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| The Journal of Israel Innovation - Life Sciences Special Edition |
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EDITOR’S NOTE
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Investing in Israel Innovations
Robin JR Blatt
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INVITED COMMENTARY
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Implementing Israel's Vision of Innovation
Dr. Eli Opper
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GUEST EDITORIAL
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The Intersection of Economics, Diplomacy and Trade
The Honorable Nadav Tamir
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FEATURES
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Israel’s Life Science Industry-Towards a Breakthrough Decade
Benny Zeevi
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Intellectual Property Protection: Basic Considerations for Emerging Companies
David Johnson, David Crosby and D'vorah Graeser
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FDA and the Critical Path to 21st Century Medicine
Peter J. Pitts
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Biotechnology Business and Revenue Models
Stephen M. Sammut
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The Secret Engine Behind Israel's Innovations
Nava Swersky Sofer
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CLEANTECH & RENEWABLE ENERGY
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The New Energy Economy: Israeli Innovations in Sustainable CleanTechnology & Renewable Energy
Isaac Berzin and Robin JR Blatt
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2008 BIOINTERVIEWS
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Professor Rafael Beyar, MD, Director, Rambam Health Care Campus
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Elka Nir, Managing Director, Life Sciences, Giza Venture Capital
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Yadin Kaufmann, Founder & Chairman, Tmura and Founding Partner, Veritas Venture Partner
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Hezi Himelfarb, CEO Remon Medical Technologies, Inc
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Zeev Zelig, Vice President, General Manager of the Genzyme ITG Region
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Sarit Soccary-Ben Yochanan, CEO, ATI
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Jonathan Fleming, Managing General Partner, Oxford Bioscience Partners
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U.S. FOOD AND DRUG ADMINISTRATION (FDA) SPECIAL SEGMENT
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Regulation of Medical Devices: Past, Present, Future
Daniel G. Schultz
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The Regulation of Medical Devices and the Worldwide Scene
Larry Kessler
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The Role of Standards and Guidance in Advancing Device Technology
Larry Kessler and Carol L. Herman
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BIOCOLUMNS
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BioR&D / BIRD Foundation: Funding Israeli-American Collaborations for Developing and Commercializing Innovative Technologies
Eitan Yudilevich
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Tech Transfer / Commercializing Intellectual Property: The Role of Technology Transfer
Benjamin Soffer
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BioInvestment / How Multinational Corporations Can Benefit from Israel's Innovation in R&D: New Initiatives Open to Foreign Investors and Strategic Partners
Robin JR Blatt
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BioResearch / The Untapped Potential: The Current Environment for Research Based Pharmaceutical and Biotech Companies in Israel
Tomer Feffer (Edited by Michelle Bartov)
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Drug Term Extensions / Drug Term Extensions in Israel
Michael Factor
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Alternative Financing / Accessing US Government Contracts and Grants: Key Points for Israeli Life Sciences Companies
William Weisberg
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Feature
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Investing in Israel Innovations
Robin JR Blatt
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Abstract:
Israel is often referred to as one of the brightest "stars" in the global science and technological universe. In recent years, Israel, and the northern city of Haifa, has been growing and gaining strategic importance as a gateway within Israel and to the Middle East while transforming the country into a destination for international life sciences research and development (R&D), clinical trials and business development ventures. Although a young country, Israel is known for its highly talented, entrepreneurial and technologically advanced multiethnic society and strong workforce engaged in some of the most cutting edge research and development (R&D) in the life sciences. The political system and economy has undergone unprecedented change and provides favorable incentives for R&D, intellectual property protection, commercialization and global collaboration in science and technology. Tremendous innovations are underway in the areas of biotechnology, minimally invasive and medical devices, pharmaceutical and cellular research, regenerative medicine, bioinformatics, biomaterials and biomedical engineering, nanotechnology, biosecurity, marine biotechnology, robotics, cleantechnology, renewable energy, high technology and other knowledge-based sectors. Many of Israel's diverse and sophisticated technologies are aided by the increasing transfer of defense visualization and navigation technologies to health care and other knowledge-based sectors. This article is designed to provide an overview of the Israel life sciences sector, and, to highlight the scientific and technological achievements and contributions to global health.
13 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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Feature
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Implementing Israel's Vision of Innovation
Dr. Eli Opper
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Abstract:
No Abstract
5 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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Feature
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The Intersection of Economics, Diplomacy and Trade
The Honorable Nadav Tamir
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Abstract:
Modern diplomacy in the context of globalization has created new models for traditional diplomats. Today, diplomacy, economics and trade are interconnected with new agenda items constantly expanding capacities and forging new alliances in diplomatic, economic, and political spheres. This article highlights the importance of integrating international cooperation, diplomacy and economic policy-making.
2 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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Feature
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Israel's Life Science Industry-Towards a Breakthrough Decade
Benny Zeevi
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Abstract:
The world healthcare market continues to grow with several important drivers. The health care market is in constant need for new diagnostics and therapeutic products to address many unmet clinical needs that exist today. The Israeli Life Science Industry is growing at a rapid pace and is filling an important role in the global health care market. This article provides an overview of the world health care market and the contributions of Israeli life science technologies to the field.
3 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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Intellectual Property Protection: Basic Considerations for Emerging Companies
David Johnson, David Crosby and D'vorah Graeser
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Abstract:
This article provides an overall discussion of intellectual property. Intellectual property is a type of property which is very important for life science companies. Companies must be certain to both secure their own intellectual property rights in a cost effective manner, and also to avoid infringing the intellectual property rights of others.
3 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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FDA and the Critical Path to 21st Century Medicine
Peter J. Pitts
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Abstract:
One of the most pressing issues that confronts the FDA is learning how to better address and assist in medical product development. FDA needs to prepare today so the agency can efficiently evaluate the technologies of tomorrow. Clearly this is an area that impacts not only health care consumers, but also our economies and financial markets. If the FDA can be a more aggressive part of the solution, they can help not only ease some of the pressures that are driving up healthcare costs, but also help all of us to maximize the value of medical innovations. This article highlights key issues associated with the FDA's Critical Path Initiative.
4 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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Biotechnology Business and Revenue Models
Stephen M. Sammut
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Abstract:
This article provides an overview of accounting of the macro conditions in the biotechnology and pharmaceutical industry and identify the factors that drive change in business and revenue models.
3 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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The Secret Engine Behind Israel's Innovations
Nava Swersky Sofer
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Abstract:
The process of transferring technology from its academic cradle to realization in industry is both challenging and rewarding. This article provides an overview of Yissum (in Hebrew: 'application'), the technology transfer company of the Hebrew University of Jerusalem and addresses the following questions: How does the process work? Who are the stakeholders? And, how success is achieved?
3 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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The New Energy Economy: Israeli Innovations in Sustainable CleanTechnology & Renewable Energy
Isaac Berzin and Robin JR Blatt
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Abstract:
It has never been more evident that concerns regarding climate change and high energy costs are converging into new era of cleantechnology and renewable energy. For global health, environmental and economic sustainability, the world must urgently develop economically viable and sustainable cleantechnology and energy alternatives. Today, Israel is leading this effort. Israeli scientists and entrepreneurs are developing
cutting edge science and technology and are motivated to find a solution for oil independence; as such, innovation in Israel has created a strong sector in clean technology and renewable energy that supports health, the environment and energy independence. Israel's position as an international center of excellence in biotechnology, nanotechnology, desert agriculture, solar energy, and entrepreneurship makes Israel especially well suited for innovation in cleantechnology and renewable energy.
4 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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JB&B Thought Leader BioInterview
Professor Rafael Beyar, MD, Director, Rambam Health Care Campus
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Abstract:
No Abstract
2 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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JB&B Thought Leader BioInterview
Elka Nir, Managing Director, Life Sciences, Giza Venture Capital
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Abstract:
No Abstract
2 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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JB&B Thought Leader BioInterview
Yadin Kaufmann, Founder & Chairman, Tmura and Founding Partner, Veritas Venture Partner
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Abstract:
In this interview, Robin JR Blatt, Publisher of The Journal of BioLaw & Business speaks with one of Israel's leading investors and corporate citizens-Yadin Kauffman-who discusses why he founded Tmura and how the organization is enhancing corporate philanthropy in Israel and assisting not-for-profit organizations with funds generated through donated stock options.
2 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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JB&B Thought Leader BioInterview
Hezi Himelfarb, CEO Remon Medical Technologies, Inc
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Abstract:
No Abstract
2 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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JB&B Thought Leader BioInterview
Zeev Zelig, Vice President, General Manager of the Genzyme ITG Region
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Abstract:
No Abstract
2 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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JB&B Thought Leader BioInterview
Sarit Soccary-Ben Yochanan, CEO, ATI
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Abstract:
No Abstract
3 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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JB&B Thought Leader BioInterview
Jonathan Fleming, Managing General Partner, Oxford Bioscience Partners
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Abstract:
No Abstract
2 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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Regulation of Medical Devices: Past, Present, Future
Daniel G. Schultz
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Abstract:
The regulation of medical devices requires a unique blend of science, law, public health policy, and common sense. This has posed an enormous challenge to both the Food and Drug Administration (FDA) and the industry since the passage of the Medical Device Amendments in 1976, and it has led to a complex and ever-evolving regulatory system designed to accommodate a very broad range of products. This article is an attempt to describe that evolution and to offer some thoughts on what the future may hold.
6 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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The Regulation of Medical Devices and the Worldwide Scene
Larry Kessler
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Abstract:
U.S. medical technology companies lead the world, producing nearly $78 billion annually and generating nearly 6% annual growth. While this is impressive enough, it pales in comparison beside the value of the medical devices that are ubiquitous in our health care, and increasingly our home, environment. This article discusses critical aspects of the FDA regulatory system for medical devices and provides an overview of the global regulatory landscape.
3 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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The Role of Standards and Guidance in Advancing Device Technology
Larry Kessler and Carol L. Herman
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Abstract:
Advancing medical device technology from the design to delivery to patients takes many steps, typically including design or modification of an existing device, bench or laboratory testing, risk analysis, clinical testing (if appropriate), review of the device by regulatory agencies, and postmarket surveillance by both the regulatory agency and the manufacturer. The development of technical guidance documents or international standards has made this process more efficient in the United States, though these processes are both underutilized and underappreciated. The history of the use of these approaches will be described, as well as recent progress and how the future of guidance and standards may evolve.
5 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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BioR&D / BIRD Foundation: Funding Israeli-American Collaborations for Developing and Commercializing Innovative Technologies
Eitan Yudilevich
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Abstract:
The mission of the U.S.-Israel Binational Industrial Research and Development (BIRD) Foundation is to stimulate, promote and support industrial Research & Development of mutual benefit to the U.S. and Israel. This article describes the BIRD Foundation and highlights the grant opportunities and benefits for U.S. and Israel companies.
3 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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Tech Transfer / Commercializing Intellectual Property: The Role of Technology Transfer
Benjamin Soffer
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Abstract:
As Israel's oldest and premier institute of science and technology, the Technion-Israel Institute of Technology has been an active and leading participant in Israel's establishment and development. With supreme effort and unyielding dedication, deserts have bloomed, swamps have been transformed into fertile agricultural valleys, and sand has given way to silicon. Technion Technology Transfer (T3) is the commercialization arm of the Technion Research and Development Foundation Ltd. (TRDF). This article highlights the role of T3 in understanding the interests and needs of the marketplace, together with up-to-date knowledge of the Technion's research projects, and the processes that support inventors and researchers in commercializing IP and forming the optimal alliances among scientists, industry and investors.
3 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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BioInvestment / How Multinational Corporations Can Benefit from Israel's Innovation in R&D: New Initiatives Open to Foreign Investors and Strategic Partners
Robin JR Blatt
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Abstract:
Within the last decade the Israeli biotechnology sector has emerged and grown impressively, with the number of companies increasing at a rapid rate. Israel's unique capabilities, particularly a large base of science-skilled academics and strong entrepreneurial spirit, provide an ideal foundation for building a leading life sciences industry with innovations that contribute to global health. This article highlights programs established by the Israeli government to enhance cooperation between the academia and industry with the goal of promoting the commercialization of Israeli biotechnology innovation worldwide.
3 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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BioResearch / The Untapped Potential: The Current Environment for Research Based Pharmaceutical and Biotech Companies in Israel
Tomer Feffer (Edited by Michelle Bartov)
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Abstract:
Israel is one of the leading countries in number of biotech startups compared to any other country in the world, outside the U.S. with more than 600 Life Sciences companies and an average of 53 new Life Sciences companies being formed per year over the last 6 years. The biotechnology sector represents one of the country's most impressive opportunities for economic and industrial growth. And yet, the government of Israel does not seem to encourage the multinational companies to increase their local presence and activities.
This article will present the shortcomings of the current government policy and its consequences.
3 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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Drug Term Extensions / Drug Term Extensions in Israel
Michael Factor
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Abstract:
In 1998 the Israel Patent Law was amended to allow experimental development of patented drugs about to expire, and their testing for licensing purposes (see Section 54 of the Israel Patent Law 1967). This article discusses the background of this amendment and the current status of drug term extension in Israel.
2 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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Alternative Financing / Accessing US Government Contracts and Grants: Key Points for Israeli Life Sciences Companies
William Weisberg
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Abstract:
The United States (US) government has traditionally been a significant funding source for biotechnology and life sciences research. For many years, that funding, whether from the National Institutes of Health ("NIH"), the Department of Defense ("DoD"), or from other agencies, imposed few legal restrictions on companies, particularly compared to the requirements imposed on "traditional" government contractors. In the last few years, that has changed, with the changes accelerating after September 11. Today, the U.S. government is funding biotechnology and life sciences research like never before. Israeli firms, either directly, through US subsidiaries, or as subcontractors or subgrantees, are participating in these programs in increasing numbers. This article highlights emerging opportunities and key points for consideration when seeking US government funding.
3 pages
©2009
by The Journal of Israel Innovation. All Rights Reserved.
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