Myasthenia gravis has become one of the most competitive therapeutic areas in neurology, with more than ten approved biologics competing across overlapping patient populations. That is good news for patients, and it raises the bar for measurement: when several effective treatments exist, the questions shift from whether a therapy works to how well, for whom, for how long, and at what cost to daily life.
The measures the field currently relies on were not designed to answer those questions. DEEP and Vitaccess are convening a pre-competitive workshop to change that, in partnership with the Myasthenia Gravis Foundation of America (MGFA), and we are inviting the MG community to help build it. Having MGFA as a Partner means patients and caregivers are involved from the first session rather than consulted at the end.
The challenge
Digital technologies capable of tracking MG symptoms continuously are arriving quickly. The problem is not a shortage of innovation, but that innovation is arriving without alignment, and the consequences land differently on each part of the community.
For research and industry, a fractured ecosystem. Powerful new tools measure similar things in different ways, creating incompatible data silos. In a rare disease where every data point is precious, evidence generated in one program cannot be compared with, or built on by, evidence from another.
For clinicians, an overwhelmed front line. Healthcare professionals already struggle to translate existing measures into treatment decisions. A flood of new, unstandardized digital scores adds noise rather than signal, and risks leaving patients feeling that the data they contribute is not leading to better care.
For patients, a risk of being measured on the wrong things. People living with MG are adopting digital tools and finding the insights useful. But their priorities are not always those of clinicians or trial designers, and concepts patients care about most get overlooked when validation studies are designed without them. Recall-based assessment in particular understates the day-to-day fluctuation that defines living with this condition.
Our goal
One shared measurement standard for MG, co-created rather than imposed, and open to the whole field.
We are not trying to pick a winning device or displace the instruments already in use, but to give the community a common foundation, so that digital measures developed by different organizations produce evidence that can be compared, pooled and trusted.
Three pillars of alignment
There are three things the field has to agree on. The workshop is built to deliver all three.
- A core outcome set. What we measure. The symptoms and impacts that matter most to people living with MG, grounded in input from a panel of people living with MG and their caregivers, brought together with MGFA, rather than in what is convenient to capture in clinic.
- A standardized approach. How we measure it. Measurement methods that hold across devices, when each platform is built on different algorithms and form factors.
- A standardized interpretation. How the results are read. How shared data informs an individual clinical decision, and how it is pooled across cohorts for research.
- A harmonized measurement stack for MG, combining Measure Definitions and Target Solution Profiles. Between them these carry what the field has agreed to measure, how it is measured across platforms built on different algorithms and form factors, and how the resulting outputs are read. Whether a sponsor chooses to build, buy or partner, the architecture is interoperable from the start.
- A mapped regulatory pathway. The closing session maps the routes available to a harmonized measure with FDA, EMA and other agencies, and identifies where a coordinated proposal from the field carries more weight than isolated submissions.
Get one or two of these right and the field still fragments. All three together are what makes a standard.
A precedent worth studying
Continuous glucose monitoring offers a useful model. Before coordination, multiple CGM devices in clinical use produced data that did not compare across products. Standards bodies, clinicians, patients and industry came together and agreed on a shared measurement concept, shared data formats and shared regulatory pathways.
The devices stayed competitive. What changed is that the outcomes the field measured against became shared, stable and trusted: a daily outcome reflecting lived experience rather than a quarterly snapshot, one signal that read the same across devices, a reliable endpoint to design trials around. That took deliberate, coordinated effort, and the same effort can do the same for MG.
What the workshop delivers
Agreement across the three pillars does not stay in the room. It is captured in a shared measurement architecture and delivered to the consortium after the workshop.
Why the Steering Committee continues after the workshop
Agreeing a standard and getting it adopted are different problems. The Steering Committee runs through 2027 to carry joint regulatory engagement forward, keep the stack current as evidence and technology move, and steward adoption across sponsor pipelines. That continuity is the difference between a durable standard and a well-attended meeting.
Why this matters
For people living with MG. Daily lived experience captured accurately and translated into evidence that actually influences care. With MGFA as a Partner, the priorities that shape the standard come from the community itself.
For clinicians. One clear, trustworthy signal to guide timely, personalized treatment decisions, instead of a growing number of scores that do not agree with each other.
For sponsors. Endpoints sensitive to the within-cycle and between-cycle dynamics that recall-based assessment understates. That de-risks Phase 2/3 endpoint design and supports comparative-effectiveness evidence for payer and HTA scrutiny, including the EU Joint Clinical Assessment, where evidence must be built years upstream of review.
For technology developers. A published interoperability target to build against, and a route into a shared standard rather than a proprietary silo.
For regulators. Measures developed with patient input from the outset, aligned to Patient-Focused Drug Development principles, arriving as a coordinated proposal from the field rather than isolated one-off submissions.
Who should participate
We are inviting pharmaceutical and biotechnology companies, digital measurement technology developers, clinical key opinion leaders, regulatory and statistical specialists, patient advocacy organizations, and people living with MG and their caregivers. Participation routes differ by role: anchor sponsors take Steering Committee seats and shape the agenda directly, and broader industry, technology partner and observer routes are also available.
Timing
The mission is recruiting now, with Letters of Intent invited through September and formal contracting and Steering Committee kick-off in Q4 2026. The two-day workshop is targeted for April/May 2027 in Washington DC, immediately preceding the AAN Annual Meeting, bringing up to around fifty active contributors into the same room across the three pillars, including people living with MG and their caregivers. Steering Committee and working groups then run through 2027, with routes for new organizations to join along the way.
Join us
If your organization wants a hand in defining how myasthenia gravis is measured, rather than adapting to a standard set without you, we would like to hear from you. Letters of Intent are invited through September, ahead of formal contracting in Q4 2026.
Mark Larkin · CEO · Vitaccess · mark.larkin@vitaccess.com
John Batchelor · Science Liaison · DEEP · john@deepmeasures.health
Thanks to our Partner, the Myasthenia Gravis Foundation of America.
MGFA takes part in this mission on behalf of the MG patient community. Its participation does not imply endorsement of any sponsor, product or technology.
If you have any questions, or if your organisation would like to contribute, please contact us.
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