Advice from the Experts on Boostrapping a Life Science Company

Scale Finance and First Flight Venture Center are joining together for a timely, and useful discussion on no-dilutive funding for life science companies. A distinguished panel of local successes will be gathered at American Underground in Durham on Oct. 8 to give startups insight, and ideas, on how to start and grow life science endeavors with limited cash flow.

Bootstrapping for a period of time allows companies to raise capital in the future and at better terms. The trick for life science and medical device companies is to identify early sources of alternative non-dilutive capital to move the business as far as you can before seeking the larger amounts of capital that will eventually be needed.

The forum panel includes the following well-known leaders:

• Rich West, currently co-founder and CEO of his fourth life sciences startup, which is focused on newborn screening (www.baebies.com)
• Peyton Anderson, CEO of Affinergy, a Duke spinout commercializing medical devices and is Chairman of Powered Research, a preclinical CRO 
• Sam Tetlow, CEO of EpiCypher 
• Dr. Eva Garland, VP of R&D for Agile Sciences 
• Gary Hayes, COO and Co-Founder of Scale Finance

Register for the event here 

Read the full press release here

Brinks Attorney Jennifer Fox to Address Recent Biotech Patent Litigation at BIO IP & Diagnostics Symposium

CONTACT
Cheryl Kennedy
Clovis, Inc.
312.346.1700 x2002
ckennedy@clovisinc.com

Risa McMahon
Brinks Gilson & Lione
312.840.3172
rmcmahon@brinksgilson.com

DURHAM, N.C.—Jennifer L. Fox, a patent attorney at Brinks Gilson & Lione, one of the largest intellectual property law firms in the United States, will be a featured speaker at BIO's 2nd Annual IP & Diagnostics Symposium (BIO IPDX) on Friday, September 26, 2014 at the Hilton Alexandria Old Town in Alexandria, Va.

Fox will present "Recent Patent Litigation and Disputes" with a panel of biotechnology and IP law professionals that will discuss the implications for the biotech industry of the decisions of the U.S. Supreme Court's decisions in the Myriad and Prometheus cases, along with other recent decisions and ongoing cases.

Fox focuses her practice on counseling pharmaceutical and biotechnology companies in patent and related transactional matters. Both a research scientist and patent attorney, she has over 17 years of experience in the pharmaceutical and biotechnology industries. She is Of Counsel in Brinks' office in Research Triangle Park, N.C.

BIO IPDX will review the current patent law landscape and evaluate its impact on both the genetic diagnostics and biopharmaceutical sectors. The program will explore IP issues for both general and companion diagnostics, as well as potential regulatory dimensions. The symposium is geared towards patent practitioners in the life sciences, both in-house and in private practice, as well as in-house regulatory affairs staff, licensing professionals, business development executives, and regulatory agency staff seeking to understand pre-marketing and intellectual property challenges in the area of diagnostics.

Although there is no fee to attend, reservations are required. For more information and to register, contact Caroline Arrington at carrington@bio.org or (202) 962-9228.

Brinks Gilson & Lione

Brinks Gilson & Lione has 160 attorneys, scientific advisors and patent agents who specialize in intellectual property, making it one of the largest intellectual property law firms in the U.S. Clients around the world use Brinks to help them identify, protect, manage and enforce their intellectual property. Brinks lawyers provide expertise in all aspects of patent, trademark, unfair competition, trade secret and copyright law. The Brinks team includes lawyers with advanced degrees in all fields of technology and science. Based in Chicago, Brinks has offices in Washington, D.C., Research Triangle Park, N.C., Ann Arbor, Detroit, Salt Lake City and Indianapolis. More information is at www.brinksgilson.com. 

Tapping into Biodefense Spending

Originally posted by Edward R. Ergenzinger, Ph.D. via Ward and Smith, P.A.  It has been shared with permission (original article here).

The 2014 Biodefense Summit
On August 26, 2014, the North Carolina Biotechnology Center held a summit on biodefense – a term that generally refers to methods for preventing, detecting, or managing an attack involving biological weapons.  The summit provided a platform for decision makers from federal funding agencies to engage with academic and industry leaders in North Carolina's life sciences sector.  The impetus for the summit was the recognition that the level of biodefense spending in North Carolina is disproportionately low given that the state is home to the third largest life sciences cluster and the fourth largest military presence in the United States.  In a nutshell, the summit was organized to kick start strategies to leverage those strengths and expand the number of biodefense government contracts awarded in North Carolina.

The summit emphasized the cutting-edge life sciences work being done in North Carolina, some of which would have been considered science fiction just a short while ago.  Mike Wanner, CFO and Executive Vice President of Operations at Medicago Inc., described  his company's work using genetically-engineered tobacco to produce vaccines much faster and simpler than traditional methods (Medicago's commercial-scale facility in Research Triangle Park is targeted to produce 10 million doses of pandemic influenza vaccine per month).  Dr. Anthony Atala, Director and Chair of the Wake Forest Institute for Regenerative Medicine and Director of the Armed Forces Institute for Regenerative Medicine, showed a video clip in which he and his team use a 3-D printer loaded with living human cells to make a transplantable kidney in about seven hours.  An earlier iteration of this technology used ink-jet printers to make bladders that were first successfully used in human patients over ten years ago.

Grants vs. Contracts
One of the takeaways from the summit was the importance of becoming familiar with all aspects of the federal contracting process.  First off, federal grants and federal contracts must be distinguished from one another.  Federal grants are typically awarded to states, local governments, universities, and non-profit organizations to accomplish some public purpose or stimulate a desired activity.  Grants are relatively flexible in terms of the scope of work required and the ability to make amendments when changes are needed.  Reports are usually only required on an annual basis and failure to perform is not likely to result in legal action or financial consequences.

By contrast, federal contracts are designed to acquire goods and services, with an emphasis placed on delivery and performance.  Contracts are more typically awarded to commercial enterprises, though states, local governments, universities, and non-profit organizations can and do receive federal contracts as well.  Contracts are relatively rigorous regarding their terms and conditions and many include set asides for small businesses, minorities, or special classes of competitors.  Frequent reports are usually required and a failure to perform and achieve the promised results or product will result in potential legal action and financial consequences.

Federal contracts are governed by the federal acquisition laws contained in the Code of Federal Regulations ("CFR").  These laws are implemented through an extensive set of rules codified in Title 48 of the CFR known as the Federal Acquisition Regulation ("FAR"), which attempt to establish uniform policies and procedures for acquisition by all federal agencies.  However, each federal agency with contracting authority can augment the FAR with its own additional regulations, known as FAR Supplements, which are codified as separate chapters under Title 48 of the CFR (e.g., additional rules unique to the Department of Defense are set forth in the Defense FAR Supplement, known as the "DFARS").  
It is the FAR clauses contained or referenced in federal contracts that are the source of the relatively rigid terms and conditions mentioned above.  For example, FAR provisions may include requirements for changing the scope of work, terminating contracts, making payments, conducting inspections and testing, accepting delivered goods and services, and intellectual property rights.  Even if a particular contract does not appear to explicitly list or incorporate by reference certain FAR clauses, other FAR and/or DFARS regulations may dictate that certain clauses should have been incorporated and they will thus be deemed by courts as implicitly incorporated, even if omitted.  Furthermore, if the prime contract recipient recruits subcontractors, many of these FAR clauses must be "flowed down" and included in the agreement between the prime contractor and the subcontractor. 

The Federal Contracting Procedure
Federal agencies typically post Request for Proposal ("RFP") solicitations for contracts on the Federal Business Opportunities website (http://www.fbo.gov/) or their own websites.  Interested companies prepare offers in response to the requirements laid out in the RFP and in accordance with applicable provisions of the FAR.  Following the submission deadline, government agency personnel evaluate all vendor submissions using the source selection method and criteria described in the RFP.  In some cases, potential federal vendors may submit unsolicited proposals for new ideas and innovative concepts pertaining to a given agency's program areas.  Such unsolicited proposals must comply with the requirements of FAR Subpart 15.6.

A key to success in securing government contracts is matching a specific product or service to the needs of a particular agency.  If it is a stretch to justify the match, the potential vendor is likely wasting its time.  In addition to searching the Federal Business Opportunities website for available RFPs, potential vendors can attend "matchmaking" events with federal agency contracting officers and follow-up with them regularly to stay apprised of agency needs.

For newcomers to the world of federal contracting, an alternative to seeking prime contracts is to explore subcontracting opportunities.  This strategy was cited at the biodefense summit by a number of panelists from companies that initially waded into the waters as subcontractors but that are now successful in securing government contracts.  By subcontracting with an experienced prime contractor, a vendor can gain familiarity with the process and gain experience to become ready to competitively bid for prime contracts.

Conclusion
With billions of dollars awarded to biodefense contractors annually, government contracts can be a lucrative source of opportunities for life sciences businesses.  However, there are many potentially costly pitfalls, especially if the provisions of a federal contract, including those that appear only in an unreferenced FAR, are not understood.  Potential federal government vendors considering venturing into the world of federal contracts would be well advised to seek expert counsel to help navigate the waters.

NC IDEA Fall 2014 Grant Cycle Opens August 11th

- Info Sessions Being Held August 11th through 15th -  Early Deadline: August 22nd; Final Deadline: September 5th - NC IDEA is seeking grant applications from NC-based entrepreneurs and startups, and those looking to locate to North Carolina, for its Fall 2014 Grant Cycle. Companies focused on software, information technology, medical devices or materials sciences are encouraged to apply at www.ncidea.org. In conjunction with the opening of the Fall 2014 Grant Cycle, NC IDEA is hosting info sessions throughout the state to give interested applicants an overview of NC IDEA's grant process and criteria, what NC IDEA looks for in an application, the types of companies eligible for funding and how to apply. See below for the full schedule of info sessions and important grant application deadlines.

NC IDEA Fall 2014 Grant Cycle Important Dates and Deadlines Monday, August 11th NC IDEA Fall 2014 Grant Cycle Opens Monday, August 11th (12:00pm) NC IDEA Fall 2014 Info Session **via WEBINAR** North Carolina companies and companies looking to locate to North Carolina are encouraged to join us for our bi-annual webinar REGISTER HERE Tuesday, August 12th (12:00pm) NC IDEA Fall 2014 Triad Info Session hosted with Flywheel Triad companies are encouraged to join us for a live discussion and Q&A session REGISTER HERE Thursday, August 14th (10:00am) NC IDEA Fall 2014 Wilmington Info Session hosted by UNCW Wilmington companies are encouraged to join us for a live discussion and Q&A session REGISTER HERE Friday, August 15th (12:00pm) NC IDEA and Groundwork Labs 'Brown Bag Lunch' Q&A Session There will be no formal presentation. Come with your questions about NC IDEA's grant program and our affiliated, "entrepreneurial community" Groundwork Labs REGISTER HERE Friday, August 22nd Early Application Deadline Friday, September 5th Final Application Deadline Visit www.ncidea.org for more information and to apply. Questions? Please contact grants@ncidea.org

Arbovax Closing In On Vaccine For Chikungunya

RALEIGH, N.C., June 19, 2014 – Arbovax, Inc., a clinical stage biotechnology company, has successfully demonstrated in an animal model the efficacy of its vaccine technology for the treatment of Chikungunya, a mosquito borne virus that has recently emerged in the US.  “There was a major outbreak in the Caribbean that started last December in St Martin and quickly spread to other islands. To date there has been over 130,000 cases, so it was only a question of time before it came to the US and we have an effective means to combat it,” said Arbovax CEO Malcolm Thomas.

According to the Center for Disease Control and Prevention, as of June 17, 2014 there are 80 confirmed cases of Chikungunya in thirteen states, Puerto Rico and the US Virgin Islands.  Fifty seven of those cases are in people who recently visited the Caribbean. Once a person becomes infected, there’s an incubation period of three to seven days.  The most common signs of the virus are fever and multiple joint pains. The virus is not usually fatal but extremely painful; it arose in Africa in the 1950s, the name “Chikungunya” comes from the Makonde language meaning ‘bent out of shape” describing the contortion brought on by the pain of the virus.

The Arbovax core technology is a whole virus vaccine developed by Drs. Dennis Brown and Raquel Hernandez of North Carolina State University. In animal tests, the vaccine has shown that it can provide a practical and cost-effective means to fight chikungunya and other mosquito borne viral diseases such as dengue fever, West Nile, Japanese encephalitis, and yellow fever.

Contact:
Malcolm Thomas
President and CEO
Arbovax, Inc.
(919) 655 0412 x301
mthomas@arbovax.com
www.arbovax.com