Oncology drug development is in a period of unprecedented innovation, driven by the evolution of targeted therapies and the explosion of immuno-oncology agents. With this growth, however, comes a number of scientific challenges that require a more integrated approach to the overall drug development process.
The complexity of preclinical studies for oncology drug development is at an all-time high with the unprecedented growth of novel immunotherapies and the continued evolution of targeted therapies. This has resulted in sustained use of tried and true models like human tumor xenografts and genetically modified mouse models. It has also meant the emergence of a wider variety of models such as the rebirth of syngeneic mouse models and creation and utilization of humanized mouse strategies. Even with all of this, there is no ‘one size fits all’ approach.
Biomarkers also now encompass all areas of immuno-oncology drug development, from discovery to registration, even as companion diagnostics. Predictive biomarkers are enriching immuno-oncology trials with patients more likely to respond to treatment – resulting in better outcomes and accelerated timelines. Finally, new clinical trial designs and changes in regulatory approvals have made it possible for new drugs to reach the market at unprecedented speed.
Join this free webinar today to learn from three thought leaders in the field of immunotherapy as they share their knowledge on trends and advances across the entire spectrum of development.
This webinar is part of a scientific series Covance is offering focused on trends, opportunities and challenges associated with current and future applications in Oncology. Learn more and register for upcoming webinars on topics such as adoptive cell therapies, biomarker technologies for the detection of cancer driver mutations, novel targeted therapies, and more.
Maryland Franklin, PhD, Executive Director of Scientific Development, Preclinical Oncology, Covance
Dr. Franklin has over 20 years of experience with preclinical pharmacology models, more than half spent in biotech and pharma companies. Dr. Franklin worked as a member of numerous multi-disciplinary teams to deliver agents from Research into Development and was a key leader in bringing four drugs into Phase 1 clinical trials. She started her industry career as a Research Scientist in the Preclinical Development Group at ZymoGenetics, working on animal models of lung fibrosis, anti-virals and psoriasis. In 2003, Dr. Franklin joined the in vivo Pharmacology Department at OSI Pharmaceuticals, where she supervised the internal and external placement of oncology-focused in vivo pharmacology studies and established and managed external collaborations around target identification, biomarkers, animal models and imaging.
Dr. Franklin was a key contributor in the discovery and early clinical development of the small molecule IGF-1R/IR dual inhibitor, OSI-906 (linsitinib) and provided key drug combination data and novel tumor models to support further clinical development of the small molecule EGFR inhibitor erlotinib (Tarceva). She received her PhD in Medical Genetics from the University of Alabama at Birmingham.Message Presenter
Suso Platero, PhD, Global Lead, Precision Medicine and Head, Biomarker Solutions Center, Covance
Dr. Platero is the Global Lead of Precision Medicine at Covance and is the Head of the Biomarker Solutions Center. He has over 20 years of experience in academia and industry. Dr. Platero was Lead of Translational Research for Lung Diseases at Janssen Pharmaceuticals. He led the discovery and implementation of companion diagnostics for BALVERSA. He has worked with small molecules, antibodies, vaccines and bispecific antibodies at both Janssen and Bristol-Myers Squibb. Prior to his pharmaceutical industry experience, he worked at Becton Dickinson developing diagnostic and prognostic tests in oncology.
Dr. Platero was a Howard Hughes Postdoctoral fellow at the Fred Hutchinson Cancer Center and received his PhD from St Louis University, his M.S. in Molecular Biology, Cell Biology and Molecular Biophysics from Columbia University and his B.S. from the University of Pittsburgh. He is a member of SARC (Sarcoma Alliance for Research through Collaboration) Board of Directors.Message Presenter
Kamal Veer Saini, MD, Senior Medical Director – Oncology, Covance
Dr.Saini is a board-certified medical oncologist based in Brussels, Belgium and contributes to medical strategy in the area of oncology and client engagement on asset development and all related aspects of medical and scientific execution.
Dr. Saini has more than 15 years of experience in academia and industry, having held numerous posts of increasing seniority across all phases of clinical drug development in various cancer types (solid tumors as well as hematological malignancies) with both regional and global responsibility. His publications include numerous articles in the areas of breast cancer, clinical trials, molecular oncology, biomarkers, global oncology, policy and other related areas.Message Presenter
Who Should Attend?
- Medical Affairs
- Project Management
- Regulatory Specialist
- Clinical Operations
- Commercial and Sales
- Chief Medical Officer
- Chief Development Officer
- Medical Director
- Operational Director
- Clinical Development Director
- Clinical Development Manager
- Procurement Manager
What You Will Learn
Attendees will learn about:
- Understand current challenges in immuno-oncology drug discovery and development
- Learn advantages and disadvantages of various preclinical mouse models to support immunotherapeutic development
- Understand the role of biomarkers – predictive, monitoring and those supporting mechanism of action identification – to support immuno-therapeutic development
- Hear the latest trends for innovative trial design, including adaptive elements in dose-finding trials and efficacy assessment, to address these unique challenges
Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.
Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.
Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.