Evchc f2010

COURSE PLATFORM HARVARD | BUSINESS | SCHOOL
Syllabus for Entrepreneural and Venture Capital

in Healthcare
Module 1: Introduction: Becoming a Player
1:30PM Thu, Sep 2, Aldrich Hall 210
TOPIC
Cynthia Fisher and the Rearing of ViaCell
MATERIALS
Cynthia Fisher and the Rearing of ViaCell (806002)
EC Weeks 1 & 2 Packet
Entrepreneurship and Venture Capital in Healthcare Fall Term 2010: Course Outline and
Syllabus (806048)
EVCHC Class Introduction
ASSIGNMENT
1. What is your assessment of Cynthia Fisher's career since she graduated from HBS in 1990, and her performance as
an entrepreneur?
2. How difficult was it to make ViaCell a successful venture?
3. What were the major hurdles Cynthia faced in launching Viacord and then ViaCell? What did she do well to overcome
these obstacles? Was there anything she should have done differently?
4. What does this case suggest are the requirements for leading a successful healthcare venture? How do these
requirements differ from other ventures?
September 03, 2010 Copyright 2010 President and Fellows of Harvard College Page 1 of 21
in Healthcare
1:30PM Fri, Sep 3, Aldrich Hall 210
TOPIC
Stan Lapidus: Profile of a Medical Entrepreneur
GUEST SPEAKER
Stan Lapidus, Chairman of the Board, Helicos Biosciences Corporation
MATERIALS
Stan Lapidus: Profile of a Medical Entrepreneur (805087)
ASSIGNMENT
1. What is your assessment of Stan Lapidus? career since graduating from Cooper Union?
2. Does Stan?s ?early stage? focus and his decisions to leave his start-ups within a few years make sense? Why or
why not?
3. Would you invest in Helicos?
4. Would you have invested in the first round of SynapDX?
End of Module 1: Introduction: Becoming a Player
in Healthcare
Module 2: Securing Intellectual Property
TOPIC
Legal Issues in Intellectual Property
GUEST SPEAKER
Duncan Greenhalgh, PhD, JD, Partner, Goodwin Proctor
MATERIALS
Duncan Greenhalgh Biography
Ten Mistakes
The State of Patent Protection
Pathway for Biosimilar Biologics
Patent Strategy for Biosimilar Era
Hypothetical
in Healthcare
TOPIC
Technology Transfer at U.S. Universities
GUEST SPEAKER
Isaac Kohlberg, Senior Associate Provost and Chief Technology Development Officer, Harvard
University
MATERIALS
Technology Transfer at U.S. Universities (807124)
ASSIGNMENT
1. Why was the Bayh-Dole act enacted?
2. What is your assessment of the impact of Bayh-Dole?
3. What is your assessment of the performance of Harvard's Office of Technology Development?
4. What advice/recommendation would you make to Isaac Kohlberg?
5. What are the implications of the Note for you as a potential healthcare entrepreneur or investor?
TOPIC
Molecular Insight Pharmaceuticals, Inc.
MATERIALS
Molecular Insight Pharmaceuticals, Inc. (805067)
EC Weeks 3 on Packet
ASSIGNMENT
1. What is your assessment of this venture?
2. Why are they having so much trouble raising Series B financing?
3. How would you describe Molecular Insight's approach to protection of intellectual property? What is your assessment
of the approach?
4. What should David Barlow do now? Be specific.
5. Would you invest in Series B financing?
in Healthcare
TOPIC
MINT
GUEST SPEAKERS
Gregory Dillon
Jonathan Deland
Howard Riina
Jeffery Milsom
MATERIALS
MINTing Innovation at NewYork-Presbyterian (810004)
Classroom
ASSIGNMENT
1. How does the licensing of medical device innovations differ from bio-pharmaceuticals?
2. How would you describe MINT? What is its purpose?
3. Is MINT a legitimate use of NewYork-Presbyterian's funds?
4. Do you think MINT will be successful? Why or why not?
5. What are the implications of programs like MINT for other hospitals and would-be healthcare entrepreneurs and
venture capitalists?
6. Please take the poll
in Healthcare
1:30PM Wed, Sep 22, Aldrich Hall 210
TOPIC
iZumi
GUEST SPEAKER
Dr Krishna Yeshwant of Google Ventures
MATERIALS
iZumi (809105)
ASSIGNMENT
1. What is your assessment of the iZumi Strategy?
2. Is the stem cell area an attractive place to start a company?
3. What do you think of the company's intellectual property plan?
4. If you were at a VC firm, would you invest in iZumi?
End of Module 2: Securing Intellectual Property
Module 3: Managing the Regulatory Environment
TOPIC
Pervasis Therapeutics
MATERIALS
Pervasis Therapeutics, Inc. (807026)
Note on the U.S. Food and Drug Administration (807050)

Pervasis Poll: Complete by 10:00 AM on the day of class
ASSIGNMENT
1. What is your assessment of Vascugel?s market potential?
2. In your opinion, what is the optimal clinical development strategy for Vascugel? What disease states would you
target? Explain.
3. Do the poll.
in Healthcare
TOPIC
A Father's Love: Novazyme Pharmaceuticals Inc.
GUEST SPEAKER
Alan E. Walts
MATERIALS
A Father's Love: Novazyme Pharmaceuticals, Inc. (603048)
ASSIGNMENT
1. What is your assesment of Novazyme's clinical trial strategy?
2. How would you design Novazyme's clinical trial for its drug to treat Pompe's disease? Be as specific as possible with
regards to trial size, patient selection criteria, number of sites, blinding and endpoints.
3. What are the other elements of Novazyme's strategy? How would you characterize and assess them?
4. What are the pros and cons of the offers from Genentech and Genzyme? Which offer would you accept? Genentech?
Genzyme? Neither?
5. Do you think that John Crowley's personal association with Pompe's disease helps or hinders his abilities to assess
his business alternatives?
in Healthcare
1:30PM Wed, Sep 29, Aldrich Hall 210
TOPIC
Targanta Therapeutics
GUEST SPEAKERS
Mark W. Leuchtenberger, Chief Executive Officer
George A. Eldridge, Chief Financial Officer
MATERIALS
Targanta Therapeutics: Hitting a Moving Target (709002)
A Managerial Perspective on Clinical Trials (709033)
ASSIGNMENT
1. Do you think Skyline Ventures and Brookside Capital made a good investment in the Targanta Series C offering in
Janury 2007?
2. What is your assessment of the regulatory history of oritavancin? Do you think the FDA should approve the drug?
3. Of the $100 million that Targanta has in cash, assume that $40 million will be spent in 2008 on normal business
operations. Of the remaining $60 million, how much would you hold in reserve and how much would you invest in the
projects described in pages ll and 12 of the case?
4. Of the projects described on pages ll and 12, which ones would you fund in 2008?
TOPIC
Novasys
GUEST SPEAKER
Debra Reisenthal, Chief Executive Officer, Novasys
ASSIGNMENT
1. What is your assessment of the Renessa procedure (from the physician, patient, provider, policymaker, payer and
people perspectives)?
2. Why is Novasys having difficulty getting a Category I CPT Code?
3. Evaluate the CPT Coding system and the process to obtain a new CPT code. What are their strengths and
weaknesses? What should be improved and how?
4. Should Debra Reisenthel: a.) Respond to the AUA, and if so, how and what should be communicated? b.) Respond
to the AMA, and if so, how and what should be communicated? c.) Do nothing?
in Healthcare
1:30PM Wed, Oct 6, Aldrich Hall 210
TOPIC
Drug Testing in Nigeria
MATERIALS
Drug Testing in Nigeria (A) (706033)
Drug Testing in Nigeria Poll: Complete by 10:00 AM on the day of class
ASSIGNMENT
1. Briefly outline the benefits of pursuing the Trovan trials in Kano.
2. What are the greatest risks involved in pursuing the Trovan trials in Kano?
3. Do the poll.
End of Module 3: Managing the Regulatory Environment
Module 4: Managing Business Development
1:30PM Thu, Oct 7, Aldrich Hall 210
TOPIC
Amylin Pharmaceuticals
MATERIALS
Amylin Pharmaceuticals: Diabetes and Beyond (809011)
Amylin Poll Complete by 10:00 am on the day of class
ASSIGNMENT
1. What are the main lessons you draw from Amylin's 18-year history?
2. How important has business development been to Amylin strategically and financially?
3. Assess Ginger Graham's performance as CEO of Amylin. What should her major objectives be for the next three
years?
4. Should Amylin pursue the in-licensing of Leptin, which will require Ginger Graham to negotiate directly with Kevin
Sharer?
5. Do the poll.
in Healthcare
TOPIC
Intuitive Surgical
GUEST SPEAKER
John Freund
MATERIALS
Intuitive Surgical - Negotiating the Deal (202094)
Deal Proposal for Intuitive Surgical

In-class handout
Note on Biotech Business Development (9807032)

ASSIGNMENT
1. What is your assessment of this venture?
2. On a scale of 1 to 10 (1 = easy, 10 = virtually impossible), how hard do you think it is going to be for the parties to
agree on a deal structure?
3. Read the Special Instructions that were distributed to you in class.
4. Fill out the deal you would propose (distributed in class and also available via link above)
in Healthcare
1:30PM Fri, Oct 15, Aldrich Hall 210
TOPIC
Proteus
GUEST SPEAKER
Andrew Thompson, Chief Executive Officer, Proteus Biomedical Inc.
MATERIALS
Proteus Biomedical: Making Pigs Fly (809051)
ASSIGNMENT
1.What is your assessment of Proteus? How do you explain the $200 million pre- money valuation that they achieved
in their Series D financing?
2.Evaluate the business development arrangements that Proteus made with its first product family, multi-sensor leads.
Were those business development deals successful?
3.What is your assessment of the process Proteus undertook to identify opportunity areas for its IEM?
4.Should Andrew Thompson:
a)accept the proposed deal with Janssen,
b)hold out for a more robust deal with Janssen or another pharmaceutical company, or
c)complete more milestones and then try to negotiate a more robust deal with pharmaceutical companies?
in Healthcare
1:30PM Wed, Oct 27, Aldrich Hall 210
TOPIC
Generation Health
GUEST SPEAKERS
Per Loftberg, Chief Executive Officer, Generation Health
Graham Gardner, Highland Capital Partners
MATERIALS
Generation Health: A Pioneer in Genetics Benefit Management (810007)
Spangler distribution
Realizing the Promise of Personalized Medicine
Generation Health Press Release
ASSIGNMENT
1. What do you think of the genetics benefit management (GBM) market? Is it a big opportunity? Are they too early?
2. Does it make sense for a company to do a big strategic deal so early?
3. Do the terms make sense?
4. What can go right? What can go wrong?
End of Module 4: Managing Business Development
in Healthcare
Module 5: Financing the Venture
TOPIC
eClinicalWorks
MATERIALS
eClinicalWorks: The Paths to Growth (807025)
McKesson: Wiring the Medical World
eClinical Works Poll: Complete by 10:00 AM on the day of class
Press Release
ASSIGNMENT
1. What key factors differentiate eCW from other EMR companies in the healthcare IT market?
2. Describe how eCW?s founders were able to bootstrap the company up until this point.
3. Do you think that eCW can achieve scale and reach >$100 million in revenues with their current product offerings and
pricing models, while remaining private? Why or why not?
4. Do you think eCW?s current corporate structure and employee compensation plan will affect the company?s
prospects for growth? Why or why not?
5. Do the poll.
End of Module 5: Financing the Venture
in Healthcare
1:30PM Wed, Nov 3, Aldrich Hall 210
TOPIC
Conor Medsystems
GUEST SPEAKER
Frank Litvack
MATERIALS
Conor Medsystems (804180)
ASSIGNMENT
1. How attractive is the opportunity that Conor Medsystems is pursuing?
2. How well have Litvack and his team done to date in managing the uncertainty inherent in pursuing the coronary stent
opportunity? Please be specific on the actions that you either found effective or ineffective.
3. Do the poll.
in Healthcare
1:30PM Thu, Nov 4, Aldrich Hall 210
TOPIC
Fred Khosravi and Access Closure
GUEST SPEAKER
Fred Khosravi, Access Closure President and CEO
MATERIALS
Fred Khosravi and AccessClosure (806044)
Access Closure
ASSIGNMENT
1. What is your assessment of Fred Khosravi's career and his record as a medical device entrepreneur?
2. What rules or generalizations, if any, about medical device start-ups can you draw from Khosravi's experiences?
3. What is your assessment of the Access Closure venture? Do you have any criticisms of how the venture has been
managed to date?
4. Which of the three alternatives--sell now, wait a year then sell, or build a stand-alone company--do you favor? Why?
5. Please take the poll
in Healthcare
TOPIC
Vertex/CF
GUEST SPEAKER
Josh Boger, CEO Vertex Pharmaceuticals
MATERIALS
Vertex Pharmaceuticals and the Cystic Fibrosis Foundation: Venture Philanthropy Funding for
Biotech (808005)
Selected Date on the Financing of Healthcare Ventures
Do new cystic-fibrosis therapies hold the key to treating other genetic dis-orders?
ASSIGNMENT
1. If you were Josh Boger, would you continue Aurora?s CF program or would you shut it down? Explain your position.
If you were Bob Beall, would you continue your CF funding with Vertex or would you cut it off? Explain your position.
What are the advantages of foundation funding for biotech companies? What are the disadvantages?
1:30PM Fri, Nov 12, Aldrich Hall 210
TOPIC
Corporate Venture Capital at Eli Lilly
MATERIALS
Corporate Venture Capital at Eli Lilly (806092)
Selected Data on the Financing of Healthcare Ventures
Eli Lilly's VC Arm Spins Out With $200M Fund
ASSIGNMENT
1. What is the role of corporate venture capital?
2. What is your assessment of Lilly Ventures?
3. What should Darren Carroll do regarding the potential investment in Protagonist?
4. What other recommendations would you have for Darren Carroll?
in Healthcare
TOPIC
Module 6: Growing the Venture and Realizing Value
1:30PM Thu, Nov 18, Aldrich Hall 210
TOPIC
Odyssey Healthcare
GUEST SPEAKER
Wyc Grousbeck
MATERIALS
Odyssey Healthcare (809052)
Selected Data on Healthcare Venture IPO
ASSIGNMENT
1. Is the evolution of hospice care in America typical of the way new service industries in healthcare develop? What are
other examples?
2. What are the advantages and disadvantages for Odyssey of being a public company?
3. Would you advise Burnham to go public or consider being acquired?
in Healthcare
1:30PM Fri, Nov 19, Aldrich Hall 210
TOPIC
WuXi PharmaTech
MATERIALS
WuXi PharmaTech (806003)
ASSIGNMENT
1. What is your assessment of WuXi PharmaTech and its growth over the past four years?
2. Do you believe that WuXi will be able to achieve the results forecast in Exhibit 4?
3. Which of the three financing options would you recommend to Dr. Li: grow internally, raise foreign VC or PE, or raise
funding domestically? Why?
4.
End of Module 6: Growing the Venture and Realizing Value
1:30PM Thu, Dec 2, Aldrich Hall 210
TOPIC
T.B.D.
in Healthcare
Module 6: Growing the Venture and Realizing Value
1:30PM Fri, Dec 3, Aldrich Hall 210
TOPIC
Primedic
Richard needs to create new study questions
Guests are confirmed
GUEST SPEAKERS
Dr. Paulino Decanini - Founder, Primedic
Alvara Rodriquez - Co-Founder, IGNIA Partners
MATERIALS
Primedic - Providing Primary Care in Mexico (810036)
Spangler distribution
ASSIGNMENT
1. What is your assessment of Primedic? Why has this venture attracted so much interest from Endeavor and IGNIA?
2. Do you think Primedic will achieve its growth plan?
3. What are the three greatest challenges Primedic will have to overcome in order to achieve its growth plan?
4. How can Primedic overcome the challenges you identified?
5.
End of Module 6: Growing the Venture and Realizing Value
in Healthcare
Module 7: Conclusion
1:30PM Wed, Dec 8, Aldrich Hall 210
TOPIC
Student Business Plan Presentations
Business Plan Presentations: James Joun, Jason Slocum, Meridith Unger
MATERIALS
ALS
Health Care Savings Could Start in the Cafeteria
Orphan Products
ASSIGNMENT
Please read and study the first three plans and skim the remaining two. For the business plan in which you have the
most interest please come prepared with three questions for the potential entrepreneur(s).
Please read the above materials. They will serve as background for the business plans that will be presented in class.
1:30PM Thu, Dec 9, Aldrich Hall 210
TOPIC
Endo Pharmaceuticals (A)
MATERIALS
Endo Pharmaceuticals (A): From LBO to...? (806064)
Endo Poll: Complete by 10:00 AM on the day of class
ASSIGNMENT
1. What is your assessment of the process by which Endo Pharmaceuticals was created?
2. What is your assessment of Endo's long-term prospects? Specifically, what do you think Percocet's sales will be in
2003?
3. Should Endo merge with Algos? Explain your reasoning.
in Healthcare
1:30PM Fri, Dec 10, Aldrich Hall 210
TOPIC
Final Lecture
MATERIALS
2010 Case Evaluation Poll
EVCHC Final Presentation
ASSIGNMENT
1. Fill out the Key Learnings Worksheet distributed in class on Thursday.
2. Do the Case Evaluation poll (link above).
3. Remember to bring your laptop to class to do the Course Evaluation.
End of Module 7: Conclusion

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COURSE PLATFORM HARVARD | BUSINESS | SCHOOL

Syllabus for Entrepreneural and Venture Capital

Module 1: Introduction: Becoming a Player

1:30PM Thu, Sep 2, Aldrich Hall 210

EVCHC Class Introduction

1:30PM Fri, Sep 3, Aldrich Hall 210

End of Module 1: Introduction: Becoming a Player

Module 2: Securing Intellectual Property

1:30PM Thu, Sep 9, Aldrich Hall 210

The State of Patent Protection

Pathway for Biosimilar Biologics

Patent Strategy for Biosimilar Era

1:30PM Fri, Sep 10, Aldrich Hall 210

1:30PM Thu, Sep 16, Aldrich Hall 210

1:30PM Fri, Sep 17, Aldrich Hall 210

1:30PM Wed, Sep 22, Aldrich Hall 210

End of Module 2: Securing Intellectual Property

Module 3: Managing the Regulatory Environment

1:30PM Thu, Sep 23, Aldrich Hall 210

Note on the U.S. Food and Drug Administration (807050)

Pervasis Poll: Complete by 10:00 AM on the day of class

1:30PM Fri, Sep 24, Aldrich Hall 210

1:30PM Wed, Sep 29, Aldrich Hall 210

George A. Eldridge, Chief Financial Officer

A Managerial Perspective on Clinical Trials (709033)

1:30PM Thu, Sep 30, Aldrich Hall 210

1:30PM Wed, Oct 6, Aldrich Hall 210

Drug Testing in Nigeria Poll: Complete by 10:00 AM on the day of class

End of Module 3: Managing the Regulatory Environment

Module 4: Managing Business Development

1:30PM Thu, Oct 7, Aldrich Hall 210

Amylin Poll Complete by 10:00 am on the day of class

1:30PM Thu, Oct 14, Aldrich Hall 210

Deal Proposal for Intuitive Surgical

Note on Biotech Business Development (9807032)

1:30PM Fri, Oct 15, Aldrich Hall 210

1:30PM Wed, Oct 27, Aldrich Hall 210

Graham Gardner, Highland Capital Partners

Realizing the Promise of Personalized Medicine

Generation Health Press Release

End of Module 4: Managing Business Development

Module 5: Financing the Venture

1:30PM Thu, Oct 28, Aldrich Hall 210

McKesson: Wiring the Medical World

eClinical Works Poll: Complete by 10:00 AM on the day of class

End of Module 5: Financing the Venture

Module 5: Financing the Venture

1:30PM Wed, Nov 3, Aldrich Hall 210

End of Module 5: Financing the Venture

Module 5: Financing the Venture

1:30PM Thu, Nov 4, Aldrich Hall 210

1:30PM Wed, Nov 10, Aldrich Hall 210

Selected Date on the Financing of Healthcare Ventures

1:30PM Fri, Nov 12, Aldrich Hall 210

Selected Data on the Financing of Healthcare Ventures

Eli Lilly's VC Arm Spins Out With $200M Fund

1:30PM Wed, Nov 17, Aldrich Hall 210

End of Module 5: Financing the Venture

Module 6: Growing the Venture and Realizing Value

1:30PM Thu, Nov 18, Aldrich Hall 210

Selected Data on Healthcare Venture IPO

1:30PM Fri, Nov 19, Aldrich Hall 210