Given the world's major needsfood, health, energybiotechnology
is one of the most exciting and potentially profitable fields imaginable.
The United States, with its advanced management and marketing expertise,
and Israel, with its highly innovative R&D community and high-quality/moderate-cost
workforce, are particularly well-placed to benefit from strategic partnerships.
Biotechnology is already big business. American has more than 1,000
biotech companies, with $3.5 billion in 1992 sales (more than 90 percent
in human health products), which directly provide almost 100,000 American
jobs. Thousands of products are in the pipeline, under development or awaiting
regulatory approval. These should emerge in the next few years, signaling
the field's next, more mature phase.
Israel, given its much smaller size, domestic market and access to venture
capital, has only about 50 domestic biotech companies, employing 3,000
Israelis. Israel's intensive interest and investment in science, however,
give her a scientific status and high-tech impact typical of industrialized
countries many times her absolute size. The specific Israeli innovations
in biotechnology, moreover, create opportunities for strategic alliances
that can benefit the companies involved and, more broadly, the citizens
of Israel and the United States.
The United States and Israel have long been partners in a variety of
mutually beneficial endeavors, many funded by binational foundations (BSF,
BARD, BIRD). New structures, such as the U.S.-Israel Science and Technology
Commission (USISTC), recently established by President Clinton, seek to
further extend the competitive edge of both the American and Israeli high-tech
sectors through increased cooperation. The USISTC's Working Group on Biotechnology,
Israel's National Committee for Biotechnology and a new U.S.-Israel Biotechnology
Council have all been particularly active.
Even before the new governmental emphasis on cooperation in biotechnology,
many U.S. companies established Israeli subsidiaries to benefit from generous
Israeli government R&D incentives, Israel's highly-trained, highly-dedicated,
moderately-priced workforce and free trade agreements with both
the U.S. and Europe. The Binational Industrial Research & Development
Foundation (BIRD) has also supported joint projects between American and
Israeli biotech firms.
The abundance of Israeli biotech innovations warrants American attention.
These include mice with transplanted human bone marrow that can produce
human antibodies; a juvenile-onset diabetes treatment that is 90
percent effective in mice; drugs that decrease recurrent attacks of multiple
sclerosis, boost human interferon production and modulate blood clotting
and safe new vectors useful in human gene therapy. Israeli researchers
also developed new processes for the commercial production of important
recombinant proteins such as human and bovine growth hormones, human superoxide
dismutase (SOD), human tissue plasminogen-activator, human beta-interferon
and human interleukin-6, a promising activator-component in experimental
Diagnostics, particularly monoclonal antibody-based test kits, were
among Israel's first biotech successes. The FDA's stringent Good Clinical
Practice (GCP) regulations for pharmaceutical testing force most Israeli
researchers to license their new drug discoveries before major (Phase III)
clinical trials. In contrast, Israel moves its diagnostic discoveries
from the laboratory to the marketplace in record time (3-5.3 years) at
record low budgets ($0.9-1.2 million), compared to their U.S. counterparts
(8-11 years, $25-30 million). Starting with the world's first ELISA test
for chlamydia in 1989, Israelis soon developed high-quality tests for Epstein-Barr
virus, cytomegalovirus, herpes I and II viruses, mycoplasmal pneumonia,
TSH, hepatitis A and B, anti-sperm antibodies and early pregnancy. They
now have simple, ultra-fast and highly accurate two-minute tests for urinary-tract
infections and AIDS. Israel's academic researchers are now shifting their
attention to DNA and RNA-based (rather than antibody-based) tests for cancer
and other diseases. New products for monitoring blood sugar and diagnosing
Alzheimer's disease are also under development.
Although foreign experts consistently praise Israeli agricultural biotechnology
as unique, agricultural R&D support and commercial activity tend to
lag behind that for medical applications. Israel is blessed with rich genetic
resources. The home and center-of-diversity of such grains as wheat, oats
and barley, Israel has been working with the U.S. Department of Agriculture
on new varieties since 1909. It also has the advanced biotechnology to
exploit valuable genes. Recent successes include increasing yields through
the production of chromosome-engineered pasta and bread wheats and raising
genetically-engineered tobacco plants that can protect themselves from
viral attack. Several other virus-resistant transgenic plants have already
been patented. Israeli ELISA-based plant diagnostic tests already protect
most U.S. seed potatoes from potato leaf-roll virus. Other researchers
have developed plant virus diagnostic kits for many other viruses, including
those affecting beans, tomatoes and tobacco.
Another Israeli specialty is biological control. Trichoderma
fungi, often improved by protoplast fusion, prevent damping-off disease
and Fusarium wilt, while boosting plant growth. Special non-virulent
Rhizoctonia strains have similar effects. Other researchers have
discovered a highly potent antiviral agent, IVR, in tobacco. They have
already identified the IVR gene, inserted it into bacteria and can now
produce IVR by fermentation. Transgenic IVR-producing virus-resistant crop
plants are next. Israel's well-known Bacillus thuringiensis var. israelensis(BTI)
produces a potent, highly selective, environmentally-safe toxin that kills
mosquito and black-fly larvae. BTI formed the basis of a recent successful
mosquito control effort in Massachusetts and a new U.S.-Israel-Jordan biocontrol
initiative sponsored by the U.S. Agency for International Development.
Animals are a major agricultural money-maker; the U.S. produces $72
billion of cattle/dairy/poultry products annually. New Israeli biotech
innovations help breed leaner chickens and more fertile cows, diagnose
Rift Valley Fever (RVF) and anaplasmosis in cattle and screen for Marek's
disease in poultry. Israeli investigators and U.S. collaborators have developed
new vaccines against RVF, Newcastle disease and Mycoplasma gallisepticum.
They have even produced and successfully tested a vaccine against fish
meningitis for use in aquaculture. Perhaps the most innovative new Israeli
vaccine reduces tick-borne diseases in cattle by binding special receptors
located near the tick's mouth, which maintain the feeding response. They
are now using a similar strategy against lice.
The report concludes with recommendations on how potential partners,
and Israel itself, could best benefit from Israeli biotech opportunities.
These include the need for a Biotechnology Innovation Development Fund
to strengthen the weakest link in Israel's laboratory-to-market chain,
Precompetitive Industrial Research Centers, Israeli Contract Research Organization's
and Clinical Research Associate training programs capable of meeting the
FDA's GCP requirements for clinical trials and further strengthening of
academic-industrial linkages. In particular, Israel's high recruitment
rates and low dropout rates could significantly speed up U.S. clinical
trials, and increase U.S. pharmaceutical competitiveness, once FDA GCP's
are met, to the mutual benefit of both countries.
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