In this webcast, Dr. Thomas Powles, Chair of Barts Cancer Centre (UK), joins Christopher Ung, our Chief Scientific Business Officer, for an in-depth conversation on the latest on Antibody Drug Conjugates (ADCs) and other innovative cancer therapies.
Key topics discussed in this webcast:
The challenges of treating metastatic bladder cancer
Targeting metastatic bladder cancer with Nectin-4 ADC
New ways of thinking about biomarkers for ADCs
How spatial biology could improve ADC assessment
Bi-specifics and other innovative therapies for metastatic bladder cancer
Being a physician and running clinical trials
Dr. Powles is a renowned expert in urology cancer and drug development, serving as the Chair of the Barts Cancer Centre at St. Bartholomew’s Hospital, Queen Mary University of London. He leads numerous clinical trials across all phases. Notably, his work in bladder and renal cancer has been pivotal in establishing new immunotherapy and antibody drug conjugate treatments as standards of care globally. Dr. Powles has been included in TIME’s list of the 100 most influential people in global health and in the Nature10 list in 2023.
Christopher Ung is CellCarta’s Chief Scientific Business Officer and has served in the companion diagnostics field since its inception. He is one of the original pioneers of the personalized medicine field. Mr. Ung currently leads the development and execution of CellCarta’s strategic and business initiatives, leveraging the company’s solid tumor and anatomic pathology services.
Let's Talk: A Conversation with Dr. Thomas Powles
November 28, 2024
In this webcast, Dr. Thomas Powles, Chair of Barts Cancer Centre (UK), joins Christopher Ung, our Chief Scientific Business Officer, for an in-depth conversation on the latest on Antibody Drug Conjugates (ADCs) and other innovative cancer therapies.
Key topics discussed in this webcast:
The challenges of treating metastatic bladder cancer
Targeting metastatic bladder cancer with Nectin-4 ADC
New ways of thinking about biomarkers for ADCs
How spatial biology could improve ADC assessment
Bi-specifics and other innovative therapies for metastatic bladder cancer
Being a physician and running clinical trials
Dr. Powles is a renowned expert in urology cancer and drug development, serving as the Chair of the Barts Cancer Centre at St. Bartholomew’s Hospital, Queen Mary University of London. He leads numerous clinical trials across all phases. Notably, his work in bladder and renal cancer has been pivotal in establishing new immunotherapy and antibody drug conjugate treatments as standards of care globally. Dr. Powles has been included in TIME’s list of the 100 most influential people in global health and in the Nature10 list in 2023.
Christopher Ung is CellCarta’s Chief Scientific Business Officer and has served in the companion diagnostics field since its inception. He is one of the original pioneers of the personalized medicine field. Mr. Ung currently leads the development and execution of CellCarta’s strategic and business initiatives, leveraging the company’s solid tumor and anatomic pathology services.
Let's Talk: A Conversation with Dr. Scott Gottlieb
September 10, 2024
The drug development landscape is rapidly evolving, with new regulatory guidance, novel therapy types, and exciting AI-powered technologies altering the face of clinical testing.
In this webcast, Scott Gottlieb, former FDA commissioner, joins Christopher Ung, our Chief Scientific Business Officer, for an in-depth conversation on the latest in regulatory and biomarker development.
Key topics discussed in this webcast:
The history and future of cell therapies
The FDA’s final rule to regulate lab-developed IVDs as medical devices
How to navigate the FDA’s new oncology IVD pilot program
T cell health in immune oncology and metabolic drug development
How AI-powered digital pathology is revolutionizing cell therapy development
Dr. Gottlieb is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration. Dr. Gottlieb’s work focuses on advancing public health through developing and implementing innovative approaches to improve medical outcomes, reshape healthcare delivery, and expand consumer choice and safety. He is currently a partner at the venture capital firm New Enterprise Associates; a resident fellow at the American Enterprise Institute; a contributor to CNBC; and a board member to Pfizer, Inc. and Illumina, Inc.
Christopher Ung is CellCarta’s Chief Scientific Business Officer and has served in the companion diagnostics field since its inception. He is one of the original pioneers of the personalized medicine field. Mr. Ung currently leads the development and execution of CellCarta’s strategic and business initiatives, leveraging the company’s solid tumor and anatomic pathology services.
Let's Talk: A Conversation with Dr. Scott Gottlieb
September 10, 2024
The drug development landscape is rapidly evolving, with new regulatory guidance, novel therapy types, and exciting AI-powered technologies altering the face of clinical testing.
In this webcast, Scott Gottlieb, former FDA commissioner, joins Christopher Ung, our Chief Scientific Business Officer, for an in-depth conversation on the latest in regulatory and biomarker development.
Key topics discussed in this webcast:
The history and future of cell therapies
The FDA’s final rule to regulate lab-developed IVDs as medical devices
How to navigate the FDA’s new oncology IVD pilot program
T cell health in immune oncology and metabolic drug development
How AI-powered digital pathology is revolutionizing cell therapy development
Dr. Gottlieb is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration. Dr. Gottlieb’s work focuses on advancing public health through developing and implementing innovative approaches to improve medical outcomes, reshape healthcare delivery, and expand consumer choice and safety. He is currently a partner at the venture capital firm New Enterprise Associates; a resident fellow at the American Enterprise Institute; a contributor to CNBC; and a board member to Pfizer, Inc. and Illumina, Inc.
Christopher Ung is CellCarta’s Chief Scientific Business Officer and has served in the companion diagnostics field since its inception. He is one of the original pioneers of the personalized medicine field. Mr. Ung currently leads the development and execution of CellCarta’s strategic and business initiatives, leveraging the company’s solid tumor and anatomic pathology services.
Let's Talk: A Conversation with CAR T-cell Therapy Pioneer Dr. Carl June
February 22, 2024
Immunotherapies such as CAR T-cell therapy hold a lot of promise in treating illnesses like cancer. However, key challenges remain in their development, in particular the need to address adverse events and patient resistance.
In this webcast, Dr. Carl June, a pioneer in the field of CAR T-cell therapy, joins Christopher Ung, our Chief Scientific Business Officer, for an in-depth conversation on developing immuno and CAR T-cell therapies.
Key topics discussed in this cell therapy focused webcast:
Academic and Industry Partnership in CAR-T Development
CAR-T Development in US and China
Biomarkers from vein to vein: Mechanism, Selection, and Resistance
Facing the Challenges: Adverse Events and Patient Resistance
New Frontiers: Solid Tumors, Evolutionary and Revolutionary CAR models
Dr. Carl June
Dr. June is a member of CellCarta’s Scientific Advisory Board and the Richard W. Vague Professor in Immunotherapy in the Perelman School of Medicine at the University of Pennsylvania.
In 2011, his research team published a paper on the first CAR-T therapy treating leukemia patients with their own genetically modified T-cells.
Mr. Christopher Ung
Mr. Ung is CellCarta’s Chief Scientific Business Officer and has served in the companion diagnostics field since its inception. He is one of the original pioneers of the personalized medicine field.
Mr. Ung currently leads the development and execution of CellCarta’s strategic and business initiatives, leveraging the company’s solid tumour and anatomic pathology services.
Let's Talk: A Conversation with CAR T-cell Therapy Pioneer Dr. Carl June
February 22, 2024
Immunotherapies such as CAR T-cell therapy hold a lot of promise in treating illnesses like cancer. However, key challenges remain in their development, in particular the need to address adverse events and patient resistance.
In this webcast, Dr. Carl June, a pioneer in the field of CAR T-cell therapy, joins Christopher Ung, our Chief Scientific Business Officer, for an in-depth conversation on developing immuno and CAR T-cell therapies.
Key topics discussed in this cell therapy focused webcast:
Academic and Industry Partnership in CAR-T Development
CAR-T Development in US and China
Biomarkers from vein to vein: Mechanism, Selection, and Resistance
Facing the Challenges: Adverse Events and Patient Resistance
New Frontiers: Solid Tumors, Evolutionary and Revolutionary CAR models
Dr. Carl June
Dr. June is a member of CellCarta’s Scientific Advisory Board and the Richard W. Vague Professor in Immunotherapy in the Perelman School of Medicine at the University of Pennsylvania.
In 2011, his research team published a paper on the first CAR-T therapy treating leukemia patients with their own genetically modified T-cells.
Mr. Christopher Ung
Mr. Ung is CellCarta’s Chief Scientific Business Officer and has served in the companion diagnostics field since its inception. He is one of the original pioneers of the personalized medicine field.
Mr. Ung currently leads the development and execution of CellCarta’s strategic and business initiatives, leveraging the company’s solid tumour and anatomic pathology services.
Get a comprehensive overview of IVDR and explore the challenges encountered during the submission and approval process for clinical trial assays, including examples of feedback received from Member States and how to address them.
In this webinar, the team discusses the delegation of responsibilities to CROs by clinical trial sponsors, as well as the importance of performance study documentation to help clinical trial assays along the path to regulatory submission and approval.
Additionally, viewers gain insights into the classification of medical devices based on the rules outlined in Annex VIII of the IVDR.
Viewers will :
Gain valuable insights into the IVDR submission process
Be equipped with the knowledge and strategies required to overcome challenges, ensure compliance and streamline the path from assay development to successful submission
Learn how to properly navigate the IVDR landscape and ensure that clinical trial assays have the best chance of approval
Pamela Swatkowski, Vice President of Global Regulatory Affairs
Pamela Swatkowski has extensive leadership experience in regulatory affairs, quality assurance, business development, clinical and research and development in the medical device and IVD industry in the US food and Drug Administration (FDA)-regulated diagnostic industry leading US and international regulatory submissions and global compliance activities.
Her medical device experience includes: molecular infectious disease, oncology, companion diagnostics, single site IVD global approvals, NGS based immuo-sequencing, microbiology, genetics and immunology in vitro diagnostic assays and instruments, injection molded devices, peritoneal dialysis catheters and orthopedic spinal implants.
She was also the President and Founder of PLS Consulting, LLC. Pamela previously held leadership positions in quality, regulatory affairs and compliance positions at Abbott Molecular and Thermofisher. She has a degree in biology and chemistry from Loyola University of Chicago.
Get a comprehensive overview of IVDR and explore the challenges encountered during the submission and approval process for clinical trial assays, including examples of feedback received from Member States and how to address them.
In this webinar, the team discusses the delegation of responsibilities to CROs by clinical trial sponsors, as well as the importance of performance study documentation to help clinical trial assays along the path to regulatory submission and approval.
Additionally, viewers gain insights into the classification of medical devices based on the rules outlined in Annex VIII of the IVDR.
Viewers will :
Gain valuable insights into the IVDR submission process
Be equipped with the knowledge and strategies required to overcome challenges, ensure compliance and streamline the path from assay development to successful submission
Learn how to properly navigate the IVDR landscape and ensure that clinical trial assays have the best chance of approval
Pamela Swatkowski, Vice President of Global Regulatory Affairs
Pamela Swatkowski has extensive leadership experience in regulatory affairs, quality assurance, business development, clinical and research and development in the medical device and IVD industry in the US food and Drug Administration (FDA)-regulated diagnostic industry leading US and international regulatory submissions and global compliance activities.
Her medical device experience includes: molecular infectious disease, oncology, companion diagnostics, single site IVD global approvals, NGS based immuo-sequencing, microbiology, genetics and immunology in vitro diagnostic assays and instruments, injection molded devices, peritoneal dialysis catheters and orthopedic spinal implants.
She was also the President and Founder of PLS Consulting, LLC. Pamela previously held leadership positions in quality, regulatory affairs and compliance positions at Abbott Molecular and Thermofisher. She has a degree in biology and chemistry from Loyola University of Chicago.
Predicting Immune Checkpoint Inhibitor Response via RNA-Seq CellCarta
June 6, 2023
Various biomarkers, such as PD-L1 expression, tumor mutation burden (TMB), cytotoxic T-cell infiltration, Microsatellite Instability (MSI), and immune gene signatures, have been proposed to predict immune checkpoint inhibitor response.
However, individual biomarkers have limited accuracy. To overcome this, a computational pipeline has been developed to quantify biomarkers including expressed mutation burden (eTMB), MSI status, infiltrating immune cells, and immune gene expression signatures from tumor RNA-sequencing data.
Machine learning and computational deconvolution algorithms enhance performance, validated on large cohorts.
Integration of these biomarkers improves the prediction of checkpoint inhibition therapy response.
Viewers will gain insights into:
A unique computational pipeline that defines several characteristics directly from the RNA-sequencing profile of a tumor such as:
Expressed mutation burden (eTMB)
Fraction of infiltrating immune cells
Various immune gene expression signatures
How this analysis is compatible with formalin-fixed paraffin-embedded (FFPE) tumor samples and does not require a matched germline DNA sample
Pieter Mestdagh is a Computational Biology Manager at CellCarta, and Professor at Ghent University, Belgium. He holds master’s degrees in industrial engineering (2004) and in bioscience engineering (2006) and obtained a PhD in biomedical sciences (2011).
He is the author of more than 100 scientific articles in international journals and co-inventor on several European patents.
Predicting Immune Checkpoint Inhibitor Response via RNA-Seq CellCarta
June 6, 2023
Various biomarkers, such as PD-L1 expression, tumor mutation burden (TMB), cytotoxic T-cell infiltration, Microsatellite Instability (MSI), and immune gene signatures, have been proposed to predict immune checkpoint inhibitor response.
However, individual biomarkers have limited accuracy. To overcome this, a computational pipeline has been developed to quantify biomarkers including expressed mutation burden (eTMB), MSI status, infiltrating immune cells, and immune gene expression signatures from tumor RNA-sequencing data.
Machine learning and computational deconvolution algorithms enhance performance, validated on large cohorts.
Integration of these biomarkers improves the prediction of checkpoint inhibition therapy response.
Viewers will gain insights into:
A unique computational pipeline that defines several characteristics directly from the RNA-sequencing profile of a tumor such as:
Expressed mutation burden (eTMB)
Fraction of infiltrating immune cells
Various immune gene expression signatures
How this analysis is compatible with formalin-fixed paraffin-embedded (FFPE) tumor samples and does not require a matched germline DNA sample
Pieter Mestdagh is a Computational Biology Manager at CellCarta, and Professor at Ghent University, Belgium. He holds master’s degrees in industrial engineering (2004) and in bioscience engineering (2006) and obtained a PhD in biomedical sciences (2011).
He is the author of more than 100 scientific articles in international journals and co-inventor on several European patents.
