About Us

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I founded The NEST after seeing too many strong teams lose time and momentum due to avoidable regulatory misalignment.

I work with biotech teams when regulatory, sterility, or microbiological questions start to carry real risk, the kind that can delay timelines, trigger FDA pushback, or complicate investor discussions.

Over the past 22 years, I’ve worked at the intersection of biomanufacturing, microbiology, and regulation, including inside the federal system where many of today’s expectations for sterility testing, microbial methods, and quality systems are shaped. I’ve seen how FDA questions actually emerge, how reviews go sideways, and where otherwise strong teams get tripped up.

My role is simple: help you anticipate those questions early, align your technical and regulatory strategy accordingly, and move forward with confidence and speed.

Experience That Translates Into Action:

My background spans:

• Biomanufacturing CMCs, including sterility testing and microbial control
• Rapid and alternative microbial methods
• Infectious disease diagnostics
• Microbiome science, probiotics, and live biotherapeutics
• Food safety and applied microbiology
• NGS-based genomics and metagenomics, including evaluation of analytical validity and regulatory defensibility

Across these domains, I’ve worked with industry, regulators, and standards bodies - often helping define the very frameworks others are required to follow. That perspective allows me to focus less on theory and more on what will actually hold up under FDA and investor scrutiny.

How I Work:

Clients work with me because I am:

• Direct and practical - focused on decisions, not academic debate
• Fast - most engagements are measured in weeks, not months
• Independent, objective, confidential, and conflict‑free
• Hands‑on, no junior staff, no hand‑offs

I don’t offer rubber stamps or generic advice. I work best with teams that value clarity, urgency, and defensible decision‑making.

When to Work With Me:

You should consider reaching out if:

• FDA has asked questions your team can’t answer cleanly
• Your sterility or microbial strategy works in practice but isn’t defensible on paper
• You’re preparing for a Pre‑IND, Q‑Sub/Pre‑Sub, or other critical FDA interaction
• Investors or partners are probing quality, sterility, or regulatory risk

Most engagements begin with a 90‑minute paid advisory call, which is credited toward the cost of any subsequent engagement.

About The NEST

The NEST was founded to provide senior‑level regulatory and microbiological judgment without the overhead, delays, or opacity of large consulting firms. Clients work directly with me to get clear answers, actionable guidance, and defensible strategies - quickly.  If you’re facing a decision where getting it wrong is expensive, I’d be glad to help.