2024
BBES Taiwan
Industrial Elite Award
Recognized by the Biotechnology and Biochemical Engineering Society of Taiwan for contributions to industry practice.
Entering the lab
0%
01 / 10
Intersection
Biotech
· AI · Regulatory Science
Where biology meets
code meets the
real
world.
I'm Kevin Tsung-Ju Li (Kevin Li) — a Ph.D. biotech R&D scientist, AI practitioner, and FDA regulatory strategist at Grape King Bio in Taiwan, working where fermentation science, AI-augmented R&D, and global regulation meet.
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to enter
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Years of discovery, framed so the world can act on it.
I'm Kevin Li — Assistant Department Manager at Grape King Bio, with a UC Davis → NCKU doctorate, 20+ SCIE publications, 8 patents, and the development of the first fungi-based botanical drug to reach Phase II clinical trials. My practice sits at the intersection of three disciplines that rarely share a room.
20+
SCIE Papers
8
Patents
2
FDA Clear.
10+
Global Talks
Domain
01
Biotech Science
Fermentation & scale-up, medicinal fungi R&D, clinical-trial design, and SCIE publication — seven-plus years at the bench-to-market frontier, turning living systems into products that ship.
Fermentation
Medicinal
Fungi
Clinical
Trials
Domain
02
Regulatory Science
FDA IND submissions, NDI notifications, and multi-jurisdiction strategy across the US, Taiwan, Thailand, and Japan. Good science only creates value when it's framed in a way regulators can act on.
FDA
IND
NDI
MASH
Botanical
Domain
03
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. The speed is the strategy.
LLM
Pipelines
Python
AI-augmented
R&D
06 — From lab work to global reach
How knowledge compounds.
Publishing alone is no longer enough. This is the loop I've built to turn specialized work into knowledge that travels across disciplines and borders — sharper with every cycle.
Phase 01 · Generate
01
Lab → Literature
Run experiments, extract clear findings, publish in high-impact journals — the record everything builds on.
IF 12.0 ·
20+ SCIE
02
AI accelerates
LLMs cut literature reviews from months to days; Python stress-tests protocols before a single experiment runs.
LLM pipelines
· 209% yield↑
Phase 02 · Translate
03
Science → Regulation
Map findings to FDA, TFDA, and PMDA requirements — framed so regulators can act on them.
IND Phase II
· NDI 1286
04
Regulation → Scale
Cleared ingredients reach production. Patents protect the work. Clinical data strengthens the next iteration.
8 patents ·
2 FDA clears
Phase 03 · Broadcast
05
Talks → Frameworks
International talks turn multi-discipline work into frameworks practitioners in other fields can use.
Singapore ·
Thailand · Taiwan
06
New questions
Every new market, collaborator, and dataset sharpens the questions worth asking — and feeds back into the lab.
Compounding
07 — Where the work landed
Proof points.
2024
Nutra-Ingredients Asia
Ingredient of the Year
Winner in the cognitive-function category for Hericium erinaceus development — now reaching markets across Asia and the US.
2024
FDA Submission
Phase II Clinical Trial IND
Filed for the GKAC botanical drug targeting MASH. AI-augmented workflows compressed the bench-to-submission timeline significantly.
08 — Recent talks & writing
Insights & talks.
2026
· Public Debut
9th
Annual Conf. · Taiwan Microbiota Consortium
Microbe-derived nutraceuticals & the debut of Agentome5
An agentic system that traces every detected compound through five layers of biology — secretome → receptor binding → pathway activation → physiological response → clinical outcome. What used to take 3–12 months of QTOF-MS annotation now runs in minutes. 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
2026 · APEC Workshop
Fungi fermentation for low-carbon proteins
Developing innovative low-carbon alternative proteins from fungal sources — and what it means for sustainable nutrition.
2025 · Asia Nutraceutical Summit, Singapore
Probiotics & mycelium for longevity
How precision fermentation and medicinal fungi open new longevity pathways — and where regulation still has catching up to do.
2025 · Indonesia-Taiwan Industrial Forum
Cross-border opportunities in nutrition
Building Taiwan-Indonesia partnerships — the most underserved ingredient opportunities exist precisely where market regulations aren't 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, what failed quietly, and what it says about AI in regulated science.
2024 · BEST Conf., Taiwan
From bench to IND
Discovery through preclinical studies to Phase II IND — the practical decisions that matter at each stage.
09 — The short version
Frequently asked.
Who is Kevin Tsung-Ju Li? +
Kevin Tsung-Ju Li, Ph.D. (also written Kevin Li), is a biotech R&D scientist and FDA regulatory strategist based in Taiwan, where he is Assistant Department Manager at Grape King Bio. He works at the intersection of fermentation science, AI-augmented R&D, and FDA-regulated botanical drug development, with 20+ SCIE-indexed papers and 8 patents.
What does Kevin Tsung-Ju Li specialize in? +
He specializes in three connected areas: biotech science (fermentation, scale-up, medicinal fungi, and clinical trial design), regulatory science (FDA IND submissions, NDI notifications, and multi-jurisdiction strategy across the US, Taiwan, Thailand, and Japan), and applied AI (LLM pipelines and AI-augmented R&D that compress literature review and protocol design from months to days).
What is Agentome5? +
Agentome5 is an agentic AI system created by Kevin Tsung-Ju Li that takes a probiotic strain's fermentation metabolite profile and traces each detected compound through five layers of biology — secretome, receptor binding, pathway activation, physiological response, and clinical outcome. Work that previously took 3 to 12 months of QTOF-MS annotation, literature mining, and pathway mapping now runs in minutes.
10
— Collaboration, advisory & speaking
Let's connect.
If you're a recruiter, collaborator, or organizer working on biotech, AI-augmented R&D, or FDA regulatory strategy, I'd genuinely like to hear from you. A LinkedIn DM is the fastest way to reach me.