We come prepared with professionals that have served that over 18 years on Capital Hill. With experiences such as serving as a Senior Policy Advisor to House Democratic Whip Steny Hoyer (D-MD), Senior Policy Advisor for Medicare & Social Security at the Senate Budget Committee and as Deputy Chief of Staff to Representative Allyson Schwartz (D-PA), we have played a key role in shaping Congressional Democrats’ strategy related to health policy, including health reform, drug pricing and public health issues. As well as being instrumental in the drafting, negotiation and enactment of numerous bipartisan health bills ranging from the 21st Century Cures Act to the Medicare and CHIP Reauthorization Act (MACRA). We also bring experience working in a bipartisan manner with Members of Congress and senior Administration officials to pass legislation and advance legislative goals of the Obama Administration, the U.S. Department of Health and Human Services (HHS) , and the House Committee on Ways and Means.

Continuing our reach across globe to Brussels, our expert in global policy has worked 8 years at the Health Department of DG Research and Innovation of the European Commission where he contributed to the launch of several research and innovation programs targeted to healthcare businesses. Prior to this, he worked at Universite Paris Dauphine, developing one of the first crowdfunding platform supporting innovative ideas generation and entrepreneurship.

We bring in over 20 years of experience applying economic and financial modeling, data-intensive analysis, and complex claims analyses across numerous industries and in a variety of operational, dispute and compliance matters. Our experts have assisted health plans, providers, pharmaceutical manufacturers and PBMs with in a variety of matter types including operational improvement and compliance consulting, nationwide class-action litigation, Medicare and Medicaid false claims and sales and marketing investigations, investigations by other government agencies, and arbitration matters.

To help round out our client’s needs, we bring to the table a professional who has served as Director of State & Local Campaigns for the American Cancer Society’s advocacy affiliate, American Cancer Society Cancer Action Network (ACS CAN), where they led the organization’s advocacy engagement on a broad range of access to coverage and care issues, in all 50 states, DC and the US territories. We have experience building, managing and convening a broad range of partners, stakeholders and coalitions. She served as chair of the Comprehensive Cancer Control National Partnership (CCCNP) – a coalition of diverse and influential national organizations focused on changing the trajectory of the cancer burden by supporting, improving and strengthening comprehensive cancer control efforts in states, tribes and US territories. Our experts have served as chair of the Comprehensive Cancer Control National Partnership (CCCNP); member of the Policy Research Advisory Group for the California Breast Cancer Research Foundation; co-chair of the National Colorectal Cancer Roundtable’s (NCCRT), Policy Action Task Group; and advisor to the HPV Roundtable State Coalitions & Roundtables Task Group.

On tap in our network, we have a strategic advisor to the FDA, having assisted them in various areas, including product quality, patient safety, data integrity, cloud computing, and digital health. For several years, our colleague has been co-leading a collaboration effort between FDA, the Medical Device Innovation Consortium (MDIC), and the medical device industry that has developed a program that leverages CMMI (Capability Maturity Model Integration) as the standard maturity model by which medical device organizations may measure their capability to produce high-quality devices and improve patient safety. We have an active collaborator among us with not only the FDA but other international agencies, including the development of an electronic trial master file (eTMF) for pharmaceutical clinical trials, validation of certified copies that are viable substitutes for paper documentation for clinical trials, and best practices concerning computerized system validation of electronic systems that maintain regulated data including electronic records and electronic signatures.

Our digital health expert runs a consultancy practice focusing on legal, regulatory and policy issues in eHealth. She spent a seven year period in eHealth technology with Cisco and eight years with the European Commission working on eHealth policy, and in particular use of patient data to drive better care. She also served as the CEO of the International Diabetes Federation.

FTI’s experts have deep experience and a global perspective to clients, having developed comprehensive external and internal communication plans, public relations strategies, and stakeholder engagements in places such as Brazil, Argentina, Chile, Mexico, Peru, Puerto Rico, Spain, the UK, and the US. We have provided public affairs and media relations support to the pharmaceutical industry as it navigated intellectual property concerns in Latin America and to the Puerto Rico Electric Power Authority as it renegotiated its debt with creditors and worked to transform its infrastructure.