Strategies & Approaches to Optimize Your Clinical Immuno-Oncology Development
Precision and Immuno-Oncology drug development is being optimized through well-defined preclinical and clinical strategies focused on safety, endpoints and biomarker targets. Evolutions in the regulatory framework, a deeper understanding of cancer and re-defining key endpoints for success in Immuno-Oncology and Precision Medicine are combining to de-risk development.
This event – designed for C-level Executives, Heads of Development, Pre-clinical & Clinical Operations leadership – will be focused on development strategies to support the more rapid movement from preclinical studies to the clinical phase of the development. Key learnings and takeaways on trial design concepts and biomarker considerations for optimizing development strategy, as well as Go / No-Go decisions for agents in the preclinical space, regulatory framework considerations and accelerating the development of new precision and IO therapies.
In addition to the planned presentations, attendees will be able to network with peers and other industry thought leaders dedicated to bringing critical new therapies to cancer patients in need.
Date: Thursday 6th of October 2022
Time: 8:30 – 11:00 CET
Venue: Medicon Village Science Park, Scheelevägen 4, 223 63 Lund, Sweden
Program
| 08:30 | Networking, registration, and light breakfast |
| 09:00 | Welcome David Munis Zepernick, Head of Member Engagement and Communication, Medicon Valley Alliance |
| 09:05 | Navigating the Regulatory Complexities of Advanced Therapies Development in Oncology Audrey Finesso, Senior Director, Clinical Regulatory Strategist, Labcorp Drug Development |
| 09:35 | Biomarker-Driven Oncology Trials: From Preclinical to Clinical Development Maria Prendes, PhD, Head of Oncology, Biomarker Solution Center |
| 10:05 | How Immuno-oncology Advances are Reshaping Traditional Clinical Development Paradigms Kamal Veer Singh Saini, MD Executive Medical Director |
| 10:35 | Q&A |
| 10:45 | Networking |
| 11:00 | End of Good Morning Meeting |
Speaker
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Audrey Finesso has 20+ years of experience in various regulatory roles within pharmaceutical and CRO organizations, including positions with Amgen, Janssen, Biogen and Merck Serono. In her current role as Senior Director, Clinical Regulatory Strategist, she supports pharmaceutical clients with regulatory strategy development, agency meetings and regulatory requirements for their unique programs. She has significant experience with programs across variety of oncology indications and with CAR T programs.
She holds a Doctor of Pharmacy from the University Claude Bernard Lyon, France and her MSc. in International Drug Development and Regulatory Affairs, University Paris XI, France.
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Dr. Prendes has over 25 years of experience identifying and characterizing biomarkers, and 48 patents on methods to characterize biomarkers in oncology. Since 2018, the Biomarker Solution Center has participated in more than 1200 clinical programs in oncology providing scientific biomarker support. In 2021 alone, Dr. Prendes provided biomarker support for over 300 programs involving oncology therapeutics.
Dr. Prendes received extensive training at Memorial Sloan Kettering, Columbia University, and Mount Sinai Cancer Center. Dr. Prendes role at the Biomarker Solution Center involves offering executive oversight on Biomarkers and working closely with the Labcorp Bioanalytical and Clinical Lab groups to further define biomarker strategies in preclinical and clinical oncology.
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Kamal Veer Singh Saini, MD, is executive medical director of oncology for Labcorp Clinical Development Services. He is a board-certified medical oncologist, with an active license to practice in the U.K. He contributes to the scientific strategic leadership of the Oncology area at Labcorp and provides clinical and medical expertise to project teams and other Labcorp departments on clients’ drug development projects. He brings 15+ years of experience in clinical research and development to Labcorp. He previously served as associate scientific director for an academic research organization and as medical advisor for Institute Jules Bordet, Brussels. The author or co-author of several peer-reviewed journal articles, he joined Labcorp in June 2015. |
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