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Challenges for Biomedical Scientists 
         as Entrepreneurs
        An Adventurous Tour




                          Stanley Chang, MD., Ph.D.
                              CEO, Medigen Biotech
                                                      1
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
                                                                  2
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
                                                             3
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)

                                                                 4
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
                                          5
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)
                                                               6
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
                                         7
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
                                            8
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)
                                           9
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)

                                                             10
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
                                                                        11
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
                                                                12
Roadmaps of Biotech Business




                               13
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 ~
                                                         14
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
                                                            15
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 
                                                                    16
~ Innovations for a Better Life ~   17

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Challenges For Scientists As Entrepreneurs_張世忠

  • 1. Challenges for Biomedical Scientists  as Entrepreneurs An Adventurous Tour Stanley Chang, MD., Ph.D. CEO, Medigen Biotech 1
  • 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 2
  • 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 3
  • 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) 4
  • 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 5
  • 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) 6
  • 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 7
  • 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 8
  • 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) 9
  • 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) 10
  • 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 11
  • 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 12
  • 13. Roadmaps of Biotech Business 13
  • 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 ~ 14
  • 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 15
  • 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  16
  • 17. ~ Innovations for a Better Life ~ 17