CDRH/Payer Summit for Medical Device Executives 2016

The CDRH/Payer Summit for Medical Device Executives 2016 addresses ways to improve patient access to safe & effective medical devices through communication of device and regulatory needs.

Key Topics

• The unique roles of different stakeholders
• Data requirements and processes for approval, coverage, recommendations, and more
• International perspective international perspectives on medical device coverage and approval coordination
• Comparing and contrasting varying industry perspectives - is alignment possible?
• Successes and lessons learned on how to maximize the value of your clinical trial
• The challenges faced by a large medical device company
• How to use registries/real world data/health outcomes data, data from clinical experience to build your reimbursement case
• Including payers in the pivotal trial planning/Pre-Submission meetings to gather valuable feedback
• How to gather data without adoption/payment for your device
• Gathering data required by payers when it is not part of your clinical trial

Who should Attend

Senior attendees from:

• Actelion Clinical Research Inc
• AbbVie
• AMAG Pharmaceuticals Inc
• Alcon Laboratories
• Astellas
• Amgen
• Baxter Healthcare
• Baxalta
• BIND Therapeutics Inc
• Bayer
• Biogen Idec
• BioBridges LLC
• Bloomberg BNA
• Biotechnology Industry Organization
• Boehringer Ingelheim
• Blue Cross Blue Shield Association (BCBSA)
• Capitol Street
• Bristol Myers Squibb
• Catalyst Healthcare
• Catalent Pharma Solutions LLC
• Celldex Therapeutics
• Celgene Corporation
• Cempra Pharmaceuticals
• Celyad
• Covance
• Coalition Healthcare Communication
• Daiichi Sankyo
• Covington & Burling LLP
• Doc Rock Presents
• Dermira Inc
• Duke University
• DSC Associates
• Eli Lilly & Co
• Eisai Inc
• Emory University
• EMD Serono
• FasterCures
• Epstein Becker & Green
• Genentech
• Food & Drug Administration
• Genesun
• Generic Pharmaceutical Association
• Greenleaf Health
• Genzyme
• Harrison Consulting Group
• GSK
• Hospira Inc
• Horizon Pharma
• Hyperion Therapeutics
• Humana
• Infectious Diseases Society of America
• ImmunoGen Inc
• Johnson & Johnson
• Janssen
• Life Science Leader
• LEO Pharma
• Mallinckrodt Pharmaceuticals
• Lupin Pharmaceuticals Inc
• Merck
• Medicaid Health Plans of America
• National Institute of Health (NIH)
• Momenta Pharmaceuticals
• Nemetz Group
• National Pharmaceutical Council
• Novo Nordisk Inc
• Novartis
• Otsuka America Pharmaceutical Inc
• Omeros Corporation
• Parent Project Muscular Dystrophy
• Paarlberg & Associates LLC
• Patients Like Me
• PAREXEL International
• Pfizer
• Peking University
• Prescient Healthcare Group
• PhRMA
• Regeneron Pharmaceuticals
• PWR
• Rho Inc
• REGENXBIO Inc
• Ropes & Gray
• Roche
• Sanofi
• Sandoz
• Sunovion Pharmaceuticals
• Sarepta Therapeutics
• Takeda Pharmaceuticals
• Synthetic Biologics Inc
• Teva Pharmaceuticals
• TetraPhase Pharmaceuticals
• Theravance Biopharma
• The NemetzGroup
• UBM Life Sciences
• Tonix
• University of Maryland
• UCB
• Utah Department of Health Medicaid & Health Financing
• Upsher-Smith Labs
• Vertex
• Validant
• XG Health Solutions Inc