PrecisionCardio™
A member-governed industry association
PrecisionCardioIndustry Alliance

Different therapies.Shared challenges.Collective action.

PrecisionCardio™ is a new, independent, member-governed nonprofit industry association for cardiovascular therapeutics companies. It is intended to be the industry’s own home for addressing shared challenges, from clinical development and regulatory science to getting therapies to patients.

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At AHA? Join us Sunday evening, November 8 →

PrecisionCardio Industry Alliance, Inc., a nonprofit industry association seeking recognition under Section 501(c)(6)

01Four areas of shared opportunity

Across development and care, companies face barriers no single company can resolve alone.

01

Regulatory science
& standards

Biomarkers, surrogate endpoints, and regulatory evidence standards.

02

Clinical research
& evidence

Clinical trial methods, endpoint assessment, and evidence generation.

03

Implementation
& care delivery

Disease recognition, diagnosis, risk assessment, treatment, and follow-up.

04

Health economics
& value

Long-term value, durable outcomes, and evidence for new payment models.

Members choose the work, then carry it out with independent scientific, clinical, regulatory, and health-system partners.

02What collective work could look like

Four examples of what collective work could pursue.

Illustrative opportunities, not a predetermined agenda. Members decide the priorities.

01Regulatory science & standards

The shared barrier

Companies use many of the same biomarkers across cardiomyopathies, but their clinical meaning differs by disease, and each company starts from scratch.

The change to pursue

A multi-sponsor approach to cardiovascular surrogate endpoint evidence

Develop shared evidence methods across cardiomyopathies with biomarker scientists and cardiovascular researchers, seeking FDA input while respecting disease-specific validation.

Builds on FDA Biomarker Qualification Program · FNIH SABRE

02Clinical research & evidence

The shared barrier

Adjudicating cardiovascular trial events is costly and time-consuming. AI could reduce that burden, but there is no shared way to know when it is reliable enough to trust.

The change to pursue

Independent validation of AI-assisted cardiovascular event adjudication

Benchmark AI against physician-adjudicated HF hospitalizations with independent events committees, trialists, and biostatisticians, and seek FDA input on validation criteria.

Builds on Friends of Cancer Research ai.RECIST · Cardiovascular AI-adjudication studies

03Implementation & care delivery

The shared barrier

The four therapies patients with HFrEF need are well established, yet too few receive them all, and there is no standard way to measure whether treatment is optimized after discharge.

The change to pursue

Making 90-day HFrEF treatment optimization measurable

Design and pilot a 90-day GDMT measure alongside professional societies, health systems, and quality-measure experts, with CMS input on its use in ACCESS.

Builds on ACC HFrEF Expert Consensus · CMS ACCESS Model

04Health economics & value

The shared barrier

A one-time gene therapy could deliver benefits for decades, but lasting value is hard to demonstrate when patients change health plans and outcomes take years to emerge.

The change to pursue

Defining durable-value evidence for cardiovascular gene therapies

Set outcome, durability, and follow-up standards that could support outcomes-based payment, working with health economists, cardiomyopathy specialists, and public and private payers.

Builds on Tufts NEWDIGS FoCUS · CMS Cell and Gene Therapy Access Model

Precompetitive by design. The work excludes coordination on product-specific pricing, contracts, coverage decisions, and anything else competitively sensitive.

Illustrative only. No partnerships or initiatives are confirmed. Member-selected work would follow scientific independence, confidentiality, and antitrust safeguards.

03Founding membership

Shape the priorities from the start.

Founding members have an early role in shaping PrecisionCardio’s governance, establishing its first priorities, and directing collective initiatives. Member companies elect the Board and vote on which initiatives to pursue. We invite your company to join as a founding member.

PrecisionCardio Industry Alliance, Inc. is a Delaware nonprofit industry association, seeking recognition as a tax-exempt business league under Section 501(c)(6).

Autumn 2026

Membership conversationsWe are here

Sunday, November 8

Meet us at AHA

December 31, 2026

Founding membership closes

Early 2027 (planned)

Members vote on the first program of work
Start a conversationStart a membership conversationDownload the November founding invitation (PDF) →

Questions? Contact Megan Sutton, President and co-founder, at megan@precisioncardio.org.

Founding leadership
Megan SuttonAlla ZarifyanLeila BerkeleyDaisy Li-Brum