Wednesday, October 1, 2014

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

Friday, September 26, 2014

Intrepid debuts first hybrid Natural Gas boat featuring Blue Gas Marine technology at Fort Lauderdale International Boat Show



 
September 23, 2014—Intrepid Powerboats offers the first hybrid yacht from factory powered by Natural Gas, featuring fuel-system technology from Blue Gas 
Marine, Inc. to power its outboard motors.  The Intrepid 327 Center Console boat will be on display at the Fort Lauderdale International Boat show in October.  The BlueGas Natural
Gas Hybrid is the first technology of its kind and it was developed by Blue Gas Marine, Inc., which is based in Apex, NC.

Boats equipped with Blue Gas Marine natural gas hybrid fuel-systems can operate on natural gas or as a hybrid that carries natural gas and a traditional fuel like gasoline. This system allows a boat operator to switch between the two fuels on-demand and at any speed with the press of a button. This technology provides tremendous value to boaters everywhere since operating on Natural Gas is 50% to 70% less expensive than gasoline and its performance is the same or better than gasoline’s. Blue Gas Marine, Inc. is now developing a network to distribute the natural gas fuel to boaters ensuring the fuel is readily available to those making the change. Boaters can even fill-up at home or from any building equipped with Natural Gas.
Intrepid is a semi-custom powerboat builder that began in 1983 and builds about 12 different models from 24-47 feet. Every boat built is presold and designed a la carte per customer to their needs. Intrepid is considered the highest quality and most innovative outboard boat builder in the world and is eager to once again be the first in this innovative project with partners at Blue Gas Marine.  Customers can now order factory ready boats featuring Blue Gas Marine, natural gas hybrid fuel systems.

“I am very excited about the possibilities that a project like this brings by being able to bring such a clean energy to a recreational industry that makes its living from a natural resource like water.” Ken Clinton, President, Intrepid Powerboats, said.

The Blue Gas Marine natural gas hybrid fuel system is designed to be installed on existing or new outboards, inboards and generator engines and uses natural gas in the compressed (CNG) or liquefied (LNG) forms.  The company markets its hybrid fuel-systems and natural gas fuel to frequent boat operators such as commercial fishermen, charter boats, ferries, tugs, large ships, the military and recreational users.

There are many benefits to boaters moving to this new technology.  Boaters can save more than 50% on fuel immediately by making the change.  On boats that have a 230 gallon tank like the Intrepid 327 it currently costs about $1150 to fill-up, based on $5 gasoline, with natural gas the cost is only about $345 when filled at home or $575 when filled at most public CNG Gas Stations and Marinas offering the fuel. These savings have a direct impact on high-fuel-usage boaters, many of whom rely on their boat for business.  The fuel savings cover the cost of the fuel system in under one year, for most frequent boaters.


The new BlueGas Natural Gas Hybrid fuel system is an excellent option for boaters trying to avoid gasoline with ethanol, now that most gasoline blends have at least 10% ethanol added, which is detrimental to marine engines.  The performance of natural gas on a boat is the same or better than with its original fuel, with the added benefit that natural gas emissions are 90% cleaner (green alternative fuel) than diesel and 70% cleaner than gasoline and do not produce any exhaust odor or smoke.  Additionally, this innovation will also positively impact boaters and the marine industry in general by meeting and exceeding the regulatory requirements of upcoming emissions law, for certain displacement-size engines ahead of the stringent regulations coming into effect in 2015 and 2016, which require cleaner operations.

Miguel Guerreiro, Blue Gas Marine CEO and Founder, said, “We are glad to partner with such an innovative company like Intrepid Powerboats.  They like to lead the market in innovation and we are trail blazing with new technology, which will revolutionize boating.  It is a great partnership and one that I know boaters will be excited about.  Boaters can do more of what they love and save money in the process by getting the most affordable and cleanest fuel alternative than any other on the market today.”

Blue Gas Marine is now taking orders for the new natural gas hybrid fuel system and dedicated natural gas systems and expanding throughout 2014.  The company is continuing to partner with Marine Service Centers to perform used-boat installations, boat manufacturers for new boat installations, marinas and individual boaters for fuel dispenser installations. Interested investors and customers can learn more at BlueGasMarine.com and through its Facebook and Linked-In pages. The partnership and model boat will be on-show case at the three largest boat shows in the world starting with Fort Lauderdale International Boat Show October 30 –November 3 2014, Miami International Boat Show February 12-16, 2015 and Palm Beach International Boat Show March 26-29, 2015.  To order new Intrepid hybrid boats, customers should contact Intrepid Powerboats directly.


Contact:  Carrie Guerreiro, Director of Corporate Administration
Email:  carrie@bluegasmarine.com
Phone:  919-238-3427

Monday, September 22, 2014

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. 

Monday, September 8, 2014

Tapping into Biodefense Spending


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.

When Does Hiring an Outside Marketing Consultant Make Sense?



Guest Post by Christina Motley, Christina Motley LLC
 
As a business owner or entrepreneur there comes a time when you face a tough decision – deciding whether to outsource your marketing to a consultant or keep it in-house.

To make an informed decision, follow these tips.


1. Perform an internal audit.

The purpose of the audit is to evaluate a number of factors. What is the importance of this strategic initiative and its alignment to your business and marketing plan? What level of in-house expertise is available? Or, do you have limited resources (staff) for leading and implementing the initiative? What tools and funds are allocated to the project? How will this initiative impact your customer growth and retention?
 2. Who do you know and trust?
Referrals are a great place to start when considering outside consultants. Tap into your team’s network for contacts and referrals. If time is not of the essence, you can also send out an RFP. In the end, trust in the consultant’s ability to perform and complete the project is crucial to achieving your desired goals.
3. Speak with several individuals, agencies or firms.
Understand that different people and firms possess unique skill sets and approaches to the work. By talking with a variety of individuals or firms, you open yourself to generating additional ideas or asking questions you may not have thought of previously.
4. Review their work, credentials and previous projects.
Upon reviewing the consultants’ work and credentials, you should be able to answer these questions:



   Do the potential candidates have a proven track record for completing similar projects? 
   What results were produced on similar, previous projects?  
   How quickly can they learn about your organization and industry?  
   What is their approach and process?  
5. Request a proposal.
At a minimum, the proposal should include a timeline and rough estimate of the project cost. (For especially complex projects, Ghantt or PERT charts can be very useful in determining expertise and proficiency.) The proposal provides enough objective data to share with your team and executive leadership to allow for cross-functional input.

6. Interview the top 2-3 contenders.
Treat the interview with prospective consultants as if you’re interviewing a candidate to join your company. Even though the project may be on a short-term basis, it’s important to feel good about and like the person (or firm) with whom you will work. While trust and talent are important, the chemistry may be stronger with one candidate when compared to others. 
7. Ask for a Statement of Work Agreement (SOW.)
SOWs define the project specifics – what is to be done within a defined scope, the number of allowable revisions, key deliverables, client expectations and estimated compensation. The purpose of a well-defined SOW is to protect your organization as well as the consultant.