Bioanalysis and Immunogenicity in the COVID-19 Pandemic
Friday, August 14, 2020
Bioanalysis and Immunogenicity in the COVID-19 Pandemic
11:45 AM Speed Networking Session
All participants will be randomly grouped into multiple speed networking rooms to interact with others with both video and audio capabilities
12:00 PM Organizer’s Opening Remarks
Emily Le, PhD, Founder & CEO, Bioinsider
Jen Lu, PhD, Sales and Marketing Manager, Sino Biological
12:05 PM Concurrent Roundtable Discussions
Roundtable Discussion 1: Challenges of Conducting Bioanalysis in Clinical Trials in the Midst of COVID-19 Pandemic
Co-Moderator: Mohamed Hassanein, PhD, Associate Director, Clinical Assay Lead, Pfizer
Co-Moderator: Michael Partridge, PhD, Associate Director, Bioanalytical Sciences, Regeneron Pharmaceuticals
- Logistical disruptions to sample collection, shipping and analysis and consequences on the conduct of clinical trials and regulatory filing
- Special considerations for vulnerable patient populations (e.g. oncology)
- Possible solutions to stream line bioanalysis during the pandemic
- Post pandemic reality and its impact on bioanalysis
Roundtable Discussion 2: How COVID-19 has Changed the Immunogenicity Risk of Immune Modulatory Biologics
Co-Moderator: Vibha Jawa, PhD, Director and Lead, Predictive and Clinical Immunogenicity, PPDM, Merck & Co Inc
Co-Moderator: Narendra Chirmule, PhD, CEO, SymphonyTech Biologics; CSO, AcuImmune
- Challenges with ongoing clinical trials and patient compliance. Will all patients on existing or new trials be prescreened for COVID?
- Will the COVID positive patients treated differently? Would they be taken off the trial?
- Is there a matrix or underlying immune activation due to COVID infection that can change the outcome of the clinical trial, especially in oncology?
- Would there be an augmentation if immune response to the biological due to cytokine activation usually observed with COVID infections?
1:00 PM End of Friday Roundtables
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Meet Our Moderators
Mohamed Hassanein, PhD, Associate Director, Clinical Assay Lead, Pfizer
Mohamed Hassanein has a combined academic and industry experience of more than 12 years in oncology, translational medicine, and regulated bioanalysis. Dr. Hassanein received his Masters in Biological Sciences from Delaware State University and PhD in Molecular Biology and Genetics from the 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. He served as Staff Scientist/Principal Scientist overseeing the bioanalytical strategy in support of clinical development of therapeutic mAbs at Regeneron Pharmaceuticals. Currently, he is the associate director in clinical assay lead at Pfizer.
Michael Partridge, PhD, Associate Director, Bioanalytical Sciences, Regeneron Pharmaceuticals
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. His current role is the bioanalytical strategic lead for multiple therapeutic areas, interacting directly with clinical teams including physicians, clinical pharmacology and regulatory departments.
Narendra Chirmule, PhD, CEO, SymphonyTech Biologics; CSO, AcuImmune
Dr. Chirmule is currently the CEO at the SymphonyTech Biologics and also the CSO at the AcuImmune. With over 23 years of experience in Immunology, he has held senior leadership positions at Amgen and Merck, in the US, in the departments of Clinical Immunology overseeing drug development in regulated laboratories. He is an expert in the area of immune responses to biologics and vaccines. Narendra completed his post-doctoral training at Cornell University Medical College, New York, and has teaching and research experience as Assistant Director at the Human Gene Therapy Group of the University of Pennsylvania. He is an advisor to the Filovirus consortium and a reviewer on the HIV vaccine study section for the National Institutes of Health. He is also an academician conducting Biotech educational seminars and has published extensively (more than 100) on the topics of immunogenicity prediction and assessment, predictive toxicology, and quality-by-design. Narendra is an MS (Zoology, Animal Physiology) and Ph.D.in Applied Biology from the University of Mumbai
Vibha Jawa, Ph.D., Director and Lead, Predictive and Clinical Immunogenicity, PPDM, Merck & Co Inc
Dr. Vibha Jawa obtained her Ph.D. in Biochemistry and Immunology with a thesis work studying the immune mechanisms behind autoimmune diseases. This was followed by a postdoctoral fellowship at the University of Pennsylvania where she did extensive work on assay development for monitoring the immune response to viral vectors. She then moved to the Bay area where she worked with a gene therapy company evaluating viral vectors for hemophilia therapy. Subsequently, she moved to Southern California where she worked for the City of Hope Cancer Centre Stem Cell and Gene Therapy group prior to moving to Amgen in 2003. Until recently she was a Principal Investigator and Clinical Immunology representative on several of Amgen’s drug development teams where she provided input to develop appropriate immunogenicity risk assessment strategies. Her current research interests include evaluating immune response biomarkers for early drug development and efficacy, immunogenicity prediction using in silico, in Vitor, and in vivo technologies, modeling the impact of immunogenicity on PK and PD, antigen processing and presentation and the role of T cells in the immune response to drug products.