The Laboratory Developed Test (LDT) approach, incorporating the single-site pre-market approval, for Companion Diagnostic (CDx) development has seen a recent increase in interest because of the evolving regulatory and business environment. In a precision medicine approach to drug development there is great uncertainty at the beginning of a program as to whether it will produce a viable companion diagnostic; the benefits of flexibility, faster results, reduced upfront investment and effective risk management make the single-site pre-market approval path an increasingly appealing option. If a successful CDx candidate does emerge, the development can bridge to an in vitro diagnostic (IVD) approach, enabling global distribution.
Presented by Covance Chief Scientific Officer, Steve Anderson, PhD and Covance Vice President, Companion Diagnostics, Tom Turi, PhD, this webinar will address the increasing demand for single-site pre-market approval models in the pursuit of CDx.
Specifically, you will learn:
- How to assess the appropriateness of a single-site pre-market approval approach
- Regulatory considerations for design and validation of the CDx assay
- Speed to commercialization benefits through a single-site pre-market approval approach
- 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 for 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.
Tom Turi, PhD, Vice President, Companion Diagnostics, Covance
Thomas Turi, Ph.D. is Vice President Companion Diagnostics for Covance. He joined Covance in 2008 to establish the Biomarker Center of Excellence and was integral to the acquisition of the Covance Genomics Laboratory and the formation of Discovery and Translational Services. He is currently responsible for Covance’s Companion Diagnostics efforts. Prior to Covance, Dr. Turi spent fifteen years in the pharmaceutical industry, where he held a broad array of scientific leadership positions of increasing responsibility. Most recently he served as the Senior Director of Translational Biomarkers and Mechanistic Biology at Pfizer.
Dr. Turi received dual bachelor’s degrees in Biochemistry and Chemistry from the University of Illinois at Urbana-Champaign and his doctorate in Molecular Genetics from the University of Cincinnati College of Medicine. He completed postdoctoral training at the Yale University School of Medicine applying molecular genetic techniques to investigate the mechanisms of protein transport.
Who Should Attend?
Chief Medical Officers, Chief Scientific Officers, plus senior level professionals involved in:
- Research and Development
- Personalized Medicine
- Biomarker Development
- Targeted Therapeutics
- Molecular Oncology
- Clinical Pharmacology
- Medical Affairs / Regulatory Affairs
- Translational Medicine
- Companion Diagnostics / Diagnostics
- Preclinical or Clinical Outsourcing
What You Will Learn
Get insights on how to assess the appropriateness of a single-site pre-market approval approach, as well as assay design and validation regulatory considerations. Learn the benefits obtained from a single-site pre-market approval approach to speed commercialization, as well as, how and when to most effectively engage a CRO / lab partner in the process.
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.