“Mind the Gap” – Let’s talk about clinical trials in Israel

The issue of conducting clinical trials in Israel is complex and often frustrating.  IBT-Tech brought together representatives of industry and startups, researchers and hospitals, and the Innovation Authority, for an honest, open dialogue.

“There are many reasons for startups to conduct clinical trials in Israel,” explains Prof. Michal Schnaider Beeri, Director of the Joseph Sagol Neuroscience Center at The Sheba Medical Center.  “Communication within Israel is always easier – we ‘speak the same language’ culturally, not just literally…and at the national level, it’s in our interest to conduct clinical studies in Israel.  This is a key opportunity for patients to get access to the newest innovative solutions, as usually companies who are not based in Israel don’t do their clinical studies here.”

Prof. Michal Schnaider Beeri

Prof. Michal Schnaider Beeri

Still many Israeli life sciences startups look across the ocean to conduct clinical  trials, and each of the parties involved – entrepreneurs, doctors, researchers, the Ministry of Health – presents different, and often conflicting needs.

“There is a  difference in approach between the industry and researchers,” says Moran Ploznik, VP Clinical & Regulatory Affairs at Neuronix.  “What interests the researcher is not always the same as what the industry wants to test. For example, at Neuronix we’re treating the symptoms of Alzheimer’s patients by improving their cognitive performance and daily functioning. Researchers are typically more interested in understanding the biological processes in the brain that enable this, whereas we are focused on the clinical outcome and practical implications.”

The main tension point is usually between startup entrepreneurs, who need to show fast results in order to raise funds, and the researchers, who require time and budget to conduct effective and scientifically sound trials.  A proof of concept for a non-invasive medical device usually takes a year and costs about $100,000.  “We’re working on creative solutions at Sheba to get around these issues,” said Prof. Schnaider Beeri.  “We are now advancing a plan in which three Israeli startups will participate in the same clinical study, and split the $100k cost three ways, making it much more doable. This also gives the companies the opportunity to interact and the scientists the opportunity to investigate whether integration of the technologies further enhances our capacity to effectively disentangle the complexities of the brain disease of interest. I can only see upsides.”

Moran Ploznik

Moran Ploznik

The recent IBT-Tech meeting, which took place at the Innovation Authority on November 29th, was a rare opportunity for an open and constructive dialogue between industry, medical centers and research.  “We got great feedback on this meetup,” says Yael Zifroni Sommer, Director of IBT-Tech, the Israeli BrainTech industry association, supported by the Innovation Authority. “It was a real ‘eye-opener’ for the participants.”

“It was surprising, and refreshing, to realize that frustration with the process is not confined to the industry alone,” says Moran Ploznik. “I heard Dr. Miki Roll, who heads R&D at Ichilov hospital, talk about their difficulties as well. In many respects, we are all in the same boat.”

Despite significant improvements in efficiency over the past few years, often the bottleneck is still regulations and bureaucracy.  The Ministry of Health has taken major steps recently to streamline the process, but the meeting participants agreed more needs to be done to make the clinical trial process faster and smoother.

What everyone agreed upon was the value of the event, and that such communication can open the gates for better processes around clinical trials in Israel – something that could be key to the success of Israeli medical startups.

 

For more information, or to join IBT-Tech, please contact Yael Zifroni-Sommer at yaelzs@israelbrain.org.

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