The document discusses the challenges of bridging pre-clinical trials and clinical trials for new drugs. It notes that the current process has a high failure rate and is poor at predicting benefits for patients. One proposed solution is to create commercial kits that better model the tumor microenvironment and heterogeneity to improve translational success. This approach could help decrease mistakes and make outcomes more predictable and survival-focused, potentially saving billions of dollars by avoiding late-stage clinical trial failures.

1. The revolution of the bridge
between the pre-clinical trial and clinical trial

2. Problem
The revolution of the bridge
between the pre-clinical trial and clinical trial
Resource: Nature Biotechnology ( 2014 V.32 P.40-51), 2003 〜 2011
IND
Human Clinical Trial
Pre-Clinical Trial
(Discovery: cell, animal model)
NDA
Marketing
Tracking

3. Problems & Opportunity
The revolution of the bridge
between the pre-clinical trial and clinical trial
Resource: Nature Biotechnology ( 2014 V.32 P.40-51), 2003 〜 2011
$50 millionUP
per failure pre-clinical trial or
basic research
High Failure RateIt’s hard to predict the benefit
for patient
Global
36.7 billion $

4. The revolution of the bridge
between the pre-clinical trial and clinical trial
BloodPatient tumor tissue
tumor microenviroment
highly tumor heterogeneity
Solution

5. ＋
Commercial Kits Pre-Clinical Individual Care
Target
Consumers
Labs Pharmacy Company (with new
drugs)
Worth -Basic research
development
-Extended new research
fields
-anti-oncology
-anti-aging
-Decreasing mistakes
-Predictable & Survival
-Estimating before expensive
drugs or treatment-process
Potential
Income
＄ *30 up ＄ *10 ＄ *10
Time Cost 15-20yrs 8-10yrs 8-10yrs
＋

6. Who I’m
• 2.5yr with basic research in stem cell field on National Chung
Hsing University.
• over 3yrs+ with a pre-clinical medical team on National Cheng
Kung University Hospital.
• CEO at Na Yi Honey
Member
The revolution of the bridge
between the pre-clinical trial and clinical trial

7. The revolution of the bridge
between the pre-clinical trial and clinical trial
Mail: g099037002@mail.nchu.edu.tw Honey Cheng

8. 3.5yrs 0.1 million $/1yr
verification & development
Including salary and wages/equipments/development/raw materials
2.5yrs 0.75 million $/1yr
- manufacturing set up
-marketing & BD
•Hospitals
•pharmaceutical raw materials
-FDA applying
3-4yr 4-6yr
2.5yrs 1.25 million $/1yr
-Lab research commercial kits
cost recovery
-IPO
6-8yr
2.5yrs 7.5 million $/1yr
-FDA approving-individual medical
-bonus
-Extended capital: global system
8-10yr Run-time