This document provides an overview of Dr. Stanley Chang's career founding and leading Medigen Biotech Corp., a Taiwan-based biotech company, from 2000 to present. It summarizes his achievements in bringing a novel cancer therapy through FDA clinical trials, establishing new business lines, and expanding Medigen's pipeline. The document also reflects on the challenges of biomedical entrepreneurship and what is required to succeed, including solid scientific knowledge, understanding business and management, securing funding, building a strong team, and managing risks.

1. Challenges for Biomedical Scientists
as Entrepreneurs
An Adventurous Tour
Stanley Chang, MD., Ph.D.
CEO, Medigen Biotech
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2. My Footprints in Medigen Biotech Corp.
Medigen Biotech Corp. (2000~2008)
Strategic alliance with Progen
A Taiwan based r&D Biotech
Pharmaceuticals, Australia,
A single project company initially 2000
Seeds money up to USD20M Focus on clinical
Brought PI‐88 from FDA IND to PII development of novel
Established NAT platform therapies for cancers and
Initiated business in China liver diseases
Expanding development pipeline Establish Nucleic Acid Test
Medigen Biotech Corp. (2009~) (NAT) Platform as the 2nd
Secure revenue from NAT business core business in 2005
Establish products portfolio
Out‐license phase III project Successfully completed FDA’s
PI‐88 HCC Phase II trial in
Strengthen financial position
2006
IPO
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3. Major Biomedical Achievements (1900~2004)
Control of reportable endemic contagious diseases
Invention of microscope and discovery of microorganisms
Finding of penicillin and other antibiotics
Elimination of traditional contagious diseases
Advances in medical/surgical technologies
New treatments for chronic and systemic diseases
Anesthesia, aseptic techniques and keyhole surgery
Organ transplantations and artificial organs
Computer assisted medical imaging technologies
Reproductive and life cloning technologies
Test tube babies
Cloning of lives
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4. The Dream of Biomedical Scientists
What I have in my profession ­ Innovation
New concepts
New discoveries Visions
New technologies (人生願景)
What I can do to help human lives
A better quality of life Translation
A healthier living body (轉譯醫學)
A happier human life
The ultimate goals of a biomedical scientist Ethics
A great scientist to contribute to mankind (醫學倫理)
The bonus of scientific achievements, if successful
Reputation Application
Financial rewards (醫學應用)
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5. The Character of Biotechnology
R&D based innovations and improvements
IP and know‐how dependent
Capital intensive investment
Global competitions
Inherently risky
Potentially high rewards
Winner takes all
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6. Biotech Stories- Good and Bad
Genentech Biotech
Insulin and Herceptin
Acquired by Roche at US$41B
Amgen Biotech
Erythropoietin (EPO)
Northfield Laboratories, Inc. (1985~2009)
US$41.5/share (2/29/00), US$0.17/share (6/1/09)
Blood substitute (incurred loss: USD220M)
Targeted Genetics Corp. (1992~2009)
US$280/share (1/31/00), US$0.23/share (6/1/09)
Gene therapy (incurred loss: USD322M)
Nanogen Inc. (1993~2009)
US$101/share (2/29/00), US$0.04/share (6/1/09)
Diagnostic kits for CV diseases (incurred loss: USD400M)
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7. Prerequisites for Biomedical Business
Yourself
Solid bioscience background
General social awareness and skill
Fundamental business knowledge
Basic managerial experience
The readiness for challenges
The courage to accept failure
Beyond yourself
Core competence
Business model/plan
Corporate strategies
Funding
Human resource
Risk management
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8. Chapter 1 – Build Basic Human “Character”
C ‐ commitment 重然諾
H ‐ honesty 要誠實
A ‐ accountability 講信用
R ‐ respect 知尊重
A ‐ attitude 展態度
C ‐ courage 有膽識
T ‐ trust 可信任
E ‐ ethics and integrity 尚正直
R ‐ responsibility 肯擔當
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9. Chapter 2 – Build Entrepreneurship
願景（Vision） 韌性（Tenacity）
決斷力（Determinant） 執行力（Execution）
好奇心（Curiosity）
膽識（Courage） 創意（Creativity）
品格（Character） 溝通力（Communicability）
信念（Conviction） 領袖魅力（Charisma）
常識（Common Sense） 能力（Competence）
危機處理能力（Crisis Management）
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10. Chapter 3 – Make a Healthy Start-up
Proprietary and cutting edge Doable and profitable
Products/pipeline Strategies
（產品與管線） （策略）
Deep and committed
Pocket
（資金）
Thorough and comprehensive Competent and reliable
Patents Team
（專利） （團隊）
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11. Chapter 4 – Find a Balance in Yourself
Bio­medical professionals are
most talent, far above average
usually innovative and creative in medical/life science
generally kind and optimistic, but may be naïve sometimes
honest and straightforward in communication and relationships
relatively poor in management, human skills and finance
Businessmen are
even more talent than the average medical professionals
very innovative in getting other people’s money into their pockets
commonly opportunistic and cunning
rarely decent, and always have personal agendas
profit‐driven, practical and sometimes bloody
born to be businessmen
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12. Chapter 5 – Do Things Right
Experience = Time + Money
Stay focused, focused and focused
Don’t count on a single expert, count on a team
Good projects come with a price; there are no free meals
Always refer to facts and evidence; do everything by the book
When in hesitation, follow the logic, not your whim
When in doubt, choose not to invest/involve
Dare to say NO, saving money is more crucial than saving face
Power you project with passion and sufficient resource
At the first sign of an injury, stop the bleeding immediately
Reward those who deserved, not those who you liked
Stay calm and patient, Rome is not built in a day
Don’t be frustrated, even big pharma make mistakes
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13. Roadmaps of Biotech Business
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14. Are You Ready ?
Essential Abilities to Learn and Build in the school
Scientific reasoning and logic thinking ability
Mastering professional knowledge and skills
Good command of native and foreign languages
Roundness in personal characters and humanities
Skills of communication, expression and teamwork
Multi‐disciplinary knowledge and expertise
Ability to deliver and to execute
Life long learning
~ Chances are only for those who are ready to take ~
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15. Suggested Reading
Good to Great by Jim Collins
Level 5 Leadership
First Who…Then What
Confront the Brutal Facts
The Hedgehog Concept
A Culture of Discipline
Technology Accelerators
Think BIG Act Small by Jason Jennings
Blue Ocean Strategy by W. Chan Kim and Renee Mauborgne
格局 -- 佈局 -- 結局
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16. Tips from the Experienced
Top 10 mistakes biotechs make
By Stephen Ferruolo, JD.
Partner, Business Law Department at Goodwin Procter
Common causes of biotech failure
Not thinking strategically about IP
Not understanding the target market
Not raising enough money
Not having a regulatory strategy
Not listening to the FDA
Designing trials poorly
Not properly powering trials
Relying heavily on third parties, especially CROs
Not being ready for success
Not knowing when to partner
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17. ~ Innovations for a Better Life ~ 17