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FDA lifts its hold on Juno’s cutting-edge cancer drug after deaths trigger delay

Posted under Blog, Cancer Drugs, Carl June, Companies, Diagnostics, Drug Safety, FDA, Funding, Juno Therapeutics, Medical Devices, Medical Supply, Memorial Sloan-Kettering Cancer Center, Pharmaceuticals, Regulatory, Startups, T Cells, Universities, Videos by John Carroll

The FDA has lifted a clinical hold placed on a study at Memorial Sloan-Kettering of Juno Therapeutics' cutting-edge approach to treating cancer using genetically tailored T cells, FierceBiotech has learned.

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BIO Expands its Statement of Ethical Principles

Posted under 2014 BIO International Convention, BIO EVENT, BIO Events, BIO International Convention, bioethics, Blog, Companies, Diagnostics, Ethical Principles, Events, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Rachel K. King, Startups, Universities, Videos by (Biotechnology Industry Organization)

Last year marked the 20th Anniversary of the BIO International Convention. In her keynote as the newly elected Chair of BIO, Rachel King emphasized BIO members’ commitment to delivering bigger lifesaving and life changing breakthroughs in medicine, agriculture and energy. “Delivering breakthroughs is at the heart of who we are,” King said in her speech, while also noting the need to effectively convey BIO’s message. “As we work to deliver breakthroughs … we must work just as hard communicating the importance of what we do … and spend the time illustrating for people just how risky innovation is … but at the end of that process we do big things – we cure disease and feed hungry people.”

BIO members are not only committed to the discovery, development and delivery of new applications of biotechnology that promise to save lives or improve the quality of life, but are also committed to advancing the socially responsible development and use of biotechnology products in healthcare, agriculture, energy and the environment. As our member companies continue to make strides in scientific developments, we recognize that this technology should be approached with an appropriate mixture of enthusiasm, oversight and humility.

The BIO Board Standing Committee on Bioethics (BSCB) was established to define, articulate and communicate BIO’s positions with respect to major bioethics issues. As part of this commitment, BIO developed and made publically available a Statement of Ethical Principles. The Statement of Principles provides a framework for our industry to consider, examine and address ethical issues as they arise. BIO has posted an expanded Statement to reflect more recent scientific and policy developments. The Statement is available here.

BIO has also examined pressing bioethical issues through other documents, including a series of “Points to Consider” for member companies and stakeholders confronting social and ethical issues such as benefit-risk, conflict of interest and expanded access programs. The “Points to Consider” series can be found here.

And our work continues. Planning for the 21st BIO International Convention in San Diego this June is well under way. The Convention provides BIO with an unparalleled opportunity to advance our commitment to encourage and facilitate discussion of the questions and controversies surrounding the development and use of biotechnology products. This year, the BSCB is sponsoring an interactive panel session on the bioethics of drug development. The session will be open to the public, without cost for attendance. The discussion will be based on a case study that focuses on the three major drug development milestones—pre-clinical development, clinical development and regulatory approval, and post-regulatory activities—and explores the intersection of drug development and ethics. The panel discussion, moderated by Steve Usdin of BioCentury, will be complemented by opportunities for audience participation including by having the audience play a role—such as company board of directors—and voting.

More information about the Convention can be found here.

We look forward to continuing the Bioethics discussion as we all work to proactively advance the socially responsible use of biotechnology.

For more information about the Board Standing Committee on Bioethics, please contact Sara Radcliffe at

Russell Medford, MD, PhD, President, Salutramed Group
Alexis Borisy, Chairman and Co-Founder, Foundation Medicine


Oregon Debates GMOs (Again!)

Posted under Blog, Companies, Diagnostics, Food And Agriculture, Funding, GMO ban, GMOs, Jackson County, Measure 15-119, Medical Devices, Medical Supply, Oregon, Pharmaceuticals, Protect Oregon Farmers, Startups, Universities, Videos by (Biotechnology Industry Organization)

A while back, Oregon looked at becoming the first state in the nation to require labeling of foods that contain genetically modified ingredients. Fortunately, the measure was voted dead 71 to 29, and many predicted that the issue would never rise again. However, now a new anti-GMO measure has popped up in “The Beaver State”.

A group of local farmers has been successfully able to get a GMO cultivation ban (Measure 15-119) on the ballot for the upcoming May 20, 2014 election in Jackson County, Oregon. Meeting the petition requirement with more than 6,700 signatures, Jackson County could become the first in Oregon to ban growing genetically modified crops.

Protect Oregon Farmers” is a coalition of Jackson County farmers, businesses, organizations and individuals opposed to Measure 15-119. This coalition includes Oregonians for Food and Shelter, Oregon Farm Bureau Federation, Oregon Wheat Growers League, Oregon Cattlemen’s Association, Oregon Women for Agriculture, Oregon Dairy Farmers Association, among many others.

Putting aside the fact that GMOs have been deemed safe to consume by more 1,700 scientific studies and numerous elite scientific bodies, this ban would be costly. If enacted, it is estimated that the measure would cost $259,302 the first year to administer and about $219,000 annually in subsequent years. Jackson County government is already struggling to pay basic budgetary obligations as well as basic county services. Measure 15-119 is bad for Jackson County, diverting funds away from basic services in order to pay for the administration and enforcement of a new program the county doesn’t need. It threatens farmers with frivolous lawsuits and empowers government inspectors to access private property to confiscate crops.

Even more dire, however, Measure 15-119 is an assault on farmer choice as described in this Capital Press editorial:

“Voters in Jackson County, Ore., will this May decide whether they are pro-choice. They will decide whether a farmer has the right to choose which crop to grow without someone from the county government showing up and forcing him to tear out his crop. Though he may have successfully grown the crop for years, that won’t matter. For him, his right to choose will have evaporated, courtesy of a vote of the people.”

To learn more on why you should oppose this initiative, visit the Myth vs Fact page on the NO on Measure 15-119 site.


Biotech Incubator Opens in Santa Fe

Posted under Blog, Business and Investments, Companies, Diagnostics, Funding, incubator, Medical Devices, Medical Supply, New Mexico, Pharmaceuticals, santa fe, Startups, Universities, Videos by (Biotechnology Industry Organization)

Starting up a biotech company is risky business. Fortunately, there are bright, determined people willing to take that risk in hopes of developing an innovative medical, industrial or agricultural application.

Fortunately, too, there are plenty of local, state, and federal legislators who recognize the value of supporting entrepreneurial innovators. A case in point is Startup America, an alliance of entrepreneurs, corporations, universities, foundations, and other leaders who work together to support high-growth, potentially job producing companies. To date, the program has mobilized well over $1 billion in business services that is expected to support as many as 100,000 startups over the next few years.

Since the 1980s the number of incubators has grown into the thousands in the United States alone. Success is still not a guarantee for these incubator companies, but there is plenty of evidence to support the notion that these tax-payer funded programs are well worth the investment.

The Santa Fe Business Incubator (SFBI) has been one of those success stories. Thanks to its proximity to Los Alamos National Laboratory and several research universities, SFBI has supported a variety of entrepreneurs that have created more than 100 businesses.

After years of planning, SFBI has just opened a new lab that provides state-of-the-art equipment for early stage biotech companies in Northern New Mexico. By providing companies access to specialized lab equipment, the BioScience Lab alleviates one of the most challenging aspects faced by biotech start-ups, the tremendous cost associated with purchasing tools and instruments needed to conduct research.

This facility represents a major step in the growth of New Mexico’s biotech community. Andrew Salazar, President of The New Mexico Biotechnology & Biomedical Association, had this to say about the milestone:

“This newest biotech-equipped laboratory will help accelerate advances in an already highly connected community that’s bringing together the research power of the state’s universities, federal laboratories and research institutions with our entrepreneurial and established business community to create new companies, grow existing ones and attract more out-of-state businesses.”

For more information, read this news release on the opening of the BioScience Lab.