SC18: COMMERCIALIZATION BOOT CAMP: MANUAL FOR SUCCESS IN MOLECULAR DIAGNOSTICS
Room Location: 103

Monday, March 11 | 8:00 – 11:00 am

ABOUT THIS COURSE:

This workshop will define the priority checklist for executing a successful strategy and operational plan for commercializing molecular diagnostics. It will examine the process of bringing a product to market by highlighting all the key features required in today’s evolving healthcare environment. Financial resources needed to execute the project plan will be measured in the current climate. Participants will learn key requirements for advancing molecular diagnostics through product development, including acquiring knowledge of strategy, regulatory, reimbursement, health economic, managing key opinion leaders and patient advocacy considerations. This course will leverage the instructors’ years of accumulated experience spanning financial, technical and scientific acumen, as well as overcoming roadblocks on the path to commercial success.

Attendees of the short course may be interested in Commercializing Novel IVDs: A Comprehensive Manual for Success, written by the Commercialization Boot Camp presenter, Harry Glorikian. 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:

  • 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?

DETAILED AGENDA:

8:00 Manual for Success in the Molecular Diagnostics Marketplace

Harry Glorikian, Healthcare Consultant

9:15 Refreshment Break

9:30 Practical Considerations for Molecular Diagnostics Success

Stan Skrzypczak, Vice President, Corporate Development and Reimbursement, Guardant Health, Inc.

10:45 Q&A with Speakers

11:00 End of Short Course

INSTRUCTORS:

Glorikian_HarryHarry Glorikian, Healthcare Consultant

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.

Skrzypczak_StanStan Skrzypczak, Vice President, Corporate Development and Reimbursement, Guardant Health, Inc.

Stan Skrzypczak is a seasoned executive with 30 years of life science/pharma experience (Searle Laboratories, Genentech, Genomic Health, Invitae, and currently working for Guardant Health). His commercialization experience is in the therapeutic classes of oncology, immunology, cardiology, genetics, pulmonary diseases, and growth disorders. His experience ranges from commercializing drugs/biologics, tumor gene expression profiling assays, and NGS-based genetic laboratory tests to NGS liquid biopsy cancer diagnostics.

Stan is currently the Vice President, Corporate Development and Reimbursement at Guardant Health. Guardant Health is a global leader in the field of liquid-based NGS somatic assays. He leads international commercialization and U.S reimbursement. Previously, Mr. Skrzypczak served as Vice President of Business Development at Invitae, a genetic testing and information services company for two years. Prior to Invitae, he was Senior Director, Marketing for a franchise product, Oncotype DX, and later he was promoted to SENIOr Director, Global Strategy at Genomic Health. Genomic Health is one of the world's leading providers of genomic-based diagnostic tests that address both the over-treatment and optimal treatment of early stage cancer, one of the greatest issues in healthcare today. He was at Genentech for 18 years prior to Genomic Health working across clinical franchise areas that included oncology and immunology from a varied sales, marketing and reimbursement role and was a sales division manager for Searle Laboratories just prior to Genentech.

He has specific experience in global business and corporate development, life cycle management, marketing, sales, reimbursement, and product development. Stan has an M.S. in Immunology and an MBA in Marketing.

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