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Mylea Charvat PhD
Fractional CMO · Medical Affairs · Diagnostics · Life Sciences

I build what diagnostics companies need but cannot yet staff full time.

Stanford-trained clinical neuroscientist. 15 years at the intersection of science, commerce, and the patients waiting for both to meet.

Stanford University School of Medicine FDA Breakthrough Device — Multiple Clients Founder, Savonix · CMO, Altoida · President Diagnostics, Viome 5 Years Fractional · Concurrent C-Suite Engagements
Featured Interview

A conversation with Susan Schneider Williams

The Cost of a Missed Diagnosis

Susan Schneider Williams speaks with Mylea Charvat about her husband Robin Williams' Lewy Body diagnosis — the years of uncertainty, the misdiagnoses, and the devastating cost of a diagnostic gap. This is why this work matters.

The companies I work with are building something genuinely new.

The gap between working science and a reimbursed, ordered, trusted diagnostic is not a science problem. It is a leadership problem. I close it.

01
Growth-Stage Diagnostics & Medtech

You have the science. You may have FDA engagement underway. What you do not have yet is the commercial infrastructure, the medical affairs function, or the regulatory strategy that gets your test in front of physicians and paid for. That is where I come in.

02
AI-Enabled Health & SaMD Companies

You are building at the intersection of AI and clinical care. The pathway to physician adoption, FDA clearance, and payer coverage is not yet defined. I have built that infrastructure across multiple platforms and regulatory environments.

03
Investors & Boards Placing Fractional Leadership

You have a portfolio company at an inflection point — a CMO departure, a regulatory milestone approaching, a launch that needs to happen faster than a full-time hire allows. I work directly with boards and investors to assess the gap and fill it.

04
Founders Navigating Science to Business

You built something that works. Now you need to translate it into a clinical workflow, a reimbursement strategy, and a go-to-market that reaches the physicians who need it. I have done this as a founder and as a fractional executive.

I don't build decks and consult from a distance. I embed in your team, build alongside you, and hand off infrastructure that stands up after I leave.
Latest Thinking

On diagnostics, AI, and what comes next.

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Leadership & Strategy
Bench to Bedside to Business: The Diagnostics Leadership Playbook

The gap between a working diagnostic and a reimbursed, ordered, trusted one is not a science problem. It is a leadership problem. Here is how to close it.

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AI & Digital Health
The AI Front Door: Why Most Health AI Tools Fail Before They Start

Physician adoption is not a technology problem. The AI diagnostic tools that fail do so before they are ever used. Here is what the evidence actually says.

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Reimbursement Strategy
What Payers Actually Want to See Before They Cover Your Test

Your white paper is not going to do it. This is what payer medical policy reviewers are actually looking for — and how to give it to them.

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Services & Expertise

What I build when I embed in your team

I don't sit on the outside and advise. I join your leadership team, work alongside your people, and build the clinical, regulatory, and commercial infrastructure your company needs — then hand it off so it runs without me.

Mylea Charvat working with a team
01
Diagnostics Commercialization Strategy

From go-to-market design to physician channel development to payer strategy. I build the commercial engine that gets your test ordered, reimbursed, and trusted — designed to survive a 12-minute clinical appointment and a payer medical policy review.

02
FDA Regulatory Strategy & Clinical Trial Design

510(k), De Novo, Breakthrough Device Designation, CLEP certification, CLIA operations, pre-submission meetings, and pivotal trial design across the US and OUS. I have navigated FDA and PMDA simultaneously. I build the regulatory strategy and the clinical evidence to support it.

03
Medical Affairs & KOL Engagement

I build medical affairs functions from zero — KOL strategy, scientific advisory boards, provider education programs, publication strategy, and pharmaceutical partnership development. For companies that need clinical credibility built fast and built right.

04
Clinical Operations Infrastructure

QMS, SOPs, GCP training, CRO selection, EDC platform implementation, site activation, and regulatory packaging. Built from scratch across ALS, oncology, Parkinson's, and CNS diagnostics — in the US, India, Australia, Japan, and Singapore.

05
SaMD & AI Diagnostic Regulatory Pathway

Workflow integration for AI diagnostic tools, physician adoption frameworks, and SaMD and AI/ML regulatory pathway planning. I design the clinical environment where AI tools actually survive and build the evidence strategy that earns physician and payer trust.

06
P&L Leadership & Commercial Infrastructure

Full business ownership across early-stage startups and growth-stage divisions — pricing, sales infrastructure, channel and partnership development, reimbursement frameworks, and team design. I have grown revenue over 300% in under a year.

07
Executive Coaching & Leadership Development

The same mind that builds something extraordinary can become the ceiling on its own growth. Neuroscience-grounded performance coaching for technical founders and executives in life sciences.

Learn more
08
Board Advisory & Director Roles

Scientific advisory boards and boards of directors for life sciences, diagnostics, and AI-enabled health companies. Independent scientific and commercial voice at the governance level.

SAB Member Board of Directors Interim Support Board Observer
Process

How a Syntara engagement works

01

Discovery and Diagnostic

A structured diagnostic of where your company is and where it needs to go — regulatory position, clinical evidence, commercial readiness, and team. I am looking for the gap between what your science can do and what your business needs to make money in healthcare.

02

Engagement Design

We define scope together — whether that is a fractional CMO, a COO, a VP Medical Affairs, or all three simultaneously. We agree on the role, deliverables, and timeline before anything starts.

03

Embed and Build

I join your leadership team. In your meetings, on FDA calls, in front of your KOLs. I build clinical, regulatory, and commercial infrastructure in parallel — because your timeline does not allow for sequential.

04

Infrastructure That Stands Up

SOPs, QMS, medical affairs programs, go-to-market frameworks, reimbursement strategies. I build it so it exists independent of me. Not building dependency — building capability.

05

Transition or Continue

At the end you have infrastructure to run without me, or the clarity to hire the permanent executive to carry it forward. If ongoing, we reset scope based on what the business needs next.

Strategy conversation
What Clients Say

The work speaks. So do the people who have seen it.

"

She is one of the most strategically astute and scientifically grounded executives I have encountered in the industry. A rare combination of deep clinical expertise paired with hands-on commercial leadership.

Beverly Salcedo, BS MBA
Market Access Strategy, Value Access & Reimbursement | Biotech/Radiopharm/Lab
"

Mylea is a force multiplier across a company — from commercial to medical to investor relations and fundraising. When Mylea speaks, it is clear she has seen it all in the pharma, medical device and clinical digital health markets.

Sean Lorenz
Senior Director of Product, Altoida
"

Mylea's expertise was instrumental in formalizing our fundraising strategy, developing a comprehensive go-to-market plan, and hiring key executives. A transformative partner for any healthcare executive.

Fox, CEO
NEXT Life Sciences, Inc.
"

She has a unique ability to meet people where they are. Mylea is a big thinker — she lays out a vision and assists the team navigating across logical milestones until that vision is met.

John M. Casiano
Operations & Strategy Executive
"

She is passionate, professional and has consistently gone above and beyond. Mylea was more than willing to work and adapt to meet our needs and challenges across international markets.

Shawn Watson
CEO, Senescence Life Sciences

"Ready to see if this is the right fit?"

Case Studies

What it looks like when this work gets done

Four examples from real engagements across diagnostics, neuroscience, and AI-enabled care delivery.

ALS · Clinical Operations
Zero to First Patient in 6 Months — No CRO

An early-stage ALS therapeutics company needed to move concept to first patient in its Expanded Access Program on a compressed timeline with no existing quality systems, SOPs, or regulatory infrastructure.

What Was Built
  • QMS and SOP library built from scratch
  • GCP training installed across the team
  • EDC platform selected and implemented
  • Regulatory packaging delivered to FDA
  • Site identification, contracting, and activation
Outcome

Concept to first patient in 6 months. No CRO. Full clinical operations infrastructure handed off to internal team.

Oncology Diagnostics · FDA Strategy
Prototype to FDA Pivotal Trial with 100% OUS Data Strategy

An oncology diagnostics company needed to take a novel early-detection test from prototype through a full FDA pivotal trial, including an out-of-US data strategy satisfying FDA requirements across multiple international markets.

What Was Built
  • Full clinical trial strategy, prototype through pivotal
  • 100% OUS data collection strategy across India and Australia
  • FDA sign-off on OUS data approach before trial initiation
  • Site identification and activation across international sites
  • Regulatory strategy aligned to pivotal submission requirements
Outcome

FDA-aligned pivotal trial executed with 100% OUS data. FDA sign-off obtained before trial initiation.

Alzheimer's Diagnostics · Turnaround
$10M Global Validation Study in 9 Months for Significantly Less

A medical device company developing a digital biomarker platform for early Alzheimer's detection needed FDA readiness for a De Novo application on a constrained budget with a 9-month timeline.

What Was Built
  • Full turnaround plan: regulatory strategy, medical protocols, product roadmap
  • Companywide GCP training and SOP installation
  • Multisite global validation study designed and executed in 9 months
  • $10M study delivered for significantly less via registry leverage
  • ML training and validation sets strengthened with data science team
Outcome

FDA readiness gaps closed. Multimillion-dollar pharmaceutical collaborations secured through KOL and industry engagement.

Parkinson's Diagnostics · Medical Affairs
KOL Strategy and Regulatory Pathway for Novel Biomarker Platform

A scientifically promising Parkinson's early-detection platform had no medical affairs function, no KOL relationships, and no defined regulatory pathway.

What Was Built
  • KOL identification and engagement strategy
  • Scientific advisory board designed and populated
  • Provider education program developed
  • Regulatory pathway defined for novel early-detection biomarker
  • Publication strategy aligned to commercial and regulatory milestones
Outcome

Medical affairs function built from zero. KOL network established. Regulatory pathway defined and aligned to clinical evidence generation plan.

Executive Coaching

The same mind that builds something extraordinary can become the ceiling on its own growth.

I work with technical founders and executives in life sciences who are brilliant at the science — and stalled on the people, the scale, or the leadership transition that growth requires.

Physiological Awareness

Learning to recognize the signs of threat response in real time using your own body as data.

Down-Regulation

Interrupting the automatic response before it drives behavior you did not choose.

Response Delay

Building the capacity to let a thing sit and respond deliberately rather than react.

Cognitive Reframing

Shifting the internal question from threat to curiosity — what are they seeing that I am not?

Case Study

From $100M to Over $1B: Learning to Lead at Scale

A mathematically gifted data scientist and intrapreneur leading a business unit expanding into new overseas markets. Brilliant at the work. Stalled on the people.

The behaviors that made him exceptional at creating the business were now preventing it from scaling. His internal responses to perceived threats were triggering unregulated fear responses that drove reactive behavior. He was not choosing how to lead. He was reacting.

The Work — Two Years

  • Physiological self-monitoring to recognize distress in real time
  • Down-regulation practices to interrupt the threat response
  • Response delay — building the capacity to choose rather than react
  • Cognitive reframing of threat states as opportunities for curiosity
The Turning Point

When his boss presented a COO candidate, he had always approached this as a battle. This time he was curious. He realized the candidate wanted to help him grow the business, not take it over. The business was his baby. We spent two years helping him find the right nanny to help him raise it.

$1B+
Revenue during the engagement, up from the $100M range
2 yrs
Engagement duration — meaningful neurological change takes time
✓
COO successfully hired and integrated. Overseas expansion executed.
"I had the opportunity to work with Mylea Charvat as my coach for two years, and her impact on my professional and personal growth has been remarkable. Mylea's extensive background in neuroscience was fundamental in helping me navigate and manage negative thoughts. Her approach, grounded in evidence-based techniques, provided me with actionable strategies to handle stress and maintain focus — which were crucial in high-pressure environments. Her experience leading startups was directly applicable to my role launching new ventures within an established company."
Senior Executive, Global Financial Services Firm
Who This Is For

You built something real. The way you have always operated is starting to cost you more than it earns you.

Maybe it looks like a team that is not performing. A partnership that keeps breaking down. An inability to delegate without watching everything fall apart.

Underneath most of these patterns is something neuroscience can explain clearly: behavior driven by unregulated fear response rather than regulated intention. Not a character flaw. A nervous system doing exactly what it was built to do — in a context where that response is now working against you.

These are not soft skills. They are neurological skills. And they are learnable.

On Stage

The face of the science
and the companies behind it.

I have been the scientific and commercial voice for companies I have founded, led, and partnered with — at the world's most important health, diagnostics, and innovation stages. From international research conferences to corporate leadership forums, I speak on neuroscience, AI, diagnostics, and the leadership challenge of getting science to patients.

Invited Keynotes & Presentations
One World Forum Stanford GSB AAIC Biotech Showcase ADPD ADDF CEOi Women Uninterrupted Duke Leadership Forum Hoover Institute Tom Tom Festival Evolve Conference VIVE HLTH USF UCSF Boston University School of Public Health Health2.0

I am available for keynotes, panels, and moderation on diagnostics commercialization, AI in healthcare, neuroscience and brain health, and the leadership challenge of getting science to patients.

Mylea Charvat speaking on stage
Featured Interview

The Cost of a Missed Diagnosis

A conversation with Susan Schneider Williams about her husband Robin Williams' Lewy Body diagnosis — the years of uncertainty, and why early, accurate diagnostics matter.

Mylea Charvat PhD
About

I have spent 15 years building things in healthcare that did not exist before. Here is why.

I was thirteen years old when I handed my grandmother something in the kitchen — something she had used hundreds of times — and she did not know what to do with it. I did not know what to do either. I was a teenager standing in front of something I could not name, watching someone I loved disappear from herself.

Both of my grandmothers had Alzheimer's. My mother lived for years with pain that went undiagnosed. Those experiences did not inspire me from a distance. They are the reason I do this work.

I went to Stanford. I trained as a clinical neuroscientist. I published research in neuroimaging and cognitive function. And then I left the academic path because the problems I cared about were not going to be solved from a lab. In 2015 I founded Savonix, a digital cognitive assessment company, and spent the next decade learning what it actually takes to build something in healthcare from zero.

After Savonix, I went deeper into the operating side. As CMO at Altoida I delivered a $10 million multisite global validation study in 9 months on a constrained budget. As President of Diagnostics at Viome I grew revenue over 300% in four months while building the infrastructure to sustain it. I have held C-suite roles simultaneously — CMO, COO, VP Medical Affairs — across oncology, neuroscience, SaMD, and AI-enabled care delivery.

For the past five years, through Syntara Life Sciences Advisors, I have been embedded in growth-stage companies as the fractional executive they need but cannot yet staff full time. I am still doing this because the problems I set out to solve are not solved yet.

$200M+
raised across CEO, CMO, and fractional roles
15 yrs
at the intersection of science and commerce
300%+
revenue growth in 4 months at Viome
75+
employees at peak as founder
Speaking & Thought Leadership

Available for conferences, panels, and corporate events.

I speak at conferences and corporate leadership events on diagnostics commercialization, AI in healthcare, and the science of early detection. I am frequently the scientific or medical face of the companies I work with at major industry events.

I serve on scientific advisory boards and boards of directors for companies building at the frontier of diagnostics and AI-enabled health.

Mylea Charvat speaking at a conference
Select Publications

Peer-Reviewed Research

PAIN, September 2016
Perturbed connectivity of the amygdala and its subregions with the central executive and default mode networks in chronic pain

Investigated amygdala functional connectivity in chronic low back pain patients. Found exaggerated amygdala connectivity with the central executive network correlated with pain catastrophizing.

Psychological Services
Point of entry and functional impairment as predictors of treatment amount and cost for patients with mental illness and substance abuse disorders

Analysis of treatment types, amounts, and costs across programs in the Santa Barbara County public mental health system.

Contact

Let's talk
about what you're building.

If you are a founder, CEO, investor, or board member working on something in diagnostics, medical devices, or AI-enabled health — and you need senior clinical, regulatory, or commercial leadership — I want to hear about it.

📍
LocationLos Altos, California
💼
⏱
Response TimeWithin 48 hours
Start the Conversation
FAQ

Frequently Asked Questions

The questions I get most often from founders, CEOs, boards, and investors figuring out whether fractional leadership is right for their company.

What does a fractional CMO actually do for a diagnostics company?

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A fractional CMO in diagnostics is not a marketing hire. The function spans clinical strategy, regulatory engagement, medical affairs, go-to-market design, physician adoption, and reimbursement planning. For most diagnostics companies at the growth stage, this function is inseparable from Medical Affairs and often the COO role — which is why my title changes depending on the organization. Same function, different place on the org chart.

Does the title matter — CMO, COO, or VP Medical Affairs?

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Less than most people think. What matters is what the company actually needs. I have been brought in as a fractional CMO and spent most of my time on clinical operations and regulatory strategy. The title matters for how I interface with the team and with external partners, but we determine that together based on what your company needs, not what sounds right on paper.

When should a company hire fractional versus full-time?

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Fractional makes sense when the work is real but the timeline does not support a permanent hire — a regulatory milestone, a product launch, a CMO departure, a Series A or B that needs a commercial story built before the close. A good fractional engagement builds the infrastructure and the evidence base that makes the eventual full-time hire successful.

How long do engagements typically run?

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Most of my engagements run 6 to 18 months. Some are shorter — a specific regulatory submission, a go-to-market sprint before a launch. Some have been ongoing for years as the company grows through successive milestones. We define scope and timeline at the start of every engagement and reset as needs change.

What does an engagement cost?

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Fractional executive rates in life sciences vary based on scope, time commitment, and the seniority of the function. I work on monthly retainers, project-based engagements, and advisory arrangements. Schedule a call and I will give you a straight answer based on what your company actually needs.

What kinds of companies do you work with?

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Growth-stage diagnostics companies, medical device and SaMD companies, AI-enabled health companies, and neuroscience platforms. I work with companies that have real science and need the clinical, regulatory, and commercial infrastructure to get it to market.

Do you work with investors and boards directly?

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Yes. Some of my engagements are initiated by investors or boards who need fractional leadership placed into a portfolio company. I am comfortable working directly with the board as the principal relationship while embedded in the operating company.

What is your background in oncology versus neuroscience?

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Both are real. My scientific training is in clinical neuroscience — Stanford fellowship, peer-reviewed publications in neuroimaging and cognitive function, and 15 years building neuroscience diagnostic platforms. My recent operating experience is heavily weighted toward oncology diagnostics, including FDA trial oversight for an oral and throat cancer screening test and regulatory and commercialization strategy for a pancreatic cancer test.

Are you available for speaking, advisory, or board roles?

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Yes to all three. I speak at conferences and leadership events on diagnostics commercialization, AI in healthcare, and building clinical operations infrastructure. I serve on scientific advisory boards and boards of directors. Reach out through the contact form.

Still have questions? The best way to get answers is a direct conversation.