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Kevin Li, Ph.D.
Intersection
Biotech, AI & Regulatory Science

Where biology meets code meets the real world.

I'm Kevin Tsung-Ju Li, a Ph.D. scientist bringing AI to biotech R&D and FDA strategy at Grape King Bio, Taiwan.

Connect on LinkedIn ↗ See the proof
Illustration of a liquid-fermentation bioreactor with mycelium growing inside the vessel

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, 25 SCIE publications cited 500+ times, 8 patents, three FDA regulatory milestones, 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.

Kevin Tsung-Ju Li, Ph.D., biotech scientist at Grape King Bio
Kevin Tsung-Ju Li Assistant Department Manager at Grape King Bio, Taiwan
25
SCIE Papers
517
Citations
8
Patents
3
FDA Milestones
13
Global Talks
Google Scholar, : h-index 12, i10-index 16 ↗

Biotech Science

Seven-plus years at the bench-to-market frontier, turning living systems into products that ship.

Fermentation Medicinal Fungi Clinical Trials

  1. Discover

    Medicinal fungi R&D, published across 25 SCIE papers in journals up to IF 12.0.

  2. Scale up

    Fermentation scale-up, with a 317% yield increase.

  3. Prove

    The first fungi-based botanical drug to reach Phase II clinical trials.

  4. Ship

    Hericium erinaceus, Ingredient of the Year 2024 at Nutra-Ingredients Asia, now in markets across Asia and the US.

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
  1. IND

    Phase II IND, cleared to proceed

    A fungi-based botanical drug.

  2. NDI 1286

    New Dietary Ingredient notification

  3. NDI

    Second NDI notification

3
FDA regulatory milestones
  • USUnited States
  • TWTaiwan
  • THThailand
  • JPJapan

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
  1. Secretome
  2. Receptor
  3. Pathway
  4. Physiology
  5. Outcome
Agentome5 traces every detected compound through five layers of biology, from secretome to clinical outcome.
Literature synthesis: from months down to days
Metabolite tracingwith Agentome5: from 3-12 months down to minutes
In its debut demo, Agentome5 surfaced three GLP-1-activating metabolites in a single strain.

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.

Generate

Lab → Literature

Run experiments, extract clear findings, publish in high-impact journals: the record everything builds on.

IF 12.0 · 25 SCIE

AI accelerates

LLMs cut literature reviews from months to days; Python stress-tests protocols before a single experiment runs.

LLM pipelines · 317% yield↑

Translate

Science → Regulation

Map findings to FDA, TFDA, and PMDA requirements, framed so regulators can act on them.

IND Phase II · 2 NDIs incl. 1286

Regulation → Scale

Cleared ingredients reach production. Patents protect the work. Clinical data strengthens the next iteration.

8 patents · 3 FDA milestones

Broadcast

Talks → Frameworks

International talks turn multi-discipline work into frameworks practitioners in other fields can use.

USA, Singapore, Thailand, Taiwan

New questions

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

Compounding

Insights & talks.

See Monthly Writing ↗
Latest · UNFF 2026, New York City

Probiotic & mycelium precision liquid fermentation

11,085 miles from Bangkok to New York City. At the USA Nutraceutical and Functional Food Summit (UNFF 2026), I presented our latest advances in probiotic and mycelium precision liquid fermentation, on a program that ran from regulatory standards to specialized health solutions.

Precision Fermentation Probiotics Mycelium
On LinkedIn ↗
Signature · 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 in an industrial-scale bioreactor.

Agentic AI Metabolomics GLP-1

· Speaker, Future Nutra Innovation Summit, Texas

Harnessing Microbes and Mycelium for the Next Generation of Self-Care

Two themes ran through the summit: ingredients need stronger evidence and standardization so consumers see measurable results, and global health is moving from acute to chronic challenges.

· Invited speaker, 10th Biotechnology International Congress, Thailand

Liquid Fermentation Tech for Sustainable Health and Industry Advancement

Shared insights with scientists at the cutting edge of research, then joined Grape King Bio's overseas team at Vitafoods Asia 2026 to present our latest functional ingredients.

BioAsia-Taiwan · Innovation of the Year

Standardized Antrodia cinnamomea for metabolic balance

A standardized Antrodia cinnamomea bioactive (90% Antrodia-related content) that supports metabolic regulation, lowers inflammation, and sustains physiological balance. Low-temperature pelletization and multilayer coating keep its heat-sensitive actives stable.

APEC Workshop

Fungi fermentation for low-carbon proteins

Developing low-carbon alternative proteins from fungal sources, and what that means for sustainable nutrition.

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.

Indonesia-Taiwan Industrial Forum

Cross-border opportunities in nutrition

Building Taiwan-Indonesia partnerships. The most underserved ingredient opportunities sit exactly where market regulations aren't yet aligned.

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.

BEST Conference, Taiwan

From bench to IND

From discovery through preclinical studies to a Phase II IND: the practical decisions that matter at each stage.

Proof points.

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.

2024 · BBES Taiwan

Industrial Elite Award

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

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.

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 25 SCIE-indexed papers (500+ Google Scholar citations), 8 patents, and three FDA regulatory milestones: two New Dietary Ingredient (NDI) notifications and a Phase II IND cleared to proceed.

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.

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 like to hear from you. A LinkedIn DM is the fastest way to reach me.