Biotech × AI × Regulatory Science

Where biology meets code
meets the real world.

I'm Kevin Li, a Ph.D. scientist, AI practitioner, and FDA regulatory strategist — 20+ SCIE publications, 8 patents, 2 FDA clearances. My work sits at the intersection of discovery-stage science and the systems that bring it to people around the world.

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Three disciplines. One integrated practice.

Core Expertise

biotech

Biotech Science

Fermentation & scale-up, medicinal fungi R&D, clinical trial design, and SCIE publication. 7+ years at the bench-to-market frontier.

Fermentation Medicinal Fungi Clinical Trials
Domain 01
gavel

Regulatory Science

FDA IND submissions, NDI notifications, and multi-jurisdiction strategy across US, Taiwan, Thailand, and Japan. Good science only creates value when framed for regulators.

FDA IND NDI MASH Botanical
Domain 02
psychology

AI & Computation

LLM deployment, Python optimization, and AI-augmented R&D. Literature synthesis now runs in days instead of months, feeding directly into FDA-grade submissions.

LLM Pipelines Python AI-augmented R&D
Domain 03

How it adds up in practice: I use AI Agents to shorten what used to take months. Literature review, protocol optimization, and regulatory precedent mapping now run in days. That speed feeds directly into FDA-grade submissions and production-scale outcomes.

From lab work to global reach

How I Create Knowledge That Reaches the World

Publishing alone is no longer enough. Here is the process I have built to turn years of specialized work into knowledge that travels across disciplines and borders, and keeps getting sharper with each cycle.

Phase 01  ·  Generate
01

Lab → Literature

Run experiments, extract clear findings, and publish in high-impact journals. That published record becomes the foundation everything else builds on.

IF 12.0 paper 20+ SCIE
02

AI Accelerates the Loop

LLMs cut literature reviews from months to days. Python optimization lets me stress-test protocols computationally before running a single experiment.

LLM pipelines 209% yield↑
Phase 02  ·  Translate
03

Science → Regulation

Map research findings to FDA, TFDA, and PMDA requirements. Good science only creates value when it is framed in a way regulators can act on.

IND Phase II NDI 1286
04

Regulation → Scale

Cleared ingredients reach production. Patents protect the work. Clinical data gives the next iteration a stronger foundation.

8 patents 2 FDA clears
Phase 03  ·  Broadcast
05

Talks → Frameworks

International talks turn complex, multi-discipline work into practical frameworks that practitioners in other fields can actually use.

Singapore Thailand Indonesia Taiwan
06

Frameworks → New Questions

Every new market, collaborator, and dataset sharpens the questions worth asking. That feeds back into the lab and starts the cycle again.

Compounding
20+
SCIE Publications
8
Patents
2
FDA Clearances
10+
Global Talks
Where the work landed

Proof Points

2025 BBES Taiwan

Industrial Elite Award — BBES Taiwan

Recognized by the Biotechnology and Biochemical Engineering Society of Taiwan for contributions to industry practice.

2024 Nutra-Ingredients Asia

Nutra-Ingredients Asia: Ingredient of the Year

Winner in the cognitive function category for Hericium erinaceus development. The ingredient is now reaching nutraceutical markets across Asia and the US.

2024 FDA Submission

FDA Phase II Clinical Trial IND

Successfully filed for the GKAC botanical drug targeting MASH. AI-augmented workflows helped compress the timeline from bench to submission significantly.

Peer-reviewed research

Selected Publications

20+ SCIE-indexed papers across biotech, clinical science, and AI.

Full Archive arrow_forward
IF 12.0 J Cachexia Sarcopenia Muscle · 2023

Sanghuangporus sanghuang Ameliorates Atrophy

description
IF 9.2 NPG Asia Materials · 2016

Handheld Energy-Efficient qPCR Device

description
IF 8.3 Biomaterials · 2013

Magnetite Nanocrystal Hyperthermia

description
IF 8.2 Future Foods · 2024

Improving iron content in sustainable mycoprotein production through seawater fermentation

description
Recent talks & writing

Insights & Talks

Where I've taken this thinking.

Writing on Substack arrow_forward
2026 Agentome5 Public Debut 9th Annual Conference of Taiwan Microbiota Consortium

Microbe-Derived Nutraceuticals: Driving the Next Generation of Precision Self-Care

First public introduction of Agentome5 — an agentic system that takes a probiotic strain's fermentation metabolite profile and traces every detected compound through five layers of biology: secretome → receptor binding → pathway activation → physiological response → clinical outcome. What used to take 3 to 12 months of QTOF-MS annotation, literature mining, and pathway mapping now runs in minutes.

Case study: the demo surfaced three GLP-1-activating metabolites inside a single strain that conventional analysis had missed — later verified at industrial-scale bioreactor.

Agentic AI Metabolomics GLP-1 Probiotics
2026 APEC Workshop

Fungi Fermentation for Low-Carbon Alternative Proteins

How fermentation can be used to develop innovative low-carbon alternative proteins derived from fungi sources — and what this means for the future of sustainable nutrition.

2025 Asia Nutraceutical Summit, Singapore

Probiotics and Mycelium for Longevity

How precision fermentation and medicinal fungi are opening new pathways in longevity nutrition, and where the current regulatory frameworks still have catching up to do.

2025 Indonesia-Taiwan Industrial Forum

Cross-Border Opportunities in Nutrition

Reflections on building Taiwan-Indonesia partnerships in nutrition. Some of the most underserved ingredient opportunities exist precisely because the regulatory frameworks between markets are not yet aligned.

2024 AI & R&D

Bringing LLMs Into the Biotech Lab

Lessons from deploying an LLM-based nutritional assistant in a real R&D environment. What worked well, what failed quietly, and what those results say about using AI in regulated scientific settings.

2024 BEST Conference, Taiwan

From Bench to IND

A walkthrough of the journey from active compound discovery through preclinical studies to Phase II IND submission. The focus is on the practical decisions that matter at each stage.

Follow the work

If you want to see where this goes next, Substack is where I write.

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