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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

Here is a recent keynote I gave for the Delaware Valley Innovation Network. The group is working on coordinating the activities of community colleges — and other parties –  between the adjacent Delaware, Philadelphia, and New Jersey regions. My objective was to use case studies to show that drawing circles around regions to count combined assets (as is too frequently done) is not enough; it is also necessary to find ways to drive collaboration.

The slideshow is shown below:

I’ll be giving a talk at the Johns Hopkins Carey Business School Entrepreneurship Conference on March 21st titled “Entrepreneurship: What Not to Do.” The talk will cover cases in failed entrepreneurship in biotechnology, elucidating some of the forseeable and unforseeable factors which can lead to failure.

Hope to see some readers there. If you can’t make it, you may want to check out “Beyond the Business Plan” or Building Biotechnology, on which this latest talk is based.

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.

Guest content from Nicolaj H. Nielsen, managing director of Biostrat.

A case-study on the recent licensing-deal between Myriad and Lundbeck: Information asymmetry, calculated bets and royalties in the biotech industry.

The share-price of Lundbeck has fallen with approximately 10 %, since the Danish pharmaceutical company announced an inlicensing deal with the US biotech company Myriad for a new drug named Flurizan aimed against mild Alzheimer. Why do investors not like the deal, and could the deal be (yet another) good sign for biotech companies?

What we know…
Flurizan has completed
phase II and the results from the two ongoing phase III studies will not be known until June 2008. Lundbeck will pay Myriad USD 100 million for the European commercialization rights + milestone payments + royalties in the range of 20-39 % of sales.

Lundbeck has clearly taken a calculated bet. Lundbeck believes so much in Flurizan that the company is willing to pay a large sum of money before the phase III data is known. The company is thereby trying to avoid a bidding-war against Big Pharma after positive phase III data, but is at the same time taking significant financial risk.

Why is the Market so skeptical?
Biotech is maybe the industry with the largest degree of information asymmetry. Biotech companies simply know much more about the strength and weaknesses of a potential product than outside investors/partners. This has been proven again and again by the lack of shareholder value creation in investment funds – even those that are managed by highly specialized investment companies.
The market believes that the information asymmetry is also in play in the Flurizan deal. If data from the ongoing phase III studies are so promising, why is Myriad outlicensing the product before the phase III data is available? Such a decision could of course be explained by a risk-minimizing strategy by Myriad – but again, if Myriad believes so much in the product, why not take the risk and wait 4 weeks for the data to be available?

The price…
The other thing that worries the market is the price of the drug. Taking the calculated bet could of course be defended if the acquisition price and royalties are very low. Many investors believe that not only have Lundbeck just spent USD 100 million on the roulette, but even if successful – the product will be very expensive for Lundbeck.
The parties have announced that Lundbeck will pay royalties in the range of
20-39 % of sales, which seems very high com compared to industry standards.

We don’t know the details of the agreement, and are therefore not in a position to judge whether the price is too high or not. We can just conclude that the market has voted with its feet, and the share-price has fallen with close to 10 % since the announcement. The market believes that Lundbeck’s bet is not generating shareholder-value.

Is the Myriad-deal good news for biotech companies in general?

We believe that the Myriad deal is yet another sign that the power between (inlicensing) Pharma companies and (outlicensing) biotech-companies are shifting to the favor of the latter.
In a time where many biotech companies, especially the companies with many early-stage projects, are struggling to get new funding, it is encouraging to see how good terms it is possible to negotiate only with phase II data. Most Pharma companies, like Lundbeck, is struggling to fill out their pipeline. The fight over good potential products is constantly getting tougher and tougher – for the benefit of biotech companies with the “right” products in their pipeline.

About the author:

This analysis was written by Nicolaj H. Nielsen, managing director of Biostrat, which provides management consulting services to the biotech industry.