regeneron, Angela has worked on the development and validation of PK, ADA, and neutralizing antibody assays in support of clinical and non-clinical studies, as well as developing tools for data analysis of immunogenicity assays.

Tatyana Yun

Merck Research Labs

Sr Scientist

Tatyana Yun obtained her Ph.D. in Biological Sciences from the State Research Center “VECTOR” in Russia, where she developed and characterized human antibodies against viral pathogens using phage display. She worked as a postgraduate researcher at the University of Texas Medical Branch, where she rescued and characterized highly pathogenic viruses in BSL-4 environment. She joined the cell-based potency assay group at the Vaccine Analytical department at Merck in 2018 and transitioned to the Immunogenicity group within the Bioanalytical division, where she is working on developing assays for detection of neutralizing antibodies.

Jeff Zhu

NIAID, NIH