Biotechnology continues to hold the greatest promise to address many of the most critical issues facing our world.  Continued innovation will lead to breakthrough new and improved cures and treatments for patients living with debilitating diseases such as cancer, HIV/AIDS, diabetes and Parkinson’s; enhanced agricultural products to feed a growing global population while protecting the environmental health of our planet; vaccines to protect against bioterrorism; and revolutionary biofuels.  The ability of BIO members to continue our shared mission to heal, fuel, and feed the world depends on having an economic and public policy environment that supports research and development that leads to continued innovation.

In the U.S., this point was underscored throughout 2011 as continuing global economic uncertainty, critical public policy debates and the ongoing need for regulatory reform discouraged investment in our industry, making an already challenging capital formation environment even more trying.  A recent National Venture Capital Association study shows that investors are increasingly pulling out of biotech. VC financing is still down 25% from its 2007 peak. Year over year, we continue to see fewer deals being done. The IPO window remains tough and selective, with companies taking a 30% haircut on their asking (filing) price to lure cautious investors.

Throughout the past year, BIO worked tirelessly to advocate for public policies designed to improve the odds for biotech companies by encouraging investment in innovation, and reforming the regulatory review process to ensure timely, science-based and patient-focused decision-making.

In 2011, BIO released our five-year plan and worked with our member companies, our allies and Congress to turn our proposals into legislation. Our recommendations are specifically designed to create new models to encourage investment in innovation and to accelerate the discovery of scientific breakthroughs.  As I write this post, we expect legislation to be introduced early next year.

We also negotiated a Prescription Drug User Fee Act (PDUFA) agreement and continued to work on healthcare reform implementation, with a specific eye on the impending release of biosimilars guidance from the FDA. Additionally, we worked successfully this year to support passage of Patent Reform legislation, while fighting against reimbursement cuts by Congress, and addressing myriad appropriations issues.

Most recently, we worked with Congress to pass legislation that reauthorizes the Small Business Innovation Research (SBIR) grant program, ending the year on a high note that will provide critical funding for small companies that may not otherwise survive.

As we look ahead to 2012, BIO will work for Congressional passage of the PDUFA package, and support legislative proposals that reflect the underlying principles of our five year plan.  We also will continue to push for extending and expanding the Therapeutic Discovery Project (TDP) tax credit to provide critical R&D funding to emerging biotech companies. The TDP program, enacted in 2010, is an example of the type of policies necessary to spur continued medical innovation, while at the same time protecting and growing high-paying U.S. jobs. The TDP program provided $1 billion in research grants and credits for small biotech companies pursuing new therapies for diseases such as Alzheimer’s, HIV/AIDs, Parkinson’s and MS.

Other BIO policy priorities include ensuring the National Institutes of Health have sufficient funding to sustain the public-private collaboration that is transforming biomedical discoveries into innovative treatments for patients. We also will work to ensure that Congress provides the FDA with the resources it needs to keep pace with rapidly evolving biomedical science and fulfill its vital health and safety mission. Working closely with our members, we will remain engaged as the Department of Health and Human Services moves to implement the Patient Protection and Affordable Care Act.In collaboration with our state affiliates, we will continue to work with state governments seeking to grow their biotech sectors as part of their economic development and job creation strategies.

Despite the challenging environment for capital formation, public policy and regulatory issues, our industry continues to make breathtaking scientific breakthroughs.  Several key approvals in 2011 highlighted the scientific progress our sector is making, particularly in the areas of personalized medicine and companion diagnostics. BIO believes drugs approved with companion diagnostic tests are the next wave of medicine and will significantly improve patientoutcomes. This year alone, the FDA approved two new drugs that completely eliminate the hepatitis C virus from patients; one of the new drugs is from Merck and the other from Vertex.

The promise of biotechnology remains as strong as ever but there is much work to be done.  At BIO, we will continue to engage with public policy leaders in Washington and throughout the world to fight for public policies that encourage innovation and enable our members to develop breakthrough technologies that save lives and transform our world.

BioInvest Israel 2012- International Partnering Event  

March 5-6, 2012

Local & Global Pharma , Medtech and Finance Companies meet in Israel to talk business AND walk the path of history

Press release

In today’s challenging market the Israeli Biomedical industry is becoming ever more attractive to global companies and investors looking for concrete business dealings such as: Mergers, Acquisitions, Creative partnering models, Alternative finance and Investments, In- out licensing, IPO, Exit and other deals that will increase the value of their companies.  

BioInvest Israel^TM 2012 that will take place on March 5 – 6, 2012, at the Dan Carmel hotel in Haifa,  is another  initiation from  The T.B.N. Group (www.thetbngroup.com)  considered the leading business development company in Israel within the biomedtech arena, and is also the firm behind Circle of Life – the first members club of Israel’s life science industry (www.circleoflife.co.il)

BioInvest Israel^TM 2012 – partnering conference is an international gathering of the Investment & Corporate Communities with the Israeli Life Sciences industry organized in response to the growing demand for an efficient healthcare partnering forum where Investors, Medtech  and Biopharma  companies  can meet for focused and defined  business talks pre- qualified and arranged  to explore partnership and business dealings.

“The reasons our partnering conference is getting much attention and interest ” said Sigal Weisswasser President of The T.B.N Group  ” is due to our profound understanding of the industry’s needs along with our active involvement and connections that put together a special blend of local and global Medtech , Pharma  and Finance companies ( Vc’s, Insurance groups, banks ..) that look for one another especially these days.

“In addition” said  Weisswasser  “our very successful cooperation with EBD Group (the global partnering event organizer) whom we represent  in Israel for many years now, allow us to offer a different kind of top of the line international partnering event using the exceptional partneringOne software to maximize the pre- qualified meeting opportunities to all participants”.

Sigal also added ” BioInvest Israel is another exciting opportunity for us to place Israel as a center for business dealings within the innovative life science industry, and being a strong believer in my industry, It is important for me that companies from around the world will come over here to meet us in person and learn that we are so different than the way  we appear on the news.  They will find an interesting and colorful country comprises of nice and warm, open and creative people that  look forward exploring business ventures with” .

To support its statement, BioInvest Israel will offer the event attendees a unique tour in Northern Israel on March 7^th “Walking the path of History”  that is sponsored by the City of Haifa and getting much interest.

For further information:

Sigal Weisswasser – sigal@thetbngroup.com  Tel: + 972 3 9032204   www.bioinvestisrael.com

Israeli researchers from Rambam Medical Center in Haifa and Technion’s medical school have managed for the first time to repair damaged tissue using components produced by embryonic stem cells.

The team was headed by the director of Rambam’s obstetrics and gynecology department, Dr. Joseph Itzkowitz-Eldor.

The experiment involved tissue regeneration in mice, but the researchers said the method might be usable in the future to repair human tissue and organs that were damaged due to insufficient blood supply. Insufficient blood flow can result from injury or disease and can cause damage to the limbs, heart, kidneys and brain.

The stem cell components used by the researchers play a key role in the growth of blood vessels. The team used fertilized human eggs that had been donated for research purposes, as well as skin and hair samples from older adult patients.

For the first time, the team succeeded in isolating the cells that are capable of repairing damaged tissue. The cells were from the outer layer of the capillaries. These cells, along with other cells in the interior of the capillaries, regulate the functioning of the blood vessels and play a key role in the generation of new blood vessels. They provide a kind of building block for the growth of cartilage, tendons and muscle.

The research team injected the cells with the regenerative properties into mice whose legs had been tied to restrict blood flow, causing damage. After the injection of the cells, the mice’s legs healed nearly completely. Within three weeks, both blood flow to the leg and muscle function were almost completely normal again.

“In the current research, we have already managed in the laboratory to substantially increase the number of healing cells, so they can serve as a future clinical model for research into diseases,” Itzkowitz-Eldor said. He noted that technology already exists that enables the duplication of various kinds of stem cells, and his team’s research is similar to current efforts to duplicate blood cells from the umbilical cord.

The development of methods to duplicate the cells with the healing properties could lead to the creation of a bank of components with a wide range of medical applications, he added. “The development of an unlimited quantity of the cells would hold wide potential for healing damaged tissue,” Itzkowitz-Eldor said. “It’s true that the research is currently focused on animals, but we already have methods to grow these cells so they would also be suitable later on for implantation into humans.”

The team’s findings were published in the November issue of “Circulation,” the journal of the American Heart Association. The journal also devoted an editorial to the findings, due to their medical significance. Itzkowitz-Eldor said his team’s research is additional evidence of the leading role Israel is playing in embryonic stem cell research.

Prof. Rafael Beyar, Director and CEO of Rambam and until 2005 dean of the medical faculty, said the research is a “breakthrough with many implications to a large number of fields. The path to implementation in patients is still protracted, but I see it as having huge potential that could be implemented in not too many years away.”