Statement On U.S. Supreme Court Review Of Isolated DNA Patents

Washington, D.C. (June 13, 2013) Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), today issued the following statement on  the U.S. Supreme Court’s decision regarding Myriad Genetics’ patent claims on isolated DNA molecules:

“The Supreme Court today summarily ruled that so-called cDNA remains eligible for patenting.  cDNA is the commercially most important form of DNA used in biotechnology.  Today’s decision offers urgently-needed certainty for research-driven companies that rely on cDNA patents for investment in innovation.

“In other respects, however, the Supreme Court’s decision today represents a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences.  In addition,  the Court’s decision could unnecessarily create business uncertainty for a broader range of biotechnology inventions.

“The United States is now the only developed country to take such a restrictive view of patent eligibility, signaling an unjustified indifference towards our global economic and scientific leadership in the life sciences.

“The term ’gene patent’ is misleading, because patents cannot cover the genes that exist in humans, plants, animals or microbes.  Patents have never conferred ownership over genes.  Nor have they stifled research, harmed patients, or interfered with medical care, as numerous independent studies have repeatedly confirmed over the years.  The past 25 years have seen an unprecedented explosion of research and scientific publication on the human genome and the genomes of bacterial and viral pathogens.  New biologic medicines, vaccines and tests have become available to treat previously untreatable conditions, benefit patients and improve medical care.  These developments were not impeded by patents – they were aided by patents.

“While Myriad Genetics is not a member of BIO, we do represent companies that research, develop and use modern biotechnology to produce products ranging from life-saving medicines and vaccines to renewable fuels, industrial enzymes and disease-or pest-resistant crops.  Such companies have long relied on patents on preparations of DNA molecules and other biological chemicals in order to bring innovative, socially beneficial products to the marketplace.  BIO will continue its efforts to ensure that these companies and our partners in research universities around the globe can secure the patent protection necessary to continue our common mission to help fuel, feed and heal the world.

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIO produces BIOtechNOW, an online portal and monthly newsletter chronicling “innovations transforming our world.” Subscribe to BIOtechNOW.

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HHS Re-issues 2013 Omnibus Solicitation to Implement Additional Provisions of the SBIR/STTR

Reauthorization Act of 2011
Original 2013 SBIR/STTR Omnibus Solicitations are now expired

All applicants to the National Cancer Institute (NCI) SBIR & STTR Programs must use the re-issued PHS 2013-2 Omnibus Grant Solicitations, PA-13-234 (SBIR) and PA-13-235 (STTR) for the upcoming August 5 and December 5 deadlines.

Funding is available to support small businesses working across a wide range of cancer-related research topic areas through the Small Business Innovation Research and Small Business Technology Transfer (SBIR & STTR) Omnibus Solicitation, an investigator-initiated grant funding opportunity. The next deadline to submit applications is August 5, 2013.

The original SBIR and STTR Omnibus Solicitations, PA-13-088 (SBIR) and PA-13-089 (STTR) are now expired.

• Applicants will receive an error during submission if these expired funding opportunity announcements (FOAs) are used.
• Please download and use the re-issued Omnibus Solicitation FOAs (PA-13-234, SBIR and PA-13-235, STTR) for all applications to the remaining due dates. This includes resubmissions (‘-A1s’).

The re-issued 2013 Omnibus Solicitation expands eligibility and impacts the application process, so please read the solicitations carefully. With this re-issue, the NIH SBIR/STTR programs implement the following provisions of the SBIR/STTR Reauthorization Act:

• Small business concerns that are majority-owned by multiple venture capital operating companies (VCOCs), hedge funds and/or private equity firms are now eligible to apply to the NIH SBIR program and compete for up to 25% of NIH’s SBIR set-aside.
• All applicants are required to register at the SBA Company Registry prior to application submission and attach proof of registration.

For further details, please see NIH Guide Notice NOT-OD-13-071 or check the NIH implementation plan website.

To view the official re-issued 2013 SBIR & STTR Omnibus Solicitations, please visit:

SBIR Program
PA-13-234, Re-issue PHS 2013-02 Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
Receipt Dates: August 5, 2013; December 5, 2013

STTR Program
PA-13-235, Re-issue PHS 2013-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42])
Receipt Dates: August 5, 2013; December 5, 2013

How to Apply
For resources and tips for applying, please click here.

NCI encourages U.S. small businesses to submit investigator-initiated SBIR & STTR grant applications for any mission-aligned innovative technologies. To review descriptions of research topics of particular interest, please click here. For more information about this opportunity, please click here.

Please visit http://sbir.cancer.gov/ to learn more about the NCI SBIR & STTR Programs.

The SBIR & STTR Programs are NCI’s engine of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat cancer. The SBIR & STTR Programs are government set-aside programs for domestic small businesses to engage in research and development that has the potential for commercialization and public benefit.

Sign up to receive updates about
SBIR & STTR funding opportunities at
sbir.cancer.gov

Conference Objectives
At the conclusion of the Conference, participants should be able to:
* Understand the benefits of Interprofessional Education (IPE) in health care training;
* Understand how rural areas are affected by trauma, how those areas can be helped through a developed statewide trauma system, and how rural areas can help themselves benefit;
* Review the major challenges and potential health strategies to address the growing problem of prescription drug abuse in Indiana
and the United States;
* Understand how the provisions of the Affordable Care Act might impact oral health in rural Indiana;
* Apply contemporary knowledge about health care quality to the smaller rural provider setting;
* Identify practices and technologies that can improve the care of patients and can be implemented by rural providers.

For more information and to register, please visit the conference website

For the past several years now, the BIO convention has dedicated floor space to special “zones” highlighting a variety of service areas.  This year the BIO Business Services Zone had the full compliment of service providers and I spent a great deal of time talking with the vendors we use, interviewing potential new providers, and learning more about the relationships these folks have with Indiana’s life science business community.

I spent a long time with the BioSurplus team and I will admit up-front to winning their prize at the end-of-show raffle, which was a happy coincidence.  But I think this offering is frequently overlooked and overshadowed by other vendors in the BIO program.  The value is there and the services can mean dollars (a lot of them!) in your pocket.  So here’s their spiel:

Whether you need to buy lab equipment, auction or sell surplus assets, make repairs to existing instruments or manage your equipment inventory, BioSurplus is here to help.

Need to buy used lab equipment? – BioSurplus maintains an inventory of over 4,000 high quality used lab instruments from some of the best manufacturers in the business.  You can view our online catablog at www.BioSurplus.com as well as visit one of our three physical showrooms, located in San Diego, the San Francisco Bay area and Boston.

Need to sell used lab equipment? – BioSurplus offers flexible tailored solutions for liquidating your surplus assets.  These include outright purchase, consignment, and online auction.

Need to repair your lab equipment? – BioSurplus’ team of experienced engineers is on call and ready to help.  We service a variety of equipment including centrifuges, CO2 incubators, HPLC, FPLC, and more.

Need to auction your surplus lab equipment? – BioSurplus has the answer.  We’ve managed auctions for a client list that includes Biogen Idec, Elan Pharmaceuticals, the Neurosciences Institute, and more. Our team will manage the entire auction process from beginning to end, allowing you to free up resources and maximize your ROI.

Need to manage your labe equipment inventory?  e-Quip™ is BioSurplus’ easy-to-use, cloud-based inventory management software.  It’s specially designed to track inventories, schedule service and repair activities and manage asset relocations and dispositions.

Now that’s just what they offer to everybody.  If you are a member of IHIF (or BIO) you get some extras:

• 5% – 7% annual purchase credit or 1% – 3.5% annual cash rebate, based on the net price of purchased equipment during the previous year
• 5% seller premium on equipment sold to or through BioSurplus
• 10% discount on the setup, inventory cataloguing and entry fees on the e-Quip™ inventory maintenance tracking software
• 5% discount on equipment repair and maintenance services
• 30-day limited warranty on most purchased equipment
• Experienced customer service representatives offering knowledgeable and reliable service

I’m just guessing they offer that last one to everybody too.  For more information on BioSurplus and on this and the other great discounts offered through the BIO Business Solutions Program, please visit http://www3.bio.org/bbs/Indiana/.   We have a lot more vendors to profile and some new relationships coming soon.  Also, if you have a suggestion for a service you would like to see offered, please drop me a note at info@ihif.org.

*This post is intended as an informational service and resource for IHIF members and members of the life science business community in Indiana.

INDIANAPOLIS, Ind. – Algaeon Inc., an Indianapolis-based biotech company that has developed algae cultivation technology for use in the nutraceutical and micronutrient markets, announced today that it has closed a $770,000 investment round of funding from early-stage growth company investors. The investment group included City Securities Corporation and multiple individual Angel investors. The funding will support the addition of capacity for sample qualification and animal testing for 3 prospective customers and the design of a commercial scale facility. This sets the ground work for the Company to expand operations and to produce products used as food supplements to promote health and disease prevention for humans and animals.
Algaeon is an early stage company entering its early growth phase. Founded in 2008, the company completed 2 rounds of funding in 2012 for $1.2 Million. The Company has currently completed technology scale-up and is working with 3 customers to secure long-term supply contracts. The company will be seeking additional funds for construction of commercial scale capacity. The first commercial scale capacity will begin operation in late 2013. Capacity will continue to be expanded thereafter to fulfill purchase contracts with industry leading companies. Algaeon’s patent-pending production technology sets a new standard in the industry for efficiency and overcomes the common industry challenges of contamination control and cost containment. Growing demand for over-the-counter health solutions is driving the need for innovative large volume supplies of nutritional supplements. Similarly, there is growing demand for improving animal production efficiency by improving survivability, health and weight gain without the use for antibiotics. Demands in these markets are growing and the industry is having difficulty obtaining sufficient supply. “The markets for our high-value algae derivative products have been growing at significant rates, and the investment will advance our entry into these high-demand areas,” said Paul DeLacey, President and CEO, Algaeon, Inc.

About Algaeon Inc.

Algaeon Inc. is an Indianapolis-based biotech company that has developed a breakthrough patent pending industrial scale microalgae cultivation technology. Unique high value products are currently being grown for leading companies in the Nutraceutical and Animal Micronutrient markets. Algaeon is developing its own cultivation capacity, as well as, licensing the technology for algae farms. For more information about Algaeon visit www.algaeon-inc.com Source: Algaeon Inc.

Research Supported by Biopharmaceutical Companies Boosts Indiana Economy, Benefits Local Patients

WASHINGTON, D.C. (June 4, 2013) – Working in collaboration with Indiana clinicians and research institutions, America’s biopharmaceutical research companies have conducted 3,266 clinical trials of new medicines in Indiana over the last 13 years, according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA). The report – “Research in Your Backyard: Pharmaceutical Clinical Trials in Indiana” – was released today at a news conference with Indiana Governor Mike Pence at Covance, a clinical research facility and biopharmaceutical services company in Greenfield.
Governor Pence, Chester “Chip” Davis, PhRMA Executive Vice President for Advocacy, and Andrew Dahlem, Ph.D., Lilly Research Laboratories Vice President and Chief Operations Officer, shared their perspectives on the importance of biopharmaceutical research and life sciences in the state.
“Indiana’s life sciences industry has tremendous potential for growth,” said Governor Pence. “We are actively working to expand the partnership among life sciences and biopharmaceutical companies and our state’s universities and hospitals to grow the economy, to attract and retain talent, and to address the critical health issues we face today.”
The economic impact of the biopharmaceutical sector extends far beyond direct jobs. Pharmaceuticals accounted for nearly $5 billion of the $7.4 billion in Indiana exports in 2009. A BioCrossroads report shows that the primary life sciences industries supported about 155,000 jobs in Indiana in 2009, including more than 64,000 pharmaceutical sector positions. Nearly 17,800 of the pharmaceutical jobs involved direct employment and about 46,500 were jobs supported by biopharmaceutical companies through statewide business arrangements. Life sciences product exports nearly tripled from $2.5 billion to $7.4 billion from 2002 to 2009, ranking Indiana as third-highest among the states, behind only California and Texas, according to BioCrossroads. Additionally, We Work for Health data released last fall revealed the businesses biopharmaceutical companies engage with in Indiana, showing that the 17 companies surveyed worked with over 3,500 vendors in 2011 alone, spending more than $1.8 billion.
“In addition to the economy, patients have been the beneficiaries of the research our companies have conducted in Indiana,” said Davis. “Working with local research institutions across the state, our companies have conducted over 1,750 clinical trials since 1999 just on the most debilitating chronic diseases – cancer, diabetes, heart disease, stroke, mental illnesses and asthma.”
Increasingly, medicines clinically tested in Indiana and across the country are cutting-edge biotechnology treatments.
“Our growing understanding of the molecular underpinnings of disease, coupled with new scientific approaches to developing medicines, gives us the capacity to create safer and more effective medications and improves our ability to predict and even prevent disease,” said Davis. “It’s impressive that a great deal of that research is underway here in Indiana.”
The report highlights how clinical trials are addressing the serious challenges of chronic disease:
• In 2011, more than 10 percent of the state’s adults had diabetes, according to the state Department of Health. Currently, 33 clinical trials of potential new treatments for diabetes are recruiting patients in the Hoosier State.
• In 2010, nearly 13,000 residents died from some form of heart disease and 3,077 died from a stroke, according to the Indiana Department of Health. Twenty heart disease and seven stroke clinical trials are seeking Indiana patients.
• Nearly 227,000 adults live with serious mental illness in the state and about 71,000 children live with serious mental health conditions, according to the National Alliance on Mental Illness. Thirty mental illness clinical trials are recruiting patients.
The findings also show that research institutions in Indiana are conducting clinical trials of new medicines in collaboration with biopharmaceutical companies, including:
• Cancer Care Center Inc., New Albany
• Central Indiana Cancer Centers, Carmel, Fishers, Indianapolis
• Children’s Center for Cancer and Blood Diseases, Indianapolis
• Indiana University Hospital, Indianapolis
• Indiana University School of Medicine, Indianapolis
• Oncology Hematology Associates of Southwest Indiana, Evansville, Newburgh
• Lafayette Regional Vein and Laser Center, Lafayette
• Deaconess Hospital-The Heart Group, Evansville
• Premier Healthcare, Bloomington

For a listing of all clinical trials recruiting patients and their locations in Indiana, consult the appendix of the “Research in Your Backyard” report, which can be found at http://www.phrma.org/innovation/research-in-your-backyard. Indiana clinical trial information can also be found at http://www.clinicaltrials.gov, the trials data base of the National Institutes of Health.

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The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested over $500 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012 alone.
Find PhRMA Online:
• Website – http://www.phrma.org
• Facebook – http://www.facebook.com/PhRMA
• Blog – http://www.phrma.org/catalyst
• Twitter – http://www.Twitter.com/PhRMA and http://www.Twitter.com/PhRMApress
• YouTube – http://www.youtube.com/PhRMApress
For information on how innovative medicines save lives, visit: http://www.innovation.org
For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org
For information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org

A new report from the Pharmaceutical Research and Manufacturers of America suggests Indiana has hosted more than 3,200 clinical research trials over the last 13 years for biopharmaceutical companies throughout the country. Governor Mike Pence says the state is working to expand partnerships between life science companies and local universities to benefit patients and the Indiana economy.

In this series, I’ll be profiling a few of the connections made at this year’s show in the hopes that they may be useful to some of you.  In this first case, I’d like to introduce a company that was introduced to me at BIO 2013 by one of our members.  Doug Johnson, is a Senior Account Manager with Datatrak.  He spent a considerable amount of time at our booth and shared a lot of detail about the services available through his company.  He provided the following description*:

For two decades, DATATRAK has been pioneering eClinical® technologies to safely accelerate drug, medical device and nutritional development timelines, from pre-clinical through Phase IV studies.   Clinical trial activities are rapidly shifting to a patient-focused model in hope of improving patient adherence and safety, as well as clinical outcomes.

DATATRAK built our innovative clinical research platform to be a disruptive force to help drive the clinical trial process down this path.  The most noticeable attribute of our system is the modern look of the software interface, the power of the unified platform to improved workflows, increased flexibility and greater visibility – visibility of clinical data in a single trial as well as across multiple trials within a drug program.  The DATATRAK One™ Clinical Research Platform is an easy to use, in multiple languages, cloud based clinical enterprise solution that empowers Sponsors and CRO’s to efficiently design, deliver and manage clinical trials.  Consisting of seven products (uCTMS™, uDesign™, uEDC™, uIRT™, uSafety™, uTrain™ and uCDR™), DATATRAK One™ improves organizational performance, and ensures regulatory compliance and standards at a lower total cost of ownership.  We use technology to build relationships directly with patients, streamline the clinical trial timelines and enhance patient safety-all while greatly reducing overall trial costs.

In addition, our DCCS (DATATRAK Clinical and Consulting Services) skilled team is gaining praise from both our Sponsors and CRO partners.   Combined with our CRO partners, DCCS’s full suite of professional services provides clients with a single source vendor for all of the clinical trial needs.   With additional opportunities utilizing our Enterprise contracting model for further cost efficiencies, our clients are able to project/budget their costs over a fixed period.

For more information, please contact: Doug Johnson, Senior Account Manager, 224-360-3484

http://www.datatrak.net/

If this is a service of interest to you or others you might know, please give Doug a call and let him know you heard about him through IHIF.

*Please note there is no endorsement of Datatrak stated or implied in this posting.  IHIF has not been compensated for this announcement.  This post is intended as an informational service and resource for IHIF members and members of the life science business community in Indiana. 

The University of Notre Dame will host the XIV International Workshop on Molecular and Cellular Biology of Plasminogen Activation June 4 to 8 (Tuesday to Saturday).

The co-chairs of the conference are Francis J. Castellino and Victoria A. Ploplis of Notre Dame’s W. M. Keck Center for Transgene Research. The conference is co-sponsored by the Indiana University School of Medicine-South Bend and Memorial Hospital of South Bend.

The plasminogen activation system and related proteolytic systems are essential regulators of tissue remodeling events as well as of cell functions through activation of cell signaling pathways. Through early studies involving in vitro biochemical investigations and, more recently, in vivo biological studies involving gene modified technology, the plasminogen activation pathway has been identified as a major participant in the regulation and progression of a number of clinically relevant human diseases. These include cancer, cardiovascular diseases, neurological pathologies and bacterial pathogenesis.

The conference’s keynote speaker will be Désiré Collen, director of the Molecular Cardiovascular Medicine Group (comprising the Center for Molecular and Vascular Biology of the Katholieke Universiteit Leuven and the Center for Transgene Technology and Gene Therapy of the Flanders Interuniversity Institute for Biotechnology) in Leuven, Belgium.

Collen has co-authored more than 620 research papers and has received four honorary degrees. He led the team that initially developed t-PA, currently the most effective drug for thrombolytic therapy of acute myocardial infarction.

Contact: Victoria Ploplis, 574-631-4017, vploplis@nd.edu