The Global Initiative to Speed the Delivery of Therapies for FSHD
Timely access to effective FSHD medicines by patients everywhere faces several challenges:
- The high failure rates of clinical trials;
- That regulatory approvals don’t guarantee coverage of costs to the patients;
- A lack of engagement and collaboration between FSHD patients and other key stakeholders to solve these problems.
But we know the solution. Project Mercury.
What is Project Mercury?
It is an open collaboration among stakeholders from across the globe coming together to overcome the challenges that could slow or prevent effective therapies from getting to patients everywhere. This collaboration takes place at the global level through a Global Task Force and at the local level, through Country Working Groups. The Task Force and the Working Groups are all led by patient advocacy organizations of the World FSHD Alliance. This global-local approach ensures customization of Project Mercury’s work at the local level while sharing resources at the global level.
Project Mercury Goals
By 2025, Project Mercury aims to build a global cohort of 10,000 clinical-trial-ready, well-characterized patients; expand and optimize the world-wide clinical trial infrastructure; and remove the barriers that delay patient access to therapies once approved.
The FSHD Society’s Role in Project Mercury
The FSHD Society and FSHD Canada Foundation are founding members of Project Mercury. The Society’s role is to provide support, management and resources for Project Mercury.
Members and Partners
Patients & Families Impacted by FSHD
Patients and families willing to participate in clinical research and contribute to the sustainability of Project Mercury’s mission are critical. In fact, the original concept of Project Mercury was created by patients and families. The work is centered around, driven and governed by patient advocates who serve on Project Mercury’s country working groups and on the Global Task Force.
The FSHD World Alliance
At the center of all Project Mercury’s work is the patient. This focus is maintained by having organizational members of the World FSHD Alliance serve as Chairs of the working group in their country and on the Global Task Force.
The FSHD Society
The FSHD Society serves as program manager for Project Mercury, providing resources, development and support for its global mission. The Society chairs the U.S. Working Group and currently serves as Chair of the Global Task Force (a position that rotates).
FSHD Canada Foundation
Canada is the first country outside the U.S. where Project Mercury has launched. The work in Canada is led by Neil Camarta, Executive Director of FSHD Canada Foundation. As Chair of Project Mercury’s Canada Working Group, Neil ensures the initiatives to create data and evidence for Canada’s regulatory and reimbursement agencies, to grow Canada’s ability to support clinical trials and to engage the FSHD patient and family community in support of Project Mercury. As Chair of the Canada Working Group, Neil also serves on the Global Task Force for Project Mercury.
Fulcrum Therapeutics
As a founding and sustaining industry member of Project Mercury, Fulcrum serves on the Global Task Force. Fulcrum provides insights, expertise and financial support for Project Mercury’s work in patient access, clinical trial capacity-building and patient engagement in clinical research globally.
Avidity Biosciences
As a founding industry member of Project Mercury, Avidity serves on the Global Task Force. Avidity provides insights, expertise and financial support for Project Mercury’s work in clinical trial capacity-building and patient engagement in clinical research in the U.S.
TREAT-NMD
Patient and clinician engagement in clinical research is critical to achieving Project Mercury’s mission around the world. To help facilitate this engagement, TREAT-NMD provides an infrastructure that is accelerating FSHD research and therapy development, increasing collaboration, improving patient care and helping to support ‘clinical trial readiness’ on an international scale. Through their Global Registries Platform and education programming, they are a vital partner helping Project Mercury’s success and serve on the Global Task Force.
Governance
Project Mercury is governed by a Global Task Force that consists of representatives from the FSHD Society, FSHD World Alliance, and biopharmaceutical industry members and clinicians. Currently serving are:
- Mark Stone, FSHD Society CEO and Project Mercury Secretariat
Mark has served as an executive leader of research-focused patient advocacy nonprofit organizations since 2004. Prior to joining the FSHD Society, he was the chief executive officer of NephCure Kidney International. During his tenure at NephCure, Stone launched the NephCure Accelerating Cures Institute (NACI), a drug discovery initiative anchored by a clinical trial network comprising more than 35 sites, which seeks to expedite potential treatments for nephrotic syndrome. Mark currently serves as Chair of the Global Task Force for Project Mercury, a position that will rotate amongst advocacy leaders globally.
- Ken Kahtava, FSHD Society Chief Business Officer
Ken joined the FSHD Society in January 2022, focused on business development strategies to support our Therapeutic Accelerator program. Ken has held senior leadership roles in non-profit/research advocacy and various private industries for more than thirty years. Ken serves on the Global Task Force as global project manager.
- June Kinoshita, FSHD Society Senior Director of Research and Patient Education
June joined the FSHD Society in 2012 and served as its Executive Director until September of 2017. June works at the intersection of research and the FSHD community. She serves on the Global Task Force, heading up patient and clinician education and engagement.
- Amanda Hill, FSHD Society Director of Research and Patient Engagement
Amanda brings deep professional expertise in biomedical research, including in clinical studies and clinical trials administration, scientific engagement and communication, and project management. In 2016, Amanda’s husband was diagnosed with FSHD, spurring her personal and now professional drive to serve and empower the FSHD community and advance research towards treatments and a cure. On Project Mercury, Amanda works closely with the global patient registry network.
- Neil Camarta, FSHD Canada Foundation and Chair of the Canada Working Group
Neil Camarta is a business entrepreneur and co-founder of FSHD Canada Foundation in Calgary, Alberta, Canada. Neil and the Foundation were instrumental in launching Project Mercury and providing financial support.
Advisers
Project Mercury has engaged experts to provide guidance and support to our Global Task Force. Current advisers:
- Josie Godfrey
Josie has worked in rare diseases and innovative therapies for over 12 years in roles with pharmaceutical companies and government regulatory bodies. She currently runs a JG Zebra Consulting in London, England, specialising in strategic market access, policy and stakeholder engagement. She is also the Strategic Director for Duchenne UK’s Project HERCULES, an award-winning global collaboration developing evidence and tools to support Health Technology Assessments (HTA’s) for new treatments for Duchenne Muscular Dystrophy. Josie serves on the Global Task Force, heading up all patient access work.
- Maryna Kolochavina
Maryna has 16 years in a lifecycle management in various roles in the pharmaceutical industry, and currently leads a global consultancy based in Germany. She has experience in a number of rare and orphan conditions, including pediatric rare, ultra rare diseases and FSHD. Maryna leads Project Mercury’s health economics and outcomes research globally and serves on the Global Task Force.