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Monthly Archives: January 2014

Susan Kling FinstonThis is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.

Last April, I wrote here about the paradox of cancer research funding where over $100 billion in R&D funding for genomic targeting of cancer tumors has yielded only modest gains for cancer patients.   Despite the persistent lack of progress in curing most metastatic forms of cancer, risk averse, sclerotic, funding policies continue to throw good money after bad.  As Nobel laureate Jim Watson points out:

“Targeted biological therapies don’t kill cancer cells, they are not curing cancer and it is unlikely that they can be made to do so in a practical or comprehensive way in the near future. It’s time for a change in strategy. We know the current approach is not working, because on the whole it has made no dent in cancer mortality.”

Now it looks like there is at least modest attention  being given to an alternative approach to cancer R&D relating to the critical tumor suppressor protein, p53 (also cited by Watson).

Professor Sir David Lane first discovered the p53 protein in 1979, dubbing it “the guardian of the genome,” for the important role the protein plays in monitoring  health of cells and preventing cancer.  Mutation or deletion of p53 is highly correlated with growth of a majority of human tumors, and up to 90% of tumors for some cancer sub-categories like ovarian cancer. Overall, Lane asserts that “nearly every tumor has an affected or moderated p53 pathway,”

Finding ways to reactivate the key p53 protein has long been considered one of the ‘holy grails’ of cancer research.  Now as reported by the New York Times, a number of the largest bio-pharma companies –  including Roche, Merck, and Sanofi – are working actively on therapeutic approaches relating to reactivation of the p53 protein and effective against a range of cancer tumors.

Although not mentioned in the New York Times Article, a much smaller company,  Cellceutix, may have the most promising p53 compound currently in human clinical trials at Harvard’s Dana Farber Cancer Center and Beth Israel Deaconess Medical Center.

Additional academic and bio-pharma start-ups also are pursuing p53 therapies at various stages of discovery and pre-clinical research.

These new therapies all focus on reactivation of the critical p53 tumor suppressor protein, responsible for controlling cell death and long recognized as the archetype of a molecular defect commonly associated with cancer tumors.  If successful, this approach to develop “guardian of the genome” therapies would be a major departure from the genetic typing of tumors to a more holistic approach across cancer sub-types.

Renewed focus on p53 tumor suppressor therapies could truly be the start of a new golden age of cancer R&D that would bring more meaningful benefits to patients in the United States and globally – and coming not a moment too soon!

About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

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Drug Patent Expirations for December 24 2013

TradenameApplicantGeneric NamePatent Expiration
ANTHELIOS SX
Loreal Usa
avobenzone; ecamsule; octocrylene
Dec 24, 2013
VIOXX
Merck
rofecoxib
Dec 24, 2013

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


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If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

This newsletter is a free service of DrugPatentWatch
DrugPatentWatch offers comprehensive details on FDA approved drugs, developers, and their patents

Drug Patent Expirations for December 23 2013

TradenameApplicantGeneric NamePatent Expiration
DDAVP
Sanofi Aventis Us
desmopressin acetate
Dec 23, 2013
DDAVP (NEEDS NO REFRIGERATION)
Sanofi Aventis Us
desmopressin acetate
Dec 23, 2013

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


Instant Access to Deep Knowledge on Small-Molecule Drugs

Subscribers have access to valuable datasets, including:
  • Patent litigation
  • Clinical trial information
  • International patent data
  • Paragraph IV challenges
  • Tentative approvals
  • Drug Master Files
  • Formulation
  • Suppliers
  • Dynamic search capabilities with data export
  • More…

More than 6,400 small-molecule drugs from 1,700 branded and generic pharmaceutical companies and 700 suppliers, and more than 80,000 U.S. and international patents.

See the Database Preview and Plan Comparison. Contact Us with any questions.

The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

DISCLAIMER:
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
All trademarks and applicant names are the property of their respective owners or licensors.

The Journal of Commercial Biotechnology is published by BiotechBlog’s producer, thinkBiotech.

Journal of Commercial Biotechnology Volume 20, Number 1bioentrepreneurship-bootcamp

Russia-Focused Venture Capital Supports In-Bound Technology Transfer and Company Building: An Analysis of Investment Trends and Outcomes
John M. Garvey, Shann Kerner, Axel Tillmann, Dmitry Kuzmin
This paper analyzes the approaches taken by the Russian government to promote innovation in the biotechnology sector within the country.  Russia is economically strong, currently with a trade surplus, and the country is investing broadly in initiatives that have resulted in in-bound technology transfer, as well as an expansion of the private sector…
Full details at the Journal of Commercial Biotechnology

Funding biotech start-ups in a post-VC world
William Bains, Stella Wooder, David Ricardo Munoz Guzman
Investment in start-up biotech. companies outside the USA has essentially disappeared. VC investment in biotechnology and healthcare as a whole has nearly returned to pre-2008 levels, but almost all is in later stage opportunities. But companies continue to be founded, and continue to flourish. We examine the VC investment patterns for the past 7 years, and show that a start-up today can expect little VC support…
Full details at the Journal of Commercial Biotechnology

Biotechnology Venture Investing and Neurodegenerative Medicine: Promise of New Approaches to Cure an Ailing Model
Dushon DeVere Riley, Mark Cochran
Neurodegenerative diseases are one of the leading public health challenges of the next 50 years. Pharmaceutical therapies have traditionally targeted the later stages of neurodegenerative diseases; however, this strategy – as the recent failures of clinical trials for Alzheimer’s drugs have highlighted – has been unsuccessful…
Full details at the Journal of Commercial Biotechnology

A biological battlefield: The potential applications of using remote sensing technology and biomarker organisms for identifying, tracking, and differentiating persons of interest within an area of operations
Jason Rivera
Since World War II, the majority of American wartime engagements have been characterized by a series of low-intensity, asymmetric conflicts. These conflicts have increased the importance of understanding the dynamics of individual actors within complex battlespaces which in turn has led U.S. military commanders, intelligence professionals, and wartime decision makers to seek a variety of means for identifying, tracking, and differentiating persons of interest…
Full details at the Journal of Commercial Biotechnology

How a large biotechnology company teamed with a translation service provider to define best practices
Jeremy Coombs
According to the World Intellectual Property Organization, nearly 100,000 pharmaceutical and biotechnology patent applications are filed each year around the world, and the trend is increasing. These companies have very little room for error in the work they conduct each day. As a result, the translations of these patent applications need to be completely accurate, which requires a translation service provider who follows best practices…
Full details at the Journal of Commercial Biotechnology

A Social Media Manifesto
Peter J. Pitts
The role of marketing communications is to advance the bottom line and the public good – and not necessarily in that order. Giving back is an integral part of the New Normal. And there has never been a better tool to accomplish this mission than social media…
Full details at the Journal of Commercial Biotechnology

Raw materials intended to be used for Gene, Cell and Tissue therapies: legal and regulatory considerations
Sophie Bisson
This paper offers some insights on the European regulatory situation with respect to raw materials used in production of gene, cell and tissue therapy products, including advanced therapy medicinal products. By focusing on the existing EU and French rules, the purpose of this paper is to review the content and scope of the measures restricting their placing on the market and/or use, the legal implications and hence key challenges ahead…
Full details at the Journal of Commercial Biotechnology

EU Legal & Regulatory Update
Ewan Grist

Full details at the Journal of Commercial Biotechnology

 

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Mergers and acquisitions: A consideration of the drivers and hurdles

Go to paper

ABSTRACT: Mergers and acquisitions (M&A) are increasingly being included by biopharmaceutical companies within earlier stage strategies as a means of accelerating technology development and thus quickening the path to shareholder value. These drivers are generally different from those of the larger established pharmaceutical companies that are more earnings focused...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

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For more information, see the Journal of Commercial Biotechnology website

Since World War II, the majority of American wartime engagements have been characterized by a series of low-intensity, asymmetric conflicts. These conflicts have increased the importance of understanding the dynamics of individual actors within complex battlespaces which in turn has led U.S. military commanders, intelligence professionals, and wartime decision makers to seek a variety of means for identifying, tracking, and differentiating persons of interest. From the jungles of Vietnam to the mountains of Afghanistan, the process of understanding the movements and activities of hostile actors has become paramount to successful military targeting and combat operations. Over the last 50 years, the military and intelligence communities have developed a plethora of technologies capable of accomplishing this task to include overhead satellites, infrared imaging, unmanned aerial vehicles (UAV), advanced biometrics, and host of other personnel identifying and tracking technologies. While these technologies have closed the gap in enabling U.S. military and intelligence professionals to understand the human aspect of the battlespace, there are still significant challenges in uniquely identifying the movements and activities of specific persons or groups of persons.

            Given the above outlined challenge of understanding the battlespace, this article will explore an alternative means of identifying and uniquely tracking individuals. Specifically, this article will explore the combined use of remote sensing technologies and genetically engineered biomarkers in order to uniquely identify, track, and differentiate persons of interest. Such a combination of two disparate technical fields would be technologically challenging both within the biological and remote imaging scientific fields, thus emphasizing the paramount importance of combining biological markers with distinct signatures that are detectable by specific and technologically matching visualization means. In addition to discussing the technical challenges associated with such a combination of technologies, this article will also discuss both the potential military benefits and negative implications this process could have in ethical, legal, and diplomatic terms. At the conclusion of this article, the reader should have a fundamental understanding of how remote sensing technologies and biomarkers can be combined to better understand the battlespace as well as the possible implications of this technological paring. 

The role of marketing communications is to advance the bottom line and the public good – and not necessarily in that order. Giving back is an integral part of the New Normal. And there has never been a better tool to accomplish this mission than social media.

But healthcare marketing –and particularly of the regulated variety --is between a rock and a hard place. On the one hand, marketers understand the importance and opportunity in social media. It’s where the people are. It’s where the action is. But then there are all those pesky regulatory concerns.

As Walter O’Malley –the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”

Neurodegenerative diseases are one of the leading public health challenges of the next 50 years. Pharmaceutical therapies have traditionally targeted the later stages of neurodegenerative diseases; however, this strategy - as the recent failures of clinical trials for Alzheimer’s drugs have highlighted - has been unsuccessful. Venture capital has underperformed as well during this time, as many new companies have been unable to maintain growth once they reach the public market and have produced less than desirable returns. As a result, venture capitalists have opted for later-stage financing. Nevertheless, new technologies are being developed to answer the question of how to best address neurodegeneration. New tools of detection will allow for much earlier diagnosis and a much greater chance of discovering and applying effective treatments. Realizing that genetic knowledge is insufficient to produce innovative treatments for neurodegenerative diseases, scientists have begun to apply the genetic knowledge attained towards a future of individualized treatments. As these new tools of detection converge with an increased ability to create very precise individual solutions, the risk of successful future investments should come down and provide the potential for outsized returns that have traditionally governed the venture capital financial model.

This paper analyzes the approaches taken by the Russian government to promote innovation in the biotechnology sector within the country.  Russia is economically strong, currently with a trade surplus, and the country is investing broadly in initiatives that have resulted in in-bound technology transfer, as well as an expansion of the private sector.  These initiatives include government venture capital and investment funds, as well as physical technology “incubator” centers.  The result has been an increase in the number of clinical-stage biotechnology companies operating in Russia, as well as an increase in the number of pharmaceutical candidates undergoing trials in the country.  The biotechnology “boom” has also resulted in an increase in the number of early-stage companies.  This paper investigates current deal and investment trends from the funds that are the principal supporters of biotechnology companies in Russia.