Home Blog Page 7

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.

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:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Drug Patent Expirations for December 2013

TradenameApplicantGeneric NamePatent NumberPatent Expiration
EMADINEAlconemedastine difumarate5,441,958Dec 8, 2013
ENTEREGCubist Pharmsalvimopan5,434,171Dec 8, 2013
EDARBYCLORArbor Pharms Llcazilsartan kamedoxomil; chlorthalidone5,583,141Dec 10, 2013
SOLAGEAqua Pharmsmequinol; tretinoin5,194,247Dec 10, 2013
EDARBIArbor Pharms Llcazilsartan kamedoxomil5,583,141Dec 10, 2013
CYMBALTALillyduloxetine hydrochloride5,023,269*PEDDec 11, 2013
ABREVAGlaxosmithklinedocosanol5,534,554Dec 13, 2013
LUPRON DEPOT-PEDAbbvie Endocrine Incleuprolide acetate6,036,976Dec 13, 2013
FROVAEndo Pharmsfrovatriptan succinate5,962,501Dec 16, 2013
MYLOTARGWyeth Pharms Incgemtuzumab ozogamicin5,585,089Dec 17, 2013
AGENERASEGlaxosmithklineamprenavir5,585,397Dec 17, 2013
DEFINITYLantheus Medclperflutren5,585,112Dec 17, 2013
AEROSPAN HFAActon Pharmsflunisolide5,980,867Dec 20, 2013
DDAVPSanofi Aventis Usdesmopressin acetate5,674,850Dec 23, 2013
DDAVP (NEEDS NO REFRIGERATION)Sanofi Aventis Usdesmopressin acetate5,674,850Dec 23, 2013
VIOXXMerckrofecoxib6,239,173*PEDDec 24, 2013
VIOXXMerckrofecoxib5,474,995*PEDDec 24, 2013
ANTHELIOS SXLoreal Usaavobenzone; ecamsule; octocrylene5,587,150Dec 24, 2013
EFFEXOR XRWyeth Pharms Incvenlafaxine hydrochloride5,916,923*PEDDec 28, 2013
EFFEXOR XRWyeth Pharms Incvenlafaxine hydrochloride6,444,708*PEDDec 28, 2013
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Subscribers have access to valuable datasets, including:

  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Sales data (top 200 drugs)
  • Paragraph IV challenges
  • Tentative approvals
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison.
Contact Us with any questions.

This 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.

My thoughts have been returning to biotechnology in Israel and how it has benefited from the state’s exceptional technology linkages.

Just ten years ago, innovative life sciences was the lagging indicator in the country’s long-running technology boom.  Bio-pharmaceutical companies in particular expressed concerns about Israel’s commitment to provide effective data exclusivity – protection for commercially valuable dossiers submitted to regulators as a condition for gaining marketing approval – and other lacunae in the outdated patent law.  In the early 2000′s, FDI in innovative bio-pharma R&D stagnated, and Israel lost luster as a clinical research destination.

Much has happened on the IP front in the last 5 years:  In 2009, the World Intellectual Property Organization (WIPO) appointed the Israeli Patent Office as an International Searching and Preliminary Authority under the PCT, in recognition of Israel’s technology prowess.  Under pressure abroad and at home, Israel initiated substantial reforms for harmonization its IP regime with international norms. This year Israel seeks to complete the legislative process this year for pending bills to address remaining key concerns relating to patent term extension.

All the while, Israel has excelled at IP management from a technology transfer perspective.  Effective technology transfer pre-dates Israeli independence, and has been carried forward by the Weizman Institute, Technion and other technology powerhouses across the country. (I wrote more about the foundational nature of tech transfer for Israel for the Biotechblog last February, here.)

Technology linkages supporting Israel’s biotech boom are captured in the 2013 US-Israel Innovation Index, released last week here in Washington DC.  The 2013 Index measures how Israel stacks up against a range of comparator countries, including Switzerland, Canada, Singapore, Germany, Sweden, South Korea, Finland, Japan, Turkey, Brazil and Russia, in descending rank.   Indicators include government support for innovation, the level of intensity of private sectors / industry activity, human capital and overall R&D.  Despite its small size – both geographically and in population – Israel ranks with Canada and is outpaced only by Switzerland.   Data sources and an annex with the data itself are available online.

Although it is not addressed directly in the 2013 Index, access to capital is another interesting factor that sets Israel apart from the rest of the Middle East / North Africa (MENA) region.  As measured by the OECD, Israel provides perhaps the most vibrant pool of VC funding outside the United States.   Moreover, Israeli VCs continue to place funds in early stage companies.

Israel’s biotech boom began with medical devices, where Israeli innovators were able to leverage IT technologies for novel Health Information Technologies (HIT).

Overall, the number of life-science companies has grown from 186 in 1996 to more than 1,100 in 2012, in a state with a population of only 7 million people. 

Most biotech funding still goes into medical devices, where the risk and development time is more favorable as compared to pure bio-pharma. Still, an increasing number of Israel’s most exciting biotechnology companies focus purely on novel therapies targeting unmet medical needs. I have met some of these pioneers and they are impressive. Their success or failure may determine the future path of biotechnology in Israel.

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.

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

Human cell- and tissue- based products: Progress, promise and regulatory issues

Go to paper

ABSTRACT: The field of cell- and tissue-based products is radically changing through the use of biotechnology. The authors outline developments that are currently taking place, leading to the need for adapted regulations, for which worldwide harmonisation is important since potential safety issues have no borders and companies operate globally...

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:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

The fourth edition of Building Biotechnology, the premier biotechnology industry primer, is now available.

Building Biotechnology has been adopted by dozens of educational programs, and is on the nightstands of many biotech CEOs. The book covers a broad range of essential knowledge in business, regulations, patents, law, policy, and science.

This fourth edition significantly expands upon the foundation laid by the first three, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables. Most importantly, Building Biotechnology enables seasoned business professionals and entrepreneurial scientists alike to understand the drivers of biotechnology businesses and apply their established skills for commercial success.

See more details at www.BuildingBiotechnology.com, or buy at Amazon.com

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

Embryo and stem cell research: Views from the USA

Go to paper

ABSTRACT: Presents a study that examined the history, ethical debates and religious views regarding embryo and stem cell research in the U.S. Effect of the abortion debate on embryo research in the U.S.; Reason behind the reluctance of the federal government to fund therapeutic research; Role of the private sector in the development of embryo and stem cell research.

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:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

This 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.

My maiden guest post for the Biotechblog last focused on the global impact of reduced funding for innovative bio-pharma development on clinical research and the threat to the global clinical research enterprise.   At that point the clinical research sector in India looked like an outlier with year-on-year increases in clinical trials and revenues projected to grow from $450 million in 2011 to $1b by 2016.  Now as we approach the end of 2013, that rosy scenario appears increasingly unrealistic.  India’s clinical research sector faces an uncertain future, with allegations including lack of informed consent and poor treatment of illiterate Indian patients.

Responding to civil society allegations of corruption and fraud, the Indian Supreme Court has intervened directly in the conduct of clinical research in India, suspending or freezing hundreds of clinical trials.  While it is tempting to put the blame for lax enforcement of standards on the recent influx to India of MNC clinical trials, India’s Parliamentary Standing Committee on Health and Family Welfare identified similar shortcomings in oversight of both domestic Indian companies and MNCs alike, going back several years in time.

Well ahead of the Indian Supreme Court decisions in 2013, the Parliamentary Standing Committee reported in May of 2012 that  the Central Drugs Standards Control Organization (CDSC) – the primary watchdog responsible for drug safety and related clinical research – had long since been captured by the industry it was charged with regulating:

The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured. p. 9  

The Parliamentary Standing Committee cited systematic fraud, for example, in the case of Cipla’s application for approval of cancer drug Pirfenidone.  The Committee concludes that Cipla never undertook the required Phase III clinical trial in India, and yet the company received marketing approval nonetheless.

Not only the regulators, but Indian academics and specialist hospital physicians are also compromised in the process.  The Committee’s report to the both chambers of Parliament continues, documenting that the company coordinated or otherwise controlled simultaneous submission 4 separate letters of recommendation of approval from institutions located in Delhi, Mumbai, Chandighargh and Secunderabad – all received exactly on the same day 2-7 2010 and diarized by DCGI office under consecutive references 4877, 4878, 4879 and 4880.” (p. 34)

(In October of 2010, Cipla issued a glowing press release announcing the launch of the “World’s First Generic Pirfenidone in India, Giving Hope to Suffers of IPF (Idiopathic Pulmonary Fibrosis)”  Despite the strong documentation presented to both Houses of Parliament supporting the contention that the Cipla did not conduct any clinical trials at all prior to approval of this first generic copy of a serious cancer drug, it remains on the market in India and internationally via Canadian online pharmacies – caveat emptor.)

Now the India Supreme Court process has taken matters to the other extreme, creating onerous and unrealistic new clinical research requirements and freezing clinical research in India, far exceeding requirements under the  International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use, known as ICH. These include mandatory compensation requirements for patients, and use of audio and visual recordings of informed consent, among others.  Paradoxically, by imposing more stringent obligations than exceed ICH standards, the Indian Supreme Court rulings further reduces the likelihood that India can build needed capacities for ethical clinical research in compliance with international compliance.

In this context,  a clinical research advocacy group known as: People for the Advancement of Clinical Research – India, has lodged an online petition at Change.org and petitioning Supreme Court of India: “Allow the Review and Approval Process for Clinical Trial Applications to Resume.” The Change.org petition provides compelling reasons for the continuation of clinical trials in India – identifying the existing standards and the extraordinary new measures now required under the recent Indian Supreme Court decisions.  Everything in the petition is both true and  yet sadly irrelevant given what we know to be the unfortunate ground realities documented by the 2012 Parliamentary Standing Committee report.

The Change.org petition seeks to reinstate the status quo ante without any serious reflection on how things have gone wrong, or suggestions on how to change a drugs development culture that tolerates cutting of corners and even outright fraud.  All good intentions aside, Indian academics, industry and government agencies together have shown remarkable effectiveness at evading and undermining India’s compliance with ICH standards.

The Indian Supreme Court may have got it wrong, but the Change.org petition does not get it right.

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.

Drug Patent Expirations for November 2013

TradenameApplicantGeneric NamePatent NumberPatent Expiration
SAMSCAOtsuka America Pharmtolvaptan5,258,510Nov 2, 2013
PROPECIAMerckfinasteride5,571,817Nov 5, 2013
ACIPHEX SPRINKLEEisai Incrabeprazole sodium5,045,552*PEDNov 8, 2013
ACIPHEXEisai Incrabeprazole sodium5,045,552*PEDNov 8, 2013
TECHNESCAN MAG3Mallinckrodttechnetium tc-99m mertiatide kit5,573,748Nov 12, 2013
EXPARELPacira Pharms Incbupivacaine6,132,766Nov 16, 2013
SURFAXINDiscovery Labslucinactant5,407,914Nov 17, 2013
SUSTIVABristol Myers Squibbefavirenz5,519,021*PEDNov 21, 2013
ATRIPLAGileadefavirenz; emtricitabine; tenofovir disoproxil fumarate5,519,021*PEDNov 21, 2013
JEVTANA KITSanofi Aventis Uscabazitaxel5,438,072Nov 22, 2013
CHILDREN'S ALLEGRA ALLERGYSanofi Aventis Usfexofenadine hydrochloride5,578,610Nov 26, 2013
ALINIARomarknitazoxanide5,578,621Nov 26, 2013
CHILDREN'S ALLEGRA HIVESSanofi Aventis Usfexofenadine hydrochloride5,578,610Nov 26, 2013
ALLEGRASanofi Aventis Usfexofenadine hydrochloride5,578,610Nov 26, 2013
ZOLINZAMerckvorinostatRE38506Nov 29, 2013
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Subscribers have access to valuable datasets, including:

  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Sales data (top 200 drugs)
  • Paragraph IV challenges
  • Tentative approvals
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison.
Contact Us with any questions.