While Europe and the US have traditionally been seen as the global leaders in clinical research, you cannot ignore Israel’s penchant for innovation, entrepreneurship and creativity in the life sciences. The nation has one of the most vibrant biopharma sectors in the world and has the most medical device patents per capita. The Israeli life sciences landscape is mostly made up of small start-up companies (66 percent of its total 1380 life science companies are less than a decade old, according to the Israel Advanced Tech Industries Group). While the innovations of these start-ups and the research of the country’s foremost institutions have contributed to solutions to some of the most serious disease areas, many global biopharma companies still seem relatively hesitant to conduct clinical trials there.
One potential reason that big pharma has been reluctant to have more of a presence in Israel is challenges inherent in navigating the regulatory environment. An increased focus on patient safety has resulted in regulations tightening worldwide but navigating the nuances of a region can require local expertise. Keeping up with small changes in regulations costs time as well as money and this can cause a lag in study start-up if not managed correctly. With the global pharmaceutical industry becoming more competitive, even a small delay in R&D timelines is one that companies can ill-afford.
Israel’s status as a melting-pot of ethnicities is both an advantage and a pitfall for international companies. On the one hand, this diverse population offers natural benefits when conducting clinical trials. However, as the population originates from a variety of nations, companies must also be aware of the variety of languages at play in Israel. This means that the Informed Consent Form must first be written in Hebrew in accordance with the Ministry of Health format and then translated into the various spoken languages (e.g. Arabic, English, Russian, etc.).
Even Israeli pharma companies can feel driven to conduct their trials further afield. For instance, there is a perception among the life sciences community in Israel that if you want to break into the American drug or device market you need American data. Even the smallest of Israeli biopharma and device companies are willing to go to the expense of conducting their trials in the US or under the supervision of an American PI to ensure that their clinical data is seen to have integrity. However, Israeli and global companies alike risk missing out on building relationships with the many talented physicians that Israel has to offer. Moreover, since the Israeli population is insured through national health insurance, the medical history of individuals is easily tracked over time, meaning that the Israeli healthcare system offers important advantages in the long-term monitoring of subjects.
Therefore the potential benefits outweigh the regulatory and cultural challenges for international companies. So what more can the nation do to ensure it has a bigger footprint on the world stage and is firmly on the radar in the boardrooms of global companies when they are discussing where to place their clinical studies?
Some think that the answer lies with Israel’s physicians who have traditionally been fantastic advocates for their patients but could potentially do more to market themselves and Israel as a nation that can deliver world-class clinical results for global companies. Since the late 1990s, there has been widespread adherence to GCP standards and Israel was the first country to accept ICH guidelines for GCP in 1997. Moreover, the excellent audits of Israeli sites by European pharmaceutical companies prove their desire to follow the letter of the law in clinical studies rather than to cut corners.
There is also the question of how Israeli physicians can effectively publicise the successful roles they have had in other studies as well as the resources that are available in Israel which can make the country a better fit for certain studies. For example, it is a particularly important market for hereditary disease trials due to the high prevalence in the population.
Multinationals like Merck, Teva and Pfizer have already led the way in utilising the resources that Israel has to offer. For instance, 15 percent of Merck’s products have Israeli roots and the company further invested in the market by recently acquiring Israeli start-up Qlight Nanotech, a key innovator in nanotechnology.
With its unique patient population, an innovative biotech hub and a host of talented physicians, can big pharma afford not to view Israel as a key market for conducting clinical trials?