Accelerating Biotech Strategies from Concept to IND

BrownBioStrategy provides biotech strategy, regulatory consulting, and other services in RNA and DNA therapeutics, synthetic biology, and vaccine manufacturing to startups, CDMOs, venture capital firms, and mid-sized biotechs to drive innovation and product development.

Biotech Startup Accelerator

I help emerging biotech companies move from scientific concept to actionable development strategy. Whether you're pre-IND or building your first platform, BrownBioStrategy will provide hands-on guidance in scientific planning, CMC and manufacturing, regulatory strategy, team structuring, and technical execution to shorten your time to value.

RNA and Synthetic Biology SME

With deep expertise in mRNA design, LNP formulation, synthetic biology platforms, and DNA engineering, I provide strategic and technical support across discovery, optimization, and early development. From construct design to scalable IVT and analytical methods, I help you translate cutting-edge science into clinical-grade products with confidence.

Scientific Due Dilligence

I provide clear, expert evaluations of therapeutic/vaccine platforms, development plans, CMC readiness for investors, acquirers, and partners. My deep technical insight in RNA, gene therapy, and early-stage biologics helps you identify risks, validate claims, and make confident, science-backed decisions.

Interim Leadership and Investor Facing Support

I can step in as fractional or interim leadership to guide R&D, CMC, or platform strategy during critical growth phases. Whether you're preparing for fundraising, diligence, or board meetings, we help shape your narrative, align technical plans with investor expectations, and represent your science with clarity and credibility.

CMC and Regulatory Advisor

I offer expert guidance across the CMC and regulatory spectrum, from early-stage strategy through IND submission. Services include regulatory writing, FDA meeting preparation, on-site GMP and quality audits, analytical strategy, and IND authoring. Whether you're building a program from scratch or refining your regulatory path, I bring deep experience to help you plan, write, and execute with confidence.

Project and CDMO Managment

I oversee complex development programs and external partnerships to ensure timelines, budgets, scope, and quality stay on track. From vendor selection to tech transfer and lot release, I act as an extension of your team—bridging science, operations, and communication across global CDMOs.

About

David M. Brown, Ph.D

With over a decade of hands-on experience in mRNA therapeutics, synthetic biology, and CMC leadership, I’ve built and led biotech teams, managed multimillion-dollar programs, and guided multiple mRNA products from design through IND submission.

 

As former Vice President at RNAimmune, Inc. and  scientist at the J. Craig Venter Institute, I’ve led IND filings, CDMO oversight, scientific programs, quality audits, due dilligence, and vaccine development.

 

At BrownBioStrategy, I offer leadership and strategic planning for biotech startups, investors, and CDMOs. My mission is to add value and empower clients with actionable insights in R&D strategy, regulatory affairs, CMC, and RNA therapeutics development. Connect with me to explore how I can accelerate your project success.

Consulting services for every stage

BrownBioStrategy combines deep startup and biotech industry knowledge with innovative approaches to support vaccine manufacturing, analytical development, and product development. BrownBioStrategy delivers customized solutions that align with your scientific and commercial goals.