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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

I’ve decided to open up Biotech U and make the comprehensive biotechnology industry overview course free for the month of July. The course is derived from my textbook, Building Biotechnology, and covers the following topics:Comprehensive Biotechnology Industry Overview

  • Biotechnology Industry Introduction
  • The Development of Biotechnology
  • Preface: The Science of Biotechnology
  • Introduction to Molecular Biology
  • Drug Development
  • Tools and Techniques
  • Applications
  • Preface: Laws, Regulations, and Politics
  • Intellectual Property Regulation
  • Politics
  • Preface: The Business of Biotechnology
  • Biotechnology Company Fundamentals
  • Finance
  • Research and Development
  • Marketing
  • Licensing, Alliances, and Mergers
  • Managing Biotechnology
  • International Biotechnology
  • Final Words

Check it out today, at http://www.BiotechU.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.

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

A recent UMD study has found that VCs pay little attention ot the content of business plans.This is not much of a surprise. I’m generally bearish on business plans, but I do recognize their important role.

Having written several business plans and having successfully competed in business plan competitions, I’ve recognized that many of the highly structured elements of  business plans are simply inappropriate for biotechnology firms. Elements such as five-year financials will almost certainly change, but what is important — and which has not been ruled out by the UMD study — is that the thought processes behind the business plan are important indicators of investment.

One of the things I look for in reviewing business plans (and in reading papers for the Journal of Commercial Biotechnology) is evidence of higher-level thinking. Is the entrepreneur just filling out the sections of a business plan with crude numbers (i.e. the market size is $x and we intend to acquire y% of that market) or have they thought about the numbers and identified the factors contributing to the market size and the steps which will be necessary to acquire any portion of market share?

Despite the recent claims that VCs don’t read business plans, I suspect that they will continue to request them — if only to see if the entrepreneur can define the business proposition. Rather than seeing business plan writing (which, incidentally is not the same as business planning) as a rote exercise, one should look at it as an opportunity to demonstrate advanced understanding of the commercial opportunity and the steps required to realize it.

In a previous post I introduced a slideshow –  Beyond the Business plan — which is a companion lecture to my textbook, Building Biotechnology. The focus of this talk is on addressing the elements beyond a traditional business plan — when conditions change (and they will), what will you do?

For all the talk of the numerous biotechnology companies with mere months of cash left and the predictions of looming liquidations, mergers, and acquisitions, it is important to note that a measure of destruction can benefit industry progress.

Economy Joseph Schumpeter coined a term for industrial progress through destruction: creative destruction. In this process, growth occurs by the development of new companies, which develop new innovations and replace older companies.

Even mergers and acquisitions can drive progress, as they free seasoned executives from their former jobs. The story of Hybritech’s key role in the development of the San Diego biotechnology cluster is a case study of this kind of growth:

Creative Destruction: Hybritech's role in building the San Diego Biotechnology Cluster

Creative Destruction: Hybritech's role in building the San Diego Biotechnology Cluster

Source: Building Biotechnology

So, while the process of creative destruction may be painful for those who are employees or investors in the destroyed companies, it is a natural element of business cycles, and an essential part of driving progress.

I’ll be giving a talk at the Kogod School of Business on Tuesday February 24th on “Drug Development – Balancing National and Commercial Needs”. The basis of the talk is that countries need access to medicines, foreign currency, and tax revenues, while drug developers need profits (or else they will cease to exist). I’ll be covering strategies used by nations and drug companies to meet their respective needs, and describing case studies in which these needs are at odds with each other, and those in which they coexist in harmony.

Looking forward to a good discussion.

I will be opening the Business Matters for Scientists program at Johns Hopkins Carey School of Business on March 6th 2009. My focus will be providing an extensive overview of the biotechnology industry and insights on paths to entrepreneurship and business planning considerations. In addition to laying out the fundamentals for success, I will also address practical considerations in developing biotechnology companies and illustrate the diversity of entrepreneurial approaches and cases of unforeseen hurdles in biotechnology business development.

For those who cannot make it to Baltimore for the certificate program, two other options exist:

  1. Biotech-U.com is an online biotechnology education platform offering self-directed courses covering the scientific, legal, regulatory, political, and commercial aspects of biotechnology.
  2. My book, Building Biotechnology, is a comprehensive biotechnology industry primer.

After months of effort, I’m pleased to announce the launch of Biotech U, a biotechnology education resource featuring web-based lessons on biotechnology business, law, IP, politics, regulations, and science.

Biotech U is based on Building Biotechnology, the leading text used in business-of-biotechnology courses. The online-learning structure is designed to meet the needs of busy professionals who seek a robust educational resource but lack the time to attend traditional classes. Feel free to try the sample course, an Introduction to Biotechnology, and I hope you enjoy this new resource.