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valuable dossiers submitted to regulators as a condition for gaining marketing approval – and other lacunae in the outdated patent law.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.
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
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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
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
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
| Tradename | Applicant | Generic Name | Patent Number | Patent Expiration |
|---|
| SAMSCA | Otsuka America Pharm | tolvaptan | 5,258,510 | Nov 2, 2013 |
| PROPECIA | Merck | finasteride | 5,571,817 | Nov 5, 2013 |
| ACIPHEX SPRINKLE | Eisai Inc | rabeprazole sodium | 5,045,552*PED | Nov 8, 2013 |
| ACIPHEX | Eisai Inc | rabeprazole sodium | 5,045,552*PED | Nov 8, 2013 |
| TECHNESCAN MAG3 | Mallinckrodt | technetium tc-99m mertiatide kit | 5,573,748 | Nov 12, 2013 |
| EXPAREL | Pacira Pharms Inc | bupivacaine | 6,132,766 | Nov 16, 2013 |
| SURFAXIN | Discovery Labs | lucinactant | 5,407,914 | Nov 17, 2013 |
| SUSTIVA | Bristol Myers Squibb | efavirenz | 5,519,021*PED | Nov 21, 2013 |
| ATRIPLA | Gilead | efavirenz; emtricitabine; tenofovir disoproxil fumarate | 5,519,021*PED | Nov 21, 2013 |
| JEVTANA KIT | Sanofi Aventis Us | cabazitaxel | 5,438,072 | Nov 22, 2013 |
| CHILDREN'S ALLEGRA ALLERGY | Sanofi Aventis Us | fexofenadine hydrochloride | 5,578,610 | Nov 26, 2013 |
| ALINIA | Romark | nitazoxanide | 5,578,621 | Nov 26, 2013 |
| CHILDREN'S ALLEGRA HIVES | Sanofi Aventis Us | fexofenadine hydrochloride | 5,578,610 | Nov 26, 2013 |
| ALLEGRA | Sanofi Aventis Us | fexofenadine hydrochloride | 5,578,610 | Nov 26, 2013 |
| ZOLINZA | Merck | vorinostat | RE38506 | Nov 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…
With prior BiotechBlog intern Fintan Burke moving on to some exciting new projects, I have time to train a few more aspiring writers.
(Professionals seeking to submit guest posts to BiotechBlog or to the Journal of Commercial Biotechnology should visit the Publishing Opportunities page).
Prospective interns are advised to see Fintan’s contributions and the other guest content. The schedule and deliverables are flexible, to accommodate your school schedule.
To apply for a BiotechBlog internship please send me writing samples, your resume, and a statement of interests to info@thinkbiotech.com.
Ananda Chakrabarty is the holder of the first patent on a genetically-modified organism. Lately he’s turned his sights to a revolutionary new approach to cancer treatment — utilizing proteins from naturally-occuring symbiotic bacteria. These exploits are described in his new book, Bugging Cancer.
For centuries mankind has been intimidated by cancer, and research has been going on for many decades as to how to address or attack the disease meaningfully so as to eradicate it. But the causes of cancer are so diverse in nature that it is extremely difficult to predict or to control the conditions, let alone fully cure it.
Bugging Cancer is a fictional book, based on real scientific progress in using bacteria and bacterial proteins to attack malignant tumor cells. Scientific results are extended in a fictional way to describe the cancer-fighting power of an imaginary bacterial protein termed neelazin.
The book also mirrors present-day issues, including international competition for scientific talent, issues in patent law, research ethics, and financing. Written by a team of seasoned scientific and business professionals, Bugging Cancer is sure to appeal to scientific researchers, patent attorneys, physicians, any anyone else interested in healthcare and scientific innovation.
Interested media outlets should contact me for a review copy, and readers can fill out the form below for notification on publication (due February 2014):
Notify me when the book is published |
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
Go to paper
ABSTRACT: The two leading therapeutic areas for biological products, in terms of current sales and pipeline focus, are oncology and AIID (arthritis, immune and inflammatory disorders). Datamonitor's biotechnology strategic market analysis team recently analysed the AIID market, since this sector is currently powering biotechnology market growth, owing to high demand for biologicals to treat rheumatoid arthritis and psoriasis (Belsey, M...
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 slated for publication in December and is ready for reviewers.
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.
Interested media outlets should contact me for a review copy, and readers can fill out the form below for notification on publication (due December 2013):
Notify me when the book is published |
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