The challenges in immuno-oncology drug development require deep scientific insights, generation and analysis of complex biological data, new state-of-the art technologies and both logistical & operational support across continents. The goal of immuno-oncology drug developers is to turn precision medicine into action, bringing life-changing therapies to patients.
Immuno-oncology clinical trials have very low success rates, with just 5.3 percent of all drugs seeking an oncology indication eventually receiving approval. In the path to precision medicines, the use of molecular markers and protein biomarkers in both early- and late-stage immuno-oncology trials has become an increasingly important way to optimize patient selection, perform safety monitoring and measure drug efficacy at the tumor level. Immunohistochemistry (IHC), flow cytometry and next-generation sequencing (NGS) are complementary technologies that, together, offer comprehensive biological insights essential for immuno-oncology clinical trials.
The use of NGS to stratify patients based on disease-causing mutation(s) can ensure only those most likely to benefit from an investigational therapy are included in a trial, potentially increasing the odds of success. NGS can also be used to develop companion diagnostics that may be necessary if a therapy is approved.
Flow cytometry is a powerful technology for systemic immune profiling in immuno-oncology trials, which provides a snapshot of how a patient is responding to therapy and can be predictive of future response. This is often paired with IHC, which can provide a more granular view of the tumor microenvironment that’s not possible with assays involving circulating tumor cells. Being able to assess the immune response at the tumor site is key to evaluating the efficacy of immuno-oncology therapies.
Register for this webinar to learn why these technologies are essential to improve the odds of success in oncology drug development and how to find a central lab capable of developing customized assays with standardized SOPs across sites.
Speakers
Jérôme Sallette, Ph.D., Chief Scientific Officer, Cerba Healthcare and Cerba Research
Dr. Jérôme Sallette has a Ph.D. in Neurobiology from The Pasteur Institute. He started as Head of International Marketing at Cerba Healthcare and after 4 years became the Group’s Chief Innovation Officer, a position he held for 6 years. He implemented the marketing strategy for the Group’s specialist medical biology activities, biology services for clinical trials, and medical biology services all around the world. He is currently the CSO of Cerba Healthcare and Cerba Research, where he pools the Group’s resources to enlarge their global offering.
Message Presenter
Shu Jen Chen, Ph.D., Chief Scientific Officer, ACT Genomics
Dr. Shu Jen Chen is the Co-Founder and Chief Scientific Officer of ACT Genomics Co., Ltd. She has gained in-depth knowledge and experience in cancer biology, drug discovery and development, and bioinformatics for over 20 years. She joined the National Health Research Institute in 1998 as an Assistant Investigator and established the high-throughput screening program for the institute. Dr. Chen moved to TaiGen Biotechnology in 2001 to serve as the Head of In Vitro Pharmacology. In 2006, she joined Chang Gung University as an Associate Professor at the Department of Biomedical Sciences. Dr. Chen specializes in automated drug screening systems, biological databases and data analysis. She has many years of experience in cancer drug discovery and next-generation sequencing operations. She is also familiar with system integration and database design. Dr. Shu Jen Chen received her Ph.D. in Biochemistry from Virginia Commonwealth University, completed her postdoctoral training at Baylor College of Medicine and then was a Research Assistant Professor at SUNY Buffalo.
ACT Genomics is an innovation-driven cancer solution provider in Asia with offices in Taipei, Hong Kong, Singapore & Tokyo. With our next-generation sequencing (NGS) technology, CAP-accredited laboratories, experienced bioinformatics team and proprietary AI algorithms, we provide optimal cancer treatment planning, immunotherapy evaluation, cancer relapse & drug resistance monitoring, as well as cancer risk assessment services to medical professionals. Together, we “Turn Genomics into Action.”
Message Presenter
Sofie Vandevyver Ph.D., Head of Business Operating and Marketing, Cerba Research
Sofie Vandevyver is the Head of Business Operations & Marketing for Cerba Research since 2020. Prior to Cerba, Sofie worked as Head of Business Operations & Marketing at BARC Global Central Laboratory. She Joined BARC global central laboratory as Contracts & Proposals Manager and has Served BARC Laboratory for 7 years, since 2014. She holds a Ph.D. in Science and Biotechnology, a study in Improvement of Glucocorticoid Therapy from University Ghent/VIB.
She received a Master’s degree in Biotechnology from Universiteit Gent and another Master’s degree in Biochemistry from Hogeschool West-Vlaanderen. She Integrates both her Contracts & Proposals experience and Scientific Background to Lead the Business Operations & Marketing functions at Cerba research.
Message Presenter
George Wei, Ph.D., Vice President, R&D Division, ACT Genomics
Dr. George Wei was trained as a cellular immunologist at Princeton University before moving to Roche Pharmaceuticals, and later, Gilead Sciences, to start his career in the biopharmaceutical industry. After returning to Taiwan in 2013, he continued R&D efforts in a few companies, the latest of which is ACT Genomics as the VP of the R&D Division, before heading up the establishment of CerbACT Asia. Dr. Wei’s expertise is in immunology, cellular therapy, and new drug/device development.
Message Presenter
Renaud Burrer, Ph.D., Head of Histopathology, Cerba Research
Dr. Renaud Burrer holds a Ph.D. in virology and immunology and has vast experience in oncology and multiplex immunohistochemistry. Formerly head of R&D at Histalim for 3 years, he is now Cerba Research’s Global Head of Histopathology.
Message Presenter
Nithianandan Selliah, Ph.D., Global Head of Flow Cytometry, Cerba Research
Dr. Nithianandan Selliah obtained his Ph.D. in Immunology and started to work on HIV research. After more than 10 years of HIV research, he joined a biotech company to work on biomarker discovery for autoimmune diseases. His interest in flow cytometry at the biotech company led him to join a global CRO to work on assay development and validation in flow cytometry for global clinical trials. He joined Cerba Research to continue to work on his passion of flow cytometry in clinical trials and take on new challenges to build the best flow cytometry service for clients. He is working with exceptional scientific teams in the US and Belgium to bring on new assays for various therapeutic indications, including immuno-oncology and autoimmune diseases.
Message PresenterWho Should Attend?
This webinar will be of interest to professionals from biotechs, mid-size pharmas, large pharmas and CROs, with relevant job areas including:
- Purchasing Directors
- Clinical Operations Staff
- Clinical Trial Directors
- Clinical Trial Managers
What You Will Learn
- The benefits of IHC and flow cytometry in oncology drug development
- How NGS testing for patient diagnostics is building databases for researchers
- How central and specialty laboratories can combine their efforts to meet the needs of immuno-oncology drug developers
Xtalks Partner
Cerba Research
Headquartered in Ghent, Belgium, Cerba Research is a Global Central & Specialist Laboratory.
Our footprint includes 6 harmonised central lab locations in Ghent, New York, Johannesburg, Shanghai, Taipei & Sydney.
Complimentary to these central labs, our network of specialty labs supports our core therapy expertise in three distinct areas – Oncology, Liver Indications & Infectious Disease. APH, Flow Cytometry Genomics, Metabolomics, Microbiology + Virology and Molecular Biology permit our clients to discern and select correct instruments, appropriate sensitivities/detection and techniques for true full-service delivery.
Also worthy of note is our unique presence in Africa. Complimentary to our Central Lab operation in Johannesburg, Cerba has the largest network of Labs, Staff Pathologists and supporting Logistics in Africa.
From preclinical transition to the clinic, and on to commercialisation, supporting emerging and established biotechs through to large global pharma clients, we are known and proud of our close partnering, higher frequency of contact and all-round availability at your demand.
Our subject matter experts enjoy open collaboration at the pace our clients require to optimise their therapeutic development and draw those pivotal insights earlier. We partner with these clients to speed up their research and development whether it be in the area of discussing, agreeing and then delivery of specialized custom assays and panels, assay transfer, or perhaps overcoming operational peculiarities baked into studies by way of challenges regarding stability of samples for testing. Every synopsis, protocol and study is unique and new challenges arise time after time. We are adept at meeting and overcoming those challenges and enjoying long-standing and fruitful relationships with our sponsors.
We are ISO 15189 accredited, CAP CLIA accredited with no deficiencies cited to date, and with significant capabilities for testing under BSL3.
Cerba Research is the pharmaceutical development arm of Cerba Healthcare. Cerba Healthcare is headquartered in Paris, France, employs >8,500 staff, including over 130 staff pathologists and conducts 40 million tests annually.
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