May 2015

The FDA issued draft guidance on Adaptive Design for Medical Device Clinical Studies. When finalized, this guidance will provide clarity on the design and use of adaptive designs for clinical studies of medical devices. Adaptive design allows for planned modifications to a clinical study based on accumulating data, while maintaining the trial’s integrity and validity. When properly implemented, adaptive design can reduce resource requirements and/or increase the chance of study success.
Biomed Companies in Israel Hit Record Numbers. The Israeli biomed field is healthy and robust, thanks to a record year of investments in 2014 and a creative startup community of researchers, engineers and medical professionals. This year’s Israel Advanced Technology Industries (IATI) Biomed 2015 conference,  held on May 12-14, 2015, attracted some 6,000 people including top healthcare industrialists from 45 countries. This is the biggest and most established annual meeting of the Israeli life-science industry, and as such attracts senior representatives from global companies that search for innovation and groundbreaking technologies.
"We realize Israel has vast experience". EVP Mikael Dolstein is looking to extend Pfizer's cooperative ventures in innovation to Israel's biomedical community Pfizer's representative at the 2015 IATI Biomed conference in Tel Aviv was president of worldwide research and development (WRD), portfolio strategy and investment committee chairman, and executive VP Mikael Dolstein. As part of his job, he is very involved in cooperative ventures with external parties. "I was very much looking forward to my visit to Israel, where I met companies, academic groups, and venture capital funds in order to see how our cooperative ventures in innovation can be extended to the Israeli biomedical community," he says.
"Israel is used to doing more with less". Medtronic senior VP Stephen Oesterle said he is a leading advocate of cooperation with Israeli biomed companies. For years, Medtronic has been one of the world's leading medical equipment companies. Medtronic has been doing business in Israel for many years, and has had a development center in the country since 2006, when it acquired Odin Medical Technologies. It also acquired Ventor in 2009 for $325 million (although it closed down this activity) and Instent in 1996 for $200 million. Medtronic has a very active marketing company in Israel, invests in several Israeli venture capital funds, and sends representatives to the biomedical conference each year.

Sanofi appoints Israel scout to find biomed start-ups. French pharmaceuticals company Sanofi is one of the biggest players in the global pharmaceuticals industry. Sanofi VP, Global Head External Innovation Operations Adam Keeney is the person responsible for partnerships with academic institutions and young companies. Sanofi have a strong presence in Israel, in terms of marketing activity, and delegations that come to Israel are seeking innovation, and now Sanofi hired a scout, Nurit Tweezer-Zaks, who is seeking ventures for Sanofi in Israel.
Pfizer to collaborate on Israeli professor’s DNA robots. Pfizer is cooperating with the DNA robot laboratory managed by Prof. Ido Bachelet at Bar-Ilan University. Bachelet has developed a method of producing innovative DNA molecules with characteristics that can be used to "program" them to reach specific locations in the body and carry out pre-programmed operations there in response to stimulation from the body. This cooperation was revealed in a lecture by Pfizer president of worldwide research and development (WRD), portfolio strategy and investment committee chairman, and executive VP Mikael Dolstein at the IATI Biomed Conference in Tel Aviv.
Medasense Pain Monitor Among Winners Of Prestigious Startup Competition at the IATI Biomed 2015. Understanding pain is still a major challenge for millions of doctors and patients around the world. An Israeli biomed startup called Medasense has developed a technology that mathematically measures pain in order to give doctors the best assessments. And that’s why last week, the company was announced as one of two winners of the startup competition at the Israel Advanced Technology Industries (IATI) Biomed Conference.
Speaking of Cold Chain ...  World Courier’s Nils Markmann featured in BioPharm International. What do biologics and boxes have in common? What does temperature have to do with targeted therapies? When it comes to the transport of drugs in development, the answer is everything. In the latest issue of BioPharm International, World Courier’s Nils Markmann shares insights on how the explosive growth of specialty drugs and global development initiatives drive demand for innovation in temperature-controlled transport.
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