Receptor-mediated therapies continue to reshape oncology by offering more precise ways to target cancer biology. These therapies require integrating molecular engineering, translational science and clinical strategy to move from promising mechanism to measurable clinical impact. This webinar brings together experts across preclinical research, flow cytometry, clinical development and regulatory strategy to outline what it takes to successfully design, validate and advance next-generation receptor-based therapeutics.
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The webinar then focuses on flow cytometry as a critical tool for bridging early research with human studies. Flow cytometry provides detailed insights into receptor expression, receptor occupancy, binding, internalization and functional activity. These assays help confirm the mechanism of action and evaluate biological plausibility for regulatory submissions. The presentation will illustrate how flow cytometry supports discovery, IND-enabling work, clinical assay development and real-time decision-making during early-phase trials.
Next, the clinical and regulatory view highlights trends and lessons learned from receptor-targeted therapies already in use, as well as those emerging across oncology. This portion will outline classes of receptor-based agents, real-world outcomes and how the current pipeline is shaping future development. Attendees will gain a clear picture of how receptor biology translates into patient impact and how regulatory expectations are shifting to accommodate novel mechanisms.
The final speaker will cover practical considerations for drug developers, with an emphasis on the FDA’s Plausible Mechanism Pathway. Topics include assay alignment, early incorporation of receptor biology, expectations for mechanism-driven development plans and strategies for balancing innovation with safety management. With a growing number of programs advancing receptor-centric designs, it is more important than ever for sponsors to anticipate regulatory needs and build adaptable platforms from the start.
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By bringing together insights from discovery science through clinical execution, this webinar offers a comprehensive view of what it takes to advance the next generation of receptor-mediated therapies. Attendees will leave with a clear understanding of the scientific, operational and regulatory components needed to translate mechanisms into meaningful clinical outcomes.
Register for this webinar to learn how receptor-mediated therapies translate receptor biology into clinically meaningful outcomes.
Speakers
Alan Miller, MD, PhD, Chief Medical Officer, TD2 Oncology
Dr. Alan Miller obtained his PhD at Roswell Park (SUNY) and his MD from the University of Miami School of Medicine. Trained as a Medical Oncologist, he was also the Associate Senior Vice President for Health Sciences for Tulane Cancer Center, where he navigated the challenges of rebuilding and re-establishing the university and hospital following Hurricane Katrina. He also served as Cancer Center Director of the Baylor Sammons Cancer Center, where he brought together a not-for-profit healthcare system and private oncology practices to form an oncology network across North Texas. Additionally, Dr. Miller built a larger system-wide oncology network while at SCL Health and established a system-wide clinical trials infrastructure for a multi-state healthcare system. He also serves as a Board Member for the American Cancer Society, Denver and the Rocky Mountain Oncology Society.
Message Presenter
Jennifer Stewart, PhD, VP Flow Cytometry Strategy, TD2 Oncology
Dr. Jennifer Stewart has 20+ years of experience with flow cytometry in academic, nonclinical and clinical settings. Throughout her career, she has had the opportunity to interface with clients to gain an understanding of the evolving demands for the technology in drug development. Her mission is to be at the cutting edge of the field, knowing that TD2’s services can help create treatments for millions worldwide who currently suffer from disease. This effort is supplemented through collaborations with other experts on research projects, publishing manuscripts, organizing workshops and speaking at symposiums.
Jennifer is currently serving as the Vice President of Flow Cytometry Strategy at TD2 Oncology and is involved in interpreting and reporting for the various flow cytometry projects. In addition, she is the Co-chair for the AAPS Flow Cytometry Action Programming Committee and has served as a Guest Editor for Cytometry Part B: Clinical Cytometry and as a Scientific Reviewer for several high-profile journals.
Message Presenter
Erin Trachet, Senior Director, Scientific Engagement, TD2 Oncology
Erin Trachet has devoted her career to oncology research with a focus on pharmacology. She has worked in both industry and the CRO space for more than 26 years. In industry, she was part of several successful small-molecule programs, including Palbociclib (Pfizer’s CDK4/6 inhibitor) and Dacomitinib (Pfizer’s pan-EGFR inhibitor). At TD2, she developed a collaborative, scientifically engaging environment in which the Sponsor, Scientific Engagement and the Execution Team all work together to drive the Sponsor’s program forward.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Biotech and pharmaceutical researchers, leaders and decision makers
- Preclinical and Translational Scientists
- Clinical Development and Clinical Operations professionals
- Regulatory Affairs and CMC teams
- Immunologists and Biomarker Scientists
- Flow Cytometry and Assay Development Specialists
- Program Directors, Project Managers and R&D Strategists
- Executives advancing targeted or mechanism-driven oncology programs
What You Will Learn
Attendees will gain insight into:
- How receptor biology informs program design across preclinical, translational and clinical development
- The role of flow cytometry in confirming mechanisms, supporting regulatory submissions and bridging early research with clinical execution
- Current trends in receptor-based therapeutics and how emerging mechanisms are influencing trial design and regulatory pathways
- Practical steps drug developers can take to align assays, streamline programs and accelerate the path to clinic
Xtalks Partner
TD2 Oncology
TD2 Oncology is a full-service CRO specializing in complex oncology trials. We partner with biotech and pharmaceutical companies to advance novel cancer therapies through a comprehensive suite of services spanning preclinical research, regulatory strategy, clinical trial management, and specialty capabilities such as flow cytometry. Our multidisciplinary team of scientists, clinicians, and regulatory experts is dedicated solely to oncology, bringing a deep understanding of cancer biology, trial complexity, and the evolving regulatory landscape. TD2 Oncology is expertly tailored to help sponsors navigate the unique challenges of cancer drug development. With focused expertise, personalized guidance, and a commitment to scientific excellence, we help sponsors overcome development hurdles and move their therapies forward with greater precision and speed.
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