CONFERENCE SERIES: Biomarkers and Diagnostics
Recorded at: ADAPT Congress
Digital Course: Strategies for Companion Diagnostic Development
About this Product:
In these presentations selected from the Strategies for Companion Diagnostic Development workshop at the Fourth Annual ADAPT Congress 2012, global IVD leaders and experienced consultants address the potential downstream effects of early decisions in the development cycle of companion diagnostics, what are the strategies to achieve successful commercialization of IVD products, how collaborative partnerships drive results and are models for successful development, and when and how a companion diagnostic should be included in drug trials.
About this Product:
Over 189 Minutes
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Lessons Learned in the Development of Companion Diagnostics
Theo McCormick, Director, RxDx Services, Management Science Associates, Inc.
Navigating the scientific, medical, regulatory, contractual and political interactions and dynamics between health-care professionals, the clinical laboratory, drug manufacturers, IVD diagnostic kit manufacturers and health plans are essential for optimal uptake of drug-diagnostic companion products. Those early decisions in the development cycle have complex downstream impact. This session will map out the trouble spots and potential effects of those decisions.
Biography: Mr. McCormick has over 25 years of health-care experience in diagnostics, pharmaceuticals and biotechnology organizations. He is focused on product development, launch and marketing strategies. He currently leads the Pharmaceutical & Diagnostics “RxDx” group at Management Science Associates. Prior to joining MSA, he was the Director of Marketing for Laboratory Corporation of America (LabCorp) where he directed the marketing efforts for multiple assays including cardiovascular, infectious disease, gastroenterology and pharmacogenomic portfolios. Previously, he was the Marketing Manager at Quest Diagnostics where he was responsible for the strategic planning and marketing of the infectious disease molecular diagnostic testing portfolio. Prior to entering the laboratory industry, he was at Pfizer where he served as product manager with marketing responsibilities for Viracept, an HIV protease inhibitor. Previously, Mr. McCormick held various sales and marketing positions at Biogen (BiogenIDEC) and GlaxoWellcome (GlaxoSmithKline/GSK). He is a graduate of Salisbury University and is enrolled at the London School of Hygiene & Tropical Medicine. Living in Raleigh, NC, he spends his time on bike rides or kayaking with his wife, toddler and chocolate lab.
Strategies for Companion Diagnostic Development and Commercialization: Perspectives from a Global IVD Leader
John F. Beeler, Ph.D., Director, Theranostics and Business Development, bioMerieux
The drug development process is witnessing a paradigm shift in which new therapies need to be tailored to well defined patient sub-groups via a companion diagnostic assay. With several theranostics partnerships in place at bioMerieux, the speaker will address the challenges of co-development programs and discuss strategies to achieve successful commercialization of these IVD products.
Biography: John Beeler, Director of Theranostics and Business Development, is responsible for oncology strategy and companion diagnostics at bioMerieux. His primary objectives include forging companion test co-development partnerships with leading pharmaceutical developers together with driving the company's broader strategy in the personalized medicine and oncology marketplaces. Most recently, he served in a business development capacity for MDxHealth (formerly OncoMethylome Sciences), a personalized medicine company and held various commercial and product development positions at GlaxoSmithKline. John received a Ph.D. in Pharmacology from the University of South Carolina and completed his post-doctoral training at the National Cancer Institute.
The Business of Successful Companion Diagnostic Partnerships
Kathryn B. Becker, Ph.D., Director, Companion Diagnostics and Global Marketing, Abbott Molecular
The business aspects of creating a successful companion product will be discussed. Pharma and IVD manufacturers have the need to engage in efficient partnerships in order to drive specific but flexible and timely health care solutions. Until recently, the “opportunistic” partnering model has prevailed, but will this give way to alternatives as the CDx market continues to grow exponentially? This talk will focus on collaborative partnerships that drive results and models for successful development and market acceptance.
Biography: Kathryn Becker, Abbott Molecular’s Global Marketing Director, CDx, is responsible for the strategy and product development of the companion diagnostic franchise, including assays and instruments. Dr. Becker leads strategic efforts focused on the development of companion diagnostic products and led the global commercialization and launch of Abbott’s Vysis ALK FISH Probe Kit, a molecular diagnostic test to detect gene rearrangements in non‐small cell lung cancer tumors. Previously, Dr. Becker was the Global Marketing Director of the oncology and fluorescence in situ hybridization (FISH) oncology and genetics product lines. In this role she drove market evaluations and implemented commercial development opportunities, including division partnerships and acquisitions. She has also assisted in the development of annual marketing strategies for microarrays and automation products. Before joining Abbott in 2004, Dr. Becker worked in multiple management roles at Applied Biosystems. Most notably, she developed and implemented employee and customer training programs for protein/small molecule and molecular biology product lines, including the TaqMan Real‐Time PCR product lines and ABI Sanger sequencing and genotyping‐based products. Dr. Becker received her Master’s degree in Biology and Ph.D. in Biology focused in Neuroendocrinology from Northern Illinois University. After her degree completion at Northern Illinois University, she worked as a postdoctoral fellow and instructor at Dartmouth Medical School from 1993 to 1996.
Adding a New Indication to an Approved Companion Diagnostic: How Hard Can It Be?
Hans Christian Pedersen, M.Sc., Department Manager, Research & Development, IHC pharmDx, Dako Denmark
HercepTest was originally developed and FDA approved as a pharmacodiagnostic test to determine breast cancer patients’ HER2 status in order to assess eligibility for Herceptin (trastuzumab). An sPMA was approved by the FDA in 2010 extending intended use for HercepTest to include gastric cancer and GE junction cancer. This talk will go over the development, approval and launch of HercepTest for gastric cancer.
Biography: Hans Christian Pedersen has been employed at Dako, an Agilent technologies company, since 2004. He works as research manager, leading a team that develops novel pharmacodiagnostic assays for oncology in collaboration with pharmaceutical companies. He has 8 years of R&D experience from the diagnostic industry working with tissue diagnostic assay development, antibody development and flow cytometry assay development. During employment at Dako, Hans Christian has spent 2 years on an EU grant working in John Bartlett’s lab at the University of Edinburgh investigating prognostic and predictive biomarkers of endocrine therapy resistance. Before joining Dako, he spent 3 years working on early drug development using cell-based assays to screen for small molecule drug candidates in cancer models in BioImage. Hans Christian graduated from the University of Copenhagen in 2001 with a Master’s degree in Molecular Biology.
Design of Drug Clinical Trials Incorporating a Companion Diagnostic
Sabah Malek, Senior Regulatory Scientist, IVD/Medical Devices, Voisin Consulting Life Sciences
Designing clinical trials, undoubtedly a key part of drug development, is challenging enough, which makes the addition of companion diagnostics an obstacle that some drug developers hesitate to face as they do not know how to proceed. The FDA has provided guidance on the optimal way to coordinate and design a clinical trial of a targeted therapeutic with a companion diagnostic; however, this is often not easily feasible in practice. This presentation will describe when and how a companion diagnostic should be included in drug trials. It will also cover meeting coordination with agencies and description of case studies.
Biography: Sabah Malek is a Senior Regulatory Scientist in Voisin Consulting Life Sciences, Cambridge, MA. She is responsible for multiple client projects involving the implementation of global regulatory strategies and submissions for the development and marketing of companion diagnostics (CDx) and on in vitro devices (IVD). Sabah has various national and international submission experiences with CDx and IVDs in the U.S., EU, Canada and China. Her work in quality management systems includes compliance with ISO 13485 and 21 CFR Part 820. Her expertise also includes knowledge of Clinical Laboratory Improvement Amendments (CLIA ’88) regulations in the U.S. related to devices in laboratories. She is currently involved in the preparation and execution of various regulatory-related activities; especially in the U.S. with the FDA including coordination and submission of pre-IDE meetings, establishment registration, and evaluation of completeness of marketing applications.
About the Conference:
Cambridge Healthtech Institute’s Fourth Annual ADAPT 2012: Accelerating Development & Advancing Personalized Therapy Congress is being held at the Renaissance Washington, DC Downtown Hotel in Washington, DC, September 19-21, 2012. This year, the coverage has been expanded to seven concurrent tracks, focusing on (1) strategies to accelerate and de-risk drug and diagnostic development through innovative clinical programs and utilizing biomarker data in decision making; (2) implementing personalized medicine though drug-diagnostic co-development; and (3) innovative non-invasive diagnostics for cancer and other diseases. ADAPT 2012 attracts a balanced mix of delegates from pharma and diagnostic companies, clinical organizations, academia, and government, providing a unique opportunity to learn from the thought leaders, network with the decision makers, and discover actionable implementation strategies bridging drug and diagnostic development.