Home Talks and Publications

Journal of Commercial Biotechnology Vol 18, Issue 3 (2012)

Could personalized medicine be the driver for widespread price controls?
Yali Friedman
Everyone should agree that the benefits of personalized medicine — prescription of drugs most likely to benefit and least likely to harm individual or groups of patients — are are positive. However, one must consider the potential practical challenges of increased implementation of personalized medicine, if the current healthcare delivery system is compatible with personalized medicine, and what regulatory/policy changes may be needed to accomodate personalized medicine…
Full details at the Journal of Commercial Biotechnology

Innovating in the New Austerity
G. Steven Burrill
We are in the midst of dramatic changes in the way life sciences companies are funded. The model of funding a company with venture capital leading to an IPO is now the exception rather than the rule for life sciences companies. Venture investors are no longer willing or able to fund companies with an indefinite exit…
Full details at the Journal of Commercial Biotechnology

Innovative biotechnology industry strategies in the U.S.’ rapidly evolving payer environment
Sarah Stanton Collins, Will Collins
In 2010 healthcare represented 17.9% of GDP; its cost is growing significantly faster (~5%) than economic growth (~ 2%).  This growth presents a challenge to all payers, whether they are governments, employers, or individuals.  Within healthcare, one of the most rapidly growing areas is “specialty drugs” which are frequently biotechnology agents, or drugs for cancer or orphan conditions…
Full details at the Journal of Commercial Biotechnology

Biotechnology in Argentina: Development and Resources
Claudia Zylberberg, Asli Ceylan Oner, Ezequiel Zylberberg
Biotechnology related developments in Argentina have gained momentum in the past few years. The creation of the Ministry of Science, Technology and Innovative Production in 2007 that focuses on high-tech growth in technology related fields including biotechnology, demonstrates the public sector commitment to a field with a thriving business sector and promising improvements in research and development…
Full details at the Journal of Commercial Biotechnology

Creating systemic oral transmucosal drug delivery strategies: Case study of APL-130277
Anthony Giovinazzo, Nathan Bryson, Timothy Tankosic
This article addresses the strategic application of systemic oral transmucosal* (i.e., sublingual and buccal) drug delivery. Circumvention of first-pass hepatic metabolism in the gut, rapid onset of action, easy access via the oral cavity, easy administration for patients with dysphagia and a high level of patient acceptance are the principal advantages of the oral transmucosal route…
Full details at the Journal of Commercial Biotechnology

What do hospital labs really need to streamline diagnostic testing: Apple vs. Microsoft environment?
Doug Millar, John Melki
Molecular diagnostic (MDx) tests are now commonplace in virtually every hospital and pathology laboratory, however many questions have arisen, such as “What do diagnostic laboratories require from the MDx revolution in order to better improve patient care?” and “Is a fully integrated ‘black-box’ device the answer to simple rapid diagnostic testing or do mainstream laboratories require more in terms of available testing menu and streamlined workflow?”  With more and more ‘black-box’ devices available on the market, laboratories need to first decide if they need to make such an investment, and if so, in which to make the most appropriate investment, whilst also considering the cost of consumables…
Full details at the Journal of Commercial Biotechnology

A general model for training the next generation of Biotechnology entrepreneurs based on recent experience of USA-UK-South Africa collaborations
Karl J. Kunert, Blessed Okole, Barend J. Vorster, Nicholas J. Brewin, Christopher A. Cullis
Preparing students for future entrepreneurial activity in the biotechnology industry is an important issue in many parts of the world because most countries seek to reap the benefits of investments in university-based teaching and research through the development of a knowledge-based economy driven by a highly skilled work force…
Full details at the Journal of Commercial Biotechnology

Biomarketing strategy and tactics 101 PART II of III
Dimitris Dogramatzis
The American Marketing Association defines marketing as the activity, set of institutions, and processes for creating, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large. According to the Pharmaceutical Research and Manufacturers of America appropriate marketing of medicines ensures that patients have access to the products they need and that the products are used correctly for maximum patient benefit…
Full details at the Journal of Commercial Biotechnology

Disaster Planning for Biotechnology Companies
Frank Goudsmit
An earthquake in Japan cuts off the supply of key equipment and/or pharmaceutical ingredients to a biotechnology company with facilities in the U.S.  High winds and flooding from a hurricane along the East coast—home to a notable number of biotechnology facilities—causes catastrophic property damage…
Full details at the Journal of Commercial Biotechnology

Are laboratory notebooks necessary in a first inventor to file world?
Deborah L. Lu, Thomas Kowalski, Smitha Uthaman
The importance of laboratory notebooks was long touted in the US to prove a date of invention. With the dawning of a first-to-file era in the US, the importance of laboratory notebooks has been questioned. A perspective on the importance of laboratory notebooks is provided as well as an answer to the question whether laboratory notebooks are necessary in a first-to-file regime…
Full details at the Journal of Commercial Biotechnology

Mayo “nays”: The Supreme Court says no to patenting laws of nature
Jennifer A. Camacho
On March 20, 2012, the U.S. Supreme Court handed down its decision in Mayo Collaborative Services, et al v. Prometheus Laboratories, Inc (“Mayo”) and ended an eight-year legal battle over patents covering processes for determining patient-specific dosing for a thiopurine drug to treat autoimmune diseases…
Full details at the Journal of Commercial Biotechnology

EU Legal & Regulatory Update
Ewan Grist
Full details at the Journal of Commercial Biotechnology

Drug discovery & Development Landscape: New Trends in Academia-Industry Partnerships
Vasu Pestonjamasp
Full details at the Journal of Commercial Biotechnology

 

For more information, see the Journal of Commercial Biotechnology

I’m back from the Filling the Pipeline conference in Boston, where I presented a talk on pharmaceutical globalization.

Maintaining control of pharmaceutical drug innovation is key for national security, public health, and economic development. We know that much of late-stage development has gone overseas, but the question remains: Where are drugs invented? Using the DrugPatentWatch database, I demonstrate a model to track pharmaceutical globalization using patents and reveal the locations of pharmaceutical innovation. For more, see the slide deck below:

The third issue of Scientic American’s Worldview is now available at www.saworldview.com.

In this latest issue I continue my comparative assessment of the biotechnology innovation environment in different countries. I also include additional highlights:

  • Which country is home to the most drug inventors?
  • Which country has the greatest biotechnology patenting intensity?
  • Which country has the greatest relative biotechnology R&D spend?
  • Which country has the most global collaboration on innovation?
  • Which region has the fastest growing drug market?
  • Which country has the largest drug market?
  • Which country has the longest drug approval lag
  • Which country has the most publications in the field of biotechnology?
  • Which country is the largest drug exporter?
  • Which country has the strongest public biotechnology markets?

I have also increased the number of countries measured from 38 last year to 48 this year.

The answers to these questions may suprise you. For answers to these questions and more, see the Scientific American Worldview project at www.saworldview.com

The following Logos Press authors will be signing books at the BIO 2011 Convention in Washington DC

Monday June 27th 3:00-4:30pm

Mark Ahn, Michael Alvarez, Anne York

Tuesday June 28th 3pm-4:30pm

Yali Friedman

Michael Salgaller

Wednesday June 29th 10:30am-12:30pm

John Avellanet

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 will be presenting in an upcoming webinar:

Going Global

Partnering and Investing in International Life Sciences

 

Today, successful life sciences companies are feverishly evaluating international partnerships in search of places that are rapidly expanding. Some make the costly mistake of only using market size as the deciding factor, which is often misleading. Success in the global marketplace is driven by many factors. Overlooking these additional factors may be detrimental to your international goals.

During this webinar, you will:

  • Hear why a deep understanding of your potential partner’s innovation record is essential
  • Learn how to measure the true size and growth rate of a specific market
  • Understand why focus must center on individual countries rather than region
  • Discover how to identify and mitigate commercial risk abroad
  • Learn how to create a checklist for partnering and investing internationally
  • See how one company has used technology to securely and efficiently accomplish their international licensing goals

Go here to learn more about this complimentary webinar sponsored by MERRILL DATASITE®.

Date & Time

June 7, 2011
1:00PM EDT / 10:00AM PDT
90 Minutes

Add to Outlook Calendar Add to Outlook Calendar

Register

 

Speakers

Yali Friedman, PhD

Yali Friedman, PhD Founder

thinkBiotech

Yali Friedman, Ph.D., is Founder of thinkBiotech. His book, Building Biotechnology, is used as a course text in dozens of biotechnology programs. His other books include Best Practices in Biotechnology Education and Best Practices in Biotechnology Business Development. Dr. Friedman also has strong exposure to leading issues in international biotechnology. Dr. Friedman teaches biotechnology management at the NIH and regularly guest-lectures for other biotechnology education programs, and writes and speaks on diverse topics such as biotechnology entrepreneurship, strategies to cope with a lack of management talent and capital when developing companies outside of established hubs, and new paradigms in technology-based economic development.

Jim Weissman

Jim Weissman Vice President of Business Development

MannKind

As Vice President of Business Development for MannKind, Jim Weissman leads MannKind’s strategic alliance and licensing partnership efforts. He brings over 20 years of experience in general management, business development, and marketing in biotech and pharmaceuticals having worked in senior management positions at Pharmacia and Pfizer. Weissman served as the General Manager for Pharmacia Biotech UK & Ireland where he headed country operations including sales, marketing, customer support, and operations. He also served as the Director of Business Development for Pfizer Japan where he headed the New Product Planning, Licensing, and Corporate Strategic Planning Departments. Weissman received his B.S. in Chemistry from Bates College and has extensive international experience having lived and worked in Europe for 5 years and Japan for 11 years prior to returning to the USA in 2006.

David Yeary

David Yeary Moderator

Merrill Corporation

David Yeary is the Vice President of Sales-Life Sciences for Merrill’s DataSite. Most recently, Mr. Yeary worked at Morgan Lewis as Director, Business and Practice Development where he assisted and lead business development opportunities in Life Sciences, Technology, Clean Tech and Digital Media and Entertainment. He also worked with private equity, venture capital and investment banks to bridge between client and investor. Mr. Yeary gained his experience at Synarc, Celera, IMS, Agouron/Pfizer and Roche/Syntex in various business development, sales and marketing roles. He has and continues to work with numerous startups as an advisor for business development, commercialization and marketing and communication functions. Periodically he can be heard on the radio or speaking at Stanford discussing the challenges and opportunities for the new entrepreneur. He holds a BS and MBA in business from California State University, Fresno.

The next issue of Scientific American’s Worldview will be released at the BIO 2011 convention in late June. Worldview explores biotechnology development around the world, highlighting the opportunities and challenges in different markets. In the WorldView scorecard, I measure biotechnology innovation capacity around the world, and present multi-faceted data-driven comparisons to reveal greater clarity on the global biotechnology industry. For more details, check out this interview, featuring:

Jeremy Abbate, Publishing Director, Scientific American Worldview
Mike May, Editorial Director, Scientific American Worldview
Yali Friedman, Editor, SA Worldview Scorecard

Scientific American Biotechnology Worldview podcast

I will be giving a talk on “Using patent information to track globalization” at the ACS conference in Anaheim next week. The talk is part of the ACS Division of Chemistry and Law session on What Can Patent Information Do For Scientists, and is based on analysis of data from DrugPatentWatch. I look forward to meeting BiotechBlog readers who may be in attendance. For those who cannot make the event, my talk will be based on my work on globalization of pharmaceutical innovation.