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PANEL DISCUSSION. Getting To Market: Biotech/Pharma. On the Panel: Duncan A. Greenhalgh, PhD: Testa Hurwitz & Thibeault LLP Amir Nashat, PhD: Polaris Venture Partners Robert H. Rubin,MD PhD: Assoc Dtr, Div of Infectious Diseases- Brigham & Women’s Hospital

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PANELDISCUSSION

Getting To Market:

Biotech/Pharma

On the Panel:

Duncan A. Greenhalgh, PhD: Testa Hurwitz & Thibeault LLP

Amir Nashat, PhD: Polaris Venture Partners

Robert H. Rubin,MD PhD: Assoc Dtr, Div of Infectious Diseases- Brigham & Women’s Hospital

Anthony J. Sinskey, ScD: MIT Professor of Microbiology &Founder of Metabolix

William F. Swiggart, JD: Swiggart & Agin

Moderator : Joe Hadzima,Senior Lecturer MIT Sloan School & Main Street Partners LLC

Tuesday November 23, 2004, 7-9 PM

Room 56-114

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Getting To Market: Biotech/Pharma

PANELIST:Duncan Greenhalgh,Testa, Hurwitz & Thibeault LLP

Duncan A. Greenhalgh, Ph.D. is an associate in the Patent and Intellectual Property Practice Group. He specializes in the protection and enforcement of intellectual property rights primarily in the field of life sciences, and represents private and publicly traded companies, and medical and academic institutions.

Dr. Greenhalgh received his B.Sc., with honors, in Biotechnology, from the University of Leeds, U.K., his Ph.D. in Biochemistry from the University of Leeds, U.K., and his J.D., magna cum laude, from Suffolk University law school. He worked for four years as a postdoctoral research associate in the Department of Chemistry at Massachusetts Institute of Technology under Nobel Laureate Har Gobind Khorana.

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Getting To Market: Biotech/Pharma

PANELIST:Amir Nashat PhD,Polaris Venture Partners

Dr. Amir Nashat is a principal specializing in life sciences at Polaris Ventures. He currently represents Polaris on the boards of ENOS Pharmaceuticals and Pervasis.

Prior to joining Polaris in 2002, Amir completed his Ph.D. as a Hertz Fellow in chemical engineering at the Massachusetts Institute of Technology under Professor Robert Langer. Amir's doctoral research focused on information flow through neurons, neural implants, and neural tissue engineering.

Dr. Nashat earned his M.S. in Materials Engineering at the University of California, Berkeley, where he developed microfabricated devices for various biomedical applications. He also collaborated with Ciba-Geigy to develop novel composite materials. He received his B.S. at UC Berkeley with a double major in mechanical engineering and materials engineering. He graduated as the top senior in both departments and was a finalist for the University Medal.

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Getting To Market: Biotech/Pharma

PANELIST:Robert H. Rubin, MD, PhD,Associate Director, Division of Infectious Diseases Brigham & Women’s Hospital

Dr. Rubin has spent much of his clinical career studying and caring for transplant patients. Among his accomplishments are the development of new strategies for preventing the most important infections, particularly those due to viruses and fungi; the establishment of the link between certain viral infections and allograft injury and the development of certain malignancies; and the development of novel antimicrobial approaches that are effective not only in transplant patients, but also in such other immunocompromised patient populations as those with AIDS and cancer. Also on the Board of Directors at Merrimack Pharmaceuticals, he brings unique insight into the clinical implementation of their novel Network Biology platform which focuses on auto-immune diseases and cancer

Robert Rubin received his B.A. from Williams college and M.D. from Harvard Medical School. He has held fellowships in infectious disease at Mass General Hospital and New England Medical Center and is board certified in infectious disease and internal medicine.

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Getting To Market: Biotech/Pharma

PANELIST:Anthony J. Sinskey, ScD,MIT Professor of Microbiology and Founder of Metabolix, Inc.

Professor Anthony Sinskey’s research goal is to establish an interdisciplinary approach to metabolic engineering, focusing on the fundamental physiology, biochemistry and molecular genetics of important organisms.

In 1992 Anthony co-founded Metabolix, Inc a bioplastics engineering firm located in Cambridge, MA based on his findings that some microorganisms store carbon in as natural polyesters. These polyesters, known collectively as polyhydroxyalkanoates (PHAs) have a wide range of valuable properties including biodegradability and thermoplasticity and the recombinant DNA technologies behind them have spearheaded the field of biopolymer engineering. He also serves on the Board of Directors at Merrimack Pharmaceuticals. Merrimack, founded in 2000 to commercialize the study of protein networks and complex interactions that mediate cellular pathways and for the purposes of drug discovery and development.

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Getting To Market: Biotech/Pharma

PANELIST:William F. Swiggart, JD,Swiggart & Agin

William Swiggart concentrates his practice in the representation of software and medical technology companies. Mr. Swiggart was with Perkins, Smith & Cohen, a Boston firm, until he founded his current practice in 1990.

Swiggart & Agin, LLC, in Boston, Massachusetts, provides legal services to companies, including computer and medical technology firms. Bill has served as General Counsel and Secretary to Bitstream Inc., a Cambridge based software company, and as General Counsel of ON Technology Corporation. Swiggart & Agin recently represented Clinical MicroArrays, an early stage life sciences company in securing its Series A round of financing.

William Swiggart is a graduate of Princeton University and the University of Connecticut School of Law, where he was a member of the Connecticut Law Review.

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Getting To Market: Biotech/Pharma

MODERATOR:Joe Hadzima,MIT Sloan and Main Street Partners

Joseph G. Hadzima Jr. is a Senior Lecturer at Sloan School of Management, where he has lectured on a variety of subjects since 1984. He has been involved with over 120 new ventures as a venture capitalist, entrepreneur, lawyer and board member.

As a practicing lawyer for 17 years he was Partner, Founder and Director of the Sullivan & Worcester High Tech/New Ventures Group. He was a Founding Judge of the MIT $50K Entrepreneurship Competition. He is Chairman of the MIT Enterprise Forum-Global. He is currently a Managing Director of Main Street Partners LLC, a venture development and technology commercialization firm located in Kendall Square Cambridge.

Joe received a B.Sc. from MIT in 1973, a S.M. in Management from the MIT Sloan School of Management in 1977 and a Juris Doctore law degree cum laude from Harvard Law School in 1979.

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The 16th AnnualThe Nuts and Bolts of Business PlansMIT Course 15.975January 2005

BUSINESS PLAN BASICS; MARKETS;

BUSINESS MODELS; FINANCIAL PROJECTIONS;

LEGAL ISSUES; PITCHING THE PLAN;

EXECUTING THE PLAN; ORGANIZATIONAL CULTURE; FINANCING SOURCES

3 Units of Pass/Fail Credit Available

6 or 7 Evenings During January 11 to 27

CHECK CLASS WEBSITE FOR FINAL DATES entrepreneurship.mit.edu/15975/

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Getting To Market: Biotech/Pharma

Getting to Market => A Road Trip Without A Map

“The Process of Getting to Market is like going on a Road Trip without a MAP- you look for points of interest that others have pointed out along the way.” (a paraphrase of a comment by Lori Pressman, former Associate Director of the MIT Technology Licensing Office)

Goal of the Panel Tonight: Construct a “Point of Interest Map”

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Getting To Market: Biotech/Pharma

“Points of Interest” Map

  • How do you evaluate a Technology’s Commercial Potential?
  • How does this Commercial Potential suggest a Business Strategy?
  • Is Forming a Company the Best Strategy?
  • Legal Aspects of Implementing the Strategy Chosen
  • Resources Needed to Implement the Plan
  • Lessons Learned
slide11
Getting To Market: Biotech/Pharma

“Points of Interest” Map

  • How do you Evaluate a Technology’s Commercial Potential?
  • How does this Commercial Potential suggest a Business Strategy?
  • Is Forming a Company the Best Strategy?
  • Legal Aspects of Implementing the Strategy Chosen
  • Resources Needed to Implement the Plan
  • Lessons Learned

Summary of Points Made:

  • Is it Big? How much $ will it take? How long will it take? Amir
  • What are the regulatory requirements? Can you make a business of it? Anthony
  • Who are the People? We invest in People more than Technology? Amir
  • What the Core Skills of the People? Robert
  • Intellectual Property? What is it? Who owns it? What IP do the Competitors own? Duncan Strategic IP - Amir
  • Market Analysis- how is the problem being solved today??? Robert
  • Does technical mechanism make sense? In Vitro success? What in Vivo proof of concept? Robert
  • Today- investors want answers to these questions before investing… Amir
  • Commercial Potential = Value Creation + Value Extraction - Joe
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Getting To Market: Biotech/Pharma

“Points of Interest” Map

  • How do you Evaluate a Technology’s Commercial Potential?
  • How does this Commercial Potential suggest a Business Strategy?
  • Is Forming a Company the Best Strategy?
  • Legal Aspects of Implementing the Strategy Chosen
  • Resources Needed to Implement the Plan
  • Lessons Learned

Summary of Points Made:

  • What does the “Package Insert” look like? What do I need to do to if I wanted that Package Insert? Robert
  • What are Your Goals? Investors goal is just to make $$$ Amir Business Strategy flows from Goals.
  • Biomarker Example. Who is it valuable to? What can you charge that person? How many people can you charge? Amir
  • Where in the “Value Chain” do you want to play? Drive to base of Mt. Everest or helping the last 200 ft? Amir
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Getting To Market: Biotech/Pharma

“Points of Interest” Map

  • How do you Evaluate a Technology’s Commercial Potential?
  • How does this Commercial Potential suggest a Business Strategy?
  • Is Forming a Company the Best Strategy?
  • Legal Aspects of Implementing the Strategy Chosen
  • Resources Needed to Implement the Plan
  • Lessons Learned

Summary of Points Made:

  • Depends on what you want to do? Do you want to do research and let others license it – I.e TLO. Anthony
  • Forming a Company is easy- Forming a Successful Company is the question. Anthony
  • Licensing Review Committees are set up to say “NO”. High level personal contact very valuable. Robert
  • Companies- can you fund it? At the right level? Anthony
  • Do-it-yourself lawyering is like do-it-yourself brain surgery…..Do it right, right from the beginning. William
  • Incremental/evolutionary vs. revolutionary. FedX example (100x more expensive, mail room politics). Amir
  • Do you have that “Feeling” that this HAS TO be done- passion factor. Amir
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Getting To Market: Biotech/Pharma

“Points of Interest” Map

  • How do you Evaluate a Technology’s Commercial Potential?
  • How does this Commercial Potential suggest a Business Strategy?
  • Is Forming a Company the Best Strategy?
  • Legal Aspects of Implementing the Strategy Chosen
  • Resources Needed to Implement the Plan
  • Lessons Learned

Summary of Points Made:

  • Assembling the team- need to have equity situation clear early on. Simple is better. William
  • Ethical aspects very important. Who is on patent? Who is part of the team? Anthony
  • Get it right the first time. It is much much more expensive to clean up - do it right at beginning. Duncan
  • It is like starting a family…. You will be together for a long time. Pick the right people. Amir
  • Importance of clear understanding among team of what everyone agrees we are doing.
slide15
Getting To Market: Biotech/Pharma

“Points of Interest” Map

  • How do you Evaluate a Technology’s Commercial Potential?
  • How does this Commercial Potential suggest a Business Strategy?
  • Is Forming a Company the Best Strategy?
  • Legal Aspects of Implementing the Strategy Chosen
  • Resources Needed to Implement the Plan
  • Lessons Learned

Summary of Points Made:

  • Advisors- experienced people want to do something interesting. Will this be FUN? (River names) Anthony
  • Onion layering. Good people attract good people. Find the “Network” and work it. Amir
  • Hardest resource to get is the CEO to run the company. Amir
  • Hire people who are better than you….. Anthony
slide16
Getting To Market: Biotech/Pharma

“Points of Interest” Map

  • How do you Evaluate a Technology’s Commercial Potential?
  • How does this Commercial Potential suggest a Business Strategy?
  • Is Forming a Company the Best Strategy?
  • Legal Aspects of Implementing the Strategy Chosen
  • Resources Needed to Implement the Plan
  • Lessons Learned

Summary of Points Made:

  • Does the Inventor have to be the Entrepreneur? No- but must have a shared Vision and Trust. Amir
  • Is this the right time to do this? Why this, why now? FDA reg change example. Robert
  • Be a Good Listener. Constantly listen, learn and adapt. Evolution and getting smarter. Amir
  • Figure out what is easy and what is hard. Anthony
slide17
Getting To Market:

Biotech/Pharma

THANK YOU TO THE PANEL

Duncan A. Greenhalgh, PhD: Testa Hurwitz & Thibeault LLP

Amir Nashat, PhD: Polaris Venture Partners

Robert H. Rubin,MD PhD: Assoc Dtr, Div of Infectious Diseases- Brigham & Women’s Hospital

Anthony J. Sinskey, ScD: MIT Professor of Microbiology &Founder of Metabolix

William F. Swiggart, JD: Swiggart & Agin

Moderator : Joe Hadzima,Senior Lecturer MIT Sloan School & Main Street Partners LLC

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