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Monthly Archives: July 2010

The Center for Policy on Emerging Technologies, where I am on the board of directors, is hosting an Emerging Technologies Roundtable:

August 13, 2010 – “Synthetic Biology: What’s the Agenda?”

Synthetic biology has hit the headlines yet again. The J. Craig Venter Institute’s recent dramatic announcement led to a replay of President Clinton’s urgent request of his bioethics commission to produce a quick report on cloning back in 1997. The new Presidential Commission on Bioethical Issues duly spent its first meeting, and no doubt will spend others, fulfilling President Obama’s request for a report within 6 months.

The application of engineering principles to organic life is both new and not-so-new. At the Bioethics Commission meeting, one expert claimed that the only fresh ethical issue raised by the Venter article was its use of the word “create” in its title, since he had adapted, not created. But the stream of bioscience heavyweights who are engaging in federally-supported research in this field underscore its significance for the future. The fact that they are some of the loudest voices calling for attention to its potential downside gives us perspective. “It’s scary as hell,” Stanford’s Drew Endy was quoted as saying in the Sept. 2009 New Yorker. “It’s the coolest platform science has ever produced, but the questions it raises are the hardest to answer.”

So what’s the agenda? C-PET’s Project on Biotechnology is convening an initial Roundtable to focus our thinking. This will be the first of three; subsequent Roundtables will focus on ethics implications (reviewing the work of the President’s bioethics commission), and on security implications.

Synthetic Biology: What’s the Agenda?

at the Center for Policy on Emerging Technologies
10 G Street NE, Suite 710
11:45AM – 1:30PM (Lunch provided, please RSVP)*

*C-PET events are audio- and video-taped and may be webcast; this may include audience video and still shots.

Register for this event

Speakers include:

J. Craig Venter
J. Craig Venter Institute (invited)

Brent Erickson
Executive VP, Biotechnology Industry Organization

Rina Singh
Director, Biotechnology Industry Organization

Jonathan Moreno
University of Pennsylvania and Center for American Progress

Jonathan Tucker
Monterey Institute of International Studies

Moderator: Nigel M. Cameron
President and CEO, Center for Policy on Emerging Technologies (C-PET)

The July 2010 issue of the Journal of Commercial Biotechnology is now available. The links below will take you to the abstract for each paper:

Volume 16, Issue 3

Editorial

Increasing clarityPDF
Yali Friedman

Commentary

Personalized medicine and oncology: A commentary and key questionsPDF
Robert Freeman

Articles

Market access – An essential investment before drug launchPDF
Sean McGrath
Rethinking commercial strategy – A patient-centered commercial modelPDF
Sanjay K Rao
Pathways to biomedical tipping points: Vertical, horizontal or other?PDF
Mark J Ahn, Anne S York, Polly Rizova
Key drivers influencing the commercialization of ethanol-based biorefineriesPDF
Anuj K Chandel, Om V Singh, Gajula Chandrasekhar, Linga Venkateswar Rao, Mangamoori Lakshmi Narasu
Made in India: Are you ready for outsourced contract manufacturing?PDF
Andrew Lees, Sheila Khatri

Intellectual Property Management

Controlling costs in patent litigationPDF
Catherine Rajwani

Legal and Regulatory Updates

Gene patent considered by English Court of AppealPDF
Philip Webber
Commentary regarding decision in Myriad Genetics on ‘isolated’ DNA claimsPDF
Thomas J Kowalski, Deborah L Lu

Book Reviews

Book Review: Biotechnology: A Comprehensive Training Guide for the Biotechnology IndustryPDF
James Harber

Now available, a new textbook from Logos Press:

Building the Case for Biotechnology: Management Case Studies in Science, Laws, Regulations, Politics, and Business

Available from Amazon.com and bookstores everywhere.

Mark J. Ahn, Michael A. Alvarez, Arlen D. Meyers, Anne S. York, editors
Foreword by G. Steven Burrill
First Edition, July 2010
Perfect Bound, 416 pages, US$79.95
ISBN: 978-1-934899-15-1

Building the case for biotechnology: Management Case Studies in Science, Laws, Regulations, Politics, and BusinessThis volume helps to fill the void in life science entrepreneurship and management case books and provides faculty and students with not only the charts, but the simulated experience of sailing the turbulent and exciting oceans of the biomedical industry toward creating significant value for patients and society.

Building the Case for Biotechnology features:

  • Foreword by G. Steven Burrill
  • Introductory chapter on how to teach bioscience using the case method
  • 22 case studies in science; laws, regulations, politics; and business
  • Ample figures, graphs, and tables to complement the text
  • Resources for further reading

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, Inc.: Realizing its Potential?
Mark J. Ahn, Alan Leong, Wei Wu1, and Masum Rahman
Atkinson Graduate School of Management, Willamette University; University of Washington, Bothell

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

OraPharma, Inc: Reformulation of an Existing Product
Payam Benyamini and Mark J. Ahn
University of California, Los Angeles; Atkinson Graduate School of Management, Willamette University

DesignMedix, Inc.: 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

Oxigene, Inc.: 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

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

XDx: Navigating Regulatory & Reimbursement Challenges
Laura Elias and Michael Alvarez
Stanford University

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

The Prince Edward Island Bioscience Cluster: Creating a Knowledge-Based Economy
Steven Casper, Juergen Krause, and Adelee MacNevin
Keck Graduate Institute and University of Prince Edward Island

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

Airway Tools Company Inc.: Changing Medical Device Standards of Care
Andrew Maxwell, Bahram Behnam, Michael Alvarez
University of Toronto; Stanford University

Part III: Business

Genentech Acquisition by Roche: Will Innovation Wither?
Mark J. Ahn, Anne S. York, David Ackerley and David Lee
Atkinson Graduate School of Management, Willamette University; College of Business, Creighton University; and School of Biological Sciences, Victoria University of Wellington

Myogen, Inc.: Are We There Yet?
Mark J. Ahn and Travis Cook
Atkinson Graduate School of Management, Willamette University

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

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

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

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

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

Guru Instruments: Bootstrapping a Bioscience Device Startup
Anne S. York
College of Business, Creighton University

Growing Pains at Camelot Biopharmaceuticals
Lynn Johnson Langer
Johns Hopkins University

Sandhill Scientific: Where to Manufacture?
Staci D. Sanford and Arlen Meyers
University of Colorado Denver

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

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

Drug Patent Expirations in July 2010

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent Number Patent Expiration
PROAIR HFATeva Globalalbuterol sulfate5,695,743Jul 6, 2010
XOPENEX HFASepracorlevalbuterol tartrate5,225,183Jul 6, 2010
PROVENTIL-HFA3malbuterol sulfate5,439,670Jul 6, 2010
XOPENEX HFASepracorlevalbuterol tartrate5,695,743Jul 6, 2010
QVAR 40Teva Branded Pharmbeclomethasone dipropionate5,695,743Jul 6, 2010
ALVESCONycomed Usciclesonide5,695,743Jul 6, 2010
ISTODAXGloucester Pharmsromidepsin4,977,138Jul 6, 2010
ATROVENT HFABoehringer Ingelheimipratropium bromide5,695,743Jul 6, 2010
PROVENTIL-HFA3malbuterol sulfate5,225,183Jul 6, 2010
XOPENEX HFASepracorlevalbuterol tartrate5,439,670Jul 6, 2010
PROVENTIL-HFA3malbuterol sulfate5,695,743Jul 6, 2010
QVAR 80Teva Branded Pharmbeclomethasone dipropionate5,695,743Jul 6, 2010
AMERGEGlaxosmithklinenaratriptan hydrochloride4,997,841Jul 7, 2010
CLARINEXScheringdesloratadine5,178,878*PEDJul 12, 2010
TRELSTAR LAWatson Labstriptorelin pamoate5,225,205Jul 20, 2010
TRELSTAR DEPOTWatson Labstriptorelin pamoate5,225,205Jul 20, 2010
DEFINITYLantheus Medclperflutren5,769,080Jul 20, 2010
BETIMOLSanten Oytimolol5,231,095Jul 27, 2010
IMODIUM MULTI-SYMPTOM RELIEFMcneilloperamide hydrochloride; simethicone5,248,505Jul 28, 2010

This information is also available in an email newsletter: Subscribe to the DrugPatentWatch Patent Expiration Bulletin. Courtesy of DrugPatentWatch.com