Market Research Report
Commercializing Novel IVDs: A Comprehensive Manual for Success
|Published by||Insight Pharma Reports||Product code||421708|
|Published||Content info||245 Pages
Delivery time: 1-2 business days
|Commercializing Novel IVDs: A Comprehensive Manual for Success|
|Published: January 13, 2017||Content info: 245 Pages||
Does your company have an idea for a novel biomarker test, but you're unsure what the market potential will be?
Have you invented a more sensitive test to diagnose a common autoimmune disorder, but you're unsure of which regulatory pathway to pursue?
The process of developing a successful in vitro diagnostic (IVD) relies on the expertise of a diverse group of individuals, including the scientists who identify the biomarkers of significance, engineers and assay developers who translate those ideas into a tangible product, and the sales and marketing staff who get the product into the market.
This unique manual will provide an overview of the major components to IVD development, from product conception through commercialization, and important considerations about individual aspects of the process including:
Specific chapters in the manual:
This is not a checklist or how-to manual with step-by-step instructions to build an IVD. It is meant to provide an overview of the major components to IVD development, from product conception through commercialization, and important considerations about individual aspects of the process: How do I approach the regulatory process? How can I plan for market access, and what can I do to make sure my IVD will be reimbursed? These ideas don't exist in a silo, but people are so focused on individual steps in the process they are responsible for, that the overall picture is sometimes missed. This is understandable-no one person can be an expert on every aspect of the IVD development process. The scientists in the lab may have little to no understanding about the different regulatory options and requirements that influence an IVD, and the sales staff may not completely understand the engineering process; neither is expected to! But it's essential to understand and identify the necessary job functions to move an IVD from product ideation through successful commercialization. This book attempts to do that by describing the overall process of IVD development, who needs to be involved, and highlighting challenges and points to consider along the way.
Harry Glorikian is an influential global business expert with more than three decades of experience building successful ventures in North America, Europe, Asia and the rest of the world. Harry is well known for achievements in life sciences, healthcare, healthcare IT and the convergence of these areas. He is a sought after speaker, frequently quoted in the media, and regularly asked to assess, influence, and be part of innovative concepts and trends. He holds four US patents in telecommunications, and has others pending.
He recently served as an Entrepreneur In Residence to GE Ventures - New Business Creation Group. He serves on the board of GeneNews Ltd. (a molecular diagnostic company). He also serves on the advisory board of Nucelis (a gene-editing industrial biotech company), Evidation Health (a digital health startup launched with support from GE Ventures), and several other companies. He is also a co-founder and an advisory board member of DrawBridge Health (a revolutionary diagnostics startup launched with support from GE Ventures).
Previously he co-founded and held the position of managing director and head of consulting services for Scientia Advisors, a company that became the go-to provider of strategic advice and implementation services for next-generation healthcare and life science innovators and Global 25 market leaders. Scientia Advisors was acquired by Precision for Medicine in November of 2012. Among his other professional roles, Mr. Glorikian served as senior manager for global business development at PE Applied Biosystems, founded X-Cell Laboratories, managed global sales at Signet Laboratories and held various roles at BioGenex Laboratories.
Mr. Glorikian holds an MBA from Boston University and a bachelor's degree from San Francisco State University. Harry has addressed the National Institutes of Health, Molecular Medicine Tri-Conference, World Theranostics Congress and other audiences, worldwide. He has authored numerous articles for industry publications, appeared on CBS Evening News and been quoted regularly by Dow Jones, The Boston Globe, BioWorld Today, Los Angeles Times, London Independent, Medical Device Daily, Science Magazine, Genetic Engineering News and many other media outlets.