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Special Issue: Biotechnology Entrepreneurship Bootcamp

 

Journal of Commercial Biotechnology Vol 18, Issue 2 (2012)

Editorial: The Biotechnology Entrepreneurship Boot Camp: From Lectern to Printing Press
Stephen M Sammut, Arthur A Boni
This issue of the Journal of Commercial Biotechnology focuses on the proceedings of the Seventh Annual Biotechnology Entrepreneurship Boot Camp held in conjunction with the Biotechnology Industry Organization (BIO) annual conference in Washington, DC in June, 2011.The Biotechnology Entrepreneurship Boot Camp was launched for the 2005 BIO Industry Organization’s Annual Meeting in Philadelphia…
Full details at the Journal of Commercial Biotechnology

New pradigms in drug R&D: A personal perspective
David C U’Prichard
The Author discusses the recent productivity problems in the pharmaceutical industry, in the context of his 30 year career, and the current responses of the industry driven strongly by disaggregation of the historic R&D model, new fluidites of capital access, and the impacts of genomics and globalization…
Full details at the Journal of Commercial Biotechnology

Project, Product or Company
Arthur Boni
This article focuses on the essentials of building effective, collaborative, team-based organizations. The entrepreneurs and innovators who found and build technology-based organizations comprise out target audience, but most specifically we address the biotechnology and biomedical field.  Two perspectives are provided in the article: 1) advice based on the experiential learning provided by years of experience of building and growing entrepreneurial organizations; and 2) identifying the keys to building effective teams based on some selected the academic or scholarly literature on building effective teams…
Full details at the Journal of Commercial Biotechnology

The Basics of Coverage, Coding, and Reimbursement
Robert Wanerman
The process of commercializing a new item or service in the U.S. health care market involves three distinct but necessary components: coverage, coding, and reimbursement.  This article provides an overview of these processes and the challenges in successfully navigating the course and spotting the particular issues for individual items and services…
Full details at the Journal of Commercial Biotechnology

Transition from the Lab to the Clinic
James G Kenimer, James Ackland
Before considering the specific regulatory requirements and expectations relating to your product it is informative to understand who regulates and why. Full details at the Journal of Commercial Biotechnology

Building Teams in Entrepreneurial Companies
Arthur Boni, Laurie Weingart
This article focuses on the essentials of building effective, collaborative, team-based organizations. The entrepreneurs and innovators who found and build technology-based organizations comprise out target audience, but most specifically we address the biotechnology and biomedical field.  Two perspectives are provided in the article: 1) advice based on the experiential learning provided by years of experience of building and growing entrepreneurial organizations; and 2) identifying the keys to building effective teams based on some selected the academic or scholarly literature on building effective teams…
Full details at the Journal of Commercial Biotechnology

The Pitch to Investors and Partners
Arthur Boni
This article covers the essentials of constructing and delivering a “pitch” of a business opportunity to potential investors or corporate partners.  We advocate constructing an effective pitch first and then using that as a guide to prepare your business plan.  The content of the pitch itself as described herein in effect comprises the elements to be incorporated into a business plan as a more comprehensive documentation of the business…
Full details at the Journal of Commercial Biotechnology

Strategic Engagement of the Science-Business Media
Moira A. Gunn
As surely as the bio-enterprise can benefit from positive media coverage, it cannot thrive in the face of unanswered negative and/or inaccurate media attention. On all counts, the bio-enterprise must be able to strategically engage with the media at every stage in its life cycle. This article describes the global science-business media landscape, including traditional media and emergent social media and information in the online space…
Full details at the Journal of Commercial Biotechnology

Achieving optimal financial and strategic transaction outcomes for small to mid-sized privately funded start-ups
Benjamin P Chen, Christa Nicholas
Non-dilutive funding and equity capital are two key reasons why life sciences companies pursue strategic partnerships…
Full details at the Journal of Commercial Biotechnology

Partnering With the NIH: Now Part of the “Value Proposition” for Start-ups
Steve Ferguson
For many years the United States has led the world in government support for non-military research and development (R&D), especially support for work that directly relates to health and human development.  A focal point for such federal investments to date in biomedical research has been the National Institutes of Health (NIH) along with other government laboratories and university-based research programs…
Full details at the Journal of Commercial Biotechnology

Licensing, Partnering, Strategic Alliances and University Relationships
Wesley Daniel Blakeslee
Abstract The biopharmaceutical industry has been undergoing change for a number of years and that change is accelerating.  Larger pharmaceutical companies are acquiring smaller ones, companies are merging, laboratories are being closed, and the number of scientists performing research in the pharmaceutical industry is declining…
Full details at the Journal of Commercial Biotechnology

What Every Biotech Entrepreneur Needs to Know about VC Due Diligence
Stephen M Sammut
Due diligence, as it applies to venture capital, is actually imprecise. Origins of the term are based in banking case law. Due diligence to the attorney is more of a precise concept. A better term is “homework.” Better indeed, because the burden of this homework weighs far more heavily on the entrepreneur than on the venture capitalist…
Full details at the Journal of Commercial Biotechnology

Valuation Methods in Early-Stage Biotechnology Enterprises: The “Venture Capital Method” at Work
Stephen M. Sammut
Valuation approaches to biotechnology companies by angel investors and venture capitalists often appear to the entrepreneurs to be based on voodoo rather than sound principles of finance. While there may be some truth to that perception, there is actually a very sound, somewhat complex, internal logic to the way private biotechnology companies are valued…
Full details at the Journal of Commercial Biotechnology

The Art of the Cap Table
Ashley John Stevens
This article provides an overview of the impact of raising capital on the equity ownership structure of a biotechnology company. The equity ownership structure as captured in a table of capitalization determines how the fruits of success will be divided between founders, management and investors at an exit event such as an acquisition or initial public offering…
Full details at the Journal of Commercial Biotechnology

 

For more information, see the Journal of Commercial Biotechnology

Building the case for biotechnology - Management Case Studies in Science, Laws, Regulations, Politics, and Business I am pleased to announce the availability of  individual cases from Building the Case for Biotechnology Management Case Studies in Science, Laws, Regulations, Politics, and Business in digital and printed formats. The casebook, which was recently reviewed in Nature Biotechnology, features 22 case studies in science; law, regulation, politics; and business, and a foreword by G. Steven Burrill.

A list of cases and links for more information and individual case ordering follows:

Part I: Science

Medarex: Realizing its Potential?
Mark J. Ahn, Alan Leong, Wei Wu, and Masum Rahman
Atkinson Graduate School of Management, Willamette University; University of Washington, Bothell
Buy this  biotechnology management case

FoxHollow Technologies: The SilverHawk® Cuts Open a New Market
Erik Miller, Dina Finan, and Michael Alvarez
Stanford University
Buy this biotechnology management case

OraPharma: Reformulation of an Existing Product
Payam Benyamini, Mark J. Ahn, and Danielle Hathaway
University of California, Los Angeles; Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

DesignMedix: Maintain Product Focus or Leverage Technology Platform?
Elizabeth R. Bivins-Smith , Bettina M. Frana , and W. Kellogg Thorsel
School of Business Administration, Portland State University
Buy this biotechnology management case

Oxigene: Realizing Value from Multiple Technology Platforms
Mark J. Ahn, Anne S. York, David Ackerley and Rebecca Bednarek
Atkinson Graduate School of Management, Willamette University; College of Business, Creighton University; and Victoria University of Wellington
Buy this biotechnology management case

Part II: Laws, Regulations, Politics

Tysabri Re-launch Decision: Promise and Perils of Addressing Unmet Needs
Mark J. Ahn & Laura Ueki
Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

XDx: Navigating Regulatory & Reimbursement Challenges
Laura Elias and Michael Alvarez
Stanford University
Buy this biotechnology management case

Dyadic International: From Doom to Dawn—What’s Next?
Polly S. Rizova, Adelaida Patrasc Lungu, and Mark J. Ahn
Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

The Prince Edward Island Bioscience Cluster: Creating a Knowledge-Based Economy
Steven Casper, Juergen Krause, and Adelee MacNevin
Keck Graduate Institute of Applied Life Sciences and University of Prince Edward Island
Buy this biotechnology management case

The Founding and Growth of On-Q-ity: Developing Advances in Personalized Medicine
Daniel Dornbusch and Mark J. Ahn
Novartis International AG; Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

Airway Tools Company: Changing Medical Device Standards of Care
Andrew Maxwell, Bahram Behnam Azad, Michael Alvarez
University of Toronto; Stanford University
Buy this biotechnology management case

Part III: Business

Genentech Acquisition by Roche: Will Innovation Wither?
Mark J. Ahn, Anne S. York, David Ackerley, Hannah A. Pearce, Mark J. Calcott, Natelle C. Quek, Sonai Lim, Rochene E. Higginson, Hannah D. Hoang, and David Lee Atkinson Graduate School of Management, Willamette University; College of Business, Creighton University; and School of Biological Sciences, Victoria University of Wellington
Buy this biotechnology management case

Myogen: Are We There Yet?
Mark J. Ahn and Travis Cook
Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

Compression Dynamics: In Search of Sales
Anne S. York and Martin Winkler
College of Business, Creighton University and University of Nebraska Medical Center, Creighton University Medical Center
Buy this biotechnology management case

iKaryos Diagnostics: The Rocky Road from Concept to Startup
Anne S. York
College of Business, Creighton University
Buy this biotechnology management case

Biocon: From Local to Global
Ashish Hajela, Shad Shahid, & Mohammad Akbar
Indian Institute of Management, Lucknow, India
Buy this biotechnology management case

Adnexus: Strategic and Resource Considerations When Developing Novel Biotechnology Medicines
Susan Sieloff, Tucker Marion, John Friar, and Raymond Kinnunen
College of Business Administration, Northeastern University
Buy this biotechnology management case

Gardasil: From University Discovery to Global Blockbuster Drug
Alan Collier, Mark J. Ahn and Brendan Gray
University of Otago; Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

Guru Instruments: Bootstrapping a Bioscience Device Startup
Anne S. York
College of Business, Creighton University
Buy this biotechnology management case

Growing Pains at Camelot Biopharmaceuticals
Lynn Johnson Langer
Johns Hopkins University
Buy this biotechnology management case

Sandhill Scientific: Where to Manufacture?
Staci D. Sanford and Arlen Meyers
University of Colorado Denver
Buy this biotechnology management case

Lumina Life Sciences: The Challenges of Raising Capital to take to Market a Promising Technology Innovation
Magda Choruzy, Andrew Maxwell, Michael Alvarez
University of Toronto; Stanford University
Buy this biotechnology management case

 

Contents Foreword
G. Steven Burrill
Burrill & Company 

Preface
Mark J. Ahn, Michael A. Alvarez, Arlen D. Meyers, Anne S. York

Introduction
Yali Friedman
thinkBiotech LLC

How to Teach Bioscience Using the Case Discussion Method
Trent Wachner and Anne S. York
College of Business, Creighton University

Part I: Science

Medarex: Realizing its Potential?
Mark J. Ahn, Alan Leong, Wei Wu, and Masum Rahman
Atkinson Graduate School of Management, Willamette University; University of Washington, Bothell
Buy this  biotechnology management case

FoxHollow Technologies: The SilverHawk® Cuts Open a New Market
Erik Miller, Dina Finan, and Michael Alvarez
Stanford University
Buy this biotechnology management case

OraPharma: Reformulation of an Existing Product
Payam Benyamini, Mark J. Ahn, and Danielle Hathaway
University of California, Los Angeles; Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

DesignMedix: Maintain Product Focus or Leverage Technology Platform?
Elizabeth R. Bivins-Smith , Bettina M. Frana , and W. Kellogg Thorsel
School of Business Administration, Portland State University
Buy this biotechnology management case

Oxigene: Realizing Value from Multiple Technology Platforms
Mark J. Ahn, Anne S. York, David Ackerley and Rebecca Bednarek
Atkinson Graduate School of Management, Willamette University; College of Business, Creighton University; and Victoria University of Wellington
Buy this biotechnology management case

Part II: Laws, Regulations, Politics

Tysabri Re-launch Decision: Promise and Perils of Addressing Unmet Needs
Mark J. Ahn & Laura Ueki
Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

XDx: Navigating Regulatory & Reimbursement Challenges
Laura Elias and Michael Alvarez
Stanford University
Buy this biotechnology management case

Dyadic International: From Doom to Dawn—What’s Next?
Polly S. Rizova, Adelaida Patrasc Lungu, and Mark J. Ahn
Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

The Prince Edward Island Bioscience Cluster: Creating a Knowledge-Based Economy
Steven Casper, Juergen Krause, and Adelee MacNevin
Keck Graduate Institute of Applied Life Sciences and University of Prince Edward Island
Buy this biotechnology management case

The Founding and Growth of On-Q-ity: Developing Advances in Personalized Medicine
Daniel Dornbusch and Mark J. Ahn
Novartis International AG; Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

Airway Tools Company: Changing Medical Device Standards of Care
Andrew Maxwell, Bahram Behnam Azad, Michael Alvarez
University of Toronto; Stanford University
Buy this biotechnology management case

Part III: Business

Genentech Acquisition by Roche: Will Innovation Wither?
Mark J. Ahn, Anne S. York, David Ackerley, Hannah A. Pearce, Mark J. Calcott, Natelle C. Quek, Sonai Lim, Rochene E. Higginson, Hannah D. Hoang, and David Lee Atkinson Graduate School of Management, Willamette University; College of Business, Creighton University; and School of Biological Sciences, Victoria University of Wellington
Buy this biotechnology management case

Myogen: Are We There Yet?
Mark J. Ahn and Travis Cook
Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

Compression Dynamics: In Search of Sales
Anne S. York and Martin Winkler
College of Business, Creighton University and University of Nebraska Medical Center, Creighton University Medical Center
Buy this biotechnology management case

iKaryos Diagnostics: The Rocky Road from Concept to Startup
Anne S. York
College of Business, Creighton University
Buy this biotechnology management case

Biocon: From Local to Global
Ashish Hajela, Shad Shahid, & Mohammad Akbar
Indian Institute of Management, Lucknow, India
Buy this biotechnology management case

Adnexus: Strategic and Resource Considerations When Developing Novel Biotechnology Medicines
Susan Sieloff, Tucker Marion, John Friar, and Raymond Kinnunen
College of Business Administration, Northeastern University
Buy this biotechnology management case

Gardasil: From University Discovery to Global Blockbuster Drug
Alan Collier, Mark J. Ahn and Brendan Gray
University of Otago; Atkinson Graduate School of Management, Willamette University
Buy this biotechnology management case

Guru Instruments: Bootstrapping a Bioscience Device Startup
Anne S. York
College of Business, Creighton University
Buy this biotechnology management case

Growing Pains at Camelot Biopharmaceuticals
Lynn Johnson Langer
Johns Hopkins University
Buy this biotechnology management case

Sandhill Scientific: Where to Manufacture?
Staci D. Sanford and Arlen Meyers
University of Colorado Denver
Buy this biotechnology management case

Lumina Life Sciences: The Challenges of Raising Capital to take to Market a Promising Technology Innovation
Magda Choruzy, Andrew Maxwell, Michael Alvarez
University of Toronto; Stanford University
Buy this biotechnology management case

Resources

A side-comment at the Mid Atlantic Biotech conference really got me thinking. One of the panelists mentioned as an aside that she thought that more companies failed due to bad boards than due to bad management (she preferred not to be named).

The board of directors is more than a set of advisors to company management — they represent the shareholders of a company and have a fiduciary duty to ensure that shareholders interests are served. They have the power to replace executives, and can be held liable if they don’t do their jobs. As seen in the case of Dyadic, boards of directors can exert great control over companies.

I’ve regularly give talks on managing unexpected risks, and I’d love to find more examples of boards of directors actions leading companies astray — does anyone have any leads?

I’ve just published a new book, by Michael L. Salgaller, PhD. In Biotechnology Entrepreneurship: From Science to Solutions Michael combines the voices of a diverse set of industry insiders with extensive experience in biotechnology commercialization to prepares nascent founders, managers, investors, and other biotechnology company stakeholders to position themselves and their companies for commercial success.

    Topics covered include:

  • Why Start a Biotechnology Company?
  • Company Formation and Organization
  • Building Your Team
  • Intellectual Property Protection Strategy
  • Financing Your Company
  • Partnering With Industry
  • Licensing and Technology Transfer
  • Regulatory Affairs
  • Roadmap to Reimbursement and Access
  • Working Toward a Successful Exit

Full details on the book are available on Logos Press’ website, and the book is available at Barnes and Noble, Amazon.com, and elsewhere.

Coming soon, a book by Michael L. Salgaller, PhD. In this new book — Biotechnology Entrepreneurship: From Science to Solutions — Michael combines the voices of a diverse set of industry insiders with extensive experience in biotechnology commercialization to prepares nascent founders, managers, investors, and other biotechnology company stakeholders to position themselves and their companies for commercial success.

    Topics covered include:

  • Why Start a Biotechnology Company?
  • Company Formation and Organization
  • Building Your Team
  • Intellectual Property Protection Strategy
  • Financing Your Company
  • Partnering With Industry
  • Licensing and Technology Transfer
  • Regulatory Affairs
  • Roadmap to Reimbursement and Access
  • Working Toward a Successful Exit

Full details on the book are available on Logos Press’ website, and the book is available for pre-order at Barnes and Noble and Amazon.com.

Media outlets interested in a review copy can contact info@logos-press.com.

These papers are from the 2010 final projects in the NIH Foundation for Advanced Education in the Sciences TECH 366 — Biotechnology Management. The students were asked to tell a story based on the course lectures, and to expand with general lessons biotechnology company management:

If You Build It, Will They Come?
Derek Francis

Profitability and Orphans: The Role of Price and Incentives in Four Different Markets
Nate Hafer

Patent Analysis: A Tool for Making Strategic Business Decisions
Eric Norman

2009 final projects are posted here.

I recently gave a talk on educating the next generation of biotechnology managers and founders at a biotechnology education workshop. My sense is that the traditional education paths are not ideal ways to prepare individuals to manage or start biotechnology companies, and I describe cases from Best Practices in Biotechnology Education and courses I have been involved with to illustrate how educational programs can better prepare students for these roles.

I’ve attached a copy of my presentation below.

I will be giving a talk on Educating the Next Generation of Biotechnology Founders and Managers at Pittcon in Orlando on March 1st.

The talk will be based on my observations in writing  Building Biotechnology and editing Best Practices in Biotechnology Education, in addition to the teaching I’ve done on the topic. I’ll be posting my slides after the event, but for a preview you can see my recent editorial on continuing education in biotechnology in the Journal of Commercial Biotechnology.

Hope to meet some readers while I’m down there…

These papers are from the 2009 final projects in the NIH Foundation for Advanced Education in the Sciences TECH 366 — Biotechnology Management. The students were asked to tell a story based on the course lectures, and to expand with general lessons biotechnology company management:

Financial opportunities for early stage biotech companies
Tamara Jones

The changing roles of CRO
Alex Bao

Discovering potential drug targets
Myung K. Kim