Oncology drug development is in a period of unprecedented innovation, driven by growth in the use of targeted therapies and immuno-oncology agents. New clinical trial designs and changes in regulatory approvals have made it possible for new drugs to reach the market at an incredible speed. These new medicines are changing the cancer conversation: we are now talking about cures.
Spearheading the change is the discovery and utilization of predictive biomarkers. Patients who present positive for these biomarkers have been shown to benefit more from a targeted therapy than those who do not. Consequently, biomarkers are now encompassing all areas of immuno-oncology drug development, from discovery to registration and ultimately market acceptance of the drug, if the biomarker can be utilized as a companion diagnostic. These predictive biomarkers are enriching immuno-oncology trials with patients more likely to respond to treatment – resulting in better outcomes and accelerated timelines.
Presented by Covance Chief Scientific Officer Steve Anderson, PhD, and Covance Global Leader, Precision Medicine, Suso Platero, PhD, this webinar will address the spectrum of immunotherapy development considerations and their implications for drug developers.
Specifically, you will learn:
- Factors driving the importance of biomarkers in I/O drug development, including:
- Relevant examples of new clinical trial designs incorporating biomarkers across all development phases.
- How these new designs have allowed clinical trials to be run in a seamless Phase I to Phase III manner, in which the different arms may account for the different Phases.
- The use of biomarkers to elucidate the mechanism of action in new drugs, and how to leverage key technologies, such as flow cytometry, immunohistochemistry and next generation sequencing.
- A real-world example of how to tackle the consequence of the boom in I/O drug development: the challenge of finding enough of the right specific patients to fully subscribe each clinical trial.
- How and when to most effectively engage a CRO / lab partner in the process.
Please join us for an insightful discussion – and answers to your questions – on these clinically and commercially relevant topics.
Steven M. Anderson, PhD, Senior Vice President, Chief Scientific Officer, Covance
Dr. Steven Anderson is the Chief Scientific Officer (CSO) of Covance. In the CSO role, he leads the development and implementation of scientific strategy throughout the various Covance business units, coordinating with the scientific teams in Early Development, Central Labs, Clinical Development, Market Access, and the LabCorp Diagnostics business.
Prior to the CSO role at Covance, Dr. Anderson served in a variety of scientific, technical and operational roles within the LabCorp organization. During his 25+ year tenure in LabCorp, these positions included Director of Operations for the Center for Molecular Biology and Pathology (CMBP), Director of Operations for ViroMed Laboratories, Director of Operations for Monogram Biosciences, Director of Operations for Integrated Oncology and Genetics, National Director of Research and Development, and Global Head of LabCorp Clinical Trials.
Dr. Anderson is a member of a variety of professional societies including the American Association for Cancer Research, the American Society of Clinical Oncology and the Association for Molecular Pathology. His research interests are in the development and applications of molecular diagnostics, including several recent examples of companion diagnostics currently in use for patient management. He has authored more than 175 articles and abstracts.
Dr. Anderson has a PhD in Genetics from Iowa State University, and was an American Cancer Society postdoctoral fellow at the Waksman Institute of Rutgers University.
Suso Platero, PhD, Global Leader, Precision Medicine, and Head, Biomarker Solution Center at Covance
Dr. Suso Platero is the leader of the Covance Biomarker Solution Center (BSC), a unit leveraging the combined scientific expertise and end-to-end assay development and operational capabilities of both Covance and LabCorp. In this capacity, Dr. Platero and his team bridge the gap between commercial, medical and scientific leaders to provide precision medicine solutions that harness the unique insights of Covance and LabCorp.
Prior to joining Covance, Dr. Platero created several groups for the discovery and translation of biomarkers into the clinic at major pharmaceutical companies. He has led companion diagnostics programs, assay development and validation of biomarkers in clinical trials from Phase I to registration. Dr. Platero has worked with small molecules, antibodies, vaccines and bispecific antibodies and has experience in developing compounds in IO, chemotherapy and targeted therapeutics.
Dr. Platero was a Howard Hughes Postdoctoral fellow at the Fred Hutchinson Cancer Research Center and received his doctorate from St. Louis University.
Who Should Attend?
Chief Medical Officers, Chief Scientific Officers, plus senior level professionals involved in:
- Personalized Medicine
- Biomarker Development
- Tailored Therapeutics
- Molecular Oncology
- Clinical Pharmacology
- Medical Affairs / Regulatory Affairs
- Translational Medicine
- Companion Diagnostics / Diagnostics
- Preclinical or Clinical Outsourcing
Covance Inc., the drug development business of Laboratory Corporation of America Holdings (LabCorp) headquartered in Princeton, New Jersey, USA, is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real®.
Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, helps our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Information on Covance’s solutions can be obtained through its website at www.covance.com.