Ruti Alon (Credit – Yoram Reshef)

To help Israeli companies prepare for the US reimbursement hurdle, ILSI has teamed with experts at Avalere Health, a leading US-based medical technology reimbursement company, to present a series of 3 teleconferences focused on major emerging trends affecting US payers. Audioconferences will be tailored towards specific issues, all directly relevant to a successful product launch, that must be mastered by ex-US technology companies in the present environment.

Each call will last 45 minutes, and will include commentary from senior Avalere staff expert on the topic and with relevant commercial expertise, with ample time for questions. Ruti Alon from Pitango, and Dan Mendelson , CEO of Avalere Health and a leading expert in reimbursement for emerging medical technologies, will facilitate discussion.

The topics will include:

1. Collaboration between the FDA and the Centers for Medicare and Medicaid Services – what you need to know about new emerging standards and the impact on your regulatory approach.

Faculty: Perry Bridger.

2. Bundled payment for technology and related services – how health reform will speed the end of fee for service payments for some technologies, and how it may affect revenues from the sale of your product.

Faculty: Mandy Bazile.

3. Changes in the managed care environment – how major payers are thinking about evidence requirements and how you can use this information for optimal positioning of your technology.

Faculty: Lauren Barnes.

Details at 03-600-5008/50018 PLEASE RSVP

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BIOINFORM. For the Bio industry

This brand new magazine seems to be very promising since it helps the bio-community to be updated with the floating news in this industry and understand each other researchers and advance local and global collaboration. In BioInform one can find personal columns written by senior scientists , the favorite topics that involve stem cell research, Genetics, Neurology, a patent attorney that introduces us the patent world in biology and the wide legal aspects that stand behind it and all in all uses an economic approach that gives a sense of what is the true status of this industry and even runs a trivia section and a technological section for commercial advantages of the ever changing market.

The magazine is delivered for free at the different laboratories and biological facilities.

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by GERSON PANITCH, FINNEGAN

June 14, 2010

Patent professionals and U.S. Supreme Court watchers alike on high alert as a Bilski decision is expected before the Court’s 2009 term comes to an end this month.  Perhaps no case is more anticipated than the decision in Bilski v. Doll, especially for those in high-tech fields such as telecom, software, and professional services.  Over a year has passed since the Supreme Court agreed to hear Bilski’s appeal (June 1, 2009), and more than seven months since hearing oral arguments (Nov. 9, 2009).  Bilski, which deals with the types of processes that are patentable in the U.S., is one of the oldest pending cases on the Supreme Court’s docket.  If no decision is reached by the end of this month, the Court must either dismiss the appeal or reset the case for a new argument in next year’s term. 

Until the Bilksi case, the U.S. was a place where it was possible to patent almost “anything under the sun that is made by man.”  Only such things as abstract ideas (e.g., mathematical algorithms); natural phenomena; and laws of nature were considered unpatentable in the U.S.  And even inventions in these areas were still patentable if expressed in a practical application.  As a result, throughout the Internet boom and to the present, the U.S. became a haven for protecting methods of doing business, even though business methods remained unpatentable in most other countries of the world.

But the Bilski case signaled that a change might be on the horizon.  Bilski tried to patent a method for managing commodity trading risk.  The U.S. Patent and Trademark Office rejected Bilski’s patent claim because it could have been performed without the use of a machine.  The appeals court affirmed the rejection, stating that a process is patentable in the United States only if:

(1) it is tied to a particular machine or apparatus, or

(2) it transforms a particular article into a different state or thing.

On Bilski’s behalf, lawyers from the Finnegan law firm argued to the U.S. Supreme Court that such a narrow interpretation traps U.S. patent law in the 19^th century by limiting patentable processes to traditional manufacturing methods, and excluding modern business practices.  Moreover, the Federal Circuit’s test effectively draws a distinction between technological fields; something the U.S. patent law has never done.  Business methods, financial services, software, and medical diagnostic inventions are now in an unacceptable state of uncertainty as they await the Supreme Court’s decision. 

The U.S. Supreme Court rarely decides patent law cases, and the decision in Bilski is sure to have far-reaching implications for patenting in the U.S.

About Finnegan 
With more than 375 intellectual property lawyers, Finnegan is one of the largest IP law firms in the world.  From offices in Washington, DC; Atlanta, Georgia; Cambridge, Massachusetts; Palo Alto, California; Reston, Virginia; Brussels, Belgium; Shanghai, China; Taipei, Taiwan; and Tokyo, Japan, the firm practices all aspects of patent, trademark, copyright, and trade secret law, including counseling, prosecution, licensing, and litigation.  The firm represents clients on IP issues related to international trade, portfolio management, the Internet, e-commerce, government contracts, antitrust, and unfair competition.  For additional information on the firm, please visit www.finnegan.com.

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Following the opening words of the event’s organizers, ILSI and Kenes, the president of Israel Shimon Peres came up to the stage and surveyed the future of Israel, which will be based on advanced technologies and serve as an example to the entire world. In his own words, “Israel should become an international lab.” Amen to that.

Neither did the following opening keynote lecture disappoint. Sanofi-Aventis, the multinational pharmaceutical company and the world’s fourth-largest by prescription sales, has presented its new view of developing new products. The lecturer divided the pharmaceutical market into two distinct sections: the small biotechnology companies, and the large business companies. The first kind is usually headed by innovative and creative scientists whose expertise is thinking outside the box. They have good ideas, but they lack the experience needed to break through in the market. That’s what the big pharma companies do exceptionally well: they have all the experience and knowledge needed to succeed in the market, but they lack the ground-breaking minds that can be found in the smaller companies.

The solution, according to Sanofi-Aventis, lies in collaboration. Well, that didn’t require a genius to figure out. Then again, such a collaboration is not easily brought about. On the one hand, the employees of the large companies view themselves as superior to those from the smaller companies. On the other hand, the scientists in the small companies treat their projects as their own personal babies, and refuse to accept criticism and ideas for change. All the same, Sanofi-Aventis is determined to bring about fruitful collaborations between the Davids and the Goliaths of the world. To that purpose, they have cut down their portfolio by 40%, and rewired all the human resources and money that became available into new projects, with a core of efficient and competent employees who collaborate with a variety of other companies.

The end result: since 2010, sixty percent of the compounds in Sanofi-Aventis’ portfolio are developed via collaborations. Such collaborations can also promote projects that integrate knowledge and expertise from different fields, such as glucose sensors connected directly to an insulin pump, or robotic hands that connect to the nervous system.

Let us all hope that this trend – collaboration in place of a take-over – will become more common, and will bring about the development of novel technologies and products more efficiently and in a shorter amount of time.

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It’s not WHAT you know, it’s WHO you know!

Relationships are the catalyst for success!

Do the above two statements look familiar? They should. They are the axioms of the Networking Theory (name not trademarked, invented on the spot). While networking seems to be the new religion of the business folks, I daresay that it’s been around for quite a bit. Even apes have it in them to do some network, hence the existence of the beta, gamma and delta males in the pack.

Quite a bit of water has flown under the bridge since our ascent from monkeydom, but the principle of networking remains. If you know the right people who can take your ideas and make something of them, or vice versa, then you have a valuable commodity on your hands. Everybody collaborates, and usually both sides of the equation come out with a profit. It is for that reason that we in the Israeli ILSI-BioMed Blog have decided to publish the profiles of some Italian companies working in the biomedical field and are coming to Israel. They are interested in meeting suitable Israeli business partners, and it is our fervent hope that profitable collaborations will come out of this post.

 The companies:

Eufoton Medical Lasers

Sprin Technologies, for sustainable chemistry

Zeta Research, business for research

Zcube, drug delivery technology concepts

Biostrands, diagnostics for drug and therapy monitoring

Source: Ms. Sonia Guetta, Israel-Italy Chamber of Commerce & Industry

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The move is supposed to strengthen Medtronic’s position in the expanding cardiovascular market. It adds to a series of purchases made by the medical device giant in the last two years, paying a total of more than $2 Billion.

In 2009, Medtronic has spent over $1 billion to acquire CoreValve as well as the Israeli Ventor Technologies. Both companies are developing ways to implant replacement heart valves through catheters snaked up the groin instead of cracking open the chest in major surgery. And in 2008, Medtronic acquired CryoCath Technologies for $380 million. The Canadian company makes catheters (tubes) that can deliver subzero temperatures to the heart.

ATS’s purchase, explained Tim Lee, an analyst with Piper Jaffrey in San Francisco, “provides the acquirer with a leading mechanical valve franchise, an emerging tissue valve franchise, and most importantly, an R&D pipeline in transcatheter valves.”

Medtronic’s competitor in the field of transcatheter valves, Edward Lifesciences, will lose its patent protection in 2011 or 2012, said Lee. “As such, we think any company working towards entering the transcatheter space may be giving a long hard look at ATS if they haven’t already done so,” Lee wrote.

Medtronic might be done with buying cardiology companies, but its competitors – Edwards, Cordis (J&J) ,Guidant ( Boston Scientific ) and others – cannot take a rest just now. Interventional Cardiology R&D is a hot area in the last years, and so whoever does not want to stay put must run very fast.

This outlook might also bring good news to Israeli interventional cardiology companies.. We already saw big purchases of local cardiology companies in the past (see table below). Continuous Israeli R&D efforts might not be a guarantee, but certainly raises the chances for another future Israeli exit, right in the field where the global giants need it the most.

* An American-Israeli company

For further reading, see:

http://www.medcitynews.com/2010/04/medtronic-inc-buys-ats-medical-for-370-million/

http://www.dicardiology.net/node/35233/

http://www.topdevicecompanies.com/2010/03/medtronic-edwards-heart-valves-said-to-have-longterm-demand.html

Taken from ILSI website

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SAVE THE DATE

May 11^th, 16:00-19:00

Beit Chel Ha’avir, 15  Jabotinski Street, Herzelia

Advantages of Manufacturing in Israel

The seminar will focus on issues related to options, advantages and Governmental policies associated with manufacturing of Medical Devices and Biopharma products in Israel. 

The event will be moderated by Moshe Mizrahy, founder of Nitzanim Medical Fund 

Agenda

16:00-16:20           Moshe Mizrahy – Introduction

16:20-16:40           Dr. Ora Dar, Head of Life Sciences Sector & Biotechnology Consultant to the Chief Scientist  
“Chief Scientist policies as related to manufacturing in Israel” 

16:40:17:00           Uri Bechor, Flextronics – electronics, mechanical, optics, 
                                      lasers  

17:00: 17:20          Shmulik Glick, STI Laser – special metal devices 

17:20-17:40          Shuki Weinstein, Sorvan – Sterilization of Medical Devices 

17:40-18:00          Dr. Elisheva Yonish-Rouach, Protein Production Services 
                                     (PPS) – protein production

18:00-18:20          Dr. Shimon Amselem, Nextar Ltd., Aminolab – GMP/GLP 
                                     Pharma manufacturing and formulation facility

18:00-18:20          Nadav Weininger, Cure Medical Neopharm Group – Pharma 
                                     and Medical Device manufacturing facility

18:20-18:40          Q&A, Conclusion

Who Should Attend? 

CEO, COO and CFO of life science start-up companies
Operations managers, purchasing & procurement managers 
QC managers

Participation fees of 100 NIS for non ILSI members and 50 NIS for ILSI members, 
will be collected at the entrance

PLEASERSVP!!! at  03-600-5008 or   03-600-5118
sima@ilsi.org.il ; ayelet@ilsi.org.il
ILSI | 155 Bialik St. | Ramat Gan | | 52523 | Israel | 03-6005008/118

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One year ago, a group of researchers at Hadassah-Hebrew University Medical Center in Jerusalem reported a sharp rise in the diagnoses of a certain metabolic disorder. To those of us who live in Jerusalem, fear not. Other than the Holyland story, nothing really happened in the Israeli capital in the last year. The only change is that the lab at Hadassah changed the supplier of its pipette tips. No more, no less.

You might find it hard to believe that the mere changing of a plastic supplier can affect the diagnosis of a medical disorder. It turns out more and more, though, that plastics can seriously influence the outcome of biomedical experiments and tests.  The most recent example was published just two days ago in BioTechniques by Lewis et al, and caught attention from Nature’s news crew who began circulating the announcement to the scientific community around the globe. It’s might important, too, as the discovery relates to protein and DNA extraction and PCR reactions, which most of the biologists do at one point or another in the research.

To sum up the results briefly, Lewis et al bring evidence that chemicals can leach out of polypropylene tubes and into the solution inside. Those chemicals absorb at wavelengths between 220 and 260 nanometers, which means they’re highly likely to distort a spectrometer reading of the amount of DNA in the solution, perhaps by as much as 300%, according to the researchers.

How to get over the problem? Lewis et al report they are using only tubes which are low in additives. This is another potential problem, obviously, since some of the additives are there for a reason: to harden the plastic, make it more heat resistant or preserving it over time. But if your research is truly important to you, I’d say it’s the right choice.

In the BioMed-ILSI week (two months from now), Prof. Daniel Cohn from the Casali Institute of Applied Chemistry in the Hebrew University will give a lecture on June 15th about Novel Biomedical Polymers and Medical Devices. It might be interesting to learn his views about this problem, and what’s more, perhaps he has an insight on the additives in question – and whether they can be found in implantable polymers as well.

The Incident in Hadassah

BioTechniques Journal

A News Article in Nature on the Matter

The Program of ILSI-BioMed week

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A few weeks ago I received my first iPhone, and ever since I’ve had a blast of a time. This single, tiny device, can take the place of so many other utilities: books, movie and music players and yes – even portable game systems. It all depends on the apps you choose to download to your iPhone, of which there is a wide variety. Of all the applications I ventured to check, one of the most interesting is called Sleep Cycle. The idea behind the app is quite simple: it turns the iPhone into an alarm clock that only wakes you up during the light sleep phase, where waking up is easiest.

I’m going to be honest now, and say that in the few days I’ve experimented with the app, I still haven’t reached a final conclusion whether or not it works. The technical idea of using the iPhone accelerometer to measure the body’s movements on the bed is quite innovative, but I don’t think the different phases of sleep can be measured accurately in this manner. All the same, this app demonstrates the one of the many potential uses of smartphones as tiny biomedical devices, a market that has hardly been explored to its fullest.

In his exciting TEDMED lecture, Dr. Eric Topol sheds light on the way we’ll soon use our smartphones to monitor our vital signs and chronic conditions. It’s highly recommended that you spare 15 minutes to watch the lecture and see the future for yourself.

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